The Federal Circuit's decision on Friday, in Braintree Laboratories, Inc. v. Breckenridge Pharmaceutical, Inc., illustrates the risks a litigant can take when agreeing to stipulation in an effort at least to reduce litigation costs and issues presented at trial.
The case involved ANDA litigation over ANDA defendant Breckenridge Labs' generic version of Braintree's bowel preparation kit (SUPREP), sold to purge a patient's colon prior to inter alia colonoscopy. The formulation as sold by Braintree comprises "two six-ounce bottles of an aqueous hypertonic solution of potassium sulfate, magnesium sulfate, and sodium sulfate," which according to the FDA-approved label are filled to 16 ounces prior to consumption (which occurs once in the evening before the procedure and once the morning of a colonoscopy). Claim 15 of Braintree's patent in suit (U.S. Patent No. 6,946,149) is representative:
A composition for inducing purgation of the colon of a patient, the composition comprising from about 100 ml to about 500 ml of an aqueous hypertonic solution comprising an effective amount of Na2SO4, an effective amount of MgSO4, and an effective amount of K2SO4, wherein the composition does not produce any clinically significant electrolyte shifts and does not include phosphate.
At issue was construction of the terms "purgation" and "from about 100 ml to about 500 ml." The former limitation was earlier construed in an unrelated litigation -- Braintree Laboratories, Inc. v. Novel Laboratories, Inc. -- where the Federal Circuit held that the term means "an evacuation of a copious amount of stool from the bowels after oral administration of the solution." This is relevant here because under this construction the two claim terms at issue are not contradictory (insofar as complete purging of the bowels is not achieved by ingesting only one bottle of the formulation, and both bottles together have a greater volume (946 mL) than the volumetric limitation permits).
Here, ANDA defendant Breckenridge stipulated that the construction of "purgation" in the Novel case would apply in this case (representing acquiescence to the reality that the Federal Circuit's construction in the Novel appeal would apply in any case). But Breckenridge's stipulation went further, wherein defendant agreed to be bound by any parts of the Novel opinion bearing on invalidity or non-infringement. As it turned out, the Novel decision did not address the volumetric limitations, and the District Court granted summary judgment that Breckenridge did not directly infringe nor induce infringement of the claims of the '149 patent, on two grounds. The first was that the term "from about 100 ml to about 500 ml" meant the entire volume ingested, which was incontestably greater (946 mL) than re recited 500 mL limit. Second, the District Court held that Breckenridge's label could not induce infringement under 35 U.S.C. § 271(e) because anything less than "full" colonic purging was not an approved use of the formulation. Braintree appealed.
The Federal Circuit reversed and remanded, in an opinion by Judge Moore, joined by Judges Newman and Wallach. The opinion rejects Breckenridge's view that the Novel opinion was not preclusive with regard to the volumetric limitation. In the panel's view, "[t]he meaning of the term 'from about 100 ml to about 500 ml' was necessarily connected to our construction of 'purgation.'" Novel had "intertwined" the two claim limitations in its noninfringement arguments, and the panel read the Court's earlier opinion to hold that "cleansing" (i.e., complete purgation), while recited as a goal expressly disclosed in the specification was not a claim limitation. The panel also read the Novel opinion to mean that "from about 100mL to about 500mL" was sufficient to induce purgation under the claims of the '149 patent. Citing the Novel opinion, this panel reminds the parties that:
Each of those half-dose sixteen ounce solutions has a total volume of 473 mL, which is within the range found in the asserted claims of the '149 patent, but Braintree concedes that neither dose accomplishes a full cleansing. Thus, Braintree's "one bottle" infringement theory asserts that one (half-dose) bottle of SUPREP, diluted with water to become a sixteen ounce solution, falls within the asserted claims. This infringement theory can prevail if purgation means the "evacuation of a copious amount of stool from the bowels after oral administration of the solution," which is something less than a full cleansing.
The Court also asserts that it is cognizant of the due process requirements, recited in Blonder-Tongue Labs., Inc. v. Univ. of Ill. Found., 402 U.S. 313, 329 (1971), that a party not be estopped by a claim construction decision where it is neither a party nor in privity with one. But Breckenridge stipulated that it would be bound by the Court's earlier decision. This stipulation foreclosed the District Court from construing the "from about 100mL to about 500mL" limitation otherwise.
With regard to the § 271(e) argument, the opinion also disagrees with the District Court's distinction between "purgation" and full colonic cleaning, based on the lower court's reading of the Novel decision. The panel says this case is unlike its earlier decisions, holding that an ANDA defendant's label could not induce infringement, based on the factual differences between those cases and this one. (The panel cited Warner-Lambert Co v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003); Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322 (Fed. Cir. 2003); and Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316, 1321 (Fed. Cir. 2012) in this regard.) In contrast with those cases, the Court states that "inducing purgation" is not a distinct use of the claimed formulation, because inducing purgation is just a means for achieving the desired result (inducing purgation of the colon of a patient) recited in the preamble of the '149 patent claims. And Breckenridge conceded that this is what its formulation was intended to do. Accordingly, the Court holds that Breckenridge's generic formulation "recommends or suggests to physicians that the drug is safe and effective for administration to patients for the purposes of inducing [purgation]." This being the only FDA-approved use for Braintree's SUPREP, the Court holds that a physician would understand that the generic label is also "safe and effective" for this use. Indeed, "[t]o hold otherwise would lead to the absurd result that a physician would understand Breckenridge's proposed product to be safe and effective for fully cleansing the colon, but not safe and effective at accomplishing a partial colon cleansing" according to the Court.
Due to Breckenridge's stipulations, that its proposed generic product would infringe the asserted claims of the '149 patent absent summary judgment, and that it would not raise defenses or counterclaims other than its noninfringement defense, the Court reversed and remanded with instructions that the District Court enter judgment in favor of Braintree. And the Court awarded Braintree its costs.
Braintree Laboratories, Inc. v. Breckenridge Pharmaceutical, Inc. (Fed. Cir. 2017)
Nonprecedential disposition
Panel: Circuit Judges Newman, Moore, and Wallach
Opinion by Circuit Judge Moore
