Isolated Genes Remain Patentable: Federal Circuit Revisits Issue in Light of Supreme Court’s Mayo Ruling


Originally published in Genetic Engineering & Biotechnology, November 1, 2012.

In a very important decision for the biotech industry, the Court of Appeals for the Federal Circuit recently reaffirmed its holding that patent claims directed to isolated genes and a method that uses the genes to screen for breast cancer risk are patent eligible.

In contrast, claims directed to methods of analyzing or comparing a patient’s sequence of a BRCA1 gene or BRCA1 RNA with a wild-type sequence to reveal cancer predisposing mutations are patent ineligible (see Assn. for Molecular Pathology v. U.S. Patent and Trademark Office, a.k.a., ACLU v. Myriad Genetics).

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