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In a case brought by a New Jersey-based pharmaceutical company, the U.S. Court of Appeals for the Federal Circuit ruled that private parties may not enforce unfair competition claims based on the Food, Drug and Cosmetic Act at the ITC—at least not until the Food and Drug Administration has provided guidance on the precise issue in dispute.

“Such claims are precluded by the FDCA,” Chief Judge Sharon Prost wrote in Amarin Pharma v. ITC.

The ruling decision is a win for the ITC, Dutch nutrition company Royal DSM N.V. and its counsel at Orrick Herrington & Sutcliffe. It's a split decision for the Justice Department and a loss for Bedminster-based Amarin Pharma Inc. and its King & Spalding counsel.

Prost also held in the May 1 decision that the ITC may decline to institute investigations when it determines a complaint fails to state a cognizable claim—notwithstanding statutory language that the commission “shall investigate any alleged violation of this section on complaint.”

Over Judge Evan Wallach's dissent, she further held that the Federal Circuit has jurisdiction to review such decisions declining to investigate, concluding that they amount to final decisions on the merits.

“The Federal Circuit's opinion recognizes that Amarin Pharma is attempting to evade and undermine the FDA's expertise and authority by misusing the resources of the International Trade Commission,” Royal DSM's counsel, Orrick, Herrington & Sutcliffe partner Mark Davies, said. “By holding that Amarin had no cognizable claim and affirming that the ITC may decline to institute an investigation when the FDA asks it to refrain from doing so, the Federal Circuit's opinion reflects careful consideration of the critical laws enacted by Congress to assure fair competition while keeping Americans safe.”

The case started in 2017 when Amarin asked the ITC to investigate Royal DSM's synthetically enhanced omega-3 products. Amarin contends they're “new drugs” that require FDA approval, such as Amarin has obtained. Instead, Royal DSM has falsely labeled them dietary supplements in violation of Section 337, the Lanham Act and the Food, Drug and Cosmetic Act, Amarin contends.

The FDA's chief counsel wrote to the ITC, saying Congress delegated to FDA the authority to determine whether products are new drugs or dietary supplements. “Any such findings by the commission on those issues may conflict with later determinations by FDA,” she wrote. The ITC obliged by declining to initiate an investigation.

King & Spalding partner Ashley Parrish argued to the Federal Circuit last year that Section 337's mandatory language required that the ITC investigate. “We have been thrown out of the commission,” Parrish said at the time.

Davies argued that the FDCA preempted the ITC from acting at least until the FDA has provided guidance. The ITC agreed. The Justice Department argued that the ITC can never get involved—that “Congress assigned to FDA, and FDA alone, the ability to enforce the FDCA.”

The Federal Circuit agreed that FDA must make the call in the first instance.

“Although Amarin presents its claims as violations of the Tariff Act, in reality those claims constitute an attempt to enforce requirements of the FDCA through the remedies provided under the Tariff Act,” Prost wrote. Therefore, Amarin failed to present a cognizable claim to the ITC.

The court didn't conclusively resolve whether Amarin could return to the ITC, once the FDA weighs in, but appeared to leave that door open.

Because Amarin's complaint failed to state a cognizable claim, the commission was within its rights to decline an investigation, Prost added. And because that declination was “intrinsically a final determination, i.e., a determination on the merits,” the Federal Circuit had jurisdiction to review the decision.

Wallach wrote in dissent that the Federal Circuit did not have appellate jurisdiction to review the case. “The ITC neither initiated an investigation, decided whether a violation of Section 1337 occurred, nor determined whether to issue an exclusion or cease-and-desist order,” he wrote. When the ITC declines to investigate, review should be only by petition for mandamus, he argued.

Prost replied that Wallach's approach elevates “form over substance.”

Ropes & Gray partner Matthew Rizzolo, who's not involved in the case, said the decision addresses a fact pattern that's been arising from time to time when pharma companies and others bring unfair-competition claims at the ITC. “This decision gives some valuable guidance to future litigants who may become involved in FDCA-related Section 337 actions,” he said.

More broadly, it clarifies that “the ITC does have discretion to decline to institute an investigation when the complaint does not state a Section 337 claim as a matter of law—but this non-institution decision is fully reviewable on appeal,” Rizzolo said.

ITC attorney Houda Morad defended the commission's decision before the Federal Circuit.  Joseph Busa argued for the Justice Department.