Nuvo Pharms. (Ir.) Designated Activity Co. v. Dr. Reddy's Labs. Inc.

Nuvo Pharms. (Ir.) Designated Activity Co. v. Dr. Reddy's Labs. Inc.

Opinion

 [*1371]  Clevenger, Circuit Judge.

Dr. Reddy's Laboratories, Inc., Mylan Pharmaceuticals, and Lupin Pharmaceuticals (collectively, "the Generics") appeal from the final judgment of the United States District Court for the District of New Jersey following a bench trial upholding the asserted claims of U.S. Patent Nos. 6,926,907 ("the '907 patent") and 8,557,285 ("the '285 patent") as nonobvious under 35 U.S.C. § 103, enabled under 35 U.S.C. § 112, and adequately described under § 112. Nuvo Pharmaceuticals, Inc. and Horizon Pharma (collectively, "Nuvo") cross-appeal from the district court's grant of summary judgment of noninfringement to Dr. Reddy's, concluding that one of its  [*1372]  drug products will not infringe the claims of the '907 patent. For the reasons set forth below, we reverse the appeal and dismiss the cross-appeal.

Background

Non-steroidal anti-inflammatory drugs, also known as NSAIDs, control pain. Common NSAIDs include, among others, aspirin and naproxen. While NSAIDs control pain, they also have the undesirable side effect of causing gastrointestinal problems such as ulcers, erosions, and other lesions in the stomach and upper small intestine. [**3]  Some theorize that the undesirable side effect is tied to the combination of NSAID with the presence of acid in the stomach and upper small intestine. So, to treat the side effect, some practitioners began prescribing acid inhibitors to be taken by a patient along with the NSAID. The NSAID treats the pain while the acid inhibitor reduces the acidity in the gastrointestinal tract, which is achieved by increasing the pH level in the tract. Common acid inhibitors include, among others, proton pump inhibitors ("PPIs") like omeprazole and esomeprazole.

The combination therapy had complications. First, stomach acid degraded the PPI before it could reach the small intestine. To fix that issue, an enteric coating that wears off after a certain amount of time has elapsed was placed around the PPI. Second, if the NSAID was released before the acid inhibitor had enough time to raise the pH level in the tract, patients would continue to suffer gastrointestinal damage. To address those complications, Dr. John Plachetka invented a new drug form that coordinated the release of an acid inhibitor and an NSAID in a single tablet. The tablet contained a core of an NSAID like naproxen in an amount effective [**4]  to treat pain, an enteric coating around the NSAID that prevents its release before the pH increases to a certain desired level, and an acid inhibitor like PPI around the outside of the enteric coating that actively works to increase the pH to the desired level. Dr. Plachetka's invention contemplates using some amount of uncoated PPI to allow for its immediate release into a patient's stomach and upper small intestine. Dr. Plachetka recognized problems associated with uncoated PPI, namely that without a coating, the PPI is at risk of destruction by stomach acid—thereby undermining the therapeutic effectiveness of the PPI.

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