Docket No. 2016-1155, -1259
MOORE, REYNA, TARANTO
January 26, 2017
Brief Summary: DC decision that patented invention was not derived from “someone at the FDA” or shown to obvious affirmed.
Summary: Mylan appealed DC rejection of its invalidity assertions regarding Cubmerland’s US 8,399,445 relating to chelating agent-free acetylcysteine compositions (Acetadote®, an intravenous antidote for acetaminophen overdoses). Mylan alleged invalidity for “derivation of the claimed invention from someone at the FDA” and obviousness. Prior art compositions included edetate disodium (EDTA) in acetylcysteine formulations to address stability issues (oxidation). The ‘445 patent stated that it was “surprisingly found that an aqueous composition containing acetylcysteine, sterilized water, and a pH-adjusting agent, is stable without the addition of a chelating agent” and claims “stable” compositions that are “free of chelating agents” (construed by the DC to mean “[l]acking one or more chelating agents”. As the FDA was considering Cumberland’s application for marketing the original formulation containing EDTA, Cumberland’s official responsible for the product (Leo Pavliv) testified that “he had the idea of testing the stability of an acetylcysteine formulation without EDTA.” The FDA approved the EDTA-containing product with Cumberland’s commitment to a post-approval study regarding the stability of a composition without EDTA. Cumberland received “encouraging stability data” and filed the application that became US 8,148,356, the parent of the ‘445 patent. After Mylan filed its ANDA, Cumberland sued for infringement of the ‘356 patent, later joined the ‘445 patent after it issued, and then withdrew its claims regarding the ‘356 patent. Mylan argued Cumberland was not entitled to the patent because Mr. Pavliv did not invent it (i.e., “he himself did not invent” it (§ 102(f)) and “someone at the FDA” did. The DC concluded Mylan had not proved this allegation (“While the ultimate question of whether a patentee derived an invention from another is one of fact, the determination of whether there was a prior conception is a question of law, which is based upon subsidiary factual findings.” Price FC 1993). The FC panel opinion explained that “[i]n an inventorship dispute, ‘the inventors named on the patent are presumed to be correct’ and ‘a person seeking to add his name ‘must meet the heavy burden of proving its case by clear and convincing evidence” (Shum, FC 2010) and that it “appl[ies] the same approach in the derivation context here” (Amax, Ct. Cl. 1975 and Hess, FC 1997). And it agreed with the DC because, e.g., “[a] request for justification of the inclusion of EDTA, supported by data, is not the same as a suggestion to remove it” (rejecting Mylan’s argument that the FDA requirements “would have inevitably led [Cumberland] to the invention”). The FC panel also agreed with the DC’s nonobviousness conclusion as its conclusion Mylan had not shown a motivation to remove EDTA or a reasonable expectation of success in achieving stability after doing so (Intelligen Bio-Systems, FC 2016) was “not clearly erroneous” (e.g., “Mylan’s own scientists expressed concern that the removal of EDTA would make the product more vulnerable to oxidation.”) Thus, the DC decision was affirmed.