Merck Sharp & Dohme Corp. has challenged Genentech’s U.S. Patent No. 7,923,221 (Cabilly III) with a complaint for declaratory judgment in the Central District of California. The patent relates to methods to produce antibody products. Merck received FDA approval to market Keytruda® (pembrolizumab) for treating certain melanomas and lung cancers, and the action date is imminent for the FDA’s priority review of bezlotoxumab for treating intestinal tract infections in older hospitalized patients. Merck alleges that Genentech has filed infringement claims under the Cabilly III patent against numerous companies that used recombinant methods similar to those Merck uses to make these products.

Another patent in the Cabilly family, Cabilly II, has been challenged in several IPRs: IPR 2016-01373; IPR2016-00383; and IPR2015-01624.