By Kevin E. Noonan –

One of the characteristics of the response to the COVID-19 pandemic were the 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 (see, e.g., Alnylam Pharmaceuticals v. Pfizer and Alnylam Pharmaceuticals Inc v. Moderna Inc.)  These have included the lipids comprising the nanoparticles and use of variant nucleotides (such as pseudouridine analogs); most of these lawsuits have settled or come to resolution (see, e.g., Arbutus Biopharma Corp. v. ModernaTx, Inc. and Moderna Sues Pfizer and BioNTech over mRNA Vaccine Technology).

The latest skirmish involves Bayer Cropscience and affiliates Monsanto and Monsanto Technology against three defendants in separately filed lawsuits: Moderna, Inc., Moderna US, Inc., and ModernaTx Inc. D. Del., No. 26-cv-12 with regard to the Spikevax^® protein component of the vaccine; Pfizer Inc., BioNTech SE, BioNTech Mfg. GmbH, and BioNTech US Inc. D. Del., No. 26-cv-13 directed to the Comirnaty^® protein; and Johnson & Johnson, Janssen Pharmaceutica NV, Janssen Pharmaceuticals Inc.,  Janssen Biotech Inc, and Janssen Vacines & Prevention N.V. D.N.J., No. 3:26-cv-71 involving Jcvoden, which unlike the other two Spike protein mRNA vaccines comprises an adenovirus-encoded Spike protein-encoding construct.*  The complaints in each case (see below) are similar and assert similar allegations, differing only in the profit amount alleged to have been garnered by the parties.

The asserted patent, U.S. Patent No. 7,741,118, had originally been directed to improving yield of pest resistance-related genes in recombinant crops, but significantly not limited to these outcomes.  The claimed technology purportedly eliminated “problem” coding sequences in mRNA of interest that “improved mRNA stability and the amount or quality of protein produced.”  Such problem sequences include A/T rich areas of the transcript, such as (specifically) ATTTA and generally “regions with over five consecutive A and/or T nucleotides.”  In the accused vaccines, the modifications acted to reduce destabilization of Spike-encoding mRNA in vivo (thought to be due to self-complementarity), thus improving translational efficiency.  The claimed methods involved substituting these problem sequences with amino acid-encoding sequences; in each case, the complaint recites specific claims alleged to be infringed by defendants, asserted to have resulted in each defendant having been able “to quickly and effectively design and synthesize [Spike-encoding] mRNA” that “was enabled in part by its use of Plaintiffs’ patented method for removing the Problem Sequences identified in the ‘118 Patent by substituting sense codons.”  The alleged infringed claims shared for each Defendant “at least Claims 59 [and] 60” of the ‘118 Patent:

59. A method of making a structural gene that encodes a protein, the method comprising:
(a) starting with a coding sequence that encodes a protein and that contains polyadenylation signal sequences listed in Table II;
(b) reducing the number of said polyadenylation signal sequences in the coding sequence by substituting sense codons for codons in the coding sequence; and
(c) making a structural gene that comprises a coding sequence that includes the codons substituted according to step (b) and is characterized by the reduced number of Table II polyadenylation signal sequences, and that encodes the protein.

60. The method of claim 59, wherein the starting coding sequence of step (a) contains ATTTA sequences, and wherein step (b) further comprises reducing the number of said ATTTA sequences in the coding sequence by substituting sense codons for codons in the coding sequence.

Each complaint also asserted the profits each defendant had made from its infringement:

In 2024, Pfizer reported $5.3 billion in global Comirnaty revenue, including $2 billion in the US; BioNTech reported €701 million ($819.3 million) in global sales. Moderna in 2024 reported $3.1 billion in global Spikevax sales, including $1.7 billion in the US. J&J reported $198 million that year from global Jcovden sales.

These complaints were filed recently and progress of the lawsuits will be monitored going forward.

* It is noted that the Emergency Use Authorizations for the Jcovden vaccine was revoked in the U.S. and the EU in 2023 and the vaccine is no longer being administered.