Braintree Labs., Inc. v. Breckenridge Pharm., Inc.

Affirming previous claim construction in related case, the district court erred in finding that proposed label would not induce physicians to practice the claimed method.

July 14, 2017

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name:  Braintree Labs., Inc. v. Breckenridge Pharm., Inc., No. 2016-1731 (Fed. Cir. May 5, 2017) (Circuit Judges Newman, Moore, and Wallach presiding; Opinion by Moore, J.) (appeal from S.D.N.Y., Nathan, J.)

Drug Product and Patent(s)-in-Suit: Suprep® (potassium sulfate / magnesium sulfate / sodium sulfate solution) Bowel Prep Kit; U.S. Patent No. 6,946,149 (“the ’149 patent”)

Nature of the Case and Issue(s) Presented:  Suprep is sold as a kit consisting of two six-ounce bottles of an aqueous solution of potassium sulfate, magnesium sulfate, and sodium sulfate. Its FDA-approved label instructs patients to fill each bottle with water to the sixteen-ounce line (473 mL) prior to consumption and directs that the first bottle be taken the evening before and the second bottle the morning of the colonoscopy. Each of the asserted method claims recite methods for “inducing colonic purgation” with a composition “comprising from about 100 ml to about 500 ml” of solution.

The Federal Circuit previously (in a case where Novel Labs (“Novel”) was the ANDA defendant) construed the “purgation” limitation to mean something less than full colon cleansing. In that case, Novel non-infringement argument was premised on the fact that one bottle of its ANDA product could not satisfy the “purgation” limitation because full cleansing only occurs after ingestion of two bottles, and that two bottles could not satisfy the volume limitation “from about 100 ml to about 500 ml” because two bottles contain 1 qt (946) mL of solution. The Federal Circuit rejected Novel’s argument, finding that Braintree’s “one bottle” theory of infringement—in which one bottle of Novel’s ANDA product both induces “purgation” and satisfies the volume limitation—can prevail under the district court’s claim construction. The dissent stated that the “one bottle” infringement theory is erroneous as a matter of law because under 35 U.S.C. § 271(e), Braintree can only assert infringement over the product as described in Novel's ANDA, which discloses 946 mL in volume. The dissent added that apart from the § 271(e) issue, Braintree’s “one bottle” theory rests on an incorrect claim construction because “from about 100 ml to about 500 ml” must refer to the total volume of consumed solution.

Relying principally on that dissent, in this action, Breckenridge moved for summary judgment of non-infringement arguing its ANDA product did not infringe the claims of the ’149 patent because its product was a 946 ml solution. The district court granted Breckenridge’s motion for summary judgment, holding that the Novel case did not preclude Breckenridge’s theory because that opinion did not address the separate volume limitation. The district court also agreed that Breckenridge’s proposed label could not induce infringement under § 271(e), finding inducing purgation without “achieving a fully cleansed colon” is not an FDA-approved use of Breckenridge’s product. Braintree appealed and the Federal Circuit reversed and remanded.

Why Braintree Prevailed:  The Federal Circuit first addressed the claim construction of the volume limitation. In response to Breckenridge’s argument that the volume limitation was not at issue in Novel, the Federal Circuit found that the meaning of the term “from about 100 ml to about 500” was necessarily connected to the construction of the term “purgation.” That construction “stemmed from the arguments presented and the claim language, which linked the ‘purgation’ and ‘from about 100 ml to about 500 ml’ limitations.” Because Breckenridge expressly stipulated that the claim construction of “purgation” adopted by the district court in Novel would apply here, Breckridge was bound by that decision regardless of the fact that it was not part of that lawsuit.

Next, the Federal Circuit addressed the district court’s non-infringement holding. The Federal Circuit distinguished this case from other cases on the basis that inducing purgation was not a distinct use of Breckenridge’s proposed product; inducing purgation was the means by which the approved indication achieved its result. Breckenridge conceded that its proposed product “cleanses the colon of a patient by inducing purgation” when taken as directed by its label. Moreover, according to the Federal Circuit, there could be no dispute that, given SUPREP’s sole approved use, the FDA had approved SUPREP as safe and effective for the indication of colon cleansing. Because Breckenridge’s labeled indication of colon cleansing required performing the claimed steps in order to achieve colon cleansing, it followed that a physician would understand Breckenridge’s ANDA label to recommend or suggest that “inducing purgation” was safe and effective.

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