It has been one of the toughest, and most impenetrable, biological patent cases in the history of the European Patent Office. But the University of Utah in Salt Lake City has finally won its battle to keep some European patents on BRCA1 — a gene associated with breast and ovarian cancer.
Myriad holds very broad patents on both BRCA1 and BRCA2 in the United States, where it charges US$3,120 for a full analysis of both genes and $460 for a single mutation test. The single test is used mainly by members of families in which a mutation has been detected before. In Europe, the tests are usually done in large academic institutions and hospitals at a cost of up to €1,500 ($1,900) for both genes. "We will wait to see what royalties the University of Utah might demand of us, but it won't stop us testing the gene in France"
In reality In 2004, the European Patent Office revoked the key patent covering any mutations in BRCA1, as well as any diagnostic method for their detection. Its oppositions board, which considers patent challenges, was convinced by arguments that Myriad had registered an incorrect gene sequence when it first filed the patent in 1994 — and that a perfect reference sequence is required to make a full diagnosis.
The patent system is neither a law of nature nor a commandment from heaven, and cases like this one emphasize the need to start looking for a better way. We need to ensure that companies receive fast, fair rewards for meaningful innovations without decade-long legal battles. These rewards must stimulate rather than prohibit competitive research and development. In an age of unaffordable health care, we need a system that does not tax the sick - or those of a certain genetic ancestry - to provide these rewards. The present system leaves enough room for improvement that we should not be shy about proposing new alternatives.
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