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US Senate Hearings Consider Bipartisan Proposal to Change Patent Laws; Could Have Big Impact on Dx

A US Senate panel will today begin hearings on a proposal to write new patent legislation that could greatly expand eligible subject matter.

The draft bill contains changes to several sections of the statutes covering patent law: it provides a legal definition for the term "useful" and states that inventions need only be useful, and not "new," as stated in the current statute. The draft bill also adds a provision that overturns judicial exceptions to patentable subject matter created by the Supreme Court over the last decade, in cases including Association for Molecular Pathology v. Myriad Genetics, Inc., Mayo Collaborative Services v. Prometheus Laboratories Inc., and Alice Corp. v. CLS Bank International.

Yesterday, the ACLU and AMP announced that 169 other organizations had signed on to their opposition letter, including ARUP Laboratories, the Broad Institute, and the New York Genome Center, as well as testing companies including Ambry Genetics, GeneDx, NeoGenomics Laboratories, and Invitae.

"This draft legislation puts patents before patients and contradicts the entire concept of precision medicine," said Tara Burke, senior director of public policy and advocacy at AMP.


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