DCT

1:26-cv-00013

Bayer CropScience LLC v. Pfizer Inc

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Key Events
Complaint
complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:26-cv-00013, D. Del., 01/06/2026
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendants Pfizer Inc. and BioNTech US Inc. are organized under the laws of Delaware, and Defendants BioNTech SE and BioNTech Manufacturing GmbH are not U.S. residents and have allegedly consented to jurisdiction in the district in prior litigation.
  • Core Dispute: Plaintiff alleges that Defendants' method for developing and manufacturing their Comirnaty® COVID-19 vaccines infringes a patent related to methods for modifying structural gene sequences to enhance protein expression.
  • Technical Context: The technology concerns the field of genetic engineering, specifically methods to increase the stability of messenger RNA (mRNA) and the yield of protein production from a given gene sequence, a critical step in creating effective mRNA-based therapeutics and vaccines.
  • Key Procedural History: The patent-in-suit is a pre-GATT patent, meaning its term is 17 years from its issue date. Its prosecution history was notably lengthy, involving an eight-year interference proceeding at the U.S. Patent and Trademark Office and related federal court litigation that ultimately confirmed priority of invention for the named inventors.

Case Timeline

Date Event
1989-02-24 U.S. Patent No. 7,741,118 Priority Date
2010-06-22 U.S. Patent No. 7,741,118 Issues
2020-01-11 Native genetic sequence for original SARS-CoV-2 spike protein public
2020-12-11 FDA authorizes Defendants' BNT162b2 vaccine for emergency use
2026-01-06 Complaint Filed

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 (“the ’118 Patent”), "Synthetic Plant Genes and Method for Preparation," issued June 22, 2010.

The Invention Explained

  • Problem Addressed: The patent addresses the challenge of expressing genes from microorganisms, such as bacteria or viruses, at high levels within eukaryotic host cells, such as those of plants and animals (Compl. ¶31; ’118 Patent, col. 1:15-23). The specification explains that foreign genes, particularly those rich in adenine (A) and thymine (T) nucleotides, often contain sequences that are misinterpreted by the host cell's machinery, leading to messenger RNA (mRNA) instability and subsequent poor protein production (Compl. ¶¶ 6, 34; ’118 Patent, col. 1:53-62).
  • The Patented Solution: The invention provides a method for re-designing a gene's coding sequence to solve this problem. The method involves identifying and systematically reducing or eliminating specific "problem sequences" believed to cause mRNA instability, including putative polyadenylation signals and ATTTA sequences (’118 Patent, Abstract). This is achieved by substituting the codons that form these problem sequences with different "sense codons"—codons that code for the exact same amino acid but do not create the problematic sequence. This "codon optimization" process results in a modified gene that produces the same protein but generates a more stable mRNA transcript, leading to dramatically higher levels of protein expression (Compl. ¶¶ 7, 36; ’118 Patent, col. 10:14-20).
  • Technical Importance: This method provided a foundational technique to overcome poor expression of foreign genes, enabling the development of genetically engineered products ranging from insect-resistant crops to, as alleged in the complaint, viral vaccines (Compl. ¶¶ 3, 7).

Key Claims at a Glance

  • The complaint asserts independent claim 59 and dependent claims 60, 73, and 79 (Compl. ¶83).
  • Independent Claim 59 recites a method with three essential elements:
    • (a) Starting with a protein-encoding sequence that contains specific "polyadenylation signal sequences" listed in the patent's Table II.
    • (b) Reducing the number of these specific sequences by substituting "sense codons" for the original codons.
    • (c) Making a final "structural gene" that includes the substituted codons and is characterized by the reduced number of Table II sequences.
  • The complaint does not explicitly reserve the right to assert other dependent claims.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are the methods used to make Defendants' COVID-19 mRNA vaccines, sold under the brand name Comirnaty®, and all related monovalent and bivalent booster vaccines targeting various SARS-CoV-2 variants (the "Accused Products") (Compl. ¶¶ 8, 56, 67).

Functionality and Market Context

  • The Accused Products are mRNA vaccines designed to provide immunity to the SARS-CoV-2 virus. They function by delivering an mRNA molecule to human cells that instructs the cells to produce the viral spike protein, triggering an immune response (Compl. ¶¶ 44-45). The complaint alleges that to make the vaccine effective, Defendants needed to stabilize the mRNA molecule and optimize its expression, and did so using the patented method (Compl. ¶46). Figure 2 of the complaint provides a CDC infographic that visually explains this general mechanism of action for mRNA vaccines (Compl. p. 19, Figure 2). The complaint alleges that Defendants have generated over $93 billion in global sales revenue from these vaccines (Compl. ¶59).

IV. Analysis of Infringement Allegations

’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; The native viral coding sequences for the SARS-CoV-2 spike protein, which Defendants allegedly used as their starting point, contained numerous instances of the nucleotide sequences listed in the patent's Table II. ¶70 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 final coding sequence for the spike protein in their vaccines by replacing codons within the identified Table II sequences with different codons that encode the same amino acids, thereby reducing the number of such sequences. ¶71 col. 10:14-20
(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 complaint alleges Defendants manufacture a DNA template in the U.S. that embodies the modified coding sequence, which has a significantly reduced number of Table II sequences but still encodes the spike protein. ¶72 col. 10:14-17

The complaint includes several data tables that allege a quantitative reduction in "Problem Sequences." For example, one table alleges that for the BNT162b2 vaccine, the number of "Table II Sequences" was reduced from 30 in the starting sequence to 1 in the final vaccine sequence (Compl. p. 27).

Identified Points of Contention

  • Scope Questions: The ’118 Patent's specification is heavily focused on expressing genes in plants. A central question for the court may be whether the claims, which are not explicitly limited to a particular organism, can be properly construed to cover a method of optimizing a viral gene for use in a human vaccine. The complaint asserts the underlying scientific principles of mRNA instability apply in both plant and animal cells (Compl. ¶6).
  • Technical Questions: The claims recite a "method of making a structural gene." The complaint alleges Defendants manufacture an optimized "DNA template" in the U.S. (Compl. ¶49). A likely point of dispute will be whether creating this DNA template constitutes "making a structural gene" as the term is used in the patent, or if the "structural gene" is more properly considered the resulting mRNA, which may raise different infringement issues.

V. Key Claim Terms for Construction

"structural gene"

  • Context and Importance: This term appears in the preamble of claim 59 ("A method of making a structural gene"). Its definition is critical because the infringement allegation centers on Defendants' creation of a DNA template that is then transcribed into mRNA (Compl. ¶49). Whether the creation of this DNA template falls within the scope of "making a structural gene" will be a pivotal issue.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent does not provide an explicit, limiting definition. A party could argue that in the context of the invention, it refers broadly to the primary coding sequence for a protein, irrespective of whether it is DNA or RNA.
    • Evidence for a Narrower Interpretation: The specification repeatedly discusses modifying "DNA regions" and using techniques like "site-directed mutagenesis of the DNA" ('118 Patent, col. 10:52-53). Conventional biological usage often defines a "gene" as a unit of heredity encoded in DNA. This context suggests "structural gene" refers to the DNA sequence, not the transient mRNA copy.

"contains polyadenylation signal sequences listed in Table II"

  • Context and Importance: Claim 59 requires that the "starting" coding sequence "contains" these specific nucleotide strings. The defense may argue that while these strings are present, they do not function as polyadenylation signals in the native virus and thus are not the "sequences" contemplated by the patent. Practitioners may focus on this term because it determines whether the accused process meets the first step of the claimed method.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language is "listed in Table II," suggesting the requirement is the presence of the literal sequence, not its biological function. The patent refers to them as "putative" signals, acknowledging uncertainty about their function but still identifying them as targets for removal based on their sequence identity (’118 Patent, col. 3:58-60).
    • Evidence for a Narrower Interpretation: The patent’s background is premised on these sequences having a destabilizing effect, even if improper, on mRNA in eukaryotic cells (’118 Patent, col. 3:53-63). A party could argue that for a sequence to be a "polyadenylation signal sequence" under the patent, it must have the potential to be recognized as such by the cellular machinery, and evidence may be required to show this for the native viral sequences.

VI. Other Allegations

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

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

  • A core issue will be one of technological scope: can a method for improving gene expression, developed and primarily exemplified in the 1980s for agricultural biotechnology in plants, be construed to cover the modern process of optimizing a viral gene sequence for a human mRNA vaccine?
  • The case will likely involve a central definitional dispute: does the accused act of synthesizing an optimized "DNA template" in a U.S. facility meet the claim limitation of "making a structural gene" as that term is defined by the intrinsic evidence of the ’118 Patent?
  • A key evidentiary question will be one of functional significance: does the infringement analysis turn on the mere presence of the nucleotide strings from Table II in the starting sequence, or must there be evidence that these specific sequences were responsible for the mRNA instability that the patent purports to solve?