Myriad Set For Another Round

On Monday October 6th, the U.S. Court of Appeals for the Federal Circuit will entertain oral argument in another case involving Myriad's BRCA1/BRCA2 diagnostic tests. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366. In the words of Myriad "[t]his appeal ... presents this Court with one of the most basic issues under patent law: should Myriad be able to enforce its patents to enjoy its remaining exclusivity or does section 101 of the Patent Act effectively say that Myriad can patent almost nothing related to its ground-breaking discovery?" Myriad Opening Brief ("Opening") at page 4. In addition to responding to Myriad's query regarding its patent estate, the Federal Circuit's review has the potential to provide much needed clarity for diagnostic innovators and patent holders, as well as the U.S. Patent and Trademark Office, regarding the scope and reach of the U.S. Supreme Court's recent patent-eligibility decisions.

Ambry Genetics and BRCA1/2 Testing

On the same day the Supreme Court issued (Assn. for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2120 (2013)) ("AMP"), Ambry Genetics Corp. ("Ambry") announced that it would begin offering its own BRCA test at a price undercutting the price of Myriad's test. Soon thereafter, Myriad sued Ambry in the U.S. District Court for the District of Utah alleging infringement of select claims from several of Myriad's U.S. patents covering pairs of synthetic DNA strands or "primer pairs" and methods for analyzing BRCA1 and BRCA2 sequences. More specifically, Myriad's asserted claims relate to pairs of single stranded DNA primers for use in the polymerase chain reaction (PCR). Other asserted claims cover methods for screening germline mutations in the BRCA1 gene.

Myriad also moved for a preliminary injunction, arguing that the sale of Ambry's test caused Myriad irreparable harm. Ambry opposed the motion, alleging that the claims were invalid under 35 U.S.C. §§ 101, 102, 103 and 112. The district court denied Myriad's motion for preliminary injunction, finding that damages would be adequate to compensate the company for its harm should it subsequently prevail. The district court also found that Ambry had raised a substantial question that the asserted claims were invalid under 35 U.S.C. § 101 (patent-eligibility) because the method claims, as a group, were similar in form to the abstract method claims invalidated in AMP.

Myriad's Appeal

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