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Keeping the Myriad Patent Decision in Perspective

Is Judge Robert Sweet's decision to overturn Myriad's BRCA1 and BRCA2 gene patents the end of gene patenting as we know it? Genomics Law Report's John Conley and Dan Vorhaus broke down the case and its implications in their blog, saying it is an important decision, but it is equally important not to overstate things. Many experts agree that Myriad will most likely appeal to the Federal Circuit Court which could reverse Sweet's decision, though the appeal could take a year. Others suggest that the case could go all the way to the Supreme Court. "As breathtaking as this opinion may be, its legal effect is currently very limited. Another federal district judge would be free [to] reach exactly the opposite conclusion tomorrow. … Things won't get serious (legally) until the Federal Circuit rules, since its opinion will bind all federal courts except the Supreme Court," Vorhaus and Conley write.

Legalities aside, however, there are practical implications to the decision. The blogosphere lit up yesterday when news of the decision made the media rounds and most the headlines dealt with the uncertainty of what the decision was going to mean in the real world of biotech. Vorhaus and Conley make reference to a recent report on gene patents from the Secretary's Advisory Committee on Genetics, Health, and Society, which emphasized the uncertainty of the existing gene patent landscape and the who-what-where-when-why of genetic testing. According to the Genomics Law Report, SACGHS recommended exemptions from patent infringement liability in the case of genetic testing "for patient care purposes" and for "the use of patent-protected genes in the pursuit of research." These recommendations, taken with Judge Sweet's ruling could lead to head-on challenges of Myriad's patents, Conley and Vorhaus say, even though it is likely this opinion won't be upheld. "Risky or not, there is a possibility that Judge Sweet's opinion will prove in time to have let the gene patent horse out of the barn in a way that cannot easily be undone, even by a subsequent reversal at a higher court," they write. "For the moment, however, we do not foresee this decision producing any radical changes in commercial, clinical or other activity surrounding Myriad’s BRCA patents, or gene patents more broadly."

Discover Magazine's 80s Beats blog seems to concur, saying the multi-million dollar biotech industry, which is built on more than 40,000 gene patents, won't see any effect on their patents at this point, and that it's unlikely the US Patent and Trademark Office will change its rulings on gene patenting because of the decision. However, "the lawsuits have no doubt just begun," Discover warns.

Misha Angrist at Genomeboy thinks this case could go all the way to the Supreme Court simply because there's too much to lose for both sides. But even if Myriad loses its appeal, it's unlikely to make a practical difference. "If you had $50 million bucks lying around, would you enter the breast cancer genetic testing market in the US? I wouldn't. Myriad's been at this for well over a decade and it's had the market all to itself. The legal hurdles may have been dealt with and barriers to entry may be pretty low at this point, but so what?" he writes.

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