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The European Patent Office has rejected an appeal by the US drug company Myriad Genetics and the University of Utah against an earlier decision revoking the patent concerning the BRCA1 gene and its applications.
The ruling has been welcomed by European researchers working on tests for a predisposition to breast and ovarian cancer. Dominique Stoppa-Lyonnet, head of the genetics department at the Institut Curie in Paris, said: “This is an important decision, since it means we can continue our work without fear of being attacked for infringing a patent.”
The decision is the latest stage in a long running battle between European public health practitioners and the US company. Myriad Genetics was granted the patent in November 2001 and handed over its rights to the University of Utah Research Foundation three years later, while keeping an exclusive licensing agreement.
The patent relates to the BRCA1 gene isolated from the human genome, to mutant forms of that gene, and to its use in diagnosing predisposition to breast and ovarian cancer. Among other things the patent describes diagnostic methods designed to identify mutant forms of the gene and to facilitate early detection of enhanced susceptibility to these forms of cancer.
Soon after the patent was awarded, opposition to the decision began to emerge among public health researchers in Europe. Beginning with the Institut Curie, Paris Public Hospitals, and the Institut Gustave-Roussy, near Paris, it soon included genetics societies, Greenpeace, and the Dutch and Austrian health ministries.
Critics feared that the patent's wide ranging nature would give Myriad Genetics a monopoly in a key area of research and would force European laboratories to send DNA samples from patients who are considered to be at risk of the cancers to the company's testing facilities in Salt Lake City.
Not only would European researchers be open to legal attack if they failed to comply, but the arrangements, argues the Institut Curie, would have enabled the company to build up the world's sole genetic data bank.
The company's opponents also maintained that when the application for a patent was made in March 1995, it was already possible to use knowledge available at the time to isolate the gene. Its complete sequence had already been published in scientific databases. As a result the conditions laid down in the European Patent Convention were not met.
In January 2005 the European Patent Office concluded that the contested patent (EP 705902) could be maintained but only in an amended form. It now relates to a gene probe of a defined composition and no longer includes claims for therapeutic and diagnostic methods.
After four days of hearings last month the office's appeal board endorsed the earlier decision. It is also considering appeals by the company and the University of Utah involving two other patents (EP 699754 and EP 705903) that relate to the BRCA1 gene.
For more information see www.epo.org.