Law Street Media

Rosacea Cream Manufacturer Claims Generic Competitor’s Product Will Infringe on its Patents

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Galderma Laboratories, L.P., Galderma S.A., and Galderma Holding, S.A. (collectively Galderma) have filed a patent infringement suit against Zydus Pharmaceuticals (USA) Inc. The complaint, filed on Thursday, claims that Zydus’s proposed generic version of Galderma’s Soolantra, a cream treatment for inflammatory rosacea lesions, will infringe on five of the plaintiff’s patents.

Galderma is a Swiss-based company whose U.S. relative, Galderma Laboratories, L.P., holds the exclusive right to use, manufacture, and sell the company’s patented products domestically. Galderma received U.S. Food and Drug Administration (FDA) approval of Soolantra’s New Drug Application (NDA) in December 2014, and approval of five related patents subsequently. Those five patents are reportedly listed in the FDA’s Orange Book as covering Soolantra.

Zydus, the filing states, is a New Jersey company that develops, manufactures, and markets generic pharmaceutical products. In early November, Zydus reportedly filed an Abbreviated New Drug Application (ANDA) with the FDA seeking to make, market, and sell a generic version of Soolantra.

The plaintiff claimed that Zydus must be disallowed from bringing its cream to market because doing so will illegally copy its patented product. In particular, Galderma claimed that Zydus’s generic will infringe on claims of each of its five patents, including claims relating to treatment methods, dosage and administration information, and clinical studies and benefits with respect to the reduction of inflammatory lesions and success in treating rosacea.

The complaint seeks declaratory relief, a permanent injunction, damages, to the extent that the defendant has made, marketed, or sold the product, its attorneys’ fees, and other relief the court deems appropriate.

The plaintiff is represented by Munck Wilson Mandala LLP.

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