Appeals Court affirms Shire’s Vyvanse patents are valid until 2023

Ruling bars generic versions of Vyvanse from entering market until patents expire.

Shire’s lawsuit included all of the known pharmaceutical manufacturers that filed Abbreviated New Drug Applications ( ANDAs) with the FDA seeking to market generic versions of Vyvanse, along with their API manufacturer of lisdexamfetamine dimesylate API. The ANDA-defendants are Actavis LLC/Actavis Elizabeth LLC; Amneal Pharmaceuticals, LLC; Mylan Pharmaceuticals Inc./Mylan Inc.; Roxane Laboratories Inc.; and Sandoz Inc. The API manufacturer and supplier to each of the ANDA-defendants is Johnson Matthey Inc./Johnson Matthey Pharmaceutical Materials.

The ruling prevents the ANDA defendants from launching generic versions of Vyvanse until the expiration of these patents in 2023. The defendants may move for rehearing at the Federal Circuit, or may file a petition at the US Supreme Court.

“We are extremely pleased that the Federal Circuit affirmed the District Court’s ruling that the patents are valid, which further confirms that Shire has strong patents protecting Vyvanse,” said Mark Enyedy, Interim General Counsel, Shire.

The Court of Appeals of the Federal Circuit affirmed the District Court’s summary judgment ruling that 18 patent claims from four of the FDA Orange Book-listed patents for Vyvanse are valid. The ANDA defendants’ infringement of these claims was not contested on appeal. These patent claims cover Vyvanse’s active ingredient, the lisdexamfetamine dimesylate compound, and a method of using lisdexamfetamine dimesylate for the treatment of ADHD.

As to the API-manufacturer, the Court of Appeals of the Federal Circuit found that Johnson Matthey was not “liable for the API it sold the ANDA defendants up to this point” because it did not submit an ANDA.