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

The asserted claims of 1% ivermectin formulation are invalid on the basis of anticipation in light of a prior art reference that teaches application of 1-5% ivermectin formulation for treatment of the same indication.

August 21, 2019

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case NameGalderma Labs L.P. v. Teva Pharms. USA, Inc., Civ. No. 17-1783-RGA (D. Del. Aug. 21, 2019) (Andrews, J.) 

Drug Product and Patent(s)-in-Suit: Soolantra® Cream 1% (ivermectin); U.S. Patents Nos. 9,089,587 (“the ’587 patent”) and 9,233,117 (“the ’117 patent”)

Nature of the Case and Issue(s) Presented: The asserted patents are directed to methods of treating papulopustular rosacea, which the court has construed as a “chronic inflammatory disorder characterized by facial papules, pustules, persistent erythema, and the presence of inflammatory infiltrates that accompany flares.” Galderma owns the NDA for Soolantra Cream 1% for the treatment of inflammatory lesions of rosacea. Ivermectin is an anti-parasitic drug derivative that has been approved for human use since 1996. Teva filed an ANDA seeking FDA approval for the commercial manufacture, use, and sale of a generic 1% ivermectin cream. Teva’s ANDA label states that the product is “indicated for the treatment of inflammatory lesions of rosacea.” Galderma then filed this action alleging infringement by Teva’s ANDA submission.

A 3-day bench trial was held where the court presided over the issues of validity and infringement of the asserted patents. Galderma asserted infringement of claim 12 of the ’587 patent, claims 2, 3, and 6 of the ’117 patent, and claims 6, 7, 10, and 11 of the ’118 patent. The parties stipulated to infringement of claim 6 of the ’118 patent. Teva argued that each of the asserted claims is invalid for lack of written description, anticipation, and obviousness. The court found each of the asserted claims invalid for anticipation.

Why Teva Prevailed: All of the asserted claims recite the same treatment method and various efficacy limitations relating to the results of the treatment method. The claimed treatment method comprises: “[1] topically administering, [2] once daily, [3] to a skin area affected by the inflammatory lesions of papulopustular rosacea [4] a pharmaceutical composition comprising about 1% by weight ivermectin and a pharmaceutically acceptable carrier.” The McDaniel prior art reference claims an invention relating to “a method for treatment of rosacea (acne rosacea) in humans employing orally-administered or topically-applied ivermectin.” McDaniel defines “Mosacea, originally termed acne rosacea,” as having clinical signs including “papules” and “pustules” which mirrors the court’s claim construction for inflammatory lesions of papulopustular rosacea. Although McDaniel describes its preferred embodiment as using oral ivermectin, it also explicitly discloses an embodiment using topical ivermectin. Therefore, McDaniel discloses every element of the claimed treatment method.

Galderma argues that McDaniel’s disclosure of “about 1-5% ivermectin” is not “sufficiently specific” to anticipate the asserted claims and is not connected to the once-daily dosing frequency. But there is no evidence that 1-5% is a particularly broad range for the purposes of the claimed treatment method. Galderma has made no allegation of criticality or provided any evidence demonstrating any difference across the range.

Aside from the treatment method, the only remaining limitations are those relating to efficacy. Therefore, McDaniel anticipates the asserted claims if the efficacy limitations are inherent to the treatment method. Galderma argued that McDaniel’s treatment of rosacea generally is insufficient for anticipation because it will not necessarily result in treatment of inflammatory lesions of papulopustular rosacea. Both McDaniel and the asserted claims state that the composition is applied to skin “affected by” rosacea. Therefore, both McDaniel and the asserted claims are directed to a method for treating rosacea. The asserted claims consist of the same steps described in McDaniel and are directed to the same use—treating inflammatory lesions of papulopustular rosacea. Using the same composition claimed by Galderma in the same manner claimed by Galderma naturally results in the same claimed skin benefits. Therefore, the claimed efficacies are nothing more than the natural result flowing from the explicit disclosure of the claimed treatment method.

Oren D. Langer

Partner

Assistant Managing Partner, New York Office
Member of Executive Board

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