The biotechnology industry breathed a deep sign of relief today, as a US Appeals court upheld a company’s controversial patents on genes linked to breast cancer.
The US Federal Appeals Court in New York overturned a lower court’s ruling in a case pitting the genetics testing firm Myriad Genetics against a legion of plaintiffs concerned that the company’s patents on BRCA1 and BRCA2 are limiting the development of tests for breast and ovarian cancer and research into these conditions.
When the case got underway in April, Nature offered this bit of background:
The plaintiffs argue that claims in seven of Myriad’s 23 patents on the two human genes, which greatly increase the risks of inherited breast and ovarian cancer, are stifling diagnostic testing and research, and limiting women’s medical care options. They also contend the patents are illegal because the genes are naturally-occurring. A precedent-setting Supreme Court decision in 1980 determined that patent claims apply only to a thing that is non-naturally-occurring and “a product of human ingenuity.” The central question at the heart of the case is whether the disputed Myriad patents, which have allowed the company to develop an exclusive, $3,000 genetic test for mutations in the two breast cancer genes, fall within that category.
In a 105-page decision released today, the court determined that isolated DNA molecules are not products of nature and therefore are eligible for patent protection. “We reverse the district court’s decision that Myriad’s composition claims to ‘isolated’ DNA molecules cover patent-ineligible products of nature,” the decision reads.
“For Myriad, this is roughly the result that we expected,” said Daniel Vorhaus, editor of the Genomics Law Report and a life sciences attorney at Robinson, Bradshaw & Hinson. “But it’s also almost certainly an interim result. The Federal Circuit made it clear that they understand just how much is riding on this case, and that if someone is going to rock the biotechnology patent boat it will have to be either the Supreme Court or Congress.”
“With three separate opinions from three separate judges, including one partial dissent, this was not a unanimous decision by any stretch,” he adds. “There is ample fodder in here for both proponents and critics of the status quo in biotechnology patents, including gene patents.”
Some in the biotechnology industry have worried that if the lower court’s ruling were upheld it could spell disaster for gene patent holders. “If you deny those patents, you are potentially putting a lot of companies and their technologies at risk,” Junaid Husain, senior medical technology analyst at Soleil Securities, a New York–based investment advisory firm, told Nature after the lower court ruling.
The US Department of Justice, in October 2010, filed a brief to the court arguing against patent protection for unmodified genes. “Common sense would suggest that a product of nature is not transformed into a human-made invention merely by isolating it,” they wrote.
In 2008, after 7 years of legal wrangling, Myriad won a similar legal battle upholding their BRCA patents in Europe.