On August 30, 2016, Judge Stanley R. Chesler of the U.S. District Court for the District of New Jersey entered a Final Judgment ending a Hatch-Waxman patent infringement lawsuit and protecting innovator pharmaceutical company Shire’s blockbuster drug Vyvanse® (lisdexamfetamine dimesylate), which had net sales of over $1.7 billion in 2015.
Frommer Lawrence & Haug LLP (FLH) represented Shire before the District Court and the U.S. Court of Appeals for the Federal Circuit in lawsuits against five generic pharmaceutical manufacturers that filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration seeking to market generic versions of Vyvanse®. The ANDA-filers were Actavis, Amneal, Mylan, Roxane, and Sandoz.
The Final Judgment follows one of the few instances in a pharmaceutical case where the Federal Circuit has issued an opinion affirming summary judgment of no invalidity. The Federal Circuit here affirmed the District Court, which also found that the claims are infringed and not invalid for anticipation, holdings that the ANDA-filers did not contest on appeal. The patent claims cover Vyvanse®’s active ingredient, the lisdexamfetamine dimesylate compound, and a method of use for the treatment of ADHD.
The Final Judgment includes injunctions preventing the ANDA-filers from launching generic versions of Vyvanse® until the full term the patents, which expire in 2023. The Final Judgment also dismissed without prejudice several patent claims concerning additional Orange Book-listed patents that were not adjudicated due to Shire’s successful summary judgment ruling. Thus, Shire’s Orange Book patents continue to provide protection for Vyvanse® against these and any future ANDA-filers.