Endo Pharms. Inc. v. Actavis Labs. UT, Inc.

Obviousness finding was appropriate where there were unpredictable results with each possible proposed combination.

January 23, 2017

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Endo Pharms. Inc. v. Actavis Labs. UT, Inc., 2016-1146, 2016 U.S. App. LEXIS 18490 (Fed. Cir. Oct. 14, 2016) (Circuit Judges Moore, Taranto, and Hughes presiding; Opinion by Taranto, J.) (Appeal from E.D. Tex., Gilstrap, J.)

Drug Product and U.S. Patent: Fortesta® (testosterone); U.S. Patents Nos. 6,579,865 (“the ’865 patent”) and 6,319,913 (“the ’913 patent”)

Nature of the Case and Issue(s) Presented: In December 2010, Endo obtained final approval from the FDA to market Fortesta. In 2013, Watson, now Actavis, filed an ANDA seeking to market a generic version of Fortesta. Plaintiffs filed suit, alleging that Actavis’ marketing of its proposed generic product would infringe claims 1, 3, 4, 6, 11, 18, 22, and 28 of the ’865 patent and claims 19 and 20 of the ’913 patent. Actavis alleged that all of the Endo-asserted claims of both patents are invalid based on anticipation and obviousness. Actavis also alleged that its ANDA product did not meet the limitations of claims 1, 3, 4, 6, 11, 18, and 22 of the ’865 patent and, therefore, its marketing would not infringe those claims. Actavis stipulated to infringement of the other three claims asserted by Endo. After a bench trial, the district court ruled that the asserted patent claims were not invalid for either anticipation, or obviousness, and that Actavis’ marketing of its product would infringe all of the asserted claims. Actavis appealed the district court’s decision regarding obviousness and infringement. The Federal Circuit affirmed.

Why Endo Prevailed: The claimed penetration enhancers differ in certain respects from claim to claim, though much remains constant. The claim-by-claim variations are significant for the obviousness analysis, but not for the usual reason that Actavis argues for invalidity on a claim-by-claim basis. Actavis makes no argument that some claims are invalid even if others stand. Presumably reflecting the content of its generic-Fortesta application to the FDA, Actavis makes a single, obviousness argument: if any one of the asserted claims survives, all do.

The Federal Circuit analyzed each of the references relied on by Actavis and found that each was missing at least one of the claimed elements, such as failure to disclose testosterone or the three-part penetration-enhancing element. The Federal Circuit recognized that the general problem of finding a delivery system that was effective and caused the least irritation was present, the record was void of showing how the particular claimed invention would have been obvious. In particular, sufficient evidence supported that each particular makeup of the penetration-enhancers would have caused unpredictable results. As such, the Federal Circuit affirmed. 

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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