Hatch-Waxman Liability May Apply to Entities Involved in ANDA Preparation

The court converted defendant's motion to dismiss to a motion for summary judgment and rejected defendant's argument that it could not be liable because another entity submitted the ANDA at issue. "[Defendant] contends that only one entity can 'submit' the ANDA to the FDA and thus incur [35 U.S.C. § 271(e)(2)] liability and that said entity must be the named applicant. The statute’s text does not define the term, 'submit,' and neither the Federal Circuit nor the Supreme Court has construed the term in this context. . . . [Defendant] has been more than actively involved in the submission; it has taken every relevant action except the final formalities. In these circumstances, to find [another defendant] but not [the moving defendant] has 'submit[ted]' the ANDA pursuant to section 271(e)(2) would be to elevate form over substance."

Purdue Pharma L.P., et. al. v. Varam, Inc., et. al., 1-10-cv-06038 (NYSD October 19, 2012, Order) (Stein, J.).