Final Patent Decisions with a Large Impact in Europe (1)
(January 9th 2009) The European Patent Office has made its final, far-reaching decisions on patents concerning the generation of human embryonic stem cell lines and diagnostic testing for the breast cancer gene, BRCA1, reports Bettina Dupont.
The European Patent Office (EPO) has recently ended its 13 year battle over a patent application from the Wisconsin Alumni Research Foundation (WARF) and the Wisconsin University stem cell researcher, James Thomson. The patent application in question describes a method to derive embryonic stem cell cultures from primates, including humans. The Enlarged Board of Appeal of the EPO has finally rejected the patent application because, under European law, it is impossible "to grant a patent for an invention which necessarily involves the use and destruction of human embryos." Patents on the use of human embryos for industrial and commercial purposes are prohibited by the European Patent Convention and the WARF/ Thomson patent would have affected the usage of some of the most common embryonic stem cell lines.
WARF expressed its disappointment at the EPO' s decision and is currently considering its options. However, the EPO ruling does not affect WARF's patent rights in the United States.
"Academic research with human embryonic stem cell lines is hardly affected by the EPO' s decision," said German stem cell expert and neuropathologist, Oliver Brüstle, from the University of Bonn. But he told
Lab Times that: "Biotech companies in Europe might profit from the EPO's decision because they can use human embryonic stem cell lines in research and development without any obligation to pay royalties. On the other hand, the field needs patents which also cover processes involving embryonic stem cells to drive translational medical development." The stem cell community especially fears that other pending patents involving human embryonic stem cells could be affected by the EPO' s ruling (
read more here).
In November, two other long-lasting patent battles were finally decided. The EPO's Technical Board of Appeal decided to maintain limited versions of patents for genetic testing of the BRCA1 gene by the University of Utah Research Foundation and 'the United States of America'. One of these patents covers the diagnosis of frame-shift mutations in the BRCA1 gene, the other relates to the diagnosis of a specific BRCA1 mutation. Such mutations are associated with an increased risk of breast and ovarian cancer.
The European Society of Human Genetics has complained that patent examination by the EPO takes too long. This creates a legal uncertainty in the interim phase and diagnostic services may already be well established by the time a final patent decision is issued.
Genetic analyses of the BRCA1 gene have been performed in Europe since the early 1990s. Are the patent owners now entitled to collect royalties?
Bettina Dupont
