Maddox Edwards earned a complete victory for its client, Amneal Pharmaceuticals, over Noven Pharmaceuticals, in connection with Amneal’s ANDA for a therapeutic equivalent of the Minivelle® estrogen patch. Other large generics had settled with Noven, rather than try to invalidate the patents covering Minivelle®. But Amneal pressed forward.
At trial, Maddox Edwards persuaded Judge Stark of the District of Delaware to invalidate all asserted claims of all three Noven patents for failure to meet both the written description and enablement requirements of Section 112 of the Patent Act. Noven Pharm. v. Amneal Pharms., No. 18-699-LPS, Doc. 222 (D. Del. Sept. 2, 2020).
Amneal focused its trial presentation on the theme that Noven had claimed far more than it really invented – which is precisely what Section 112 is intended to prohibit. The Court agreed, in an 82-page opinion, which incorporated portions of Amneal’s post-trial brief. Noven did not appeal.
The Hatch-Waxman litigators at Maddox Edwards have the experience to identify your strongest positions, and the skill to successfully execute at trial.