This month the Federal Circuit held that Breckenridge’s proposed labeling for a generic colonoscopy prep kit would induce infringement of Braintree’s patent covering SUPREP.  Braintree Labs., Inc. v. Breckenridge Pharm., Inc., No. 16-1731 (Fed. Cir. May 5, 2017).  In doing so, the Federal Circuit clarified when proposed labeling amounts to an affirmative intent to induce infringement.

The asserted patent claims compositions and methods for purging a patient’s colon before a colonoscopy.  The asserted claims require, inter alia, “inducing purgation of the colon of a patient” using a “composition comprising form about 100 ml to about 500 ml” of solution.

In a previous appeal involving a different defendant (Braintree Labs., Inc. v. Novel Labs., Inc.), the Federal Circuit construed “purgation” to mean “an evacuation of a copious amount of stool from the bowels after oral administration of the solution.”  While that appeal was pending, Breckenridge stipulated to that same construction.  Under that construction, the district court granted summary judgment of noninfringement because Breckenridge’s label instructed consumption of the product for “preparation for colonoscopy” rather than “inducing purgation,” which is a distinct treatment from colon cleansing that is not an FDA-approved use.

On appeal, the Federal Circuit addressed induced infringement under § 271(e), reasoning that this case is different from its precedents where an ANDA applicant’s label did not induce infringement because the claims were directed to uses that had not been approved by the FDA (and so the label did not encourage the claimed use).  In those cases, the Court explained, the proposed labels did not suggest to physicians that the drugs were safe and effective for administration to patients for the claimed uses, despite the fact that the generic product may necessarily lead to claimed effects.

In this case, however, the Court found that the claimed use—inducing purgation—is the very means by which the invention accomplishes the approved indication.  The Court reasoned that the claimed method is completely subsumed by the labeled indication such that the claimed method and labeled indication were indistinguishable.

Based on this decision, it appears the Federal Circuit will not hold ANDA applicants liable for infringement of method claims directed to non-FDA-approved uses unless the uses are necessarily related to the FDA-approved indication.  ANDA filers should be wary that a proposed indication need not perfectly track a method claim in order to result in an infringement verdict.