An administrative law judge (AJL) of the International Trade Commission (ITC) has recommended a ban on importing Njoy Ace products into the United States following a patent-infringement claim filed by Juul Labs.
Ace is the first pod-based vapor product and the only pod-based menthol vapor product authorized by the U.S. Food and Drug Administration as appropriate for the protection of public health. According to Njoy parent company Altria Group, an exclusion order banning the importation of Ace would severely limit FDA-authorized choices for adults and undermine public health.
“Altria and NJOY respectfully disagree with the ALJ’s initial determination, and Njoy looks forward to presenting its position to the full ITC, which is expected to issue a final decision by December 23, 2024,” Altria Group wrote in a statement.
In August 2023, Njoy filed a similar, independent patent infringement complaint against Juul with the ITC seeking a ban on the importation and sale of Juul products in the U.S. A hearing before the ALJ was held in June 2024, and an initial determination is expected in late September. A positive outcome in this case would not preclude an exclusion order against Njoy Ace from taking effect.
“We continue to work to bring this issue to resolution,” Altria wrote in its statement. “The parties have engaged with a mediator to attempt to negotiate a resolution of these disputes. In addition, Njoy recently filed substantial equivalence (SE) exemption requests with the FDA to allow Njoy to market an already-developed Ace product with minor modifications that we believe avoid three of the four Juul patent claims at issue in the case.”