Gene patents prevail in a landmark case over two genes associated with hereditary forms of breast and ovarian cancer.
The lawsuit against Myriad Genetics, a diagnostic company, based in Salt Lake City, Utah, that holds patents on the genes BRCA1 and BRCA2, has bounced from court to court since 2010. In a 2-1 decision today, a federal appeals court reaffirmed their latest decision that genes represent patent-eligible matter.
Biotechnology and drug companies own thousands of genetic sequences. Industry, therefore, largely welcomes the decision, which they say will foster innovation for diagnostic tests and other biomedical tools that advance personalized medicine.
Meanwhile, the news has disappointed several scientists, patients and medical societies who filed legal briefs on behalf of the plaintiffs, represented by the American Civil Liberties Union (ACLU) and the Public Patent Foundation. In a statement released today, ACLU attorney Chris Hansen called the decision extremely disappointing. “This ruling prevents doctors and scientists from exchanging their ideas and research freely,” he added. “Human DNA is a natural entity like air or water. It does not belong to any one company.”
In March, the US Supreme Court asked the US Court of Appeals for the Federal Circuit to reconsider the case in light of a ruling against patents on a different, non-genetic diagnostic test. In this case, patents were rendered invalid because they merely reiterated ‘laws of nature’.
But according to the latest judges, the patents Myriad holds do not reiterate these laws. In the court’s decision, Judge Alan Lourie writes: “Each of the claimed molecules represents a nonnaturally occurring composition of matter.”