What Is “a Patient?”

by McDermott Will & Emery

Braintree Labs, Inc. v. Novel Labs, Inc.

On appeal from summary judgment, the U.S. Court of Appeals for the Federal Circuit construed “a patient” to mean “a population of patients,” overturning the district court’s construction and vacating the infringement ruling.  Braintree Labs, Inc. v. Novel Labs, Inc.  The dissent would have held the term to mean “one or more patients,” as the district court had determined.  Case No. 13-1438 (Fed. Cir., Apr. 22, 2014) (Prost, J.) (Moore, J., dissenting).

This Hatch-Waxman litigation concerns an Abbreviated New Drug Application (ANDA) filed by Novel Laboratories, Inc. (Novel) for a generic version of the SUPREP® Bowel Prep Kit (SUPREP), a product used to purge the bowel prior to colonoscopy. Braintree held a patent that covers SUPREP and sued Novel for infringement.  SUPREP’s advantage over other purgatives is that it comprises a relatively small fluid volume but does not cause the life-threatening electrolyte level changes that can occur with other low-volume purgatives. This key trait is embodied in the disputed claim term “wherein the composition does not produce any clinically significant electrolyte shifts.”  The district court held that this term is limited by the preambular “a patient,” which it defined as “one or more patients.”  Relying on this construction, the district court held that Novel’s generic product infringed.

Novel appealed, arguing that construing “a patient” to mean “one or more” would improperly result in infringement even when 99 out of 100 patients did experience significant electrolyte shifts, as long as at least one did not.  Braintree countered that the term “a patient” must mean “one or more,” because to hold otherwise would lead to the incorrect conclusion “that no infringement can occur if SUPREP causes a clinically significant electrolyte shift in a single patient.”

The Federal Circuit agreed with Novel, concluding that the disputed term means “a patient population.”  The Court also echoed Novel’s reasoning, stating that to hold otherwise would lead to the “absurd result of infringement even if a composition causes clinically significant electrolyte shifts in a large percentage of patients.” In support, the Court cited to sections of the specification that discussed the product’s performance “in patients” and whether “normal people” tolerated it.

In dissent, Judge Moore argued that precedent held the plain and ordinary meaning of “a patient” is “one or more” when used with “comprising,” as should be the case here:  “In the few instances where we have ever deviated from this general rule, we concluded that the intrinsic evidence made it clear that the patentee intended ‘a’ to mean one and only one.”  Yet the Court did not point to such definitive evidence or apply such reasoning here.  Neither did the Court cite to a clear statement redefining the singular “a patient” as a plural “patient population.”  Instead, it tried to avoid the “absurd result” of infringement where a product meets the claim limitations one out of 100 times.  While Judge Moore agreed that this was a concern, it “is a question of damages, not infringement.” According to Judge Moore, the Court was improperly rewriting this term to avoid a finding of infringement.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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