Federal Circuit Court affirms validity of Horizon’s PENNSAID® 2% patent
Green Griffith successfully defended the validity of one of Horizon’s Orange Book-listed patents (U.S. Patent 9,066,913) for its PENNSAID® 2% topical diclofenac sodium product at the Federal Circuit against generic challenger Teva’s appeal of the district court ruling.
Green Griffith founding partner Caryn Borg-Breen, Ph.D. presented oral arguments before the Federal Circuit on June 5, 2018. In a decisive win, the Federal Circuit affirmed the district court’s decision, which found Horizon’s ’913 patent to be nonobvious.
The case on appeal involved application of a “results-effective variable” analysis to the question of whether a series of changes to a prior art topical composition could be reasonably predicted. The district court found, and the Federal Circuit affirmed, that because the variables to be optimized interacted in an unpredictable or unexpected way the claimed PENNSAID 2% formulation was not the result of routine experimentation and was therefore nonobvious.
As a result of this decision Teva will be enjoined from marketing a generic PENNSAID 2% product until the expiration of the ’913 patent on October 17, 2027.