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Court Refuses to Dismiss Entity that Worked on Development of the ANDA Product

October 24, 2012

By DAVID M. CONCA & LEONARD A. MONFREDO

In a recent decision of interest, the Southern District of New York interpreted the term "submit" in 35 U.S.C. § 271(e)(2) to find that an entity that did not formally submit the ANDA could nevertheless be held liable for infringement under the Hatch-Waxman Act. This case and its predecessors may be an important weapon for innovator companies dealing with generics that attempt to forum shop by creating paper holding companies for the sole purpose of owning and submitting ANDAs in venues perceived to be favorable for the generic.