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Myriad Genetics
On July 29, 2011, the Federal Circuit handed down its decision in Ass'n for Molecular Pathology et al. v. U.S.P.T.O., (often referred to as the “Myriad Genetics gene patent” case). The divided panel's three opinions reveal areas of broad agreement and notable disagreement about patent eligibility under 35 U.S.C. ' 101 of several categories of patent claims of interest to life sciences industries.
Background
The plaintiffs, an assortment of medical organizations, researchers, genetic counselors, and patients, brought suit against Myriad seeking a declaration that certain claims related to BRCA1 and BRCA2 (Breast Cancer Susceptibility Genes 1 and 2) were not patentable subject matter under 35 U.S.C. ' 101 and thus invalid. They challenged 15 composition and method claims from seven patents. The composition claims cover “isolated” human BRCA1 and BRCA2 genes and certain mutations associated with a predisposition to breast and ovarian cancers. A representative claim of this group recites “An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2″ where SEQ ID NO:2 has the amino acid sequence of the BRCA1 protein. Other claims cover methods of “analyzing” or “comparing” a patient's BRCA sequence with the normal, or wild-type, sequence to identify the presence of cancer-predisposing mutations. One claim is directed to a method of screening potential cancer therapeutics by comparing the growth rates of cells containing a BRCA1 gene known to cause cancer both in, and outside, the presence of the potential therapeutic.
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