A high-impact result for R&D licensing programs in the pharmaceutical industry

In this ANDA case, our client, Elan Corporation PLC, filed suit to prevent infringement of its patent directed to naproxen formulations for once-daily oral administration. The district court held Elan’s patent claims invalid in view of Elan’s offer to license technology directed generally to the joint R&D of such pharmaceutical products. The Federal Circuit vacated the district court’s holding and remanded the case so that Elan could pursue its claims on the merits. This case has a far-reaching impact in the pharmaceutical industry, affecting views toward R&D licensing programs and the ability to negotiate licensing programs before a patent application is filed.