The Patentability of Stem Cells in Europe: Referral to the European Court of Justice

This article was included in our Summer 2010 edition of Inside IP magazine.

As reported in earlier articles (http://www.vennershipley.co.uk/show-news-id-173.html and http://www.vennership-ley.co.uk/show-news-id-182.html), the Enlarged Board of Appeal (EBA) of the European Patent Office decision G2/06 confirmed that a patent application which only describes methods for obtaining embryonic stem cells that involve destruction of a human embryo will not be granted in Europe.

Decision G2/06 concerned European Patent No.  0770125, the so-called “WARF Stem Cell Patent”, which described a method by which primate (including human) stem cells derived from an embryo can be maintained in vitro without losing their potential to differentiate into any cell of the body.

The patent was ultimately refused, on the basis that Rule 28(c) of the European Patent Convention forbids the patenting of claims directed to products which – as described in the application – at the filing date could be prepared exclusively by a method which necessarily involved the destruction of the human embryo from which said products are derived, even if the method is not part of the claims.

The G2/06 decision did not, however, give the clarity that was hoped for in areas relating to the use of stem cells.  Questions remain, such as whether it is possible to obtain patent protection in Europe for an invention involving cells derived from a human embryo obtained via a method which does not involve the destruction of the embryo (for example, removing a few cells from an otherwise undamaged embryo), or whether it would be possible to obtain patent protection in Europe for inventions relating to the use of human embryonic cells, if such inventions used existing cell lines rather than requiring the destruction of an embryo de novo.

A recent decision by the Bundespatentgericht (the German Federal Patent Court) to refer questions concerning this area to the European Court of Justice (ECJ) may cast some light upon these issues.

A referral to the ECJ can only be made by a national court.  It was for this reason that the EBA refused WARF’s request during the appeal of its patent for questions relating to the use of stem cells to be referred to the ECJ.

The patent at the centre of the referral by the Bundespatentgericht (DE 19756864) was granted in 1999 and partially rescinded in 2006 after a challenge from Greenpeace.  The case is now under appeal.  The patent encompasses the use of cells that originate from a blastocyst (a group of cells resulting from fertilisation of a human egg).

The question that has been referred to the ECJ concerns Article 2 of the German Patent Act, which corresponds to Article 6 of Biotechnology Directive, which states:

“1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.

2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable…..(c) uses of human embryos for industrial or commercial purposes.”

The Judge of the Bundespatentgericht stated that more legal clarity was needed before his Court could make a decision on whether the subject matter of DE 19756864 was patentable.  Accordingly, questions regarding interpretation of the terms “human embryo” and “uses of human embryos for industrial and commercial purposes” were referred to the ECJ.  In particular, whether a “human embryo” includes all stages of development beginning with the fertilisation of the ovum, or whether attainment of a certain development stage is required; and whether stem cells derived from an unfertilised human ova, or from a blastocyst, are still considered to be an embryo.

A note from the UK Intellectual Property Office on the referral to the ECJ can be found here: http://www.ipo.gov.uk/ecj-2010-c3410.htm

A decision of the ECJ will be binding upon national courts of the EuropeanUnion, but does not affect countries outside the EU, and thus does not directly affect the EPC.  Nevertheless, as all EU Member States are now signatories to the EPC, and as the EPC requires harmonisation of national patent laws in conformity with it, it is likely that the EPO’s practice would be adjusted to achieve the same effect as an ECJ ruling.  It will, however, be some time before the outcome of the ECJ’s deliberations are known but we shall let you know what happens.

Kate McNamara 14 Jun 2010

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