Shire plc reported that the US District Court for the District of New Jersey granted Shire's summary judgment motion in a patent infringement lawsuit, holding that certain claims of the patents protecting Vyvanse (lisdexamfetamine dimesylate) were both infringed and valid. Vyvanse is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients six years of age and older.

The ruling prevents five pharmaceutical manufacturers, which had filed abbreviated new drug applications (ANDAs), from launching generic versions of Vyvanse until the earlier of either a successful appeal to the US Court of Appeals for the Federal Circuit, or the expiration of these patents in 2023. To appeal successfully, the ANDA-defendants must overturn the court's rulings for each of the 18 patent claims, according to Shire. The court's summary judgment ruling concerning Shire's motion included 18 patent claims from four of the FDA Orange Book-listed patents for Vyvanse, which cover Vyvanse's active ingredient, the lisdexamfetamine dimesylate compound, and a method of using lisdexamfetamine dimesylate for the treatment of ADHD.

Shire's Vyvanse patents expire in 2023, but Shire recently announced that it has agreed to a written request by the US Food and Drug Administration (FDA) to conduct pediatric clinical studies to investigate the potential use of Vyvanse for the treatment of ADHD in preschool-age children, ages four to five. Upon FDA confirmation of a timely submission and review of data that adheres to the requirements of the written request, Shire will be entitled to the benefits of the Best Pharmaceuticals for Children Act, including a six-month extension to the exclusivity afforded by Shire's patents for Vyvanse.

Shire's lawsuit is against the five ANDA Defendants that filed ANDAs with the FDA seeking to market generic versions of Vyvanse, and their active pharmaceutical Ingredient (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. This lawsuit includes all of the known ANDAs that are currently pending for Vyvanse. 

Shire's summary judgment motion did not include every patent claim in the litigation and, accordingly, the court's decision did not dispose of the litigation in its entirety. In addition to Shire's motion, the court also ruled on five summary judgment motions filed by the defendants. The court's rulings denied API-supplier Johnson Matthey's motion to dismiss certain indirect infringement claims, dismissed Shire's willful infringement claims, granted defendants' motion concerning noninfringement of certain method of use claims, and denied defendants' two invalidity motions. At this point, the court must decide whether to conduct a trial on the remaining patent claims or allow the defendants to immediately appeal this ruling to the federal circuit, according to Shire. 

Source: Shire