Healthier Choices Management Corp. v. Philip Morris USA, Inc., No. 22-1268 (Fed. Cir. 2023)
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HCM sued Philip Morris for allegedly infringing at least one claim of HCM’s patent, which is directed to an electronic nicotine-delivery device. Philip Morris manufactures the IQOS electronic nicotine-delivery system, which “heats tobacco-filled sticks wrapped in paper [HeatSticks] to generate a nicotine-containing aerosol.” Philip Morris markets IQOS as a “heat-not-burn” system; the tobacco is heated at a low enough temperature that the tobacco does not burn, therefore, in Philip Morris’s view, preventing combustion.
Philip Morris argued that an exhibit HCM attached to its original complaint conclusively demonstrated that IQOS does not initiate a combustion reaction as required by the asserted claims. The district court agreed that a Modified Risk Tobacco Product Application that Philip Morris submitted to the FDA when it sought a modified risk order to sell IQOS established that IQOS did not initiate a combustion reaction and thus did not infringe the asserted claims. The court granted Philip Morris attorneys’ fees under 35 U.S.C. 285.
The Federal Circuit reversed. HCM’s original and amended complaints recite sufficient allegations to raise a facially plausible case of patent infringement and specifically rejected the notion that IQOS does not initiate a combustion reaction.
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