25th Jun 2014 07:00
LONDON (Alliance News) - Shire PLC said Wednesday that the US District Court for the District of New Jersey has granted the company's summary judgement motion in a patent infringement lawsuit, holding that certain claims of the patents protecting Vyvanse or lisdexamfetamine dimesylate were both infringed and valid.
Shire said that the ruling prevents the five pharmaceutical manufacturers - the ANDA- Defendants - which have filed Abbreviated New Drug Applications 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.
In order to appeal successfully, Shire said the ANDA- Defendants must overturn the Court's rulings for each of the 18 patent claims.
The Court's summary judgement ruling of 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 Attention Defecit Hyperactivity Disorder. Shire's Vyvanse is indicated for the treatment of ADHD in patients aged six years and above.
The lawsuit is against the five ANDA- Defendants that filed ANDAs with the US Food and Drug Administration seeking to market generic versions of Vyvanse, and their Active Pharmaceutical Ingredient 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.
Shire's summary judgement 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, said the company. In addition to Shire's motion, the Court also ruled on five summary judgement 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.
The pharmaceutical company said in a statement that 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.
Shares in Shire last traded at 4,404 pence per share.
By Alice Attwood; [email protected]; @AliceAtAlliance
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