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Sandoz claims Amgen ( AMGN ) patents blocking competition

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Seeking injunction on use of patent rights, damages

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Wants to launch its own competitor drug as soon as possible

By Oliver Hirt

ZURICH, April 14 (Reuters) - Swiss generic drug manufacturer Sandoz said on Monday it had filed an antitrust lawsuit in the United States against Amgen ( AMGN ) over the alleged entrenchment of the market position of its blockbuster medicine, Enbrel (etanercept).

Sandoz alleges Amgen ( AMGN ) blocked competition from more cost-effective biosimilar competitors, including Sandoz etanercept biosimilar, Erelzi, by unlawfully purchasing and using certain patent rights to entrench its dominant market position.

Amgen ( AMGN ) said it did not comment on pending litigation.

Submitted on Friday, Sandoz's lawsuit alleged Amgen ( AMGN ) has used a "thicket of patents" to protect its monopoly for Enbrel through 2029 in violation of U.S. federal antitrust law.

Filed in a Norfolk, Virginia, federal court, it accused Amgen ( AMGN ) of "reaping billions in profits while denying purchasers and patients access to the lower prices they would have paid in a competitive market, where Sandoz was able to launch."

Sandoz in its lawsuit said it "continues to lose out on millions of dollars in sales each month that it remains sidelined by Amgen's ( AMGN ) illegal activity."

In 2024, Enbrel generated $3.3 billion in revenue in the United States, Sandoz said. Etanercept is used to treat a range of inflammatory diseases, including rheumatoid arthritis.

Sandoz wants an injunction to prevent Amgen ( AMGN ) from using patent rights to block biosimilar competition and allow Sandoz to launch Erelzi as soon as possible. It is also seeking damages.

Sandoz general counsel Ingrid Sollerer said it was too early to say how much the firm was seeking but said the company was looking at profits lost since the potential market entry.

Basel-based Sandoz received U.S. Food and Drug Administration approval for Erelzi in 2016.

"Patent law should reward innovation, not protect old monopolies," Sollerer told Reuters.

She said that while patients in Europe, Canada, and South America have been able to get Enbrel biosimilars for around a decade, in the United States they are still denied access to such low-cost alternatives. (Reporting by Oliver Hirt, Abinaya Vijayaraghavan and Mike Scarcella Writing by Dave Graham Editing by Rashmi Aich, Rachel More and Joe Bavier)