Braintree Labs. Inc. v. Breckenridge Pharm., Inc.

Because the ANDA product does not satisfy the claimed volume limitation of the patent and the use claimed in the patent is not FDA-approved, the ANDA product does not infringe the patent-in-suit.

April 07, 2016

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Braintree Labs. Inc. v. Breckenridge Pharm., Inc., C.A. No 12-cv-6851 (AJN), 2016 U.S. Dist. LEXIS 33336 (S.D.N.Y. Mar. 15, 2016) (Nathan, J.)

Drug Product and Patent(s)-in-Suit: Suprep® (sodium sulfate / potassium sulfate / magnesium sulfate); U.S. Patent No. 6,946,149 (“the ’149 patent”)

Nature of the Case and Issue(s) Presented: SUPREP is sold as a kit containing two 6-ounce bottles of solution, each of which must be diluted with water to 16 ounces prior to consumption. SUPREP’s label instructs a patient to take one bottle of solution (diluted to 16 ounces/473 mL) the night before a scheduled colonoscopy, and the second bottle of solution (again diluted to 16 ounces) ten to twelve hours later. If approved, the ANDA product would be sold and ingested in the same way.

In a prior litigation involving the same patent but a different ANDA filer, Novel Labs., the District of New Jersey construed certain terms of the patent, considered a number of non-infringement arguments advanced by Novel, and ultimately granted Braintree’s motion for summary judgment of infringement. Novel appealed the D.N.J. court’s judgment to the Federal Circuit, which affirmed in part, reversed in part, and remanded to the D.N.J. for further proceedings. While the D.N.J. proceedings were going on, Braintree and Breckenridge stipulated that (i) per the D.N.J. claim construction, the claim term “purgation” meant “an evacuation of a copious amount of stool from the bowels after oral administration of the solution”; and (ii) there’d be no argument “other than that based on the ‘from about 100 mL to about 500 mL’ limitation” in the ’149 patent.”

Breckenridge filed a motion for summary judgment of non-infringement. Breckenridge argued that its ANDA product does not infringe the “from about 100 mL to about 500 mL” claimed limitation because its ANDA product consists of 32 ounces/946 mL of solution. Relatedly, Breckenridge argued that its ANDA product does not violate Section 271(e)(2) because the ’149 patent does not claim the FDA-approved use of its ANDA product. Braintree asserted three counter-arguments: (i) the Federal Circuit’s decision in the prior litigation bars both of Breckenridge’s arguments; (ii) Breckenridge’s arguments involve claim construction, which the parties stipulated not to address; and (iii) the Breckenridge is wrong on the merits. The Court granted Breckenridge’s motion.

Why Breckenridge Prevailed: Firstly, the Court found that Breckenridge’s arguments here were not raised by the parties or addressed by the majority opinion in the prior litigation Federal Circuit decision. In the prior litigation, Braintree was faced with a problem: the ’149 patent claimed a “composition comprising from about 100 mL to about 500 mL of aqueous hypertonic solution” and its commercial embodiment, SUPREP, required the administration of 946 mL of solution. As a result, Braintree advanced a “one bottle” theory of infringement under which each appropriately diluted bottle of the ANDA product independently infringed the ’149 patent. Novel raised numerous arguments that one bottle of its ANDA product did not satisfy the various claim limitations, but each was rejected by the D.N.J. court. According to the Court here, Novel did not appeal the D.N.J. court’s determination with respect to each limitation; instead, it appealed the proper construction of the terms “purgation” and “clinically significant electrolyte shifts” in the respective limitations. Despite Novel’s failure to appeal all issues, Braintree noted that Breckenridge’s exact arguments were raised sua sponte by Judge Dyk in a concurring opinion. However, Braintree pointed to no authority suggesting that the Federal Circuit’s failure to exercise its discretion to consider arguments not raised by the parties, even if raised sua sponte by the concurrence, should be interpreted as a rejection of those arguments on the merits.

Secondly, the parties’ stipulation did not preclude Breckenridge from making the arguments it did in its summary-judgment motion. The stipulation indicated that Breckenridge “agrees not to present any defense of non-infringement…other than that based on the ‘from about 100 mL to about 500 mL’ limitation.” The language of the stipulation clearly contemplates the precise argument raised here: that Breckenridge’s ANDA product fails to satisfy the volume claim limitation.

Finally, the Court rejected Braintree’s arguments on the merits. The specification of the ’149 patent demonstrated that the claimed volume limitation referred to the entire volume of solution administered to a patient over a treatment period, rather than the volume of a single bottle, or half-dose. The fact that the specification repeatedly gave volume measurements as the total volume administered rather than the volume of a particular half-dose supported Breckenridge’s construction of the “from about 100 mL to about 500 mL” limitation. The prosecution history further confirmed this understanding. In its request for patent reexamination, Braintree distinguished the prior art by comparing the “from about 100 mL to about 500 mL” volume claimed in its patent to larger volumes used in other colonic lavage products. Because these large volume solutions are not administered at one time but are instead administered in a series of partial doses, such references suggest that “from about 100 mL to about 500 mL,” refers to the entire volume of solution administered to the patient.

Moreover, the fact that the D.N.J. court construed “purgation” as something less than complete colon cleansing also doomed Braintree’s argument. The FDA-approved use of the ANDA product is “for cleansing of the colon as a preparation for colonoscopy in adults,” while the method claims of the ’149 patent recite “[a] method for inducing colonic purgation in a patient, ….” Thus, because the use claimed in the patent was not FDA-approved, the ANDA product would not induce infringement of the ’149 patent method claims.

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