D'Arcy v Myriad Genetics Inc & Anor
[2015] HCATrans 146
[2015] HCATrans 146
IN THE HIGH COURT OF AUSTRALIA
Office of the Registry
Sydney No S28 of 2015
B e t w e e n -
YVONNE D’ARCY
Appellant
and
MYRIAD GENETICS INC
First Respondent
GENETIC TECHNOLOGIES LIMITED ABN 17 009 212 328
Second Respondent
FRENCH CJ
KIEFEL J
BELL J
GAGELER J
KEANE J
NETTLE J
GORDON J
TRANSCRIPT OF PROCEEDINGS
AT CANBERRA ON TUESDAY, 16 JUNE 2015, AT 10.15 AM
Copyright in the High Court of Australia
MR D.K. CATTERNS, QC: May it please the Court, I appear with my learned friend, MR P.K. CASHMAN, for the appellant. (instructed by Maurice Blackburn Lawyers)
MR D. SHAVIN, QC: May it please the Court, I appear with my learned friend, MR C. DIMITRIADIS, SC, for the first respondent. (instructed by Jones Day)
FRENCH CJ: There is a submitting appearance for the second respondent. Yes, Mr Catterns.
MR CATTERNS: May it please the Court. Your Honours, before I go to the propositions and the three pages that we have handed the Court, may I just mention a couple of them in advance, which are in those propositions. Your Honours, in short, our submission is that a product of nature is not patentable. It is not a manner of manufacture within section 18(1)(a) of the Patents Act. The Full Court erred, we submit, in holding that the High Court in the NRDC Case had expressly rejected that exception.
Your Honours, although the three claims in issue here refer to isolated – that is the nub of the case, really – nucleic acids, ranging from the whole of the coding sequence of the natural gene – that is the natural mutated gene possessing the mutations that are referred to in the claim ranging from that whole gene coding sequence, we readily accept it does not refer to the introns – down to a sequence of 15 nucleotides. The fact of isolation, we submit, as a matter of substance does not – and I will address the Court as to why that is an appropriate way of looking at it – take the claim sequences out of the exclusion.
Your Honours, at bottom we think this is a – we submit this is a matter of properly construing the claims or perhaps appreciating the level of discourse at which they are written which is it is about the possession of all or part of the coding sequence of the gene – the natural gene possessing the natural mutations or polymorphisms.
FRENCH CJ: Perhaps underlying the “product of nature” terminology, which may or may not be useful, is the question what is it that is done to make the invention – when you look at the integers and particularly, the existence of the mutations or polymorphism which are an accident of the particular person from whose body you have taken the sample.
MR CATTERNS: Yes, your Honour, exactly. I agree, with respect. I will take the Court in a minute to an example of a particular person who possessed a particular mutation which leads to her sequence being different which means that the protein that her body expresses is different and a single amino acid difference in a protein means that it folds up differently. It has a different shape with a different result in the body. The discovery of that, of course, was a fine piece of science, a fine and laborious piece of science.
Of course there is no dispute that the application of that discovery, including of those – first, of the gene itself and, secondly, the mutations or polymorphisms in particular people or groups of people, the applications of that discovery in later claims, claims for and following, which I will take the Court to briefly, of course that is patentable, but they are claims to manners of manufacture, that is, the application of a discovery which is what the High Court mentions in the NRDC Case. Such applications are within the developed ambit of the concept which takes us back to the Statute of Monopolies. Your Honours, if I may now go directly to our three‑page note?
FRENCH CJ: Is any light thrown on the question of identifying the thing you have to do to make the invention by asking the question, for the purposes of infringement, what do you have to do to exploit the invention in terms of unpacking that into making the invention?
MR CATTERNS: Your Honour, we submit there are some – I am sorry, had your Honour finished?
FRENCH CJ: No, no, that is all right.
MR CATTERNS: We think there is some light in that, in two ways, really. This is perhaps not a direct answer. The first one is even infringement is dealt with as a matter of substance and I am emphasising “substance”, but secondly, it is important in this case, looking at the sheer breadth of the claims because they are not limited to an application – the evidence was clear that when you isolate a person’s DNA you infringe them whether or not – sorry, if it so happens that she possesses the mutations. But you do not know that ‑ ‑ ‑
FRENCH CJ: Nothing you do is responsible for the fact of the mutations.
MR CATTERNS: What you do is not responsible, did your Honour say?
FRENCH CJ: Yes.
MR CATTERNS: Yes, exactly, your Honour. The patent does not even bother to tell us how to isolate the DNA. It is a routine task – it was a routine task by the date of the patent and the primer tells the detailed way it is broken down but, your Honours, exactly - the natural mutations, which is what is particularly important in genetic testing, they occur in the body and it is the possession of those mutations which I will come to show the Court in a minute - that is, the value of the discovery applied later in claims 18 and following to genetic tests but also other like applications I have described, making proteins.
FRENCH CJ: Maybe in that context you can tell us at some stage, appropriately in your submissions, what utility the taxonomy of product of nature versus something else has.
MR CATTERNS: Well, your Honour, perhaps anticipating that slightly in our paragraph 4, we submit that there is not a lot of magic in a particular phrase. For example, to call this a “principle of nature” or some of the other phrases that the American cases use is probably not the answer and we do not propound any test beyond the NRDC test in that - except that we say the question of whether this is a kind of subject matter that is patentable in accordance with the developed principles of 400 years is to be approached as a matter of substance. So we do submit in paragraph 4 that there is no magic in terminology, your Honour.
In paragraph 1, your Honours, we emphasise the fact that it is isolated, which is the heart of our friends’ defence of their claims. Just to remind your Honours that claim 1 – I am sorry, your Honours, they are at page 568 in volume 2 – so that is page 185 and the patent at page 568 at volume 2 of the book. Just to remind your Honours of the structure, claim 1 refers to an isolated nucleic acid, so that covers both DNA and RNA, and that nucleic acid is coding for a mutant or polymorphic BRCA1 polypeptide which is the polypeptide encoded for by the BRCA1 gene, and the said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence.
So we are comparing the nucleic acid that is being claimed with the encoding sequence, which is a sequence of nucleotides, sequence ID No 1, to see whether or not, compared to the normal sequence that we have all got, we hope, you possess on our chromosome 17 one or more of the mutations. Your Honours, there are mutations in tables 12A and 14 and polymorphisms which are deviations from the normal or wild‑type gene, not certain to be cancer predisposing. Table 19 is a mistake, your Honours, we can put it aside. Just to complete it, your Honours, claim 2 narrows claim 1 specifically to DNA in those three tables, and claim 3 narrows it to DNA and the polymorphisms in effect in table 18.
FRENCH CJ: Is it a matter of concession that on its proper construction – on their proper construction – the claims are limited to sequences of exons only?
MR CATTERNS: Your Honour, you would not escape – I do not think it is a matter of concession, but we might agree – I think you would ‑ ‑ ‑
FRENCH CJ: It is not apparent on the face of the claim itself.
MR CATTERNS: No, your Honour, but I think if you isolated a string of DNA that contained the claimed sequence and additional, you would still infringe.
FRENCH CJ: Yes. So this is not limited necessarily to complementary DNA produced by the reverse transcription process?
MR CATTERNS: Definitely not, your Honour, definitely not.
BELL J: Claim 1 would include that but it includes DNA and RNA.
MR CATTERNS: Yes, your Honour, and it includes complementary DNA or cDNA. But his Honour Justice Nicholas, the primary judge, noted our agreement that if anything within the claim – in other words, things other than the cDNA – are not patentable, then the claims fall. That is traditional patent law of course, your Honours, as with novelty or obviousness.
So, your Honours, if I may then go to the tables, just to give your Honours the structure, at page 472 in the patent, in volume 2, the inventors give us – in example 9, they analyse tumours to find common mutations in them, and in table 12 there are different types of mutations which they discovered predispose people to cancer. The types of mutations we can see ‑ your Honours see on the left there are the actual patients by their code name; they are particular people.
Your Honours, just to give some phrases or some terms that we see in the primer also, sometimes if there is a ‑ your Honours can see the first patient, there is a change in the sequence of the nucleotides at a particular point, “Codon 1541”, where instead of G there is a T and that results in – instead of the – as your Honours know every group of three nucleotides is a codon and it codes for a particular amino acid. If you have “TAG” that tells – if I give the anthropomorphism – that tells the ribosomes that pull the amino acids out of the cell and attach them in a row to stop transcribing – I am sorry, to stop transcribing.
The next one is when there is a single base pair missing from your DNA the whole thing shifts one out and so the little groups of codons, 3‑3/3‑3 – all are shifted by one. You have a totally different set of amino acids being coded for. Your Honours, I was going to use as the example the next one, a person, BT106 at codon 1708, which I will show your Honours.
There is a mutation in her genome whereby the row of DNA – as your Honours know, the GCs, Ts and As represent the basis of each of the nucleotides. Because of that change from GCG to GAG, there is a different amino acid at that point in the polypeptide, or the protein, for which her genome codes – and that has disastrous results. Your Honours, she is referred to on the next page at 473, line 10:
BT106 was diagnosed at age 24 with breast cancer. Her mother had ovarian cancer, her father had melanoma, and her paternal grandmother also had breast cancer.
This gene is a tumour suppressor gene, and if you have a defect in it, your protein will not act in the various cascades in the body to suppress tumours as well as with the normal gene. Your Honours, just for completeness, table 14 is at page 483. That is a further set of mutations – I am sorry, I skipped over 12A, your Honours, which is on page 475 – and we give your Honours in our paragraph 1 the rest of the references to the tables.
Your Honours, as the Court knows – I am now in our paragraph 2 – what is claimed as a nucleic acid, which is a sequence of nucleotides which are either DNA or RNA, and the reason that it is called SEQ ID No 1, the BRCA1 polypeptide encoding sequence, is it encodes a natural polypeptide, namely, that is, it possesses the code which, in the cell, is translated and then transcribed into the natural protein, the polypeptide. The polypeptide is a sequence of amino acids, reminding your Honours that every codon of three nucleotides codes for a particular nucleic acid. I was going to go back to a couple of the passages in the description. At page 384, lines 6 to 19 ‑ ‑ ‑
FRENCH CJ: I did not quite catch that. Was that 384, did you say?
MR CATTERNS: Yes, your Honour, thank you. At page 384, lines 6 to 19, we are told specifically:
the present invention relates to methods and materials used to isolate and detect . . . gene (BRCA1), some mutant alleles of which cause susceptibility to cancer, in particular, breast and ovarian cancer. More specifically, the invention relates to germline mutations –
Your Honours, the germline mutations are the heritable ones in sperm or ova. It also relates to somatic mutations, your Honours, which is other cells. Then, your Honours see – back to 10 – the reference to germline mutations:
and their use in the diagnosis of predisposition to breast and ovarian cancer.
If you possess the mutation, you have that predisposition. The invention relates to somatic mutations - at line 15, I am sorry –
The invention also relates to the therapy of human cancers which have a mutation in the BRCA1 gene, including gene therapy, protein replacement therapy . . . Finally, the invention relates to the screening of the BRCA1 gene for mutations, which are useful for diagnosing the predisposition to breast and ovarian cancer.
Your Honours, there are no claims in relation – just as it happens – to gene therapy. Although maybe some of the applications in the claims could be useful, it would be unlikely that the mutated sequences would be used in gene therapy. You would not be ‑ ‑ ‑
KIEFEL J: Can I just take you back at about line 18:
Finally, the invention relates to the screening of the BRCA1 gene –
Is that the only relevance you say in those stated relationships of the invention to claims 1 to 3?
MR CATTERNS: Yes, your Honour, although there are later claims specifically to screening – methods of screening.
KIEFEL J: Methods of screening.
MR CATTERNS: Yes. I will take the Court to those in a minute, if I may.
KIEFEL J: But it is your case that claims 1 to 3 really relate only to the identification of the gene.
MR CATTERNS: Of the gene, yes, your Honour. Not its later claims that apply it to things like screening.
KIEFEL J: Yes, quite so.
MR CATTERNS: Exactly, your Honour. Your Honours, just briefly in the background, as it were, on pages 388 and following, there is further description of the – it is similar to what I just took the Court to. We have given your Honours the reference to that. Your Honours, at 409 there are various definitions – it is probably best to go to 409, line 7 now, although I will be coming back to it, if I may, your Honours. This is the definition of “encode” and this is a point that seemed to loom large in the Full Court’s reasoning, contrary to his Honour the primary judge’s reasoning. It says:
A polynucleotide is said to “encode” a polypeptide if, in its native state –
May I stop there? Of course, in the native state it is transcribed – which your Honours know is the move from DNA to RNA – and then translated – which is the move from codons into amino acids linked together to form proteins – or polypeptides.
BELL J: The point is, as defined, it is the capacity to code for the protein.
MR CATTERNS: Yes, your Honour, because ‑ ‑ ‑
BELL J: In other words, the distinction between passive action in the cell and inaction in the isolated material.
MR CATTERNS: Yes, your Honour, the claim of course is to a product. It is not to a method of manufacture of – sorry I do not want to use ‑ of making, it is not a process claim to the manufacture of polypeptides. There are such claims.
BELL J: Yes, I thought, Mr Catterns, that there was an issue concerning the distinction apparently drawn by the Full Court ‑ ‑ ‑
MR CATTERNS: Yes, there is, your Honour.
BELL J: ‑ ‑ ‑ between coding for and encoding and that you are taking us to encode as defined to make the point that in the definition, for the purposes of the specification, encoding addresses the capacity of the nucleic acid in the body to code for.
MR CATTERNS: Yes, your Honour. Or, indeed, when it is isolated - as a matter of fact when you isolate it you still can use it to make proteins. There is a finding about that and I do not think there is any dispute. The paragraph your Honour is referring to is, I think, 175 and I was going to come to that.
FRENCH CJ: Does it, for our purposes, really mean anything more as used in the claim, that is the word “coding”, than that it is the same sequence of codons as do in the DNA in its native state in the body lead to the production of this particular polypeptide?
MR CATTERNS: That is our submission exactly, your Honour. It has nothing to do with the actual making of the polypeptide and that is our ‑ to come to the nub of the argument ‑ that is our submission of the Full Court’s main error. Their Honours say it is chemically, structurally and functionally different and they say it is functionally different because it is not making the polypeptide when it is isolated.
FRENCH CJ: Well, it does not have a function of making a polypeptide.
MR CATTERNS: That is right, your Honour, whereas we say the relevant function is possession of the code so you can see whether there is a mutation or not. That really is the heart of it. That is why, in a sense, it is a question of construction or appreciation of the level of discourse at which the claim is written. Your Honours, there are some other definitions there which I just wanted to show your Honours quickly. At the bottom of 409, line 23, there are definitions of the “BRCA1 gene”, inter alia, referring to polynucleotides in the BRCA1 region:
that are likely to be expressed in normal tissue, certain alleles of which predispose an individual to develop –
those cancers.
Mutations at the BRCA1 locus ‑
in other words that part of the chromosome –
may be involved in the initiation and/or progression of other types of tumours.
Your Honours, just one last definition. I think we have agreed on this and the Full Court mentions it. At 411, lines 6 to 10:
The DNA sequences used in this invention will usually comprise at least about five codons (15 nucleotides), more usually at least about 7‑15 codons, and most preferably, at least about 35 codons.
So, your Honours, you would – within the scope of this claim are sequences as short as five codons, if they possess the mutation. Your Honours, I was then going to show the Court – finally, your Honours, at 461 to 462, just so far as the text of the specification goes, I will not read it out of course, but at 461, after describing the work they did, which we readily accept as a fine piece of science, they put it all together, and at page 462, line 3, after having done all the work:
Conceptual translation of the cDNA revealed a single long open reading frame of 208 kilodaltons -
That is the polypeptide, which is SEQ ID No 2 – I am sorry, I should have gone back to the bottom of page 461, line 29:
Combination of sequences . . . allowed construction of a composite full length BRCA1 cDNA (SEQ ID NO:1) ‑
which I will come to now, your Honours. At page 502, we meet SEQ ID No 1. At about line 25 in this Court’s numbering we see the information for SEQ ID No 1. It is 5914 base pairs long. It is a nucleic acid – and we can see because it has got Ts in it rather than Us in it, that it is DNA, double stranded, and the particular one is a cDNA, excluding the introns. At about line 38 – the original source is “Homo sapiens” – so it is human DNA. After some introductory nucleotides, at line 50, we get the first codon of three nucleotides, whose bases are A, T and G, and on it goes. The first one – ATG codes for methionine, and so on, according to the table, which is in the primer and also in the Full Court’s reasons.
Your Honours, at page 510, in the right‑hand column, the very right, we see the nucleotide number – that is 5255 – and underneath, because underneath the nucleotides we are seeing the corresponding nucleic acids ‑ your Honours, we see, after the 1705 we can count across to 1708, and that codon – GCG – is the one that is mutated in the person I took your Honours to - BT106 in table 12. She has the different code, which codes for the different amino acid, with disastrous results.
Your Honours, the SEQ ID No 2 commences at page 511 and we can see at line 40 the information begins, 1864 amino acids long, it is a protein. Again we get the list of amino acids and we can find, your Honours, the same mutation at page 517 – sorry, not the mutation, the same site where in the natural gene – I am now at page 517, about line 39. Again we can see the number 1705 and the nucleic acid “Ala” at 1708. That is the one that is mutated in the woman who is BT106. She has a different amino acid there.
Now, your Honours, may I just quickly, partly by way of identification – I certainly did not propose to read it all or anything like it – go to the agreed primer, just to lay some of the groundwork. I will do this briefly. Your Honours, I hope your Honours forgive our little note at the beginning of it. There is no dispute about any of the science here, but we did object to – and your Honours can see at line 19 of the primer – the admissibility of those paragraphs that are there as being scientifically correct but at a level of complication irrelevant to the present question. We consented to them being admitted subject to that objection.
Your Honours, we also mention there in the third line of it four particular paragraphs, 44, 48, 70 and 71, which refer to findings of the Full Court, particularly findings in about paragraphs 175 to 178 which I will come to and make our criticisms when we get to them, so I do not need to take time over that, our qualification that we asked for at the beginning.
But, your Honours, all I wanted to mention currently, there is the description of the cell, then from paragraphs 7 and following there is discussion of the chemical structure of DNA. So DNA and RNA are both called nucleotides and they are made up of three things. There is the base and it is that base at the top right which is GCA or T - that is how we write down the genetic code, and it was the brilliant discovery of Watson and Crick that G would bind with C and A would bind with T and all else would follow when they discovered the double helix structure.
Your Honours, the sugar in blue in my copy is the five‑membered ring, or the ribos of ribonucleic acid. Your Honours, it is what has the numbers – 1’ starting at 3 o’clock where the base joins, that is numbered 1’, then over we go clockwise the first OH is 2’, then 3’, then at 9 o’clock it is 4’ and then we go up to the carbon, that is the 5’. So your Honours can see some of the discussion is about 5’ and 3’. They are those two positions. Those carbons are numbered in the way I have just mentioned.
We see on the next page – and the reason I am taking time about this is that the Full Court places some significance on the breaking of the covalent bonds as did the Circuit Court in the US. The 5’ – that is where the phosphate is – binds with the 3’ where the OH was and we can see that working our way down where the phosphates were in circles, so that there is the 5’ M up the top there, then we see it go down to the sugar. Then it is now joining itself on to the next sugar, in effect, via that. That is where there is a covalent bond.
We accept, and the evidence was, that when you separate out a strand of DNA by the processes of isolation, either end there will be a broken covalent bond. However, the fifteen nucleotides that might come within the claim ‑ ‑ ‑
FRENCH CJ: That is not a physical thing.
MR CATTERNS: No, your Honour.
FRENCH CJ: It is not something hanging off the end. It is the electromagnetic ‑ ‑ ‑
MR CATTERNS: Of course not, your Honour. It is a shared electron ‑ ‑ ‑
FRENCH CJ: Yes, that is right.
MR CATTERNS: ‑ ‑ ‑ between atoms, one or more electrons between atoms. But it is only at the ends of the sequence, which is why his Honour said they are not necessarily broken within that relevant sequence. If you have a sequence of 200, there will be a broken covalent bond at either end. In the middle, there will not be, and the strand of 15 nucleotides that will cause infringement, as it were, around the mutation may or may not have a broken covalent bond. It really, with respect, we submit, is a far too narrow a way to decide this case.
Your Honours, just to continue, there is the discussion in paragraph 9, the 5’ and the 3’ ends. We meet the bases in paragraph 10. Your Honours, paragraph 11 refers to the bases being covalently bonded as sugar group. That is not the covalent bond that is broken, as far as I understand it.
Your Honours, in paragraph 12, we meet the double helix where the bases are on the inside and they are bound – G always binding with C, A always binding with T – by hydrogen bonds, which is not even shared electrons - that is electrostatic charge between the two sides, as it were. There is, I think, three between each pair of bases.
Your Honours, that would be even less of a reason to hold that the fact of isolation made a difference because in the cell, naturally the DNA is constantly splitting off, more DNA being made – that was Watson and Crick’s great postulation when they wrote in a footnote “the implications of this for the replication of life have not escaped us”. In the cell, there is plenty of single‑stranded DNA where the hydrogen bonds have already been broken.
We meet the base pairing in paragraph 13. We see the base pairing in paragraph 14, including those hydrogen bonds in the middle. Your Honours see the phrase at the top of the centre of it “Complementary base pairing”. The little hexagons are – pictures of the – sorry, the things that go across represent the hydrogen bonds.
Your Honours, 15 deals with the way our DNA is packed in every cell nucleus. It is literally, not figuratively, two metres long, but incredibly thin in each cell, and it is wrapped around these proteins in a very complicated way. It is very true that when it is isolated, it no longer possesses that physical structure, but we submit that is not relevant to the discourse of the claims.
Your Honours, if I could then skip to paragraph 20 – we have just gone past the structure of RNA – where we meet the genes and we see the distinction in paragraph 22 – I am sorry, in paragraph 21, it is said – and this is a finding of the primary judge that carried through:
Human genes generally comprise sequences of DNA that specifically code for –
using that phrase -
a particular protein, interspersed with sequences that do not code for a particular protein.
We then meet the exons and the introns and there is a picture of those at the bottom of page 9 of the primer. Your Honours, very significantly for these claims, paragraph 24 gives the list of the 24 natural amino acids out of which proteins are made. They are described in paragraph 25. Your Honours, as I have already submitted, we see in 26 the codons of the various – sorry. There are obviously 64 possibilities – four by four by four – for every three but there are only 20 amino acids; hence, the redundancy of the code. That is referred to in paragraph 27.
There are also a few other complications where some act as start signals and some act as stop signals. The table occurs in – sorry, we can see it in paragraph 29. We take the letter on the left, then the vertical letter, then the letter on the right‑hand column and we can see what amino acids are coded for by each group of three. That is explained in paragraph 30.
Your Honours, just finally on that, the process of “gene expression” is then described and there is a good picture. Professor Rasko, by the way, was not cross‑examined and we treated his evidence – sorry, we did not cross‑examine him. We did not require him. We treated his evidence, in effect, as a primer before his Honour.
So, your Honours, what happens in the cell is the DNA is transcribed – this is looking at the picture – into RNA or pre‑messenger RNA, then it is spliced so the coding parts are spliced together – leaving aside the – putting aside the introns – then it leaves the cell nucleus. In the cytoplasm, the ribosomes, which are themselves complicated, assemblies of proteins, as it were, draw amino acids out of the cytoplasm and link them together like a zipper every three - for the appropriate three bases – three nucleotides represented by their bases which is a codon and amino acid comes down. Then the next one, then the next one, then the next one and a protein is made.
Your Honours, that process of transcription and translation, which I have tried to explain in rather a lay way, goes to paragraph 39. Your Honours, finally, while we are in the primer, paragraphs 57 to 66 show us the process of isolation of DNA which relies on the various physical attributes of it to get it out of the blood and isolate it.
So, your Honours, we respectfully submit – this is now our paragraph 3 – that something that naturally occurs in the body, even when isolated, that per se is not a manner of manufacture within the terms of section 18(1)(a) of the Act. I do not think I need to go to that, your Honours, that is what 18(1)(a) says. Schedule 1 defines invention as a manner of new manufacture, within the meaning of section 6 of the Statute of Monopolies, which of course, as we are about to see in a second, your Honours, is a broad concept, we readily agree, a flexible and developing one. It has been able to cope with many, many developments in technology, and as his Honour the Chief Justice said in the Apotex v Sanofi Case, case by case, the courts explore and develop the concept. May I take the Court, please, to the NRDC Case (1959) 102 CLR 252?
Your Honours, this celebrated case related to claims for the use of known chemicals for a new purpose, namely, as a selective herbicide. There were two – or I should really say three attacks or three bases on which the Commissioner said, or had held below and submitted it before the Court that these were not patentable. The first argument was an argument based on the Microcell Case. I am looking, your Honours, at page 261, at the bottom of – I beg your pardon, your Honours, if I can just tidy myself up ‑ your Honours, we see the claim at the top of page 261:
“1. A method for eradicating weeds from . . . leguminous fodder crops . . . which comprises applying to the crop areas a herbicide of the class –
Your Honours, then, at the bottom of the page, five lines – seven lines – from the bottom, their Honours refer to the Microcell Case, and there is a discussion about:
the word “alleged” goes only to the epithet “new” –
But, importantly, your Honours, there are two concepts. The first is that ‑
the Commissioner may properly reject a claim for a process which is not within the concept of a “manufacture”.
That is the second half of the Court’s reasons, the Commissioner’s submission that these claims were not within the concept. Then there is also another idea, your Honours, which this Court has discussed in the Philips v Mirabella Case and the Ramset Case:
that even if the process is within the concept the Commissioner is not bound to accept the allegation of the applicant that it is new . . . “nothing but a claim for a new use of an old substance”.
Now, your Honours, that is the first part of the Court’s reasons answering that submission relating to “new use of an old substance”, and it is – the reason I stress that, your Honours, is that it is in that context that the remarks of Justice Frankfurter appear at the bottom of 263 and 264, but I was going to come back to those, if I may, your Honours. So, the Court deals with the argument that this is merely a new use of a known substance until page 268. That is not today’s argument, of course, your Honours. Their Honours say in line 6 that:
The purpose of going thus fully into the contents of the specification is to show that it is out of the question to hold that on the face of the document, properly construed, the process . . . as nothing but a new use of an old substance.
So that, your Honours, that was that argument but the passages that are relevant to us commence in the next paragraph:
The central question in the case remains. It is whether the process that is claimed falls within the category of inventions to which, definition, the application of the Patents Act is confined.
Then we see the definition being exclusive ‑
The Commissioner, adopting certain judicial pronouncements –
which were the cases that referred to vendible product, we see, your Honours. I do not need to take much time on them ‑
emphasizes the word “manufacture” and contends for an interpretation of it which, though not narrow, is restricted to vendible products and processes for their production –
So, your Honours, that is really the second approach of the Commissioner; the first one being “me and you use”. The third one is, “and excludes all agricultural . . . processes” and their Honours deal separately with the suggested restriction, which is vendible products, and then in the last two pages of their reasons to the suggested exclusion, agricultural.
Your Honours, the famous passage begins at the bottom of page 268. As your Honours remember, section 1 of the statute declared all monopolies to be utterly void and the case against monopolies was D’Arcy’s Case. I think D’Arcy was a favourite of Queen Elizabeth and he was granted the monopoly in playing cards or perhaps it was an assignee of his by then. But your Honours see the declaration –sorry, section 6 ‑ so the declaration in section 1 was that all monopolies shall be utterly void but then there is a saving:
“shall not extend to any letters patents and graunts of privilege . . . hereafter to be made of the sole working or makinge of any manner of new manufactures within this realme, to the true and first inventor and inventors –
Your Honours, as in the Apotex v Sanofi Case, we do not have any separate argument about generally inconvenient. Your Honours, after the references to the Act, at about line 10, the previous and the current Acts, defines the word invention, not by direct explication and the language of its own day, nor yet by carrying forward the usage of the period, Statute of Monopolies.
These are the important phrases, your Honours, but by reference to the established ambit of section 6, the inquiry which the definition demands is an inquiry into the scope of the permissible subject of letters patent, not into the meaning of a word so much as into the breadth of the concept which the law has developed.
May I skip a little? The word is not reducing –
a question of patentability to a question of verbal interpretation, but simply as the general title found in the Statute of Monopolies for the whole category under which all grants of patents which may be made in accordance with the developed principles of patent law are to be subsumed.
So, the question is not “is this a manufacture?” Then, your Honours, we see the right question at the end of the paragraph –
“Is this a proper subject of letters patent according to the principles which have been developed for the application of s 6 –
Your Honours, I do not seek to go through the whole discussion of vendible product, where that is put aside, but I was going to just mention the next page and a half, and we have put these in a supplementary bundle. The 18th and 19th century cases that establish the ambit of our concept began with Boulton v Bull. Your Honours see at the top of page 70 Chief Judge Eyre – I am at 270 – in Boulton v Bull, which was James Watt’s invention, but just on the other page here, your Honours, it says:
“the exposition of the statute, as far as usage will expound it, has gone much beyond the letter” –
Then their Honours refer to his statement that –
“manufacture” extended “to any new results of principles carried into practice . . . new processes in any art producing effects useful to the public” –
Then it was cleared by Crane v Price that it included processes, and the phrase “vendible product” went all the way back to Justice Heath in Boulton v Bull –
in the course of maintaining the opinion, which must now be considered heretical, that there could not be a patent for a method –
The reason there is an argument in Boulton and Watt v Bull was that the way James Watt wrote his patent was he wrote it as if it were about a principle. He said “I have the principle of condensing the steam in a separate vessel which is kept cold” but the court eventually held that it was not limited to a principle and was indeed a manufacture within the concept of the 1623 definition. As we see at the bottom of the page, Chief Judge Eyre maintained the opposite view – sorry, Chief Justice, I think it is, your Honours –
and reached the conclusion in the particular case which was ultimately upheld in Hornblower v Boulton. Abbott CJ in R v Wheeler having spoken of a “thing made, which is useful for its own sake, and vendible as such” –
did not find any absolute test –
“Something of a corporeal and substantial nature ‑ ‑ ‑
FRENCH CJ: So, does this lead us ultimately – and I am looking forward across your outline – to the formulation of the apposite question for the application of established principles as to whether or not this is a manner of new manufacture?
MR CATTERNS: Yes, your Honour.
FRENCH CJ: We can look at all the exclusions. What is the apposite question?
MR CATTERNS: The apposite question remains what we saw on page 269; is this within the developed concept?
FRENCH CJ: Narrowing down a bit.
MR CATTERNS: We say that these cases illustrate they are about the arts, manufacture of things made by man, et cetera, not something that is natural. I respectfully submit it is clear. Indeed, the phrase we are about to see, your Honour, on page 277 about an artificial effect is the antithesis, we submit, of natural, and so, your Honours, the question here is whether the isolation provides sufficient artifice, is that sufficient, and this is a pattern which when we read as a whole there is no suggestion that the act of isolation involves any – it is done by humans – but involves any particular skill.
FRENCH CJ: I suppose what I am still a bit fixated on is the question I put to you at the outset and that is what does the inventor, or the person who seeks to exploit the invention within the meaning of the Patents Act, do to give rise to the integer that refers to polymorphisms and mutations?
MR CATTERNS: Well, your Honour, in the blood of the person who is about to have her blood removed for testing, she already has the mutation. So that is occurring in the person – in the cells of the person.
FRENCH CJ: So I am asking what is it doing as the integer of an invention, as claimed?
MR CATTERNS: I submit that what is put forward is the isolation of it, that is what claim 1 says, and I respectfully submit that merely to isolate a person’s naturally occurring blood, when it is not acclaimed to a method of isolation, merely to isolate a person’s blood, naturally occurring, possessing a naturally occurring mutation does not constitute manufacture within the terms of the cases that we have been seeing.
FRENCH CJ: Is it necessary in order to deal with the question I put to you to label something as either a product of nature or an artificial state of affairs?
MR CATTERNS: Well, your Honour, I adhere to the submission I think I made in Apotex v Sanofi and we made below here that that mechanistic application of such phrases is not the proper approach, but I suppose whether or not we attribute a label, at least we start from the fact that this is a person’s – this is a human being’s naturally occurring DNA, and then we look at the nature of what is done in claim 1, claims 1 to 3, and what is done is to isolate it, full stop. It is completely different in claim 18 where it is applied in some way, and that distinction between ‑ your Honours saw from our paragraph 4 we are trying not to tie ourselves to particular phraseology, although the best we can do is natural product, but something that naturally occurs merely to isolate it when the isolation involves no – and not even asserted to involve any inventive exercise – that does not render this a manner of manufacture.
KIEFEL J: Does the patent disclose a discovery?
MR CATTERNS: It discloses discovery, yes, your Honour.
KIEFEL J: But do you say claims 1 to 3 – the discovery being the locus of the gene.
MR CATTERNS: The gene, and the mutations?
KIEFEL J: And the mutation. But do you say claims 1 to 3 are merely conventional steps undertaken as a prelude to the application you see in the following claims? The isolation – that is, that claims 1 to 3 identify two things. One is the sequence itself and the method by which that can be taken out for the purpose of later application under the following claims.
MR CATTERNS: I think I agree with that, your Honour, except I would not agree with the phrase “the method by which”, because any ‑ ‑ ‑
KIEFEL J: Because it is a product ‑ ‑ ‑
MR CATTERNS: Just the fact ‑ ‑ ‑
KIEFEL J: Yes.
MR CATTERNS: ‑ ‑ ‑ that it is taken out – so this natural thing is taken out and put here, and we submit while that will later have applications as your Honour just said, that within these claims, merely to isolate it is not – does not – is not the kind of activity ‑ ‑ ‑
KIEFEL J: I take your point that it is not a method we are looking at in terms of the isolation of it, except that the product that the claims identify, the isolated gene, is the result of a conventional method.
MR CATTERNS: Yes, your Honour.
KIEFEL J: But what you are saying is the – what results taken out of the human body involves relevantly no human intervention. It is the same.
MR CATTERNS: That is right, your Honour.
KIEFEL J: There are differences, but not in the sequence, is that what it really comes down to?
MR CATTERNS: Yes, your Honour, exactly ‑ ‑ ‑
KIEFEL J: The sequence remains the same. The differences are in matters which are not relevant to the sequence for the purpose of identification.
MR CATTERNS: That is our submission, your Honour. The differences include the fact that it is – the covalent bonds, which I respectfully submit is not an important point – the fact that they are no longer wrapped around the histones. There are ‑ ‑ ‑
KIEFEL J: It cannot do other things. It is regarded as inert in a sense. Is that right?
MR CATTERNS: Yes, although you can – there are techniques available, and the court says so – there are techniques available, even from an isolated polynucleotide, to make a protein from it. You can do it in vitro, in a test tube. But, your Honour, looking at the claim at the right level of discourse, it is about the code, the possession of the code. That is why the differences which we readily accept occur as a result of isolation - it has lost all of the surrounding material, it has been separated from all the surrounding material, but the thing that has not changed is the code, the relevant part of the code.
KIEFEL J: You say that is what is identified as a matter of construction in the claims?
MR CATTERNS: Yes, your Honour.
KIEFEL J: And no more.
MR CATTERNS: Yes, your Honour, because it says an isolated nucleic acid coding for the polypeptide – mutant or polymorphic polypeptide – containing in comparison with the encoding sequence. None of that is – I respectfully submit they are not verbs making these things. I think they are probably adjectives, or part of adjectival phrases describing the possession of the sequence of, which might be as long as the 5000 nucleotides or as short as 15 nucleotides, which is exactly the same as nature, as the person who possesses the mutation. Your Honours, I was not going to take much time ‑ ‑ ‑
KIEFEL J: Could I just, whilst you are on that, you said earlier – you mentioned that you can – was your submission that the Full Court led itself into error in relation to the notion of encoding or coding for ‑ ‑ ‑
MR CATTERNS: Yes, your Honour.
KIEFEL J: ‑ ‑ ‑ which might be different. Could you explain the error that you say ‑ ‑ ‑
MR CATTERNS: Yes, your Honour. It is in volume 2. This is a section which is perfectly convenient to deal with now, your Honours. We refer to them a bit later in our note. Your Honours, I guess it begins in particular at 175, your Honour.
FRENCH CJ: Page?
MR CATTERNS: Page 699, sorry, your Honour.
FRENCH CJ: Page 699, thank you.
MR CATTERNS: Your Honours, our submissions are noted in paragraphs 171 and following which are, I think, close to what I have just put to her Honour Justice Kiefel. Where we think there is an error – submit there is an error – is in paragraph 175 where their Honours say:
An alternative approach is to distinguish between those terms –
which is “encode” and “code for” which we saw up in 172 –
such that “code for” is understood as carrying the code –
which is what we submit it means -
(passive; having the potential to produce the polypeptide) and “encode” means actually to produce the polypeptide (the active).
We respectfully submit that is not what that definition that I took the Court to says -
The definition of “encode” distinguishes between the polynucleotide in the native state, transcribed and translated without the intervention of man, and the polynucleotide, which needs to be manipulated to do so. If that approach is adopted, there is a difference because the nucleic acid sequence as it occurs in nature can code for –
I think their Honours mean “encode” -
the polypeptide –
We all agree, your Honours, that it can make the polypeptide but that is not the – our short submission is that is not the discourse of these claims.
KEANE J: So is it your case that this error that you are suggesting exists in paragraph 175 has led to a misconstruction of claims 1 to 3?
MR CATTERNS: Yes, your Honour. Their Honours get from this, in the paragraphs we are going to see – because they are reading the claims – they are reading as relevant to the claims the ability to make the protein. They say because it is isolated it does not make the protein. Therefore, it is different in function from the natural and that difference – in addition to the other differences their Honours point to – this difference, whether it be structure or function, that is central to their Honours’ reasons. Because it does not make the protein or the polypeptide it is different from nature.
Now, that is an interesting advance for an invention – what makes it patentable is its inability to make the polypeptide - but that is perhaps the debating point, your Honour, but we respectfully submit that it is just not the relevant discourse. We can see it at the top of page 700, your Honour – I am sorry, the bottom of 699:
nucleic acid sequence as it occurs in nature can code for the polypeptide due to its existence within the cell –
That is right –
The isolated nucleic acid, removed from the cellular environment (e.g. ribosomes) –
The ribosomes are what drag the amino acids down –
cannot code for the polypeptide without further intervention.
This recurs, your Honours, but we submit that that is true, although you can code for it – we are going to see in the next paragraph that you can make a polypeptide in a test tube, but we submit that is not relevant. It is not a relevant difference. Your Honours, when we come to the later claims where the code – the possession of the code with the mutations is central to the diagnostic testing, it is whether or not you possess the mutations, the doctor tells you that and you make various judgments.
KIEFEL J: What is the claimed utility of claims 1 to 3?
MR CATTERNS: They are not limited to diagnostic testing but you infringe them if you do a diagnostic test. As I have said already, your Honour ‑ ‑ ‑
GORDON J: What is it that Myriad is entitled to do if claims 1 to 3 are valid, and the flip side of that is what do you do to infringe it?
MR CATTERNS: Your Honour, you infringe it the minute you isolate a woman’s DNA if she happens to have the mutations.
KIEFEL J: What is the infringing act?
MR CATTERNS: The act is the act of isolation because you have made – I am sorry, there are other acts including use it – but the doctor infringes by isolating the woman’s blood before he or she knows that she has the mutation, but the moment the mutation is found, we know there has been an infringement. Your Honours, there is reference about it ‑ ‑ ‑
KEANE J: Does that mean that if a doctor does a blood test on a person who happens to have the predisposing gene and then it emerges that there is a cancer, that those facts alone prove infringement?
MR CATTERNS: Yes, your Honour, and you do not know that you have infringed until you compare the sequence of this woman’s DNA with the database in which table 12 exists.
GORDON J: Does that mean you have an exclusive right then - is that the way it is put by you - that Myriad therefore has an exclusive right to do the isolating?
MR CATTERNS: Yes, your Honour, exactly.
KEANE J: Without claiming ‑ ‑ ‑
MR CATTERNS: Well, claim 1 has that effect ‑ ‑ ‑
KEANE J: Without claiming that the process of isolating is new.
MR CATTERNS: Yes, your Honour. Claim 1 has that effect. Your Honour, may I take the Court, if it is convenient ‑ ‑ ‑
FRENCH CJ: Sorry, just before you do – just coming back to coding for a moment, can one properly construe the term “coding” in claim 1 and following as containing the sequence of codons necessary for the production of BRCA1 polypeptide, et cetera, in the DNA in its natural state, its native state.
MR CATTERNS: Yes, your Honour, exactly. The shorthand I have used is “possessing the code”, but we ‑ ‑ ‑
FRENCH CJ: Yes. It is a sequence of codons.
MR CATTERNS: Exactly, your Honour, the sequence of nucleotides which form the codons.
FRENCH CJ: I am sorry, yes.
MR CATTERNS: Yes, your Honours. Just, if I may, I hope I have answered her Honour Justice Kiefel’s question. I will come back to those paragraphs, if I may.
KIEFEL J: I am still just a little unclear on what the claimed usefulness of the invention disclosed in claims 1, 2 and 3 is – that is, the isolated sequence per se.
MR CATTERNS: Well, it is of great use in that you know when you have looked at it, when you have compared it, when you have ‑ ‑ ‑
KIEFEL J: It permits identification. That is it.
MR CATTERNS: Yes, your Honour, yes.
KIEFEL J: It permits identification because you are looking at what appears in the natural state.
MR CATTERNS: Yes.
KIEFEL J: Because as a diagnostic tool it would be useless if it – it would be invalid, would it not, if it differed from the natural state?
MR CATTERNS: Yes, your Honour, and “valid” is the phrase that Dr Suthers used in describing diagnostic tests. The validity of the diagnostic test is exactly what your Honour said.
FRENCH CJ: It brings you the sequence that exists in a natural state.
MR CATTERNS: Yes.
BELL J: Now, you conceded utility, and do I understand that that was the useful effect that the Full Court describes in paragraph 8 on page 662 of the appeal book, namely:
a state of knowledge for the person upon which to contemplate, or assess, treatment.
MR CATTERNS: Precisely, your Honour. We say that that, however, a state of knowledge is not patentable whereas, your Honours, finishing that, there seems to be something of an internal tension with 214.
BELL J: Yes.
MR CATTERNS: Which says:
The isolation of the nucleic acid also leads to an economically useful result – in this case, the treatment of breast and ovarian cancers.
We respectfully submit that what we see in paragraph 8 is the correct approach.
FRENCH CJ: Again, putting it in fairly simple terms, if you have a population of patients for examination and you apply to samples from each of them exactly the same isolation process, in some cases where the polymorphisms and the mutations appear you will have infringed, in the other cases you will not.
MR CATTERNS: That is exactly right, your Honour.
FRENCH CJ: If the claim be valid.
MR CATTERNS: Your Honour, as it happens, there was evidence about that, and that was what I was going to take the Court to in answer also to her Honour Justice Gordon’s question. The reference, your Honours, is in our paragraph 7 of our note. This is Dr Suthers, whose practice related to diagnosis.
Your Honours, this is evidence in‑chief. At page 27, just at the very bottom, line 45, he was asked about “a more limited universe of people”. He does not test everybody, because tests are expensive. They already do some pre‑screening about family history, and so on. We do not know what the universe of all possible variants in South Australia is. Then the last two words:
In the context of the clinical service that I have been managing –
he has criteria about how many people he in fact offered the test. Your Honours, about line 6 –
of the women we end up testing, about 1 in 5 . . . is found to have an inherited mutation in either the BRCA1 or BRCA2 gene. And it’s split fifty‑fifty between the two. So, looking at it another way, of the women we actually end up testing . . . about 10 per cent have an inheritable mutation in the BRCA1 gene –
That is not just these mutations, though, we are about to see. His Honour notes that –
HIS HONOUR: They’re not necessarily the mutations that are picked up in claim 1, are they?
That is the issue –
We have to regard each patient as a fresh start, as it were.
HIS HONOUR: How do you do that without isolating nucleic acid?
The answer is, you cannot –
We isolate the DNA from a blood sample of the woman, and then sequence the entire coding sequence –
So they look at the whole sequence –
essentially the cDNA sequence, as outlined in seq ID 1 –
that we saw, your Honours –
and compare the sequence in the patient with a reference sequence.
MR CATTERNS: And to what extent . . . have you come across the mutations –
we asked him, and then he said –
in the tables 12 through 14, there were I think 54 different mutations identified. International databases have now catalogued over 1500 mutations –
and he made a rough assumption that it is about 3 per cent –
Irrespective of that number, most of the women in whom we find a BRCA1 mutation do not have a mutation listed in tables 12 to 14.
But, your Honours, as his Honour asked –
you wouldn’t know until you’ve carried out the test, anyway?‑‑‑Until we’ve tested them, correct.
I hope that answers her Honour Justice Gordon’s question too.
GORDON J: Can I just pick up on something Justice Kiefel asked? When you took us to paragraph 214 of the Full Court’s decision, was the point you were making was that the identification there of what was economically useful was irrelevant to the assessment of claims 1 to 3 because it was a different economic question?
MR CATTERNS: Yes, your Honour. In fact, we do not see in this patent, as it happens – it is probably a slip in 214 – there is a reference to gene therapy, but there are no claims to gene therapy, for example. It is relevant to treatment in that knowing whether you have inherited breast cancer no doubt affects the treatment that physicians give you.
Your Honours, I am sorry, I have not quite finished the NRDC Case, but accepting the cautions put to me by his Honour the Chief Justice, at 270, there is a discussion of “vendible product” which is not our – we have moved past that, your Honours. At pages 266 to 267, their Honours arrive at a very broad conclusion about the kinds of things that can be manners of manufacture.
Your Honours, we ran, in the Apotex v Sanofi Case, the methods of medical treatment case, an argument that it attempted to confine the ratio here to products and processes. We accept that that argument failed there and we are not taking any time with it here. Where their Honours say, in the middle of the page:
the tenor of the passage seems to be that what is meant by a “product” in relation to a process is only something in which the new and useful effect may be observed . . . “something” need not be a “thing” in the sense of an article –
Their Honours are talking then about – because they are in the discourse of processes. Then, your Honours, at the top of page 277, is the famous phrase – sorry, the phrase, in particular, was the basis of his Honour the primary judge’s reasoning in this case:
is that the method the subject of the relevant claims has as its end result an artificial effect falling squarely within the true concept of what must be produced by a process if it is to be held patentable.
Their Honours, as it were, broaden the idea of vendible product to that effect. So, your Honours, we respectfully submit that the fact that something is artificial is not itself a guarantee that we have a manner of manufacture. Your Honour, just for completeness, just at the bottom of page 277 and following, there is the further argument that the Commissioner put that there was something special about agricultural processes that made them unpatentable. That was rejected. I do not need to take the Court to it except for just a little score in the wind in the middle of 278. There is a reference to a case, Re R.H.F.’s Application where Justice Morton:
approved a statement of the examiner which had been made to illustrate that the vendible product test . . . was not definitive. The statement was that fruit and other growing crops, although the assistance of man may be invoked for their planting and cultivation, do not result from a process which is a “manner of manufacture”. This may be agreed. However advantageously man may alter the conditions of growth, the fruit is still not produced by his action.
We do not need to argue today about crops, and as your Honours know, there is a whole regime about that. But, your Honours, the sequence here is not produced by the action of man.
Your Honours, that takes us to paragraph 4 of our note where we have made the submission that there has always been certain categories of subject matter that are excluded – the fine arts, for example. Your Honours, we give a reference to those three old cases. I was not going to take the Court to those, although they were in our supplementary bundle. We also give the Court a reference to the Apotex v Sanofi Case methods of medical treatment where the Court, including his Honour the Chief Justice, described this process of evaluation as being a case by case one. I do not think I need to go into any more detail of those passages, your Honours.
The case that we place a lot of weight on is the US Supreme Court decision in the Association for Molecular Pathology v Myriad Case 133 S Ct 2017, the counterpart case to the present. Your Honours, may I just remind the Court, the wording of the US section is quite similar to ours. There is a constitutional power not dissimilar to ours, except that there is a purpose in the power, the advancement of science and the useful arts. Prima facie, the US jurisprudence is likely to be helpful.
This Court has numerous times looked at Supreme Court authority in patent cases, including the Alphapharm Case, Aktiebolaget Hassle v Alphapharm Case, in the context of obviousness, the Lockwood v Doric Case in relation to obviousness and other cases. So this was a very similar case to the present case and, if I may, Justice Thomas delivered the judgment of the court beginning at 2110 and at the top of, after referring to their inventor’s discovery, about five lines down in the left‑hand column:
This case involves claims from three of them and requires us to resolve whether a naturally occurring segment of deoxyribonucleic acid (DNA) is patent eligible under 35 USC § 101 by virtue of its isolation from the rest of the human genome. We also address . . . (cDNA) –
and then his Honour gives a summary of the holding -
we hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible -
Your Honours, then there is a description of the science over the next two pages, which our primer deals with and the Full Court made findings about. In B on page 2112, there is a description of Myriad’s discovery which is they identified the exact location of the genes on the chromosome. They also disclosed the mutations as your Honours know. Your Honours, we see the claims on page 2113. They do not seem to be limited to the mutations. They are claims to the gene itself. At the bottom of 2113, under C:
Myriad’s patents would, if valid, give it the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes (or any strand of 15 or more nucleotides within the genes) by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome -
also cDNA. Then their Honours talk about the facts about threats of infringement in relation to genetic testing at the top of 2114. Now, your Honours, if your Honours forgive my being a little bit exhaustive here to save coming back to it under other headings, at the bottom right‑hand column of 2114, their Honours refer to the judgment of the Court of Appeal for the Federal Circuit and their Honours note, the judge at first instance, Judge Sweet, had upheld the attack on the claims. A majority of Judges Lourie and Moore held that they were patent eligible, we see at the bottom of 2114:
but disagreed on the rationale. Judge Lourie relied on the fact that the entire DNA molecule is held together by chemical bonds and that the covalent bonds at both ends of the segment –
as I have attempted to explain –
must be severed –
and his Honour, we see on 2115 in that first paragraph, regarded that as being dispositive. Now, may I remind your Honours that the Full Court in our case preferred the reasoning of the Circuit Court of Appeals to that of the Supreme Court:
Judge Lourie found this chemical alteration to be dispositive . . . even though the chemical alteration does not change the information‑transmitting quality of the DNA.
There is a quote there about the “informational content” being “irrelevant”, and our submission is that that is the heart of these claims. Now, your Honours, that is the significance of the chemical alteration argument. Judge Lourie is the only judge in the United States, judge or justice, in the United States, who considered that to be significant. Judge Moore concurred, but said your Honours see:
“To the extent the majority rests its conclusion on the chemical differences . . . I cannot agree that this is sufficient to hold that the claims are directed to patentable subject matter”.
Her Honour placed a lot of weight on the Patent Office practice. Then, dissenting, Judge Bryson said:-
“[T]here is no magic to a chemical bond –
Your Honours, looking at the Supreme Court’s reasoning at 2116, their Honours quote section 101, which your Honours see is not identical to, but has affinities with our section. Then their Honours say, quoting the Mayo v Prometheus Case:
We have “long held that this provision contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable.”
That is one of the reasons, in answering his Honour the Chief Justice’s question, we try not to tie ourselves to a particular verbal formulation. I would not find it very apposite to say this is a law of nature about what we see on our chromosome 17. Perhaps it is. We prefer product of nature, but I do not think much turns on the terminology one uses. In any event, your Honours, at the bottom of the page, the last three lines:
The rule against patents on naturally occurring things is not without limits, however, for “all inventions at some level embody, use . . . laws of nature, natural phenomena –
That, again, quoting the Mayo Case. Your Honours, then there is a discussion of Chakrabarty at the bottom of page 2116. There is a criticism by the Full Court in our case of the way the US Supreme Court deals with the Chakrabarty Case, but, your Honours, the Chakrabarty Case was completely different, we submit, because it was a genetically engineered bacteria. It was not a naturally occurring bacteria. It had plasmids inserted into its genome. As we see at the bottom, your Honours:
In Chakrabarty, scientists added four plasmas to a bacterium, which enabled it to break down various components of crude oil . . . The Court held that the modified bacterium was patentable.
An important phrase, your Honours, appears at the top of 2117, about 10 lines down:
The Chakrabarty bacterium was new “with markedly different characteristics from any found in nature,” –
Your Honours, we do not put forward that as a rule or a test. We prefer to say as a matter of substance, but perhaps in answering a question of substance in that case, it was markedly different. Your Honours, what his Honour says at the end of that paragraph is:
Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.
It is not suggested to be in the patent, your Honours. Then, in terms not dissimilar to the High Court in NRDC:
Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.
Then, referring to the majority judgment in the Funk Bros Case, of which his Honour Justice Frankfurter concurred in the result but for different reasoning ‑ your Honours, that case, the Funk Case, the patentee had discovered that different bacteria affect different plants to enable them to fix nitrogen. In short, his suggestion was a mixture – sell a mixture of six, or three of these bacteria. He did not in any way alter the bacteria. That was held not to be patentable.
His Honour Justice Frankfurter concurring, but with different reasons, had reasoning close to what we might regard as sufficiency of definition or fair basis, whereas the other members of the court held that what we are about to see, your Honours, at the top of the right‑hand column:
The Court held that the composition was not patent eligible because the patent holder did not alter the bacteria in any way . . . (“There is no way in which we could call [the bacteria mixture a product of invention] unless we borrowed invention from the discovery of the natural principle itself”). His patent claim thus fell squarely within the law of nature exception.
Your Honours, at the top of 2118 – I am sorry, this takes a moment – the description of the fine piece of science at the end of that paragraph:
But extensive effort alone is insufficient to satisfy the demands of § 101.
Just in relation to the chemical bonds, your Honours:
Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule.
Of course, your Honours, when you chop it up into shorter sequences such as are within the claim it is a different molecule with lesser molecular weight as Dr Suthers readily conceded. But the important thing, your Honours, is the discourse of the claims:
Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes . . . Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.
Your Honours, we submit that is the crucial part of the reasoning. Your Honours, at the top of page 2118, there is a reference to the US Patent and Trademark Office’s “practice of awarding gene patents”, and then their Honours deal with that in the particular US circumstance. We make a submission at the end of our written submission here – our three‑page outline – that the practice of granting gene patents in Australia, which we accept of course exists, does not have a lot of value in answering our question in the way the NRDC Case suggests we should, for two reasons. First, we do not know but we respectfully submit we can assume that all of those patents did not just claim genes per se but would also have claimed applications, as this patent does, and if it matters as Professor Brown’s did which was in evidence.
Secondly, your Honours, the Microcell Case, and many cases since, show that at the level of acceptance of patents – there has been some changes in wording in the Act but at least at the time that this patent was granted the duty on the Commissioner was that she had to accept a patent – and this is the terminology in the Microcell Case – unless it was practically certain that letters patent granted on the specification would be held to be invalid. So we respectfully submit that just by parity of reasoning with what we see here the practice of the Commissioner in granting patents does not take matters much further.
Indeed, just at 2119, your Honours - and in addition, the US Government appeared as amicus in that case - their Honours hold that cDNA is patentable, and we do not need to get into that now. We respectfully submit that the Full Court below in our case made too much of our acceptance that cDNA is or might be patentable because it is human made and it has removed the introns.
We can have an argument another time about that. But, as I have submitted in answer to her Honour Justice Bell, the fact that things that are not cDNA are within the claims renders them invalid. Then Justice Thomas continues under III:
there are no method claims before this Court –
and, your Honours, I will show the Court those in a minute. Then, importantly, your Honours, perhaps another element of our argument about approaching this as a matter of substance is when there is no application of the discovery in claims 1 to 3, although there is in later claims, then we fall within well‑known exceptions that we really are at the level of a discovery or a product of nature, not an application of them. At 2120 the court says:
Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson, aptly noted that, “[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications.”
As here, your Honours. Your Honours, nor do their Honours deal with the question of changing the order of the nucleotides. Here the correct order is of the essence of these claims. His Honour Justice Scalia concurred. At the bottom of the page it says it is sufficient for him to affirm:
that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state -
and then cDNA.
GORDON J: Mr Catterns, at page 2118 in the bottom left‑hand corner, Justice Thomas propounds a contention that the reference to chemical composition is irrelevant because you could avoid infringement by adding in a bit which would change the chemical composition. Is that apposite here?
MR CATTERNS: Well, in principle, yes, your Honour, if you change the sequence. Particularly if you change the sequence by one nucleotide you would shift the reading frame and you would code for a different polypeptide altogether. The only reason I pause, your Honour, is tiny changes do not always save you from infringement. Speaking generally, one might not escape infringement by a tiny change.
GORDON J: I think the point is more subtle than that. I think when I read Justice Thomas, is he not talking about changes in chemical composition as distinct from the thing which is important, which is the coded information?
MR CATTERNS: Well, yes, his Honour is saying if the patent is dependent on the creation of a unique molecule, adding another nucleotide makes it a completely different molecule.
FRENCH CJ: Just on the cDNA question, if it be a vice of the claim that it contains an integer which derives not from anything done by the person making the invention, but from the natural conditions in the body from which the sample is taken, what does it matter – what does the method by which that sequence is produced matter? What difference does it make that it is cDNA, if that be a vice?
MR CATTERNS: Well, your Honour, I respectfully agree. We, as it were, consented to put cDNA out of the argument because it was good enough for us to have anything within the claim. That is why I submitted perhaps too airily that that would be an argument for another day, based on what your Honour just put to me. Merely to chop off the introns, as in fact happens in nature in the splicing process, would not be enough.
At first instance, your Honours, we put a separate argument based on RNA which would only have invalidated claim 1, which is identical to the sequence. The introns are chopped out of it except for what was called “the cap and the poly‑A tail. But, your Honours, it is fair to say that before the Full Court we focus on DNA. I either accepted – or near enough accepted – that cDNA was patentable for present purposes. But, your Honour, I think what your Honour put to me, with respect, is a valid reason why cDNA might not be patentable. But that water has passed under the bridge so far as we are concerned but it does not matter.
Your Honours, the acceptance by both sides that if anything within the claim – which is sequences other than cDNA such as are isolated from normal human – sorry, a human being’s body – are not patentable, the whole claims fall. That is recorded by his Honour the primary judge in paragraph 8.
GAGELER J: Mr Catterns, perhaps I am dumbing it down far too much, but if one goes to Justice Scalia’s sentence that you read where he said that it was sufficient to conclude:
that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state –
does that capture your argument?
MR CATTERNS: Yes, it does, your Honour. But I think, to be fair, I must say “identical” in the relevant sense because we accept that “in its natural state” - if you look at it with a microscope, it is wrapped around the histones, for example. But it is identical in terms of the code and that is the discourse of these claims, your Honour, as I have submitted.
GAGELER J: Relating that to NRDC, you would say that that is itself sufficient to take it outside the principles that it developed in relation to section 6 of the Statute of Monopolies?
MR CATTERNS: Yes, your Honour. Your Honours, the reason we gave – at the bottom of our page 1 – references to the UK and the European Convention is not – I will not take the Court to them – is just they are examples of express exclusions of patent subject matter. They are always – the mere fact that something is artificial is not enough. Your Honours, our submission in 5, which I have largely made, is that one excluded category is naturally occurring things. As I submitted a moment ago, that is the antithesis of the artificial effect.
Your Honours, the Full Court in several places – and we give your Honours the reference there - may I just pick one example of it, paragraph 217, page 709 - the Full Court, as your Honours can see, prefer the reasoning of Judges Lourie and Moore of the Federal Circuit and so that it accords with NRDC - we can skip over cDNA:
It rejected the isolated nucleic acid of claim 1 because it accepted, wrongly, with respect, that the isolated nucleic acid is a “product of nature”. In any event –
This is what I want to come to -
that exclusion is not in accordance with the principles of patent law in Australia and has been specifically rejected as a reason for exclusion in NRDC.
Your Honours, in our paragraph 5, we give your Honours other paragraphs that are to the same effect. The primary judge’s reasoning was not to that effect. His Honour did not accept that submission when our friends made it below. I do not need to take the Court to that.
But we respectfully submit that the Full Court’s regarding this as having been rejected for exclusion in NRDC stems from the misreading of NRDC which I am sorry to have to ask the Court to go back to just quickly for that purpose in 102 CLR. Your Honours, at 263 and I was at pains to try and demonstrate that the structure of the Court’s reasons was their Honours were dealing with the argument based on the Microcell Case that a mere new use of an old thing is not patentable. In that context, at page 263, 10 lines from the bottom, their Honours say:
It is not decisive – it is not even helpful – to point out in such a case that beyond discovery of a scientific fact nothing has been added except the suggestion that nature, in its newly ascertained aspect, be allowed to work in its own way.
Justice Frankfurter answered them in Funk Bros:
“It only confuses the issue,” the learned Justice said, “to introduce such terms as ‘the work of nature’ and the ‘laws of nature’ . . . Everything that happens may be deemed ‘the work of nature’, and any patentable composite exemplifies in its properties ‘the laws of nature’. Arguments drawn from such terms for ascertaining patentability could fairly be employed to challenge almost any patent”. The truth is that the distinction between discovery and invention is not precise ‑ ‑ ‑
FRENCH CJ: We seem to be stuck in a bit of a time warp here. Glancing at your outline, I thought we had covered most of everything that appears up to at least paragraph 12. We seem to be back in this black hole at paragraph 5.
MR CATTERNS: Your Honour, may I refer to three more lines there and your Honour is right, in many ways, with respect, and try and draw the strands together. So, your Honour, there is a discussion there, your Honours, of the distinction between – level with their Honours’ names:
There may indeed be a discovery without invention ‑ either because the discovery is of some piece of abstract information without any suggestion of a practical application . . . or because its application lies outside the realm of “manufacture”.
That is the distinction we have been drawing, your Honours. We give your Honours the reference to the Funk Bros Case where the other members of the majority held in the way described by Justice Thomas. Your Honours, in paragraph 7, we draw that distinction between the discovery of one of nature’s laws or, perhaps, the properties of natural DNA and its application to some new and useful purpose. I do not wish to go back to those references again, your Honours.
I have submitted many times, your Honours, the distinction between these claims and the other claims, that is our paragraph 7, but may I just go to the other claims as promised? Your Honours, they are at 568. Your Honours see that we start to apply discovery. The first is a probe which is something that has a sequence of nucleic acids which you might radio label, put into a person’s blood and see whether it binds to it.
Without taking the Court to it, there is a description of those, if your Honours care to note it, at about page 412, line 16. That describes probes. Then, from about page 418 onwards, we see vectors. This is cloning, your Honours, whereby the vector includes isolated DNA and you put it into a host cell and multiply it up for various purposes including testing. So, your Honours - and claim 7 is the host cell which might be a bacterium, for example, transformed with this sequence so as to multiply it.
Then, your Honours, just apropos of the Full Court’s reasoning about making proteins or polypeptides, from paragraphs 8 to 14, they claim methods of making polypeptides – they aid the inventor’s claim using the sequence. Your Honours, use of a polypeptide as an immunogen for antibody production is in 15. That might well be a method of treatment of cancer. Then, your Honours, 17 through 30 are all claims to methods of diagnosis. Your Honours, we readily accept that those kinds of applications are the kinds of things that fall within the concept of a manner of manufacture.
Your Honours, we made the submission in paragraph 8 that the court’s error was to hold that the claim is to an isolated nucleic acid, a chemical molecule characterised in a certain way. Your Honours, the way this DNA is characterised is by its possession of the code. It is not characterised by the function of making proteins, nor the structure of being wrapped around histones, et cetera, and all the rest of the complicated cell machinery, nor by the possession of the chemical bonds intact at either end.
Your Honours, then in our following paragraphs, 9, 10 and following, we respectfully submit that – we break down the three aspects. First, as to chemical bonds, your Honours, we adopt Justice Thomas’ phrase “the claims just are not expressed”. That is not the right level of discourse. As I have submitted, the court wrongly put aside the reasons of the Supreme Court, and I do not need to go back to that, your Honours.
We give your Honours the references to the Diamond v Chakrabarty Case, so I will not take the Court to it. The reason that case was famous is there was a dispute about whether living things at all were patentable, and the dissent in that case related to that. The majority held that the genetically modified bacterium in that case was sufficiently different from the naturally occurring bacterium to be patentable. I have made our submissions about what physically happens. Then, your Honours, so far as the structural attributes go – and this overlaps, I think, with the ‑ ‑ ‑
FRENCH CJ: It is the same sequence point?
MR CATTERNS: Yes, your Honour, it is the same sequence. Your Honours, in those paragraphs that we quote at the top of our page 3 – without discourtesy to the Full Court, I was not going to go to them in detail. I had come to a halt at paragraph 175, I think. I do not really need to go to the other paragraphs, I do not think. They are to a similar effect. There is a lot of emphasis by the court on the non‑production of the polypeptide, and shorter sequences do not make the polypeptide.
I am sure our learned friends will take the Court to some of the evidence whereby – let me start as follows. There is no doubt that when you have the full‑length sequence in the body it codes for the BRCA1 protein, the polypeptide. However, as Professor Brown explained, what we used to think was junk DNA is no longer junk. Even this particular stretch of code can code for additional things.
If other proteins bind at the right spot of it, it might code for a different protein over a different section. Indeed, apparently, it might even code in the opposite direction and make a different thing. The reason we submit that that is irrelevant is a discourse of this kind focuses on that particular gene – the exonic sequence of it, the coding sequence – that does code for the polypeptide uniquely, and shorter bits of it which are not making proteins but which possess the mutations that we are interested in.
So, your Honours, that is our submission in 11. The discourse of these claims is this is not making proteins – although, as the court noted, you can, in vitro – it is about possession of the code. Your Honours, I have made the submission in 12, at least in the body of 12. The references we give your Honours to the US cases where it has been approached as a matter of substance – perhaps our friends could criticise it as being a little too mechanistic to use the phrase, “adopted from Chakrabarty”, used there emphatically to describe the difference between the bacterium and nature, significantly different or markedly different.
We do not put that forward as a test. But in each of those cases – Bilski v Kappos was a method of treatment case – I am sorry, a business method case. Mayo was a method of treatment or method of diagnosis, method of treatment, really. Alice Corporation was another, to put it shortly, business method case. In each of those cases – in the two business ones – the mere attachment of a computer, or recitation of a computer, was not held to be enough.
Your Honours, we have given the Court a reference and I was not going to take the Court to it, to a decision of the Full Court of the Federal Court in the last case there, Research Affiliates v The Commissioner. That is another business method type patent where the – where you – it was a way of making an index for your share portfolio, or your customer’s share portfolio, using a computer. The court held, as a matter of substance, that did not take it out of an impermissible abstract idea. We give your Honours the references to it there. Their Honours applied Alice Corporation. So, your Honours, the Myriad Case, Bilski, Mayo and Alice, are four recent cases of the US Supreme Court where these kinds of exceptions that we propound have been treated as a matter of substance.
Your Honours, we have made the submission in paragraph 13, well and truly. Then, as his Honour the Chief Justice pointed out, I am now at 14. Your Honours, the European position is not as different from the Australian position as one might think. I do need to go quickly to the first two sources; that is, the European Directive.
The reason I am doing this, your Honours, is that as their Honours Justices Crennan and Kiefel pointed out, concordance with our trading partners is a matter of some significance. We know the American position. The European position is not as different as one might think. I readily accept it is different. I think your Honours have the European Directive on the Legal Protection of Biotechnological Inventions, Directive 98/44. I wanted to mention – for better and for worse for us, your Honours – three or four of the recitals, recitals (20) to (23), where the Commissioner is saying, we are going to make it:–
clear that an invention based on an element isolated from the human body . . . which is susceptible of industrial application –
That is what we wish to stress –
is not excluded from patentability, even where the structure of that element is identical . . . given that the rights conferred by the patent do not extend to the human body -
Then, your Honours:
Whereas such an element isolated from the human body or otherwise produced is not excluded from patentability since it is, for example, the result of technical processes –
which humans can do. Then, your Honours, in (22), it is controversial, the last four lines:
whereas the industrial application of a sequence or partial sequence must be disclosed in the patent application as filed –
Your Honours, our submission has been that the – that is the European position. We submit that in Australia the right position is that it is in the claims that one should focus on, and claims that apply the discovery, or the natural product, as the later claims do here are patentable.
BELL J: So that on your contention, claims 1 to 3 here would not meet Article 5(3).
MR CATTERNS: That is exactly right, your Honour.
BELL J: And the balance of the claims which you accept would because they come within Article 5(3).
MR CATTERNS: Yes, your Honour, exactly. Your Honour, just to finish on the recitals – I am sorry – (23) says:
Whereas a mere DNA sequence without indication of a function does not contain any technical information –
by which they mean an industrial application –
and is therefore not a patentable invention -
Then, picking up the article that her Honour Justice Bell took me to, Article 5(1):
The human body . . . and the simple discovery of . . . a gene, cannot constitute patentable inventions.
An isolated gene, however, can, even if identical, as the recital foreshadowed - “The industrial application”, as her Honour drew my attention to in 5(3). Your Honours, then the last thing I wanted to take the Court to was the Kirin‑Amgen Case [2005] RPC 9 in the UK House of Lords. Your Honours, this was the discovery of EPO, erythropoietin, famous in cycling circles but also very, very important for other proper medical reasons – this is a judgment of the House of Lords given by Lord Hoffmann. It is an important case for reasons relating to construction of patents in the UK and Europe, but in paragraph 12, Lord Hoffmann looks at the patent and describes EPO:
It then describes the methods which Dr Lin used to find the gene in the DNA of monkeys and humans and sets out the full sequences for both species in Tables V and VI –
So table VI is the human gene for erythropoietin. Now, your Honours, there was a debate – we can see the claim in paragraph 13:
Claim 1 is for:
“A DNA sequence for use in securing expression in a procaryotic or eucaryotic –
Where eucaryotic are cells, your Honours, procaryotic are bacteria –
host cell of a polypeptide product . . . erythropoietin –
Your Honours, what the case turned on is whether the host cell was the person – if we are talking about people – the person’s own cell or something that is exogenous. If it had been the person’s own cell, it would not have been valid. It was only because it was a foreign host cell that made it valid. We can see the two constructions, your Honours – and we have given your Honours the references in 14 – at 67 and 68. At 67, page 194:
The judge thought that the invention was the discovery of the sequence of the EPO gene and the associated information. It followed that any method of making EPO which used that information, whether by the expression of exogenous or endogenous DNA, would operate in the same way and that this would be obvious to the person skilled in the art.
The question of obviousness in the art relates to infringement there -
Furthermore, there was no reason why the patentee should have wished to insist upon any particular method . . .
The Court of Appeal, on the other hand, thought that the invention was a way of making EPO.
Crucially, your Honours -
The information about the sequence of the gene was necessary to enable the invention to be performed but was not and could not be the invention itself. It followed that a different way of making EPO –
et cetera. Then finally, your Honours, at 76 and 77, Lord Hoffmann says that he agreed with the latter construction that it had to be exogenous:
First, I think that the judge’s construction pays no attention to the claims. It does not even use them as “guidelines” –
That is the European controversy about modes of interpretation - that was the German approach - but goes straight to table VI and declares that to be the invention, namely the DNA –
Secondly, I think that the Court of Appeal was right in saying that Table VI could not have been the invention. Standing alone, it was a “discovery . . . as such” –
and discoveries as such are specifically excluded in the UK. Then, there is a quote from Justice Whitford at first instance in the Genentech Case:
you cannot patent a discovery, but if on the basis of that discovery you can tell people how it can be usefully employed –
That is a distinction, your Honours, that we have made many times this morning. Then, your Honours, at 77:
In such a case, while it may be true to say, as the Court of Appeal did ([2003] R.P.C. 3) that Table VI –
which was the human DNA sequence –
lay “at the heart of the invention”, it was not the invention.
Then, the next sentence is quoted by the Full Court in our case -
An invention is a practical product or process, not information about the natural world –
and the social contract. So, your Honours, we respectfully submit that the European and UK position is similar to the submission that we have been putting, and your Honours I have made the submission in paragraph 15, except for the last sentence – we respectfully submit that legislative silence on this point does not carry the matter any further, because this is precisely
the point – and the Court has explained this in both his Honour the Chief Justice’s reasons and Justices Crennan and Kiefel’s reasons in Apotex v Sanofi – this was deliberately left to development by the courts in the way suggested by NRDC. So, your Honours, we respectfully submit that these claims do not fall within the concept. May it please the Court.
FRENCH CJ: Thank you, Mr Catterns. Yes, Mr Shavin.
MR SHAVIN: If the Court pleases. My learned friend has finished slightly faster than we had anticipated, and during the course of the morning I have caused our three‑page outline to be recast, but the new version has not yet arrived down from upstairs. I can either proceed with the old outline, or I could start without the outline, or I could start at 2.15, whichever is most convenient to the Court.
FRENCH CJ: I think we might adjourn and come back at 2 o’clock.
MR SHAVIN: If the Court pleases.
AT 12.27 PM LUNCHEON ADJOURNMENT
UPON RESUMING AT 2.00 PM:
FRENCH CJ: Yes, Mr Shavin.
MR SHAVIN: If the Court pleases. It might be simplistic to state, as we do in the first paragraph of our outline, that the invention claimed, relevantly in the patent, is to an isolated nucleic acid having the features defined by the claims. It is not to an isolated human gene. It is not to genetic code, or to genetic information, to chemical compound. There is a shorthand isolated nucleic acid, but you could actually write it out as you could any other chemical compound identifying the molecules, identifying the bonds. All that is encompassed in those words is the shorthand for that chemical formula.
The utility of the formula arises from the fact that it is isolated, an essential feature of the claim. It is not important because of what it cannot do; it is because of what it can do. If you have the product isolated from its natural environment in the cell, isolated from the histones, isolated from bonding to other parts of the genome, isolated from most of the non‑coding sequences, you can do something with it.
KIEFEL J: Yes, but the doing something is found in claims 4 and following, is it not? I mean, claims 1 to 3, the point made by the appellant is the fact of being isolated is not itself of economic utility.
MR SHAVIN: With respect, when you have a product claim, your Honour, in our respectful submission, you do not have to identify the purpose of the product. It is not a product for a limited purpose. It is a product itself. So that one can claim an engine, one can claim a gearbox, one can claim any mechanical device. You can claim a chemical compound.
KIEFEL J: Which is useful.
MR SHAVIN: It is useful, but you do not identify the utility within the claim and that is why when our friend took the Court to the European Directive to which we will seek to return later, what is said in the European Directive is that utility has to be identified in the application. It does not have to be identified within the claim itself. It is not customary to identify the utility of the item.
KIEFEL J: No, it is not as a matter of form in the way in which patents are set out in Australia.
MR SHAVIN: Yes.
KIEFEL J: But, one can usually discern that from the claims.
MR SHAVIN: From the content of the body of the specification, we would respectfully respond, because if you have a claim for a new molecule ‑ ‑ ‑
KIEFEL J: It must follow from the claims. They are not two matters having nothing to say to each other.
MR SHAVIN: Yes. But, if you have a claim for a chemical compound, you can claim the compound. You will not identify the use to which you are going to put the compound.
NETTLE J: Would not the compound formula vary according to the number of sequences that you extracted?
MR SHAVIN: Yes.
NETTLE J: So, you would have a claim for a number of chemical compounds on that analysis.
MR SHAVIN: Yes. You can have a claim for a class of compounds.
NETTLE J: Well, is that what it is, a class of compounds?
MR SHAVIN: Yes, I think properly understood; yes, your Honour.
NETTLE J: So, how would one derive from the claim the full suite of formulae which describe the limits of the chemical compounds within the suite?
MR SHAVIN: Because of the comparator.
NETTLE J: Being?
MR SHAVIN: If one goes back to the form of the claim itself ‑ ‑ ‑
KIEFEL J: The comparator tells you what you are looking for, does it not?
NETTLE J: It does not tell you anything about the chemical composition.
MR SHAVIN: Well, it is implicit in what is said in the shorthand.
NETTLE J: But you said that you could write out the chemical formulae of the molecule over which you make your claim.
MR SHAVIN: Yes.
NETTLE J: Or, as you now put it, the chemical formulae of the molecules over which you make your claim.
MR SHAVIN: Yes.
NETTLE J: But how would one delineate the formulae, given that it is infinitely variable depending on the number of sequences that you extract?
MR SHAVIN: Whether it is infinitely variable, I do not know that I need to go that far, and the evidence does not disclose quite the limit of that.
NETTLE J: Might it not be, depending on how many hydrogen, or…..bonds, for example, broke off in addition to the covalent bonds?
MR SHAVIN: Yes, it could be – but then, the class of the compound is identified by the comparator, because you have to have certain characteristics.
NETTLE J: But that would not identify, would it, the chemical composition of the molecules over which you make your claim.
MR SHAVIN: It would, with respect, the core of it. The part that was relevant.
NETTLE J: You mean the nucleus.
MR SHAVIN: If I could put it in this way, your Honour. You have an isolated nucleic acid coding for which, we accept – I think it appears now to be common ground – possesses the code for, in the passive. A mutant or polymorphic polypeptide contain in comparison certain things, so that the class will be ‑ ‑ ‑
NETTLE J: Well, that is its functionality that you are describing now, namely that you can observe within it certain mutations which have been found to produce an incidence of cancer. That does not describe anything, it is about its chemical formulae.
MR SHAVIN: Well, with respect, it will because those mutations and polymorphisms will themselves be different chemical entities so the class of chemical entities will be the class of chemical entities encompassed by the tables.
KIEFEL J: What you are saying is genes are composed of chemicals.
MR SHAVIN: I am sorry, your Honour.
KIEFEL J: What you are saying is genetic material is composed of chemical.
MR SHAVIN: Yes.
KIEFEL J: But what you are talking about here is a particular substance which a code is for; that is what you are looking for, you are talking about ‑ you are being led to something in the material.
MR SHAVIN: Yes. So, you are looking for a chemical compound which has certain characteristics it possesses, certain nucleotide sequences which you can identify as in a chemical formula, but it is coding for ‑ it possesses those sequences for a mutant or polymorphic polypeptide, which in comparison to SEQ ID No 1 and one or more of the mutations on polymorphisms.
So you have got a series of shorthand. You have got nucleotides which become codons, which generators our friend has accurately described, amino acids, and in the process of encoding from those amino acids, you will end up with a number of polypeptides. And, indeed, if you do not have the full sequence, you will have different polypeptides constituted by the fragments and that is found in the primer and was not contested below. Indeed, it was the evidence of our friend’s expert, Mr Suthers.
NETTLE J: But you could, on the analysis I have just put to you, have an infinite array of chemical compounds, depending upon the number of sequences extracted, which would nevertheless code for the identified mutations and polymorphisms.
MR SHAVIN: If I could say, a very wide number, your Honour.
NETTLE J: Extremely wide number.
MR SHAVIN: Yes. That would not itself invalidate the claim.
NETTLE J: How would one, at least in point of principle, delineate the bounds of this very wide class of chemical compounds over which you claim the monopoly?
MR SHAVIN: Because it has to have the characteristics identified within the claim.
FRENCH CJ: These are not characteristics you confer upon it by your process. They are set up as integers of the claim, are they not, the existence of the polymorphisms and the mutations?
MR SHAVIN: Yes, so that the limitations – it is not simply any isolated nucleic acid. It is not simply any isolated nucleic acid which was in the United States claim, simply SEQ ID No 1, which was a hybrid cDNA sequence. What is here contained is a subset of that. It has to be a combination of SEQ ID No 1 including one or more of the mutations or polymorphisms.
FRENCH CJ: You have not constructed a nucleic acid which contains polymorphisms or mutations. You have isolated a nucleic acid and found, dependent upon the source of the sample, that it either contains or does not contain the polymorphisms or mutations. In the first case, it is not within your claim; in the second case, it is. There is something odd about that.
MR SHAVIN: With respect, no, we would say, your Honour. What we started with was a cell. Within the cell, there is a gene. In that condition, one cannot do very much with it. The person who has it bears it and bears the consequences of it.
We discovered the sequence but our invention is the product claimed which is to take that which was in the cell, do a number of things to it so that it is isolated. In its isolated form, it is artificial. It does not take that form in nature. It is chemically different. It is structurally different and it has different functions because the things for which you can use the isolated nucleic acid, you cannot use the intracellular gene. When one views it in that sense, and remembering that the only thing that is in issue in these proceedings is whether it is patentable subject matter, what is not in issue in these proceedings was whether or not it was obvious, whether it was novel, whether the requirements of section 40 were satisfied.
FRENCH CJ: None of that is implicit in the question that I have put to you, or that anybody has put to you. Could you have a valid claim in terms of claim 1 without reference to the mutation of polymorphism characteristics?
MR SHAVIN: Yes. If it was novel or non‑obvious, yes.
KIEFEL J: How would you infringe it?
MR SHAVIN: By isolating that, which is why, in our respectful submission ‑ ‑ ‑
KIEFEL J: Isolating it which has no distinctive feature such as a mutation or a polymorphism.
MR SHAVIN: In America, you see, the claim was, in fact, precisely that which the Chief Justice put to me. Claim 1 in America was quite different to our claim 1. It was simply a claim to SEQ ID No 1 which was the cDNA sequence. You would infringe it by isolating the nucleic acid. That may raise questions as to whether it was fairly based. It may raise questions as to obviousness or novelty, but none of those are being dealt with in these proceedings. As a matter of concept, therefore, in our respectful submission, you determine patentable subject matter by identifying the subject matter of the claim, not by extrapolating down and trying to work out how you would deal with the question of infringement. But, the patentable subject matter set out in section 6 of the Statute of Monopolies, as elucidated by this Court in NRDC, looks at the very – is this the proper subject matter?
KIEFEL J: But, sometimes looking at the question of infringement helps identify what it is exactly that is claimed because you cannot determine infringement without truly identifying that.
MR SHAVIN: Yes, I do not believe, your Honour, that that would be the only claim for which that would hold true. There are some claims, for example, that you can only know whether there is infringement once you look at what happens inside the body. There is inherent infringement so that one cannot determine in advance precisely ‑ ‑ ‑
KIEFEL J: You are talking about a process of legal analysis.
MR SHAVIN: As a process of legal analysis, the infringement is plain. If you isolate a nucleic acid with the characteristics claimed, and you hold that isolated nucleic acid, that would constitute an infringement.
KIEFEL J: And it happens to have the mutations or polymorphisms identified here.
MR SHAVIN: Yes.
NETTLE J: So, if the pathologist isolates the gene in a woman who does not have the polymorphisms or mutations, he commits no infringement of your patent?
MR SHAVIN: Absolutely.
NETTLE J: But if she happens to have the mutations, then he does.
MR SHAVIN: Yes.
FRENCH CJ: And what you have done – your conduct, in the one case, is indistinguishable from your conduct in the other. So, when you make the invention for the purposes of exploitation and thereby infringement, you do nothing different.
MR SHAVIN: No, and – but ‑ ‑ ‑
FRENCH CJ: Which says something about the integer, does it not, of the polymorphism and the mutation?
MR SHAVIN: Well, yes, it does and it does not, your Honour. Can I turn that around for the purpose of argument? Your Honour put a question to my learned friend this morning, which arises strikingly in the US Supreme Court decision. That is, the court distinguished cDNA from any other form of isolated nucleic acid. The court had no difficulty properly accepting, in our respectful submission, that cDNA was patentable, even under the laws of nature of exclusion in the United States. Yet, there is no difference between an isolated nucleic acid created from cDNA which is plainly artificial. If one looks at page 78 of this patent, in example 8, and works through it quietly and carefully, one realises that SEQ ID No 1 comes from a whole raft of different people, males and females, and they have chopped up little sequences and ultimately worked out which sequences were relevant and stitched them together. Out of that hybrid came SEQ ID No 1.
Now, there can be no doubt that that is completely artificial. There can be no doubt, as was accepted by the United States Supreme Court, that it is not found in nature. Even under a laws of nature exemption, the US Supreme Court said, that is patentable. In our respectful submission, if you apply the test in NRDC, the test is simpler and more precise in determining the bounds of what was a vendible product in Morton J’s test. The High Court said for a product, is it an artificially created state of affairs of economic utility? Now, economic utility is conceded here, so that the cause – and this is where we join issue with our friend’s approach to NRDC – is that the Court looked intensely at the concept of patentability that has been enshrined in section 6 as it has evolved over the centuries.
It did not simply look at Microcell and then say, well, that was one issue, and then it looked at manner of manufacture and said it was another issue. It started off by looking precisely at section 6 and what was inherent in the concept of a manner of new manufacture. From Microcell it simply started off, well, you cannot have a patent for a new use for an old subject. Then it is speculatable what happens if you are taking advantage of some hitherto unsuspected property. From that it found there is some superadded material that gives you some things that is proper subject matter. In that context, the High Court looked at page 263, and said, when you are having this discussion, it does not help to use phrases like “laws of nature”.
So, the statement by Justice Frankfurter in Funk was not taken simply in a Microcell context, but taken in the context of the Court seeking to understand what content it gives to section 6 of the statute. Now, when one starts from that point, and then goes through the second part of the phrase and looks at manufacture, and starts with a product and then product by process, as it evolved, what this Court found in NRDC ‑ and we would say, with respect, reaffirmed 18 months ago in Apotex ‑ was that the essential element that makes a product suitable for a patent – putting to one side all the other restrictions, but simply looking at whether it is patentable subject matter – is to say, is this an artificially created state of affairs.
BELL J: What is artificially created about the state of affairs involving patient BT106? A sample of tissue of that patient is taken. It is isolated by a well‑understood process, and in its isolated form, that being the isolated form of patient BT106’s DNA, contains one or more of the mutations or polymorphisms from SEQ ID No 1. What is artificial about that?
MR SHAVIN: What is artificial is the isolation.
BELL J: We are back to the breaking of the covalent bonds, are we?
MR SHAVIN: Not just that. It is a more complex process. It is not like taking out a rubber snake, your Honour.
NETTLE J: There is nothing new in using those processes to isolate particular fragments. It is as old as the hills now.
MR SHAVIN: But what the High Court said in NRDC is that you must look holistically. You do not say “have you got novelty at every stage?” If you have got the new use, you do not need to have a novel method of application.
NETTLE J: But what is the new use?
MR SHAVIN: Here, we have – because we are talking not about a process, but a product – we have a new product, we have the isolated form. That is a form which is not the same as anything that is previously found. It is created artificially. We are assuming novelty here, we are assuming inventiveness ‑ ‑ ‑
BELL J: It is created by cleaving the bonds which may or may not be relevant to the segment that corresponds to the description for the purpose of the claim. What, beyond that, is relied upon for the artificial state of affairs?
MR SHAVIN: We say that it is artificial because of the three characteristics that were accepted below.
BELL J: So, the structure – that is, it is no longer wrapped around the histones ‑ ‑ ‑
MR SHAVIN: And it no longer has a cap or a poly‑A tail. It no longer has introns, or most of them ‑ ‑ ‑
BELL J: When you say it no longer has the poly‑A tail, it may be that the segment that answers the description in claim 1 – that is, the infringing substance – is in the middle of a larger quantity of material that has been separated, and so the absence of a poly‑A tail, one might think, is neither here nor there.
MR SHAVIN: Save with respect that if it is a fragment from the middle, it is plainly structurally different, because intracellularly the gene is intact. It is intact albeit that between the coding sequences – as we saw, the coding sequences are a very small portion of the matter found within the gene ‑ ‑ ‑
NETTLE J: But the string of nucleotides is still in exactly the same form it was in the body of the woman.
MR SHAVIN: Save that there are things in the middle that have been removed.
NETTLE J: The exons.
FRENCH CJ: Is that necessarily derived from the claim?
MR SHAVIN: Yes, and when you look at the definition ‑ ‑ ‑
FRENCH CJ: In other words, the claim would not cover an isolated nucleic acid where their introns were retained.
MR SHAVIN: “Isolated” is defined on page 26 of the patent, which is – 409, I am sorry:
substantially separated from other cellular components which naturally accompany a native human sequence or protein ‑
FRENCH CJ: That does not exclude introns, does it?
NETTLE J: The sequence is still the same for the nucleotides.
MR SHAVIN: The sequence is still the same, but the sequence does not appear as a sequence of codons that are all adjacent to each other in a nice tight little line.
FRENCH CJ: That is right, the sequence ‑ the claim is defined by reference to the sequence but the sequence may manifest in a variety of ways, including with introns in between, as it were, the various exons.
MR SHAVIN: Yes, and wrapped around histones, and in circumstances where the sequence alone does not determine the polypeptide that is produced because what comes out depends where the reading frame starts, and if you are taking a fragment, of course, you are producing a different polypeptide with the fragment.
BELL J: But can I just understand this. The reference to the reading frame ‑ this is to the idea that within the cell you may have the starting point for a particular production of a polypeptide ‑ may differ by one nucleotide and then you will get a different amino acid. Is that roughly right?
MR SHAVIN: Yes, it is, absolutely, if your Honour pleases.
BELL J: Well, how does that relate? If we just come back simply to the words of the claim ‑ ‑ ‑
MR SHAVIN: Yes, your Honour.
BELL J: ‑ ‑ ‑ either one has an isolated nucleic acid which codes for one or more of the mutations in SEQ ID No 1 in the tables or it does not. So, being aware that in fact one may, within the cell, have activity which does not produce that result, does not assist us with understanding necessarily what is artificial about the case, when one takes patient BT106’s tissue, isolates a portion of it, and happens to get from that portion of that patient’s tissue correspondence with the sequence in the claim.
MR SHAVIN: Yes. There is no contest, your Honour, that to be useful you will have a correspondence of a sequence or a part of a sequence but, in our respectful submission, that is not looking to determine whether the product claimed is artificial, as opposed to something underlying it.
Our friend took the Court to Kirin‑Amgen, the erythropoietin case, where Lord Hoffmann said it was quite wrong to identify the invention by reference to some tables in the body of the specification rather than to look at the product claimed, and here the product claimed is the isolated nucleic acid with certain characteristics and, in our respectful submission, to look to underlying information and to say, that is in fact what you are claiming, is to fall into the same trap that Lord Hoffmann criticised the patentee in Hoechst Marion Roussel.
NETTLE J: Mr Shavin, could I just endeavour to clarify for my own purposes, when one takes out the section of the DNA which may code to the SEQ ID No 1 sequence one take a variable length of nucleotides?
MR SHAVIN: I am sorry, your Honour.
NETTLE J: One can take a variable number of nucleotides.
MR SHAVIN: Yes.
NETTLE J: Within that number, which one does take, is it or is it not the position that the sequence – the array of nucleotides is identical to what it was in the cell?
MR SHAVIN: It will be substantially similar; it does not have to be identical.
NETTLE J: What has changed? When it does change, what changes?
MR SHAVIN: We might be slightly at cross‑purposes, your Honour. SEQ ID No 1, of course, is a hybridised generalisation, so that people will vary to some extent, and what is being concentrated upon in the tables is certain particular variances.
NETTLE J: Certainly.
MR SHAVIN: There might be other variances, so it may not be identical, it might be substantially similar.
NETTLE J: No, no. When I – I being the pathologist to take and make a dose of isolated nucleic acid for the purposes of testing it against the table to see whether the polymorphism is there, once I have isolated that nucleic acid by the two processes mentioned by Dr Suthers, what is their difference between the isolated segment at which I am looking and that segment as it was in the gene?
MR SHAVIN: You will not find in the gene that segment as it is in the isolated form. You will find the nucleotides in the same sequence.
NETTLE J: Exactly. So the nucleotides are there in exactly the same order, exactly the same pattern, as it were, apart from three dimensional aspects about the curving which they were in the cell.
MR SHAVIN: Yes, but they cannot – the thing in the cell cannot do what the isolated can and the isolated ‑ ‑ ‑
NETTLE J: I have got all that. No, that is not what I am worried about. The sequence – the nucleotides are the same nucleotides that were in the woman’s cell and they are in the same order and array as they were in the woman’s cell.
MR SHAVIN: At least substantially, yes.
NETTLE J: Nothing has been altered by the process of isolation in either of those respects.
MR SHAVIN: No, no.
NETTLE J: All that has been done is strip away other bonds and other material through which those processes might be translated from the codons.
MR SHAVIN: To make something useful.
NETTLE J: And that is a process which has been taken for a number of years now by pathologists in isolating various fragments of nucleic acid in order to test them for mutations.
MR SHAVIN: Yes, but as I noted, there has been no challenge on obviousness or inventive step.
KIEFEL J: Is it, though, a process of purification, so to speak?
MR SHAVIN: There is some technical debate about ‑ ‑ ‑
KIEFEL J: All right, well, I will not go there.
MR SHAVIN: ‑ ‑ ‑ what is meant by purification. I just pause, your Honour, because sometimes purification is talked about of getting rid of impurities, so then you can have a debate as to what constitutes an impurity.
KIEFEL J: I meant, really, so that one can focus upon that product which is identified in the claims.
MR SHAVIN: In the primer, your Honour will have read that there is a mass of material within the cell and within the nucleus of the cell and all of that material operates to regulate the gene and the genome, and all of those regulatory influences which were colloquially described below as the “committee” have been stripped away. Now, whether one describes that as a purification or a separation ‑ ‑ ‑
KIEFEL J: I should not introduce unnecessary complications ‑ ‑ ‑
MR SHAVIN: No, no, it is a ‑ ‑ ‑
KIEFEL J: ‑ ‑ ‑ but I was really coming to this point. When you are looking for that part of the product, the isolated nucleic acid, which codes for the mutant or polymorphic elements, are you looking at any of the differences in structure et cetera of the isolated nucleic acid or are you not? What are you looking at?
MR SHAVIN: Well, you are trying to get rid of the structure that is within the cell so you can use it.
KIEFEL J: To come down to just this.
MR SHAVIN: Yes, and, of course, the way in which it is done which is described again within the primer, is that there are a number of ways of isolation and the most common one is to chop it up into small pieces to amplify it and to stitch them back together again. It is not simply a process of taking a piece of string, cutting it here and cutting it here. It is a much more complicated process.
We are not claiming that process, but the process results in destruction before reconstruction, and what you are seeking to do, your Honour, is you are seeking by the isolated nucleic acid to strip it of everything else so that you can concentrate on what were thought to be useful sequences, something you cannot do in its intracellular state. Indeed, the first step is lysis, that is, to burst the cell. So, to go back to the tree example, you do not have a leaf off a tree and still have a leaf, it is destroyed in the process.
NETTLE J: But you could cut a piece out of the leaf, break covalent bonds, have a different molecular structure to the leaf, and use it as a way of testing something about the tree, could you not?
MR SHAVIN: You will not have the leaf. You might have mulched it up.
NETTLE J: You could have a piece of leaf.
MR SHAVIN: You have mulched it all up.
FRENCH CJ: Claim 1: A piece of leaf.
MR SHAVIN: It is not just a piece – but you do not have the piece of leaf at the end, that is the thing. It has changed completely from the leaf and that, of course, was where in the US you had the difference between the majority and the dissent, because you had to destroy it. It is an inapt analogy to say that the isolated gene is the leaf because, in fact, it is destroyed and it is transformed, and what you have got does not in any shape or form resemble the physical leaf. You have something underlying it, but what you have created is artificial. It is new, in the sense that it is not anywhere else found.
NETTLE J: The string of nucleotides is not new. Have we not established that? The string of nucleotides ‑ ‑ ‑
MR SHAVIN: But the string of nucleotides isolated is new.
NETTLE J: What do you say, isolated?
MR SHAVIN: The emphasis is on the ‑ ‑ ‑
NETTLE J: Isolated or unisolated, it is common, is it not?
MR SHAVIN: I am sorry, your Honour?
NETTLE J: I said, isolated or unisolated, the string of nucleotides is common.
MR SHAVIN: Only in the sense that they exist, but not in the form in which they exist.
NETTLE J: Because they are stripped of the committee.
MR SHAVIN: Yes.
FRENCH CJ: You construct them according to the sequence that occurs in nature.
MR SHAVIN: Yes, but in doing so you have created something different.
KIEFEL J: You have brought the sequence out, in a form in which it is ‑ ‑ ‑
NETTLE J: Could be seen.
KIEFEL J: Yes.
MR SHAVIN: And used.
NETTLE J: But you did not put it together, did you?
MR SHAVIN: Well, only in the sense that you break it up to stitch it back together. If I could take the Court to the primer, at page 20, and the section of the primer that is relevant is really paragraphs 57 to 66. The parties in the primer have given the Court references both to judgments and to some of the underlying evidence, where it is spelled out in greater technical detail. But, in 57, it simply stated:
an isolated DNA sequence is a sequence of DNA that has been removed from its normal cellular environment.
You get a sample, the tissue sample is broken down – that is paragraph 58 – then:
The bursting of the cell membrane or the nuclear membrane is referred to as cell lysis and can be achieved through techniques –
which are there described –
In this way the contents of the nucleus, including the DNA and RNA, can be released into a free‑floating liquid suspension. Cell lysis results in the entire genomic DNA being released ‑
There is further detailed discussion in 60 to 62. Could I draw the Court’s attention to 63 where you have the process of isolating nucleic acid by extraction and purification and in 64 where Professor Rasko identified a number of techniques that may be used? For present purposes, that which is most relevant is a technique for template‑based DNA synthesis which involves the use of messenger RNA as a template to create complementary DNA called reverse transcription ‑ ‑ ‑
NETTLE J: We are not worried about that at the moment, are we?
MR SHAVIN: No. Then, that is described in 67, 65 and 66. If I could draw the Court’s attention to a very helpful passage ‑ ‑ ‑
NETTLE J: But where does it say here that you break down the order of the nucleotides and then reassemble them in the course of the process?
MR SHAVIN: Could I take the Court to a short extract of Mr Suther’s evidence which appears at page 40 of volume 1 of the appeal book? At about line 37, I asked Dr Suthers:
Now, if you had a gene in the chromosome, and you were going to isolate a sequence not by synthesising it but by extracting it, what you would need to achieve would be at least the following – I’m not saying all the steps?‑‑‑Sure.
You would need to break the hydrogen bonds between the bases?‑‑‑Yes.
And you would need to have at least some breaks in the covalent bonds so that you could take out an extract?‑‑‑Yes.
Now, when you break the covalent bonds between the sugar and the phosphate so that you can pull out your extract from the strand, in breaking that bond what you have isolated is chemically different, isn’t it –
Yes. Then, if I go to line 10:
In fact, in the mid‑1990s when you had something – we will say 100,000 bases, 100 kilobases long, you would normally break it up into much smaller pieces, wouldn’t you, and then amplify them?‑‑‑Absolutely.
And isolate them?‑‑‑Yes.
And in undertaking that process, which is the process, isn’t it, described by Professor Rasko.
Then, if I could take the Court to line 24:
The conventional way of doing it was that you would break it up into small pieces, you would amplify them and you would stitch them together. Talking colloquially?‑‑‑You may stitch the information together. You may, in some situations, physically stitch the amplified DNA together, but usually it was a matter of taking discrete bits of information from each of the fragments and knitting those together conceptually into information such as sequence ID number 1.
Does that help your Honour understand the process that is described by Dr Suthers – Dr Suthers, of course, being our friend’s expert?
NETTLE J: I think it does, Mr Shavin. So the net result of all of this is that the nucleotides are disarrayed in the course of the synthetic process and then re‑arrayed again back into their original order. Is that the case?
MR SHAVIN: Yes, but without the committee.
NETTLE J: Without the committee. But you do change the order and then reassemble it again.
MR SHAVIN: Yes, or you break it up. Whether you change the order – what you are doing is – it is effectively taking something and you have got lots of little snippets floating around.
NETTLE J: Yes.
MR SHAVIN: If I can describe this at a very high level of generality. Then there is a process of matching the snippets up and reassembling them. It is done chemically and there are ways in which you can use probes to find them. It was a tedious process back in the 1990s. I think it is a somewhat simpler process now.
NETTLE J: Thank you very much.
MR SHAVIN: So, line 41, you see:
Yes, and when you break up the gene into a number of small pieces, each of those small pieces will be chemically different –
which it is.
NETTLE J: That is because they have different lengths and different things around them.
MR SHAVIN: Yes.
NETTLE J: But not the essential nucleotide structure is different, is it?
MR SHAVIN: No. Well, only to the extent that you have a fragment of the whole rather than the whole.
NETTLE J: Yes.
MR SHAVIN: Yes. But we are not saying that the nucleotide sequence in the isolated nucleic acid is relevantly different to a sequence in SEQ ID No 1.
NETTLE J: I appreciate that, but what I really am struggling with is whether or not, in the course of this process of isolating the nucleic acid, the order of the nucleotides is altered and then reassembled in the order in which it was in the cell, or not.
MR SHAVIN: My understanding of the correct answer to that is that in many instances, yes, there are a number of different ways that were known at the priority date of isolation. As Dr Suthers says, the way in which it was generally done was to break it up. That is because it is easier to deal with very small fragments than it is to deal with large ones.
NETTLE J: Yes, he did say that, but he never suggested that you altered the nucleotide order in breaking up the small fragments.
MR SHAVIN: You are not reassembling it into a different order. If I implied that, I was in error and I apologise.
NETTLE J: Well, it is really the essence of the matter. If you disarray the nucleotides and then reassemble them in an original order in the course of a synthetic process, then I might readily understand that what you are doing is making something artificial and new. But if all you are doing is stripping away something and leaving what was there, the creation of nature, then it may well be different.
MR SHAVIN: Yes. My understanding, your Honour, from the evidence of Dr Suthers is with the former, not the latter.
NETTLE J: Thank you.
KIEFEL J: Could I take you to the re‑examination of Dr Suthers at appeal book page 77? I think this is something in the nature of a summary of his earlier evidence. He talks about isolating the DNA of the 24‑year‑old woman who has been discussed, and then at about line 43, he says:
At that point, we have got something that is clearly not natural because the DNA sequence is devoid of its partners – of its committee. It’s devoid of all those co‑dependent factors that allowed the functions of DNA to be carried out. But the DNA is – it’s been extracted, the things that we don’t want to look at have been removed, so I wouldn’t categorise it as artificial in the sense of being synthesised. But I would classify this as being artificial in the sense that it’s not natural.
MR SHAVIN: Yes.
KIEFEL J: The part that I am interested in, of course, is the reference to “But the DNA [has] been extracted, the things that we don’t want to look at have been removed”.
GORDON J: In fact, it is the next bit of the re‑examination which continues which is critical. What it then says is it still carries the code, and in fact, if it did not carry the code, the test would be of no assistance. When you actually stop to ask yourself “what is it I have”, the purposes of your comparator in claim 1 – the product which is produced is not a new product in the sense that the isolation of a nucleic acid has been done beforehand, and the things which bring about the isolation, which is the stripping away of the committee, the structure is irrelevant to your comparison in determining whether or not the mutants or the polymorphisms exist. The chemical properties it had in the cell are irrelevant because they are not relevant to doing the comparator at that point in time, as is the function in the cell because they are not relevant to identification of the mutants either. Is that not the position - in other words, the critical focus is that which is the last - at lines 10 to 19 of the re‑examination.
MR SHAVIN: We respectfully say no, your Honour. The essence that gives the isolated nucleic acid its utility is that it has been isolated. You could not simply take the cell and use it. The cell would be useless to you. The utility comes from the isolation. What you isolate is something which, as your Honour has said, has the same sequence, but you get to the sequence by the isolation, and without the isolation, you do not have something of utility. What is not claimed is the code. What is not claimed is the DNA sequence.
KIEFEL J: What is not claimed is the method of isolation, but what it is that you have isolated.
MR SHAVIN: Yes, it is the product, not the process.
KIEFEL J: What you have isolated is the same genetic code.
MR SHAVIN: Yes, but in isolation, you have created something quite artificial. That is the interesting part of this claim, because when one looks at the analysis of this Court in NRDC, in trying to identify what it is that is embodied within the phrase, “a manner of new manufacture”, through all of the analysis over the 19th and 20th centuries, which is when the discussion effectively evolved, this Court concluded that the way you characterise patentable subject matter is to look to an artificially created state of affairs. But, it also said that you have to look at it holistically. You cannot just look at part of the process and say, that is old. Could I refresh the Court’s memory – at NRDC, if the Court has NRDC available? If I could take the Court to the line that is just below the reference to Justice Windeyer?
KIEFEL J: I am sorry, which page are you, Mr Shavin.
MR SHAVIN: Page 264 – I do apologise.
KIEFEL J: Thank you.
MR SHAVIN: My learned friend referred to National Research Development Corporation v Commissioner 102 CLR 252, and particularly at 264. Does the Court see the sentence:
But where a person finds out that a useful result may be produced by doing something which has not been done by that procedure before, his claim for a patent is not validly answered by telling him that although there was ingenuity in his discovery that the materials used in the process would produce the useful result no ingenuity was involved in showing how the discovery, once it had been made, might be applied. The fallacy lies in dividing up the process that he puts forward as his invention. It is the whole process that must be considered; and he need not show more than one inventive step in the advance which he has made beyond the prior limits of the relevant art.
So that what, in our respectful submission, the Court is saying here is, you look to see if you have got an artificially created state of affairs – let us put to one side utility. We know that here there is no issue as to inventiveness and there is no issue as to novelty. So, at that point, it does not answer Myriad’s claim for a patent to say, well, the process of isolation was known.
Other things may have been known. Plainly, what was not known was the structure of the gene. What is produced as a new product, that is the artificial nucleic acid with certain criteria and characteristics articulated in claim 1, but to say, well, you did not create the mutations of polymorphisms or to say you did not create the process of isolation, given that we have got no challenge to novelty and obviousness, is not an answer to the claim, is this patentable subject matter, in our respectful submission. Here, because we have an artificially created state of affairs of utility, we satisfy the criteria for patentable subject matter within the meaning of 18(1)(a) or the precatory words, as discussed by this Court in Mirabella.
NETTLE J: But you are not claiming a process.
MR SHAVIN: No.
NETTLE J: So it is not relevant to inquire whether your process results in an artificial state of affairs of economic utility. This reasoning is directed to that proposition, rather than to whether a product of manufacture has been produced.
MR SHAVIN: Yes, save that the Court drew all this together at 277.
NETTLE J: The passage we were taken this morning?
MR SHAVIN: Yes, because the Court was, of course, in NRDC, concerned with a process ‑ ‑ ‑
NETTLE J: Yes.
MR SHAVIN: ‑ ‑ ‑ and then it took the analysis and made the comparative analysis to a product and, in our respectful submission, there is a parity of reasoning. If in fact you have got a product which is an artificially created state of affairs, it does not mean that every element of the product has to be inventive.
NETTLE J: No, but it does not mean either, does it, that simply because you have got an artificially created state of affairs of economic utility, you have got a product.
MR SHAVIN: But there is clearly a product here. There is a chemical entity that is claimed.
NETTLE J: That is the question, is there one.
MR SHAVIN: In our respectful ‑ ‑ ‑
NETTLE J: That is what is claimed. The question is, whether it exists.
MR SHAVIN: Well, it is accepted as being of utility, your Honour.
NETTLE J: Certainly.
MR SHAVIN: So, it must exist, or be capable of existing, as long as you articulate ‑ going back to fundamentals ‑ as long as you articulate your invention and a method of producing it. You do not actually have to have produced it. In fact, they had, but there can be no doubt that there can be an isolated nucleic acid that falls within claim 1. That is why we are here.
BELL J: It is a question of whether ‑ ‑ ‑
MR SHAVIN: It is a real acid.
BELL J: What is the artificial state of affairs that claim 1 is directed to. You take artificiality by reference to the three features that do not bear on the essential characteristic of claim 1 which is the description, namely, matching the mutations or polymorphisms in the tables to SEQ ID 1.
MR SHAVIN: We respond to that, your Honour, by saying that your Honour is overlooking the word “isolated” because in isolated is the element that is artificial and the three characteristics to which we point show the difference between that which is created and that which was heretofore in existence.
GORDON J: Can I test that proposition? I had understood from the way you put your argument that if I isolate the nucleic acid which does not have the mutations, I have not infringed the patent. So, the isolation itself cannot be the element.
MR SHAVIN: Yes. It is what you isolate, your Honour.
GORDON J: Justice Bell’s question ‑ ‑ ‑
MR SHAVIN: Can I amplify that response? You have to isolate a nucleic acid which has the characteristics of the limitations in claim 1, so that in claim 1 the characteristics of the isolated nucleic acid has to be that it codes for a mutant or polymorphic BRCA1 polypeptide containing in comparison to the sequence in SEQ ID No 1 one or more of the mutations on polymorphisms from those set forth in the tables.
NETTLE J: But you cannot manufacture that. No matter what you do, you cannot put it in there, it is there.
MR SHAVIN: No, you are isolating it.
NETTLE J: Granted, but in that much which is left after the process of isolation, the sequence is and was always there. You did not put it in there.
MR SHAVIN: No, but, in our respectful submission, a patent is not confined to something that is manufactured in the traditional sense. That is why the High Court moved away from the very narrow version of vendible product in Morton J’s rule to an artificially created state of affairs. The very essence of the development that is traced through from pages 269 to 277 of NRDC is to show the growth of the concept of manufacture, so that although there was a word and the Court said do not get hung up on the word “manufacture” ‑ this is at page 262, 263 ‑ when you are looking at the Statute of Monopolies you are looking at a concept and the concept that was articulated through a discussion of the authorities from the mid‑19th century was to say that a manufacture is an artificially created state of affairs. It does not have to be something you produce in a factory.
NETTLE J: But you must create the artificial locality.
MR SHAVIN: Yes, and we do from – we have not taken some ore from the ground and put it in a smelter. We have taken some plasma or a cell and we have isolated from it something which can be used which has a different chemical structure, a different function.
FRENCH CJ: But if you had taken ore from the ground and put it in a smelter and got some gold out of it, putting aside questions of novelty and obviousness, you would say the gold is a manner of manufacture, in a logically consistent way to the way in which you say this is a manner of manufacture.
MR SHAVIN: There would be differences – you would have minor problems with inventiveness and obviously ‑ ‑ ‑
FRENCH CJ: Assuming that gold is in the ore in a bound state and you reduce it and ‑ ‑ ‑
MR SHAVIN: Yes, but the gold would be there as gold. Here you do not have the sequence separated physically as a sequence. If I could take the Court back to 270 in NRDC, after the discussion – the line next to “Commissioner of Patents”, after reference to Boulton v Bull, the Court said:
it was finally settled that “manufacture” was used in the Statute of Monopolies in the dual sense which comprehends both a process and a product . . . But a question which appears still to await final decision is whether it is enough that a process produces a useful result or whether it is necessary that some physical thing is either brought into existence or so affected as the better to serve man’s purposes. In some of the cases it is suggested that the process must issue in some “vendible matter” or a “vendible product”. The former expression was used by Heath J. in Boulton v. Bull in the course of maintaining the opinion, which must now be considered heretical, that there could not be a patent for a method, but no such expression appears in the powerful judgment in which Eyre C.J. maintained the opposite view and reached the conclusion in the particular case which was ultimately upheld in Hornblower v. Boulton. Abbott C.J. in R. v. Wheeler having spoken of a “thing made, which is useful for its own sake, and vendible as such”, went on to show that he did not find in such expressions as those any absolute test. He said (the italics are ours): “Something of a corporeal and substantial nature, something that can be made by man from the matters subjected to his art and skill, or at the least some new mode of employing practically his art and skill, is requisite to satisfy this word”. It is of course not possible to treat such a statement as conclusive of the question. The need for qualification must be confessed –
and then we get into C. & W. which is not relevant here. If one then moves forward to page 276 – and this is about six lines from the end of the main – the principal paragraph. Does the Court see:
It is, we think, only by understanding the word “product” as covering every end produced, and treating the word “vendible” as pointing only to the requirement of utility in practical affairs, that the language of Morton J.’s “rule” may be accepted as wide enough to convey the broad idea which the long line of decisions on the subject has shown to be comprehended by the Statute.
Now, perhaps that is the clearest articulation that leads into, on the next page, the artificially created state of affairs, and ‑ ‑ ‑
GAGELER J: Mr Shavin, what is the relationship between the artificiality and the utility that is referred to on page 277? If you can identify the characteristics that make a state of affairs artificial must it be the same characteristics that make that state of affairs of utility?
MR SHAVIN: Yes, but in our respectful submission, that is so here, because the reason that it is useful is because it is isolated. If you simply had the sequence, the sequence alone is not going to be useful to you.
GAGELER J: Well, you ‑ ‑ ‑
MR SHAVIN: It is only because it is isolated. It is a combination of the isolation and what it is you have isolated that gives you something of utility.
BELL J: You explained this in part in your submissions on page 12, where you point to the uses that the isolated product can be put to. But, these are the matters that are the subject of the succeeding claims that are not challenged. There does seem to be a tension that Mr Catterns identifies in the reasoning of the Full Court between the utility that is identified in paragraph 8 and then their Honours’ conclusions at paragraph 214 and following.
MR SHAVIN: This one, as we respectfully submit, encompasses the other. If we look back at the two paragraphs in the Full Court, which is to be found – paragraph 8 is to be found on page 662 of volume 2 - here, the court notes that:
In that context, humans intervene to isolate the nucleic acid that is different in chemical composition from its state in the body, and to assess whether that which is present in that (different) isolated product by way of exon sequence coincides with what has been found, by work and effort, to be a sequence (derived itself from a human‑made product, cDNA) that bespeaks susceptibility to cancer, and so to be bring about a useful effect, being a state of knowledge for the person upon which to contemplate, or assess, treatment.
Now, if we go to 194 – I think it was 194 to which your Honour ‑ ‑ ‑
KEANE J: Paragraph 214.
MR SHAVIN: I am indebted to your Honour Justice Keane. This is page 708:
The isolation of the nucleic acid also leads to an economically useful result – in this case, the treatment of breast and ovarian cancers. This is surely what was contemplated by a manner of new manufacture –
They have a state of knowledge which is to contemplate or assess treatment. All that is being referred to in 214 is the next stage.
KEANE J: But that is the point, is it not?
BELL J: It is a significant leap, is it not? There is no contest as to the patentability of the methods of treatment and the other matters, the use of probes and vectors and the like. What is in dispute is the generality of claim 1, and 2 and 3. In that respect, they are claims, are they not, which are akin to the claim that the United States Supreme Court observed, if valid, would give the exclusive right to isolate an individual’s BRCA1 and BRCA2 genes, or a strand of 15 or more nucleotides with the genes.
MR SHAVIN: Yes. If one is looking ‑ ‑ ‑
KIEFEL J: That is right, is it not, though, Mr Shavin? That is what follows. That is the right claim by the patent?
MR SHAVIN: Claim 1 is limited to isolating the acid which has the qualifications.
KIEFEL J: But tested by reference to infringement. The only way one could avoid infringement is not to test for what is in claim 1; that means, at all.
MR SHAVIN: By testing what is in claim 1, the monopoly would extend to testing for the mutations in the tables, but not outside them.
KIEFEL J: But you could not avoid that.
GORDON J: You are not going to know they exist until you test, so therefore, as a pragmatic matter, you have restrained any testing.
KIEFEL J: Which, I think, brings into focus here the difficulty which the NRDC Case, of course, addresses. What is it that is actually the end produced here that is the subject of the claim? That is what we are having difficulty with.
MR SHAVIN: My answer is to suggest to the Court that it is a mistake to test patentability by infringement. The first step in the process in section 18 is to determine whether you have patentable subject matter. Then, there are a series of tests in section 18 and section 40 for determining the validity of the claim. We are concerned only with determining the first step, that is, are we in the field of patentable subject matter.
At that level, we say, that in determining utility you do look at that which makes it artificial because here it is the isolation – the fact that makes it artificial that provides this thing with the utility that enables you to do the testing.
KIEFEL J: But, critically, what you are doing at either the test for patentability or for infringement is looking at what is the subject matter of the patent.
MR SHAVIN: Yes. Here, we would respectfully suggest – your Honours use the word of the patent ‑ ‑ ‑
KIEFEL J: Subject matter of the claim.
MR SHAVIN: Yes, I would narrow into the claim, if we could respectfully suggest that.
KIEFEL J: I am pleased I corrected myself. Thank you, Mr Shavin.
MR SHAVIN: They may not be the same. Certainly, the patent is wider than the claim.
KIEFEL J: Yes, quite.
MR SHAVIN: The disclosure in the patent is much wider.
FRENCH CJ: Is the claim in substance – this is sort of an unease I have that we are somehow at the boundaries between product and method.
KIEFEL J: Yes.
FRENCH CJ: If one were to reclaim one simply by changing it to say the isolation of a nucleic acid coding for, et cetera, how would it be different in substance in terms of the monopoly it would confer? It would have the same practical effect precisely, would it not?
MR SHAVIN: It may do, your Honour. I have not really thought of it in process terms because this is one of those claims which is plainly delineated in product terms rather than process or product by process.
FRENCH CJ: Well, I am just wondering about that – whether this is a jumped‑up method - putting it crudely, Mr Shavin.
MR SHAVIN: We would not accept that it is a jumped‑up method, your Honour.
KIEFEL J: But, so much of the focus of what you have said has been upon isolation as the creation of the artificial state of affairs.
MR SHAVIN: Yes – but not the method of isolation.
KIEFEL J: But, no, you have pointed, actually, to so many aspects of its complexity ‑ ‑ ‑
MR SHAVIN: Yes.
KIEFEL J: ‑ ‑ ‑ to help us towards seeing the artificial state of affairs as something which has involved great change. That has been part of your advocacy on this topic.
MR SHAVIN: Absolutely, your Honour, we accept that. But we do that not to show that there is invention in the method but we do that to show that what you end up with is different – chemically, structurally, functionally – to what you had in the cell.
KIEFEL J: That there are differences.
MR SHAVIN: That there are differences.
KIEFEL J: It might be a different way.
MR SHAVIN: The distinction that, in our respectful submission, you can find between NRDC and the United States, to which we will come in due course, is that in the United States they look for a sameness with nature. In NRDC, you are looking for differences. You are looking for what makes it artificial.
KIEFEL J: The question is whether or not it is a relevant difference, is it not, if we are looking for – in the claim – what codes for. The question has to be relevant to what codes for.
MR SHAVIN: We would respectfully differ with that. See, what is claimed is a new chemical entity. The end produced is the artificially – is the isolated, sorry, nucleic acid that codes for – not just something intracellularly that codes for.
KIEFEL J: Yes, I appreciate the distinction.
MR SHAVIN: Yes, there is – and we accept what your Honour said and Justice Gordon and Justice Bell, I think, have been putting the same issue to me in slightly different ways is that this is not a claim which says that what we have produced is a mutant or polymorphic BRCA1 polypeptide. That is not what is claimed.
What is claimed is the isolated nucleic acid, which possesses nucleotide sequences – chemical entities for such polypeptides. But, the emphasis on the artificial is isolated, and that is what gives it utility, so that the nexus that one might find in 277 of NRDC, in our respectful submission, is present here because the real distinction is the thing that gives it value. Without the isolated nucleic acid, you do not have something of value.
GAGELER J: Mr Shavin, the chemical differences, the structural differences and the functional differences between the isolated nucleic acid and the intracellular nucleic acid are what you rely on to show the artificiality of the product.
MR SHAVIN: Yes.
GAGELER J: The difficulty I am having is that none of those differences appear to be relied on to give the isolated nucleic acid utility. The utility relies not on the differences, the artificiality, but on the similarities, substantial identity. That is my problem.
MR SHAVIN: May we approach it in this way. Your Honour has put to me the observe of the proposition which I have made a few minutes ago, where our principal submission is that that which gives utility to the nucleic acid sequence is that it is isolated. What your Honour is saying to me is that what gives utility to the isolated acid is that it has the coding sequence. What that points to is that they are complementary, that what you have of utility is the sequence isolated. That which makes it artificial is the isolation, and the fact of isolation makes it useful.
But it is not being said that the sequence is what is artificial, but it is the form in which you find it. If you find the sequence in the cell it will have a function, all being well, subject to the committee, it will produce a polypeptide. But when you take that sequence outside the cell, you isolate it, you create it in an artificial form, it has an entirely different functionality. It has an economic utility.
So you vest the sequence with the utility by its isolation. Isolation alone, absent the sequence, is not useful. Sequence, absent isolation, is not useful. What gives the sequence the utility is the artificiality of it not being in the cell, of it being extracted from the cell into an artificially created state of affairs of utility, which is ‑ ‑ ‑
BELL J: I am sorry, but there just seems to be some level of conflation of claims 1, 2 and 3 with the claims that follow and in respect of which the utility is apparent and it is the issue, I think Mr Catterns touched on this in his submissions, in the Full Court’s reasons at 701, paragraph 181, their Honours observed that:
the limitation in claim 1 to an “isolated” nucleic acid is the operative factor –
and they go on to say –
even more so where a short nucleic acid which has no demonstrated function in the genome, is isolated and utilised.
Now, the difficulty I think – well, for my own part, that I am having, is appreciating the utility other than the state of knowledge to which the Full Court referred at paragraph 8 of the isolated nucleic acid that has the coding for the mutation or polymorphism.
MR SHAVIN: In our respectful submission, the error is to try and break it down and look for utility in each part because the utility of the short acid comes from the fact it is isolated. Anything isolated by itself does not necessarily have utility but if you simply found in the cell that short string of bases, that is not going to give you utility. By itself, it does not do anything in the cell but it gains a utility when you isolate it and then you have a product and it is the product which is claimed that has utility.
So, certainly the isolated nucleic acid depends upon what it is that is isolated to be useful but what it is that has been isolated is useful only because of the fact of isolation because otherwise in its natural state it does not have that utility.
KIEFEL J: But its economic utility surely cannot be described as being either, on the one hand, no utility because it is in the body and utility because it is now out of the body. It may be accepted that in vivo that it is not useful for the purposes of the claims, but its isolation surely just serves as a platform for its economic utility and its true economic utility for claim 1 is evidence or knowledge for diagnosis. That is its area of economic utility. Isolation is the step towards that.
MR SHAVIN: Yes, but it is the fact of isolation. It is the isolation that creates the product that is separate, that is artificial, that is useful.
KIEFEL J: But the isolation is not the end result of the state of affairs which gives its economic utility. You have to go a step further. You have only got to a particular point. You have isolated it, you have made it clear. Its utility, its application, I think that is the step you are missing, its application lies in its use for diagnosis for claim 1.
MR SHAVIN: But its application is possible only ‑ ‑ ‑
KIEFEL J: Yes, but that is the springboard of the platform. You are just saying if there is an essential feature that is sufficient for patentability.
MR SHAVIN: The defining characteristic in terms of why it is artificial is also the defining characteristic that enables it to be of utility.
GORDON J: But, I thought, Mr Shavin, you accepted that there would be some isolations which would not have the necessary mutants and therefore would not have that utility. So, it cannot just be the isolation, because that would not infringe the patent. It does not fall within your claim.
MR SHAVIN: When I was talking of the isolation that gives utility, I am only talking of the isolation that is within the scope of the claim.
NETTLE J: So it is really a claim for a monopoly to isolate the BRCA1 gene from the DNA of a woman who happens to have one or more of the scheduled mutations or polymorphisms?
MR SHAVIN: Yes, where we have identified the mutations and polymorphisms.
NETTLE J: Yes.
MR SHAVIN: Yes, and the question of course, which I hesitate to remind the Court, but perhaps it is important in the scheme of the dialogue, is that what we are looking at is, is that patentable subject matter? It is very easy to slide into some of the other territory and what, in our submission, is the issue and the only issue that is raised by our friends in this proceeding is whether that is patentable subject matter. Is it a manner of manufacture to isolate something so that it is in a form which has the three forms of difference – chemical, structural, functional – that enables it to have the utility that your Honour Justice Kiefel has put to me.
NETTLE J: I was just wondering, having regard to what the Chief Justice said a little earlier, light heartedly, but I perhaps more seriously – what we think is perhaps the possibility that claim 1 is contrived to make appear as if it were a product claim, what in truth is a process claim, the process being to isolate the BRCA1 gene in order to examine it to see whether there is evident the mutations or polymorphisms in the schedule.
MR SHAVIN: That is not what is claimed.
NETTLE J: I see that. That is why I think it might be said it is a little – the Chief Justice’s expression was “trumped up”, or “contrived”, anyway.
MR SHAVIN: Contrived, yes ‑ ‑ ‑
NETTLE J: To make appear what is in truth a process claim appear to be as if it were a product claim.
MR SHAVIN: There are, of course, a number of specific process claims.
NETTLE J: I appreciate that ‑ ‑ ‑
MR SHAVIN: In the claim ‑ ‑ ‑
NETTLE J: This is a bit like the “reach too far” in the House of Lords, is it not?
MR SHAVIN: Well, we would respectfully say no because here we are claiming something that, in our respectful submission, falls plainly within NRDC. Now, in the House of Lords, of course, erythropoietin was before the UK had given effect to the European Directive because, as the trial judge noted, in 2000, the 1977 Act in the UK was amended by the insertion of 76A and annexure 2. The effect of that was to give full force and effect in the UK to the directive, Article 5(2), so that in the UK now, in our respectful submission, this would be plainly patentable.
NETTLE J: I suppose what bespeaks the contrivedness of claim 1 is that one falls within the scope of the monopoly if, fortuitously, one takes the BRCA1 gene from a woman who has the mutations, but not if he does not. If he takes them from a healthy woman, then he does not fall within.
MR SHAVIN: Yes.
NETTLE J: It is a very odd state of affairs for something which is supposed to be created artificially. It is a useful state of affairs of economic consequence.
MR SHAVIN: It is perhaps not in the same form as a number of claims that your Honour would see in other patents, but the question raised still is if this was not to fall within the confines of NRDC, where and why are you drawing the boundary, because we see in the United States that they draw a boundary around laws of nature and natural phenomena and they go through what was described ultimately analysis - a two‑stage process the Court will be familiar with.
One of the interesting observations one can make of the United States jurisprudence is that in Chakrabarty something is found to be plainly patentable because it is non‑natural, and in Myriad the United States Supreme Court held that notwithstanding that it was non‑natural, it was not patentable subject matter.
NETTLE J: The big difference with Chakrabarty is that the sequence was put in by the introduction of the extraneous bacteria.
MR SHAVIN: Yes. Accepting that, your Honour, it was the description of the justification for making it patentable and the contrast that can be found in the United States Supreme Court. Can I take the Court to those two passages, because in understanding the rationale for the result in the United States there are significant implications for what is the law in Australia? Could I take the Court first to Chakrabarty to which my friend took the Court earlier, Diamond, Commissioner of Patents and Trademarks v Chakrabarty (1980) 447 US 303– it is in my friend’s bundle –and at page 110 of our friend’s bundle, if the Court has that.
GORDON J: What page number of the case is it, Mr Shavin?
MR SHAVIN: The case starts at 303 and in the bundle I am looking – I have just lost my page.
BELL J: In the bundle it is at 110.
MR SHAVIN: Yes, at page 116 of the bundle, page 309 of the opinion of the Court, in the paragraph at the bottom of the page:
Judged in this light, respondent’s micro‑organism plainly qualifies as patentable subject matter. His claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter – a product of human ingenuity –
Now, when we come then to the decision of the United States Supreme Court in Myriad 133 S Ct 2107, to which our friends took the Court before, at page 2118 in the left‑hand column the court said in the paragraph starting a third of the way down the column:
Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and therefore creates a nonnaturally occurring molecule.
So that the test in Chakrabarty of non‑naturally occurring evolves by the time you get to Myriad, where non‑naturally occurring is no longer the litmus test. Now, our friend ‑ ‑ ‑
BELL J: It depends on the meaning of “non‑naturally occurring”. One simply cannot take Chakrabarty involving the genetic engineering by the introduction of the plasmids into the microorganism as relevantly bearing on the way the test is expressed in Myriad. It is apples and pears.
MR SHAVIN: At one level, with respect, we would accept what your Honour says, but at another level, it is not, because the question is in defining what is the limit of patentable subject matter. The approach that was taken in the United States was quite different to the approach that was adopted by this Court in NRDC.
BELL J: At the moment, I am just testing with you the question of the distinction; your suggestion that the United States Supreme Court was moving on and abandoning the Chakrabarty test. That really seems, in the context of the non‑natural occurrence being described in Myriad, to be perhaps putting it too high.
MR SHAVIN: If I accept that, and perhaps if I might rephrase it in this way. This Court in NRDC accepted the criticisms of Justice Frankfurter in Funk of having something that one might describe as a “laws of nature” exemption. It was in fact the application of a “laws of nature” exception that caused the United States Supreme Court to reject the Myriad claims that were before that court. When one then tries to tease out what is meant by a “laws of nature” exception, in Chakrabarty, the conclusion that was drawn by the court is that because of the changes that had been made, it was a non‑naturally occurring substance. But when one gets to the approach that is adopted by the Supreme Court in Myriad, the non‑naturally recurring substance is not the test which one uses to determine whether or not something falls within, or falls outside, the “laws of nature” exemption.
Our friend said we can gain a great deal from the United States because section 1 is very similar to our section. We would, with love and affection, differ from our friend because when one looks to section 1 and the form of section 1 – 101 – it is materially different. The form has been put in our friend’s materials – this is Title 35, section 101:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of the title –
I am sorry, your Honour, I have gone in front of you.
BELL J: Go ahead.
MR SHAVIN: What, of course, we do not have is the broad language, which had such a flexible development in the English and Australian common law of a manner of new manufacture. Thus, the approach that was taken was to look at the dictionary, for example, to determine the meaning of manufacture within the class that appears within that section. That was to be found in Chakrabarty where, at page 115 of our friend’s bundle, the court said:
Guided by these canons of construction, this Court has read the term “manufacture” in § 101 in accordance with its dictionary definition to mean “the production of articles for use from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand‑labor or by machinery.”
So that you do have ‑ ‑ ‑
FRENCH CJ: What page of the judgment was that? Some of us are working from electronic devices.
MR SHAVIN: I quite understand, your Honour. It is at page 308 of the judgment.
FRENCH CJ: Thank you.
BELL J: But then the judgment goes on to talk of the legislative history supporting a broad construction and by reference to the Patent Act of 1793 to the statutory subject matter:
as “any new and useful art, machine, manufacture, or composition of matter, or any new or useful improvement –
That is a truly broad definition.
MR SHAVIN: It is a broad definition but in a different statutory context.
BELL J: Just in terms of the significance of the differing statutory contexts, one sees in neither a statutory set of exclusions. So that one sees, by reference to the NRDC Case, the notion of eligible subject matter being an artificial state of affairs having economic utility ‑ ‑ ‑
MR SHAVIN: Yes.
BELL J: ‑ ‑ ‑and in the United States one sees the idea of ineligible subject matter being those things that are products of nature.
MR SHAVIN: Yes.
BELL J: And, at a crude level, Mr Shavin, there does seem to be a certain correspondence between the two.
MR SHAVIN: Save for this. What I was seeking to demonstrate in the contrast in the language – or a contrast of the expressions used in Chakrabarty and in Myriad by the United States Supreme Court – is that as Justice Frankfurter had said, the concept, or language such as laws of nature or product of nature, is perhaps not helpful because, at the extreme, everything is a product of nature. So, where do you draw the line? In trying to determine patentable subject matter, what one has found in the United States is that it has evolved over a number of cases where language that has been used perhaps to guide everybody as to what is being meant by the section, has been applied in different ways.
The beauty of the principles that were articulated by this Court in NRDC was to go to the essence of the question of what is patentable subject matter. And, as this Court has said, perhaps your Honour the Chief Justice, in slightly different language to Justice Kiefel and Justice Crennan, but was to look at what would be the justification for an exclusion of a method of medical treatment. In other words, if you are going to hive something out, what normative principle is going to guide you?
In our respectful submission, when one looks at patentable subject matter, the formulation by this Court in NRDC, which perhaps is why it was such a celebrated case around the world where so many countries followed it, is because it goes to the essence of the answer to the question: Is this proper subject matter for protection within the Statute of Monopolies? You do that in respect of a product by asking a very simple question. Is it an artificially created state of affairs? Is it vendible? Is it of economic utility? If you do that, you can have a guiding normative principle, and the problem with the American approach ‑ we say with the very greatest of respect, because that was articulated by our Chief Justice this morning ‑ they have no difficulty in saying that cDNA is artificial.
So that if you had an isolated nucleic acid prepared as cDNA, plainly patentable subject matter, but if you have it produced by a polymerase chain reaction, they would say, well, it is not, and then you ask yourself, well, what normative principle says that if that which is claimed is the product, determining whether it is patentable subject matter is decided by the way you produce it. Either the product is patentable subject matter, the validity of any patent then to be determined by the remaining provisions of section 18 and section 40, or you say, it is not.
FRENCH CJ: Well, that takes you into the Apotex v Sanofi territory of the incoherence resulting from an anomalous carve‑out, if you like.
MR SHAVIN: Yes, precisely, your Honour.
FRENCH CJ: But we are not in that territory here, and I think – you are properly drawing the distinction, I think. If you have a fundamental problem – and this is the thing I was flagging, I suppose, with Mr Catterns and with you earlier – with the mutation integer, then it cuts across all forms of the isolated nucleic acid, be it cDNA or anything else.
MR SHAVIN: Because we say that here the answer lies in looking at the context. The product is not the information, as our friends would describe it. The product is in its isolated form.
FRENCH CJ: I understand that point. The problem is with this integer.
MR SHAVIN: And in that sense we say, you overcome the problems of normative principles, because you can say, well, that is patentable subject matter. Now, you then might say, well, the claim is too wide ‑ section 40(3). You might talk about full support, you might talk about all sorts of things as the Act has evolved, but that is not what is before the Court. The only question here is this anterior question as to whether it comes within the class of patentable subject matter that enables you to go to the next question.
It is at that point that ‑ it is our respectful submission that the Court should be very cautious before it attempts to make a carve‑out from the principle in NRDC, perhaps because of its subject matter, perhaps because of a concern as to what is something underlying it. That really, here, it is not to look at what is the underlying disclosure that is found in the specification, but what is in the character of the product claimed. And when you look at that character and you say, well, it is different from nature and it is different from nature in the critical respect, that it is the difference that makes it useful.
GAGELER J: Now, Mr Shavin, you took us earlier to a sentence in Myriad when you were distinguishing Myriad from Chakrabarty.
MR SHAVIN: Yes.
GAGELER J: Could I ask you to turn back to that sentence? I think I am reading it in a different print.
MR SHAVIN: This is at 2118.
GAGELER J:
Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule.
MR SHAVIN: Yes.
GAGELER J: Now, as I read that sentence, it is simply introductory to the two sentences which follow.
MR SHAVIN: Yes.
GAGELER J: And what I would like to understand is what you say about the sentence that immediately follows.
MR SHAVIN: Yes. That is that:
Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation –
GAGELER J: Yes.
MR SHAVIN: In our respectful submission, the court there is wrong in the first context and misunderstands the issue in the second.
GAGELER J: Factually or legally?
MR SHAVIN: Factually in the first and factually and mixed matter of fact and law in the second. May I explain that in this way?
GAGELER J: Yes.
MR SHAVIN:
Myriad’s claims are simply not expressed in terms of chemical composition –
is factually wrong and isolated nucleic acid is plainly a shorthand for a chemical compound, and it is a shorthand but there is no denying the fact that what we are looking underneath that is a molecule. But the second part:
nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA ‑
in our respectful submission is in error. The question is not does the mutational polymorphism change with the isolation, but do you get the utility from the isolation and the isolation is critical to what you can do with it. So that the change in the chemical composition, it is only because you have broken the bonds, it is only because you have got a different structure that in fact you end up with a different function.
KIEFEL J: But your artificially created state of affairs relies upon the changes, that is, your artificially created ‑ ‑ ‑
MR SHAVIN: Yes.
KIEFEL J: But, accepting that there are changes as a result of the process and therefore this artificially created state of affairs, the code however has not changed and utility lies in the code.
MR SHAVIN: Isolated, we would add.
KIEFEL J: Utility still lies in the code.
MR SHAVIN: We do not deny, your Honour, that utility lies in the code but you cannot actually use it if you have not got it in the isolated – the artificial form. This is the concept ‑ ‑ ‑
KIEFEL J: It is looking very much like a process.
NETTLE J: I said a process…..product.
MR SHAVIN: I understand what your Honour says but it is not what is claimed.
NETTLE J: May we not go behind what is claimed, if it appears truly to be a contrivance to mask the reality of what lies below.
MR SHAVIN: In our respectful submission, there is not the background here to suggest that there is some contrivance to avoid the law, something that has been done to create an appearance of a product that does not exist. When you look at the succeeding claims, of course, there are lots and lots of product claims but the essence of the product claims is the product that is in claim 1 so that if you go, for example, to claim 4 you have got a nucleic acid probe where the nucleotide sequence is a portion of a nucleic acid as claimed in claims 1 to 3.
NETTLE J: Yes.
KIEFEL J: The question which would probably arise though is whether or not there is a product having the claimed utility.
MR SHAVIN: Yes, well, the claimed utility ‑ ‑ ‑
KIEFEL J: Which is what we are trying to do, identify the product.
MR SHAVIN: We say the product is the isolated nucleic acid ‑ ‑ ‑
KIEFEL J: I know.
MR SHAVIN: ‑ ‑ ‑ with the characteristics. I cannot say it other than that but then, with respect, we are bound by the terms of the claim itself.
KIEFEL J: But there is still a question about what it is to which the economic utility attaches and we accept that that is the code.
MR SHAVIN: Yes, in our respectful submission, it is the combination. It is the fact of the sequence isolated and if you do not have one with the other, you do not have utility. The isolated sequence by itself intracellularly does not have utility – sorry, that is a contradiction in terms. Could I withdraw that and start again? The nucleotide sequence intracellularly does not have the utility that the isolated nucleic acid has, so to say that the only thing of utility is the sequence, in our respectful submission, is to fall into error.
KIEFEL J: Perhaps not, if the isolation does just that, it isolates it and brings it into focus, but you are claiming utility really at an earlier point. You say the utility is in the isolation and not in the code as it is applied in diagnosis.
MR SHAVIN: We are saying that utility is in the isolated code.
KIEFEL J: Is in its isolation, I think is really what you are saying.
MR SHAVIN: Yes, the isolation of the code means that the form in which you have it is artificially created and it is that artificially created form which has utility.
KEANE J: That is not quite what the Full Court said in paragraph 8. They said:
that bespeaks susceptibility to cancer, and so to be bring about a useful effect, being a state of knowledge for the person upon which to contemplate, or assess, treatment.
“Bring about a useful effect” not so as to itself be a useful effect. It is talking about bringing about a useful effect in terms of diagnosis. It is really about the immediacy of the connection between the artificial state of affairs and the economic significance that that is supposed to have. The economic significance that is claimed in claims 1, 2 and 3 cannot really be understood without talking about the source of things that are addressed in claims 4 and following; diagnosis and so forth, diagnosis, treatment.
MR SHAVIN: But it is the product. It is the building block for those.
KEANE J: Well, it might be a necessary precursor, but why does that mean that it has an economic effect in itself? One can see that it might have an economic effect if one gets a patent for it, because then you can stop people having tests. That is to regard its economic effect as being the equivalent of the conferral of patent rights. The economic effect has to be something apart from the consequences of the conferral of patent rights.
MR SHAVIN: Yes. If you take a pharmaceutical compound, and we all see every day patents for pharmaceutical compounds, the courts see more of the secondary and tertiary patents because very rarely now are the primary patents for the compounds challenged. But with every new pharmaceutical composition and method of use, you will find underlying it an original patent for the compound, the compound that will be synthesised and it will be claimed. What will be claimed will be the compound; it will not be a compound for use in the treatment of cancer, or for use in the treatment of heart disease or high blood pressure. It will simply be a compound, the product.
In our respectful submission, what one finds in claims 1 to 3 is a claim to the product. It is a claim to the isolated nucleic acid as described, in slightly different ways in each of the three claims. You do not need as a matter of patent law to append the usage, nor do they – in the European Directive, because in the European Directive, you simply have to show the utility in the application. Utility is shown, of course, in the body of the specification. It is not sitting isolated by itself; it is a matter of construction. Of course, it is now well settled that you look at the claim and you read the claim and the context of the body and the figures.
Thus, in our respectful submission, it is not a matter of, in the claim, saying “I have this isolated nucleic acid and it can be useful for X”. Myriad is entitled to say “I have this product”. If it is not of economic utility, it has no utility and that cannot be discerned from the specification read as a whole that is a different question. But that is not being asserted here. Indeed, it has been conceded.
BELL J: The difference may be with the chemical compound for the pharmaceutical product it is just that, whereas to return to the analysis that the United States Supreme Court made, if claim 1 is valid, it is giving the exclusive right to isolate an individual’s BRCA1 or BRCA2 gene. One comes back to the question of what is the suitable subject matter for a patent, and it might be that isolating an individual’s BRCA1 or BRCA2 gene is a very different matter to a patent for a chemical compound for pharmaceutical purposes.
MR SHAVIN: That would be to graft on to the Statute of Monopolies a concept of pre‑emption.
BELL J: Would it be instead of grafting a concept of pre‑emption to consider what constitutes an artificial state of affairs for the purpose of the NRDC test?
MR SHAVIN: Without restating the obvious of Justice Frankfurter’s slippery slope, in our respectful submission, there is no normative principle that would guide that because an artificially created state of affairs is just that. In our respectful submission, it is like being half pregnant. You are either artificial, or you are not artificial. You cannot have degrees of artificiality.
BELL J: So that is the area for debate, since Mr Catterns contends when you look to the matters that you rely on for artificiality, they are of such a trivial character, looking at the breaking of the covalent bonds and the like, that they ought not to qualify within the NRDC test. It is not a question of departing from the test. It is what does it mean in this context.
MR SHAVIN: But our friend then is confronted with the difficulty that in the cell you cannot do all those things.
BELL J: I think we understand that.
MR SHAVIN: The issue, you see, is our friend – as we understood him this morning – said that what the Full Court has done is unusual, because it has looked to what the claimed invention cannot do, but in our respectful submission, that is an incomplete analysis of the Full Court because the Full Court certainly did look at what it can do.
GAGELER J: So, on your analysis, if I understand it, you start with a state of affairs which is isolated nucleic acid. But the question is what is artificial about that and then the question becomes, well, how is that useful? Is that the way you do it?
MR SHAVIN: Yes. So, we say that the analysis in NRDC is that simple, and in this case, on those principles, we have an artificially created state of affairs which is useful because it is isolated. Now, of course, the utility is inextricably linked with what is isolated. We accept that. But it gets its utility here because it is isolated.
GAGELER J: Does not the answer to the first question, though, lead you to focus the second question? You ask what is artificial about that, you identify what is artificial, and then you need to link the utility to the artificiality.
MR SHAVIN: Yes, and we do that by saying it is because the bonds are separated. The bonds are broken and it is separated. Because it is structurally different – it has been extracted – and has the structure of an extracted nucleic acid – that it gets the functionality that gives utility. Now, we accept inextricably linked is the sequence, but when you are looking at the artificiality, it is because it is isolated, we say, that it has the utility required by NRDC.
Of course, our friends confront this difficulty as a logical extension and that is how you determine what is a trivial difference. There is no doubt you break a bond you have a different compound. The whole essence of the difference in compounds is their structure. So what is trivial? Do you say, well, I will just take this ring off here, is that trivial? It gives you a completely different product. I will just take this hydrogen bond away – well, that gives you a different product too and it can give you completely different characteristics to a compound.
So, you cannot treat it by saying, well, I will take just a little hydrogen away, or I will put this little ring on and say it is a little trivial change to the molecule. It is a change. So, our friend’s approach is to say, well this is too trivial, then what is trivial? What is substantive? What is the measure? The beauty, as we have said again, of what this Court did in NRDC was to cut through all of that and say patentability of the subject matter.
You only ask this question – is it an artificially created state of affairs? The evolution from Microcell at the beginning through to the discussion of vendible product shows the way the court grappled with, well, new use of an old subject – no; new use of an old matter where you are taking advantage of an unsuspected property or hitherto unknown characteristic – yes. So you are looking at what is the essence of a manner of manufacture – yes. Do not use laws of nature. That is not helpful. Let us explore it a little bit more. What is a manufacture? You go to Morton J’s rules – vendible product – what does that mean? Then there were those two passages at 276 and 277.
Then just to cap it out, the rejection of the Commissioner’s argument about agricultural and horticultural exemptions is really quite important because it echoes back to the rejection of a “laws of nature” exemption. You would say you cannot say there is an exclusion from patentability just because it is horticultural, just because it is agricultural. You have to look at what is artificial and simply doing something in an age‑old fashion is not patentable subject matter. But you do something that creates something that did not previously exist and it is.
FRENCH CJ: Mr Shavin, it seems to me that with our disruptive assistance you have been to the end of your outline and back again but I was wondering whether in particular you were going to say something about statutory context. I do not want to take you out of whatever other order you have in mind.
MR SHAVIN: No, I think any pretence at order has disappeared, your Honour.
FRENCH CJ: Yes. That is the way of the world, is it not?
MR SHAVIN: Your Honour the Chief Justice in Apotex warned against looking at legislative inaction and we do not seek to challenge that as a proposition where what one has is silence because that would require one to try and read the impenetrable minds of people on another hill.
Here, however, we have a different context, which was articulated by the Full Court at 156 to 161 and that is that both from a combination of acceptance by the court of recommendations from committees of inquiry and the rejection of a Private Members’ Bill, you have a plain statement by the legislature that it will not enact the exclusion. It is in that context that we say that the legislative history, taken together with what has happened in the United Kingdom and Europe, does provide a context.
So that at pages 695 to 697, and particularly at 696, the Full Court referred to the Australian Law Reform Commission Report, which considered whether a new approach to the patentability of genetic materials was warranted, and concluded it was not. They set out – and I was not going to read it to the Court ‑ but they set out their conclusions and the reasons why they think there should not be a change. Then, in 159:
Subsequently, in late 2010, a Private Members’ Bill (the Bill) was introduced into the Australian Senate which, if passed, would have excluded patents for ‘biological materials including their components and derivatives, whether isolated or purified or not and however made, which are identical or substantially identical to such materials as they exist in nature’. The term “biological materials” was defined to include DNA and RNA. The Legal and Constitutional Affairs Legislation Committee to which the Bill was referred for inquiry recommended by majority that the Senate not pass the Bill, which eventually lapsed.
So, here, you do not have silence where there is no indication of the legislative intent. You have a Law Reform Commission report, you have a Bill, and then you get a response to both the Bill and the Law Reform Commission report, which is set out in paragraph 160:
The Australian Government’s response . . . specifically accepted the ALRC recommendation that the Act not be amended to exclude genetic materials and technologies from patentable subject matter. It did make a number of recommendations, including stricter tests in relation to other patentability requirements and, importantly in the consideration of the balance between incentives and the flow of information (taken into account by the US Supreme Court), the introduction of a new “experimental use” defence. The recommendations resulted in the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth).
Of course, as the Court knows, that Act deliberately focused the Australian Patents Act on the European experience. The traditional test for “fair basis” in section 40(3) has been changed into a support test which is, according to the explanatory memorandum, supposed to be the same – and this Court will no doubt tell us in the fullness of time whether it is – as the European test of full support, as a replacement for the old test of “fair basis” that had been discussed by this Court in Lockwood v Doric (No 1).
In our respectful submission, the context here is acceptance of recommendations from a report, rejection of a bill, acceptance of other recommendations which lead to the current Act, which is European‑centric, and in that context, of course, we have the European Directive to which our friends took the Court, and to which if I may very briefly return – this is Directive 98/44/EC of the European Parliament of the Council, 6 July 1998. In our materials, it is tab 12, but I am not sure that the Court has them in that sequence. Our friend took the Court to the four recitals from (20) to (23), and in (22) was:
Whereas the discussion on the patentability of sequences or partial sequences of genes is controversial; whereas, according to this Directive, the granting of a patent for inventions which concern such sequences or partial sequences should be subject to the same criteria of patentability as in all other areas of technology: novelty, inventive step and industrial application; whereas the industrial application of a sequence or partial sequence must be disclosed in the patent application as filed –
not in the claim. When one comes to Article 5, again, what is found in Article 5 is:
2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element –
3. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application -
not in the claim. So that Article 5(2) in Europe would have the effect for which we contend, namely that it is patentable subject matter. Then his Honour the learned trial judge looked at the position in the United Kingdom. If I could take the Court to volume 2 at 639, paragraph 125, his Honour the learned trial judge referred to the European Directive, noticed that it came into force on 6 July and:
The EU States were given until July 2000 to implement the directive though not all did so. However, the BPD has now been implemented by all current members of the EU.
His Honour refers to some secondary materials including the classic text by LexisNexis. Then at 126, his Honour noted:
In the UK, the BPD was implemented by an amendment made in 2000 to the UK Act which introduced s 76A. It provides:
(1)Any provision of, or made under, this Act is to have effect in relation to a patent or an application for a patent which concerns a biotechnological invention, subject to the provisions of Schedule A2.
Schedule A2 is set out relevantly in paragraph 127 and clause 1 is:
An invention shall not be considered unpatentable solely on the ground that it concerns –
(a)a product consisting of or containing biological material; or
(b)a process by which biological material is produced, processed or used.
5.An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.
So that in United Kingdom now, exactly the same provision has been given effect as that in the European Directive and when one looks at the discussion by Lord Hoffmann in erythropoietin, to which our friends referred this morning, that is Kirin‑Amgen v Hoeschst Marion Roussel [2005] RPC 9 at page 182, in paragraphs 18 to 22, his Lordship set forth the extent of protection of the statutory provisions and it is plain that they are the 1977 Act, prior to the 2000 amendments. So that this decision, to which our friends referred, in our respectful submission, applied to the pre‑implementation of the European Directive.
So that when one looks at the legislative context, it is relevant, in our respectful submission, to consider not only the overt responses by government, the legislative intent by the lapsing of the Private Members’ Bill, but also to look at the state of the European Union, so that in fact, the odd country out, if it might respectfully so describe it in this context is the United States. This is in a context where raising the bar is orienting our attention under the Patents Act to Europe. That is the plainly spoken intent in the 2013 amendments to the Patents Act.
KEANE J: So, with the European Directive, if there was non‑compliance with Article 5(3) by an applicant for a patent, what would be the consequence of that?
MR SHAVIN: Can I just reopen it? I am sorry, your Honour, I had just put it away.
KEANE J: You have got ‑ ‑ ‑
MR SHAVIN: Our understanding would be that it would not be patentable; that you would need a condition of patentability, is the disclosure.
KEANE J: So that, in substance, the extent of practicable patentability depends upon the extent to which the industrial application is disclosed in the application?
MR SHAVIN: Yes. That would be, in our respectful submission, analogous to the discussion in NRDC of the vendible part of product. It is vendible because it is of economic utility. What is being identified in the European Directive is that that must be in the application, that is, the specification claims read as a whole. It does not have to be articulated in the claim. So there is no debate but that the economic utility is disclosed in this patent specification. When the specification and claims are read as whole, what is being said by our friends is that it is not disclosed in the claim but that is not a requirement of the European Directive.
So, if you said, for example, in the body you can use this product for X, that would be a disclosure. You do not have to put those words as limitation in the claim. There is no distinction between a patent application relevantly in Europe and in Australia. The patent application is not a claim set. There is a document which has the body of a specification, claims and any figures that are appended. Indeed, this Court has from time to time had to consider patents which have been filed initially in Europe and come under EPC into Australia.
But if that is the test here, it is plainly satisfied. Indeed, our friends concede that all the other claims tell you what you can do with it, and that would be part of the disclosure, and there is disclosure in the body in great detail in the body of the specification. For example, I am reminded that at page 421 of volume 2, at about line 50, there is a heading “Methods of Use: Nucleic Acid Diagnosis and Diagnostic Kits”. One can see how the isolated nucleic acid is used, so that if there was that requirement, in our respectful submission, it is satisfied.
Now, there were two other matters that I was going to take the Court to, albeit, I can do it briefly, it depends – I am in the Court’s hands. I advised my friends yesterday that I would like to take the Court briefly to Philips v Mirabella, and I would like, if I may, to take the Court through part of Apotex.
FRENCH CJ: We might adjourn then to 10.15 tomorrow morning and you can address those aspects then.
MR SHAVIN: I will just see that I have – I think I have covered almost everything else.
FRENCH CJ: I am sure you have.
MR SHAVIN: That is the way I have gone through.
FRENCH CJ: I have closely scrutinised the outline, thank you. The Court will now adjourn til 10.15 tomorrow morning.
AT 4.10 PM THE MATTER WAS ADJOURNED
UNTIL WEDNESDAY, 17 JUNE 2015
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