Client Successes

Securing FDA Authorization for Innovative ENDS Products

Marshall Gerstein congratulates its client, Glas LLC, in securing multiple authorizations from the U.S. Food and Drug Administration (FDA) to market age-gated electronic nicotine delivery system (ENDS) products through the premarket tobacco product application (PMTA) pathway. The authorizations mark the first time the FDA permitted non-tobacco, non-menthol flavored ENDS products for sale in the United States.

Marshall Gerstein’s team, led by Sandip Patel, Matt Jorge, and Nick Terrell, counseled Glas and prepared and prosecuted several patents directed to the underlying technology that notably differentiated the Glas products from other ENDS products, including those that the FDA has denied marketing orders. The technology requires age verification using government-issued identification, Bluetooth pairing with a verified smartphone, and ongoing authentication measures to ensure use only by authorized adults.

Smoking is the leading preventable source of chronic disease and premature death in the United States. The FDA’s authorization of the Glas products therefore represents a significant milestone in the evolving regulatory framework for ENDS products. “By helping to prevent youth use, device access restrictions are a potential game changer,” said Dr. Bret Koplow, acting director of the FDA’s Center for Tobacco Products. The Glas “technology is also an indication of the role innovation may serve in the effort to protect young people from threats posed by nicotine use and addiction while helping to enable availability of an expanded array of flavored options for adults who smoke who may use these products to completely switch away from regular cigarettes.”

The FDA’s authorization is a significant result for our client. “We are very grateful for Marshall Gerstein’s assistance on this journey and the expertise you have shared to help us in achieving this milestone,” said Kevin Higgins, the Chief Operating Officer at Glas. “It is a fantastic outcome and we were very fortunate to have you all on our team.”

Marshall Gerstein Counsels CureVac through Global Resolution of Patent Litigation with Pfizer/BioNTech

Marshall, Gerstein & Borun LLP represented CureVac, a global biopharmaceutical company developing a new class of transformative medicines based on mRNA, in a high-profile intellectual property infringement lawsuit originally filed in June 2022. The case involved allegations that Pfizer and BioNTech’s COVID-19 variant-adapted vaccines, including those targeting the Omicron and XBB1.5 variants, infringed CureVac’s patents, including European Patent EP4023755 relating to split poly-A tail mRNA vaccines.

In May 2023, CureVac filed counterclaims in the U.S. asserting infringement of nine U.S. patents, later expanded to include a tenth patent (U.S. Patent No. 11,667,910), covering mRNA purification methods — a critical component of the mRNA manufacturing process.

In August 2025, it was announced that BioNTech and CureVac reached a global resolution. Under the terms of the agreements, CureVac and GSK will receive in aggregate a payment of $740 million as well as single-digit royalties on sales of COVID-19 vaccines in the United States going forward. Additionally, CureVac will receive $50 million from GSK for monetizing a portion of U.S. product royalties due under its existing license agreement announced on July 3, 2024.

The resolution resolved all pending U.S. and European litigation, including what would have been the first U.S. trial over COVID-19 vaccine patents. It was one of the most-watched biotechnology patent disputes in recent years.

Partner Mark H. Izraelewicz led CureVac’s U.S. litigation strategy, alongside a team at Marshall Gerstein, which included Kevin M. Flowers, John R. Labbé, Michael R. Weiner, Sandip H. Patel, Michael J. Allikian, Thomas R. Burns, Izabella N.C. Higson, Daniel Gonzalez, and Christopher J. Hall.

For more coverage, see the following articles:

CureVac's Patent Settlement: A Strategic Win for mRNA Innovation and Future Revenue Streams

GSK collects $320M as BioNTech, Pfizer settle mRNA patent spat with CureVac | Fierce Pharma

IPR Win for ACCO’s ClickSafe® Locks

Marshall Gerstein successfully represented ACCO Brands Corporation and ACCO Brands USA LLC in Inter Partes Reviews (IPR) before the Patent Trial and Appeal Board (PTAB), appeal of that decision to the U.S. Court of Appeals for the Federal Circuit, and in related infringement litigation in the Eastern District of New York, in which Think Products accused ACCO’s ClickSafe® line of computer locks of infringing two Think Products patents.

Marshall Gerstein petitioned for IPR of each asserted patent, arguing that the Think Products patents were obvious over combinations of prior-art references, and anticipated by a published video disclosing the accused ClickSafe® product.

In both IPRs, the PTAB ruled in favor of ACCO on all grounds of review, cancelling all challenged claims of the patents, and these decisions were upheld on appeal to the Federal Circuit.

Protecting Carbon-Capture Technologies

Marshall, Gerstein & Borun LLP obtained a successful result for CO₂ Solutions, Inc., in an Inter Partes Review (IPR) of one of CO₂Solutions’ patents covering its enzyme-based technology for capturing carbon dioxide from exhaust gas. The Patent Trial and Appeal Board (PTAB) at the U.S. Patent and Trademark Office ruled in favor of CO₂ Solutions on four of the five grounds of review, upholding CO₂Solutions’ commercially significant claims of the challenged patent.

CO₂Solutions’ proprietary carbon-capture technologies, as covered by the upheld patent claims and by other patents in CO₂Solutions’ portfolio, provide environmentally-friendly, efficient, and cost-effective methods for reducing carbon emissions. As stated by Evan Price, President and CEO of CO₂Solutions, “We believe this confirms CO₂Solutions’ possession of the least expensive and most environmentally friendly carbon capture technology available on the market.”

Sandip H. Patel, Partner