Mart 2024
The US International Trade Commission (ITC) decided to lift the IQOS importation ban1 following the global patent infringement settlement between British American Tobacco (BAT) and Philip Morris International (PMI). Accordingly, there is no regulatory or legal hurdle left for PMI to launch IQOS in the US as of May 2024.
February 2024
The global patent infringement settlement between BAT and PMI (that resolves all ongoing patent infringement litigation between the parties related to heated tobacco and vapour products) removed a key hurdle for IQOS3 launch in the USA. The Settlement Agreement is valid for a term of eight years from February 1, 2024 and comes just three months ahead of the expected US launch date (May 2024).
October 2023
PMI submitted PMTAs (seeking right to market) and MRTP Applications (seeking reduced exposure claim) to the US FDA for three IQOS ILUMA devices and five TEREA heated tobacco stick variants. PMI has 8 granted marketing orders (PMTA approvals) so far and is applying for 8 new ones (- see the summary below).
However, PMTA process is not the only bottleneck for PMI to launch IQOS in the USA. We expect BAT to request removal of IQOS 3 from the market (on the basis that IQOS 3 is infringing BAT’s granted patents) as soon as PMI launches IQOS 3 in the USA.
BAT is likely to be successful in this request. As the USA applies a more liberal approach of novelty and inventive step (non-obviousness) in the interpretation of patents, it is more difficult for PMI to invalidate BAT granted US patents. PMI needs to find a solution in order to launch IQOS in the US on permanent basis – either by reaching an agreement with BAT or by gaining a (PMTA) marketing order for IQOS ILUMA (at the moment of writing, not a subject of patent infringement).
Background: Philip Morris International vs. BAT
In September 2021, the US International Trade Commission (ITC) barred PMI and Altria from importing and selling IQOS in the US. The decision was the result of a patent case filed by BAT/Reynolds. The trade agency found that IQOS infringed on two of Reynolds’ patents. The import and sales ban took effect after the 60-day review deadline passed without any action by the Biden Administration to overturn the ITC’s order
In April 2023, the Federal Circuit affirmed the ban “on its entirety”, noting that an ITC notice in the Federal Register is enough to satisfy a statutory requirement to consult with the US FDA. In Sept 2023, PMI’s challenge to BAT/Reynolds’ (infringed) patent was defeated in a federal appeals court. On both occasions, PMI lost the bid to flip the IQOS ban.
BAT also accused PMI of infringing its patent for induction heating technology (IQOS ILUMA). The IP dispute trial was opened in London in September 2022.
Further Readings:
IQOS USA: Regulation & Taxation
References:
