A U.S. District Court in Delaware today granted an injunction preventing Teva Pharmaceuticals USA, Inc., Teva Pharmaceuticals Industries Ltd., and Barr Laboratories, Inc. from commercializing generic versions of Amgen's (Nasdaq: AMGN) Sensipar(R) (cinacalcet) until expiration of the drug's U.S. patents. The latest Sensipar expiry is in 2018. Sensipar is approved for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) on dialysis and for the treatment of elevated levels of calcium in patients with parathyroid carcinoma.
"We are pleased with the Court's ruling, which validates Amgen's position that the Sensipar patents are valid, enforceable and infringed," said David Scott, Amgen's senior vice president, general counsel and secretary. Scott added: "Amgen will continue to vigorously defend its innovative products from infringement."
Three patents were the subject of the injunction: U.S. Patent No. 6,011,068 ("the `068 patent") and U.S. Patent No. 6,031,003 expire Dec.14, 2016, but the `068 patent is the subject of a patent term extension which will extend the term to March 8, 2018. U.S. Patent No. 6,211,244 expires Oct. 23, 2015.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.