Thursday, August 28, 2014

Off-Label Use of Generic Drug Cannot Establish Existence of Noninfringing Uses

Following a bench trial, the court found that defendant indirectly and contributorily infringed plaintiff's patents for gabapentin through its generic drug product. "[T]he ANDA product may not be marketed for non-infringing uses. Drug companies are not permitted to promote their products for anything other than what is approved in the label. . . . Defendant argues that this element of the contributory infringement analysis (i.e., that there are not significant noninfringing uses) has not been met due the existence of a number of off-label uses exist for the ANDA. However, because [defendant] cannot expressly market its product for any of these uses, the Court finds this . . . element to be met."

Depomed, Inc. v. Actavis Elizabeth LLC et al, 3-12-cv-01358 (NJD August 25, 2014, Order) (Pisano, J.)

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