Originally published June 17.
By Turna Ray
Myriad Genetics has made good on its promise to appeal a federal district court's recent determination that seven of its BRCA1/2 gene patents are invalid.
In issuing a Notice of Appeal this week to the US Court of Appeals for the Federal Circuit, Myriad is challenging the decision issued in March by the New York Southern District Court in Association for Molecular Pathology et al. vs. the United States Patent and Trademark Office et al. In that decision, Judge Robert Sweet ruled that Myriad's BRCA patents conferring susceptibility to breast and ovarian cancer were invalid on statutory grounds (PGx Reporter 03/31/10).
The federal district court's decision, if upheld in higher courts, could end the practice of patenting genes in the US, based on Sweet's determination that isolated DNA is not markedly different in function or the information it contains from gene sequences in the body. As such, the judge decided that isolated DNA is not patentable subject matter. This may have a broad impact on the 40,000 gene patents held by the biotech industry currently.
Although industry players expressed concern about the impact of the district court's anti-gene patenting decision in March, many realized at the time that Sweet's decisions wasn't going to be the final word on gene patenting, and that the legal battle over the patentability of genes would play out over many years.
Myriad has assured its investors that Sweet's decision will not impact the company's operations or its ability to sell its BRACAnalysis tests. In fact, in the months since the decision, facing lower-than-expected revenues, the company has only expanded its direct-to-consumer and physician marketing efforts for BRACAnalysis in untapped regions throughout the US (PGx Reporter 05/05/10).
Currently, little is known about Myriad's strategy for appealing the federal district court's determination. Public Patent Foundation Executive Director Daniel Ravicher told PGx Reporter that Myriad will not file anything more with the court regarding its appeal until a briefing takes place later this summer. Oral arguments for the appeal are slated for this fall. Ravicher is co-counsel alongside American Civil Liberties Union lawyer Chris Hansen in representing the medical professionals, researchers, women's groups, and patients challenging the BRCA patents held by Myriad and the University of Utah.
With the case now in the realm of the Federal Court of Appeals in Washington, DC, the legality of gene patenting is still unlikely to be settled there. Legal experts expect this case will go all the way to the US Supreme Court.