Amgen wins appeal in US patent case over generic psoriasis drugs

[April 20, 2023]  By Blake Brittain

(Reuters) - Amgen Inc convinced a U.S. appeals court on Wednesday to uphold patents that barred generic versions of its blockbuster psoriasis drug Otezla proposed by Zydus Pharmaceuticals and Novartis' Sandoz Inc.

The U.S. Court of Appeals for the Federal Circuit affirmed a New Jersey federal court's ruling that Amgen patents covering the drug were valid and that the proposed generics would infringe them.

The ruling blocks proposed Otezla generics until 2028. The Federal Circuit also upheld a decision to invalidate one of Amgen's patents that Sandoz said would have barred its generics until 2034.

A spokesperson for Sandoz said Wednesday that the company was pleased with the decision allowing for Otezla generics in 2028 instead of 2034.

Representatives for Amgen and Zydus did not immediately respond to requests for comment.

Thousand Oaks, California-based Amgen sold over $2.2 billion worth of Otezla worldwide last year, according to a company filing with the U.S. Securities and Exchange Commission.

An Amgen sign is seen at the company's office in South San Francisco, California October 21, 2013. REUTERS/Robert Galbraith/File Photo

Amgen bought Otezla from Celgene Corp in 2019 for $13.4 billion. Celgene sued several drugmakers over their proposed Otezla generics starting in 2018, and 17 of the 19 lawsuits have been settled since.

U.S. District Judge Michael Shipp said in 2021 that Switzerland-based Sandoz and India-based Zydus' generics would infringe three Amgen patents.

Zydus and Sandoz appealed the decision that two of the infringed patents were valid. The Federal Circuit on Wednesday affirmed the ruling.

The court also affirmed that Amgen's patent that would have expired in 2034 was invalid over Amgen's cross-appeal.

The case is Amgen Inc v. Sandoz Inc, U.S. Court of Appeals for the Federal Circuit, Nos. 22-1147 and 22-1149.

(Reporting by Blake Brittain in Washington)

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