Last week I attended a breakfast at Eversheds, a law firm in Cambridge entitled Stem cell patenting, Brüstle v Greenpeace: business breaker or business as usual? which focused on the practical implications of the recent decision from the Court of Justice of the European Union on human embryonic stem (ES) cells. The event organizer, Adrian Toutoungi began the session with a summary of where things stand for hopeful patent applicants which included much of the information that Ubaka Ogbogu reported in his recent article on this site with two interesting supplements:
- If the implementation of the invention requires the destruction of human embryos, it will not be patentable and it is irrelevant that such destruction may occur at a stage long before implantation
- Inventions are also not patentable even if the claims of the patent do not cover the actual use of human embryos.
Following this groundwork, two speakers gave their viewpoints on where this leaves the field, both with respect to pursuing patents in the current climate and with the future of ES cell research in the UK.
First up, Neil Thornton provided historical context for the ruling. Prior to this new ruling, the status quo was the Wisconsin Alumni Research Foundation (WARF) patent that prohibited human ES cells and cells derived from human embryos from being patented. This new ruling extends the prohibition to cells derived from human ES cell lines or cells derived from human ES cells. Whereas the WARF ruling allowed for patents on inventions that utilized previously created ES cell lines, the Brüstle v. Greenpeace ruling very clearly does not. Dr. Thornton pointed out that the European Patent Office (EPO) is not bound by the Court of Justice of the European Union and has not yet made an official statement regarding the Brüstle v. Greenpeace ruling (though one is expected soon). However, he did quote EPO president Benoit Battistelli from his blog where he said, “If the judges rule in favour of a restrictive interpretation of biotech patentability provisions, the EPO will immediately implement it.”
Dr. Thornton also speculated on the way forward for those pursuing patents, saying that inventions excluded because they use human ES cells could be viewed as applying to only those technologies where there is no plausible alternative. Therefore, depending on what exactly ends up in the EPO statement, there may be room to patent an invention that could plausibly have used cells from these alternate sources at the time of patent filing (i.e.: using a non-embryo destructive cell source or technique like induced pluripotent stem cells (iPS) or single blastomeres.
Dr. Thornton elaborated with a clever analogy of a obtaining a patent on a method to open a locked safe, which would have a morally acceptable use (by a locksmith) and a morally unacceptable use (by a burglar). Under the EPO’s current guidelines, he continued, a morally unacceptable use for an invention is not sufficient to deny patent protection if the invention can also be used in a morally acceptable way. He then speculated that if inventions relating to human ES cells were treated in the same way, the EPO could possibly grant claims that would cover the use of cells produced by embryo destructive or non-destructive techniques. There was some discussion following this point around how similar iPS cells are to ES cells and whether or not they could be viewed as a plausible alternative.
The second speaker was Cathy Prescott of Biolatris (I featured Dr. Prescott in a previous entry on the Royal Society meeting in 2010), who presented on the impact of this ruling for venture capitalists, industry, and academics. Dr. Prescott started with some numbers that made very clear the low level of investment from members of the BVCA (British Venture Capital Association) into the biotechnology field (1% of all technology investments in the UK) citing reasons of uncertain risk management especially in the area of intellectual property which is viewed as the major currency in the biotech sector. According to Dr. Prescott, “No IP = a non starter.”
From an industry perspective, she noted that the products and services focused on human ES cells were largely either “tools and reagents” or “therapeutics” and quoted a major company delivering tools and reagents into the research market as saying “if this ban were to prevent patenting of downstream methods… [it would] negatively affect business.” The final area that Dr. Prescott commented on was academic research. The most obvious impact, which has precedence in the United States, is that scientists themselves may relocate to those more permissive environments – in this case, to those where they can protect their of applied research. Secondly, it is entirely possible that various EU states may query whether or not it is worth funding non-commercializable research. For now though, Dr. Prescott stressed that both the EC and the UK are committed to continuing to fund ES cell research as a priority area despite patent concerns, including the major government investment made last autumn.
Overall, as an academic researcher, I found the event particularly useful as a high quality synthesis of the ruling’s implications. It certainly left the impression that things were far from decided. For now, it seems that we will have to wait and see what the EPO decides with respect to ES related patents and how stem cell scientists and universities will move forward with respect to patenting in this sector.
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