#INTA2025

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Moderna mRNA Vaccine Claims Invalidated

– A Legal Battle with Potential Implications for Future mRNA Vaccine Development

Photo Credit: Spencer Davis

Without exaggeration, messenger ribonucleic acid (mRNA) vaccines can be considered a breakthrough development which during the COVID-19 pandemic turned Moderna’s, Pfizers’s, and BioNTech’s vaccines into household names. The benefits and the future potential of mRNA vaccine technology are undisputed and go far beyond the COVID-19 vaccines. Not surprisingly, vaccine developers attempt to obtain maximum protection for the intellectual property associated with their research efforts. While this may be in the interest of the owner of the intellectual property, it may impede related efforts by other players.

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Section 337 Recently: A Big Win for

Small Markets and U.S. Importers

Photo Credit: John Simmons

Almost a decade after its Lelo decision, the Court of Appeals for the Federal Circuit (“Federal Circuit”) clarified the domestic industry requirement of 19 U.S.C. § 1337 (“Section 337”), in favor of U.S. businesses against foreign infringers. In two recent decisions, the court explained that “small market segments can still be significant” and expenditures related to enterprise functions, like sales and marketing, are relevant to establish the existence of an industry, even in the absence of manufacturing practice.

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Trademark Genericness

and Time of Assessment

Photo Credit: Anthony Torres

The case of Bullshine Distillery LLC v Sazerac Brands LLC, focused on a critical issue in trademark law: the appropriate time period for assessing whether a mark was generic such that it could not be registered in the first instance. This issue, which was one of first impression, has significant implications for how trademarks are evaluated and protected. While the case also addressed the likelihood of confusion between Sazerac’s "FIREBALL" trademark and Bullshine’s proposed "BULLSHINE FIREBULL" mark, the primary focus was on the question of genericness and the timing of its assessment.

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Written Description Requirement of 35 USC 112 Applies to Preamble of Jepson-Format Claims

Photo Credit: Mari Helin

So-called “Jepson” claims have long been considered to be written in a high-risk claim format in U.S. patent practice. While they are more common in other jurisdictions and even encouraged in certain USPTO guidance, U.S. practitioners have traditionally avoided them due to their restrictive nature. A Jepson claim structure designates the preamble as admitted prior art, leaving only the limitations following "wherein the improvement comprises" to define the claimed invention. In In re Xencor, the U.S. Court of Appeals for Federal Circuit has amplified these risks by holding that the preamble of a Jepson claim must be supported by the same sufficient written description required under 35 U.S.C. § 112 for the invention itself. This decision significantly impacts patent applicants, as it effectively mandates disclosure of the inventive improvement as well as the admitted prior art content recited in the claim preamble.

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