Validity of certain patent claims covering ZEGERID Capsule and Powder upheld
Santarus, Inc.Martha L. HoughVP Finance & Investor Relations(858) 314-5824orDebra P. CrawfordChief Financial Officer(858) 314-5708orWestwicke Partners, LLCStefan Loren, Ph.D. ()(858) 356-5930orRobert Uhl ()(858) 356-5932
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.
Santarus, 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 (metformin hydrochloride extended release tablets) and (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes, and on (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 .