Bartlit Beck Wins Testosterone Injection Patent Appeal For Endo And Bayer

July 13, 2018

Adam Mortara, Scott McBride, Nevin Gewertz, Faye Paul, Taylor Meehan and Meg Fasulo won a complete affirmance of a trial victory for Bayer and Endo Pharmaceuticals in ANDA litigation over Endo’s testosterone undecanoate intramuscular injection Aveed®.  Aveed® is the first FDA-approved long-acting testosterone replacement therapy injectable.  Defendant Custopharm, Inc. sought to market a generic version of Aveed® and challenged as obvious two patents covering Aveed®’s unique composition and dosing regimen.  At a bench trial in 2016, Judge Sue Robinson of the District of Delaware issued a memorandum opinion and order finding that Custopharm, Inc. had failed to show that the patents covering Aveed® were invalid as obvious. Today, the Federal Circuit affirmed in a precedential opinion (available here).