The U.S. Court of Appeals for the Federal Circuit in connection with patent litigation involving DUEXIS® tablets (800 mg ibuprofen and 26.6 mg famotidine), a drug approved for treating the signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers. Each of the patents-in-suit was owned by Horizon Medicines LLC (“Horizon”) and related to pharmaceutical compositions that combine 800 mg ibuprofen and 26.6 mg famotidine in a tablet.
In the litigation, Horizon sought to prevent Alkem from marketing a generic equivalent to DUEXIS® tablets. After a three-day bench trial held in September 2020, the District Court for the District of Delaware (Judge Richard A. Andrews) held that the asserted claims of U.S. Patent No. 8,067,033 (the “‘033 patent”) were invalid for obviousness under 35 U.S.C. § 103, and not infringed either literally or under the doctrine of equivalents, and that the asserted claims of U.S. Patent No. 8,067,451 (the “‘451 patent”) were not infringed based on a favorable claim construction entered before trial.
Alkem launched its product while Horizon’s appeal was pending, and lawfirm successfully defeated Horizon’s motion for an injunction pending appeal in the District Court. The Federal Circuit affirmed the District Court’s finding that the asserted claims of the ‘033 are invalid for obviousness, the District Court’s construction of the ‘451 patent, and the District Court’s finding that the asserted claims of the ‘451 are not infringed.