Shire’s ADHD Medication Patents Found to Be Infringed and Valid by US District Court

Shire plc announces that Judge Stanley R. Chesler of 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.

The ruling prevents the five pharmaceutical manufacturers (the ANDA- Defendants) who have 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.

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.

“We are extremely pleased with the Court’s ruling, which affirms Shire’s belief that it has strong patents protecting Vyvanse,” said Flemming Ornskov, MD, Chief Executive Officer for Shire.

Shire’s Vyvanse patents expire in 2023, but Shire recently announced that it has agreed to a Written Request by FDA to conduct pediatric clinical studies to investigate the potential use of Vyvanse for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in preschool-age children, ages 4–5. 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 6-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 FDA seeking to market generic versions of Vyvanse, and 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. This lawsuit includes all of the known ANDAs that are currently pending for Vyvanse.

The Court found that “[t]here is no real dispute about the ANDA Defendants’ direct infringement of the compound claims,” Johnson Matthey “is liable for inducing the ANDA Defendants’ direct infringement of the compound claims,” and “the ANDA Defendants have induced infringement” of a claimed method of treating ADHD. As to validity, the Court found that “Defendants have not shown that lisdexamfetamine was disclosed in the prior art” and “Defendants have failed to point to evidence sufficient to persuade a reasonable jury that [prior art reference] AU ’168 anticipates by disclosing lisdexamfetamine dimesylate,” and “have failed to defeat the motion for summary judgment regarding invalidity due to obviousness of the compound patents.” In addition, the Court found that “Defendants have not offered evidence sufficient to prove [method of treating ADHD] claim 4 of the ’486 patent is invalid due to obviousness or anticipation.”

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. Shire maintains its belief that it has strong infringement claims against each of the six defendants for the patent claims that were not included in Shire’s motion, and strongly believes that the asserted patent claims are valid.