Cumberland Pharmaceuticals, Inc. v. Mylan Institutional LLC, No. 16-1155 (Fed. Cir. 2017)Annotate this Case
Cumberland Pharmaceuticals owns the 445 patent, which describes acetylcysteine compositions substantially free of chelating agents. It is listed in the Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) as covering Cumberland’s chelating-agent-free formulation of Acetadote®, an intravenous antidote for overdoses of acetaminophen. When Mylan filed an abbreviated new drug application to market its own chelating-agent-free acetylcysteine formulation, Cumberland filed a patent-infringement action. Mylan stipulated to infringement but asserted invalidity based on derivation of the claimed invention from someone at the FDA and obviousness. The district court rejected both challenges, finding that Mylan proved neither that anyone at the FDA conceived of the claimed invention before the named inventor nor that there was a reasonable expectation that the claimed formulations, without any chelating agents, would succeed. The Federal Circuit affirmed. Mylan offered evidence that there is no need to chelate trace metal ions because degradation may be effectively avoided by an inert vial atmosphere together with modern manufacturing practices that leave very low levels of metal contaminants, but the evidence did not establish that relevant skilled artisans would have reasonably expected success for those reasons in 2005. The district court had sufficient evidence to find otherwise.