If a drug’s product label includes instructions that could cause some users to perform the patented method, then courts may find that the manufacturer had an affirmative intent to induce infringement. FDA labeling requirements may thwart specific attempts to avoid the infringing method.

AstraZeneca LP v. Apotex, Inc., No. 09-1381 (Fed. Cir. Nov. 1, 2010).

The patentee, a pharmaceutical manufacturer, filed suit against an ANDA applicant that was seeking to launch a generic drug (a budesonide product) covered under method and kit claims of two patents-in-suit. The New Jersey district court granted the patentee’s request for a preliminary injunction barring the generic drug’s launch on the basis that the patentee would suffer irreparable harm and was likely to succeed on the merits of its claim of infringement by inducement. The court also ruled that the patentee’s kit claims were invalid. Both parties appealed to the Federal Circuit.

The Federal Circuit affirmed, concluding that the district court did not abuse its discretion or otherwise err in granting the preliminary injunction. One of the key considerations was whether patients using the generic drug would be induced to infringe the patents based on the generic label. The method claims claimed once-daily administration of the drug, but the generic manufacturer had specifically excluded any mention of once-daily dosing in its product labels, explicitly indicating that the drug should be administered twice-daily, and no less. However, FDA requirements demanded the inclusion of language encouraging patients to “titrate down” to the lowest effective dose of the medication to reduce side effects.

The Federal Circuit agreed that the downward titration instruction would necessarily cause some patients to use once-daily dosing, thereby infringing the patents-in-suit. The generic manufacturer was aware of the infringement problems associated with once-daily dosing, as evidenced by its attempts to avoid such language in its label. Despite this awareness, the generic manufacturer chose to proceed with plans to launch its product. Ultimately, the Federal Circuit found that if the proposed label instructs users to perform the patented method, then it may support a finding of an affirmative intent to induce infringement. The court acknowledged the challenge of adhering to FDA requirements while simultaneously reducing the risk of infringement. In this case, the generic manufacturer chose to satisfy the FDA by including the titration language in order to receive approval for its drug; the inherent risk of this choice was an eventual finding of infringement by inducement. The only way to avoid the hazards of either decision would have been to delay the product’s launch until after the expiration of the patents-in-suit.

A copy of the opinion can be found here.