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 / Belgium / Pennsylvania)
  • Plaintiff’s Counsel: Midlige Richter, LLC
• Case Identification: 2:26-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 where they have committed acts of infringement.
• Core Dispute: Plaintiff alleges that Defendants' method of developing their Jcovden COVID-19 vaccine infringes a patent related to modifying genetic sequences to enhance protein expression and mRNA stability.
• Technical Context: The technology at issue is codon optimization, a genetic engineering technique used to improve the production of a desired protein in a host organism by modifying its underlying DNA coding sequence.
• Key Procedural History: The asserted patent is a pre-GATT patent with a 1989 priority date that issued in 2010 after a lengthy prosecution, including an eight-year interference proceeding. The complaint notes that the inventors' priority of invention was confirmed by a district court, the Federal Circuit, and the Board of Patent Appeals and Interferences in prior disputes.

Case Timeline

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

U.S. Patent No. 7,741,118 - "SYNTHETIC PLANT GENES AND METHOD FOR PREPARATION"

• Patent Identification: 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’s background section describes the difficulty of achieving high levels of protein expression when a gene from one type of organism (e.g., bacteria) is placed into a different type of organism (e.g., a plant) (Compl. ¶34). This low expression can be caused by the presence of certain nucleotide sequences in the foreign gene's coding region that lead to unstable messenger RNA (mRNA), hindering the cell's ability to produce the intended protein (’118 Patent, col. 1:16-35).
• The Patented Solution: The invention provides a method for modifying a gene's coding sequence to improve protein expression. The method involves identifying and reducing the number of specific, destabilizing sequences—such as putative polyadenylation signals, ATTTA sequences, and regions rich in adenine (A) and thymine (T)—and substituting them with alternative codons that code for the same amino acid but lack the problematic sequences (’118 Patent, Abstract; col. 10:10-20). This "codon optimization" results in a more stable mRNA molecule and dramatically increased protein production (Compl. ¶39, ¶41).
• Technical Importance: This method provided a systematic way to overcome a key bottleneck in genetic engineering, enabling the robust expression of foreign proteins for applications ranging from insect-resistant crops to viral vaccines (Compl. ¶3, ¶42).

Key Claims at a Glance

• The complaint asserts independent claim 59 and dependent claims 60, 73, and 79 (Compl. ¶75).
• Independent Claim 59 recites a method with the following essential elements:
  • Starting with a protein-encoding sequence that contains specific "polyadenylation signal sequences" listed in the patent's Table II.
  • Reducing the number of those specific signal sequences by substituting them with "sense codons" (codons that code for an amino acid).
  • Making a final structural gene that contains the substituted codons and is therefore characterized by a reduced number of the Table II signal sequences.

III. The Accused Instrumentality

Product Identification

• The accused instrumentality is the method used to create the codon-modified DNA sequence for the SARS-CoV-2 spike protein in Defendants’ COVID-19 vaccine, marketed as Jcovden or Ad26.COV2.S (Compl. ¶8, ¶49). The complaint also asserts infringement by the Jcovden vaccine itself, as a product made by the patented method (Compl. ¶59).

Functionality and Market Context

• The Jcovden vaccine is a viral vector vaccine that uses a modified adenovirus to deliver the genetic instructions for the SARS-CoV-2 spike protein to human cells (Compl. ¶47). The complaint alleges that to ensure the vaccine would be effective, Defendants "codon-optimized" the native spike protein gene to enhance its expression in human cells (Compl. ¶48). The complaint presents a table summarizing the alleged reduction of problematic sequences between the native viral gene and the sequence in the Jcovden vaccine (Compl. ¶48). The complaint notes that the vaccine generated billions of dollars in revenue for Defendants (Compl. ¶53).

IV. Analysis of Infringement Allegations

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

Identified Points of Contention

• Scope Questions: A central question may be whether the claims, which originate from a patent titled "SYNTHETIC PLANT GENES" and containing numerous examples in plants, can be construed to cover a method used to create a human vaccine. The complaint anticipates this by arguing that the inventors claimed the method broadly without limiting it to a particular cell or gene type (Compl. ¶44). The resolution may depend on whether the claim language itself, or the specification as a whole, limits the invention to the agricultural context.
• Technical Questions: The complaint's infringement theory is supported by a summary table showing a dramatic reduction in the claimed "Problem Sequences" (Compl. ¶48). A key factual question will be whether Defendants' codon optimization process specifically targeted the sequences listed in the patent's Table II, as defined in a figure in the complaint (Compl. ¶38, "Figure 1"), or if the reduction was an incidental result of an algorithm optimizing for other, distinct parameters (e.g., overall GC content or codon usage bias in humans).

V. Key Claim Terms for Construction

The Term: "a method for making a structural gene that encodes a protein"

• Context and Importance: This preamble language defines the overall scope of the claimed method. Practitioners may focus on this term because the patent's title, abstract, and detailed examples are heavily focused on making genes for expression in plants. Defendants may argue that the term, when read in light of the specification, should be limited to methods for agricultural applications, whereas Plaintiffs will likely argue the phrase is general and not limited by the preferred embodiments.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The plain language of Claim 59 does not specify the type of protein or the organism in which it is to be expressed (Compl. ¶60). The complaint points to specification language teaching the method could be used to express a "viral coat protein" to "achieve virus resistance," which it argues provides a direct link to vaccine technology (Compl. ¶42; ’118 Patent, col. 38:25-29).
  • Evidence for a Narrower Interpretation: The patent is titled "SYNTHETIC PLANT GENES AND METHOD FOR PREPARATION" (’118 Patent, Title). The specification repeatedly refers to expression in plants, and nearly all the detailed examples describe modifying genes for insect resistance in tobacco, cotton, and tomato plants (’118 Patent, Examples 1-11).

The Term: "polyadenylation signal sequences listed in Table II"

• Context and Importance: This term is the technical heart of the claim, defining the specific sequences that must be reduced. The infringement allegation stands or falls on whether Defendants' process addressed these exact sequences.
• Intrinsic Evidence for Interpretation:
  • Evidence for a Broader Interpretation: The term is defined by an explicit and finite list in Table II, which is reproduced in the complaint (Compl. ¶38). The patent refers to these as "potential" or "putative" signals, which may suggest that their mere presence in the starting sequence is sufficient, regardless of whether they are proven to be functionally active as polyadenylation signals in that specific context (’118 Patent, col. 15:50; col. 3:58-63).
  • Evidence for a Narrower Interpretation: A party could argue that for a sequence to be considered a "polyadenylation signal sequence," it must have some potential to function as such in the native gene. However, the claim language explicitly ties the definition to the sequences "listed in Table II," which may limit the viability of a functionality-based argument.

VI. Other Allegations

• Indirect Infringement: The complaint primarily alleges direct infringement under 35 U.S.C. § 271(a) and infringement under § 271(g) for the importation and sale of a product (the Jcovden vaccine) made by the patented process (Compl. ¶59, ¶75). The complaint does not plead specific facts to support claims for induced or contributory infringement.

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

• A core issue will be one of claim scope: can claims from a patent rooted in agricultural science, with a specification heavily focused on expressing proteins in plants, be interpreted to cover the codon optimization of a human virus gene for use in a human vaccine? The outcome may depend on the extent to which the specification's detailed embodiments are used to interpret the otherwise general claim language.
• A key evidentiary question will be one of infringement and causation: does the evidence show that Defendants' "codon-optimization" process for the Jcovden vaccine was, in fact, an implementation of the patented method—specifically, that it involved identifying and reducing the particular sequences listed in the patent's Table II? The case may turn on whether Plaintiffs can demonstrate this specific modification was a deliberate part of Defendants' design, as alleged, rather than a coincidental artifact of a different, unpatented optimization strategy.