Lack of Evidence of Efficacy Invalidates Patent on Combination Drug
Before Prost, Clevenger, and Wallach. Appeal from the U.S. District Court for the District of New Jersey.
Summary: Written description is not satisfied when the claimed drug is understood to be ineffective by a person skilled in the art and the description includes only making and using the drug.
Dr. Reddy’s Laboratories, Mylan, and Lupin (collectively, “the Generics”) filed two ANDAs with the FDA seeking to market generic variants of Vimovo®, a combination tablet of a non-steroidal anti-inflammatory drug (NSAID) and a proton pump inhibitor (PPI). Nuvo and Horizon (collectively, “Nuvo”) filed a patent infringement suit against the Generics in the U.S. District Court for the District for New Jersey. NSAIDs, used to treat pain, have the undesirable side effect of causing gastrointestinal problems. PPIs can be used in combination with NSAIDs to address this side effect by raising pH levels in the intestines. However, stomach acid may degrade the PPIs before reaching the intestines. To address this, PPIs are coated to time the release. Nuvo’s patents claim formulations for a combination of NSAID and uncoated PPI. Among other defenses, the Generics asserted the patents lacked written description for failing to describe the efficacy of uncoated PPI. Following a bench trial, the district court upheld the validity of the asserted claims.
The Federal Circuit reversed the district court’s decision, finding the patent invalid for lack of written description on the efficacy of uncoated PPI. The Federal Circuit held that there was no evidence that the inventor possessed the claimed efficacy of uncoated PPI beyond a mere wish or hope. Merely describing the formulation of the drug is insufficient to demonstrate to a person of skill in the art that the uncoated PPI was effective because he or she would not have expected it to raise the intestinal pH levels. The Federal Circuit also rejected Nuvo’s arguments that the efficacy was inherent in the drug formulation because the specification lacked any disclosure in any way on the efficacy of uncoated PPI to raise pH levels.
Editor: Paul Stewart