Forest Labs., LLC v. Sigmapharm Labs., LLC

Plaintiff’s testing of representative ANDA products demonstrated literal infringement.

November 16, 2018

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Forest Labs., LLC v. Sigmapharm Labs., LLC, Civ. No. 14-cv-1119-MSG, 2018 U.S. Dist. LEXIS 195458 (D. Del. Nov. 16, 2018) (Goldberg, J.)

Drug Product and Patent(s)-in-Suit: Saphris® (asenapine maleate); U.S. Patent No. 5,763,476 (“the ’476 patent”)

Nature of the Case and Issue(s) Presented: Forest manufactured Saphris, a sublingual tablet used to treat schizophrenia and other bipolar-related disorders. Sigmapharm filed an ANDA seeking to market a generic version of Saphris. Forest filed suit, alleging infringement of the ’476 patent, which claimed a pharmaceutical composition of Saphris. After a bench trial, the Court concluded that Sigmapharm’s generic product infringed the ’476 patent.

Why Forest Labs Prevailed: At trial, the parties’ dispute focused on a single issue—whether Sigmapharm’s generic product disintegrated “within 30 seconds in water at 37° Celsius.” Forest Labs took a direct approach to proving its case, devising a 30 and 55 second test demonstrating that the generic tablets did, in fact, disintegrate as claimed. The court found the test, and accompanying expert testimony, persuasive and accurate. Accordingly, the court ruled that Sigmapharm infringed the ’476 patent.

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