Until there is ECJ clarification in this field, non-embryonic sources are being explored" /> Until there is ECJ clarification in this field, non-embryonic sources are being explored" />

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Stem cell patents

Until there is ECJ clarification in this field, non-embryonic sources are being explored

books_hammerIn 1998, under the direction of Dr James Thomson, a Professor at the University of Wisconsin in the US, the first human embryonic stem cells were successfully isolated and cultured in vitro. This work was designated "Breakthrough of the Year" by the journal Science, and Dr Thomson himself appeared on the cover of TIME magazine.

European Patent No. 0770125, the so-called WARF (Wisconsin Alumni Research Foundation) Stem Cell Patent, was filed in 1996 with James Thomson as the named inventor. The application describes 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 claims of the application are directed to a cell culture comprising embryonic stem cells, rather than to a method of generating these cultures.

On 13 July 2004, an Examining Division (ED) of the European Patent Office (EPO) refused to grant a patent for the WARF application, on the basis that it contravened the European Patent Convention (EPC). In particular, the disclosed method of obtaining stem cells used a primate (encompassing human) embryo, which was destroyed in the process. This was held to contravene Article 53(a) and Rule 23d(c) EPC 1973 (now Rule 28(c) EPC 2000).

Rule 28(c) states: "European patents shall not be granted in respect of biotechnology inventions which, in particular, concern uses of human embryos for industrial or commercial purposes."

The ED asserted that the WARF patent application disclosed the generation of cell cultures exclusively by a method which required the dissociation of a pre-implantation embryo. The ED stated that use of an embryo as starting material for the generation of a product of industrial application was considered to equal industrial use of the embryo.

The ED explored the possibility that an exception to the exclusion from patentability may exist for the use of human embryos. They turned to the Biotechnology Directive (Directive 98/44/EC), which qualifies the one exception as: "inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it". The ED did not consider that the WARF case fell under this exception.

The decision was appealed by WARF, who asserted that the ED had misinterpreted Rule 23d(c). WARF also submitted moral arguments, asserting that inventions relating to human embryonic stem (hES) cells are not so abhorrent that the grant of patent rights would be inconceivable. WARF pointed out that the development of hES cells from supernumerary embryos (left over from IVF) is permitted in several EPC states, including Belgium, Denmark, France, Greece, Spain and the UK.

The ED did not, however, change its decision, and referred the appeal to the Technical Board of Appeal of the EPO. WARF requested that the patent be upheld, but in the case that it was not, requested that certain questions relating to the case were referred to the EPO Enlarged Board of Appeal (EBA).

The Technical Board of Appeal upheld the finding of the ED and duly referred four questions to the EBA, stating: "The Board considers the question of the patentability of human embryonic stem cells and of the conditions therefore as being an outstandingly important point of law ... for which a decision by the EBA is required. The patentability of human embryonic stem cells is a highly critical matter which is passionately debated ... A decision on the matter by the EBA will lay basic and reliable ground to the treatment of other cases concerning the patenting of human embryonic stem cells."

The decision of the EBA (Decision G2/06) (pdf) was published on November 25, 2008.

In summary, the EBA confirmed that Rule 28(c) EPC applies to all pending applications, including those filed before the entry into force of the Rule, and that the Rule 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 EBA considered that the legislators of both the EPC and the Biotechnology Directive had intended to exclude such inventions from patentability. Finally, it was confirmed that it was not of relevance that, after the filing date of the patent application, the same products could be obtained without having to recur to a method necessarily involving the destruction of human embryos.

European Court of Justice
The G2/06 decision 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. However, G2/06 did not 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 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) and whether it would be possible to obtain patent protection 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 and 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 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, clarification was sought on 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 ovum, or from a blastocyst, are still considered to be an embryo.

See the Intellectual Property Office for a note on the referral to the ECJ

Binding decision
A decision of the ECJ will be binding upon national courts of the European Union, 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 be some time before the outcome of the ECJ's deliberations are known.

UK position
Following publication of the G2/06 decision, the UK Intellectual Property Office (UK IPO) reconsidered practice in the area of the patentability of stem cells. A Practice Notice was issued on February 3, 2009, which stated that the UK IPO will not grant patents for processes for obtaining stem cells from human embryos, on the basis that uses of human embryos for industrial or commercial purposes are not patentable inventions, but that patents will continue to be granted for inventions involving pluripotent human embryonic stem cells (cells that do not have the potential to develop into an entire human body), provided they satisfy the normal requirements for patentability and provided that at the filing date of the patent, the invention could be obtained by means other than the destruction of human embryos.

The future
The use of human embryonic stem cells has long been a contentious issue. In view of this, scientists around the world continue to look for ways to develop stem cells from non-embryonic sources. The development of human induced pluripotent stem cells (iPS), which are obtained by reprogramming adult somatic cells, is an example of the progress made in this regard.

Thus, while it is likely to be some time before there is greater certainty about the subject matter in this field for which patent protection will be granted, developments in scientific techniques indicate that the science may stay one step ahead of the legal process.

The Author
Dr Kate McNamara is a chartered and European patent attorney with Venner Shipley LLP

To comment on this article, email pme@pmlive.com

9th August 2010

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