Santarus, Inc. (NASDAQ: SNTS) today announced that the U.S. Court of Appeals for the Federal Circuit reversed in part a lower court decision of invalidity involving certain asserted patent claims covering ZEGERID ® Capsules and ZEGERID Powder for Oral Suspension. The Federal Circuit found that certain claims of asserted U.S. Patent numbers 6,780,882 and 7,399,772, which Par Pharmaceutical, Inc. had been found to infringe, were not invalid due to obviousness. The Federal Circuit also upheld the District Court’s finding that there was no inequitable conduct. The case will be remanded back to the U.S. District Court for the District of Delaware for further proceedings consistent with the appellate decision.
These patents were the subject of lawsuits brought by Santarus in 2007 against Par for patent infringement associated with Par’s submission of Abbreviated New Drug Applications (ANDAs) to the U.S. Food and Drug Administration (FDA). The patents at issue expire in July 2016. In July 2010, following the District Court decision that five patents covering ZEGERID were invalid due to obviousness, Prasco, LLC, under a distribution and supply agreement with Santarus, and Par launched generic versions of ZEGERID Capsules.
“We are very pleased with the ruling of the Federal Circuit and are assessing our options. Given that the Federal Circuit found certain claims to be not obvious, we believe Par has no meritorious basis to further dispute infringement or validity. We plan to aggressively pursue all remedies available to us, including damages as well as seeking an order halting further sales of Par’s generic product,” said Gerald T. Proehl, president and chief executive officer of Santarus.
About SantarusSantarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company’s current commercial efforts are focused on GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes, and on FENOGLIDE® (fenofibrate) tablets, which is indicated as an adjunct to diet to reduce high cholesterol. Santarus has a diverse product development pipeline. A New Drug Application for UCERIS ™ (budesonide) tablets for induction of remission of mild to moderate active ulcerative colitis is under review by the U.S. Food and Drug Administration with a response expected in January 2013. The pipeline also includes two late-stage investigational drugs in Phase III clinical studies: RUCONEST ® (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema and rifamycin SV MMX ® for treatment of travelers’ diarrhea. In addition, the company’s investigational monoclonal antibody, SAN-300, is being evaluated in a Phase I clinical program. More information about Santarus is available at www.santarus.com. Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: Santarus’ ability to obtain a court order halting further sales of Par’s generic product and/or recover damages from Par in a timely manner or at all; the difficulty in predicting the timing and outcome of the further District Court proceedings and whether Par raises any further challenges concerning infringement or invalidity; the impact of the appellate decision on the additional pending patent litigation relating to ZEGERID and ZEGERID OTC ® or delays relating to the development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products; and other risks detailed in Santarus’ prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Santarus ® , FENOGLIDE ® , UCERIS ™ , ZEGERID ® and ZEGERID OTC ® are trademarks of Santarus, Inc. GLUMETZA ® is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET ® is a trademark of VeroScience LLC. MMX ® is a trademark of Cosmo Technologies Limited. RUCONEST ® is a trademark of Pharming Group N.V.
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