Final Patent Decisions with a Large Impact in Europe (2)
(January 9th 2009) Fetal and adult stem cells, such as blood-forming stem cells, have been patented in Europe for some time now. However, any application involving human embryos faces patenting problems, regardless of whether it involves stem cells or not, reports Bettina Dupont.
Stem cell expert, Oliver Brüstle, from Bonn University hopes that the latest decision of the EPO will not affect other patents which relate to the use of pre-existing human embryonic stem cells for biomedical applications. "We need patents which cover the use of pluripotent stem cells in biomedicine to drive translation in this area. It is not the job of universities to engage in product development. This is the realm of biotechnology. But to succeed, biotech needs investors. And investors want to see patents," he said.
Pierre Treichel, patent law expert at the EPO, told
Lab Times that the EPO's decision "does not and cannot give an immediate answer on whether inventions taking human embryonic stem cells as the starting material - for example, obtained from an existing stem cell line - are excluded from patentability under the European Patent Convention."
The EPO's Enlarged Board of Appeals emphasises that its decision does not concern the general question of human stem cell patentability. According to Treichel, this suggests "that future or already pending inventions in the field of human embryonic stem cells do not automatically fall under the patenting prohibition." For each invention "it has to be assessed whether there is a misuse of the human embryo."
Treichel thinks that this is likely to occur only in a minority of cases. "Stem cell technology has dramatically evolved since the filing of the WARF application in 1995. In particular, it is no longer indispensable to directly use and destroy the human embryo in order to obtain human embryonic stem cells. The latter can be obtained from pre-existing stem cell lines. Moreover, some alternative stem cell procurement techniques have emerged," said Treichel. "In the field of stem cells, where many ethical and legal questions remain, patent law will certainly remain an ethical battlefield."
Clara Sattler, a patent law expert from the Max Planck Institute for Intellectual Property in Munich (Germany) considers the EPO's decision to be problematic. "At the level of the European member states, we have moral pluralism concerning the use of human embryonic stem cells for research and development. Whereas national laws in Austria, Ireland, and Poland are very restrictive in this respect, Belgium, the UK, and Sweden have less restrictive national laws," said Sattler. She added, "With its rejection of the WARF/ Thomson patent on grounds of public order and morality, the EPO has followed the most restrictive opinions on the regulation of human embryonic stem cell research in Europe. Additionally, there is no appeal against this decision. An administrative organisation should not exercise such power." Despite the EPO's decision, stem cell researchers still have the possibility to apply for national patents.
Brüstle hopes for a clearer and more supportive attitude towards translational stem cell research. "Weighing potential risks and benefits of emerging biotechnologies, the latest patent decisions in Europe have served as brakes rather than motivation drivers," he said.
Bettina Dupont
