Should the International Trade Commission investigate complaints about allegedly falsely labeled drugs imported into the United States, or does the Food and Drug Administration have exclusive jurisdiction?
The U.S. Court of Appeals for the Federal Circuit wrestled with that issue Friday, and it didn’t get much help from government lawyers representing the two agencies, who were unable to unite behind a single theory.
“I am once again reminded of Pogo saying we have met the enemy and he is us,” Judge Evan Wallach joked during arguments in Amarin v. ITC.
Amarin has attracted interest around the FDA and ITC bars because it tests the limits on each agency’s jurisdiction. A Department of Justice lawyer told the Federal Circuit the ITC can never investigate complaints that require interpreting the Food, Drug and Cosmetic Act. An ITC attorney said that once the FDA has rendered its interpretation, the ITC can then adjudicate private party actions.
The case started last August when New Jersey biopharma Amarin Corp. asked the ITC to investigate Dutch competitor Royal DSM’s synthetically enhanced omega-3 products. Amarin contends they’re “new drugs,” and they don’t have FDA approval like Amarin’s product. Instead, they’ve been falsely labeled dietary supplements in violation of §337, the Lanham Act, and the Food, Drug and Cosmetic Act, Amarin contends.
FDA chief counsel Rebecca Wood wrote to the ITC in October, 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 for Amarin on Friday that §337 uses mandatory language. It states that “the commission shall investigate any alleged violation of this section on complaint under oath or upon its initiative.”
“We have been thrown out of the commission,” Parrish said. “There is no remedy for us to address the violations of 337 and the Lanham Act.”
Chief Judge Sharon Prost suggested he might not have recourse at the Federal Circuit either. Because the ITC took no action, the Federal Circuit may lack appellate jurisdiction, she said.
Parrish pointed out that the ITC has conceded the Federal Circuit has at least mandamus authority to review the case.
“The government’s decisions on reviews of jurisdiction don’t necessarily compel us to have the same views,” Prost replied.
Orrick Herrington & Sutcliffe partner Mark Davies argued for Royal DSM that an FDCA violation “is not something that the ITC should be looking at.” As for the word “shall” in §337, it’s qualified by the phrase “upon its initiative,” which makes it less than compulsory, Davies said.
“Well, you can tell the Supreme Court that ‘shall’ means ‘may’ and not ‘must,’ but I’m a little scared to try to do that,” Prost quipped. She was referring to the high court’s April decision in SAS Institute v. Iancu, in which the justices held that the use of “shall” in the America Invents Act strictly limits PTO discretion over patent validity challenges.
ITC attorney Houda Morad staked out a middle ground, saying the ITC is barred from ruling on FDCA issues in the first instance, but not after the FDA has spoken.
Judge Todd Hughes seemed comfortable with that position. That way, a company such as Amarin could “first go to the FDA and get a determination that these products are drugs, and then come to you and say they’re being improperly labeled as supplements.”
But Justice Department attorney Joseph Busa, appearing as amicus curiae, disagreed. “It takes difficult scientific and technical judgments as well as deep knowledge of the FDA and its regulations” to decide such issues, he said. “That’s why Congress assigned to FDA, and FDA alone, the ability to enforce the FDCA.”
Prost seemed to think the government had pulled a bait and switch. “Don’t you think the implication of what was told to us in the briefs or in the [FDA] letter suggested otherwise?” she asked.
Hughes also sounded skeptical. The ITC can’t exclude the imports “even if the FDA says this is a drug, and they continue to try to bring it in marked as a supplement?” he asked.
Davies, Royal DSM’s lawyer, emphasized that there’s no disagreement between the two agencies at present. “We have the FDA saying they would like to investigate,” he said. “We have the ITC saying, ‘We agree, you’re a better place to investigate.’ The ITC does the IP work, doesn’t do FDCA work.”
Ropes & Gray counsel Matthew Rizzolo, who’s not involved in the case, said the ruling could have big impact. “If the court does get to the merits—which seems like far from a foregone conclusion—this case could potentially make the ITC a much more attractive forum for commercial litigation,” he said. “A ruling in favor of Amarin might open up the ITC not just to FDCA-related claims, but lead to more creative Section 337 unfair competition claims based on a variety of legal theories.”