Bayer CropScience LP v. Johnson & Johnson Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Bayer CropScience LLC, Monsanto Company, and Monsanto Technology, LLC (Delaware, Missouri)
  • Defendant: Johnson & Johnson, Inc.; Janssen Pharmaceutica NV; Janssen Pharmaceuticals, Inc.; Janssen Biotech, Inc. and Janssen Vaccines & Prevention NV (New Jersey, Pennsylvania, Belgium, Netherlands)
  • Plaintiff’s Counsel: Midlige Richter, LLC; Munck Wilson Mandala LLP
• Case Identification: 3:26-cv-00071, D.N.J., 01/06/2026
• Venue Allegations: Venue is alleged to be proper in the District of New Jersey because certain defendants are incorporated there or have a regular and established place of business in the district, and have committed acts of infringement there.
• Core Dispute: Plaintiff alleges that Defendant’s Jcovden COVID-19 vaccine was developed using a patented method for modifying structural gene sequences to enhance the expression of a desired protein.
• Technical Context: The technology relates to genetic engineering, specifically the "codon optimization" of genes from microorganisms (like viruses) to ensure stable and high-level protein expression in eukaryotic host cells (like human cells).
• Key Procedural History: The complaint notes that the patent-in-suit claims priority to a 1989 application, making it a "pre-GATT" patent. It also highlights that the inventors' priority was confirmed through an eight-year interference proceeding at the patent office and affirmed by prior federal court litigation, including a decision by the U.S. Court of Appeals for the Federal Circuit.

Case Timeline

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

U.S. Patent No. 7,741,118 - "Synthetic Plant Genes and Method for Preparation," issued June 22, 2010.

The Invention Explained

• Problem Addressed: The patent addresses the challenge of achieving high levels of protein expression when a gene from one organism (e.g., a bacterium) is inserted into a different type of organism (e.g., a plant or animal cell) (Compl. ¶34). The specification explains that low expression can be caused by the instability of messenger RNA (mRNA), the molecule that carries genetic instructions from DNA to the cell's protein-making machinery ('118 Patent, col. 1:21-25). This instability is linked to certain nucleotide sequences within the gene that can signal for premature termination or degradation of the mRNA (Compl. ¶¶36-37).
• The Patented Solution: The invention provides a method for re-engineering a gene's coding sequence to improve its expression in a foreign host. The method involves identifying and reducing the number of specific "problem sequences"—such as putative polyadenylation signals (listed in the patent's Table II), ATTTA sequences, and other A+T-rich regions—that contribute to mRNA instability ('118 Patent, Abstract; Compl. ¶¶38-40). This is achieved by substituting the codons containing these problem sequences with different "sense codons" that code for the exact same amino acid but lack the destabilizing sequences, thereby enhancing mRNA stability and leading to higher protein production (Compl. ¶¶39, 44).
• Technical Importance: This method provided a systematic way to overcome a key bottleneck in genetic engineering, enabling the reliable and high-level expression of foreign proteins, which is critical for applications ranging from developing insect-resistant crops to producing viral proteins for vaccines (Compl. ¶¶7, 42).

Key Claims at a Glance

• The complaint asserts infringement of claims 59, 60, 73, and 79, with a focus on independent claim 59 (Compl. ¶75).
• Independent Claim 59:
  • (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.
• The complaint also details infringement of dependent claims that add further limitations, such as reducing ATTTA sequences (Claim 60) and regions with more than five consecutive A+T nucleotides (Claim 79) (Compl. ¶¶65, 72).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the method used to make the codon-modified nucleotide sequence for the SARS-CoV-2 spike protein, which is a key component of Defendants' COVID-19 vaccine, marketed as Jcovden or Ad26.COV2.S (Compl. ¶¶8, 48-49). The complaint also accuses the resulting vaccine product itself, as a product made by the patented method (Compl. ¶75).

Functionality and Market Context

The Jcovden vaccine is a viral vector vaccine that uses a modified, harmless adenovirus to deliver the genetic instructions for the SARS-CoV-2 spike protein into human cells (Compl. ¶47). Once inside the cell's nucleus, the instructions are transcribed into mRNA and then translated into spike protein fragments. This process stimulates an immune response, producing antibodies that protect the patient from future infection (Compl. ¶47). The complaint alleges that this process would be ineffective if the spike protein were not adequately expressed, and that Defendants used the patented method to "codon-optimize" the native viral gene sequence to ensure effective expression in human cells (Compl. ¶¶47-48). The complaint alleges Defendants have generated billions of dollars in revenue from the vaccine (Compl. ¶53). An infographic from the CDC is included in the complaint to illustrate how viral vector vaccines work (Compl. p. 18, Fig. 2).

IV. Analysis of Infringement Allegations

Claim Chart Summary

U.S. Patent No. 7,741,118 Infringement Allegations

Identified Points of Contention

• Scope Questions: The patent’s title is "Synthetic Plant Genes and Method for Preparation," and its examples focus heavily on expressing bacterial proteins in plants ('118 Patent, Examples 1-8). A primary point of contention may be whether the claims, despite this focus, are broad enough to cover a method for modifying a viral gene for expression in human cells for a vaccine. The complaint preemptively addresses this by citing the patent's disclosure of applicability to animal cells and expressing viral coat proteins (Compl. ¶¶7, 42).
• Technical Questions: The complaint alleges on "information and belief" that Defendants' "codon-optimization" process is the same as the claimed method of "substituting sense codons" to reduce specific, enumerated "problem sequences" (Compl. ¶¶61, 63). The case may turn on whether Defendants' process, which likely involves complex bioinformatics algorithms, technically meets the claim limitation of "substituting sense codons for codons," or if it constitutes a different, non-infringing method of de novo gene design that achieves a similar result.

V. Key Claim Terms for Construction

• The Term: "substituting sense codons for codons in the coding sequence"

• Context and Importance: This term defines the specific action performed to modify the gene. Its construction is critical because modern "codon optimization" can be a holistic, algorithm-driven de novo synthesis process rather than a direct, one-for-one substitution on a pre-existing sequence. Whether Defendants' method falls within the scope of this term will be a central issue.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The claim language itself is functional and does not specify a particular technique (e.g., site-directed mutagenesis). Plaintiffs may argue that any process that starts with a native sequence as a reference and results in a final sequence where problematic codons have been replaced with functionally equivalent ones meets this limitation, regardless of the tools used.
  • Evidence for a Narrower Interpretation: Defendants may point to the specification's examples, which describe more discrete modification techniques like using synthetic oligonucleotides for site-directed mutagenesis ('118 Patent, col. 11:4-10, Example 1). They may argue this context limits the claim to a more direct replacement process, not a complete redesign of the gene from scratch, even if the native gene served as an initial template.

• The Term: "structural gene"

• Context and Importance: The claim requires "making a structural gene." The parties may dispute whether the final, modified DNA sequence that is incorporated into the adenovirus vector for the vaccine qualifies as a "structural gene" as the term is used in the patent.

• Intrinsic Evidence for Interpretation:

  • Evidence for a Broader Interpretation: The patent does not appear to provide a special definition, so the term could be given its ordinary meaning in the art, which is a gene that codes for any RNA or protein product other than a regulatory factor. A sequence encoding a viral spike protein would meet this definition.
  • Evidence for a Narrower Interpretation: Defendants may argue that the patent's context, focused on creating transgenic plants, imbues the term with a narrower meaning, such as a gene integrated into a particular type of expression cassette or plasmid intended for plant transformation ('118 Patent, Fig. 5), which is different from the context of a viral vector for human vaccination.

VI. Other Allegations

• Indirect Infringement: The complaint alleges that "Defendants performed and/or directed the performance of the infringing method by its agents in the United States" (Compl. ¶59). While not pleaded as a separate count, this language may support a theory of induced or contributory infringement. The primary infringement allegation, however, is for direct infringement under 35 U.S.C. § 271(a) and for importing or selling a product made by a patented process under § 271(g) (Compl. ¶¶59, 75).

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

• A core issue will be one of technological scope: can claims from a 1989-priority patent, conceived and heavily exemplified in the field of agricultural biotechnology for creating insect-resistant plants, be construed to cover the methods used for modern, algorithm-driven codon optimization of a human viral vaccine?
• A key evidentiary question will be one of mechanistic equivalence: can the plaintiff prove that the defendant's proprietary "codon-optimization" process for the Jcovden vaccine is the same as the claimed method of "reducing" a specific list of destabilizing sequences by "substituting sense codons for codons," or will discovery reveal a fundamentally different technical approach to designing the synthetic gene?