Addressing the issue of whether composition and method of use claims covered a half dose, or were instead limited to the full dose, the US District Court for the Southern District of New York concluded that the claims were limited to the full dose and granted defendant Breckenridge’s motion for summary judgment of non-infringement. Braintree Labs Inc. v. Breckenridge Pharmaceutical, Inc., Case Nos. 12-cv-6851 (S.D.N.Y. March 15, 2016) (Nathan, J.).

Breckenridge filed an abbreviated new drug application (ANDA) seeking approval from the US Food and Drug Administration (FDA) for a generic version of its drug Suprep® (sodium sulfate, potassium sulfate and magnesium sulfate), which is a laxative indicated for “cleansing of the colon in preparation for colonoscopy in adults.” Braintree filed suit contending that Breckenridge’s ANDA product would infringe its ‘149 patent, which covers compositions for inducing “purgation” of the colon and methods of using the claimed compositions. Crucially, the claims at issue all require a composition “comprising from about 100 mL to about 500 mL” of solution.

Suprep is sold as a kit that includes two six-ounce bottles of solution, each of which must be diluted with water to 16 ounces (473 mL) prior to consumption. According to the label, the full dose of Suprep taken to achieve cleansing prior to a colonoscopy is 946 mL and is ingested in two half doses of 473 mL over a 10- to 12-hour period. Breckenridge’s ANDA provides that its product will be packaged in the same manner, with the same instructions as to dilution and ingestion.

In Breckenridge’s motion for summary judgment of non-infringement, it argued that its product (the full 946 mL of solution) would not meet the “about 100 to about 500 mL” volume limitation of the composition claims. In its opposition, Braintree contended that each bottle in the kit constituted an infringing composition. Essentially, the parties’ dispute centered on whether the claimed “about 100 mL to about 500 mL” solution was limited to a full dose, or whether it could encompass a half dose.

Turning first to the specification, the court concluded that the disclosure “clearly demonstrates that the ‘from about 100 mL to about 500 mL’ limitation refers to the entire volume of solution administered to a patient over a treatment period rather than the volume of a single bottle, or half-dose.” In the examples cited by the court, the total volume of solution was less than 500 mL and was administered in two separate half-doses. Turning next to the prosecution history, the court noted that during re-examination, Braintree compared the full dose of the prior art compositions with its 100 to 500 mL range. In view of the intrinsic evidence, the court concluded that the volume limitation “refers to the total amount of solution administered to a patient over the treatment period rather than a single bottle, or half-dose” and thus concluded that Breckenridge’s ANDA product would not infringe the composition claims.

With respect to the method claims, Breckenridge argued that the sole FDA approved indication, cleansing of the colon in preparation for colonoscopy in adults, was not covered by the ‘149 patent. According to Breckenridge, the claimed method of “inducing purgation” was not the same as the full cleansing contemplated by the approved indication. This argument was based on the construction of “purgation” that Braintree had successfully advanced in another case over the same patent. In the other case, Braintree had argued, and the US Court of Appeals for the Federal Circuit had agreed, that the “purgation” term meant “something less than a full cleansing.” Applying the construction approved by the Federal Circuit, the court found that “it is possible to induce purgation…without achieving the goal of full cleansing sufficient for a colonoscopy.” Accordingly, the claimed method of “inducing purgation” refers to “some point on the colon cleansing spectrum short of ‘a full cleansing.’” Thus, the court concluded that “[i]nducing purgation without ‘achieving a fully cleansed colon for a colonoscopy’…is not an FDA-approved use”, so Breckenridge’s ANDA product would not induce infringement the asserted method claims.