Intellectual Property Group Co-Leader Imron Aly represented Alkem Laboratories Ltd. as part of a group of generic drug makers urging a Federal Circuit panel to nix patents for the tapentadol opioid painkiller Nucynta, marketed by Depomed (now Assertio). IP Law360 reported on the oral argument.
In 2016, a U.S. District Court upheld the validity of U.S. Patent Number 7,994,364, which relates to a claimed polymorph — where drug compounds can take different crystalline shapes. The patent does not expire until 2025, but Aly argued in front of the Federal Circuit Panel that the ‘364 patent offered nothing new over the prior art, and should be invalidated.
Aly argued that the ‘364 patent would have been obvious for other drug makers, since tapentadol was already in the prior art and an FDA Guidance directed people in the field to do a polymorph screen. A 1995 article by Stephen Byrn explained how to perform a polymorph screen, which resulted in the polymorph claimed in the ’364 patent. Aly asserted that the Byrn article provided direction towards at least the “low-hanging fruit” polymorphs that should be obvious and not the subject of a new patent. The parties are awaiting a decision.
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