Commonwealth Scientific and Industrial Research Organisation v BASF Plant Science GmbH
[2016] APO 83
•23 November 2016
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Commonwealth Scientific and Industrial Research Organisation v BASF Plant Science GmbH [2016] APO 83
Patent Application: 2005217079
Title:Method for producing polyunsaturated fatty acids in transgenic plants
Patent Applicant: BASF Plant Science GmbH
Opponent: Commonwealth Scientific and Industrial Research Organisation
Delegate: K. Wagg
Decision Date: 23 November 2016
Hearing Date: 21 July 2016 (with further written submissions received 11 August 2016)
Catchwords: PATENTS – Opposition under section 59 – Manner of Manufacture raised by the Commissioner in view of Myriad – Novelty and Inventive Step dependent on Priority Date – Priority date considered – Clarity – Fair basis – Opposition unsuccessful on all grounds
Representation: Counsel for the applicant: Helen Rofe QC
Patent attorney for the applicant: Amanda Jones, Chris Vindurampulle and Carolyn Harris of Watermark
Counsel for the opponent: Ben Fitzpatrick
Patent attorney for the opponent: Dr Ian Rourke of FB Rice
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2005217079
Title:Method for producing polyunsaturated fatty acids in transgenic plants
Patent Applicant: BASF Plant Science GmbH
Date of Decision: 23 November 2016
DECISION
The opposition is unsuccessful on all grounds.
The amendment to the statement of grounds and particulars is allowed with no terms specified.
Subject to appeal, I direct that the application proceed to grant.
Costs are awarded against the applicant, BASF Plant Science GmbH, up to and including the date of allowance of the amendments, i.e. 20 January 2016, and against the opponent, Commonwealth Scientific and Industrial Research Organisation, from that date of allowance onwards.
REASONS FOR DECISION
Patent application number 2005217079 was filed on 23 February 2005. The applicant is BASF Plant Science GmbH (the Applicant). The request for examination was filed prior to 15 April 2013. As a consequence, substantive amendments of the Patents Act 1990 brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the present patent application. This includes the amendment to subsection 60 (3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition exists. I also note that any subsequent reference to the Patents Act relates to the Patents Act1990 (the Act), prior to amendment by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012.
The application was examined and accepted by the Commissioner. Acceptance was advertised on 2 February 2012. A notice of opposition to the grant of the patent was filed by Commonwealth Scientific and Industrial Research Organisation (CSIRO) on 2 May 2012 (the Opponent). A hearing was held on 21 July 2016 to decide the opposition. The application was amended during the evidentiary periods with the last amendments received on 5 September 2015. The Applicant was represented by Helen Rofe QC instructed by Amanda Jones, Chris Vindurampulle and Carolyn Harris of Watermark and the Opponent was represented by Ben Fitzpatrick of Counsel instructed by Dr Ian Rourke of FB Rice, Dr Vicki Locke and Dr Robert de Feyter of CSIRO also attended.
Standard of proof
The onus of proof in this opposition proceeding rests with the Opponent, who must demonstrate that it is clear that a valid patent cannot be granted (F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283; 50 IPR 305 at [67]; Commissioner of Patents v Sherman [2008] FCAFC 182; 79 IPR 426 at [18]).
The Statement of Grounds and Particulars
The opponent sought to amend the statement of grounds and particulars (the SGP) on 7 July 2016 when they filed their submissions for the hearing. A delegate of the Commissioner refused the amendment as he deemed it to be adding an extra ground. The opponent then filed a further amended SGP on 14 July 2016 removing the disputed ground. The applicant requested refusal of the amended SGP of 14 July 2016 stating that there were extra particulars for both internal and external fair basis and said in their letter:
“the Opponent has failed to provide an explanation or justification for why the amendment of the SGP at this very late stage in the proceedings should be allowed given the closeness of the hearing.
The [Opponent] has had at least 6 months from 20 January 2016 to amend the [SGP]. The proposed amended particulars are not raised by or specific to the amendments made to the claims in January 2016, and could have been raised in the amendments to the [SGP] filed on 2 January 2014 or at any time since then, rather than the week of the hearing.”
The Applicant then went on to say that:
“The Applicant will be prejudiced by allowance of the amended [SGP]. The Applicant is based in Germany, and its experts are also based overseas, hence there is insufficient time for consultation.”
They finished by saying:
“Rejection of the proposed amendments is requested.”
On 19 July 2016, a delegate of the Commissioner responded stating that the addition of new particulars does not contravene the regulations governing amendments to the SGP and the delegate therefore allowed the amendments. The delegate noted that further evidence is available to the Applicant if they thought it necessary to deal with the added particulars. This matter was left to the hearing officer for further consideration. The delegate also noted that the amendment to the SGP could be considered when costs are being determined. I will address this matter before deciding the opposition.
The Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 has changed the regulations governing the treatment of SGPs. These changes come into force for oppositions commenced after 15 April 2013. Given that the notice of opposition for the present case was filed on 2 May 2012, the regulations as they existed before Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 apply. Regulation 5.9, as it existed before Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013, therefore applies. This regulation states that:
(1) Subject to subregulation (2), the Commissioner, on the request of an opponent and subject to such terms as the Commissioner may specify:
…
(c) must amend particulars relating to a ground set out in a statement that is served and filed under regulation 5.4. (my emphasis).The conditions of subregulation (2) state that the Commissioner must not allow an amendment under subregulation (1), if:
(a) dismissal is being considered
(b) determination is being considered
(c) the case is being re-examined(d) he or she does not reasonably believe that the applicant has been notified of the amendment.
I note that none of the conditions of subregulation (2) are at play. I also note that the use of the term “must” in reg 5.9(1)(c) does not give me any discretion.
I discussed this with the parties at the hearing noting that the Commissioner may specify terms such as allowing further submissions. As the hearing progressed the Applicant was able to answer the case put forward by the Opponent and they informed me that they did not wish to make any further submissions.
I therefore allow the amendments to the SGP with no terms specified.
The opposition
The SGP identified six grounds of opposition:
(1) Manner of Manufacture
(2) Novelty
(3) Inventive Step
(4) Claims do not define the invention
(5) Clarity
(6) Fair basis.At the hearing, the grounds of manner of manufacture and claims do not define the invention were not pursued.
In relation to manner of manufacture, the application had been accepted prior to the High Court’s decision in D’Arcy v Myriad Genetics Inc (Myriad) [2015] HCA 35; 89 ALJR 924; 325 ALR 100; 115 IPR 1. Since there were a number of claims directed towards nucleic acid sequences per se I invited submissions from the applicant under Section 60 in regards to those claims.
The parties relied upon evidence by several declarants.
Evidence in Support consisted of:
Date of Declaration Declarant Abbreviation Exhibits 4 February 2013 Ian J Rourke Rourke #1 IJR-1 to IJR-66 2 January 2014 Ian J Rourke Rourke #2 IJR-67 to IJR-83 2 January 2014 Allan Green Green #1 AGG-1 to AGG-3
Evidence in Answer consisted of:
Date of Declaration Declarant Abbreviation Exhibits 28 April 2014 Carolyn Joy Harris Harris CJH-1 to CJH-7 28 July 2014 Johnathan Napier Napier #1 JN-1 to JN-7 28 August 2014 Toralf Senger Senger #1 TS-1 to TS-25 11 September 2014 Johnathan Napier Napier #2 JN-8 to JN-11
Evidence in Reply consisted of:
Date of Declaration Declarant Abbreviation Exhibits 12 January 2015 Allan Green Green #2 AGG-4 11 January 2015 Randall Weselake Weselake RW-1 12 January 2015 Jean-Philippe Ral Ral JPR-1 12 January 2015 Surinder Pal Singh Singh SPS-1 to SPS-2
Further Evidence consisted of:
Date of Declaration Declarant Abbreviation 1 April 2015 Johnathan Napier Napier #3 28 April 2015 Toralf Senger Senger #2 The specification
The specification relates to a process for the production of polyunsaturated fatty acids (PUFAs). In particular long chain PUFAs (LCPUFAs), such as eicosapentaenoic acid and docosahexaenoic acid (EPA and DHA) which the reader will appreciate are the ω3-fatty acids present in fish oil.
The process uses molecular biology to take the genes for the enzymes responsible for the production of LCPUFAs from lower species, such as algae and marine fungi, and express them in higher plants, such as oil crop plants. The specification ends with 33 Figures, 28 claims and a sequence listing. Claims 1-16 are process claims, claim 17 is a product by process claim, and claim 18 is a claim directed to the use of the enzymes in the production of C18, C20 and C22 PUFAs. Claims 19-22 are directed towards a recombinant nucleic acid molecule, claim 23 is directed towards a transgenic plant, claim 24 is directed towards a process of producing oil compositions by mixing the product with other oils, claim 25 is directed towards the use of the oils produced in feed, foodstuffs, cosmetics or pharmaceuticals. Claim 26 is directed towards an isolated nucleic acid molecule and claims 27 and 28 towards the gene constructs.
What is the invention as described
Before commencing to construe the specification, I note what Middleton J said in Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214; 100 IPR 451 at [139]:
"It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date."
The background to the invention
The specification discusses the importance of fatty acids on page 3 lines 14-15:
“Fatty acids and triacylglycerides have a multiplicity of applications in the food industry, in animal nutrition, in cosmetics and the pharmaceutical sector.”
It goes on to state at line 18 that linoleic and linolenic acid are essential for mammals and then states at lines 19-26:
“This is why polyunsaturated ω3-fatty acids and ω6-fatty acids are an important constituent of human and animal food. Thus, for example, lipids with unsaturated fatty acids, specifically with polyunsaturated fatty acids, are preferred in human nutrition.”
The specification goes on to mention that supplementing food with ω3-fatty acids can reduce the risk of heart disease, strokes or hypertension (page 3 lines 24-26) and can be useful in managing inflammatory conditions associated with immunological diseases such as rheumatoid arthritis (page 3 lines 28-30).
This discussion continues and page 4, lines 5-10 states:
“Polyunsaturated long-chain ω3-fatty acids such as eicosapentaenoic acid (=EPA, C20:5Δ5,8,11,14,17) or docosahexaenoic acid (=DHA, C22:6Δ4,7,10,13,16,19) are important components of human nutrition owing to their various roles in health aspects, including the development of the child brain, the functionality of the eyes, the synthesis of hormones and other signal substances, and the prevention of cardiovascular disorders, cancer and diabetes.”
It follows with:
“Owing to the present-day composition of human food, an addition of polyunsaturated ω3-fatty acids, which are preferentially found in fish oils, to the food is particularly important.”
The specification then discusses sources of these fatty acids on page 4 lines 26-31:
“Very long-chain polyunsaturated fatty acids such as DHA, EPA, arachidonic (ARA, C20:4Δ5,8,11,14), dihomo-γ-linolenic acid (C20:3Δ8,11,14) or docosapentaenoic acid (DPA, C22:5Δ7,10,13,16,19) are, however, not synthesized in oil crops such as oilseed rape, soybeans, sunflowers and safflower. Conventional natural sources of these fatty acids are fish such as herring, salmon, sardine, redfish, eel, carp, trout, halibut, mackeral, zander or tuna, or algae.”
The specification moves to mention various prior art and previous attempts to utilise genes from microorganisms for PUFA production and concludes with:
“…only limited amounts of the desired polyunsaturated fatty acids such as DPA, EPA and ARA can be produced with the aid of the abovementioned microorganisms.”
The specification then notes on page 6 lines 22-23 that:
“Higher plants comprise polyunsaturated fatty acids such as linoleic acid (C18:2) and linolenic acid (C18:3). ARA, EPA and DHA are not found at all in the seed oil of higher plants, or only in miniscule amounts.”
It then states at lines 25-34 that:
“…the production of LCPUFAs in higher plants, preferably in oilseed crops such as oilseed rape, linseed, sunflowers and soybeans, would be advantageous since large amounts of high-quality LCPUFAs for the food industry, animal nutrition and pharmaceutical purposes might be obtained economically. To this end, it is advantageous to introduce, into oilseed crops, genes which encode enzymes of the LCPUFA biosynthesis via recombinant methods and to express them therein. These genes encode for example Δ6-desaturases, Δ6-elongases, Δ5-desaturases, Δ5-elongases or Δ4-desaturases. These genes can advantageously be isolated from microorganisms and lower plants which produce LCPUFAs and incorporate them in the membranes or triacylglycerides. Thus it has already been possible to isolate Δ6-desaturases genes from the moss Physcomitrella patens and Δ6-elongase genes from P. patens and from the nematode C. elegans. ”
The specification then introduces Figure 1 (Figure 1/33) which is reproduced below:
If the reader looks at Figure 1 they will see that ARA, EPA and DHA are shown. EPA is designated “20:5Δ5,8,11,14,17” which means it is a chain of 20 carbons with 5 double bonds (or desaturations) at carbons 5, 8, 11, 14 and 17 from the acid group. The opposite end to the acid group is referred to as ω. EPA is an ω3 as it has a double bond at carbon 17. The pathways can be appreciated by seeing that elongases add a carbon and desaturases add a double bond to the fatty acid.
The aim of the invention
The specification states on page 9 lines 9-12 that the object of the invention was:
“…to develop a process for the production of large amounts of polyunsaturated fatty acids, specifically ARA, EPA and DHA, in the seed of a transgenic plant.”
The nature of the invention
In general terms the specification states on page 1 lines 25-29 that:
“In a preferred embodiment, the invention furthermore relates to a process for the production of arachidonic acid, eicosapentaenoic acid or docosahexaenoic acid and a process for the production of triglycerides with an elevated content of unsaturated fatty acids, in particular arachidonic acid, eicosapentaenoic acid and/or docosahexaenoic acid, in transgenic plants, advantageously in the seed of the transgenic plant.”
It then goes on at line 30:
“The invention relates to the generation of a transgenic plant with an elevated content of polyunsaturated fatty acids, in particular arachidonic acid, eicosapentaenoic acid and/or docosahexaenoic acid, as the result of the expression of the elongases and desaturases used in the process according to the invention.”
The specification then further notes that:
“The invention furthermore relates to recombinant nucleic acid molecules comprising the nucleic acid sequences which encode the polypeptides with Δ6-desaturase, Δ6-elongase, Δ5-desaturase and Δ5-elongase activity, either jointly or individually.”
The claims
The correct approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70; 81 IPR 228 at [118] – [120]:
"the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear … while the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole … it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification … terms in the claim which are unclear may be defined or clarified by reference to the body of the specification".
Claims 1 and 26 are the only independent claims and so I have reproduced them below.
Claim 1 reads:
A process for the production of C18-, C20-, and C22-, polyunsaturated fatty acids in the seed of a transgenic oil crop plant with a content of at least 20% by weight based on the total lipid content, which comprises the following process steps:
a) introducing, into the oil crop plant, at least one nucleic acid encoding a Δ6-desaturase and at least one nucleic acid encoding a Δ6-elongase, wherein the Δ6-desaturase has the amino acid sequence shown in SEQ ID NO: 202 or an amino acid sequence having at least 60% sequence identity thereto, or
introducing, into the oil crop plant, at least one nucleic acid encoding a Δ9-elongase, at least one nucleic acid encoding a Δ8-desaturase, at least one nucleic acid encoding a Δ6-desaturase and at least one nucleic acid encoding a Δ6-elongase, wherein the Δ6-desaturase has the amino acid sequence shown in SEQ ID NO: 202 or an amino acid sequence having at least 60% sequence identity thereto, and
b) introducing, into the oil crop plant, at least one nucleic acid encoding a Δ5-desaturase, and
c) introducing, into the oil crop plant, at least one nucleic acid encoding a Δ5-elongase, and
d) introducing, into the oil crop plant, at least one nucleic acid encoding a Δ4-desaturase.
Claim 26 reads:
An isolated nucleic acid sequence which encodes a polypeptide with Δ5-elongase activity and which has the sequence shown in SEQ ID NO: 197.
Manner of manufacture
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies.
The opponent chose not to pursue manner of manufacture. However, at the hearing I invited submissions on claims 19-22 and claims 26-28 under subsection 60(3).
Subsection 60(3) states:
“The Commissioner may, in deciding a case, take into account any ground on which the grant of a standard patent may be opposed, whether relied upon by the opponent or not.”
I allowed the applicant three weeks to file submissions and these were received on 11 August 2016.
In Myriad the High Court found that claims encompassing isolated nucleic acids, which in that case coded for a mutant or polymorphic BRCA1 polypeptide, were not a manner of manufacture. They found that the substance of the claims to the nucleic acids was genetic information. The information was genetic information embodied in, and conveyed by the nucleic acid sequence. That information was naturally occurring; it had not been “made” by human action and, as a consequence, the claims did not define a manner of manufacture (at [91], [95]).
It is therefore necessary to determine the substance of these claims and then determine whether or not that substance has, or has not, been made.
Claim 19 reads:
A recombinant nucleic acid molecule comprising:
a) one or more copies of a promoter which is active in plant cells, preferably a seed-specific promoter, and
b) at least one nucleic acid sequence as defined in claim 10 which encodes a polypeptide with Δ6-desaturase activity, and
c) at least one nucleic acid sequence as defined in claim 10 which encodes a polypeptide with Δ5-desaturase activity, and
d) at least one nucleic acid sequence as defined in claim 10 which encodes a polypeptide with Δ6-elongase activity, and
e) at least one nucleic acid sequence as defined in claim 14 which encodes a polypeptide with Δ5-elongase activity, and
f) one or more copies of a terminator sequence.
Claim 19 defines a single recombinant nucleic acid molecule of unspecified length, comprising at least one nucleic acid coding sequence selected from each of four specified enzyme classes, which are regulated individually and/or in combination by the promoter and terminator sequences, which regulate expression of the enzyme.
Claim 19 part b), by its dependence on claim 10, defines a group of nucleic acid sequences consisting of those that encode the SEQ ID NO: 202 Δ6-desaturase and those encoding Δ6-desaturases having an amino acid sequence with at least 60% identity to SEQ ID NO: 202. The SEQ ID NO: 202 Δ6-desaturase is from Ostreococcus Tauri, a marine algae.
Claim 19 part c), by its dependence on claim 10, defines nucleic acid sequences encoding a Δ5-desaturase consisting of the group:
·the nucleic acid sequence of SEQ ID NO: 11;
·nucleic acids sequences which hybridise under stringent conditions to the complementary strand SEQ ID NO: 11;
·nucleic acids sequences encoding an amino acid sequence having at least 60% identity to that of SEQ ID NO: 11; and
·nucleic acid sequences that encode the amino acid sequence of SEQ ID NO: 12.
SEQ ID NO: 11 encodes, and SEQ ID NO: 12 provides the amino acid sequence for, the Δ5-desaturase from Thraustrochytrium species which are marine fungi.
Claim 19 part d), by way of claim 10, defines a group of nucleic acid sequences encoding a Δ6-elongase selected from the group consisting of:
· the nucleic acid sequences of SEQ ID NOs: 27 and 199;
· nucleic acid sequences which hybridise under stringent conditions to the complementary strand of SEQ ID NO: 27 or 199,
· nucleic acid sequences having at least 60% identity to SEQ ID NO: 27 or at least 80% identity to SEQ ID NO: 199; and
· nucleic acid sequences that encode the amino acid sequences of SEQ ID NO: 28 or 200.
SEQ ID NO: 27 and 199 encode, and SEQ ID NO: 28 and 200 provides the amino acid sequences for the Δ6-elongase from Physcomitrella patens which is a moss, and Ostreococcus tauri a marine algae, respectively.
Claim 19 part e), refers to claim 14 to identify nucleic acid sequences encoding a Δ5-elongase. Claim 14 is dependent on claims 9-13, the last of which identifies Δ5-elongase-nucleic acid coding sequences. Therefore, claim 19 part d) by way of claim 13 defines a group of nucleic acid sequences encoding a Δ5-elongase selected from the group consisting of:
·the nucleic acid sequences of SEQ ID NOs: 43, 47, 49, 51, 53, 59, 61, 63, 65, 67, 75, 77, 79, 83, 85, 113, 117, 119, 131, 133, 135, 137, 197;
·nucleic acid sequences that encode the amino acid sequences of SEQ ID NOs: 44, 48, 50, 52, 54, 60, 62, 64, 66, 68, 76, 78, 80, 81, 86, 114, 118, 120, 132, 134, 136, 138, 198;
·nucleic acid sequences which hybridise under stringent conditions to the complementary strand of SEQ ID NOs: 43, 47, 49, 51, 53, 59, 61, 63, 65, 67, 75, 77, 79, 83, 85, 113, 117, 119, 131, 133, 135, 137, 197; and
·nucleic acid sequences having at least 60% identity to SEQ ID NOs: 43, 47, 49, 51, 52, 59, 61, 63, 65, 67, 75, 77, 79, 83, 85, 113, 117, 119, 131, 133, 135, 137, 197.
These Δ5-elongases nucleic acid and amino acid sequences are derived from numerous species including Ostreococcus tauri and Thraustochytrium sp., referred to above, in addition to Thalassiosira sp. (marine diatoms), Crypthecodinium chonii (microalgae), and the model organisms Oncorhynchus mykiss (rainbow trout), Xenopus laevis (clawed frog), Ciona intestinalis (AK112719) (sea squirt), Euglena gracilis (a single-celled flagellate), and Arabidopsis thaliana (a plant).
Claim 20 and claim 21 are dependent on claim 19 with claim 20 adding a Δ12-desaturase and claim 21 adding another polypeptide involved in fatty acid biosynthesis or lipid metabolism selected from an exhaustive list. Dependent claim 22 adds a Δ4-desaturase, Δ8-desaturase, Δ9-desaturase and Δ9-elongase.
Clearly, the substance of claim 19 and dependent claims is the genetic information embodied in the recombinant nucleic acid molecule which encodes the desaturase and elongase enzymes and includes associated regulatory sequences. Having determined that claim 19 is to genetic information, the next step is to determine whether or not that information has been made. If this genetic information is naturally occurring it would not be a manner of manufacture in view of Myriad at [92] and [93].
The applicant submitted that:
“Amongst the specific nucleotide sequences claimed (via the reference to claim 10) are nucleic acid sequences encoding a variety of enzyme activities, all of which are sourced from different (non-oil crop plant) organisms.”
The applicant provided an example where the nucleic acids of claim 19 parts a), b) and c) are sourced from different organisms and on this basis it submitted:
“The recombinant nucleic acid molecule claimed in claim 19 (and its dependent claims 20 to 22) does not have a counterpart in the genome of a plant (or any single organism). The claims the subject of the Delegate’s objection, comprise nucleic acid sequences originating from a variety of sources ‘stitched together’ into one recombinant nucleic acid molecule. None of the sequences in the recombinant nucleic acid molecule claimed in claim 19 come from the same organism. They are not found together in nature on the same DNA molecule. The recombinant nucleic acid molecule of claim 19 is an artificial state of affairs, which has economic utility: the production of PUFAs in plants.”
Although claim 19 encompasses homologous nucleic acid sequences derived from species other than those identified in the specification, I have no reason to believe that the combination of enzyme-encoding nucleic acids and associated regulatory sequences specified in claim 19 would necessarily exist naturally in one nucleic acid molecule in any one organism. I therefore conclude that the claimed recombinant nucleic acid molecule has been made by human action. Furthermore, the information conveyed by the sequence of claim 19 and dependent claims has clear economic utility as it encodes enzymes which synthesise LCPUFAs.
I therefore find that the subject matter of claim 19 and dependent claims is a manner of manufacture.
Claim 26 is directed towards an isolated nucleic acid sequence which encodes a polypeptide with Δ5-elongase activity and which has the sequence shown in SEQ ID NO: 197. Claims 27-28 are dependent on this claim.
The substance of claim 26 is the genetic information embodied in SEQ ID NO: 197.
It is now necessary for me to determine whether or not this information is naturally occurring or alternatively, made by human action.
The applicant argued that:
“Importantly, SEQ ID NO: 197 have been codon optimised for expression in oil crop plants. This is readily apparent from comparing SEQ ID NO: 197 with that of SEQ ID NO: 67 which encodes the unmodified Ostreococcus tauri Δ5-elongase.”
The applicant provided two annexures showing a pairwise sequence alignment of SEQ ID NO: 67 with SEQ ID NO: 197. It showed many bases had been changed.
Codon optimisation had been considered in Cargill Incorporated v Dow AgroSciences LLC [2016] APO 43 at paragraphs 41 to 45. In this decision the Delegate found that the codon optimisation, which gave a sequence optimised for expression in a different species, provided a manner of manufacture. The Delegate found the substance of the sequence was not just naturally occurring information but the information had been altered for expression in a different species. That alteration had real economic utility.
The present sequence has been altered, from one that occurs naturally in an alga, so that it can be expressed in oil crop plants. This has obvious economic utility, such as the ability to harvest the crop. I consider that the information has been changed to be expressed in oil crop plants and the effect of this is an artificially created state of affairs and involves a manner of manufacture.
I therefore conclude that claims 19-22 and 26-28 are a manner of manufacture.
Novelty
It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, is novel. Subsection 7(1) states that an invention is taken to be novel unless it is not novel in the light of the prior art. A citation is part of the prior art base for the purposes of novelty if it was published before the priority date of the claim.
It is well established that the general test for lack of novelty is the reverse infringement test. The classic formulation of this test is that given by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19; 137 CLR 228 at 235:
"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement".
This test is satisfied if the alleged anticipation discloses all the essential features of the invention as claimed (see Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517). In order to meet this requirement, the prior art must “contain clear and unmistakeable directions to do what the patentee claims to have invented” (The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited (General Tire) [1972] RPC 457 at 486).
Australian courts have often cited with approval the words of the UK Court of Appeal in the General Tire case at 486:
“To anticipate the patentee's claim the prior publication must contain clear and unmistakeable directions to do what the patentee claims to have invented: Flour Oxidizing Co. Ltd. v. Carr & Co. Ltd. (1908) 25 R.P.C. 428 at 457, line 34, approved in B.T.H. Co. Ltd. v. Metropolitan Vickers Electrical Co. Ltd. (1928) 45 R.P.C. 1 at 24, line 1). A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee."
The opponent relied on one document as the particular to the ground of lack of novelty. This document is D69 in the SGP, this document is:
D69 WO 2010/057246
For convenience I will refer to it as D69.
D69 was filed on 17 November 2009 and published on 27 May 2010. This is well after the earliest priority date which is 27 February 2004. In order for a document to be considered as anticipating the claims under section 7 it must be published before the priority date or be a patent with an earlier priority date.
The opponent argued that the current claims are not entitled to claim priority from any of the priority documents.
I will therefore make a decision on the priority date first.
Priority
The claims in suit claim priority from six priority documents. These were filed in evidence in their original German language text by the opponent and then the applicant filed English language translations as exhibits as evidence in answer. The quality of the translations was not disputed and so, as a matter of convenience, I will rely on the English translations. They are set out as follows:
Priority Document (PD) Number Filing Date Evidence PD1 DE 10 2004 009 457.8 27 February 2004 Exhibit CJH-2 PD2 DE 10 2004 012 370.5 13 March 2004 Exhibit CJH-3 PD3 DE 10 2004 017 518.7 8 April 2004 Exhibit CJH-4 PD4 DE 10 2004 024 014.0 14 May 2004 Exhibit CJH-5 PD5 PCT/EP2004/007957 16 July 2004 Exhibit CJH-6 PD6 DE 10 2004 062 543.3 24 December 2004 Exhibit CJH-7
Jagot J, provided a good summary of the law on priority in Gilead Sciences Pty Ltd v Indenis Pharmaceuticals LLC (2016) 117 IPR 252 at 256 et seq. The test for priority is the same test as fair basis, that is there must be a real and reasonably clear disclosure of the invention claimed. There are some subtle differences and because of this priority is often referred to as external fair basis
Relevant to the current opposition is F. Hoffman-La Roche & Co. Aktiengesellschaft v Commissioner of Patents 123 CLR 529 at 542, where Gibbs J said the following:
“It is crucial, in my view, that it is not suggested that the compounds the subject of proposed claims 2, 3 and 4 have been selected because they have any special utility. If a basic application disclosed a large class of compounds, all of which were claimed to be of pharmaceutical utility, and it were found that the claim was false, in that only some of the compounds were useful, or it appeared that some of the compounds had a particular and peculiar value, there would be much to be said for the view that a claim limited to those compounds selected for their utility or special value would not be fairly based on matter disclosed in the basic application, at least if the basic application did not itself provide a guide to that selection, and a fresh inventive step were necessary to enable it to be made. Here however a large class of compounds is disclosed, and clearly disclosed, in the basic application and proposed claims 2, 3 and 4 in the complete specification are for compounds forming part of that class, but not selected because they alone are useful or because they have utility greater than that of other members of the class.”
The Full Federal Court also dealt with this issue in Coopers Animal Health Australia Ltd v Western Stock Distributors Pty Ltd and Others (Coopers) 11 IPR 20. In the Coopers case the patent in suit was a petty patent which claimed a pour-on formulation for sheep. The specification stated that the solvent DGBE “has been found to be particularly useful. It has minimal adverse effect on the skin in terms of mild epidermal shedding seen with other solvents in some sheep. It also exhibits good spreading over the skin and fleece of the sheep.” This advantage of DGBE was not stated in the provisional specification and Fox J notes at 29:
“The patent claim concerning DGBE is not simply a more specific application of what is claimed in the provisional specification. It is the result of further experimentation, and can properly be regarded as involving an inventive step. Indeed, the whole product is different from any which could be regarded as part of an invention disclosed in the provisional specification, but what has been since been arrived at, although in a sense derived from various ingredients mentioned in the provisional specification, is itself a special product. A reading, or study, of the provisional specification would not lead readily, or by a process of selection, to what is set forth in the patent claim.”
The Full Court noted in Multigate Medical Devices Pty Ltd v B Braun Melsungen AG (Multigate) [2016] FCAFC 21 at 189 that the use of “disclosed” rather than “described” connotes greater flexibility in the test for external fair basis. They continued with the following at 190:
“In the context of external fair basis, the test of real and reasonably clear disclosure requires attention not on whether a subsequent claim had previously been made, but whether in the earlier specification there had been a real and reasonably clear disclosure of the invention that is claimed. Further, a real and reasonably clear disclosure in the prior specification need not be made only in the verbal description, but can appear from the accompanying drawings (CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 (CCOM) at 280 per Spender, Gummow and Heerey JJ; Leonardis at 137 per Burchett, Hill and Tamberlin JJ referring also to the fact that expert assistance may be necessary to interpret the drawings). Further, the relevant passage(s) from the prior specification need not be disclosed as part of the invention claimed therein. Further, the task of determining whether there has been a real and reasonably clear disclosure is not to be undertaken with an over-meticulous verbal analysis: Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 at 240 per Barwick CJ; approved in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1 at [15] per Gleeson CJ, McHugh, Gummow, Hayne and Callinan JJ and in Lockwood No 1 at [57], [68] and [69]. Further, the relevant disclosure is not limited to the description of preferred embodiments.”
In Multigate at 229-330 the Full Court found that the aid of experts may be an aid in construction but the incorporation of externally made statements into a patent specification was not of assistance in that case and the consideration is to be made by the text alone of each specification.
The opponent argued that the Δ6-desaturase having the amino acid sequence of SEQ ID NO: 202 had a special utility as was the case in F. Hoffman-La Roche.
The special utility relied on by the opponent is that the SEQ ID NO: 202 desaturase was the first identified plant acyl CoA-dependent Δ6-desaturase, and the surprising feature of such an enzyme is that all PUFAs it produces are in a form that is immediately available for the following elongase step in the biosynthesis of PUFAs (Senger #1 at 77). In contrast, in the amino acid sequence SEQ ID NO: 194 the specification identifies a phospholipid-dependent Δ6-desaturase. This latter enzyme acts on an alternative substrate and the product produced is not readily available for the elongase, resulting in a bottleneck in LCPUFA synthesis (Senger #1 at 77).
The opponent argued that the special utility of the SEQ ID NO: 202 Δ6-desaturase was not disclosed in any of the priority documents nor in the specification prior to amendment.
I note that the special utility is not part of the current specification but instead was provided in evidence.
In their submissions the opponent argued that the claims are not entitled to a priority date earlier than 20 January 2016 when the claims were last amended and these were allowed.
The opponent further submitted that the claims were not entitled to a priority date earlier than the amendments of 18 January 2012, at which date the claims also included SEQ ID NO: 194 as an option for the Δ6-desaturase.
They also stated that the claims were not entitled to the priority date of amendments filed on 25 January 2011 which replaced the production of compounds of formula 1 with C18, C20 and/or C22 PUFAs.
The opponent then focussed on the priority documents and further argued that the current claims are not entitled to claim priority from any one of them.
I will look at the features of the claims highlighted by the opponent and discuss them as they occur in the priority documents.
PUFAs
The opponent argued that PUFAs are not fairly based on disclosures in PD1 and PD2 because they disclose Markush type structures as formula I. This formula had been the subject of the claims prior to the amendments of 25 January 2011. It is introduced in the following context (page 6 lines 27 of PD1 and page 6 line 36 of PD2):
“A further object of the present invention was the provision of genes or enzymes which make possible a shift from the ω6-fatty acids to the ω3-fatty acids. Another object was to develop a process for the production of polyunsaturated fatty acids in an organism, advantageously in a eukaryotic organism, preferably a plant or a microorganism. This object was achieved by the process according to the invention for the production of compounds of the formula I.”
Dr Green discussed formula I in his first declaration with reference to the formula in the specification before it was amended. He concluded at paragraph 31 that:
“In conclusion, based on the description on pages 9a-12 of the Application, the ‘compounds of general formula I’ do not include all of the C18-, C20- and C22-PUFA containing compounds in the plants as a whole or in the seeds because they do not include, for example, the SM-PUFA-SM TAGs.”
He further states that:
“I also conclude, as described at paragraph 30, that the ‘compounds of general formula I’ include compounds where the PUFA moiety is not a C18-, C20 or C22-PUFA, since the definition of general formula I include PUFA with a chain length of C10-C32”.
Senger #1 responds to these comments in paragraphs 31-40. He states in paragraph 36 that:
“I find that the conclusions of paragraphs 31 and 32 of Dr Green’s declaration to be based on an incorrect interpretation of the specification of the Accepted Application.”
I disagree with the opponent’s submissions on this point. There is an overly meticulous examination of the periphery of formula I and the meaning of C18-, C20- or C22-PUFA. Yes there is some overlap with formula I and C18-, C20- or C22- PUFAs. The periphery that does not overlap is taken out of context of the specifications and the priority documents.
In PD1 and PD2, formula I is presented as one object, this object is achieved in the overlapping area. Furthermore it is not necessary to look for obscure fatty acids within formula I or other C18- C20- or C22- PUFAs which might exist, but instead it is necessary to look for a real and reasonably clear disclosure of C18-, C20- or C22- PUFAs as part of the invention in the priority documents.
The priority documents introduce formula I in the context of ω3-fatty acids and they discuss ARA, EPA and DHA throughout. It states at page 5, last line of PD1 and page 6 lines 8-9 of PD2:
“Higher plants comprise polyunsaturated fatty acids such as linoleic acid (C18:2) and linolenic (C18:3). ARA, EPA and DHA are found not at all in the seed oil of higher plants, or only in miniscule amounts.”
They go on:
“…the production of LCPUFAs in higher plants, preferably in oil crops such as oilseed rape, linseed, sunflower and soybeans, would be advantageous”.
100. They then state at page 9 lines 31-34 of PD1 and page 10 lines 1-3 of PD2:
“Fatty acids produced in the process advantageously have 18, 20 or 22 C atoms in the fatty acid chain; the fatty acids preferably comprise 20 or 22 carbon atoms in the fatty acid chain.”
101. Again at page 30 lines 39-40 of PD1 and page 32 lines 33-34 of PD2:
“The PUFAs or LCPUFAs produced by this process are advantageously C18-, D20‑ [sic] or C22-fatty acid molecules, advantageously C20- or C22-fatty acid molecules.”
102. And at page 30 lines 42-43 of PD1 and page 32 lines 36-37 of PD2:
“These C18-, C20- or C22-fatty acid molecules can be isolated from the organism in the form of an oil, a lipid or a free fatty acid.”
103. On page 31 lines 34-40 PD1 and page 33 line 35-39 of PD2 states:
“The oils, lipids or fatty acids according to the invention comprise…”
104. This is followed by a list of percentages of at least up to 15% ARA, and “especially advantageously” at least up to 10% EPA and/or DHA.
105. Page 33 lines 34-36 of PD1 and page 35 lines 35-36 of PD2 states:
“The activity of the desaturases and elongases used in the process according to invention preferably leads to C18-, C20- and/or C22- fatty acids”.
106. Furthermore at page 33 lines 42-page 34 line 2 of PD1 and page 36 lines 1-3 of PD2:
“Products of the process according to the invention are especially preferred are dihomo-γ-linolenic acid, arachidonic acid, eicosapentaenoic acid, docosapentaenoic acid and/or docosahexaenoic acid.”
107. The general thrust of PD1 and PD2 is to produce C18-, C20- and C22- PUFA, specifically ARA, EPA and DHA. Though there are some differences in a peripheral analysis of certain objects presented (formula 1), the invention is to provide C18-, C20- and C22- PUFA, and more specifically ARA, EPA and DHA.
108. I am satisfied that these disclosures satisfy a real and reasonably clear disclosure of C18-, C20- and C22- PUFAs.
At least 20% by weight of total lipid content
109. The opponent argued that the priority documents did not disclose the oils being produced in quantities of at least 20% by weight of the total lipid content.
110. The opponent relies on Green #1 in their submissions. Green #1 discusses the meaning of “total lipid content” at paragraphs 24-28 where Dr Green discusses the difference in meaning in the art between a lipid and a fatty acid and concludes at paragraph 27 that:
“It is clear to me that the reference in the Application to, for example, ‘at least 20% by weight on the total lipid content’ (page 9) means something different than the ‘at least 20 % by weight based on the total fatty acids’ (page 28, line 5) because the total lipid content is not the same as total fatty acid content. For example, as described at paragraph 24-26 above, the lipid content may comprise more than the fatty acids. That is, the phrases have a different reference point for the 100%.”
111. The applicant responded that Dr Green did not take into account the definition which is in the Application on page 69 lines 5-18, PD1 page 32 lines 9-22, PD2 page 34 lines 9-13:
“The term ‘oil’, ‘lipid’ or ‘fat’ is understood as meaning a fatty acid mixture comprising unsaturated, saturated, preferably esterified, fatty acid(s). The oil, lipid or fat is preferably high in polyunsaturated free or, advantageously, esterified fatty acid(s), in particular linoleic acid, γ-linolenic acid, dihomo-γ-linolenic acid, arachidonic acid, α-linolenic acid, stearidonic acid, eicosatetraenoic acid, eicosapentaenoic acid, docosapentaenoic acid or docosahexaenoic acid. The amount of unsaturated esterified fatty acids preferably amounts to approximately 30%, a content of 50% is more preferred, a content of 60%, 70%, 80% or more is even more preferred. For the analysis, the fatty acid content can, for example, be determined by gas chromatography after converting the fatty acids into the methyl esters by transesterification. The oil, lipid or fat can comprise various other saturated or unsaturated fatty acids, for example calendulic acid, palmitic acid, palmitoleic acid, stearic acid, oleic acid and the like. The content of the various fatty acids in the oil or fat can vary, in particular depending on the starting organism.”
112. Furthermore there is disclosure on page 31 lines 34-39 of PD1 and page 33 lines 35-40 of PD2 of the amounts of ARA, EPA and DHA based on total fatty acid content:
“The oils, lipids or fatty acids according to the invention advantageously comprise at least 0.5%, 1 %, 2%, 3%, 4% or 5%, advantageously at least 6%, 7%, 8%, 9% or 10%, especially advantageously at least 11%, 12%, 13%, 14% or 15% of ARA or at least 0.5%, 1%, 2%, 3%, 4% or 5%, advantageously at least 6% or 7%, especially advantageously at least 8%, 9% or 10% of EPA and/or DHA based on the total fatty acid content of the production organism, advantageously of a plant, especially preferably of an oil crop plant.”
113. In view of this disclosure and the definition, the total amount of ARA, EPA and DHA is at least 20%.
114. The opponent also submitted that there is no disclosure of this being in the seed. However, this needs to be read in the context of the whole document. On page 30 lines 20-25 of PD1 and page 32 lines 13-17 of PD2 the extraction of the fatty acids is from seeds. Furthermore both specifications disclose examples where the genes are expressed specifically in seeds and seed specific promotors are used (PD1 page 33 lines 4-5 and examples; PD2 page 35 lines 4-5 and examples). The examples where expression is carried out in plants is always seed-specific.
115. I therefore find that there is a real and reasonably clear disclosure of at least 20% by weight of total lipid content in the seed.
SEQ IDNO: 202 Δ6-desaturase and special utility.
116. The opponent argued at the hearing that PD1 disclosed a different invention which focused on Δ5-elongase activity.
117. The applicant responded to this by highlighting Δ6-elongases in PD1. These have been taken from the same species as the Δ6-desaturase with the amino acid sequence of SEQ ID NO: 202.
118. The example given is Example 14 which is on page 78. It states:
“Example 14: Cloning genes from Ostreococcus tauri
By searching for conserved regions in the protein sequences with the aid of the elongase genes listed in the application with Δ5-elongase activity or Δ6-elongase activity, it was possible to identify two motifs in Ostreococcus tauri sequence database.”
119. I note that the Δ6-desaturase with SEQ ID 202 is not disclosed in PD1. The applicant argued that techniques were provided that the skilled person could then find SEQ ID 202 and put the invention into practice.
120. I consider this would require some experimentation and for a clear feature in the claim this does not suffice.
121. There would need to be a selection to choose the Δ6-desaturase of Ostreococcus tauri based on the disclosure of PD1. As a consequence, I do not find SEQ ID NO: 202 of the current claims to be fairly based on PD1.
122. PD2 discloses Δ6-desaturases as enzymes of the invention and SEQ ID NO: 202 is one of them. The sequence of SEQ ID NO. 202 as currently claimed, is called SEQ ID NO. 89 in PD2. On page 59 lines 9-13:
“Isolated nucleic acid sequences encoding polypeptides with Δ6-desaturase activity, selected from the group consisting of:
a) a nucleic acid sequence with the sequence shown in SEQ ID NO: 89”.
123. Example 32 on page 104 uses the expression cassette OtDes6.1 which includes SEQ ID NO: 89.
124. I note that the accepted claims claimed either using SEQ ID NO: 194 or SEQ ID NO: 202 and amendments after acceptance resulted in the claims no longer referring to SEQ ID NO: 194. The question then becomes has this been a selection which changes the nature of the invention. While the amino acid sequence of SEQ ID NO: 202 is present in PD2, has there been an inventive step involved in selecting it or is merely a reasonable development?
125. The opponent’s position is that SEQ ID NO: 202 has special utility as the evidence by Senger shows it has advantages. This evidence, while helpful in construction, is an external statement that has not been made part of the invention as it is described in the specification in suit (Multigate at 229-330).
126. It is usual for there to be some natural variation within a class, particular within enzymes. It follows that the deletion of SEQ ID 194 to leave SEQ ID 202 in the claim has merely resulted in the claiming of a better choice amongst alternatives in a class where there is natural variation. It has not resulted in a new inventive step based on any disclosure of advantages in the current specification.
127. Given this I am satisfied that the priority date is 13 March 2004 for the disputed features of the claims and I have no evidence that this is not the priority date for all of the claims.
128. The consequence of my decision on the priority date means that the ground of novelty must fail as the document was published after the priority date.
Inventive step
129. It is a requirement of subsection 18(1) of the Act that the invention, so far as claimed in any claim, involves an inventive step. Subsection 7(2) states that an invention is taken to involve an inventive step unless it would have been obvious to a person skilled in the art in the light of the common general knowledge, considered alone or together with the prior art. A document is prior art for this purpose if "a skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood, regarded [the document] as relevant" (subsection 7(3)).
130. The test for whether an invention is obvious is to ask whether it would have been a matter of routine to proceed to the claimed invention. In Wellcome Foundation Ltd v V.R. Laboratories (Aust.) Pty Ltd [1981] HCA 12; 148 CLR 262 at 286 Aickin J stated:
"The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not."
131. The High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; 212 CLR 411 approved this approach.
132. The opponent made the following submissions on inventive step which are all dependent on the priority date:
a) if the priority of the claims is deferred until 14 May 2004, being the filing date of priority document 4, then the claims lack inventive step over CGK combined with the availability of the complete Ostreococcus tauri genome;
b) if the priority of the claims is deferred until 24 December 2004, being the filing date of priority document 6, then the claims lack inventive step over CGK combined with D21 (Ral);
c) if the priority of the claims is deferred until 25 January 2011, or later then, for the reasons advanced in relation to novelty the claims lack an inventive step in view of D69.
133. Given my decision is that the priority date is 13 March 2004 and each of these arguments requires a later date, this ground of opposition must fail.
Clarity
134. It is a requirement of subsection 40(3) of the Act that the claims must be clear. This requirement is understood to be satisfied if a person could ascertain "whether or not what he proposes to do falls within the ambit of the claim" (Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59).
135. The opponent argued that the phrase “20% by weight of total lipid content” was unclear as to whether or not it contained endogenously produced C18 PUFAs. That is, this percentage includes linoleic and linolenic acids which plants do produce, particularly linseed or flaxseed, where the “lin” in the name is derived.
136. On reading the specification as a whole and taking into consideration table 2, which includes the amounts of fatty acids, it is clear the 20% total lipid content claimed does include C18 PUFAs which are not the product of the invention.
137. Furthermore the claims state C18-, C20- and C22- which means there must be some C20 and C22 PUFAs in the product. The C20 and C22 PUFAs were not produced at all in the wild type in table 2, so any production is included within the scope of the claims. I do not find this unclear when reading the words of the claims themselves and when read in the context of the specification there is no ambiguity.
138. The opponent also argued that the term “stringent conditions” in claims 10, 11 and 13 is unclear and redundant as the description defines “hybridizes under stringent conditions” on page 24, lines 31-34. I disagree that this is unclear or redundant. Furthermore the calculation of 60% homology using stringent conditions can be found by looking at the definition in the description. It is a common technique used for measuring homology.
139. This ground of opposition fails.
Fair basis
140. It is a requirement of subsection 40(3) of the Act that the claims must be fairly based on the matter described in the specification. The High Court in Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [2004] HCA 58; 217 CLR 274 at 300 approved the words of Gummow J in Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 at 95:
"the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification".
Sequence of 60% identity
141. The opponent argued that the claims that include the requirement for the Δ-desaturase to have at least 60% amino acid sequence identity to SEQ ID NO 202 were not fairly based as the description only has a real and reasonably clear disclosure of a Δ-desaturase with 100% sequence identity to SEQ ID NO 202.
142. They argued that at this level of homology it might be closer to different enzymes. In doing this they cited other desaturases and gave their percentage identity to SEQ ID NO: 202. However, the sequences cited only have 41-43 % homology to SEQ ID NO 202.
143. The claim explicitly identifies a Δ6-desaturase, so any amino acid sequence without activity as a Δ6-desaturase would not be within the scope of the claim. There is therefore a real and reasonably clear disclosure of this feature.
144. The specification states at page 9 lines 9-11 that the process is for the production of large amounts of ARA, EPA and DHA. At the hearing the opponent stated that if the claims mean that the naturally occurring C18- PUFAs can be included in the 20% then the claims do not produce “large amounts of PUFAs”.
145. This is subjective; a few percent can be a large amount in a crop that previously produced 0%.
146. The specification as a whole is consistent with this construction, particularly when table 2 is taken into consideration.
147. Therefore this ground of opposition fails.
Conclusion
148. The opposition has been unsuccessful. Subject to appeal, I direct that the application proceed to grant.
Costs
149. The parties submitted that costs should follow the event. The opponent has been unsuccessful in their case on the other hand the applicant filed amendments during the course of the opposition. If the amendments overcame certain grounds in the original SGP the opponent could be seen as being partially successful. This was the case in British American Tobacco (Germany GmbH) v Philip Morris Products S.A. [2016] APO 59 at [123]. In Innovia Security Pty Ltd v OVD Kinegram AG [2016] APO 73 at [112]-[121] the delegate found that s 104 amendments filed during the course of the opposition added a feature that was instrumental to the decision and adjusted costs appropriately citing Meat & Livestock Australia Limited and Dairy Australia Limited v Cargill Inc and Branhaven LLC, [2016] APO 26.
150. The applicant filed a first set of amendments under s 104 on 13 June 2014. I note that these amendments were not allowed because of the use of the word elevated. The applicant then filed further amendments under s 104 on 20 April 2015 which were said to “further narrow the claims” and to “add clarity”. In response to the opponent’s comments to the latter amendments the applicant filed further amendments under s 104 on 29 June 2015 and again on 03 September 2015. The amendments of 03 September 2015 were allowed on 20 January 2016.
151. I note that these amendments were after the evidence in support had been filed and the applicant’s admission that they “narrow” and “add clarity” to the claims. This suggests that the amendments were made to avoid an adverse finding in the opposition.
152. I therefore award costs in accordance with Schedule 8 against the applicant up to and including the date the s 104 amendments were allowed on 20 January 2016 and costs against the opponent from that date of allowance onwards.
K. Wagg
Delegate of the Commissioner of Patents
0
15
0