Braintree Labs., Inc. v. Novel Labs., Inc. (Fed. Cir.)

Case Name: Braintree Labs., Inc. v. Novel Labs., Inc., 749 F.3d 1349 (Fed. Cir. Apr. 22, 2014) (Circuit Judges Dyk, Prost, and Moore presiding; Opinion by Prost, J.; Concurrence-in-part and Dissent by Dyk, J.; Dissent by Moore, J.) (Appeal from D. N.J., Sheridan, J.)

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

Nature of the Case and Issue(s) Presented: Novel appealed the grant of summary judgment by the district court of infringement of the ’149 patent, which was entered based on the construction of the terms “purgation” and “clinically significant electrolyte shifts.” Following a bench trial on Novel’s invalidity defenses, the district court found that Novel failed to prove that the asserted claims were invalid. Novel appealed that decision as well. After reversing the district court’s construction of the term “clinically significant electrolyte shifts,” the Federal Circuit vacated the grant of summary judgment of infringement and remanded for further findings to determine whether Novel’s ANDA product infringes under the new claim construction. The Federal Circuit affirmed the validity findings.

Why Novel Prevailed: The district court construed “purgation” to mean “an evacuation of a copious amount of stool from the bowels after oral administration of the solution.” The asserted claims cover compositions “comprising from about 100 mL to about 500 mL of an aqueous hypertonic solution.” Braintree’s Suprep kit contains 2 bottles of concentrated solution, which a patient is supposed to ingest after dilution with water. Each diluted bottle, or half dose, has a total volume of 1 pint (473 mL), which is within the claimed volume limitation. But Braintree concedes that neither half dose by itself accomplishes a full cleansing of the colon prior to receiving a colonoscopy. Braintree’s “one-bottle” infringement theory can prevail if the Federal Circuit affirms the district court’s construction of “purgation,” which is something less than a full “cleansing,” Novel’s proposed construction. The Federal Circuit affirmed the construction of “purgation” on the basis that the claims themselves do not contain language that requires achieving a fully cleansed colon and that although the specification contemplates scenarios in which an effective amount of the covered product could produce a full cleansing, “it does so only in terms of a preferred embodiment.” Because “purgation” does not require a full cleansing of the colon, the Federal Circuit affirmed the finding that one bottle of Suprep met the “purgation” limitation as would Novel’s proposed ANDA product.

The district court construed “clinically significant electrolyte shifts” to mean “alterations in blood chemistry that are outside the normal upper or lower limits of their normal range or other untoward effects.” It later modified its construction to mean “alterations in blood chemistry that are both outside the normal upper or lower limits of their range and accompanied by or manifested as other untoward effects.” The Federal Circuit found that the former construction was in line with the patentee’s lexicographic definition in the ’149 patent specification and rejected the latter construction. The district court also found as part of construction “at least one patient to whom SUPREP is administered will experience, or has experienced, no clinically significant electrolyte shifts.” In doing so, the district court carried the term “a patient”—which it interpreted to mean “one or more patients”—from the preamble into the claim. While the Federal Circuit agreed that “a patient” was a limitation, it found the district court’s definition in correct. In view of its construction of “clinically significant electrolyte shifts,” the Federal Circuit found that the district court’s application of “a patient” “leads to the absurd result of infringement even if a composition causes clinically significant electrolyte shifts in a large percentage of patients.” It then construed “a patient” to mean “a patient population.” In view of these corrected constructions, the Federal Circuit remanded the case for further findings concerning the issue of infringement.

Regarding validity, the Federal Circuit affirmed the district court’s holding that the Hechter prior art patent did not anticipate the ’149 patent. The Federal Circuit reasoned: Hechter did not disclose the administration of a hypertonic solution; the alleged hypertonic solution disclosed in Hechter was never actually tested to see if in fact is was hypertonic; and Hechter taught away from the administration of hypertonic solutions. With regard to obviousness, the Federal Circuit found that a person of ordinary skill in the art would not have been motivated to combine the various references that Novel relied on at trial.

Judge Dyk’s dissent would have the Federal Circuit enter summary judgment of non-infringement in favor of Novel based on Federal Circuit precedent that an ANDA cannot infringe an asserted patent when the FDA-approved dose is not the dose claimed in the patent. Novel’s ANDA seeks approval for a 1-quart (946 mL), two bottle regimen to induce colon cleansing, based on Braintree’s NDA. Therefore, Novel’s ANDA product cannot infringe the ’149 patent, which claims a composition with a volume of 100-500 mL for inducing purgation and a method of using the same.

Judge Moore’s dissent would have the Federal Circuit affirm the district court’s summary judgment of infringement because of her disagreement with the majority’s construction of the term “a patient.” Given Federal Circuit precedent that holds that the term “a patient” means “one or more patients” and the “undisputed evidence” that at least one patient who was treated with the accused composition has experienced “clinically significant electrolyte shifts,” Judge Moore believes that infringement has been established as a matter of law.