District court finds patent covering AstraZeneca’s type II diabetes drugs Onglyza^® and Kombiglyze^® valid in ANDA litigation

The U.S. District Court for the District of Delaware ruled in favor of Finnegan client AstraZeneca AB, finding that the listed patent for the active ingredient, saxagliptin, in AstraZeneca’s type II diabetes drugs Onglyza^® and Kombiglyze^® was valid and infringed. Having conceded infringement prior to trial, 11 generic pharmaceutical companies alleged that claims directed to the compound saxagliptin were invalid as obvious. Finding that the generic defendants failed to establish by clear and convincing evidence that the asserted claims would have been obvious at the time the patent application was filed, the presiding judge held that defendants’ alleged motivations were “at odds with the teachings of the prior art” and appeared to be “the product of a classic hindsight analysis.” The generic defendants are enjoined from making, using, offering for sale, selling, or importing into the United States their proposed generic saxagliptin products before the expiration of AstraZeneca’s patent. The patent at issue was also sustained in a parallel IPR proceeding.