PMI Makes Case for IQOS at FDA

Philip Morris International met with the U.S. Food and Drug Administration on Nov. 5 to present its argument for why the multinational and Altria Group should be allowed to import and sell the IQOS tobacco-heating device in the U.S., reports CNBC.

According to a CNBC source, PMI told the FDA that IQOS is unique in its ability to transition smokers away from combustible cigarettes, which the company says are more harmful to health than tobacco-heating devices.

In late September, the International Trade Commission ruled that IQOS infringed on two of Reynolds’ patents. The Biden administration is conducting an administrative review until Nov. 29 to decide if the sale and import of the cigarette alternative will be banned.

During the FDA meeting, PMI reportedly argued that the ITC overstepped its bounds, given that the FDA is in charge of regulating which tobacco products can be sold.

The U.S. Trade Representative will make a recommendation to President Joe Biden after listening to input from a number of agencies, including the FDA, which regulates tobacco products.

If the administration sides with R.J. Reynolds in the dispute, IQOS could be off of U.S. shelves for months as it waits for a decision on a separate claim from Reynolds with the U.S. Patent and Trademark Office.

PMI has successfully defended similar cases in the U.K. and elsewhere. BAT has already pursued litigation over IQOS in Poland, the Czech Republic, Bulgaria, Romania and Greece and through the European Patent Office.

In the worst-case scenario for Altria and Philip Morris, the two companies would have to go back to the drawing board, moving production to the U.S. or changing up the design enough to avoid patent infringement claims.