Saumel T. LocknerTodd S. Werner

Our client, Teva, was the first drug manufacturer to file a Paragraph IV ANDA challenging the validity of a patent covering Protonix® (pantoprazole), a product that had annual U.S. sales in excess of $2 billion. The patent at issue was a compound patent, covering the active pharmaceutical ingredient itself, widely regarded by branded pharmaceutical companies as the most important and difficult to invalidate patents. Discovery was lengthy and hard fought, and as the 30-month stay precluding FDA approval of Teva’s ANDA neared expiration, the patentee filed a motion for a preliminary injunction seeking to enjoin Teva from selling its proposed product. Our team successfully defeated the motion, marking the first time a court ever denied a motion for a preliminary injunction in a case involving a pharmaceutical compound patent. We successfully defended the decision at the Federal Circuit, which affirmed the decision on appeal. As a result, our client was able to begin selling its product on the market years before expiration of the compound patent for pantoprazole.