The US District Court in Delaware has granted Amgen's request for a permanent injunction prohibiting Sanofi and Regeneron from infringing two patents that Amgen holds for Repatha (evolocumab) by manufacturing, using, selling or offering alirocumab for sale in the US. The injunction will not take effect immediately as the court has delayed its imposition for 30 days to allow defendants the opportunity to seek expedited review of this decision.
The judge’s decision follows a jury verdict in March 2016 in Amgen's favour in a trial on the validity of two Amgen patents that describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9).
Stating that he was pleased with decision that recognises Amgen is entitled to an injunction against further infringement of its patent rights, Robert Bradway, chairman and CEO, Amgen, said, “Sanofi and Regeneron admitted that they had infringed our patents, and the jury upheld our patents as valid. Protecting intellectual property is essential to our industry as it reinforces the incentives for the large and risky investments we make in innovation to bring forward new medicines to treat serious diseases.”
Repatha helps in the treatment of patients suffering from heart ailment by providing a profound reduction in LDL-cholesterol.
Repatha (evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). By inhibiting the binding of PCSK9 to the low-density lipoprotein receptor (LDLR), Repatha increases the number of LDLRs available to clear low-density lipoprotein (LDL) from the blood, thereby lowering LDL-C levels.
Repatha is approved in more than 40 countries, including the US, Japan, Canada and in all 28 countries that are members of the European Union.