When Can Biologic Patent Disputes Go Before the ITC?

Under which situations might the International Trade Commission (ITC) be the right choice for biosimilar patent disputes instead of federal district court?

A panel discussed these questions at the ACI 10th Summit on Biosimilars on Monday in New York City, although the panelists noted that as of yet, the administrative body, which oversees US trade laws, has yet to hear a case involving a biologic or biosimilar. In that respect, the conversation was largely theoretical, although all 3 panelists expect that to change in coming years.

The ITC has 2 remedies available to enforce Section 337 of the Tariff Act: an exclusion order to prevent the importation of articles into the United States, and a cease-and-desist order directed to US companies to prevent sales of items that are already in the country.

Most of the cases before the ITC, which are resolved more swiftly before the ITC than they would be in district court, generally relate to consumer goods.

The so-called 337 investigations are carried out by the United States, said moderator Jonathan Bachand, JD, a partner at Knobbe Martens, and involve trade secrets, trademark infringements, patent infringements, or “unfair methods of competition and unfair acts.”

Bachand said he could imagine a potential case in which an employee of a maker of a reference product leaves and goes to work for a biosimilar company, and the former employer believes that trade secrets where misappropriated.

Kevin S. Prussia, JD, a partner at Wilmer Cutler Pickering Hale and Dorr LLP, said questions could also be raised in situations involving “skinny” labeling, wherein a biosimilar product seeks a narrower indication that what is approved on the original reference product.

Another way an ITC proceeding could be used is as a complement to a district court proceeding, Prussia said, given the timing of the patents involved.

“There’s this sweet spot between getting a decision on your patents quickly to incentivize a biosimilar to launch,” he said. But he said he doesn’t see the ITC being a substitute for district court litigation.

A type of case that cannot be brought before the ITC, however, is demonstrated in the Amarin case, Bachand said, where a party cannot attempt to use it as a “private enforcement action.” Earlier this year, the ITC refused to back Amarin Pharma’s claim alleging that the import and sale of certain omega 3 fish oil products constituted unfair competition because they were unlawfully labelled and marked as “dietary supplements” but were in fact “new drugs.”

Amarin makes Vascepa, a high-dose fish oil pill that it is seeking approval of supplemental New Drug Application after trial results showed that it cut cardiovascular events.

The ITC determined the Section 337 claims were precluded by the Food, Drug and Cosmetic Act (FDCA) and required a determination of whether the products at issue violated the FDCA.

Importation of products is one of the necessary requirements in order to have standing before the ITC. Companies may also try to prove “imminent importation” (for example, showing that a company is having discussions or trying to seed a new market with their product).

Bachand asked the panel to consider what is a good timeframe for going to the FTC.

Paul Atkinson, JD, a director at Sterne Kessler, said the release of the180-day notice might be 1 such point in time at which to consider a filing; earlier than that might raise questions, he said.

One of the factors the ITC considers is public interest. There are 4 ways the ITC can consider the public interest as a limit in exclusion orders, Prussia said; this is the area where it is possible that biosimilars could potentially demonstrate a public interest factor:

• Public health and welfare
• Competitive conditions in the US economy
• Production of like or directly competitive articles in the United States
• Effect on US consumers

However, parties should be judicious in deciding which claims to assert before the ITC, Bachand said.

In addition, the filing and/or start of an inter partes review will not delay an ITC investigation, he noted.