Patenting Exclusion for Human Beings
In brief: Partner Dr Trevor Davies (view CV) and Patent Attorney Dr Kathryn Sunn review a recent Australian Patent Office decision providing an interpretation of what constitutes a 'human being' and 'biological processes for the generation of human beings' with regard to exclusion for patenting purposes.
Background
Subsection 18(2) of the Patents Act 1990 (Cth) (the Patents Act) provides that human beings, and the biological processes for their generation, are not patentable inventions. Section 107 of the Patents Act provides the Commissioner of Patents power to direct an applicant to amend a specification for the purposes to remove a lawful ground of objection. Until recently, there has been no judicial consideration, nor any decisions by the Commissioner of Patents on ss18(2).
Inventions that are clearly encompassed by ss18(2) are totipotent cells or groups of cells that can, on their own, develop into a human embryo. Such inventions include:(a) human beings, foetuses, embryos or fertilised ova or totipotent human cells that are the products of nuclear transfer procedures; and (b) methods of in vitro fertilisation or cloning methods which generate human beings, foetuses, embryos, fertilised ova and totipotent cells. Other inventions such as human genes, tissues and cell lines are clearly outside the provision and would be patentable (provided they meet all the other statutory requirements). Note that within the above range of inventions, there will inevitably exist a 'grey area' where it is not clear whether an invention falls foul of ss18(2).
A recent decision of the deputy Commissioner of Patents, Fertilitescentrum AB and Luminis Pty Ltd [2004] APO 19 (13 July 2004), provides a thought provoking interpretation into what is considered to constitute a 'human being' for patenting purposes and the Commissioner's discretion to direct amendments under section 107 of the Patents Act.
The Patent Application
Fertilitescentrum AB and Luminis Pty Ltd filed application No 44916/99 under the provisions of the Patent Cooperation Treaty. The basic concept of the invention was the discovery that a substance called 'granulocyte-macrophage colony-stimulating factor' (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 and the invention involves ensuring its presence 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 embryos, and the IVF program, as being contrary to ss18(2) of the Patents Act. The applicant deleted the claims to the IVF program, but maintained that the claims to the method of growing a human embryo did not offend against ss18(2). It was 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.
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 s107, proposing a direction to delete the claims to the method of growing embryos. The applicant requested to be heard in the matter and a hearing was held in Canberra on 19 April 2004.
Submissions at the Hearing
The Examiner alleged that Claims 10 to 23 contravene ss18(2). Claim 10, the sole independent claim in respect of this subject matter, was:
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.
Claims 11 to 23 were dependent on claim 10.
The position taken by the examiner was that the claimed method was a step along the path of generating a human being, and was therefore covered by ss18(2). The primary submission of the applicants was 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.
Decision
In order to come to a decision on this matter, the Deputy Commissioner reviewed the history on the late inclusion of ss18(2) into the Patents Act. This review provides an interesting reading and a good background as to the political intentions during the legislative process back in 1990.
The correct interpretation of ss18(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.
As the claims in question fall within the interpretation of ss18(2), the applicant was directed to delete the claims.
Conclusion
Subsection 18(2) superficially looks very simple, however, it has the inherent difficulty of defining the exclusion by reference to `human beings and biological processes for their regeneration', without any definition of what constitutes a `human being'. The above decision is the first consideration of ss18(2) by the Commissioner and provides an thought provoking interpretation of what constitutes a 'human being'. Biotechnology innovators should be aware of this interpretation when considering pursuing patent protection for biological reproductive processes in order to ensure that claims to the invention fall wholly outside the exclusion provisions of ss18(2).
For further information, please contact:
- Dr Trevor DaviesPartner, Allens Patent & Trade Mark Attorneys,
Sydney
Ph: +61 2 9230 4007
Trevor.Davies@allens.com.au