Fertilitescentrum AB and Luminis Pty. Ltd
[2004] APO 19
•13 July 2004
OFFICIAL NOTICE
DECISION OF A DEPUTY COMMISSIONER OF PATENTS
Application : No. 44916/99 in the name of Luminis Pty Ltd and Fertilitescentrum AB
Title: Method and medium for in vitro culture of human embryos
Action: Proposed direction under s.107 to delete certain claims
Decision: Issued 13 July 2004
Abstract
The application included claims to a ‘method of growing pre-blastocyst human embryos’ in a particular medium. The examiner objected that these claims contravened s.18(2), and a direction under s.107 was proposed to delete those claims. Applicant argued that a human being was generated at fertilisation. And since the claimed method was applied at a later stage, it could not be a process for generating a human being.
· The correct interpretation of s.18(2) is ascertained by recognising a human being as being in the process of generation from the time of the processes that create a fertilised ovum (or other processes that give rise to an equivalent entity) up until the time of birth. This arises either as a general belief that the status of human being does in fact arise over a period of time, or as a reflection of the divergent views in society about when a human being comes into existence (with no view being more right than others).
· The prohibition of ‘human beings’ is a prohibition of patenting of any entity that might reasonably claim the status of a human being, including a fertilised ovum and all its subsequent manifestations.
· The prohibition of ‘biological processes for (the generation of human beings)’ clearly covers all biological processes applied from fertilisation to birth – so long as the process is indeed one that directly relates to the generation of the human being.
· The exclusion of biological processes includes the processes of generating the entity that can first claim a status of human being. For example, processes for fertilising an ovum; processes for cloning at the 4-cell stage by division; processes for cloning by replacing nuclear DNA.
· Direction given to delete claims directed to a method of growing preblastocyst human embryos.
PATENTS ACT 1990
DECISION OF A DEPUTY COMMISSIONER OF PATENTS
Re:Patent Application 44916/99 in the name of Luminis Pty Ltd and Fertilitescentrum AB, and a proposed direction under s.107 to delete certain claims
BACKGROUND
Application 44916/99 was filed under the provisions of the Patent Co-operation Treaty. The basic concept of the invention is the discovery that a substance called ‘granulocyte-macrophage colony-stimulating factor’ (otherwise referred to as GM-CSF) ‘is effective at substantially increasing the proportion of early embryos that develop to blastocyst and increasing the proportion of those embryos that continue to expanded blastocyst and then hatched blastocyst stages of development’. This substance is apparently present in the natural environment of the fallopian tube. The present invention involves ensuring its present in an IVF environment.
As filed, the application included claims to a culture medium, to a method of growing preblastocyst human embryos, and an IVF program. During examination, the examiner objected to the claims to the method of growing, and the IVF program, as being contrary to s.18(2) of the Act. The applicant has deleted the claims to the IVF program, but has maintained that the claims to the method of growing the human embryo did not offend against s.18(2).
Having regard to the fact that the examiner had no objection to the first group of claims (to the medium per se), the Commissioner invoked s.107, proposing a direction to delete the claims to the method of growing. The applicant requested to be heard in the matter. A hearing was held in Canberra on 19 April 2004. The applicant was represented by Dr P Wyk of APT (Adelaide), who was accompanied by one of the inventors – Associate Professor S Robertson.
Claims 10 to 23 are said (by the examiner) to infringe against s.18(2). Claims 11 to 23 are all dependent claims. Claim 10, the sole independent claim in respect of this subject matter, is:
10.A method of growing preblastocyst human embryos, the method including the step of incubating the embryos in vitro in a culture medium containing an effective amount of human GM-CSF to increase the chance of implantation of the embryos, the amount of the GM-CSF being sufficient to increase the proportion of blastocysts formed from the preblastocyst embryos when compared to embryos incubated in a medium lacking GM-CSF.
Fundamental to the present matter is the interpretation of s.18(2) of the Patents Act 1990, which provides:
(2)Human beings, and the biological processes for their generation, are not patentable inventions.
The position taken by the examiner is that the claimed method was a step along the path of generating a human being, and is therefore covered by the exclusion. The primary submission of the applicant (which was amplified at the hearing) is that a human being is created at the time the pronucleii of the fertilised ovum have coalesced so as to obtain mixing of the genetic materials from the respective parents. And since the method of the invention is applied after that stage, it cannot be a method of generating a human being – rather it is merely a treatment of a human being.
Submissions at the hearing
I am grateful for the explanation provided at the hearing by Professor Robertson about the processes that occur from the time of placing sperm in the environment of the ovum up until the blastocyst stage. One of the issues raised in the present application is the question of when in the reproduction process can it be said that a human being is created. Professor Robertson argued that a human being was created at the time when the two pronucleii merge so that the chromosomes from the two parents are mixed in a single nucleus – and the cell could then mature into a birthed entity. And on this basis, the process was not a process of generating a human being – merely a method of treatment. Professor Robinson also referred to the value of patents in encouraging innovation.
I interpose here to note that while it is settled in Australian law that methods of medical treatment of human beings are patentable [Bristol-Meyers v Faulding 46 IPR 553], the conclusion of that decision is expressly conditioned on the absence of any statutory exclusion. Hence it is not logically possible to argue the scope of the exclusion under s.18(2) by reference to the alleged patentability of methods of medical treatment.
Dr Wyk also provided me with extracts from two recent reports:
· The report of the Senate Committee considering provisions of the Research Involving Embryos and Prohibition of Human Cloning Bill 2002 (available at with extracts from chapter 3 of that report; and
· The Australian Law Reform Commission Discussion Paper Gene Patenting and Human Health, with extracts from chapter 16 of that paper.
I have found the deliberations of the Senate Committee interesting. Paragraphs 3.14 to 3.70 discuss the ‘Moral status of the human embryo’. The Committee used three broad ways to consider the moral status of the human embryo:
· no moral status;
· the same moral status as an adult human being; and
· limited or different moral status compared with an adult human being.
In the discussion on ‘Same moral status…’, paragraphs 3.30 to 3.38 discuss the ‘Commencement of human life’. At paragraph 3.30, the report states
“There is in fact little disagreement that the embryo is a human life and that its life commences at fertilisation. The difficulties arise in specifying exactly in what sense it is to be considered ‘a life’, and hence the significance to be attached to it.”
Paragraphs 3.36 and 3.37 relate to a question put to a witness about whether a fertilised ovum was a ‘human being’. When asked to agree that a human embryo at fertilisation [a human entity] was a ‘human being’, the witness responded with:
“I am not sure I understand the declension. I said ‘entity’ because the view that I and many other people would take is that, in embryology and in the development of the human person – and, indeed, even theologically, in the implantation of a soul – it might well be a gradual process”
and the witness noted:
“There are many overtones to the word ‘being’ that I would build into it, and perhaps you would build different ones in…. But I am quite happy to agree to ‘entity’.”
The Committee concluded its discussion on this topic in paragraph 3.38, which states:
“In essence (the witness’s) distinction points to the fact that, although it may be relatively uncontroversial to identify the embryo as biologically human, that identification does not necessarily settle the question of the sense in which the embryo shares our humanity and hence of the significance to be attributed to it.”
SOME PRACTICAL ISSUES RELEVANT TO THE APPLICATION OF S.18(2)
S.18(2) has not been the subject of any judicial consideration, nor any decisions by the Commissioner. Standard texts on patents in Australia (eg Lahore on Patents, Trademarks and Related Rights by Butterworths, and Australian Industrial & Intellectual Property by CCH) provide no elucidation other than a brief reference to what is in the Patent Office Manual of Practice and Procedure. This section, which superficially looks very simple, has the inherent difficulty of defining the exclusion by reference to ‘human beings’, without any definition of what constitutes a ‘human being’. Reproductive technology exposes a range of fundamental issues concerning the nature of human life vis-à-vis human beings – issues that are essentially ethical or moral in nature, with no clear scientific answer. Illustrative of the issues are:
· In the context of human reproduction, when is a human being created? Is a human being created at a single step along the path from fertilisation to birth – and if so, where along the path? Or is it something that evolves along the path, with there being no clear beginning or end?
· The divergent societal values inherent in the debates concerning abortion, and the right to life of an unborn child; and in the rights of children to seek damages for adverse events that occurred before they were born.
· Societal concerns about the disposal of excess human embryos from in vitro fertilisation processes, and the natural disposal (in mensae) of human embryos that fail to implant in the uterus (a natural, very commonly-occurring process)
· Is there a difference between a human life form, and a human being? Is a human being in full existence in the human life form that exists at fertilisation, or does it entail extra characteristics that are imparted during some part of the gestation (or even after birth)?
· The requirement for a funeral in the event of miscarriage, but only if the miscarriage occurs after 20 weeks gestation or the foetus exceeds 400 grams weight (with there being differences between the States on the application of the 400 gram criterion).
· As technology and our knowledge of biochemical processes increase, our ‘technical’ perceptions of when a human being/life form is created can change. For example, one can talk about life being created ‘at the moment of fertilisation’ – but does that mean when the sperm enters the ovum, when the two pronucleii form, the two pronucleii fuse, or when the chromosomes within the two pronucleii mix [which is typically about 15 hours after the sperm enters the ovum]? And while this process is relevant to diploid embryos, is it compatible with haploid embryos (where there is only a single copy of each chromosome). [My understanding is that technology has not yet enabled haploid growth in animals beyond a few weeks, but the generation of a haploid ‘human being’ cannot be said to be impossible in the future.]
· Cloning processes that entail the removal of nuclear DNA from an ovum and inserting the nuclear DNA from a cell of an existing human being, are prima facie incompatible with a concept of defining a human being by the bringing together of the DNA from different parents.
· Cloning processes that occur around the 4-cell stage, where the embryo is split in half, are incompatible with a concept of defining a human being by the bringing together of the DNA from different parents – as this cloning process does not affect the nuclear DNA in any manner. Rather it takes an existing life and physically divides the cells into two or more groups – so that two or more lives are created from the original one. Presumably such techniques are (only) viable before cell differentiation occurs – in which case the number of possible ‘human beings’ derivable from a single fertilised ovum is not determinable until after cell differentiation has occurred.
· What is entailed by ‘generating’ a human being? In the ‘natural’ environment, is it copulation, gestation, or both? Are the considerations different when the process is considered at a microbiological level? If one considers a fertilised ovum to be a human being, are the ‘processes for generating’ a human being necessarily confined to events that occur before fertilisation? Is a process that is applied to an embryo such that it will properly grow a process of medically treating a human being or a process of generating a human being?
· Certain diseases and medications can affect the development of a foetus. Notorious examples are rubella (German Measles), and Thalidomide. Thalidomide administered in the 1st trimester can severely affect the growth of foetal limbs (arms, legs, hands, feet), and puts the foetus at risk of other injuries, including eye and ear defects and severe internal defects of the heart, genitals, kidneys, and digestive tract. Rubella can cause eye defects (resulting in vision loss or blindness), hearing loss, heart defects, mental retardation and, less frequently, cerebral palsy, if the infection occurs before ~16 weeks gestation. This suggests that the process of generation (if viewed in the context of producing a ‘normal’ offspring) extends to at least the end of the 1st trimester of gestation. Is the administration of a pharmaceutical to a mother for the express intention of treating the foetus a process for generating a human being, or merely medical treatment of the foetus? [For example, if without treatment the foetus would have severe abnormalities or defects, and the treatment ensured that the foetus grew without such abnormalities or defects.] Is treatment of a mother to prevent a disease from taking hold during pregnancy and affecting the foetus (eg vaccination against rubella) a treatment of the mother or part of a process for generating a human being?
· Is sorting to preferentially select sperm of a particular sex (or other genetic characteristics) part of a process of generating a human being? Is selection of fertilised ovum for implantation, on the basis of (for example) greatest viability or of sex, part of a process of generating a human being? Is genetic treatment of sperm or ovum such that the fertilised ovum will not be affected by a genetic defect, part of the process for generating a human being?
· In the context of gene therapy, how much ‘non-human’ DNA can be present in a foetus before it is considered to be non-human?
HISTORICAL BACKGROUND TO S.18(2)
S.18(2) did not exist in the exposure draft of the Bill that was released as the Patents Bill 1989, which lapsed when Parliament was prorogued. The subsequent Patents Bill 1990 took into account the public consultations following from the 1989 Bill; the Bill as tabled in the Senate did not include s.18(2). And there is no reference to such a provision contained in the IPAC report that led to the Patents Act 1990, nor in the report of the Streamlining Working Party that made a number of recommendations for streamlining the Act. Accordingly there is nothing to be found in any of the materials leading up to the tabling of the Bill to indicate any relevant government policy concerning this subsection.
When the Bill was introduced in the Senate, it was referred to the Senate Standing Committee on Industry, Science, and Technology. In that committee, Senator Coulter moved an amendment containing inter alia:
(2) A patentable invention shall not include the following:
(a)a gene or genes, whether derived from cells or chemically synthesised;
(b)a genome either complete or one which has had genetic material added or deleted;
(c)the altered organism (human, plant, animal or micro-organism) produced by having its genome manipulated; and
(d)the progeny of the genetically engineered organism which also carries the altered genome.
(3) Subsection (2) does not limit the patenting of technologies, techniques and processes involved in the carrying out of genetic engineering.
The report of the Committee does not indicate the substance of the debate that followed. It merely notes that ‘The amendments were negatived’, and that Senator Coulter requested that his dissent to the vote be recorded.
The report of the Committee then records that Senator Harradine suggested amendments to clause 18 – which are now the words of s.18(2). The report of the Committee again does not indicate the substance of the debate that followed. It merely notes that ‘The amendments were agreed to by the Committee.’
Subsequently the Bill returned to the Senate. Hansard records that Senator Coulter proposed his amendments again (including some extra items, such as a referral committee, and definitions of certain words). In the ensuing debate:
Senator Collins (Government) stated:
… the Government indicates that it will not be supporting those amendments on this particular area although the Government indicates its support for Senator Harradine’s amendment.
Senator Archer (Opposition) stated:
I realise that Senator Coulter’s amendments are based on the premise that patenting generally is an undesirable practice and I understand that very clearly. I do not think there is anything in these amendments which would make the Opposition have any more thought than was the case last week. In case it is not clear, or in case any people either in this chamber or outside of it wish to chance their arms to the contrary, I make it absolutely clear that the Opposition totally rejects any notion that there can be any patenting of any human production process for generation in any way, shape or form. ….
In response, Senator Coulter stated:
While I will be supporting Senator Harradine’s suggested amendment… I would also say that it does not really achieve a great deal because it says that humans shall not be patented. We all know that humans as such are not patentable….. So the first words do not mean a great deal.
But where the amendment goes on to say ‘the biological processes for their generation’ – referring specifically to human beings – it begs the very question of which we need some clarification. What are the biological processes for the generation of human beings? I would expect that those words would mean the normal processes for the generation of human beings which would involve a male and female human being in certain actions which have been the processes of generation of human beings for perhaps six million years. But we now have very complex and different ways of making creatures which are quasi-human. That is the very point I believe this legislation should develop, but it will not do so unless it is amended in the ways I have suggested.
Senator Coulter’s amendments were rejected. Senator Harradine moved the amendments that had been agreed in the Committee. He stated:
I need to clarify a point raised by Senator Coulter in addressing an amendment before the vote was taken. Senator Coulter indicated that my amendment could possibly cover the normal processes connected with the generation of human beings. Presumably, he meant the act of sexual intercourse. It is presumably nobody’s intention to have meters in bedrooms to collect a cent a time. It is an interesting thought. A law professor and writer on biotechnology, George Annas, likens patenting biological processes for the generation of human beings to ‘patenting a position in sexual intercourse’.
Let me give an extreme example of a process which my amendment would prohibit. I refer to the techniques that may well be developed for cloning a human embryo at the four-cell stage. That is an example, albeit an extreme one, of the type of technique or process which my amendment to this Bill would prohibit from being patentable.
The amendments were agreed to by the Senate. In the House of Representatives, the second reading speech by Hon. Crean stated:
The Bill, as introduced now, also takes into account certain concerns expressed in the other place on the issue of patentability of human beings. The minister…. has consistently stated that no patent for a human being would be granted under existing Australian law – nor would one have been granted under this Bill as introduced in the other place. Nevertheless, amendments to this Bill were agreed to in the other place with the effect of codifying this policy and to ensure that the biological processes for the generation of human beings would also not be patentable inventions. The Government does not oppose those amendments.
Mr Prosser (opposition) discussed Senator Coulter’s amendments. He stated:
The Democrats sought through their amendment to preclude all human life forms from being patentable. In doing this, they were precluding from the scope of patents all innovations based on genes, genetic material, animals and plant. The Democrats’ amendment was rejected by both the Standing Committee on Industry, Science and Technology and the Opposition. From our point of view, the amendment precluded the patenting of animal and plant life. Both of these play a fundamental role in the development of crucial vaccines and medicines.
The amendment was also restrictive. As it stood, it would have prevented the patenting of sufficient numbers of vaccines and antibiotics which are based on live genetic material – for example, viral vaccines, live polio vaccines and one particular tuberculosis vaccine. The amendment would also have precluded the patenting of new medical techniques – for example, skin growth techniques, which are becoming increasingly widely used in burns cases.
A flow-on effect from the Democrats’ amendment would have been to substantially hinder research into and development of new technology. This would particularly apply to the medical and pharmaceutical fields. Effectively the amendment would have stopped most research into life, genes and living organisms.
If there is no incentive or award for an inventor, currently provided through the patent system, he or she will simply not undertake the research. To illustrate that, pharmaceutical industry research can cost hundreds of millions of dollars and is primarily motivated by the reward at the end.
However, the Senate did agree to one amendment moved by Senator Harradine. His amendments modified those moved by the Democrats and precluded the patenting of human beings and their biological processes. This essentially precludes in-vitro fertilisation and cloning for reproductive purposes from being patentable.
Finally, Hon. Crean stated:
The second point is the question of patenting of life forms. Whilst this aspect is not opposed by the Opposition, it is important to remind the House that the Act has, for many years, allowed the patenting of life forms. Whilst we have accepted the amendment by Senator Harradine, in the other place, apart from senator Harradine’s amendment the Bill represents no change in policy in relation to the patentability of life forms. Effectively, Senator Harradine’s amendment means that human beings and the biological processes for their generation would not be patentable inventions. As I say, we have taken the view that it is important to continue the practice that has existed for a very long time of allowing the patentability of life forms, subject to that qualification and amendment to which I have just alluded.
The reason for our doing that is that it is impossible to foresee what inventions there will be in the future. Flexibility is required. Patent laws need to have that inherent flexibility to cope with changing technology. In our view, a Patents Act which is not flexible enough to deal with the unforeseen would not serve the inventors, the public or the Government. The Patents Act which was passed in 1952 did not prohibit the patenting of life forms; nor did it discriminate between biological or other technologies. The Patents Act 1903, the first Commonwealth Act in this area, was similar. The first Australian patent for an invention involving a living organism was granted as far back as 1921; this was for a tuberculosis vaccine containing a tuberculosis bacterium. The first Australian claims for micro-organisms themselves were allowed in 1976.
From this history, it might be inferred that s.18(2) owes its existence more to political process than to detailed policy deliberation. Nevertheless, several points can be gleaned from the Parliamentary debates:
· Much of the debate was a contrary reaction to Senator Coulter’s amendment, which would have had the effect of excluding genetic material and life forms from patentability;
· There was a clear intention to continue to allow the patentability of life forms – with a recognition that research into medical issues was very important;
· There was unanimous agreement that human beings (whatever might be encompassed by the term) were not patentable;
· There was a clear intention to exclude not just human beings, but also of the ‘biological processes for their generation’; and
· While the scope of ‘biological processes for their generation’ was queried by Senator Coulter, there was no detailed elaboration. Senator Harradine gave techniques for cloning at the four-cell stage as an ‘extreme example’ – which suggests the exclusion relates primarily to reproductive technologies of much lesser significance than cloning. The opposition thought the exclusion was ‘essentially’ of in-vitro fertilisation and cloning for reproduction purposes. But they also thought that there should not be patenting of ‘any human production process for generation in any way, shape or form’. The government merely stated that the biological processes for their generation would not be patentable inventions – without any indication of scope, nor disagreement with the views of the opposition or Senator Harradine.
INTERPRETATION OF S.18(2)
S.18(2) involves two components: Human beings, and the biological processes for their generation. If it can be said that a human being comes into existence at a particular stage in the reproductive process, then prior to the ‘point’ where a human being has come into existence processes are excluded – but any ‘thing’ is not a human being and is patentable. After that ‘point’, the ‘thing’ is excluded for being a human being, but any process cannot be for generating that thing – as it occurs after the human being has been generated. [In the context of the present application, the allowability of the method claims would depend upon whether or not a fertilised ovum is a human being.] The grammatical construction of s.18(2) superficially invites a construction based on this premise, but I note that there is in fact nothing in the language of s.18(2) that requires that a human being comes into existence at a particular point.
A first approach to interpreting s.18(2) is to ask the question – at what point in the reproductive process does a human being come into existence? The fundamental problem with this question is the absence of any legislative or agreed societal definition of what constitutes a human being. As is clear from the Senate report discussed above, while there would seem to be little disagreement that a fertilised ovum is a human life form, there is no agreement about when that life form takes on the characteristics of a human being.
Having regard to the absence of any legislative or agreed societal definition of what constitutes a human being, I fail to see how s.18(2) can be interpreted on the basis that a human being comes into existence at some particular point in the reproductive process. Any effort to do that seems to me to lead inexorably to disagreement about where the point is, with no way of reconciling the divergent views.
A second approach to interpreting this provision is to try to focus on the ‘wrong’ that Parliament was addressing. This is difficult having regard to how this provision came into existence. One could infer that a primary concern of Parliament at the time was cloning, or other processes that controlled the genetic makeup of the entity – all occurring near the time of fertilisation. Notionally, the exclusion would then be interpreted as applying to the creation of any ‘self-contained entity that has everything needed to multiply and grow into a (human being)’, and such entities. In practical terms, the exclusion of processes would be limited to the pre-blastocyst stage of development.
This approach has the advantage of being deterministic, and excludes the cloning methods explicitly referred to in the parliamentary debates. In particular, cloning by division, and cloning by replacing the nuclear DNA, would both be excluded. However the parliamentary debates suggest that the intention was not to be limited to cloning as such – with one senator referring to cloning as being an ‘extreme’ example of what was excluded. Most significantly, this approach completely ignores the question of what is a human being – which is the primary subject of the exclusion – and an interpretation that in effect ignores express words used in a provision is prima facie incorrect. This difficulty can be avoided by interpreting this self-contained entity as a human being. But this differs from the first approach only by allowing for the asserted time of creation of a human being to depend upon the method used [fertilisation for normal reproduction; time of splitting, or of nuclear transfer (etc), for cloning.] That is, it would merely be the first approach – with an asserted point of creation of a human being that is dependant upon its method of creation – and is therefore subject to exactly the same criticisms as the first approach.
A third approach is to explicitly recognise that there is no agreement about when in the reproductive process a human being comes into existence. That is, the generation of a human being (as distinct from a human life form) occurs over a substantial period of time. I think it is important to note that this could arise in two ways – either as a general belief that the status of human being does in fact arise over a period of time; or as a reflection of the divergent views in society about when a human being comes into existence, with none being more right than others.
To deal with this approach, it is necessary to specify the start and end points of the period in which a human being is generated. In my view, there is little doubt that a human life form is created at fertilisation. Further, I have little doubt from the parliamentary debates that Parliament intended to exclude a fertilised ovum from patentability. And as a human life form that has the inherent capacity to grow to a mature human being, I consider it has at least SOME of the characteristics that go to make up a human being – such that it properly falls within the ambit of the term ‘human being’. And to the extent that there can be a significant difference in time between when a sperm enters an ovum, and the entanglement of the DNA, I think it is appropriate to take the starting point as being when the sperm enters the ovum – for at that time the ovum has all it needs to go on and develop as a human being.
Defining the end point of when a human being is generated is less clear cut. In my view, the fact that rubella can cause defects if the infection occurs prior to the 16th week, and thalidomide causes serious deformities if administered in the first trimester, is clear indication that (at least in the physical sense) the human life form is still being generated up to at least the 16th week. I note the legislative regimes in the States for the distinction between abortions and still-births, which occurs at the 20th week. This suggests that by this stage of its development there is both a legislative and societal recognition that the foetus has significant aspects of being a human being – sufficient to require ‘proper’ disposal rather than as hospital waste.
On the other hand, subsequent to birth there is ongoing development of the human, including the major physical changes that occur during puberty. But I think that no-one would seriously argue that a pre-pubescent child was not a human being – which clearly indicates that the status of human being is not dependant upon maturity, or on obtaining completion of growth.
The other significant stage in the development of a human is birth – where the foetus ceases to have physical dependency on the mother. Furthermore, a foetus does not have the same legal rights as a child that has been born (eg right to sue for damages; criminal charges that are available in the event of its death) – even if they are at the same stage of development from conception. This to me suggests that the full status of human being is not acquired until birth.
It seems to me that of these three approaches, only the third approach provides a satisfactory interpretation of s.18(2). Accordingly, in my view the correct interpretation of s.18(2) is ascertained by recognising a human being as being in the process of generation (in either of the two ways I refer to in paragraph 31) from the time of the processes that create a fertilised ovum (or other processes that give rise to an equivalent entity) up until the time of birth.
The prohibition of ‘human beings’ in my view is a prohibition of patenting of any entity that might reasonably claim the status of a human being. Clearly a person that has been born is covered by this exclusion. But to the extent that there is a process of generation of a human being that lasts from fertilisation to birth, I consider that a fertilised ovum and all its subsequent manifestations are covered by this exclusion.
The prohibition of ‘biological processes for (the generation of human beings)’ clearly covers all biological processes applied from fertilisation to birth – so long as the process is indeed one that directly relates to the generation of the human being. I also consider the exclusion of biological processes includes the processes of generating the entity that can first claim a status of human being. For example, processes for fertilising an ovum; processes for cloning at the 4-cell stage by division; processes for cloning by replacing nuclear DNA.
DECISION
Having considered the scope of the exclusion proscribed by s.18(2), I can now proceed to determine whether there is a lawful ground of objection to the present application such that the proposed direction under s.117 should be made.
Claims 10 to 23 are directed to a method of growing preblastocyst human embryos. It is a method applied to a human embryo. The method has clear advantages in better simulating the natural environment, and reducing apoptosis of cells in the blastocyst, resulting in greater success in implantation, and babies of greater body mass and having fewer complications compared to IVF babies born without the benefit of the method – all of which demonstrates that the process is one that directly relates to the generation of a human being. The process is a biological process – it is a process involving the presence of a chemical such that the in vitro environment better simulates the natural fallopian tube environment. I am satisfied that these claims fall within the ambit of ‘biological processes for {the generation of human beings}’ as proscribed by s.18(2).
This matter is the first instance where a proposed direction under s.107 has proceeded to a hearing. In the present matter, the Commissioner proposed a direction that claims 10 to 23 be deleted. I have heard the applicant, and am satisfied that there are lawful grounds of objection. I am also satisfied that those grounds of objection would be removed by the proposed direction. However S.107 provides for an applicant to amend the statement of proposed amendments. It also provides that the amendments must be allowed if the Commissioner is satisfied that the amendments set out in a statement (or an amended statement) are allowable and would, if made, remove all lawful grounds of objection to the patent request and complete specification – that is, if the application is in order for acceptance having regard to all issues that can arise in examination. In the present case, I do not believe that any amendments (other than deletion) can be made to these claims to avoid the s.18(2) problem. Accordingly I believe it is appropriate to direct the deletion of these claims. I am also required to specify a time in which to file such a statement of amendments. In this regard I note that there are no other grounds of objection to the application – the application is otherwise in order for acceptance. In these circumstances I see no reason to specify a time prior to the current final date for acceptance of the application – 12 August 2004.
DIRECTION UNDER S.117
I direct the applicant file amendments to delete claims 10 to 23. I set the time for filing such a statement to be the current final date for acceptance of this application – 12 August 2004.
D Herald
Deputy Commissioner of Patents13 July 2004
Patent attorneys for the applicant : APT Patent Attorney Services, Adelaide
2
0
0