Thursday, May 31, 2007

Novartis Trouble Over Diclofenac Patent

Earlier this month, on May 03 US-based Biogan Biopharmaceutical and Swiss-based Jagotec filed a patent infringement lawsuit against Novartis Consumer Health Inc. (NCH) in the US District Court for District of New Jersey alleging infringement of the US Patent Nos. 5,852,002 (the ‘002 patent), 5,929,048 (the ‘048 patent) and 5,985,850 (the ‘850 patent) covering topical gel formulation of Diclofenac sodium, marketed as Solaraze®. The subject patents are assigned to Jagotec and exclusively licensed to Bioglan, and are directed to claims for dosage form and method of treatment. The complaint is filed in response to NCH submission of New Drug Application (NDA) No. 22-122 to the US FDA under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act along with Para IV certification (21 USC § 355(b)(2)(A)(iv)) seeking approval to sell diclofenac sodium topical gel before the expiration of Solaraze Orange Book listed ‘002, ‘048 and ‘850 patents. In its complaint, Bioglan alleged that NCH had actual and constructive notice of the ‘002, ‘048 and ‘850 patents prior to the filing of the NCH NDA and filed the NDA with a Para IV certification without adequate justification for claiming the patents will not be infringed.

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