Sanofi, Regeneron win EU patent case against Amgen over Praluent
"We are pleased with today's decision by the European Patent Office, which upholds the rigorous standard for pharmaceutical patents that we argued for in this case, affirming that Amgen's asserted claims against Sanofi in Europe are invalid," said Karen Linehan, Executive Vice President, Legal Affairs and General Counsel, Sanofi.
Paris: The European Patent Office (EPO) Technical Boards of Appeal has ruled in Sanofi and Regeneron's favor, invalidating certain claims of Amgen's European patent (EP 2 215 124) directed to PCSK9 (proprotein convertase subtilisin/Kexin type 9) antibodies relevant to Praluent (alirocumab). Praluent will continue to be available in European countries where it is approved for use and for sale.
"We are pleased with today's decision by the European Patent Office, which upholds the rigorous standard for pharmaceutical patents that we argued for in this case, affirming that Amgen's asserted claims against Sanofi in Europe are invalid," said Karen Linehan, Executive Vice President, Legal Affairs and General Counsel, Sanofi.
"This decision validates our years-long commitment to vigorously defending this case."
Today's EPO decision follows a ruling in Sanofi and Regeneron's favor in August 2019 by the U.S. District Court for the District of Delaware which found as a matter of law that certain of Amgen's asserted patent claims for antibodies targeting PCSK9 are invalid based on lack of enablement.
Praluent is not available in Germany, following an injunction granted by the Düsseldorf Regional Court in July 2019. Sanofi has appealed this decision, and a hearing for the appeal is scheduled for November 5, 2020.
Praluent (alirocumab) inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to the low-density lipoprotein (LDL) receptor and thereby increases the number of available LDL receptors on the surface of liver cells to clear LDL, which lowers LDL cholesterol (LDL-C) levels in the blood. Praluent was developed by Sanofi and Regeneron under a global collaboration agreement.
Sanofi possesses sole rights for Praluent outside the U.S. Regeneron has sole rights for Praluent inside the U.S.
Praluent is approved in more than 60 countries worldwide across the European Union (EU), North and South Americas, Asia, Africa, and Australia.
In the European Union (EU), Praluent is approved for use in adults:
with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet:
- in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
with established atherosclerotic cardiovascular disease (ASCVD) to reduce cardiovascular (CV) risk by lowering LDL-C, as an adjunct to correction of other risk factors:
- in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
- alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
The effect of Praluent on CV morbidity and mortality has been recognized and approved by regulatory authorities in the EU, U.S., China and other international markets.
Also Read: USFDA Approves Praluent- Breakthrough Drug To Lower Bad Cholesterol
