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Supernus, Nestle’s Galderma win acne-drug patents ruling

11 December 2014 15:19 (UTC+04:00)
Supernus, Nestle’s Galderma win acne-drug patents ruling

By Bloomberg

Supernus Pharmaceuticals Inc. and Nestle SA’s Galderma unit fended off a challenge to patents on the acne medicine Oracea in the first review of its kind at the U.S. Patent and Trademark Office.

The patent office yesterday rejected arguments by closely held Amneal Pharmaceuticals LLC that three patents covered obvious variations of earlier research. The patents expire in 2024 and 2025.

The review was under proceedings begun two years ago to take a second look at issued patents. Of the more than 2,000 challenges filed with the agency, less than 10 percent involve pharmaceuticals. This is the first decision in which a would-be maker of a generic medicine opted for the patent review over court proceedings, said Galderma lawyer Gerald Flattmann of Paul Hastings in New York.

Galderma had earlier won a separate court ruling involving Mylan Inc. that upheld a patent expiring in 2027. Because all four of the patents are related, if Bridgewater, New Jersey- based Amneal had won the challenge the results could have been used to try to invalidate the 2027 patent, Flattmann said.

Amneal can appeal the decision to the U.S. Court of Appeals for the Federal Circuit in Washington, which specializes in patent law. A district court challenge is unlikely because it’s easier to invalidate a patent at the patent office than before a judge.

“They already shot their best arrows out of their quiver, so there’s little hope for a district court action at this stage,” Flattmann said. Supernus, based in Rockville, Maryland, owns the patents and licenses them to Galderma.

Officials with Amneal had no comment, according to Cheryl Lechok, a spokeswoman for the company.

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