Wednesday, May 27, 2009

Compliance with FDA's Labeling Requirements Leads to Finding of Intent to Induce Infringement

Defendant's compliance with the FDA's labeling requirements, after unsuccessfully proposing alternate labeling options, established defendant's intent to induce infringement and warranted entry of a preliminary injunction. "[Defendant] was aware of and certainly concerned about the potential infringement problem posed by its label such that it attempted to cure the problem by proposing labeling alternatives to the FDA. . . . When the FDA unsurprisingly rejected these proposals, [defendant] decided to press forward with its label anyway. [Defendant] did so despite the fact that the label contained language that [it] knew to be problematic and, by its own conduct, attempted to remedy, albeit unsuccessfully. In this Court’s view, this conduct shows an intent to induce infringement."

AstraZeneca LP v. Apotex, Inc., 1-09-cv-01518
(NJD May 22, 2009, Supplemental Opinion) (Bumb, J.)

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