We discussed Braintree Labs v. Novel Labs in a previous post.  In the panel decision, Judge Prost, with Judge Dyk joining, found the term “a patient” in Braintree’s Suprep colon cleanser patent to mean a general class of persons, i.e., a patient population.  Accordingly, the panel vacated and remanded the infringement ruling relying on erroneous claim construction.  Judge Newman dissented, agreeing with the district court’s interpretation that “a patient” means “one or more patients.”

The more interesting issue presented involves infringement.  The panel affirmed the district court’s holding Novel liable for infringement by seeking FDA approval for a generic version of Suprep with a total volume of 946 milliliters in two bottles, consumed one bottle at a time, 10-12 hours apart.  Braintree’s patent only describes a dose of between 100 and 500 milliliters (we will call this issue “infringement through double-dosage”).  Both parties sought en banc review.

Braintree sought en banc rehearing on the construction of “a patient,” arguing that the construction was inconsistent with the plain meaning, went against precedent construing “a” to mean “one or more,” and would lead to an increased burden by potentially requiring statistical analysis to establish infringement. Novel urged denial of Braintree’s petition for en banc rehearing, arguing that Braintree’s construction would be a “useless invention,” ignore the inventors’ intention, and would require no statistical analysis because Braintree’s claimed composition cannot result in any “clinically significant electrolyte shifts.”

Novel petitioned for rehearing on the issue of infringement through double-dosage, arguing that the Federal Circuit’s ruling “turned well-settled precedent on its head” and created a new basis for infringement that “has the potential to impact all future litigation under the Hatch-Waxman Act.”  Braintree responded that Novel’s argument had been waived because it was not presented to the panel and was not appropriate for en banc review.  Substantively, Braintree argued that administration of each bottle (473 milliliters) infringes Braintree’s patent claiming between 100 and 500 milliliters, and Novel cannot “turn two infringing acts into none.”

The issue of “infringement through double-dosage” could be an important issue for future Hatch-Waxman litigation.  We suspect that the Federal Circuit may actually take this case en banc.  Stay tuned.