Galderma Labs., L.P. v. Teva Pharms. USA, Inc.

The appellate court reversed and remanded the district court’s finding that the asserted claims are invalid as anticipated.

January 29, 2020

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Galderma Labs., L.P. v. Teva Pharms. USA, Inc., No. 2019-2396 (Fed. Cir. Jan. 29, 2020) (Circuit Judges Moore, O’Malley, and Stoll presiding; Opinion by O’Malley, J.) (Appeal from D. Del., Andrews, J.)

Drug Product and Patent(s)-in-Suit: Soolantra® (ivermectin); U.S. Patents Nos. 9,089,587 (“the ’587 patent”), 9,233,117 (“the ’117 patent”), and 9,233,118 (“the ’118 patent”)

Nature of the Case and Issue(s) Presented: The patents-in-suit claim methods of treating papulopustular rosacea (“PPR”) using topical ivermectin compositions. PPR is a subtype of rosacea—a chronic inflammatory disorder—that results in facial papules and pustules and is characterized by the presence of inflammatory lesions. The asserted claimed limitations recited various efficacy thresholds, including: (i) lesion count reduction, i.e., the difference in the number of inflammatory lesions before and after treatment; (ii) Investigator’s Global Assessment (“IGA”) success rate, i.e., the percentage of patients who achieved an IGA of 0 to 1 on a five-point scale of rosacea severity; and, (iii) relapse-free time, i.e., the time period between a patient’s IGA success rate of 0 or 1 to the patient’s first reoccurrence of an IGA of 2 or more.

The district court found that the McDaniel prior-art reference taught “methods for treatment of rosacea, including inflammatory lesions of PPR; a topical formulation containing about 1-5% ivermectin; and once-daily application of ivermectin,” and concluded it inherently disclosed the claimed efficacy limitations. In reaching this conclusion, the district court relied on the parties’ stipulation that “Manetta enables McDaniel … as to the [claimed] formulation.” In sum, the district court concluded that “a person of ordinary skill in the art would have been able to practice McDaniel’s disclosed treatment method with Manetta’s formulation without undue experimentation.” On appeal, the Federal Circuit reversed and remanded.

Why Galderma Prevailed: Galderma argued that, by relying on the parties’ stipulation that McDaniel’s formulation was enabled by Manetta, the district court had incorporated one of Manetta’s formulations into McDaniel. In response, Teva argued that disclosure of a genus (McDaniel’s disclosure of a 1–5% ivermectin formulation) anticipated the claimed species because a POSA would discern the species (the so-called Soolantra formulation) upon reading the disclosure. The Federal Circuit explained, however, that Teva’s logic confused the concepts of anticipation and enablement. Specifically, the Federal Circuit explained that the parties’ stipulation meant one thing: a POSA would have been able to practice the general formulations disclosed in McDaniel (1-5% ivermectin formulation in a topical formulation). The stipulation did not, however, mean that McDaniel specifically disclosed the Soolantra formulation, and Teva did not establish that McDaniel’s disclosure of 1-5% topical ivermectin was a small enough genus that the species was anticipated.   

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