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Paul Hastings Wins Federal Circuit Affirmance Upholding Key Patent Covering Once-Daily Formulation for ORACEA

On August 7, 2013, the U.S. Court of Appeals for the Federal Circuit issued a unanimous per curiam decision affirming the judgment of the U.S. District Court for the District of Delaware that U.S. Patent No. 7,749,532 patent covering the formulation for Oracea® is infringed by several proposed generic versions of Oracea® and is not invalid as anticipated or obvious. Oracea® (marketed in by Galderma Laboratories, L.P.) is a specially formulated once-a-day, 30 mg immediate-release, 10 mg delayed-release doxycycline composition indicated for the treatment of the inflammatory lesions (papules and pustules) of rosacea, and the '532 patent claims this novel once-daily, low dose formulation and its use to treat rosacea.

Paul Hastings represented Galderma and patent holder Supernus Pharmaceuticals Inc. in the appeal (argued by Gerald J. Flattmann, Jr. on July 9, 2013), as well as in the July 2011 bench trial before Judge Stark in the District of Delaware. Read the Federal Circuit's decision here. As a result of the Federal Circuit's decision, generic challengers Mylan, Lupin and Impax continue to be enjoined from marketing a generic version of Oracea® until the expiration of the '532 patent in December 2027.


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