Claim Construction Analysis Begins And Remains Centered On The Language Of The Claims Themselves

In Braintree Laboratories, Inc. v. Novel Laboratories, Inc., No. 13-1438 (Fed. Cir. Apr. 22, 2014), the Federal Circuit affirmed the district court's validity finding, reversed the district court's claim construction of the claim term "clinically significant electrolyte shifts," vacated the district court's SJ of infringement, and remanded for further factual findings on the issue of infringement.

Braintree Laboratories, Inc. ("Braintree") holds U.S. Patent No. 6,946,149 ("the '149 patent"), directed to a composition for inducing purgation of a patient's colon in preparation for a colonoscopy. The commercial embodiment of the '149 patent is Braintree's SUPREP® Bowel Prep Kit ("SUPREP"). Upon learning that Novel Laboratories, Inc. ("Novel") had filed an ANDA to market a proposed generic copy of SUPREP, Braintree filed an action for infringement of the '149 patent against Novel. In response, Novel asserted counterclaims of noninfringement and invalidity. After construing claim terms, the district court granted SJ of infringement in favor of Braintree and found that the '149 patent was valid.

On appeal, Novel challenged the district court's (1) construction of the claim terms "purgation" and "clinically significant electrolyte shifts"; (2) failure to find U.S. Patent No. 4,975,286 ("Hechter") anticipated the claims of the '149 patent; (3) failure to find the asserted claims of the '149 patent obvious in light of the prior art; and (4) failure to find the claim term "purgation" indefinite.

Considering the district court's construction of "purgation" as "an evacuation of a copious amount of stool from the bowels after oral administration of the solution" and Novel's argument relying on evidence from the specification that the claim term "purgation" should be interpreted instead as "cleansing," the Federal Circuit found Novel's arguments unpersuasive. Slip op. at 5 (citations omitted). The Court stressed that claim construction must be centered on the claims themselves, and that while cleansing was the goal specifically articulated in the specification, it was not a claim requirement. The Court also concluded that Novel's reliance on the claim term "effective amount" was also misplaced because "effective amount" only required purgation and not a full cleansing. Moreover, the Court concluded that Braintree's statement in its postissuance patent term extension request, in which it stated that SUPREP is a product for "cleansing (i.e., purging),"...