Bayer’s crop-gene patent survives dismissal bids in mRNA vaccine cases

The story

A U.S. federal judge has allowed Bayer CropScience and Monsanto Technology to continue patent-infringement cases against Moderna, Pfizer and BioNTech over methods used to design messenger-RNA vaccines. In a September 28 memorandum opinion, Judge William C. Bryson of the U.S. Court of Appeals for the Federal Circuit, sitting by designation in the District of Delaware, denied the defendants’ motions to dismiss. The ruling is important but narrow: Bayer’s allegations are sufficiently plausible to proceed, not proven.

The dispute centers on U.S. Patent No. 7,741,118, titled “Method for preparing synthetic genes.” The patent claims priority to February 1989, was issued in June 2010 and, according to the court’s opinion, is scheduled to expire on June 22, 2027. Its history is agricultural. Monsanto researchers studied why some introduced genes produced unstable messenger RNA and low protein expression in plants. The patent describes replacing selected problem sequences—including certain A-and-T-rich motifs—with synonymous codons that encode the same amino acids but can improve RNA stability and expression.

Bayer alleges that the defendants used this kind of sequence optimization when developing the DNA templates from which their COVID-19 vaccine mRNA is produced. Its complaints assert four method claims—59, 60, 73 and 79—and cite public regulatory filings, scientific material and company statements. Those allegations remain contested. Pfizer, BioNTech and Moderna have not been found to infringe, and the court did not decide whether their development or manufacturing processes ultimately satisfy every limitation of the asserted claims.

Moderna attacked both the sufficiency of Bayer’s infringement allegations and the patent’s eligibility under Section 101 of the Patent Act. It argued that the claims were directed to a natural relationship between nucleotide motifs, mRNA stability and protein expression. Judge Bryson rejected that characterization at this stage. He concluded that the asserted methods use scientific knowledge to make a man-made gene through specified codon substitutions and achieve a concrete result, rather than merely observe or claim a law of nature.

That Section 101 ruling does not make the patent invulnerable. The opinion expressly says that questions involving prior art, other grounds of invalidity and actual infringement are not resolved by the eligibility analysis. Moderna can still develop defenses as the record expands. The distinction matters because an unsuccessful motion to dismiss often means only that factual and technical disputes require discovery; it is not equivalent to a final judgment after claim construction, expert evidence or trial.

Pfizer and BioNTech raised a different set of issues. They argued that Bayer had not plausibly alleged performance of all claimed steps and had not shown that a single entity practiced the complete method inside the United States, as required for direct infringement under Section 271(a). Bayer alleged that relevant optimization and manufacturing work occurred at U.S. facilities in Missouri, Massachusetts and Michigan, while also advancing theories involving the companies’ collaboration. The judge held that these allegations provided fair notice and presented factual disputes that could not be resolved on a dismissal motion.

The court also left Bayer’s alternative Section 271(g) theory in place. That provision can reach products imported into the United States when they are made abroad by a patented process, subject to statutory limits. Pfizer and BioNTech disputed how the rule could apply to vaccine production and whether later processing materially changed the alleged product. The opinion found no basis to dispose of the theory at the pleading stage, leaving the geography and sequence of the companies’ work for evidence rather than assumption.

The litigation is unusual because technology associated with crop genetics is being asserted against products from a different industry and historical moment. Yet the underlying engineering problem—redesigning a coding sequence without changing the protein it specifies—can travel across applications. That is precisely why claim language matters more than the field in which an invention first became commercially visible. A valid patent claim can reach later uses if they practice its limitations, but a shared scientific concept alone is not enough to establish infringement.

The remedies also require precision. Bayer’s January complaints seek monetary relief and an ongoing royalty; Reuters reported that the company is not asking the court to stop vaccine production. The next stages will test the patent against specific process evidence, prior art and the defendants’ remaining legal arguments. For innovators, the cases are a reminder that patents can migrate across sectors, but also that surviving an early procedural challenge is only the opening threshold in proving a technologically complex infringement claim.

INNOVOX analysis

The ruling shows how a method developed in one technical field can acquire new commercial significance when the same molecular design problem appears elsewhere. Bayer has cleared the first procedural barrier, but the harder questions remain: what the claims mean, where each step occurred, whether the accused vaccine-development processes actually practiced them and whether prior art or other validity defenses defeat the patent.

What to watch

Watch the defendants’ answers, discovery into codon-optimization and manufacturing workflows, claim-construction proceedings and any renewed validity challenges. Territorial evidence will be central for Pfizer and BioNTech, while damages and a possible ongoing royalty—not an injunction—will define the practical stakes as the patent approaches its stated June 22, 2027 expiration.