Opinion ID: 4396806
Heading Depth: 3
Heading Rank: 1

Heading: A pharmaceutical composition in unit dosage

Text: form suitable for oral administration to a patient, comprising:
effective to raise the gastric pH of said pa- tient to at least 3.5 upon the administra- tion of one or more of said unit dosage forms;
(NSAID) in an amount effective to reduce or eliminate pain or inflammation in said NUVO PHARMACEUTICALS v. DR. REDDY’S LABORATORIES 5 patient upon administration of one or more of said unit dosage forms; and wherein said unit dosage form provides for co- ordinated 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 me- dium 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 me- dium 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 por- tion 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 me- dium 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 is released regardless of the pH of the medium. ’285 patent col. 22 ll. 9–19. 6 NUVO PHARMACEUTICALS v. DR. REDDY’S LABORATORIES The shared specification discloses that the invention “is directed to a pharmaceutical composition in unit dosage form suitable for oral administration to a patient” that “contains an acid inhibitor present in an amount effective to raise the gastric pH of a patient to at least 3.5, preferably to at least 4, and more preferably to at least 5, when one or more unit dosage forms are administered.” ’907 patent col. 3 ll. 19–25. 1 It discloses exemplary acid inhibitors like PPIs, which the patents teach includes omeprazole and esomeprazole. It recites amounts of omeprazole between 5 and 50 mg and amounts of esomeprazole between 5 and 100 mg, “with about 40 mg per unit dosage form being preferred.” Id. at col. 7 ll. 9–13. The specification discloses that “[t]he pharmaceutical composition also contains a nonsteroidal anti-inflammatory drug in an amount effective to reduce or eliminate pain or inflammation.” Id. at col. 3 ll. 39–41. It provides that “[t]he most preferred NSAID is naproxen in an amount of between 50 mg and 1500 mg, and more preferably, in an amount of between 200 mg and 600 mg.” Id. at col. 3 ll. 48–50. The specification teaches methods for preparing and making the claimed drug formulations, including in tablet dosage forms. It provides examples of the structure and ingredients of the drug formulations that comport with the invention. It is undisputed that there is no experimental data demonstrating the therapeutic effectiveness of any amount of uncoated PPI and coated NSAID in a single dosage form. Appellant’s Opening Br. 23, 33; Appellee’s Resp. Br. 35, 43; Oral Arg. at 34:08–40, http://oralarguments.cafc.uscourts.gov/default.aspx?fl=2017-2473.mp3. Furthermore, although the specification expressly provides that PPIs are “enteric coated to avoid destruction by 1 Because the ’907 and ’285 patents have nearly identical specifications, we cite to the ’907 patent only unless stated otherwise. NUVO PHARMACEUTICALS v. DR. REDDY’S LABORATORIES 7 stomach acid,” there is no alternative disclosure explaining that uncoated PPI could still be effective to raise pH. ’907 patent col. 2 l.6; Oral Arg. at 34:08–39:28. Pozen ultimately sold its rights to the ’907 and ’285 patents to Nuvo Pharmaceuticals, and Horizon Pharma maintained its previously obtained license under those patents. Nuvo makes and sells a drug called Vimovo®, which is a commercial embodiment of the ’907 and ’285 patents. The Generics want to market a generic version of Vimovo®. They submitted Abbreviated New Drug Applications (“ANDAs”) to the U.S. Food and Drug Administration (“FDA”) seeking approval to market products covered by the claims of the ’907 and ’285 patents. Dr. Reddy’s also submitted a second ANDA covering a product slightly different than Vimovo® because it contains a small amount of uncoated NSAID in the outer layer of the tablet, which is separate from the enteric-coated NSAID that releases only when the pH rises to about 5.5.