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ARTICLE · 10 NOVEMBER 2021

Formulation And Administration Claims Asserted In Hatch-Waxman Pass Muster

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In Cephalon, Inc. v. Slayback Pharma Ltd. Liab. Co., the Federal Circuit summarily affirmed under Rule 36 the district court's decision that all asserted claims of the asserted patents are not invalid,...

United StatesIntellectual Property
Paul W. Browning
Paul W. Browning
Emma N. Ng
Emma N. Ng
Stacy Lewis
Stacy Lewis
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Holding

In Cephalon, Inc. v. Slayback Pharma Ltd. Liab. Co., the Federal Circuit summarily affirmed under Rule 36 the district court's decision that all asserted claims of the asserted patents are not invalid, and that Defendants infringed and induced infringement. Cephalon, Inc. v. Slayback Pharma Ltd. Liab. Co., 456 F. Supp. 3d 594 (D. Del. April 27, 2020), aff'd, 856 Fed. App'x. 309 (Fed. Cir. Aug. 13, 2021), reh'g denied (Fed. Cir. Oct. 15, 2021).1

Background

Teva Pharmaceuticals Int'l GmbH, Cephalon, and Eagle Pharmaceuticals sued Apotex, Fresenius Kabi USA, Mylan Labs., and Slayback Pharma under the Hatch-Waxman Act, 35 U.S.C. § 271(e)(2)(A). Defendants had filed Abbreviated New Drug Applications (“ANDAs”) to market generic versions of Bendeka®. Bendeka®'s active ingredient is bendamustine hydrochloride (referred to by the parties as bendamustine). The patents at issue were U.S. Patent Nos. 9,265,831 (“the '831 patent”), 9,572,797 (“the '797 patent”),

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