DCT

2:26-cv-00071

Bayer CropScience LP v. Johnson & Johnson Inc

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Key Events
Amended Complaint
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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:26-cv-00071, D.N.J., 08/27/2026
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendants Janssen Pharmaceuticals, Inc. and Janssen Biotech, Inc. have regular and established places of business in the district. For other foreign-domiciled defendants, venue is based on their extensive contacts with the United States.
  • Core Dispute: Plaintiff alleges that Defendant's method for developing its Jcovden COVID-19 vaccine infringes a patent directed to methods for modifying genetic sequences to remove destabilizing elements and thereby enhance protein expression.
  • Technical Context: The technology involves the strategic modification of messenger RNA (mRNA) sequences, known as codon optimization, to improve their stability and increase the yield of a desired protein, a foundational technique in modern biotechnology and vaccine development.
  • Key Procedural History: The patent-in-suit is a pre-GATT patent with a priority date in 1989. The complaint notes that the patent's validity and the inventors' priority were confirmed through prior federal court litigation, an appeal to the Federal Circuit, and an eight-year interference proceeding before the Board of Patent Appeals and Interferences.

Case Timeline

Date Event
1989-02-24 '118 Patent Priority Date
1999-08-17 Mycogen Plant Science, Inc. v. Monsanto Co., 61 F. Supp. 2d 199 (D. Del. 1999) decision
2001-03-14 Mycogen Plant Science, Inc. v. Monsanto Co., 243 F.3d 1316 (Fed. Cir. 2001) decision
2004-01-29 Barton or Fischhoff v. Adang, 2003 WL 23280019 (BPAI Jan. 29, 2004) decision
2010-06-22 '118 Patent Issue Date
2020-01-11 Native genetic sequence for SARS-CoV-2 spike protein becomes public
2020-03-30 Defendants announce lead vaccine candidate for COVID-19
2020-07-27 Defendants begin Phase 1 clinical trials for Ad26.COV2.S
2021-02-27 FDA grants Emergency Use Authorization for Jcovden vaccine
2023-06-01 Defendants request withdrawal of Emergency Use Authorization for Jcovden
2026-08-27 Complaint Filing Date

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

  • Patent Identification: U.S. Patent No. 7,741,118, "SYNTHETIC PLANT GENES AND METHOD FOR PREPARATION", issued June 22, 2010 (the "'118 Patent").

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

The Invention Explained

  • Problem Addressed: The patent's background section addresses the problem of poor protein expression when introducing a gene from one type of organism (e.g., a bacterium or virus) into a "higher organism" like a plant or animal Compl. ¶34 This low expression is attributed to the resulting messenger RNA (mRNA) being unstable and rapidly degraded within the host cell (Compl. ¶6; Compl. ¶7, Compl. ¶¶col. 1:21-49).
  • The Patented Solution: The invention provides a method for re-engineering a gene's coding sequence to improve its expression. The inventors identified specific nucleotide sequences, such as "ATTTA" motifs and various "putative polyadenylation signals," that act as destabilizing elements within an mRNA molecule Compl. ¶7 '118 Patent, col. 1:53-62 The patented solution is a method of identifying these "Problem Sequences" in a target gene and systematically replacing them with different codons that encode for the exact same amino acid but lack the destabilizing characteristics, thereby increasing mRNA stability and dramatically boosting protein production Compl. ¶39 '118 Patent, abstract
  • Technical Importance: This method of enhancing heterologous gene expression was a significant advance that found applications in diverse fields, including creating insect-resistant crops in agriculture and, as alleged in this case, enabling the production of viral proteins for vaccines in pharmaceuticals Compl. ¶7

Key Claims at a Glance

  • The complaint asserts independent claim 59 and dependent claims 60, 73, and 79 (Compl. ¶¶60; Compl. ¶65; Compl. ¶69; Compl. ¶72).
  • The essential elements of independent claim 59 are:
    • A method of making a structural gene that encodes a protein, the method comprising:
    • (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 reserves the right to assert additional claims Compl. ¶59

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the method used to develop the Jcovden (Ad26.COV2.S) COVID-19 vaccine, and the vaccine itself is alleged to be a product made by that infringing method Compl. ¶8 Compl. ¶59

Functionality and Market Context

  • The Jcovden vaccine is a viral vector vaccine that uses a modified human adenovirus to deliver the genetic instructions for the SARS-CoV-2 spike protein to human cells Compl. ¶8 Compl. ¶47
  • The complaint alleges that to ensure the spike protein was adequately expressed in human cells, Defendants performed a "codon-optimization" on the native gene sequence of the Wuhan-Hu-1 SARS-CoV-2 spike protein (Compl. ¶8; Compl. ¶9). This optimization process allegedly involved removing "Problem Sequences"-specifically, putative polyadenylation signals (Table II sequences), ATTTA sequences, and regions of high A+T content-that are taught by the '118 Patent to cause mRNA instability Compl. ¶48
  • A table provided in the complaint contrasts the number of these alleged "Problem Sequences" in the native spike protein gene with the significantly reduced number in the final Jcovden vaccine sequence, illustrating the outcome of the accused modification process Compl. ¶¶48-49
  • The complaint alleges that the Jcovden vaccine generated billions of dollars in revenue for the Defendants Compl. ¶53

IV. Analysis of Infringement Allegations

The complaint includes Figure 1, which reproduces Table II from the patent listing the specific "Potential Polyadenylation Signals" that form a basis of the infringement claim Compl. p. 14

'118 Patent Infringement Allegations

Claim Element (from Independent Claim 59) Alleged Infringing Functionality Complaint Citation Patent Citation
(a) starting with a coding sequence that encodes a protein and that contains polyadenylation signal sequences listed in Table II; Defendants allegedly started with the native coding sequence for the SARS-CoV-2 spike protein, which is alleged to have contained 30 of the polyadenylation signal sequences listed in the patent's Table II. ¶62; ¶48 col. 15:50-64
(b) reducing the number of said polyadenylation signal sequences in the coding sequence by substituting sense codons for codons in the coding sequence; and Defendants allegedly designed the modified ("codon-optimized") coding sequence for the spike protein by substituting sense codons, thereby reducing the number of Table II sequences from 30 to 2. ¶63; ¶¶48-49 col. 10:17-20
(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 resulting modified structural gene, characterized by the reduced number of Table II sequences, was allegedly made and included in the Accused Product to encode the SARS-CoV-2 spike protein. ¶64; ¶¶48-49 col. 16:6-9
  • Identified Points of Contention:
    • Jurisdictional Questions: The complaint asserts direct infringement under 35 U.S.C. § 271(a), which requires the patented method to have been practiced within the United States Compl. ¶59 A central point of contention may be whether the Plaintiffs can produce sufficient evidence that the alleged gene design and "codon-optimization" activities occurred in the U.S., as Defendants are a mix of U.S. and foreign entities.
    • Scope Questions: The '118 Patent's specification is heavily focused on expressing bacterial genes in plants to confer insect resistance Compl. ¶35 A question for the court may be whether the patent's claims, which are not explicitly limited to plants, can be interpreted to cover the development of a human viral vaccine, or if the technological context of the disclosure implicitly limits the claim scope. The patent's mention of applicability to "animal cells" may support a broader construction Compl. ¶37 '118 Patent, col. 2:21-27
    • Technical Questions: The complaint also alleges infringement under 35 U.S.C. § 271(g) for importing a product "made by" the patented process Compl. ¶75 The litigation may turn on whether a method of designing a gene sequence (information) constitutes a process by which the final vaccine (a physical product) is "made," a legal question that has been subject to judicial interpretation.

V. Key Claim Terms for Construction

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

  • Context and Importance: This term defines the specific "problem sequences" central to the infringement allegation. The case hinges on whether the sequences Defendants allegedly removed from the native spike protein gene fall within this definition.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent explicitly presents these sequences in "Table II" under the heading "List of Sequences of the Potential Polyadenylation Signals" '118 Patent, col. 15:50-64 Plaintiffs may argue that infringement only requires a match to these literal sequences, as the patent refers to them as "putative" signals, suggesting their actual function in any given context is not a prerequisite Compl. ¶44 '118 Patent, col. 10:15-16
    • Evidence for a Narrower Interpretation: Defendants may argue that for a sequence to be a "polyadenylation signal," it must be shown to be functionally active as such in the relevant biological context (i.e., in a human cell). The patent's detailed discussion of how these signals disrupt mRNA accumulation could be used to argue that function is an implicit requirement of the term, not just sequence identity '118 Patent, col. 2:51-3:63

  • The Term: "substituting sense codons"

  • Context and Importance: This term defines the action of modifying the gene. The parties may dispute whether the complex algorithms used in modern "codon optimization" for vaccine design constitute the "substitution" method described in the 1989-priority-date patent.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent describes the substitution of codons as a way to alter the nucleotide sequence while preserving the amino acid sequence, a fundamental principle of codon degeneracy '118 Patent, col. 10:1-13 Plaintiffs may argue this broadly covers any form of codon optimization that achieves the claimed result of reducing "problem sequences."
    • Evidence for a Narrower Interpretation: The patent teaches substituting codons to achieve specific goals, such as removing the "Problem Sequences" and increasing G+C content Compl. ¶¶39-40 A defendant could argue its optimization was driven by different or more complex factors, such as matching human cell tRNA availability, and that any reduction in the patent's "problem sequences" was an incidental byproduct, not a "substitution" as taught by the patent.

VI. Other Allegations

The complaint does not contain specific counts for indirect or willful infringement.

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

  • A central factual question will be one of jurisdiction and evidence: what proof can Bayer provide that Janssen's gene "codon-optimization" activities-the core steps of the asserted method claim-were actually performed within the United States, as required for direct infringement under 35 U.S.C. § 271(a)?
  • A core legal issue will be one of cross-disciplinary scope: can the patent's claims, which originated from and are heavily exemplified in the context of improving protein expression in plants, be construed to cover the sophisticated bioinformatic algorithms used for developing modern human vaccines, or does the technological context of the disclosure limit the patent's reach?
  • A key legal question will concern the scope of 35 U.S.C. § 271(g): is a final vaccine product considered to be "made by" a patented process that claims a method of designing a gene sequence (an informational step), or does the statute require the patented process to be more directly involved in the physical manufacture of the final product?