Braintree owns US Pat. No. 6,946,149 ("'149 patent") and manufactures the SUPREP® Bowel Prep Kit ("SUPREP"), which is for cleansing of the colon as a preparation for colonoscopy. Braintree's '149 patent was directed to a composition for inducing purgation of the colon of a patient that does not produce any clinically significant electrolyte shifts. Novel filed an ANDA for a proposed generic copy of SUPREP and sent Braintree a Paragraph IV certification of invalidity/noninfringement letter. Braintree filed an action seeking a declaration that Novel's ANDA product infringes the '149 patent. Novel asserted counterclaims of noninfringement and invalidity. The district court granted summary judgment of infringement in Braintree's favor and found that the '149 patent is valid.

On appeal, the Federal Circuit reviewed the claim constructions of "purgation" and "clinically significant electrolyte shifts." Novel argued that the claim limitation "purgation" should be construed as cleansing. As a support for this argument, Novel proffered Braintree's patent term extension request that includes the sentence "the SUPREP product is an osmotic laxative for cleansing (i.e., purging) of the colon…" The Federal Circuit disagreed with this argument by reasoning that the post-issuance statement of the patentee does not modify the plain meaning of the word purgation. In regard to the claimed limitation "clinically significant electrolyte shifts," Novel argued that the district court ignored the inventor's clear definition of this term in the specification. The Federal Circuit agreed with this argument and reversed the district court’s construction of "clinically significant electrolyte shifts.”

Based on its claim constructions, the Federal Circuit first found that one bottle of SUPREP meets the purgation claim limitation. However, the Federal Circuit vacated the district court’s grant of summary judgment of infringement based on its reversal of the "clinically significant electrolyte shifts” term and remanded the case back to the district court for further proceedings in view of the Federal Circuit’s interpretation of the term.