U.S. Appeals Court Affirms Shire's Vyvanse Patents Valid Until 2023

(RTTNews) - Shire plc (SHPG, SHP.L) said that the Court of Appeals of the Federal Circuit has upheld the summary judgment ruling of the U.S. District Court for the District of New Jersey that certain claims of the patents protecting Vyvanse (lisdexamfetamine dimesylate) are valid.

Shire's lawsuit included all of the known pharmaceutical manufacturers that filed Abbreviated New Drug Applications or ANDAs with the U.S. Food and Drug Administration or FDA seeking to market generic versions of Vyvanse, along with their Active Pharmaceutical Ingredient or 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 U.S. Supreme Court.

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.

Vyvanse is a prescription medicine used for the treatment of Attention-Deficit/Hyperactivity Disorder or ADHD in patients 6 years and above. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.