(CN) – Generic drugmakers can use federal law to challenge the accuracy of a patent application, the Supreme Court ruled Tuesday.
Before granting an application to market a generic drug, the Food and Drug Administration must consider whether the drug would infringe on a patent for a brand-name product. It makes this determination by considering the “use code” submitted by the brand manufacturer to describe the scope of its patents.
Since the FDA does not investigate the accuracy of use codes, generic companies said federal law empowered them to take matters into their own hands.
“The relevant statute provides that a generic company ‘may assert a counterclaim seeking an order requiring the [brand manufacturer] to correct or delete the patent information [it] submitted … under [two statutory subsections] on the ground that the patent does not claim … an approved method of using the drug,'” Justice Elena Kagan wrote for the unanimous court. “We hold that a generic manufacturer may employ this provision to force correction of a use code that inaccurately describes the brand’s patent as covering a particular method of using the drug in question.”
Caraco Pharmaceutical Laboratories faces a patent-infringement suit over the diabetes drug repaglinide, which has three FDA-approved uses.
Novo Nordisk A/S, which manufactures the drug under the brand name Prandin, holds a patent for one of the three FDA-approved repaglinide uses. It brought suit as Caraco sought to market a generic version of the drug for the two other uses.
While Caraco was working with the FDA on its application, however, Novo changed the use code for its patent, claiming that it protects all three FDA-approved methods for repaglinide to treat diabetes.
Caraco filed a counterclaim in the underlying infringement suit to make Novo “correct” its use code.
Though a federal judge issued Caraco an injunction at summary judgment, the Federal Circuit reversed in 2010. A majority of the three-judge panel said Caraco lacked the statutory authority to assert its counterclaim, adding that the counterclaim provision covers only the patent number and expiration date.
On Tuesday, the high court was unanimous in its reversal.
“We cannot say that the counterclaim clause is altogether free of ambiguity,” Sotomayor wrote. “But when we consider statutory text and context together, we conclude that a generic manufacturer in Caraco’s position can use the counterclaim.”
“An overbroad use code therefore throws a wrench into the FDA’s ability to approve generic drugs as the statute contemplates,” she added. “So it is not surprising that the language Congress used in the counterclaim provision sweeps widely enough to embrace that filing.”
In a concurring opinion, Justice Sonia Sotomayor said “the counterclaim can only lessen the difficulties created by an overly broad use code; it cannot fix them.”
“In short, the counterclaim cannot restore the smooth working of a statutory scheme thrown off kilter by an overly broad use code,” she added. “At best, it permits the generic manufacturer to do what the scheme contemplates it should do – file an ANDA with a section viii statement – but only after expensive and time-consuming litigation. A fix is in order, but it must come from Congress or FDA.”