Navigating the patentability of stem cells
This is a guest post from the BiotechBlog Intern, Fintan Burke. Fintan is a student at the School of Biotechnology at Dublin City University. Do you have a response to Fintan’s post? Respond in the comments section below.
In Europe the 1998 EU Biotechnology directive (98/44/EC) states that Totipotent stem cells (stem cells that develop into a foetus) are unpatentable on human dignity grounds. The issue of pluripotent stem cell (those that develop tissues and organs, and the focus of research) patentability is vague, and there have been no amendments or replacements since the directive was passed. A further obstacle for stem cell patenting comes from a 2008 decision made by the European Patent Office to disallow any patent that requires the disruption or destruction of human embryos.
This vague patent legislation was finally called into question in October 2011, when Greenpeace brought German researcher Dr. Oliver Brüstle to the Court of Justice of the European Union (CJEU) over his patent for specialised stem cells to treat neurological conditions. Dr. Brüstle, perhaps aware of the EU directive, did not mention that the stem cells used in the patent originated from embryonic cells. The case brought up vital questions about the directive that needed to be elucidated, such as a clear legal definition for the term “human embryo”, their use in industry and in Dr. Brüstle’s case the eligibility of a patent that does not explicitly mention the use of stem cells. The court, following the Advocate General’s opinion, ruled that any fertilised human ovum can be regarded as an embryo and thus any stem cells gathered from them cannot be protected by patent law.
The decision also highlights the differences between the US and EU stem cell patent laws. While the US Patent office allows patents for stem cell generation, the 1996 Dickey-Wicker Amendment banned government funding to programs where human embryos are created or destroyed for research. This amendment has been effectively muted by the executive orders issued by President Bush in 2001 and President Obama in 2009, both of which allowed federal funds to be spent on human embryo research under strict terms. These orders were in turn suspended by a preliminary injunction by US District Court Judge Royce Lamberth (which has since been overruled).
Before the ban on federally sponsored stem cell research, most funding came from private firms. Perhaps one of the most prolific patent applicants under this model was Dr. James Thompson of the University of Wisconsin, whose innovative stem cell patents were acquired for the Wisconsin Alumni Research Foundation (WARF) and funded for by the pharmaceutical company Geron. Over the years, however, WARF have had to revise and abandon their patents, due to pressure from consumer watchdogs who claimed that the patents detailed processes that were too obvious to be patented in the first place.
While EU and US legislation are in place to protect the origins of a human, the advent of induced Pluripotent Stem Cells (iPSCs) may cause a radical rethink of policy. iPSCs, which are derived from somatic cells, eliminate the concern of interfering or destroying the human embryo. Though many existing stem cell policies still apply to iPSCs, Timothy Caulfield et al outline existing laws that are hindering iPSC research. In the paper, the authors note “the regulatory field in California is in a state of flux at present”, with researchers having to deal with three overlapping Californian stem cell research guidelines as well as the National Academy of Science guidelines. The paper also mentions that some of the state guidelines seem to deliberately exclude iPSC research in their guidelines, adding to the confusion. Legislation does not improve in the UK either. Since iPSCs are derived from somatic cells, they are covered by the broad UK Human Tissue Act instead of the 1990 Human Fertilisation and Embryology Act, which covers embryonic stem cells. Furthermore should iPSC go on from research, there are increasingly complex applications to multiple regulators before it can undergo clinical trials.
Stem cell patenting legislation is in a unique position; it is governed not only by commercial concerns, but ethical ones too. The consequence of this is a potentially prolonged development time due to the myriad of regulatory bodies and ambiguous legislation that exist in the EU and US. It remains to be seen whether the EU’s ban on patents will stifle future competitiveness in this international market, though the development on iPSCs go a long way to quell many ethical concerns. In a review published in Nature this year Daisy Robinton and George Daley note that should a new, uniform guideline emerge for these more ethically agreeable stem cells researchers may be able to realise their full medical and commercial potential.