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Amgen Wins PCSK9 Lawsuit, Sanofi and Regeneron to Appeal

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Amgen Inc. (AMGN - Free Report) received encouraging news with a Delaware jury ruling in favor of the company in its patent infringement lawsuit against Sanofi (SNY - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) for its PCSK9 inhibitor, Repatha.

The jury declared two patents owned by Amgen, which describe and claim monoclonal antibodies to PCSK9, to be valid and that Sanofi and Regeneron had failed to prove the patents (U.S. Patent Nos. 8,829,165, and 8,859,741) invalid for lack of written description and enablement. Prior to the case going to the jury, the court dismissed it on “obviousness.”

However, Sanofi and Regeneron announced that they strongly disagree with the jury’s ruling and therefore plan to appeal the decision. Both companies further noted that the decision doesn’t affect their ability to sell their PCSK9 inhibitor, Praluent this point in time. Meanwhile, proceedings on damages are yet to be set and a hearing to consider a permanent injunction will follow.

In Oct 2014, Amgen had filed a patent infringement lawsuit against Sanofi and Regeneron in the U.S. District Court of Delaware. Amgen through this lawsuit was looking to prevent the manufacture, use and sale of Praluent.

We note that both Repatha and Praluent are used to inhibit a protein known as PCSK9 that lowers the liver's ability to remove "bad" cholesterol (LDL-C) from the blood. While both drugs hit the markets within a month or so of each other in 2015, the companies have been working rigorously on securing deals with health insurers and pharmacy benefit managers.

Praluent registered global sales of €9 million in 2015 while Amgen is yet to disclose the sales of Repatha. We note that Praluent is a key drug for both Regeneron and Sanofi. On the one hand, Regeneron is looking to expand its horizon beyond its eye drug Eylea while Sanofi is working on bringing new products to market in order to lessen the impact of patent expirations and genericization.

Investor focus is expected to remain on the next development on this front.

Amgen is a Zacks Rank #2 (Buy) stock. While Sanofi carries a Zacks Rank #3 (Hold), Regeneron is a Zacks Rank #5 (Strong Sell) stock. Actelion Ltd. is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).

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