Amgen’s Otezla Improvements Justified New Patent, Fed. Cir. Says

Amgen Inc. fended off generic pharmaceutical makers’ patent challenge to its psoriasis treatment Otezla, as a Federal Circuit panel held that the drug’s “unexpected” strength and efficacy saved the patent from being invalid.

Wednesday’s ruling ensures that a generic can’t come to market before February 2028, when the last of the patents covering the drug expire. Novartis AG’s Sandoz Inc. and Zydus Pharmaceuticals USA Inc. both are seeking to make and sell Otezla copies.

The claims of one of Amgen’s patents, US Patent No. 7,427,638, spell out a variation of a preferred compound, apremilast, that would treat inflammation while reducing a patient’s side effects.

The US Court of Appeals for the Federal Circuit agreed with a New Jersey federal judge that certain ‘638 patent claims weren’t invalid as obvious based on evidence that the newer apremilast variation was more potent than one covered by an earlier patent.

Two other patents at issue in the case were US Patent Nos. 7,893,101, and 10,092,541, which also cover various aspects of Otezla, used to treat psoriasis and psoriatic arthritis. Judge Michael Shipp of the US District Court for the District of New Jersey knocked out the ‘541 patent as obvious, but rejected the generic makers’ arguments that the ‘638 and ‘101 patents covered obvious components.

The panel also upheld Shipp’s findings on the ‘101 and ‘541 patents.

Judges Alan D. Lourie wrote the opinion, joined by Judges Tiffany P. Cunningham, and Leonard P. Stark.

Sidley Austin LLP and Covington & Burling LLP represent Amgen. Winston & Strawn LLP represents Sandoz. Locke Lord LLP represents Zydus.

The case is Amgen Inc. v. Sandoz Inc., Fed. Cir., No. 22-1147, opinion 4/19/23.