EU: patentability of stem cell

Greenpeace’s attempts to have “stem cell” patents of Oliver Brüstle revoked moves to the European Court of Justice: The Budnesgerichtshof (German Federal Supreme Court) has referred to the ECJ several questions about the patentability of the use of stem cells to treat various neural diseases.

IPKat has details here, summarising the issues as :

The ECJ will now have to rule on the interpretation of “human embryo” in the sense of art. 6 Directive 98/44/EC. Is a stem cell derived from a blastocyst which has lost its ability to develop into a human still an embryo? If so, is a blastocyst a human embryo? If so, is purely therapeutic use of stem cells a “commercial or industrial purpose” in the sense of art. 6?

By way of comparison, section 18(2) of our Act baldly declares:

Human beings, and the biological processes for their generation, are not patentable inventions.

This provision was introduced at a late stage of the legislative process. Deputy Commissioner Herald had to try and work out its meaning in Fertilitescentrum AB and Luminis Pty Ltd’s Application [2004] APO 19 where he considered that:

36. 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.
37. 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.

36. 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.

37. 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.

In application of that ruling, the Examiner’s Manual indicates that the Commissioner’s policy with respect to stems cells is that:

it follows that human stem cells and human stem cell lines per se are patentable because these cells are not considered to be human beings or potential human beings within the meaning of s18(2).

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