Tobacco company Altria on Tuesday responded to the U.S. International Trade Commission (ITC) administrative law judge’s (ALJ) initial determination regarding the patent infringement complaint Juul Labs Inc. filed against Njoy.
Richmond, Virginia-based Altria acquired the e-vapor company Njoy, whose products are now distributed by Altria Group Distribution Co., in June 2023.
“Last week, the ALJ provided notice of her initial determination supporting Juul’s allegations in its complaint and recommending an exclusion order that would prohibit the importation of Njoy Ace into the United States,” Altria said in a statement on Aug. 27.
The tobacco company said it “respectfully” disagrees with the ALJ’s initial, determination, and Njoy will present its position to the full ITC, which is expected to issue a final decision by December 23.
In 2023, Washington, D.C.-based Juul Labs filed complaints against Njoy alleging its Njoy Ace e-cigarette device infringes on several patents of Juul Labs.
Altria subsidiary Njoy filed a similar complaint last year against Juul Labs with the ITC. A hearing before the ALJ was held in June, and an initial determination is expected the end of September, Altria said. The tobacco company said a “positive outcome in this case would not preclude an exclusion order against Ace from taking effect.”
“We continue to work to bring this issue to resolution,” Altria said. “The parties have engaged with a mediator to attempt to negotiate a resolution of these disputes.”
Njoy recently filed substantial equivalence (SE) exemption requests with the Food and Drug Administration (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,” Altria said.
In June the FDA issued marketing granted orders to Njoy for four menthol-flavored e-cigarette products: Njoy Ace Pod Menthol 2.4%, Njoy Ace Pod Menthol 5%, Njoy Daily Menthol 4.5% and Njoy Daily Extra Menthol 6%. The announcement marks the first non-tobacco flavored e-cigarette products to be authorized by the FDA.
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