Altria and NJOY Respond to ITC Initial Determination in Complaint Against NJOY

Rhea-AI Summary

Altria Group, Inc. (NYSE: MO) and NJOY respond to an initial determination by the U.S. International Trade Commission (ITC) Administrative Law Judge regarding JUUL Labs' patent infringement complaint against NJOY. The judge recommended an exclusion order to prohibit NJOY ACE importation into the U.S. Altria and NJOY disagree with this determination and await the full ITC's final decision by December 23, 2024.

NJOY filed a similar complaint against JUUL in August 2023, with a hearing held in June 2024 and an initial determination expected in September. The parties are engaged in mediation to resolve these disputes. NJOY has also filed Substantial Equivalence Exemption requests with the FDA for a modified ACE product to avoid patent issues.

An exclusion order on ACE, the first FDA-authorized pod-based e-vapor product, could limit choices for adult smokers and impact public health efforts.

Positive

• NJOY ACE is the first pod-based e-vapor product and only pod-based menthol e-vapor product authorized by the FDA
• NJOY filed Substantial Equivalence Exemption requests with the FDA for a modified ACE product to avoid patent issues
• Parties are engaged in mediation to resolve patent disputes

Negative

• ITC Administrative Law Judge recommended an exclusion order prohibiting NJOY ACE importation into the U.S.
• Potential ban on NJOY ACE importation could limit FDA-authorized choices for adult smokers
• Patent infringement disputes with JUUL Labs could impact NJOY's market presence

Insights

Legal Expert

The ITC Administrative Law Judge's initial determination supporting JUUL's patent infringement allegations against NJOY is a significant development in the e-vapor industry. If upheld, the recommended exclusion order could severely impact NJOY's market presence by prohibiting ACE imports. However, this is not final, as NJOY will present its case to the full ITC, with a decision expected by December 23, 2024.

Interestingly, NJOY's counter-complaint against JUUL, seeking a similar import ban, adds complexity to the situation. The ongoing mediation and NJOY's FDA submission for a modified ACE product demonstrate proactive strategies to mitigate potential negative outcomes. These legal battles highlight the intense competition and intellectual property disputes in the e-vapor market, which could reshape industry dynamics and market share distribution.

Public Health Analyst

The potential exclusion of NJOY ACE from the U.S. market raises significant public health concerns. As the first pod-based e-vapor product and only pod-based menthol e-vapor product authorized by the FDA, ACE's removal would limit FDA-authorized choices for adult smokers seeking less harmful alternatives. This could potentially hinder tobacco harm reduction efforts and impact public health strategies aimed at transitioning smokers to potentially less harmful products.

The situation underscores the complex interplay between patent law, public health policy and tobacco harm reduction strategies. It also highlights the challenges in balancing intellectual property rights with public health objectives in the rapidly evolving e-vapor market. The outcome of this case could have far-reaching implications for the availability of FDA-authorized e-vapor products and the broader tobacco harm reduction landscape.

Financial Analyst

For Altria, the potential exclusion of NJOY ACE represents a significant business risk. NJOY is a key component of Altria's smoke-free portfolio and its strategy to transition beyond traditional smoking products. An exclusion order could substantially impact Altria's revenue diversification efforts and its position in the growing e-vapor market.

However, Altria's diversified portfolio, including leading positions in combustible cigarettes, smokeless tobacco and oral nicotine pouches, provides some financial buffer. The company's proactive approach, including mediation efforts and seeking FDA approval for a modified ACE product, demonstrates strategic agility. Investors should closely monitor the ITC's final decision and NJOY's counter-complaint against JUUL, as these outcomes could significantly influence Altria's market position and future growth prospects in the evolving tobacco industry landscape.

RICHMOND, Va.--(BUSINESS WIRE)-- Altria Group, Inc. (NYSE: MO) and its operating company NJOY today respond to the U.S. International Trade Commission (ITC) Administrative Law Judge’s (ALJ) initial determination regarding the patent infringement complaint JUUL Labs, Inc. (JUUL) filed against NJOY.

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 (ACE) into the United States.

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.

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 United States. 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 ACE from taking effect.

We continue to work to bring this issue to resolution. 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.

ACE is the first pod-based e-vapor product and the only pod-based menthol e-vapor product authorized by the FDA as appropriate for the protection of public health. An exclusion order banning the importation of ACE would severely limit FDA-authorized choices for adults and undermine public health.

Altria’s Profile

We have a leading portfolio of tobacco products for U.S. tobacco consumers age 21+. Our Vision is to responsibly lead the transition of adult smokers to a smoke-free future (Vision). We are Moving Beyond Smoking™, leading the way in moving adult smokers away from cigarettes by taking action to transition millions to potentially less harmful choices - believing it is a substantial opportunity for adult tobacco consumers, our businesses and society.

Our wholly owned subsidiaries include leading manufacturers of both combustible and smoke-free products. In combustibles, we own Philip Morris USA Inc. (PM USA), the most profitable U.S. cigarette manufacturer, and John Middleton Co. (Middleton), a leading U.S. cigar manufacturer. Our smoke-free portfolio includes ownership of U.S. Smokeless Tobacco Company LLC (USSTC), the leading global moist smokeless tobacco (MST) manufacturer, Helix Innovations LLC (Helix), a leading manufacturer of oral nicotine pouches, and NJOY, LLC (NJOY), an e-vapor manufacturer with a commercialized product portfolio fully covered by marketing granted orders from the U.S. Food and Drug Administration (FDA).

Additionally, we have a majority-owned joint venture, Horizon Innovations LLC (Horizon), for the U.S. marketing and commercialization of heated tobacco stick products.

Our equity investments include Anheuser-Busch InBev SA/NV (ABI), the world’s largest brewer, and Cronos Group Inc. (Cronos), a leading Canadian cannabinoid company.

The brand portfolios of our operating companies include Marlboro®, Black & Mild®, Copenhagen®, Skoal®, on!® and NJOY®. Trademarks related to Altria referenced in this release are the property of Altria or our subsidiaries or are used with permission.

Learn more about Altria at www.altria.com and follow us on X (formerly known as Twitter), Facebook and LinkedIn.

Forward-Looking and Cautionary Statements

This release contains certain forward-looking statements that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to the status of currently pending litigation and regulatory filings, which are inherently subject to risks and uncertainties, and we cannot predict the timing or outcome of any litigation or regulatory filing. Factors that could cause actual results to differ materially from those contained in, or implied by, the forward-looking statements included in this release include uncertainty and delays with respect to pending or future litigation proceedings and regulatory review timelines, and unfavorable outcomes with respect to such litigation proceedings or regulatory reviews, among others. Other risk factors are detailed from time to time in our publicly filed reports, including our Annual Report on Form 10-K for the year ended December 31, 2023. These forward-looking statements speak only as of the date of this release. We assume no obligation to provide any revisions to, or update, any projections and forward-looking statements contained in, or implied by, this release.

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Source: Altria Group, Inc.

FAQ

What is the ITC's initial determination regarding JUUL's complaint against NJOY?

The ITC Administrative Law Judge recommended an exclusion order that would prohibit the importation of NJOY ACE into the United States, supporting JUUL's patent infringement allegations.

When is the full ITC expected to issue a final decision on the JUUL vs. NJOY case?

The full ITC is expected to issue a final decision by December 23, 2024.

Has NJOY filed any counter-complaints against JUUL?

Yes, NJOY filed a similar patent infringement complaint against JUUL with the ITC in August 2023, seeking a ban on the importation and sale of JUUL products in the United States.

What steps is NJOY taking to address the patent issues with its ACE product?

NJOY has filed Substantial Equivalence Exemption requests with the FDA to market an already-developed ACE product with minor modifications that they believe avoid three of the four JUUL patent claims at issue.

How might an exclusion order on NJOY ACE affect Altria's stock (MO)?

An exclusion order banning the importation of NJOY ACE could potentially impact Altria's stock (MO) by limiting the company's presence in the e-vapor market and affecting its smoke-free product portfolio.