On May 5, 2017, the U.S. Court of Appeals for the Federal Circuit issued a non-precedential opinion reversing a decision of noninfringement under 35 U.S.C. § 271(e) by the U.S. District Court for the Southern District of New York. See Braintree Labs, Inc. v. Breckenridge Pharm., Inc., No. 2016-1731 (Fed. Cir. May 5, 2017) (“Braintree Opinion”). Click here for the opinion.
Braintree Laboratories (“Braintree”) sued Breckenridge Pharmaceuticals (“Breckenridge”) for infringing U.S. Patent No. 6,946,149 (“the ’149 patent”) and Breckenridge moved for summary judgment of noninfringement. The district court granted the motion, finding that Breckenridge did not directly infringe or induce infringement of the asserted claims of the ’149 patent under 35 U.S.C. § 271(e). On appeal, the Federal Circuit reversed, holding that, by seeking FDA approval for proposed drug product labeling directing patients to consume two bottles of solution in divided doses for the indication of “cleansing of the colon in preparation for colonoscopy in adults,” Breckenridge would induce infringement of patent claims reciting a method for “inducing colonic purgation.” This ruling provides further guidance in the recent body of decisions under the Hatch-Waxman scheme regarding when proposed drug labeling evidences a specific intent to induce patent infringement.
Under the Hatch-Waxman Act, 35 U.S.C. § 271(e)(2)(A) enables branded drug manufacturers to bring an early patent infringement suit against generic drug manufacturers by creating an artificial act of infringement based on the submission of an Abbreviated New Drug Application (“ANDA”) that seeks FDA approval for a drug “claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.” When the patent claims at issue recite a method of treating patients, the infringement inquiry under § 271(e) further turns on whether the generic drug manufacturer, if its product were approved and marketed as described in its ANDA, would “actively induce” infringement of the claimed methods under 35 U.S.C. § 271(b). In the Hatch-Waxman context, the elements of induced infringement—including showing direct infringement by an end-user (e.g., doctors or patients), and specific intent of the accused infringer to induce infringement—are typically shown by evidence that the instructions in the labeling for which the generic drug manufacturer seeks FDA approval would inevitably direct at least some end-users to practice the claimed method. The infringement inquiry for such claims under §§ 271(e) and 271(b) thus often depends on a court’s findings as to the relationship between the claimed treatment method and what is actually instructed by the accused infringer’s proposed labeling.
Braintree’s ’149 patent is directed to composition and method claims “for purging a patient’s colon, as is routinely performed prior to a colonoscopy.” In particular, each of the claims at issue in the litigation between Braintree and Breckenridge recite methods for “inducing colonic purgation” through oral administration of compositions in a volume of “from about 100 ml to about 500 ml.” The FDA-approved indication for Braintree’s FDA-approved product SUPREP, copied in Breckenridge’s proposed labeling, is for “cleansing of the colon in preparation for colonoscopy in adults.” The branded SUPREP product and Breckenridge’s proposed generic product are both kits containing two bottles, with drug product labeling instructing patients to fill each bottle to 473 mL, and to consume one bottle the night before and the second bottle the morning of a colonoscopy procedure. The SUPREP labeling states that “[t]he dose for colon cleansing requires administration of two bottles of SUPREP”—i.e., a total volume of 946 ml of solution.
In the litigation below, the district court granted Breckenridge’s motion for summary judgment of noninfringement, on several grounds. With respect to claims 19 and 20 of the ’149 patent reciting “[a] method for inducing colonic purgation in a patient,” the district court construed “purgation” to mean ‘‘an evacuation of a copious amount of stool from the bowels’’—which it explained to be “something less than” the indicated use recited in the SUPREP labeling and Breckenridge’s proposed labeling, i.e., “a full [colon] cleansing.” In view of that construction, the district court held that Breckenridge’s proposed labeling did not induce infringement under § 271(e) because “inducing purgation without ‘achieving a fully cleansed colon’ is not an FDA-approved use of Breckenridge’s product . . . .”
The Federal Circuit’s Braintree Opinion Finding Induced Infringement
In the Braintree Opinion, the Federal Circuit reversed the district court’s findings of noninfringement, including its finding that Breckenridge’s proposed drug product labeling did not induce infringement under § 271(e) of claims reciting “[a] method for inducing colonic purgation in a patient.” While acknowledging that the labeled indication was “colon cleansing,” and that “inducing purgation is not a distinct use of Breckenridge’s proposed product,” the Federal Circuit explained that Breckenridge’s proposed labeling nonetheless evidences a specific intent to induce infringement of the claimed method because “inducing purgation is the means by which the approved indication achieves its result.” That is, Breckenridge’s proposed product “‘cleanses the colon of a patient by inducing purgation’ when taken as directed by its label.” The Court thus found that the district court erred in ruling that, merely because “purgation” was construed to be something different than “full colon cleansing,” that “purgation” was necessarily a “distinct treatment, rather than merely a mechanism to achieve the goal of full colon cleansing.”
The Federal Circuit also found that, even though Breckenridge’s proposed labeling did not recite “inducing purgation” as an approved indication, physicians reading the labeling would understand it “to recommend or suggests that ‘inducing purgation’ [with Breckenridge’s generic product] is safe and effective.” In reaching this conclusion, the Federal Circuit explained that the FDA approved SUPREP as safe and effective for the indication of “colon cleansing,” and Breckenridge’s label “requires performing the claimed steps [of inducing purgation] in order to achieve colon cleansing . . . .” The Court reasoned that “[t]o hold otherwise would lead to the absurd result that a physician would understand Breckenridge’s proposed product to be safe and effective for fully cleansing the colon, but not safe and effective at accomplishing a partial colon cleansing” that is achieved during the treatment process.
The Federal Circuit distinguished prior cases finding that an ANDA applicant’s proposed label would not induce infringement where the indicated usage was entirely “distinct” from the use recited in the asserted patent claims. For example, in Warner-Lambert Co. v. Apotex Corp., the Federal Circuit held that Apotex’s ANDA label indication for partial seizures did not induce infringement of the claimed method of using gabapentin for the treatment of neurodegenerative diseases, because the claimed use was “entirely distinct” from the FDA-approved indication, and was never approved by the FDA as safe and effective even for the brand product. In Allergan, Inc. v. Alcon Labs., Inc., the Federal Circuit held that Alcon’s ANDA label for using “brimonidine for the reduction of intraocular pressure” could not induce infringement on Allergan’s patents claiming methods of “neural protection,” because even though the claimed use might be a result from administering the drug as indicated, it was a distinct indication that was not supported by an FDA finding of safety and efficacy.” The Court also distinguished Bayer Schering Pharma AG v. Lupin, Ltd., noting that in that case, the Federal Circuit held that Lupin’s ANDA label for using the drug Yasmin only for oral contraception could not induce infringement of Bayer’s patent claiming a method for the unapproved, distinct usage of “simultaneously achieving, during premenopause or menopause, a contraceptive effect, an antiandrogenic effect, and an antialdosterone effect.”
Analysis and Implications
The Braintree decision adds further dimension to a recent body of cases fleshing out when drug product labeling submitted to the FDA for approval under the Hatch-Waxman scheme can be evidence of an affirmative intent that the product be used to infringe a patented pharmaceutical method—even when the patented method is not expressly found as the “Indication” for which FDA approval is sought. The Federal Circuit has long held that patents claiming truly “off-label” uses are generally not infringed under § 271(e)(2)(A) by a generic drug application with proposed labeling that recites only indications that are entirely distinct from the patented use. On the other hand, the Federal Circuit has also explained that the showing of specific intent to induce infringement can be satisfied where the accused infringer’s labeling “would inevitably lead some [users] to practice the claimed method,” including by instructions or warnings found outside the “Indication” portion of the labeling. In Braintree, the Federal Circuit confirmed that intent to induce infringement can be shown where a claimed usage (“purgation”) necessarily occurs on the way to carrying out an indicated use in the proposed labeling (fully “cleansing” the bowel), or is the mechanism or means by which the labeled use is achieved.
The Braintree decision comes on the heels of several other Federal Circuit decisions over the last several years addressing the use of pharmaceutical product labeling as evidence of induced infringement. In the 2015 Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp. decision, the Federal Circuit held that patent claims directed towards methods of treating “acute” gout flares were not infringed by an accused colchicine product with an FDA-approved indication for “prophylaxis of gout flares,” and stating that safety and effectiveness for “acute treatment of gout flares during prophylaxis has not been studied.” While the accused colchicine product in Takeda included a statement that patients experiencing gout flares while taking the product for prophylaxis should “tell [their] healthcare provider,” the Federal Circuit found that to be too “vague” a label statement to show inducement, and in any event found insufficient evidence of what physicians would “inevitably” do if approached by such a patient. In contrast, earlier this year in Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., the Federal Circuit ruled that a generic product label for the chemotherapy drug pemetrexed evidenced intent to induce infringement of claims to co-administration of pemetrexed with vitamins including folic acid, where the labeling featured “repeated instructions and warnings regarding the importance of and reasons for folic acid treatment, and there is testimony that the Physician Prescribing Information, as the name indicates, is directed at physicians.”
As Braintree and Lilly show, even where the “Indication” recited in the labeling of an accused infringing drug product does not read squarely on a patent claim reciting a method of treatment, in the proper case, a close reading of the proposed labeling and thoughtful development of technical facts may support a showing of intent to induce infringement.