The Federal Circuit Affirms in AstraZeneca v. Apotex, Finding Induced Infringement Based On Use of FDA-Mandated Labeling
The Federal Circuit’s recent decision in AstraZeneca LP v. Apotex Inc. illustrates the tension that generic drug manufacturers may face between complying with FDA labeling requirements and avoiding trespassing on others’ patent rights. In that decision, the Federal Circuit affirmed the District Court of New Jersey’s ruling enjoining Apotex’s “at risk” launch of a generic version of an inhaled corticosteroid for asthma patients. In short, AstraZeneca owned a method patent on once-daily dosing of the drug at issue. Although Apotex omitted all references to once-daily dosages from its product label, it was required by the FDA to include “downward titration” language that encouraged patients to reduce their daily intake of the drug to the lowest dose that provides a beneficial effect. AstraZeneca argued that this language induced patients to infringe its method patent, and the court agreed.
For its part, Apotex argued that it lacked the specific intent required to induce infringement because its product label did not instruct patients to engage in the infringing once-daily dosing, and because its instructions allowed for non-infringing use of the drug. The Federal Circuit was not persuaded. Rather, it agreed with the lower court that the language encouraging reduced intake would necessarily result in some users engaging in AstraZeneca’s patented method. The court also found that Apotex’s attempt to design its label around the infringing use showed that it had the requisite knowledge and intent to induce infringement.
Under 21 U.S.C. § 355(j)(2)(A)(viii) a generic seeking approval from the FDA for a method of use not claimed in a ‘method of use patent’ for a listed drug must submit a statement declaring the patent does not claim such a use and must remove any mention of the patented method of use from the generic drug label. During its review of Apotex’s label, the FDA concluded that Apotex could omit references to the claimed “once-daily” dosing without sacrificing safety and efficacy. The FDA also found that the downward titration language did not “teach” once-daily dosing. The Federal Circuit disagreed, noting that the FDA is not the arbiter of patent infringement issues and that the mere existence of non-infringing uses does not preclude infringement.
The case is particularly interesting because of the dilemma that Apotex faced. It could not sell its drug without including the FDA-mandated downward titration language. Nonetheless, it was precisely that language that resulted in sales of the drug being enjoined.