Purdue Pharma L.P. v. Epic Pharma, LLC, No. 14-1294 (Fed. Cir. 2016)
Annotate this CaseOxycodone hydrochloride—the active pharmaceutical ingredient (API) in OxyContin®—is an opioid analgesic used to treat moderate to severe pain. In 2014 the FDA became concerned about 14-hydroxycodeinone, which belongs to a class of potentially dangerous compounds known as alpha, beta unsaturated ketones (ABUKs), and mandated that oxycodone hydrochloride manufacturers either provide evidence that the 14-hydroxy levels in their formulations were safe or reduce the amount of 14-hydroxy to less than 10 ppm. Purdue’s four low-ABUK patents recite an improved formulation of oxycodone hydrochloride, describing an oxycodone salt with extremely low levels of ABUKS. In 2011, Purdue sued Teva for infringement of the low-ABUK patents in response to Teva’s filing of an abbreviated new drug application (ANDA) seeking FDA approval to market generic versions of Reformulated OxyContin®. Purdue later filed similar lawsuits against others. In consolidated cases, the district court found that the asserted claims were infringed by Teva’s proposed generic product, but also held that all of the claims were invalid as anticipated by or obvious over the prior art. The Federal Circuit affirmed, finding claims obvious in light of prior art, 35 U.S.C. 103(a).
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