Judge Freeman of the Northern District of California issued an order on February 1, 2016, denying plaintiff Gilead Sciences, Inc.’s motion for summary judgment of invalidity of two patents assigned to Merck Sharp and Dohme Corp. and alleged to cover Gilead’s blockbuster Hepatitis C (HCV) drug sofosbuvir. Sofosbuvir is a key component of Gilead’s Sovaldi(R) and Harvoni(R) products. Gilead argued that the asserted claims were invalid for failure to satisfy “the utility prong of enablement.” This theory is based on the requirement that “the how to use prong of section 112 [requires] that the specification disclose as a matter of fact a practical utility for the invention,”—designed to “prevent the patenting of mere ideas, research proposals, and hypotheses.”
Gilead argued that “one having ordinary skill in the art…would not have accepted the assertion that the nucleoside compounds claimed by the asserted patents could treat HCV.” Merck countered that a “skilled artisan would have understood the methods and compounds claimed in the asserted patents would be useful in treating HCV.” The court agreed with Merck and found “that there is enough evidence to create a disputed issue of material fact as to whether a skilled artisan would have ‘accept[ed] the allegations [in the asserted patents] as obviously correct.’”
In addition, Judge Freeman granted Merck’s uncontested motion for summary judgment concerning both direct and indirect infringement. The issue of ultimate liability remains to be determined at trial following consideration of Gilead’s outstanding invalidity defenses.
Gilead Sciences, Inc. v. Merck & Co, Inc., 13-cv-04057-BLF (N.D. Cal., Feb. 1, 2016).