Oct. 3, 2022 update
Oral arguments in PMI's appeal of the 2021 ITC decision to ban IQOS were heard today in a federal appeals court in Washington, D.C., according to Reuters.
The product has not been sold in the United States since the ITC ordered it off the market.
The U.S. International Trade Commission (ITC) has found that Philip Morris International’s IQOS heated tobacco product violates British American Tobacco patents, and therefore imports of the device to the United States are illegal. The ban will take effect in 60 days.
The ruling, which affirmed a preliminary decision from earlier this year, applies to imported devices sold within the U.S. The Biden administration’s U.S. Trade Representative could overrule the trade agency’s decision, but that happens rarely, according to Bloomberg News. The ITC supported BAT’s patent claims during the trial.
Altria is expected to file an appeal in the U.S. Court of Appeals, but the ban would remain in place until the appeals court decides the case, which could take up to a year. Another possible route for Altria/PMI, according to the Tobacco Reporter, would be to shift IQOS production to the U.S., since the decision only applies to imports. IQOS is manufactured in Europe and Asia.
IQOS has been authorized by the FDA for sale in the U.S. under both the Premarket Tobacco Application (PMTA) and Modified Risk Tobacco Product (MRTP) pathways. It has been sold here since 2019 in limited markets by Altria, which has licensed the product from PMI for U.S. sales. It is currently available only in Georgia, North Carolina, South Carolina and Virginia.
The ITC found that IQOS violates two patents held by Reynolds American Inc. (RAI—the former RJ Reynolds), which is now a subsidiary of international tobacco giant BAT. Since the IQOS dispute began, Reynolds and PMI/Altria have filed multiple lawsuits against each other in federal courts, both claiming infringement of various patents. BAT has also unsuccessfully challenged IQOS patents in European courts.
BAT sells its own HTP device, called glo, in Europe and Asia. The company announced in 2017 that it planned to submit marketing applications to the FDA for U.S. glo sales, but apparently never did.
Heated tobacco products (HTPs) heat tobacco to a temperature too low to combust but high enough to create a nicotine-containing vapor inhaled by the user. HTPs are sometimes called heat-not-burn (HNB) products.