Docket No. 2018-1054

May 3, 2019

Brief summary: DC holding that Endo’s claims to low “ABUK” oxymorphone were not shown to be invalid for obviousness affirmed.

Summary: Actavis appealed DC holding that claims 1-6 of Endo’s US 8,871,779 claiming “[a] hydrochloride salt of oxymorphone comprising less than 0.001% of 14-hydroxymorphinone” (see FN3 explaining that this is an oxymorphone impurity/precursory, aka “oxymorphone ABUK”; and 14-hydroxycodeinone is an ABUK impurity in oxycodone, aka “oxycodone ABUK”). Actavis argued that the DC erred by “misconstruing the claim term 14-hydroxymorphinone” and in the obviousness determination. The FC panel explained that in a claim construction analysis in which the DC “consult[s] extrinsic evidence”, “as here”, the FC reviews the DC’s “factfinding…for clear error: (Teva, US 2015; Profectus, FC 2016 (“definite and firm conviction that a mistake has been made”)). Actavis argued that the 14-hydroxymorphinone limitation required no construction due to the plain meaning of the term but the DC relied “on intrinsic and extrinsic evidence” to “determine[] that a PHOSITA would understand” it “to mean ’14-hydroxymorphinone hydrochloride,’ i.e., the ‘salt form’”. The FC panel reviewed the claims (Phillips, FC 2005; “the Asserted Claims only claim 14-hydroxymorphinone as part of the salt”), “the broader specification” (Trs. of Columbia, FC 2016 (“always highly relevant to the claim construction analysis and is, in fact, the single best guide to the meaning of a disputed term”); e.g., “14-hydroxymorphinone’s use in the broader specification is relatively unsupportive of either proferred construction”), and the extrinsic evidence (Phillips, FC 2005; e.g., expert testimony regarding the ‘779 examples)), but not the prosecution history since neither party “identified anything” therein “that further elucidates the proper construction”. The FC panel concluded that “the intrinisic and extrinsic evidence support the [DC’s] construction of 14-hydroxymorphinone as 14-hydroxymorphinone hydrochloride” (which also eliminated Actavis’ anticipation argument, not addressed by the FC panel (Knowles, FC 2018)). On obviousness, the DC “held that a PHOSITA ‘would have understood it would not have been feasible’ to employ Chapman’s solution to the reappearing ABUK problem to Weiss’s catalytic hydrogenation process for oxymorphone”, that the PHOSITA would not have had a reasonable expectation in success in practicing Rapoport’s “low-ABUK” process, or from the “FDA communications” (which the FC panel, but not the DC, held to be prior art (see FN9; OddzOn, FC 1997 (§ 102(f) ‘does not pertain only to public knowledge, but also applies to private communications between the inventor and another which may never become public’” (pre-AIA, “he did not himself invent the subject matter”); Geo. M. Martin, FC 2010 (“a reference need not work to qualify as prior art”)). The FC panel concluded that the DC “did not clearly err” in finding no reasonable expectation of success in combining Weiss, Chapman, and Rapoport (e.g., “Weiss…does not provide key reaction conditions” and “disclosed a material difficulty”, Endo’s expert testified that “a PHOSITA would not believe that Rapoport “would ever be able to get to…10 [ppm]”, and “FDA communications recite a goal without teaching how the goal is attained” (Abbott, FC 2008; Innogenetics, FC 2008 (“[K]knowledge of a problem and motivation to solve it are entirely different from motivation to combine particular references.”); Allergan, FC 2013 (“potential for FDA approval…may properly be considered”); “the inventors of the ‘779 patent engaged in extensive experimentation, involving much failure, to ultimately produce the oxymorphone of the Asserted Claims”). Thus, the DC decision was affirmed. Judge Stoll’s dissent argued, e.g., that “the FDA’s mandate disclose[s] every limitation of claim 1” and the DC “erred in imposing a requirement that a reference must teach how to solve a problem to provide a motivation to combine, conflating enablement and reasonable expectation of success requirements with motivation.”

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Patrick Halloran

Pat has a Ph.D. in Microbiology and Immunology from The University of Health Sciences / The Chicago Medical School (now the Rosalind Franklin Institute (North Chicago, IL) (1994)). He also completed post-doctoral studies at The National Cancer Institute (1994-1996) where he developed novel approaches for gene therapy of melanoma. Pat has been an attorney (IL) since 1999 after graduating from Chicago-Kent College of Law, which was recently ranked as one of the top five law schools for Intellectual Property in the U.S. (U.S. News and World Report link). Pat also has a B.A. in Biology from Augustana College (Rock Island, IL; 1989) where he was on two NCAA Division III National Championship football teams (1985, 1986). He currently resides in Center Valley, PA.