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Tobacco Patent War May Lead to a U.S. Ban of IQOS

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An intellectual property claim by RJ Reynolds could shut down United States sales of Philip Morris International’s controversial IQOS product before PMI’s partner Altria is able to launch the device on a national scale. IQOS is currently sold in a few test markets, including Atlanta and Richmond.

IQOS is a heated tobacco product (HTP—sometimes called heat-not-burn or HNB). Unlike e-liquid-based vapes, it heats actual tobacco until a vapor is produced. IQOS has been sold since 2014 in many Asian and European countries. American tobacco giant Altria is licensing IQOS from PMI for sale in the U.S. Other tobacco companies have their own HTPs, including British American Tobacco (glo) and Japan Tobacco (Ploom).

Reynolds American (RAI, or RJ Reynolds), a subsidiary of British American Tobacco (BAT), says that IQOS infringes its HTP patents, and is asking the U.S. International Trade Commission (ITC) to block future imports of the product. The two companies have also traded lawsuits in a Virginia federal court.

“BAT’s attempt to secure an importation ban against IQOS in the U.S. is part of a broader global strategy meant to undermine the heated-tobacco segment, where they lag far behind, and protect their core cigarette business,” PMI said in a statement.

The ITC represents the public in the ongoing ITC trial, and has indicated support for two of Reynolds’ patent claims, according to Bloomberg. A final decision by the ITC judge will be made by September. If IQOS is ordered off the market, the action will take effect in November.

IQOS has been approved for sale in the U.S. through both the FDA through both the Premarket Tobacco Application (PMTA) and Modified Risk Tobacco Product (MRTP) pathways, meaning that the agency has determined the product is "appropriate for the protection of public health.". BAT and Reynolds are not currently selling any HTP products in the U.S., and it is unclear if a PMTA has been submitted for BAT's glo device.

RJ Reynolds launched the first primitive HTP, called Premier, in 1988 (it was withdrawn a year later), and tried again a few years later with Eclipse, which remained on the market for nearly two decades, but achieved little success.

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