CJEU C-34/10 - European Stem Cell Industry
Replacement neurons to treat spinal cord injury, insulin-producing cells to treat diabetes, dopamine-producing neurons to treat Parkinson’s disease... the possibilities are endless. As embryonic stem cells are undifferentiated, they theoretically have the ability to develop into any one of the specialised cell or tissue types found in the human body. This offers enormous potential for generating cells or tissues for therapy and drug screening.
However, the patentability of human embryonic stem cells (hESC), their uses and derived products has been uncertain, which has the effect of stifling investment in the technology.
The source of the uncertainty is Rule 28(c) of the European Patent Convention (EPC), which states that European patents shall not be granted in respect of biotechnological inventions which concern “uses of human embryos for industrial or commercial purposes”. The most widely used procedure for the isolation of hESC involves the destruction of a blastocyst, a very early pre-implantation stage embryo consisting of approximately 150 cells.
The question of whether Rule 28(c) EPC should prohibit patent applications relating to hESC has given rise to considerable legal and ethical debate. In 2007, a referral was made to the Enlarged Board of Appeal of the European Patent Office (EPO) with various questions relating to the patentability of hESC cultures (G2/06).¹ It was held that a patent cannot be granted for an invention which necessarily involves the use and destruction of human embryos.
G2/06 effectively precluded patent protection for old patent applications for which the only technology available for the generation of hESC involved destruction of a blastocyst. However, human embryonic stem cell lines are now publicly available, which are suitable as a starting point for many stem-cell based inventions.
Following G2/06, an unofficial interim practice arose at the EPO. Patent applications which post-date the deposit of hESC cell lines by the Israel Institute of Technology (Technicon) at the US National Institutes of Health in May 2003 were generally considered to escape the exemption on the grounds that, as deposited human embryonic stem cells lines were available, it was not necessary to destroy a human embryo as part of the practice of the claimed invention.
However, the Court of Justice of the European Union (CJEU) has now issued its decision in case C-34/10 Brüstle v Greenpeace which relates to the patentability of technology based on the use of human embryonic stem cells.
The decision of the CJEU appears to have gone one step further than G2/06: it holds that an invention is excluded from patentability where the technical teaching which is the subject matter of the patent application requires the prior destruction of human embryos or their use as a base material, whatever the stage at which that takes place.
It also specifically states that:
The fact the destruction may occur at a stage long before the implementation of the invention, as in the case of the production of embryonic stem cells from a lineage of stem cells the mere production of which implied the destruction of a human embryo is...irrelevant.²
This appears to mean that a patentee cannot rely on the existence and availability of stem cell lines to argue that a stem cell-related invention is outside the scope of the exclusion. The current practice of the EPO in generally considering patent applications filed after May 2003 to be outside the exclusion may need to be rethought.
However, stem cell technology evolves at a very fast pace, and there are now other ways of obtaining stem cells which do not involve the destruction of an embryo. For example, Advanced Cell Technology, based in Santa Monica, California, uses hESC cells obtained from a blastocyst in such a way that the blastocyst is still viable (ie, it is not destroyed). Also, in 2007, induced pluripotent stem (iPS) cell technology was described in which adult cells may be reprogrammed to an embryonic-like state.
The most likely outcome in terms of EPO practice is that there will be a flurry of argumentation and evidence to establish the date on which such alternative technologies were available. It will also be necessary to establish that such alternative technologies are suitable for use with the invention in question. It is likely that the date for such technologies, however, will be after the May 2003 date of availability for the Technicon stem cell lines.
What will happen to the European and national patents already granted which cover such inventions? In the immediate term, they will remain in force until challenged, but they will become essentially unenforceable.
A further extended period of uncertainty is very bad news for European stem cell companies in terms of investment. The fact that it is possible to obtain patents on such technologies in the US and elsewhere may mitigate the situation, or it may mean that both the funding and the expertise are eventually driven out of Europe.
The European patent situation may act as a general disincentive for stem cell investment and research – on 14 November 2011, Geron, the California-based flagship company for stem cell therapies, announced that it is dumping its stem cell research program and axing 38% of its workforce. The timing may be coincidence, or the question mark over patentability in Europe may have been a contributing factor. Time will tell whether this represents the first of a general move away from stem cell technology, with companies and investors taking the view that it is just too risky.
¹ G2/06: Official Journal EPO 5/2009, 306.
² C-34/10 Paragraph 49
Full text of decision C-34/10
Full text of decision G2/06
Geron axes its research program