In a divided opinion issued in Braintree Labs., Inc. v. Novel Labs., Inc., the Federal Circuit reversed the district court on one of two challenged claim construction issues and vacated the district court’s finding of infringement to remand for further factual findings. When no judge agrees with the basis of the decision and neither party is satisfied with the outcome, what can we learn from this case?

The Patent at Issue

The patent at issue was Braintree’s U.S. 6,946,149, which is listed in the Orange Book for its SUPREP® Bowel Prep Kit for preparing patients for colonoscopies. Reexamined claim 15 was treated as 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.

According to the Federal Circuit decision, “Braintree sells SUPREP® in a kit containing two six-ounce bottles of concentrated solution, along with a dilution cup.” To use the product, “[a] patient must dilute each of the two six-ounce bottles with ten ounces of water to form two sixteen-ounce solutions,” each of which has a volume of 473 mL. Thus, Braintree’s theory of infringement (and basis for listing the patent in the Orange Book for SUPREP®) is that one bottle of the two-bottle kit falls within the scope of the claims. The Federal Circuit decision refers to this as the “one bottle” theory of infringement.

The ANDA Litigation

Novel filed an ANDA seeking approval to market a generic version of SUPREP®, and making a paragraph IV certification against the ‘149 patent. In the ensuing ANDA litigation, the district court construed the claims, granted summary judgment of infringement, and upheld the validity of the patent after a bench trial.

The claim construction issues challenged on appeal related to the meaning of “purgation” and the meaning of “clinically significant electrolyte shifts.” While not treated as an independent claim construction issue, the impact of the term “a patient” in the preamble also was important to the infringement issue.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Prost. Judge Dyk wrote an opinion concurring-in-part, dissenting-in-part, and concurring in the result, while Judge Moore wrote a dissenting opinion. The judges appear to agree on the claim construction issues, but disagree on infringement and/or the “patient” issue.

“Purgation”

As noted by the Federal Circuit, “[t]he district court construed ‘purgation’ to mean ‘an evacuation of a copious amount of stool from the bowels after oral administration of the solution.’” Novel argued that “purgation” should mean the type of complete “cleansing” required to permit visualization of the colon for a colonoscopy. The Federal Circuit disagreed, focusing on the plain language of the claims and interpreting “inducing purgation” as meaning “inducing diarrhea.”

“clinically significant electrolyte shifts”

As noted by the Federal Circuit, the district court construed “‘clinically significant electrolyte shifts’” to be ‘alterations in blood chemistry that are both outside the normal upper or lower limits of their range and accompanied by or manifested as other untoward effects.’” The Federal Circuit reversed that claim construction, because the specification expressly defined the term as meaning “alterations in blood chemistry that are outside the normal upper or lower limits of their range or other untoward effects.”

Infringement

The Federal Circuit decision vacates the district court’s summary judgment of infringement. Judge Dyk concurred in that result, but believes that Novel established non-infringement as a matter of law because he disagrees with the “one bottle” theory of infringement. In contrast, Judge Moore dissents because she disagrees with Judge Prost’s treatment of the “a patient” language.

The district court considered infringement from two perspectives:

• does one bottle of SUPREP® induce purgation
• does one bottle of SUPREP® avoid producing clinically significant electrolyte shifts

Judge Prost affirmed the district court’s decision that one bottle of SUPREP® induces purgation, even though two bottles are required to prepare a patient for a colonoscopy. Judge Dyk disagrees with the “one bottle” theory of infringement because it is inconsistent with the product at issue in the ANDA. That is, because Novel’s ANDA sought approval of a two-bottle product wherein the patient is administered a total volume of 946 mL, it could not infringe a claim reciting “a composition with a volume or 100-500 mL for inducing purgation and a method of using the same.”

Judge Prost vacated the district court’s summary judgment of infringement because there was a genuine issue of material fact as to whether SUPREP® avoids producing clinically significant electrolyte shifts in a patient population. While the district court interpreted the “clinically significant electrolyte shifts” clause in conjunction with the “a patient” referenced in the preamble as requiring that “at least one patient” not experience those effects, Judge Prost interpreted the claim as requiring that “a patient population” not experience those effects. Judge Moore disagrees with the collective view of the side effects clause, and finds that the specification indicates that “clinical significance is measured in an individual patient.” Thus, she would have found the product to infringe even if only one patient out of 100 does not experience clinically significant electrolyte shift.

Non-Infringement in the ANDA Context

In the ANDA context, non-infringement is found if making, using, or selling the proposed generic product for use in accordance with the approved labeling does not infringe the Orange Book listed patent(s). In many cases, generic companies may be able to design around the patents in such a way that the generic product is somewhat different from the approved brand name product. In this case, however, Novel’s proposed product appears to be identical to SUPREP®. Thus, a finding that Novel’s ANDA does not infringe the patent would indicate that the Orange Book listed patent does not, in fact, cover the approved product and so should not have been listed in the Orange Book.

View This Blog