The same memorandum opinion and order was filed on September 28, 2026, as ECF No. 38 in Bayer CropScience LLC v. Moderna, Inc., No. 1:26-cv-00012, and as ECF No. 53 in Bayer CropScience LLC v. Pfizer Inc., No. 1:26-cv-00013. The plaintiffs are Bayer CropScience LLC, Monsanto Company, and Monsanto Technology, LLC, whom the opinion calls Bayer. The Moderna defendants are Moderna, Inc., Moderna US, Inc., and ModernaTX, Inc. The Pfizer defendants are Pfizer, Inc., BioNTech SE, BioNTech Manufacturing GmbH, and BioNTech US, Inc. Judge William C. Bryson signed the opinion as a United States Circuit Judge. The opinion denies both motions to dismiss.
The patent and who is on the assignment record
The opinion concerns U.S. Patent 7,741,118, Synthetic plant genes and method for preparation, issued June 22, 2010. The opinion says the patent claims priority to an application filed in 1989 and will expire on June 22, 2027. It says Bayer alleges that the defendants used the claimed methods to produce the mRNA that coded for the spike protein in the COVID-19 coronavirus and was essential to the development of mRNA COVID-19 vaccines. Assignment Center shows one recorded assignment of the '118 patent, executed June 11, 2001, and recorded June 13, 2001, at reel/frame 12350/0224. The conveying party is entered as Pharmacia Corporation, formerly known as Monsato [sic] Company, and the assignee is Monsanto Technology LLC, one of the three plaintiffs.
Google Patents' legal events for the '118 patent list certificates of correction dated July 5, 2011, and August 16, 2011. They do not list an inter partes review or a reexamination. This page did not review the certificates. Google Patents' litigation listings for the patent include both Delaware cases and two District of New Jersey numbers, 2:26-cv-00071 and 3:26-cv-00071. Both New Jersey numbers are captioned Bayer CropScience LP v. Johnson & Johnson Inc., filed January 6, 2026, the same day as the Delaware cases, and assigned to Judge Madeline Cox Arleo. The named defendants include Johnson & Johnson Inc. and Janssen entities. This page did not review the New Jersey complaint.
Which claims the opinion treats as asserted
The opinion says Bayer represented that the complaint asserts claims 59, 60, 73, and 79, and that those claims do not contain the insecticidal-gene or plant-promoter requirements Moderna challenged. On that representation, the court denied as moot the part of Moderna's motion aimed at the insecticidal claims. Issued claim 59, which the opinion quotes, is a method of making a structural gene that encodes a protein: start with a coding sequence that encodes a protein and contains polyadenylation signal sequences listed in Table II; reduce the number of those sequences by substituting sense codons; and make a structural gene that includes the substituted codons, has the reduced number of Table II sequences, and encodes the protein. Issued claim 60 depends from claim 59 and adds reduction of ATTTA sequences by sense-codon substitution. The opinion describes claim 73 as directed to replacing all the ATTTA sequences, and claim 79 as reducing regions of more than five consecutive adenine and thymine nucleotides by sense-codon substitution.
Issued claim 73 is a method according to any one of claims 51 through 54 and 56 through 68 in which the structural gene made by the method contains no ATTTA sequences. That range includes claims 59 and 60. Issued claim 79 is a method according to any one of claims 51, 58 through 64, and 66, and it adds reducing the number of regions with more than five consecutive adenine and thymine nucleotides by substituting sense codons.
Section 101 at the pleading stage
Moderna argued that the non-insecticidal claims, including the four Bayer says it asserts, are ineligible under 35 U.S.C. 101 as directed to a law of nature. The court held that the asserted claims have aspects of both method and composition claims, because they recite methods of making a structural gene that is not found in nature, and it analyzed them under both frameworks. Under Diamond v. Chakrabarty and Association for Molecular Pathology v. Myriad Genetics, Inc., it held that the claims survive because the gene the method produces is the product of a human-engineered alteration, not a natural product. Under Alice Corp. v. CLS Bank International and Mayo Collaborative Services v. Prometheus Laboratories, Inc., it held at step one that the claims are not directed to a natural law, so the second step was unnecessary, and that in any event the substitution of sense codons for the problem sequences is an additional element that makes the claims a patent-eligible application. The opinion also relies on the Federal Circuit's 2026 decision in REGENXBIO Inc. v. Sarepta Therapeutics, Inc. That is a denial of a motion to dismiss. It is not a judgment that every claim of the '118 patent is valid.
The pleading rulings
Moderna's pleading challenge was aimed at the insecticidal claims and was denied as moot, as described above. Pfizer moved on three grounds: that Bayer had not plausibly pleaded performance of the claimed method steps; that the section 271(a) claim should be dismissed for failure to plead that the method was practiced in the United States; and that the section 271(g) claims should be dismissed because the accused product is not a product made by a patented process, because Bayer did not plead the notice in 35 U.S.C. 287(b)(2), and because infringement was not plausibly alleged. The court held oral argument on Pfizer's motion at Pfizer's request and denied it. It held that the complaint's allegations, many drawn from the defendants' own public filings and statements, give fair notice, and that facts peculiarly within the defendants' knowledge may be pleaded on information and belief. On section 271(a), it accepted at this stage Bayer's allegations that the claimed steps were performed in the United States, including in Chesterfield, Missouri; Andover, Massachusetts; and Kalamazoo, Michigan, and held the joint-infringement allegations sufficient. On section 271(g), it held that the exception for a product materially changed by subsequent processes refers to changes made before importation, not after. On notice, it held that a section 271(g) complaint need not plead compliance with the section 287(b) notice requirement, which the court treats as a defense against liability for damages in appropriate circumstances, and it also relied on Bayer's allegation that the defendants practiced the patented process.
What to watch next
Watch the answers, the proposed protective order now due October 8, 2026, and any claim construction or eligibility record in both Delaware cases.