Jury Upholds Amgen's Patents On Repatha (evolocumab)
THOUSAND OAKS, Calif.,?-?Amgen?(NASDAQ:AMGN) today announced that a?Delawarejury delivered a verdict in?Amgen's?favor upholding the validity of two?Amgen?patents related to PCSK9 antibodies. These patents describe and claim antibodies, like?Amgen's?innovative Repatha??(evolocumab) product, that bind to a specific region on PCSK9 and reduce LDL-C levels in the body. This verdict follows a previous trial in?March 2016?where?Sanofi?and Regeneron admitted infringement of?Amgen's?patents and where a prior jury also upheld the validity of?Amgen's?patents. The prior jury decision was partially reversed on appeal and the case was remanded to the district court for a new trial on two validity issues. In today's verdict, the jury found that the?Amgen?patents meet the legal requirements of written description and enablement.
"Today's decision protects intellectual property which is essential to innovators who are bringing forward new medicines for patients with serious diseases.?Amgen?scientists discovered and developed Repatha, which can play a key role in the fight against cardiovascular disease," said?Robert A. Bradway, chairman and chief executive officer at?Amgen. "We are thankful that the jury weighed the evidence carefully and recognized the validity of?Amgen's?patents."
Today's decision follows recent decisions in the European Patent Office and the Japanese Patent Office which also rejected challenges to the validity of?Amgen's?PCSK9 antibody patents brought by?Sanofi, Regeneron and other potential competitors.?Amgen?is seeking to enforce these patents in the national courts in?Europe?and?Japan?against?Sanofi?and Regeneron.
About Repatha??(evolocumab)
Repatha??(evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.
Repatha is approved in more than 60 countries, including the U.S.,?Japan,?Canada?and in all 28 countries that are members of the?European Union. Applications in other countries are pending.
Important U.S. Product Information
Repatha is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor antibody indicated:
- to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease.
- as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) to reduce low-density lipoprotein cholesterol (LDL-C).
- as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C.