European Patent Office Invalidates Moderna’s mRNA Patent: A Dive into the Ongoing Patent Warfare

The latest twist in the saga of patent battles surrounding mRNA technology has unfolded as the European Patent Office (EPO) rendered a pivotal decision, invalidating a crucial patent held by Moderna, a prominent figure in the domain of COVID-19 vaccines.

The patent in question, fiercely contested by several biopharma entities, including Moderna’s competitors Pfizer, BioNTech, and Sanofi, pertains to betacoronavirus vaccines utilizing RNA polynucleotides encoding viral antigens. While primarily targeted at COVID-19 vaccines, the patent claims encompass protection for combatting other viral respiratory infections such as MERS and SARS.

The Patent Dispute

The European Patent Register outlines the scope of the contentious patent, elucidating its claims and the subsequent challenges mounted against it. Notably, BioNTech, in response to the EPO’s decision, welcomed the ruling, asserting that patents like Moderna’s fail to meet the necessary requisites for granting a patent.

In a contrasting stance, Moderna expressed disagreement with the EPO’s verdict and announced intentions to appeal within the stipulated two-month window. This decision marks the latest chapter in an ongoing legal tussle over mRNA technologies integral to COVID-19 vaccine development.

A Prolonged Legal Duel: The Timeline of Patent Warfare

The skirmish over mRNA patents traces its roots to August 2022 when Moderna initiated lawsuits against Pfizer and BioNTech, alleging infringement on patents fundamental to mRNA technology underpinning their Comirnaty vaccine. Emphasizing a commitment to not enforce these patents across numerous low- and middle-income countries, Moderna’s legal actions mirrored the intensity of the race for vaccine supremacy.

In a countermove, Pfizer and BioNTech retaliated in December 2022, filing a countersuit seeking dismissal of Moderna’s initial lawsuit. The battleground extended to the U.S. Patent and Trademark Office in August 2023, where Pfizer and BioNTech launched efforts to invalidate Moderna’s patent protections.

The Substantive Argument: The Essence of the Dispute

At the heart of this dispute lies an 87-page petition by Pfizer and BioNTech, disputing the breadth of Moderna’s patents, asserting that they lay claim to pre-existing knowledge predating the patent’s priority date in 2015. The partners vehemently argue that the application of injected mRNA for inducing protein production traces its roots back to scientific practices from the 1990s. They further contend that Moderna’s patents unduly monopolize the entire realm of mRNA technology.

Looking Ahead: Implications and Future Actions

The reverberations of the EPO’s decision are yet to unfold fully. Moderna’s intention to appeal denotes a protracted legal battle ahead, casting a shadow on the future trajectory of mRNA patent disputes within the pharmaceutical landscape.

The evolving narrative underscores the complex interplay between scientific innovation, intellectual property rights, and corporate rivalry, thereby prompting close scrutiny by patent experts and legal practitioners alike.

Key takeaways

The annulment of Moderna’s mRNA patent by the European Patent Office signifies a pivotal moment in the protracted legal skirmish over COVID-19 vaccine-related patents. As legal battles intensify and key players maneuver within the intricate web of patent law, the implications of these decisions reverberate across the biopharmaceutical landscape, shaping the contours of innovation and intellectual property protection in the realm of mRNA technologies.