Just weeks after the U.S. Supreme Court determined that naturally occurring human genes are not patent eligible and thus found certain Myriad Genetics patent claims invalid, Myriad Genetics and other patent assignees filed patent infringement claims against Ambry Genetics Corp., alleging that the company’s addition of BRCA1 and BRCA2 analyses to its clinical diagnostic and genomic services infringes a number of patents that were not apparently affected by the Supreme Court’s ruling. Univ. of Utah Research Found. v. Ambry Genetics Corp., No. 13-0640 (U.S. Dist. Ct., D. Utah, Cent. Div., filed July 9, 2013).
Details about Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (U.S. 6/13/13), appear in Issue 59 of this Bulletin.
The plaintiffs seek temporary and permanent injunctive relief to bar Ambry from infringing the patents, damages no less than a reasonable royalty, the destruction of infringing products, an accounting, attorney’s fees, costs, and interest.
According to a press report, it had been unclear whether Myriad would seek to enforce the claims in patents underlying its BRACAnalysis®, although the company emphasized after the Supreme Court ruling that it still had 500 valid and enforceable claims. Several companies, including Ambry, announced that they would begin testing for BRCA alterations, and Ambry has apparently always included BRCA1 and BRCA2 on its cancer panels but did not perform analysis or reporting until after the ruling issued. Myriad has reportedly held a monopoly on the commercial BRCA testing market for 20 years; each analysis costs some $4,000. It alleges in its complaint against Ambry that it has invested more than $500 million to implement its discovery “and create a molecular diagnostic test for hereditary breast and ovarian cancer related to the BRCA1 and BRCA2 genes.” GenomeWeb.com, July 10, 2013.