IP Law Daily, PATANT NEWS: Cadence claims infringement of its patents for OFIRMEV® drug, (Jan 29, 2014)

By Peter Reap, J.D., LL.M.

Cadence Pharmaceuticals, Inc., has filed suit in the federal district court in Newark against Wockhardt Limited, Wockhardt Bio AG, and Wockhardt USA LLC (collectively “Wockhardt”) alleging infringement of two patents related to OFIRMEV®, the first and only intravenous (“IV”) formulation of acetaminophen available in the United States. Specifically, Cadence asserts United States Patent No. 6,028,222 (“the '222 Patent”), titled “Stable Liquid Paracetamol Compositions, and Method for Preparing the Same,” and United States Patent No. 6,992,218 (“the '218 Patent”), titled “Method for Obtaining Aqueous Formulations of Oxidation-Sensitive Active Principles,” both of which it claims to license exclusively.

Cadence holds approved New Drug Application (“NDA”) No. 022450 for OFIRMEV®. OFIRMEV® was approved by the FDA on November 2, 2010. OFIRMEV® is indicated for the treatment of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.

According to the complaint, on or about December 13, 2013, outside counsel for the owner of the '222 and '218 Patents received a letter dated December 12, 2013, on letterhead for Defendant Wockhardt USA LLC. The Wockhardt Letter states that Defendant Wockhardt Bio AG had submitted ANDA No. 205746 seeking approval to engage in the commercial manufacture, use, sale or offer for sale, and/or importation of Wockhardt’s Generic Product prior to the expiration of the'222 and '218 Patents.

Defendant Wockhardt Bio AG’s submission of ANDA No. 205746 to the FDA, including the §355(j)(2)(A)(vii)(IV) allegations, constitutes infringement of the Patents-in-Suit under 35 U.S.C. §271(e)(2)(A), according to Cadence. Moreover, in the event that Wockhardt commercially manufactures, imports, uses, offers for sale, or sells Wockhardt’s Generic Product or induces or contributes to such conduct, said actions would constitute infringement of the Patents-in-Suit under 35 USC §271(a), (b) and/or (c). Further, Wockhardt was aware of the '222 and '218 Patents prior to filing ANDA No. 205746, and their actions rendered this an exceptional case under 35 U.S.C. §285.

The complaint requests injunctive relief; monetary relief if Wockhardt commercially manufactures, uses, offers for sale, or sells their respective generic versions of Cadence’s OFIRMEV® brand product; and an award of attorney fees and costs.

The complaint in Cadence Pharmaceuticals, Inc. v. Wockhardt Ltd., Case No. 2:14-cv-00485-KM-MCA, was filed January 23, 2014.

Attorneys: Gina R. Gencarelli (Latham & Watkins) for Cadence Pharmaceuticals, Inc.

Companies: Cadence Pharmaceuticals, Inc.; Wockhardt Ltd.

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