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Nuvo Pharmaceuticals (Ireland) Designated Activity Company v. Dr. Reddy's Laboratories Inc.

United States Court of Appeals, Federal Circuit

May 15, 2019

NUVO PHARMACEUTICALS (IRELAND) DESIGNATED ACTIVITY COMPANY, HORIZON MEDICINES LLC, Plaintiffs-Cross-Appellants
v.
DR. REDDY'S LABORATORIES INC., DR. REDDY'S LABORATORIES, LTD., MYLAN, INC., MYLAN PHARMACEUTICALS INC., MYLAN LABORATORIES LIMITED, Defendants-Appellants

          Appeals from the United States District Court for the District of New Jersey in Nos. 3:11-cv-02317-MLC-DEA, 3:13-cv-00091-MLC-DEA, 3:13-cv-04022-MLC-DEA, Judge Mary L. Cooper.

          James B. Monroe, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC, argued for plaintiffs-cross-appellants. Plaintiff-cross-appellant Horizon Medicines LLC also represented by Charles Collins-Chase.

          Stephen M. Hash, Baker Botts, LLP, Austin, TX, for plaintiff-cross-appellant Nuvo Pharmaceuticals (Ireland) Designated Activity Company. Also represented by Jeffrey Sean Gritton.

          Alan Henry Pollack, Windels Marx Lane & Mittendorf LLP, Madison, NJ, argued for all defendants-appellants. Defendants-appellants Dr. Reddy's Laboratories Inc., Dr. Reddy's Laboratories, Ltd. also represented by Stuart D. Sender.

          Andrew Dufresne, Perkins Coie LLP, Madison, WI, argued for all defendants-appellants. Defendants-appellants Mylan, Inc., Mylan Pharmaceuticals Inc., Mylan Laboratories Limited also represented by Autumn N. Nero; Dan L. Bagatell, Hanover, NH; Shannon Bloodworth, Washington, DC.

          Sailesh K. Patel, Schiff Hardin LLP, Chicago, IL, for defendants-appellees Lupin Ltd., Lupin Pharmaceuticals, Inc.

          Before Prost, Chief Judge, Clevenger and Wallach, Circuit Judges.

          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 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

         I

         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. 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 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.

         Dr. Plachetka received the '907 patent on his invention, which he assigned to Pozen Inc. He also received the '285 patent, which is a division of an abandoned application that was a division of another application that itself was a continuation-in-part of the application that resulted in the '907 patent. The '285 patent is also assigned to Pozen. The two patents bear the same title, "Pharmaceutical Compositions for the Coordinated Delivery of NSAIDs," and have nearly identical specifications.

         Claim 1 of the '907 patent and claim 1 of the '285 patent are representative. They read as follows:

1. A pharmaceutical composition in unit dosage form suitable for oral administration to a patient, comprising:
(a) an acid inhibitor present in an amount effective to raise the gastric pH of said patient to at least 3.5 upon the administration of one or more of said unit dosage forms;
(b) a non-steroidal anti-inflammatory drug (NSAID) in an amount effective to reduce or eliminate pain or inflammation in said patient upon administration of one or more of said unit dosage forms;
and wherein said unit dosage form provides for coordinated release such that:
i) said NSAID is surrounded by a coating that, upon ingestion of said unit dosage form by said patient, prevents the release of essentially any NSAID from said dosage form unless the pH of the surrounding medium is 3.5 or higher;
ii) at least a portion of said acid inhibitor is not surrounded by an enteric coating and, upon ingestion of said unit dosage form by said patient, is released regardless of whether the pH of the surrounding medium is below 3.5 or above 3.5.
'907 patent col. 20 ll. 9-32.
1. A pharmaceutical composition in unit dosage form comprising therapeutically effective amounts of:
(a) esomeprazole, wherein at least a portion of said esomeprazole is not surrounded by an enteric coating; and
(b) naproxen surrounded by a coating that inhibits its release from said unit dosage form unless said dosage form is in a medium with a pH of 3.5 or higher;
wherein said unit dosage form provides for release of said esomeprazole such that upon introduction of said unit dosage form into a medium, at least a portion of said esomeprazole ...

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