United States: FLH Client Shire Files Petition For Rehearing En Banc Concerning API Supplier Liability In Hatch-Waxman Cases

On October 26, 2015, Shire filed a petition for Panel rehearing and rehearing en banc with the U.S. Court of Appeals for the Federal Circuit, requesting that the Panel's decision that an Active Pharmaceutical Ingredient (API) supplier cannot be liable for induced infringement in a Hatch-Waxman case be vacated as contrary to long-standing precedent.

Frommer Lawrence & Haug LLP (FLH) represented innovator client Shire before the Federal Circuit and the District Court in lawsuits against five generic pharmaceutical manufacturers that filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) seeking to market generic versions of Shire's blockbuster drug product Vyvanse®, and also against the API manufacturer and supplier to each of the ANDA-filers, Johnson Matthey Inc./Johnson Matthey Pharmaceutical Materials (collectively, JM).

The panel reversed the District Court's induced infringement judgment against the API supplier, holding that JM was not currently liable for induced infringement because of the statutory safe harbor, and that it cannot be liable for future infringement because it did not file an ANDA.

Shire's petition argues that the panel's decision is contrary to the Federal Circuit's precedent in Forest Laboratories v. Ivax Pharmaceuticals, which came to the opposite conclusion on similar facts, as well as contrary to Glaxo Grp. v. Apotex, Allergan v. Alcon Laboratories, and Warner Lambert v. Apotex. For example, Forest found that the Hatch-Waxman Act "may support an action for induced infringement," and found that an API supplier induced the future acts of an ANDA filer "that will constitute direct infringement [of a compound patent] upon approval of the ANDA." Thus, the District Court's induced infringement judgment against JM should be affirmed.

In addition to the API supplier issue, the Panel affirmed the District Court's summary judgment ruling that 18 patent claims from four of the FDA Orange Book-listed patents for Vyvanse® are non-obvious (the ANDA-filers did not appeal the District Court's summary judgment of infringement). The ANDA-filers are Actavis LLC/Actavis Elizabeth LLC; Amneal Pharmaceuticals, LLC; Mylan Pharmaceuticals Inc./Mylan Inc.; Roxane Laboratories Inc.; and Sandoz Inc. The ANDA-filers did not file a petition for rehearing.

The patent claims that were the subject of the Federal Circuit's decision cover Vyvanse®'s active ingredient, the lisdexamfetamine dimesylate compound, and a method of using lisdexamfetamine dimesylate for the treatment of ADHD. The ruling prevents the ANDA-filers from launching generic versions of Vyvanse® until the expiration of these patents in 2023.

To view the ip360 article, please click here.

To view the non-confidential petition, please click here.

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