Quo Vadis mRNA Vaccine Technology? The State of the IP Lawsuits

One of the beneficial characteristics of the response to the COVID -19 pandemic were pledges from companies involved in developing vaccines (such as Moderna, Pfizer, BioNTech, and others) not to enforce patents on relevant technology during the duration. That restraint has long-since vanished (as has the global pandemic effects of the virus), and there have been several lawsuits, in the U.S. and abroad, relating to various components of the vaccine.

Many of them surround lipid nanoparticle technology, which had been the subject of research and companies obtaining patent protection for several decades. This technology has now become the subject of several lawsuits. One, Alnylam Pharmaceuticals Inc v. Moderna Inc., resulted in settlement after several adverse decisions against Alnylam’s asserted claims in U.S. Patent Nos. 11,246,933 and 11,382,979. Nevertheless Alnylam has continued its lawsuit against BioNTech and Pfizer on similar claims; see Alnylam Pharmaceuticals v. Pfizer.

Arbutus Biopharma sued Moderna on its claims of U.S. Patent 9,404,127 to “stable” nucleic acid lipid particles, which were invalidated in an inter partes review proceeding by the Patent Trial and Appeal Board and affirmed by the Federal Circuit. Those claims recited certain physicochemical structures (termed “non-lamellar”). Arbutus has also sued BioNTech and Pfizer on claims to its LNP technology as claimed in U.S. Patent Nos. 8,492,359; 9,504,651; 11,141,378; and 11,318,098.

On the other hand, Arbutus and Genevant Sciences recently settled their lawsuits with Moderna over LNP technology specifically comprising a particular cationic lipid claimed in U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668, 9,364,435, 9,504,651, and 11,141,378:

Relevant features of this settlement include an immediate (July 2026) payment by Moderna of $950 million with an additional $1.3 billion being subject to a determination on appeal regarding Moderna’s claim that these sums should be paid by the Federal Government because their COVID-19 vaccine, Spikemax®, was produced under the provisions of 28 U.S.C. § 1498(a). Moderna for its part also received a global nonexclusive license to patented technology for SM-102-containing mRNA vaccines for infectious diseases (specifically SPIKEVAX, mNEXSPIKE and mRESVIA, according to Arbutus’s Form 8-K filing with the Securities and Exchange Commission on March 5^th, wherein the latter vaccine is directed to respiratory syncytial vaccine), and an agreement not to sue for “certain” (undisclosed) patents on Moderna’s products using the technology. It is unclear whether Moderna vaccines against diseases other than infectious disease would fall within the scope of this license (for example, Moderna’s anticancer vaccines, which have recently had positive clinical trial results).

Moderna has separately sued rivals Pfizer and BioNTech for infringing patents related to mRNA technology, U.S. Patent 10,702,600; 10,898,574; and 10,933,127, directed to beta-coronavirus mRNA and methods of use thereof. BioNTech challenged the ‘600 and ‘127 patents in inter partes review and the PTAB found them to be invalid. This decision is on appeal to the Federal Circuit.

BioNTech countersued Moderna in February, arguing Moderna’s ⁠next-generation ​COVID-19 shot, MNEXSPIKE, infringes its U.S. Patent No. 12,133,899.

A different and distinct patented component of this technology was the basis for Bayer to sue a number of COVID vaccine makers earlier this month. In those proceedings Bayer filed suit separately against Moderna, Inc.; Moderna US, Inc.; and ModernaTx Inc.; Pfizer Inc.; BioNTech SE; BioNTech Mfg. GmbH; and BioNTech US Inc.; and Johnson & Johnson; Janssen Pharmaceutica NV; Janssen Pharmaceuticals Inc.; Janssen Biotech Inc.; and Janssen Vaccines & Prevention N.V. with respect to U.S. Patent No. 7,741,118. This technology is directed at the mRNA component of the vaccines, which reduces the number of polyadenylation signals (ATTTA) in an mRNA payload and as a result improves translation efficiency.

And for its part BioNTech has also filed suit against Moderna based on their mRNA technology. According to BioNTech’s complaint, claims in U.S. Patent No. 12,133,899 are infringed by the mRNA payload for Moderna’s mNEXSPIKE^® vaccine against COVID (SARS-CoV-2), which comprises a “streamlined vaccine design,” which triggers “an equally strong immune response to that of the complete spike protein” despite comprising only select domains thereof, specifically, a receptor binding domain, a secretory signal, a transmembrane domain, all from the SARS-CoV-s Spike protein, and a trimerization domain from the heterologous T4 fibritin protein. This permits the vaccine to be given to patients at lower dosages and is more stable during storage and transport.

Finally, last summer, BioNTech reached a settlement with Curevac over its U.S. Patent Nos. 10,760,070; 11,667,910; 11,786,590; 11,865,084; 11,883,486; 11,918,643; and 11,920,174 (among others, albeit not all of which were directed to coronavirus) over mRNA production and purification methods and pharmaceutical compositions produced thereby. In a complex settlement, BioNTech acquired Curevac and GlaxoSmithKline received a monetary settlement in recompense for a failed joint venture with Curevac.

One significant feature of all these lawsuits is that none of the Plaintiffs has asked the court for an injunction, a remnant of the ethical positions taken by patentees during the pandemic.

Various combinations of companies that have had variable successes with developing and marketing COVID-19 vaccines are involved with or have concluded (by settlement or otherwise) their disputes over patents for technologies that have developed over time. The question now is the extent to which vaccines and other developing therapeutics will rely on these fundamental patents (and their relatives adapted to other uses, such as chronic diseases) and the extent to which, absent the pressures created by a global pandemic, the motivation and incentive for at least some level of cooperation remains for the benefit of mankind.