Tag: litigation

  • SMOK Files Appeal of FDA’s Marketing Denial Orders

    SMOK Files Appeal of FDA’s Marketing Denial Orders

    SMOK’s factory

    One of the oldest MOD makers in the vaping industry has filed an appeal of the U.S. Food and Drug Administration’s marketing denial orders for six of the company’s open-system vaping devices.

    China-based Shenzhen IVPS, the parent to SMOK brand vaping devices, filed the appeal after with the New Orleans, Louisiana-based U.S. Court of Appeals for the Fifth Circuit, and was joined in the suit by a Dallas, Texas-based distributor of the SMOK products that were denied marketing.

    The FDA claimed that it had issued the MDOs for the premarket tobacco product applications (PMTAs) for the SMOK products because the applications “failed to provide sufficient data to characterize constituent delivery, product stability, and product abuse liability.” The agency also stated that SMOK failed to provide a specific e-liquid and consumers could use any e-liquid in the devices.

    Shenzhen IVPS strongly challenges those assertions, as the company “invested more than $30 million in its applications, which totaled well over 600,000 pages in all, and collaborated with the world’s leading laboratories to conduct robust harmful and potentially harmful constituent aerosol testing, in vitro toxicology testing and toxicological analysis, accelerated and 24-month storage and stability testing, and rigorous clinical pharmacokinetic studies to test the products’ potential abuse liability profiles,” according to a press release.

    Welfer Ouyang, Shenzhen IVPS CEO, said he was “very concerned” that the agency issued marketing denial orders on open-system devices that are sold without any nicotine-containing e-liquid.

    “FDA is using isolated data from testing of the devices with e-liquid formulations that the products’ instruction manuals specifically warn are not compatible with these devices, and ignoring the overwhelmingly positive toxicological and safety profile of these products,” said Ouyang.

    On Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting PMTAs of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.

    The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.

    The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.

  • Judge Grants Stay for Multnomah County Flavor Ban

    Judge Grants Stay for Multnomah County Flavor Ban

    Credit: Stock Pics

    Multnomah County’s flavored tobacco ban is now on hold.

    The flavor ban in the largest county in Oregon was set to go into effect on Jan. 1.

    In a ruling Friday, the Oregon Court of Appeals issued a temporary stay against the policy, pending ongoing litigation.

    The owner of a local vape shop said they were preparing to pull dozens of products off their shelves before getting the news.

    He said flavored products make up 90% of their business, according to KATU news.

    “It was going to be a trip. Like I’d have zero nicotine devices available, but again, those aren’t like a popular seller, so it was going to take some strategy to even to be able to stay in business,” said Marcus Nettles, owner of Rose City Vapers.

  • Dunkin Suing Vape Company for Trademark Violation

    Dunkin Suing Vape Company for Trademark Violation

    Credit: Alan

    Doughnut chain Dunkin’ sued an e-cigarette maker in New York federal court on Friday, claiming its “Vapin’ Donuts” products violate the chain’s trademark rights.

    The lawsuit said Singh Handicraft Corp uses branding that is “nearly identical” to Dunkin’s on disposable vaporizers shaped like an iced coffee cup and a glazed doughnut, with a logo in the same “distinctive orange and pink color scheme and rounded font,” Reuters reports.

    Massachusetts-based Dunkin’ also said that Singh sells the vaporizers in identical flavors to some of the chain’s drinks, including White Mocha and Iced Cappuccino. It accused Farmingdale, New York-based Singh of intentionally associating its products with Dunkin’ in a way that is likely to cause consumer confusion.

    Representatives for Dunkin’ and Singh did not immediately respond to requests for comment on the lawsuit.

    The complaint said that Singh’s products are sold through several online and brick-and-mortar vaping outlets. It said buyers of the e-cigarettes have “expressed that the only reason they purchased Defendants’ products is out of an affection for Dunkin’,” citing internet comments.

    Dunkin’ also accused Singh of targeting underaged buyers and said that such “morally reprehensible and illegal conduct” hurts the chain’s reputation.

    Dunkin’ asked the court for an order to stop Singh’s alleged trademark infringement and an unspecified amount of money damages.

    Singh applied for a federal trademark covering “Vapin’ Donuts” in March. Its application is still pending.

  • Amicus Brief Supports Limiting ‘Chevron Deference’

    Amicus Brief Supports Limiting ‘Chevron Deference’

    Image: Tobacco Reporter archive

    Keller and Heckman has filed an amicus brief with the U.S. Supreme Court on behalf of members of the electronic nicotine-delivery system (ENDS) industry in support of petitioners in a case to overturn or limit the so-called Chevron deference.

    Named after a landmark Supreme Court decision dating from 1984, the Chevron deference is a legal doctrine that generally requires courts to defer to an administrative agency’s interpretation of ambiguous statute so long as that interpretation is reasonable. 

    In practice, Chevron deference often gives agencies broad leeway to reach beyond the limits of a statute’s plain language, often bypassing the rulemaking process otherwise required under the Administrative Procedure Act and making it more difficult to challenge an agency action in court.

    In the years since ENDS became subject to Food and Drug Administration regulation, the vast majority of courts reviewing ENDS industry challenges to premarket application denials, as well as FDA rulemakings and guidance documents, have rubber-stamped the agency’s interpretation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the “appropriate for the protection of the public health” standard, Keller and Heckman wrote on its blog.

    Critics contend that the Chevron deference has enabled the FDA to impermissibly interpret the TCA to implement a de facto ban on all nontobacco-flavored ENDS products without any requisite notice and comment rulemaking or congressional amendments to the TCA.

    The filers on the amicus brief urge the Supreme Court to at least restrict the application of Chevron deference so that it is the exception, not the rule. The Supreme Court will hear oral arguments in the case in its fall 2023 term.

    The petition to overturn or limit the Chevron deference was brought by a group of fishing companies challenging the National Marine Fisheries Service’s construction of the Magnuson-Stevens Act to require the industry to pay the salaries of federal monitors.

    The ENDS industry amici include the American Vaping Manufacturers Association, the American Vapor Group and Bidi Vapor.

  • U.S. Court Grants Stay of Reynolds Menthol MDOs

    U.S. Court Grants Stay of Reynolds Menthol MDOs

    scales of justice
    Credit: Sang Hyun Cho

    The U.S. Court of Appeals for the Fifth Circuit has granted an administrative stay of a U.S. Food and Drug Administration marketing denial order (MDO) for two R.J. Reynolds Vapor Co. menthol flavored refill pods.

    The order was granted as a temporary stay pending a motion to file a stay with the court by Feb. 1, 2023.

    On Jan. 24, the FDA denied marketing applications for two menthol refills used in Vuse Vibe and Vuse Ciro vaporizers, which are sold in the U.S. by BAT subsidiary R.J. Reynolds. According to the agency, Reynolds’ applications presented insufficient evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.

    British American Tobacco said on Jan. 25 that it intended to appeal the MDO for its Vuse Vibe Tank Menthol 3.0% and Vuse Ciro Cartridge Menthol 1.5%, the company announced in a statement.

  • Two Tobacco Firms Allowed to Sue for EU Flavor Ban

    Two Tobacco Firms Allowed to Sue for EU Flavor Ban

    The Four Courts Building on the river Liffey in Dublin, Ireland (Credit: Nigel)

    Two manufacturers of next-generation tobacco products have been granted permission by Ireland’s High Court to bring a challenge over a new EU directive banning flavored heated tobacco products.

    Ireland is set to transpose the new EU law by next July. But the country’s oldest tobacco manufacturer, PJ Carroll and Co., along with BAT-owned next-generation nicotine firm, Nicoventures Trading, claim the EU directive is invalid. Their challenge is against the Minister for Health, Ireland and the Attorney General.

    Under previous regulations, flavored heated tobacco products were not banned, but this was changed by the EU Commission which wants member states to transpose the ban by July 23rd, according to Breaking News Ireland.

    In 2021, PJ Carroll, which currently holds 10 percent of the Irish market for e-cigarettes, says it began taking steps to commercialize heated tobacco products in Ireland, including flavored ones.

    However, the company says, the banning of these products by the EU severely undermined its “ability to capitalize fully on the unique opportunity of being the first company to launch heated tobacco products on the Irish market for adult smokers who would otherwise continue to smoke.”

  • Reynolds Hit with $95 Million Verdict in Vapor Patent Dispute

    Reynolds Hit with $95 Million Verdict in Vapor Patent Dispute

    Photo: New Africa

    A jury in the U.S. District Court for the Middle District of North Carolina awarded Altria Client Services more than $95 million after finding that Reynolds Vapor Co.’s Vuse Alto e-vapor product infringed three Altria patents.

    The jury awarded $95.23 million in past damages through June 30, 2022. Post-trial proceedings will address ongoing damages through the expiration of Altria’s patents in 2035. At trial, Altria urged the jury to find a royalty rate of 5.25 percent, which the jury accepted in returning its award of past damages.

    “Patents are at the core of innovation, and we take very seriously protecting our intellectual property,” said Murray Garnick, executive vice president and general counsel of Altria, in a statement. “We are pleased that the jury recognized the importance of Altria’s innovation and the value of its patent rights.”

    At issue in this case were three patents awarded to Altria Client Services by the U.S. Patent and Trademark Office based on filings dating back to April 2015. The jury found that Reynolds Vapor violated Altria’s patents covering the pod assembly used in Vuse Alto.

    The case is Altria Client Services vs. Reynolds Vapor Company et al.

  • Court Denies Stay of Fontem’s Marketing Denial Order

    Court Denies Stay of Fontem’s Marketing Denial Order

    Fontem US had its request for an emergency motion for a stay of its marketing denial order (MDO) denied by the United States Court of Appeals for the District of Columbia. The court denied the stay mainly because Fontem waited too long to file the motion. The denial was filed July12.

    Fontem Ventures, a subsidiary of Imperial Brands PLC and parent to Fontem US, owns the global e-cigarette brand blu. The ruling means that legally, Fontem should have to pull its Myblu products from store shelves that received MDOs from the FDA while the appeal of its MDO goes through the legal process.

    “Fontem has demonstrated that the marketing denial order is causing it harm, but by waiting more than two months after the marketing denial order’s issuance to seek emergency relief, Fontem weakened its claim of irreparable harm,” the court wrote. “That delay also suggests it may have been practicable to seek a stay from the agency.”

    The court stated that Fontem “has not made a strong showing” that it is likely to succeed in its appeal of the MDO issued by the U.S. Food and Drug Administration on merits, noting that as to the multiple bases for the MDO identified by the FDA, the agency likely afforded Fontem fair notice.

    “Fontem US, LLC has not satisfied the stringent requirements for a stay pending court review,” the court wrote.

    The FDA issued MDOs to several myblu brand products manufactured by Fontem US. Tobacco and vaping products subject to a negative action regarding a premarket tobacco product application (PMTA) submission, including those subject to an MDO, may not be offered for sale, distributed or marketed in the US. 

    “On April 8, FDA issued MDOs to Fontem US, LLC for several myblu electronic nicotine-delivery system (ENDS) products after determining their applications lacked sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health,” the FDA stated in a release.

    Fontem’s appeal is expected to move forward and the court is requiring the case to be expedited
    and the following briefing schedule is to apply:

    • Petitioner’s Brief August 10, 2022
    • Respondent’s Brief September 9, 2022
    • Petitioner’s Reply Brief September 30, 2022
    • Deferred Appendix October 7, 2022
    • Final Briefs October 14, 2022

    “The Clerk is directed to calendar this case for oral argument on the first appropriate date following completion of briefing. The parties will be informed later of the date of oral argument and the composition of the merits panel,” the court wrote.

  • VPR Settles 3 More Patent Suits for Auto-Draw Technology

    VPR Settles 3 More Patent Suits for Auto-Draw Technology

    Illustration: VPR Brands

    XL Vape, VGOD and Saltnic have agreed to pay VPR brands $155,000 to settle patent-infringement litigation related to VPR’s auto-draw technology, according to a press release. As part of the deal, VPR brands has granted each of the companies a non-exclusive license to practice the invention set forth in the disputed intellectual property.

    Dating from 2009, U.S. patent 8,205,622 covers electronic cigarette products containing an electric airflow sensor, including a sensor comprised of a diaphragm microphone. The sensor turns the battery on and off, and covers most auto-draw, button less e-cigarettes, cig-a-likes, pod devices and vaporizers using an airflow sensor rather than a button. The technology is covered under electronic cigarette utility patent

    VPR Brands has started to identify and notify over 50 of the leading companies using its auto-draw technology. XL Vape, VGOD and Saltnic were prioritized based on their sales volumes and popularity.

    According to VPR Brands, most nicotine vaping devices sold in the U.S. today utilize an auto-draw/button-less technology. The company is investigating all button-less vape devices within the nicotine, CBD, and cannabis space that initiate vaporization from the user’s airflow inhalation as they would be suspect of infringement.

    The company says it may also seek a buyer for its patent in the future, citing the example of Ruyan, which in August 2013 sold its e-cigarette patent to Imperial Tobacco group for $75 million.

    VPR’s settlement with XL Vape, VGOD and Saltnic follows earlier settlements with Nepa 2 Wholesale and HQDTech, and PHD Marketing.

  • PMI Earns Wins Over Reynolds in HnB Patents Lawsuit

    PMI Earns Wins Over Reynolds in HnB Patents Lawsuit

    A Philip Morris International Inc. affiliate has earned two federal patent victories involving its heat-not-burn (HnB) technology dispute with Reynolds American Inc (RAI). A three-judge panel of the federal Patent Trial and Appeal Board said Wednesday it had determined as unpatentable all RAI Strategic Holdings Inc. claims for the “915” patent and claims 1 through 12 and 18 through 30 for the “542” patent.

    Credit: Bill Oxford

    The “915” patent “relates to smoking articles that employ an electrical heating element and an electrical power source to provide an inhalable substance in a vapor or aerosol form, without substantially burning or completely burning tobacco or other substances,” according to JournalNow.

    Meanwhile, the “542” patent “is directed to articles wherein tobacco, a tobacco derived material or other material is heated, preferably without significant combustion, to provide an inhalable substance … in a vapor or aerosol form.” The “542” patent is designed to create improvements and alternatives to “provide the sensations associated with cigarette, cigar, or pipe smoking, without delivering considerable quantities of incomplete combustion and pyrolysis products.”

    In both cases, the decisions are the final word from the board. However, those decisions can be appealed for review to the U.S. Court of Appeals for the Federal Circuit, which RAI has indicated it will pursue. According to federal law, a claim is unpatentable if “the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.”