Judge Robinson finds Bayer’s U.S. Patent 6,534,070 valid and infringed by Glenmark’s generic Azelaic Acid Gel

In March 2013, plaintiffs Bayer Healthcare Pharmaceuticals Inc., Intraserv GmbH & Co. KG, and lntendis GmbH filed this patent infringement case following defendant Glenmark Pharmaceuticals Limited’s filing of an Abbreviated New Drug Application to market a generic azelaic acid hydrogel.  lntendis GmbH, et al. v. Glenmark Pharmaceuticals Limited, et al., C.A. No. 13-421-SLR (D. Del. July 27, 2015).

Plaintiff Bayer is the the holder of the New Drug Application for Finacea® Gel, 15%, indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Plaintiff lntraserv is the assignee of the patent-in-suit, U.S. Patent No. 6,534,070 titled “Composition with Azelaic Acid.”  Plaintiff Intendis is the exclusive licensee of the ‘070 patent.

Following a bench trial in February 2015, the Court recently issued its Findings of Fact and Conclusions of Law.  Judge Sue L. Robinson found the ‘070 patent valid and infringed by Glenmark’s proposed ANDA product.

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