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Amarin asks Supreme Court to hear dispute involving omega-3 supplements

Amarin Pharma Inc. wants the nation’s highest court to hear a long-running dispute with several dietary supplement companies that the U.S. International Trade Commission (ITC) declined to investigate in 2017.

Amarin, the maker of the pharmaceutical drug Vascepa, filed a July 30 petition for a writ of certiorari with the U.S. Supreme Court after an appeals court affirmed ITC’s decision.

It’s Amarin’s last chance in the judiciary to compel ITC to investigate its complaint over the legality of certain “synthetically produced omega-3 products” promoted as dietary supplements, a category of products principally regulated by FDA.

A ruling by the Supreme Court could provide clarity over ITC’s authority to hear complaints involving unsettled issues within FDA’s expertise. A quasi-judicial federal agency, ITC has broad powers over matters of trade, including enforcement of the Tariff Act of 1930.

Representatives for FDA and ITC declined to comment on the petition.

“This case offers the Court an opportunity to restore the private rights of action that Congress granted parties under the Tariff Act of 1930 in order to protect domestic industry from unfair trade practices,” Amarin wrote in its 38-page petition through its outside counsel, Ashley C. Parrish of King & Spalding LLP.

Amarin’s grievances are with several prominent dietary supplement firms, including Nordic Naturals Inc., Nordic Pharma Inc., Pharmavite LLC, DSM Nutritional Products LLC and related DSM entities.

“We are disappointed that Amarin continues to pursue this issue, and we are confident that the U.S. Supreme Court will rule consistent with the ITC and the Federal Circuit Court rulings on this matter,” said Hugh Welsh, president of DSM North America, in an email.

Nordic Naturals, Nordic Pharma and Pharmavite did not immediately respond to requests for comment.

In its 2017 complaint, Amarin alleged the companies’ products above are unapproved new drugs under the Federal Food, Drug & Cosmetic Act (FDCA). Therefore, the false labeling of the products, Amarin argued, constituted an unfair act or method of competition under Section 337 of the Tariff Act of 1930 because the acts violate the Lanham Act and standards the FDCA established.

FDA asked ITC to refrain from an investigation because the agency hadn’t determined whether the products subject to the complaint were drugs or dietary supplements. And in June 2018, a U.S. Department of Justice (DOJ) attorney noted a guidance from FDA on the regulatory classification of these articles would not be forthcoming.

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Supreme Court Divided on Sales Taxes for Online Purchases

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A closely divided Supreme Court struggled on Tuesday to decide whether internet retailers should have to collect sales taxes in states where they have no physical presence.

Brick-and-mortar businesses have long complained that they are disadvantaged by having to charge sales taxes while many of their online competitors do not. States have said that they are missing out on tens of billions of dollars in annual revenue under a 1992 Supreme Court ruling that helped spur the rise of internet shopping.

By the end of arguments on Tuesday, it was not clear whether there were five votes to overrule the 1992 decision, Quill Corporation v. North Dakota, which said the Constitution bars states from collecting sales taxes from companies that do not have a substantial connection to the state.

Several justices expressed concerns about imposing crushing burdens on small businesses that sell goods on the internet and about making them liable for back taxes. Justice Sonia Sotomayor said the case before the court, South Dakota v. Wayfair, No. 17-494, raised “a host of questions” and “a whole new set of difficulties.”

Sounding almost plaintive, she added that Congress, rather than the Supreme Court, was the right forum in which to settle the matter.

“Is there anything we can do to give Congress a signal that it should act more affirmatively in this area?” Justice Sotomayor asked.

But Chief Justice John G. Roberts Jr. said that “it would be very strange for us to tell Congress it ought to do something in any particular area.”

Both he and Justice Elena Kagan said the fact that Congress has so far chosen not to act was itself a telling indication that it was satisfied with the current system.

The chief justice added that the marketplace may already be addressing the problem.

“The bigger e-commerce companies find themselves with a physical presence in all 50 states,” he said, “so they’re already covered.”

The tenor of the argument was a surprise, as three members of the Supreme Court had indicated that they may be ready to reconsider the Quill decision. Justices Clarence Thomas and Neil M. Gorsuch havewritten about their uneasiness with the ruling and the constitutional justifications for it.

Justice Gorsuch seemed prepared on Tuesday to reconsider the Quill decision. “Why should this court favor a particular business model?” he asked.

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