Family Feud: mRNA Edition
Events Leading Up to the Current State
The biotech industry has seen a surge in patent disputes involving mRNA vaccine technology. GlaxoSmithKline (GSK) has filed lawsuits against Moderna, Inc., Pfizer, Inc., and BioNTech SE, alleging patent infringement related to mRNA technology and lipid nanoparticles used in their respective COVID-19 and RSV vaccines. GSK claims that its patents, acquired from Novartis in 2015, cover foundational mRNA technology dating back to 2008. Linked here is the complaint.
The rapid development and rollout of mRNA vaccines during the COVID-19 pandemic brought mRNA technology into the spotlight. Moderna, Pfizer, and BioNTech were among the leading companies that successfully developed and distributed mRNA vaccines, contributing significantly to global efforts to combat the pandemic. However, this success has led to increased scrutiny and legal challenges over the underlying technology.
Allegations Against GSK and Vice Versa
GSK alleges that Moderna's Spikevax (COVID-19 vaccine) and mResvia (RSV vaccine) infringe on several GSK patents covering mRNA technology and lipid nanoparticles. The mRNA technology and lipid nanoparticles at issue are crucial to GSK’s own vaccine products, not just those of the alleged infringers, underscoring the significance of these components and how they form the foundation for both GSK’s and the infringers' products, illustrating the wide-ranging implications of GSK’s patents⁴. GSK filed a similar lawsuit against Pfizer and BioNTech, claiming their COVID-19 vaccine Comirnaty infringes on GSK patents. GSK argues that the use of lipid nanoparticles and specific mRNA formulations in Comirnaty violates GSK’s intellectual property rights⁵.
Moderna, Pfizer, and BioNTech deny the allegations, stating that their technologies are independently developed, do not infringe on GSK's patents, and predate GSK’s patents⁴. Moderna has expressed willingness to license the patents on commercially reasonable terms, suggesting an openness to negotiation and resolution without litigation⁵.
Other Cases That Might Influence The Outcome
Several patent lawsuits have been filed involving mRNA pioneers, such as the one filed in 2022 by Moderna against BioNTech (with Pfizer) relating to sales of the Moderna and BioNTech/Pfizer COVID-19 vaccine products (Spikevax® and Comirnaty®, respectively). That lawsuit was one of the first high-profile cases involving the mRNA technology and set the stage. The overall mRNA patent litigation landscape, including the following cases, provides precedents likely to influence the outcome of Moderna's lawsuit against Pfizer, which, in turn, might affect the GSK vs. Moderna litigation.
On February 28, 2022, Arbutus and Genevant sued Moderna in the U.S. District Court for the District of Delaware. The complaint alleges that Moderna infringed several Arbutus-owned patents (e.g., U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668, 9,364,435, 9,504,651, and 11,141,378) through the sale of its Spikevax® vaccine product. The patents-in-suit are directed to lipid nanoparticle (LNP) delivery technology, designed to protect and release an mRNA payload within recipient cells. The U.S. District Court will address these infringement claims. Meanwhile, the Federal Circuit affirmed the Patent Trial and Appeal Board's decision that claims 1-22 of U.S. Patent No. 9,404,127 were invalid as anticipated by Moderna's earlier patent, U.S. Patent No. 8,058,069. See Arbutus Biopharma Corp. v. Moderna, Inc., No. 20-1183 (Fed. Cir. 2023). This decision by the PTAB, upheld by the Federal Circuit, will likely impact how similar claims are evaluated in the Moderna vs. Pfizer case, as both involve mRNA delivery technologies.
On March 17, 2022, Alnylam sued Moderna and Pfizer, separately, in the U.S. District Court for the District of Delaware, alleging infringement of U.S. Patent No. 11,246,933 through their sales of Spikevax® and Comirnaty® vaccine products. The ‘933 patent pertains to cationic lipids, a key component in encapsulating the mRNA payload specifically designed for mRNA vaccine formulations. The Federal Circuit ruled in favor of Moderna and Pfizer, finding that the disputed claim term "head group" was not protonatable at physiological pH, thus not infringing Alnylam's patent. See Alnylam Pharmaceuticals, Inc. v. Moderna, Inc. and Pfizer, Inc., No. 23-2357 (Fed. Cir. 2023). Similar to the Arbutus case, the Federal Circuit's ruling will influence the consideration of cationic lipid use in mRNA technology, directly affecting the Moderna vs. Pfizer dispute.
On March 18, 2022, Acuitas sued Arbutus and Genevant in the U.S. District Court for the Southern District of New York, seeking a declaratory judgment that Pfizer's Comirnaty® product does not infringe certain Arbutus-owned patents and challenging their validity. The District Court granted defendants’ motion to dismiss the case without prejudice. In particular, the Court found that Acuitas lacked standing to seek a declaratory judgment of non-infringement and invalidity, and Acuitas appealed. This case is still pending and has not yet been decided by the Federal Circuit.
On July 7, 2022, CureVac sued BioNTech in the German Regional Court in Düsseldorf for infringement of one European Patent and three German patents related to mRNA payload and lipid features. BioNTech and Pfizer responded with a lawsuit in the U.S. District Court for the District of Massachusetts, seeking a declaratory judgment of non-infringement. The transatlantic legal battle highlights the complexity and global nature of mRNA patent disputes.
The rulings in these cases will likely provide guidance for the legal interpretations and strategies that may influence the Moderna vs. Pfizer litigation by clarifying the scope of patent protections for mRNA technology and lipid nanoparticles. That guidance would likely affect the GSK vs. Moderna litigation and could generally influence principles of patent law such as the doctrine of equivalents and claim interpretation.
Implications Of Outcomes
If GSK’s patent infringement suits prevail, GSK could recover significant monetary damages and secure potentially ongoing licensing fees from Moderna, Pfizer, and BioNTech. This financial windfall could bolster GSK's position in the biotech industry and provide greater resources for further research and development. Additionally, a ruling in favor of GSK could set precedent by affirming the validity and enforceability of mRNA patents, specifically those related to lipid nanoparticles and delivery mechanisms.
If Moderna, Pfizer, and BioNTech prevail, they would avoid paying damages and continue operating without the need for licensing agreements. This outcome would allow them to allocate resources to other areas of research and development, potentially leading to new breakthroughs in mRNA technology and other fields. The ruling could encourage further innovation and competition in the biotech industry more generally, as companies would feel more confident in developing new technologies without fear of patent infringement claims in the mRNA space. Such an environment could lead to a more dynamic and competitive market, ultimately benefiting consumers and patients.
In the Acuitas vs. Arbutus/Genevant case, Acuitas sought a declaratory judgment stating that their liquid nanoparticle formulations used in Pfizer and BioNTech’s Comirnaty vaccine do not infringe on Arbutus patents. The CureVac vs. BioNTech/Pfizer transatlantic legal battle further highlights the complexities of global mRNA patent disputes.
A victory for Moderna, Pfizer, and BioNTech would resonate with these cases by establishing clearer guidelines for enforceability and non-infringement positions for liquid nanoparticle formulations fostering a more predictable legal environment. Such an outcome would support innovation and competitive market dynamics.
What to Watch for Moving Forward
The outcomes of these ongoing lawsuits will be closely watched as they will set important precedents for the biotech industry. Lawyers and industry stakeholders will be monitoring these cases to understand how courts interpret and apply patent law in the context of mRNA technology.
The willingness of the parties to negotiate licensing agreements and cross-licensing deals will be crucial in resolving the disputes. Successful negotiations could lead to collaborative partnerships that advance the field of mRNA technology and benefit the industry as a whole.
Continued advancements in mRNA technology and lipid nanoparticles will likely lead to further patent disputes and litigation. As new technologies emerge, companies will need to navigate the patent landscape to protect their innovations and avoid infringing on existing patents.
Authored by: David Habib
