Appeals court validates Myriad's gene patents

The U.S. Court of Appeals for the Federal Circuit ruled again that composition and method claims in patents from Myriad Genetics Inc. (NASDAQ:MYGN) covering the breast cancer 1 early onset (BRCA1) and BRCA2 genes are valid under Section 101 of the Patent Act. In March, the U.S. Supreme Court vacated CAFC's prior decision in the suit -- Association for Molecular Pathology, et al. v. U.S. PTO, et al.-- and ordered the court to reconsider the suit in light of the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories Inc. (see BioCentury Extra, March 26).

The appeals court reiterated that Myriad's claims for isolated DNA molecules are patent eligible because the molecules have a different chemical structure than DNA molecules found in nature. CAFC said the claims represent compositions of matter and therefore do not preempt a law of nature, which was the Supreme Court's concern in Mayo. CAFC also upheld the eligibility of Myriad's method claim for screening potential cancer therapeutics via changes in cell growth rates. The method uses specific host cells that are transformed with an altered BRCA1 gene, which the court said does more than "simply apply a law of nature." However, CAFC did find that other methods in Myriad's patents covering steps for comparing or analyzing DNA were ineligible because they do not include transformative steps. The judges said the claims were indistinguishable from those ruled invalid in Mayo. ...