Bayer CropScience LLC v. Moderna Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:

  • Plaintiff: Bayer CropScience LLC, Monsanto Company, and Monsanto Technology, LLC (Delaware & Missouri)
  • Defendant: Moderna, Inc., Moderna US, Inc., and ModernaTX, Inc. (Delaware & Massachusetts)
  • Plaintiff’s Counsel: Richards, Layton & Finger, P.A.; Munck Wilson Mandala LLP

• Case Identification: 1:26-cv-00012, D. Del., 01/06/2026

• Venue Allegations: Venue is alleged to be proper in the District of Delaware because all Defendant entities are organized under the laws of Delaware and therefore reside in the district for venue purposes.

• Core Dispute: Plaintiff alleges that Defendant’s COVID-19 and RSV mRNA vaccines, and other pipeline products, are made using a patented method for modifying genetic sequences to enhance mRNA stability and protein expression.

• Technical Context: The lawsuit concerns foundational technology in genetic engineering, specifically the optimization of nucleic acid sequences to improve the yield of a desired protein in a host organism, a critical step in the development of effective mRNA-based therapeutics.

• Key Procedural History: The complaint notes that the asserted patent claims priority to 1989 and was issued in 2010 after a lengthy prosecution that included an eight-year interference proceeding, which the complaint states confirmed the inventors' priority. The patent is identified as a pre-GATT patent, meaning its term is 17 years from the date of issuance.

Case Timeline

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 7,741,118 - "Synthetic Plant Genes and Method for Preparation"

The Invention Explained

• Problem Addressed: The patent addresses the challenge of expressing genes from one type of organism (e.g., bacteria) in a different, higher-level organism (e.g., a plant or animal cell). The specification explains that such "heterologous" expression often results in very low levels of the desired protein, in part because the messenger RNA (mRNA) transcribed from the foreign gene is unstable within the host cell (Compl. ¶31; ’118 Patent, col. 1:15-32).
• The Patented Solution: The inventors identified specific, frequently occurring nucleotide sequences within genes that they theorized contribute to mRNA instability in eukaryotic cells. These "problem sequences" include putative polyadenylation signals (sequences that can prematurely terminate mRNA processing), ATTTA sequences, and other regions rich in adenine (A) and thymine (T) bases (’118 Patent, col. 1:53-62). The patented method involves systematically modifying a gene's coding sequence to reduce or eliminate these problem sequences by substituting them with different codons that encode for the exact same amino acid (i.e., "sense codons"), thereby preserving the final protein structure while increasing mRNA stability and dramatically improving protein expression (Compl. ¶¶34-36; ’118 Patent, col. 10:11-20).
• Technical Importance: This method provided a systematic approach to overcoming a fundamental obstacle in genetic engineering, enabling the robust expression of foreign proteins in host organisms for applications ranging from agriculture to medicine (Compl. ¶¶3, 7).

Key Claims at a Glance

• The complaint asserts independent claim 59 and dependent claims 60, 73, and 79 (Compl. ¶¶66-81).
• Independent Claim 59 recites a method with three essential steps:
  • (a) Starting with a coding sequence that encodes a protein and contains specific polyadenylation signal sequences listed in the patent's Table II.
  • (b) Reducing the number of those signal sequences by substituting sense codons for the original codons.
  • (c) Making a structural gene comprising the modified coding sequence, which is characterized by the reduced number of Table II sequences and still encodes the original protein.
• The complaint notes that dependent claims 60 and 73 add limitations for reducing ATTTA sequences, and dependent claim 79 adds a limitation for reducing regions with more than five consecutive A+T nucleotides (Compl. ¶¶71, 75, 78).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are products made by the allegedly infringing method, including Moderna's COVID-19 vaccines (marketed as Spikevax® and incorporating mRNA sequences such as mRNA-1273 and its variants) and its respiratory syncytial virus (RSV) vaccine (marketed as mRESVIA®) (Compl. ¶¶65-66). The complaint also extends allegations to other mRNA vaccine products in Moderna's pipeline (Compl. ¶60).

Functionality and Market Context

The accused products are mRNA vaccines that deliver a set of genetic instructions to human cells, directing them to produce a viral protein (e.g., the SARS-CoV-2 spike protein) (Compl. ¶¶43-44). The complaint alleges that to ensure the mRNA is stable enough to produce a sufficient amount of this protein to trigger an effective immune response, Moderna utilized a "sequence engineering" and "mRNA tailoring" process (Compl. ¶¶46-47). This process, according to the complaint, involves designing and synthesizing modified mRNA sequences that eliminate or substantially reduce the very "Problem Sequences" identified in the ’118 Patent from the native viral gene sequences (Compl. ¶¶50, 54). The complaint alleges these vaccines have generated over $47 billion in global sales revenue for Moderna (Compl. ¶56).

IV. Analysis of Infringement Allegations

’118 Patent Infringement Allegations

Identified Points of Contention

• Scope Questions: A central question may be whether the term "structural gene," as used in a patent developed in the 1980s for modifying DNA in plants, can be construed to read on the synthetic mRNA molecules used in Moderna's modern human vaccines.
• Technical Questions: The analysis may focus on the mechanism of Moderna's proprietary "sequence engineering" algorithms. The complaint provides tables showing the outcome of Moderna’s process—a reduction in the specified sequences (Compl. ¶54). A key question for the court will be whether the method itself involved specifically identifying and reducing the claimed sequences, or if the reduction was an incidental byproduct of a different codon optimization strategy (e.g., one based on maximizing GC content or matching host cell tRNA abundance).

V. Key Claim Terms for Construction

• The Term: "structural gene"

• Context and Importance: The definition of this term is fundamental to the infringement case. If construed narrowly to mean only a double-stranded DNA sequence as it exists in a chromosome, Moderna's final mRNA product may fall outside the claim's scope. If construed more broadly to mean a nucleotide sequence that codes for a protein, it may cover the accused mRNA. Practitioners may focus on this term because the patent's specification is heavily rooted in the context of modifying DNA for expression in plants, which may provide a basis for a narrow construction.

  • Intrinsic Evidence for a Broader Interpretation: The patent abstract refers to "modifying structural gene sequences," and the claims recite making a "structural gene that comprises a coding sequence," language that could be argued to focus on the informational content of the sequence rather than its specific chemical form (DNA vs. RNA).
  • Intrinsic Evidence for a Narrower Interpretation: The detailed description repeatedly discusses modifying genes for insertion into plant transformation vectors and achieving expression in plant cells, often in the context of DNA manipulation (e.g., ’118 Patent, col. 13:15-23). The term "gene" itself is most commonly associated with DNA.

• The Term: "reducing the number of said... sequences... by substituting sense codons"

• Context and Importance: This method limitation defines the allegedly infringing act. The dispute may turn on whether this requires a deliberate process of targeting the patent's specific "problem sequences" for removal, or if any codon optimization process that results in their reduction infringes.

  • Intrinsic Evidence for a Broader Interpretation: The claim language focuses on the action ("reducing") and the means ("by substituting sense codons") without specifying the underlying reason or algorithm for the substitution. An argument could be made that if the proscribed sequences are reduced via sense codon substitution, the claim is met regardless of the designer's primary optimization goal.
  • Intrinsic Evidence for a Narrower Interpretation: The patent's specification frames the invention as a solution to a specific problem caused by specific sequences (’118 Patent, col. 1:53-62). An argument could be made that the claimed "method" is one that is directed at solving this problem by targeting these sequences, not a general-purpose codon optimization that has other goals.

VI. Other Allegations

The complaint alleges direct infringement under 35 U.S.C. § 271(a) for performing the patented method in the United States to create the mRNA sequences (Compl. ¶65). It also alleges infringement under 35 U.S.C. § 271(g) for importing, selling, or using products (the vaccines) in the United States that were made abroad by the patented process (Compl. ¶81). The complaint does not contain explicit allegations of indirect or willful infringement.

VII. Analyst’s Conclusion: Key Questions for the Case

• A core issue will be one of definitional scope: Can claims drafted in the 1980s for modifying DNA to create insect-resistant plants be interpreted to cover the modern design of synthetic mRNA sequences for human vaccines? The construction of the term "structural gene" will be dispositive.
• A key evidentiary question will be one of process versus result: What evidence will show that Moderna’s proprietary "sequence engineering" platform performs the specific method of "reducing" the patent's enumerated "Problem Sequences," as claimed? The case will likely require a deep technical inquiry into whether Moderna's algorithms merely achieve a similar outcome through a different, non-infringing process of codon optimization.