Gilead Scis., Inc. v. Natco Pharma Ltd.

Patent Infringement: The obviousness-type double patenting doctrine prohibits a patent owner from extending their exclusive use right through a later-expiring patent that is not patentably distinct from the earlier-expiring patent.

Opinion (Chen): Natco Pharma Limited (“Natco”) appealed a United States District Court for the District of New Jersey judgment of infringement. Gilead Sciences (“Gilead”) owned multiple patents, 5,763,483 (“483”) and 5,952,375 (“375”), that are directed to antiviral compounds and the methods for their uses. Natco requested approval from the Food and Drug Administration to market a generic version of one of Gilead’s drugs that is covered under Gilead’s 483 patent. Natco argued that Gilead’s 483 patent was invalid because Gilead’s 375 patent expired before the 483 patent. The obviousness-type double patenting doctrine prohibits Gilead from extending an exclusive use right through a later-expiring patent that is not patentably distinct from the earlier-expiring patent. This obviousness-type double patenting doctrine is based on the principle that when a patent expires the monopoly created by the patent ceases to exist, and the right to use what the patent formerly covered becomes public property. The Court held that because the public was not free to use what was covered under Gilead’s 375 patent when it expired because of the presence of Gilead’s 483 patent, Gilead’s 483 patent was invalid because of the double patenting doctrine. VACATED AND REMANDED