Adverio Pharma Gmbh v. Alembic Pharms. Ltd.

Dismissal granted when plaintiff made no allegation (or reasonable basis to infer) that defendant would be involved in the commercial manufacture, use, or sale of ANDA applicant’s product after FDA approval.

February 13, 2019

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Adverio Pharma Gmbh v. Alembic Pharms. Ltd., C.A. No. 18-73-LPS, 2019 U.S. Dist. LEXIS 23021 (D. Del. Feb. 13, 2019) (Stark, J.) 

Drug Product and Patent(s)-in-Suit: Adempas® (riociguat); U.S. Patent No. 6,743,798 (“the ’798 patent”)

Nature of Case and Issue(s) Presented: Plaintiffs have legal rights in relation to the Adempas NDA and the patent-in-suit. Defendant Alembic sought to market a generic version of Adempas prior to the expiration of the ’798 patent. Plaintiffs further name INC Research, LLC (“INC”) as a defendant. The complaint’s allegations against INC are sparse. Other than statements relating to INC’s connections to Delaware, the allegations against INC consist entirely of the following: “On information and belief, INC Research is in the business of, among other things, performing contract research for pharmaceutical companies”; “On information and belief, Alembic Pharma and/or INC Research are designated U.S. FDA agent(s) for APL”; and “On information and belief, Defendants acted in concert to prepare and submit ANDA No. 211127 to the FDA.” There is no specific, express allegation that INC played any role in the preparation of the ANDA. Nor is there any specific, express allegation that INC will benefit financially from the FDA’s approval of the ANDA or that INC intends to (or will be) involved in the commercial manufacture, use, or sale of the proposed ANDA product. The complaint does not seek any particular relief against INC, apart from the relief already sought from “Defendants” as a whole. INC moved for dismissal, which the court granted.

Why INC Prevailed: Alembic is an Indian corporation and is required to appoint an attorney, agent, or other authorized official who resides or maintains a place of business within the US to sign the ANDA. INC asserts that the only substantive allegation directly connecting INC to Alembic’s ANDA is that INC was the U.S. FDA agent for Alembic. INC argues that it must be dismissed from this case because “simply serving as a U.S. FDA agent for a foreign entity in connection with an ANDA filing does not create a basis for liability under 35 U.S.C. § 271(e)(2).”

Although Adverio alleges that all defendants “acted in concert to prepare and submit ANDA No. 211127 to the FDA” and all “intend[] to engage in the marketing, commercial manufacture, use, offer for sale, sale, and/or importation” of the generic drug if approved, allegations lumping multiple defendants together without providing allegations of individual conduct are frequently (as here) insufficient to satisfy the notice pleading standard. The group allegations are inadequate because they do not include a plausible allegation that INC will have a role in the commercial manufacture, use, or sale of Alembic’s proposed ANDA Product. Moreover, nothing in the complaint alleges that INC was the ANDA applicant, is corporately related to the ANDA applicant, was actively involved in the preparation of the ANDA, or intends to benefit from approval of the ANDA.

While Adverio argued that INC would receive a financial benefit, the court disagreed. Any financial benefit INC would receive is not, based on the current complaint, “a financial interest in the manufacture or distribution of the drug that is the subject of the ANDA.” Finally, the court reasoned that it could provide complete relief to Plaintiffs, consistent with the purposes of the Hatch-Waxman Act, even without entering an order directed to INC. There is no basis to conclude that retention of INC as a defendant is necessary in order to achieve the timely, pre-launch resolution of patent disputes between the parties with interests in the patents protecting a branded drug and the parties who will be involved in the commercial manufacture, use, and sale of a potential generic competitor drug.

Oren D. Langer


Assistant Managing Partner, New York Office
Member of Executive Board

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