Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S
Issues
Does the counterclaim provision of the Hatch-Waxman Act authorize a generic drug manufacturer in a patent infringement suit to assert a counterclaim compelling the patent holder to modify an overly broad description of its patent?
Petitioner Caraco Pharmaceutical Laboratories, a generic drug manufacturer, sought FDA approval to market the diabetes drug repaglinide. Pursuant to the Hatch-Waxman Act's expedited FDA application process for generic drugs, Caraco certified that its drug label would not conflict with Respondent Novo Nordisk’s patented repaglinide-metformin use combination. Relying on Novo’s description of its patent, the FDA denied the certification. Caraco invoked the Act’s counterclaim provision to compel Novo to revert to a narrower patent description. The United States Court of Appeals for the Federal Circuit found that Caraco could not assert the counterclaim. Caraco argues that the Federal Circuit’s reading of the counterclaim provision is incorrect and that the purpose of the counterclaim provision—to “correct” misleading patent descriptions—supports reversal. Novo asserts that the statute plainly permits a counterclaim only if Novo’s patent does not claim any approved method of use. The Supreme Court’s reading of the counterclaim provision may affect healthcare costs and the generic drug manufacturing industry.
Questions as Framed for the Court by the Parties
When the Food & Drug Administration (FDA) approves a drug for multiple uses, the Hatch-Waxman Act allows generic drug makers to avoid contested patent litigation by marketing generic versions of the drug solely for non-patented uses. The FDA lacks the authority and expertise needed to verify the patent information submitted by name-brand drug companies, however, so it defers to their descriptions of the scope of their patents. Such companies can therefore block the approval of generic drugs by submitting overbroad patent descriptions to the FDA, effectively extending their patents to cover non-infringing uses.
To combat this problem, the Act allows a “counterclaim seeking an order requiring the [patent] holder to correct or delete the patent information submitted by the holder . . . on the ground that the patent does not claim . . . an approved method of using the drug.” 21 U.S.C. § 355(j)(5)(C)(ii)(I). In a 2-1 decision that conflicts with this Court's precedents and recent D.C. Circuit authority, the Federal Circuit held that the counterclaim provision effectively authorizes only “delet[ing]” improperly listed patents, but not “correct[ing]” information that misrepresents the scope of the approved uses claimed by a patent. That ruling expressly invalidates longstanding FDA regulations defining “patent information,” which the FDA deems “essential” to administering the Act, without seeking the agency's views. The question presented is:
Whether this counterclaim provision applies where (1) there is “an approved method of using the drug” that “the patent does not claim,” and (2) the brand submits “patent information” to the FDA that misstates the patent's scope, requiring “correct[ion].”
The Hatch-Waxman Act expedites the process by which generic drug manufacturers can obtain approval from the Food and Drug Administration (“FDA”) to market generic drugs, and allows generic drug manufacturers to produce and market brand-name drugs for FDA-approved uses that are not covered by existing patents. See 21 U.S.C.