In early June, the Supreme Court ruled that Myriad Genetics Inc.’s patents on isolated BRCA genes (useful for predicting an increased risk of breast and ovarian cancer) are invalid, and that isolated genes are not patentable subject matter [see previous post]. The Supreme Court made two other rulings in that case. First, the Court affirmed that DNA sequences that do not exist in nature, e.g. cDNA which contains no intronic sequences, do constitute patentable subject matter. Second, the Court stated that a short strand of cDNA that is indistinguishable from natural DNA, because there was no intervening intron removed when creating the cDNA, is not patent eligible under 35 U.S.C. § 101. Following the Supreme Court’s ruling there was speculation in the biotech community that the ability of companies to protect their R&D investments via patent litigation had been compromised.
Some companies, including Gene By Gene and Ambry Genetics, introduced cancer tests based on the isolated BRCA genes after the Supreme Court’s Myriad decision. Gene By Gene and Ambry Genetics are now facing infringement lawsuits brought by Myriad Genetics. The Supreme Court’s decision invalidated only five patent claims, leaving Myriad with 515 surviving claims related to this genetic testing. The presently asserted claims either require the use of cDNA, which appear to be supported by the Supreme Court’s decision, or are method claims which the court expressly excluded from its Myriad decision.
These new lawsuits confirm that the Supreme Court’s ruling in Myriad has left room for biotech companies to continue to assert patents in an effort to protect their inventions and market positions.