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Santarus, Inc. v. Par Pharm., Inc.

United States Court of Appeals for the Federal Circuit

September 4, 2012, Decided

2010-1360, 2010-1361, 2010-1362, 2010-1363, 2010-1364, 2010-1365, 2010-1366, 2010-1367, 2010-1368, 2010-1369, 2010-1370, 2010-1371, 2010-1372, 2010-1373, 2010-1374, 2010-1375, 2010-1376, 2010-1377, 2010-1378, 2010-1379, 2010-1380

Opinion

 [***1643]  [*1346]   Per Curiam.

Appeal and cross-appeal are taken from the judgment of the United States District Court for the District of Delaware.1 Plaintiff  [**2] Santarus, Inc. is the exclusive licensee of patents on specified formulations of benzimidazole proton pump inhibitors (PPI) — a class of chemical compounds that inhibit gastric acid secretion and help prevent and treat stomach acid-related diseases and disorders. The patents are for the inventions of Dr. Jeffrey Phillips, and are assigned to the University of Missouri. Santarus provides the PPI product omeprazole in the formulations covered by the Phillips patents, with the brand name Zegerid®.

Defendant Par Pharmaceutical, Inc. filed an Abbreviated New Drug Application (ANDA) for FDA approval to sell a generic counterpart of the Santarus Zegerid® products, invoking the Hatch-Waxman Act (the Drug Price Competition and Patent Term Restoration Act of 1984), which established a procedure called a "Paragraph IV certification," 21 U.S.C. § 355(j)(2)(A)(vii)(IV), whereby an entity that seeks to market a generic counterpart of a patented drug product or method of use, before the patent has expired, may challenge the patent before actually marketing the drug. Thus the parties are here litigating the issues of infringement,  [**3] validity, and enforceability of the Phillips patents. The district court found that Par's ANDA products infringe the Phillips patents, but held all of the asserted claims invalid on the ground of obviousness, 35 U.S.C § 103. The court also held certain claims invalid on the ground of inadequate  [*1347]  written description, 35 U.S.C. § 112. On the defense of unenforceability, the district court held that there was not inequitable conduct by Dr. Phillips, the University of Missouri, or their counsel in procuring the patents. Each side appeals the rulings adverse to it, except that Par does not appeal the finding of infringement. We conclude that the district court erred by holding that some of the thirty-six asserted claims would have been obvious over the prior art; these rulings are reversed. The court's other rulings are affirmed.

I. The phillips patents

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694 F.3d 1344 *; 2012 U.S. App. LEXIS 18592 **; 104 U.S.P.Q.2D (BNA) 1641 ***; 2012 WL 3797966

SANTARUS, INC., Plaintiff-Appellant, AND THE CURATORS OF THE UNIVERSITY OF MISSOURI, Plaintiff-Appellant, v. PAR PHARMACEUTICAL, INC., Defendant-Cross Appellant.

Prior History:  [**1] Appeals from the United States District Court for the District of Delaware in consolidated Case Nos. 07-CV-0551 and 07-CV-0827, Chief Judge Gregory M. Sleet.

Santarus, Inc. v. Par Pharm., Inc., 720 F. Supp. 2d 427, 2010 U.S. Dist. LEXIS 37030 (D. Del., Apr. 14, 2010)

Disposition: AFFIRMED-IN-PART, REVERSED-IN-PART, and REMANDED.

CORE TERMS

omeprazole, patent, coated, prior art, buffering, sodium bicarbonate, dosage, teaches, acid, district court, suspension, composition, sucralfate, non-enteric, patients, stomach, mEq, specification, invalidity, invention, pharmaceutical, tablets, capsules, formulations, uncoated, asserted claim, discloses, proton, skill, pump

Patent Law, Nonobviousness, Elements & Tests, Prior Art, Teaching Away From Invention, Infringement Actions, Claim Interpretation, Construction Preferences