US District Court Invalidates Amgen Patent Claims Targeting PCSK9

Court rules in favor of Regeneron and Sanofi in ongoing Praluent® (alirocumab) patent litigation

(STL.News) – Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced today that the U.S. District Court for the District of Delaware ruled in their favor and found as a matter of law that Amgen’s asserted patent claims for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) are invalid based on lack of enablement.

“Today’s decision by the U.S. District Court for the District of Delaware validates our position that Amgen’s patents are overly broad and invalid,” said Joseph LaRosa, Executive Vice President, General Counsel and Secretary, Regeneron. “Praluent was developed using Regeneron’s proprietary science and technology and the judge has confirmed our position by issuing this ruling.”

Today’s ruling overturned portions of an earlier jury verdict upholding the validity of three claims. On February 25, 2019, a jury previously found in Regeneron and Sanofi’s favor that two other asserted Amgen patent claims are invalid.  This means that Regeneron and Sanofi have successfully invalidated all five asserted Amgen patent claims.

“It has been our longstanding belief that all of Amgen’s asserted U.S. PCSK9 patent claims are invalid, and we are pleased today’s decision reaffirms this,” said Karen Linehan, Executive Vice President and General Counsel, Sanofi.

About Praluent

Praluent® (alirocumab) inhibits the binding of PCSK9 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 Regeneron and Sanofi under a global collaboration agreement and invented by Regeneron using the company’s proprietary VelocImmune® technology that yields optimized fully-human monoclonal antibodies.

Praluent is approved in more than 60 countries worldwide, including the U.S., European Union (EU), Japan, Canada, Switzerland, Mexico and Brazil.  In the U.S., Praluent is approved to reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established cardiovascular disease.  Praluent is also approved as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce LDL-C.

Important Safety Information for the U.S.

Do not use Praluent if you are allergic to alirocumab or to any of the ingredients in Praluent.

Before you start using Praluent, tell your healthcare provider about all your medical conditions, including allergies, and if you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed.

Tell your healthcare provider or pharmacist about any prescription and over-the-counter medicines you are taking or plan to take, including natural or herbal remedies.

Praluent can cause serious side effects, including allergic reactions that can be severe and require treatment in a hospital.  Call your healthcare provider or go to the nearest hospital emergency room right away if you have any symptoms of an allergic reaction including a severe rash, redness, severe itching, a swollen face, or trouble breathing.

The most common side effects of Praluent include: redness, itching, swelling, or pain/tenderness at the injection site, symptoms of the common cold, and flu or flu-like symptoms.  Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Talk to your doctor about the right way to prepare and give yourself a Praluent injection and follow the “Instructions for Use” that comes with Praluent.

You are encouraged to report negative side effects of prescription drugs to the FDA.