Gene Patent Case Heads Back to Court

The court battle over the legality of gene patents, which will affect the future of genetic disease diagnostics, heads back to court this summer.

On July 20, 2012, the battle over the patenting of genetic discoveries will resume. That is when the US Court of Appeals for the Federal Circuit is set to hear another round of arguments over the validity of patents Myriad Genetics holds on isolated gene sequences in the BRCA1 and BRCA2 cancer gene and on screening potential cancer therapeutics via changes in cell growth rates. The federal government has granted thousands of patents on similar genetic discoveries.

In the end, the outcome will have an impact on funding availability for future biotech research.

In July 2011, the appellate court upheld the composition claims on Myriad’s patents. The plaintiffs in that case—who included Association for Molecular Pathology (AMP), American College of Medical Genetics, and American Society for Clinical Pathology—argued that genes were “products of nature” and therefore not patentable. Their concerns, as voiced by AMP president Jan Nowak, are that "gene patents can serve as a disincentive to innovation in molecular testing because they deny access to a vital baseline of genomic information."

On the other hand, however, if barriers to the patenting genetic discoveries are introduced, "it's going to be harder for small companies with technologies in the diagnostic testing area to get funding," predicted biotech patent lawyer Matthew S. Gibson from the law firm McAfee & Taft in Oklahoma City.

In March, US Supreme Court sent the case back to the Federal Circuit, instructing the judges to take a new look at the issue. That reexamination is to be based on a unanimous decision the high court handed down in another key genetic patent case: Mayo v. Prometheus. In that case, a group of patents on a way to determine the proper dose of thiopurine drugs for an ulcerative colitis patient by measuring the levels of a particular thiopurine metabolite was challenged.

Under US patent law, discoveries cannot be patented if they are merely laws of nature. Gibson said: "Although the patent was based on a new and useful discovery of the correlation between metabolite levels and indications of toxicity and efficacy, the Supreme Court held that the mere discovery of this correlation and the application of it using routine, conventional activity was not enough."

According to John M. Conley, a law professor associated with the University of North Carolina Center for Genomics and Society, "the message is out that you can't patent just anything. There are some limits."

Now, the arguments will be over just what those limits are. Last year, the judges held that because the BRCA patents cover "isolated" DNA molecules that do not occur in nature, they are patentable. "Prometheus has literally nothing to do with product claims," Conley noted. But that decision may signal to the appellate judges that they should be stricter when considering whether a discovery is just a law of nature.

Daniel B. Moskowitz