I’ll be liveblogging today’s panel on Hot Topics in European Bio-Patent Law (co-sponsored by the Broad Institute), with several guest speakers from the European Patent Office (EPO).
Ben Roin, Heiken Assistant Professor of Patent Law here at HLS, is moderating. Speakers will be Dr. Aliki Nichogiannopoulou on stem cells, and Dr. Anja Schmitt on gene patents, Dr. Maiake van der Kooij, all of the EPO, followed by Tom Kowalski of VedderPrice.
Dr. Nichogiannopolou begins by talking about stem cells, and opens with a few background points about the EPO. The agency has its own implementing legislation separate from the EU, and includes 38 member states – 10 more than the EU itself, including industry-important Switzerland. The EPO supports innovation, competitiveness, and economic growth for the benefits of European citizens, and has the mandate to grant European patents for inventions.
Biotechnology patents are governed by the European Patent Convention (EPC) of 2000, case law of the Board of Appeal of the European Patent Office. And while the EPO isn’t governed by EU law, when the EU speaks with one voice, the EPO frequently follows. So by its own motion the EPO adopted EU Directive 98/44/C on the legal protection of biotechnological innovations.
She proceeds with a brief review of basic EU patent law, which allows broad patents with some exceptions. Relevant here are exceptions (Art. 53) for inventions contrary to “ordre public” or morality, plant or animal varieties or essentially biological processes for the production of plants or animals, and methods of treatment of the human or animal body by surgery or therapy and diagnostic methods.
Under the morality clause, the EPO can be held morally accountable, and patenting is no longer morally neutral. This is challenging for patent examiners, who are technically qualified but not typically moral philosophers. And the EU populace – especially in Germany – tends to have very strong feelings on ethical and biotechnological issues.
For the purposes of the EPC, the relevant cultural norms are “European culture and society” – not exactly a uniform domain in terms of bioethics. The huge variety of ethical norms make it effectively impossible to find moral/ethical consensus.
She turns now to stem cell patents in particular.
In 1999, the EPO granted the Edinburgh patent, relating to human embryonic stem cells (among other things), and lead to tremendous political debate, including protests on patents on life in front of the EPO headquarters.
The challenge of stem cells, of course, is that stem cells are obtained from human fetuses. Fetal stem cells are different from embryonic stem cells; the former are surrounded by the legal entity of the mother, but the latter are in vitro. As a result, Rule 28 of the EPC–democratically implemented, and introduced by the charming line, “I am Greek, so democratic principles are in my DNA methylation pattern”–forbids the patenting of the use of human embryos for industrial or commercial purposes.
Dr. Nichogiannopoulou–a strong believer that embryonic stem cells are an invention, not a discovery–then describes a key stem cell case EBoA Decision G2/06, 11/25/2008), which found that human stem cells which can only be obtained by destroying human embryos are not patentable. The Wisconsin Alumni Research Foundation, defending the patent application, requested that the European Court of Justice review that decision, but was denied – as mentioned earlier, the EPO doesn’t have formal links to EU institutions.
In a German case, though, Prof. Brustle holds patent DE19756864; his patent was found invalid by German courts and appealed to the ECJ. The court a) defined a human embryo; b) that patents are by definition for commercial or industrial applications; and c) that materials obtained from someone who destroyed an embryo aren’t suitable for patenting (so no stem cell lines initially from embryos).
The EPO, in reaction and in desire to create some opportunity for stem cell patents, came up with a way that at least some such patents could issue – if the inventor obtains materials from someone who obtained stem cells without destroying an embryo, then the inventor hasn’t directly used an embryo nor gone down a causal chain that had an earlier embryo destruction. It seems a “nice” answer in the old sense of the word, and I’m curious what’s happened since.
Read posts on the other presentations:
Part II: Dr. Anja Schmitt, EPO
