Appeals Court affirms patent infringement rulings against Roche's peg-EPO product.
The Court of Appeals for the Federal Circuit affirmed the Massachusetts District Court's decision that Roche's peg-EPO product, Mircera, infringes four Amgen, Inc. (Thousand Oaks, CA) patents ('868, '698, '933 and '422) relating to recombinant erythropoietin erythropoietin /eryth·ro·poi·e·tin/ (-poi´e-tin) a glycoprotein hormone secreted by the kidney in the adult and by the liver in the fetus, which acts on stem cells of the bone marrow to stimulate red blood cell production (EPO EPO
EPO Erythropoietin, see there ) and processes for making it. Regarding a fifth patent ('349), the Federal Circuit reversed the holding of non-infringement by the District Court and remanded that issue for a new trial allowing Amgen to show that Roche's product infringes that patent as well. The Federal Circuit also affirmed the validity of Amgen's patents except for a single issue of obviousness-type double patenting which only impacts Amgen's later expiring patents ('933, '422 and '349). The Federal Circuit remanded this issue to the District Court for further analysis.
"We are pleased with today's decision," said David Scott, Amgen's senior vice president and general counsel. "The successful enforcement of intellectual property rights enables Amgen to continue to invest in truly innovative new medicines."
Today's decision affirms the infringement and validity on all grounds for Amgen's process patents ('868 and '698), affirms the infringement on Amgen's product patents ('933 and '422), affirms all but one validity issue which will be further reviewed by the district court on the '933, '422 and '349 patents, and allows Amgen a new trial to show infringement of the '349 patent.
The Federal Circuit left undisturbed the permanent injunction permanent injunction n. a final order of a court that a person or entity refrain from certain activities permanently or take certain actions (usually to correct a nuisance) until completed. that prohibits Roche from selling its pegylated EPO product, Mircera in the United States.
Scott added, "Biotechnology innovation is complex, expensive and extremely risky. Companies and investors need appropriate intellectual property protection to justify the risk and to realize an appropriate return on investment."
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 Kidney Disease Definition
Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease. , rheumatoid arthritis rheumatoid arthritis
Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. , and other serious illnesses.