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Post-SCOTUS BRCA Litigation

This post has been updated to clarify which of Myriad's claims were upheld by the Supreme Court.

So, if the US Supreme Court has now said that human genes are not patentable under US law, then why are the new gene testing companies that have jumped into the BRCA testing game in the wake of the ruling getting sued, the Washington Post WonkBlog's Timothy Lee asks.

Since the Myriad decision last month, several firms were ready to start offering BRCA testing almost immediately, and Myriad and other partners, have already starting litigation.

Last week, Myriad, along with the University of Utah, University of Pennsylvania, the Hospital for Sick Children, and Endorecherche, who also hold patent assignations for the BRACAnalysis test, filed lawsuits against Ambry Genetics and Gene by Gene for offering tests for BRCA1 and BRCA2 mutations.

"If these lawsuits succeed, they could transform last month’s Supreme Court ruling into little more than a symbolic gesture," Lee says.

The SCOTUS ruling invalidated several of Myriad's claims on isolated BRCA sequences as products of nature, which are invalid under US patent law. However, the court upheld several of Myriad's claims on complementary DNA synthesized in a lab and used as probes and primers in diagnostic testing. The court also emphasized that the company still had valid patent claims that described novel applications of the knowledge about the association between BRCA alterations and cancer risk.

One of the patents left standing under the ruling claims the concept of diagnosing breast cancer by "determining the nucleotide sequence of the BRCA1 gene" from a "female individual" and then checking for mutations on the gene, with no specific limit set on the type of technology that is used to handle the isolation or analysis.

"Myriad lost the theoretical argument over whether human genes could be patented. But if the courts want that ruling to have practical significance, they will need to take a hard look at Myriad’s other patents, which are gene patents in all but name," Lee writes.

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