Bayer Skin Care Patent Upheld

July 29, 2015

A Delaware Court ruled that the Mumbai-based pharmaceutical company Glenmark Pharmaceuticals Ltd. (Glenmark) had infringed the patent of Bayer Healthcare Pharmaceuticals Inc. (Bayer) for Finacea, a treatment for the skin disorder rosacea. The outcome followed Bayer's successful efforts, since 2013, to prevent Glenmark's generic azelaic acid gel -- a key ingredient that had been reverse-engineered from Finacea -- from entering the market

In this case, an Analysis Group team led by Managing Principal John Jarosz was retained by the plaintiffs, who argued that the commercial success of Finacea, as "the number one prescribed branded topical treatment for rosacea in the United States with net sales exceeding $562 million," supported a finding of nonobviousness. Mr. Jarosz testified "that the composition of components in Finacea, as a whole, delivered the benefits of increased bioavailability, greater efficacy, and favorable cosmetic properties" compared with other branded products that included "metronidazole as the active ingredient," with which it competed at the time of its 2003 launch. The court agreed with Mr. Jarosz's assessment of a prima facie case of nexus linking commercial success and the patented product, noting that "no ingredient or element on its own demonstrates the desirable characteristics of the claimed composition such as increased bioavailability and favorable cosmetic properties." The court ultimately concluded that defendants had infringed the plaintiff's patent and upheld a finding of nonobviousness.

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