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Chief Judge Stark Holds that U.S. Agent of Foreign Company Does Not "Submit" ANDA Under Section 271(e)

March 29, 2019

In Adverio Pharma GmbH v. Alembic Pharmaceuticals Ltd., No. 18-73-LPS (D. Del. Feb. 13, 2019), a Hatch-Waxman case, Chief Judge Stark granted defendant INC Research, LLC’s motion to dismiss for failure to state a claim. The plaintiff sued the defendants for submitting an ANDA for a generic version of the plaintiff’s brand drug. The complaint alleged that INC Research was a U.S. FDA agent for one of its co-defendants, an India-based pharmaceuticals company.

INC Research argued that it did not “submit” the ANDA application within the meaning of the patent laws. In determining whether INC Research was a “submitter,” the Court placed weight on the language of Section 271(e)(2)(A) that the submission of an ANDA is for the “purpose” of “engag[ing] in the commercial manufacture, use, or sale” of the generic drug. To face liability for the submission of an ANDA, the Court reasoned, an entity must financially benefit from the approval of the application, i.e., from the commercial manufacture, use, or sale of the ANDA product. An entity that, e.g., collects materials for the ANDA, signs the ANDA, or presents the ANDA to the FDA—even if it has a financial interest in performing these activities—does not “submit” within the meaning of the statute, according to Chief Judge Stark.

With this understanding, Chief Judge Stark found that the allegations that the defendants as a group “acted in concert to prepare and submit” the ANDA, that INC Research performed contract research, and that INC Research was the U.S. FDA agent for one of its co-defendants did not suffice plausibly to allege that INC would have a financial interest in the commercial manufacture, use, or sale of the ANDA product upon approval. The Court further found INC Research would not be needed as a party to provide complete relief to the plaintiff. For these reasons, the Court granted the motion to dismiss.

Key Point: Chief Judge Stark explained how Judge Plager’s concurring opinion in In re Rosuvastatin Calcium Patent Litigation, 703 F.3d 511, 529 (Fed. Cir. 2012), persuaded him that he had earlier placed “too much weight” on the representations made by a signatory of the ANDA when determining whether an entity “submits” an ANDA within the meaning of Section 271(e)(2)(A).