Wednesday, November 26, 2008

Wholly-owned subsidiary of a foreign ANDA applicant, who signs the ANDA as agent for such applicant, is proper defendant in action under Hatch-Waxman

Because the Hatch-Waxman Act does not define the term "submit" as applied to an ANDA, the courts must look at congressional intent. Considering such intent, "a wholly-owned subsidiary of a foreign ANDA applicant, which signs an ANDA as the agent of its parent-applicant, and which intends to benefit directly if the ANDA is approved -- by participating in the manufacture, importation, distribution, and/or sale of the generic drug [constitutes] one who has 'submitted' an ANDA. . . . To hold that a patentee may not rely on the agent's signature on the ANDA, but must instead determine before filing suit [within the 45 day window to do so following receipt of notice] the precise role such signatory had in the preparation of the ANDA, could regularly deprive patentees of the automatic stay Congress provided for, thus imposing a burden on patentees that would be inconsistent with the Hatch-Waxman framework."

AstraZeneca Pharmaceuticals LP v. Teva Pharmaceuticals USA, 1-08-cv-00426 (DED November 24, 2008, Report & Recommendation).

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