Does an Off-label, Non-Infringing Use of a Drug Constitute a "Substantial Non-Infringing" Use Sufficient to Defeat a Claim for Contributory Patent Infringement?
September 15, 2014

(September 15, 2014) In a recent decision following a bench trial, Judge Joel A. Pisano (D.N.J.) found an accused defendant would contributorily infringe plaintiff’s patents for gabapentin despite defendant’s argument that off-label use of its generic product was evidence of noninfringing uses. See Depomed, Inc. v. Actavis Elizabeth LLC, No. 12-1358 (JAP), at *44 (D.N.J. Aug. 18, 2014).

“Contributory infringement occurs if a party sells or offers to sell, a material or apparatus for use in practicing a patented process, and that ‘material or apparatus’ is material to practicing the invention, has no substantial non-infringing uses, and is known by the party ‘to be especially made or especially adapted for use in an infringement of such patent.’” Id. at 20 (citing 35 U.S.C. § 271(c) (emphasis added)). “To establish contributory infringement, the patent owner must prove that: (1) there is direct infringement; (2) the accused infringer had knowledge of the patent at issue; (3) the component has no substantial noninfringing uses; and (4) the component is a material part of the invention.” Id. at 20. In assessing whether an asserted noninfringing use is substantial, the fact finder considers the frequency and practicality of the infringing use as well as the invention’s intended purpose and the intended market. Id. at 21. “A substantial non-infringing use is one that is not unusual, farfetched, illusory, impractical, occasional, aberrant, or experimental.” Id. (citation omitted).

The defendant argued that there could not be contributory infringement due to the existence of a number of non-infringing, off-label uses for the drug gabapentin. Id. at 43. The court noted that “ANDA product[s] may not be marketed for non-infringing uses” and “[d]rug companies are not permitted to promote their products for anything other than what is approved in the label.” Id. “[T]he label provided by Actavis indicates that it may be used only for the management of postherpetic neuralgia, which is a form of neuropathic pain and a therapeutic use.” Id. In rejecting defendant’s argument that there was no contributory infringement “due to the existence of a number of off-label uses [that] exist for the ANDA,” the court found because the defendant could not expressly market its product for an off-label use, there could be no substantial, noninfringing use. Id.