The US Supreme Court [official website] ruled unanimously [opinion, PDF] Tuesday in Caraco Pharmaceutical Laboratories, Ltd v. Novo Nordisk A/S [SCOTUSblog backgrounder] that a generic drug manufacturer may employ the counterclaim provision of the Hatch-Waxman Act [text, PDF] to force correction of a use code that inaccurately describes the brand's patent as covering a particular method of using a drug. When the Food and Drug Administration (FDA) [official website] 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 [21 USC § 355(j)(5)(C)(ii)(I) text] 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." The US Court of Appeals for the Federal Circuit held [opinion, PDF] 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. In an opinion by Justice Elena Kagan, the Supreme Court reversed:
The statutory counterclaim we have considered enables courts to resolve patent disputes so that the FDA can fulfill its statutory duty to approve generic drugs that do not infringe patent rights. The text and context of the provision demonstrate that a generic company can employ the counterclaim to challenge a brand's overbroad use code. We accordingly hold that Caraco may bring a counterclaim seeking to "correct" Novo's use code "on the ground that" the '358 patent "does not claim ... an approved method of using the drug"indeed, does not claim two.Justice Sonia Sotomayor filed a concurring opinion.
The court heard arguments [JURIST report] in the case in December. JURIST Guest Columnist Carlos Angulo argued recently that the Federal Circuit decided the case incorrectly [JURIST op-ed]. He argued that if the Supreme Court had affirmed the Federal Circuit, "it [would] significantly undermine Congress's goal in the so-called Hatch-Waxman Amendmentsensuring patients' access to affordable generic drugs."