Suprep® - USA

On May 05, 2017, The Federal Circuit ruled that Breckenridge Pharmaceutical Inc.’s planned generic version of the laxative drug SUPREP® infringes a patent owned by Braintree Laboratories Inc., reversing a New York federal judge’s 2016 ruling.

U.S. Patent No. 6,946,149 is directed to compositions and methods for purging a patient’s colon, as is routinely performed prior to a colonoscopy. Braintree markets a bowel prep kit named SUPREP, which is listed in orange book. SUPREP is sold as a kit consisting of two six-ounce bottles of an aqueous hypertonic solution of potassium sulfate, magnesium sulfate, and sodium sulfate. Its FDA-approved label instructs patients to fill each bottle with water to the sixteen-ounce line (473 mL) prior to consumption and directs that the first bottle be taken the evening before and the second bottle the morning of the colonoscopy. According to SUPREP’s label, “[t]he dose for colon cleansing requires administration of two bottles of SUPREP.

On March 15, 2012, Breckenridge submitted an Abbreviated New Drug Application (“ANDA”) to the FDA, seeking approval to market a generic version of SUPREP. Braintree filed the instant action accusing Breckenridge of infringement. The parties’ dispute centers on the relationship between the “purgation” and “from about 100 ml to about 500 ml” limitations. Court previously construed the “purgation” limitation of the ’149 patent in Braintree Laboratories, Inc. v. Novel Laboratories, Inc., 749 F.3d 1349 (Fed. Cir. 2014). While the Novel appeal was pending, Breckenridge stipulated that the district court’s Novel construction of “purgation” would apply in this case. Breckenridge further stipulated to “be bound by a final decision in the Novel Case . . . on any issues having to do with patent invalidity . . . and non-infringement” other than the “from about 100 ml to about 500 ml” limitation.

Breckenridge subsequently moved for summary judgment of noninfringement based on this limitation, arguing its proposed generic does not infringe the claims of the ’149 patent “because it is administered as 946 ml of aqueous solution, and thus falls outside the recited volume range.” It argued that based both on the claim construction of the term and the infringement inquiry under § 271(e), “from about 100 ml to about 500 ml” must refer to the total volume of solution administered. It argued its proposed label could not induce infringement of method claims 19, 20, and 23 under § 271(e) because its ANDA label instructs patients to consume the “entire amount” of solution (946 mL) for the sole indication of “preparation for colonoscopy”—not only one bottle to “induce colonic purgation.”

The district court granted Breckenridge’s motion for summary judgment of noninfringement. It held that Novel did not preclude Breckenridge’s noninfringement theory because that opinion did not address the separate volume limitation. It construed “from about 100 ml to about 500 ml” to mean “the entire volume of solution administered to a patient over a treatment period rather than the volume of a single bottle, or half-dose.” Because every asserted claim requires “from about 100 ml to about 500 ml,” the district court found that Breckenridge’s proposed product, with a total volume of 946 mL, does not infringe any of the asserted claims. The district court also agreed that Breckenridge’s ANDA label could not induce infringement under § 271(e), finding inducing purgation without “achieving a fully cleansed colon” is not an FDA-approved use of Breckenridge’s product.

During appeal  Breckenridge argues the district court’s summary judgment of noninfringement should be affirmed notwithstanding its construction of the volume limitation because Braintree’s infringement theory is contrary to 35 U.S.C. § 271(e). Court disagreed. This case is distinguishable from the cases in which we have held an ANDA applicant’s proposed label would not induce infringement [Warner-Lambert Co v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003); Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322 (Fed. Cir. 2003); Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316, 1321 (Fed. Cir. 2012)].

In contrast, inducing purgation is not a distinct use of Breckenridge’s proposed product; inducing purgation is the means by which the approved indication achieves its result. Breckenridge concedes that its proposed product “cleanses the colon of a patient by inducing purgation” when taken as directed by its label. J.A. 1780–81 ¶¶ 25, 37–38 (emphasis added). Its stipulations make clear that inducing purgation is not supplemental or ancillary to its proposed indication of colon cleansing—it is plainly within the scope of Breckenridge’s proposed indication. Therefore We hold that Breckenridge’s labeled indication for colon cleansing “recommends or suggests to physicians that the drug is safe and effective for administration to patients for the purposes of inducing [purgation].” There can be no dispute that, given SUPREP’s sole approved use, the FDA has approved SUPREP as safe and effective for the indication of colon cleansing. Because Breckenridge’s labeled indication of colon cleansing requires performing the claimed steps in order to achieve colon cleansing, it follows that a physician would understand Breckenridge’s ANDA label to recommend or suggest that “inducing purgation” is safe and effective.

Finally Federal Circuit said that we have considered all of Breckenridge’s arguments on appeal and find them to be without merit. For the foregoing reasons, we reverse the district court’s grant of summary judgment of noninfringement and remand for entry of judgment for Braintree.