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Gene patenting: the legal battle goes on

Several European patents on genes linked to hereditary cancers have been revoked or restricted, following complaints from cancer research institutes.

In 2001, the European Patents Office accepted three patents registered by the US firm Myriad Genetics for genes linked to hereditary breast and ovarian cancer (BRCA1 and BRCA2). These patents give Myriad Genetics a monopoly on the BRCA analysis test, at an elevated cost. Before the patent was granted, testing was carried out in European laboratories by other methods and at a lower cost. In Europe, a number of health authorities and several cancer research institutes (notably the Institut Curie in Paris) have demanded the revocation of Myriad Genetics' patents, invoking the argument that the patented invention was not new, as the genes had been identified long before. In 2004 and again in 2005, The European Patents Office essentially found in favour of the plaintiffs and either cancelled or severely restricted the scope of the patents in question, thus breaking Myriad Genetics' legitimate monopoly. The company is lodging an appeal. The Patents Office's decisions are of a legal not an ethical nature (failure to comply with the conditions for the granting of a patent). They do not challenge European policy on the legal protection of biotechnology inventions, which permits a gene isolated from the human body to be patented if its industrial application is concretely stated in the patent application.

©Prescrire November 2005

Source: "Révocation et limitation de brevets sur le gène BCRA1, lié aux cancers du sein et de l'ovaire" Rev Prescrire 2005 ; 25 (266) : 778-780.

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