DCT

4:23-cv-00085

Bayer CropScience LP v. Duffy

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 4:23-cv-00085, E.D. Mo., 01/25/2023
  • Venue Allegations: Venue is alleged to be proper as the Defendant resides and operates his farming business within the judicial district, and because the parties contractually agreed to the Eastern District of Missouri as the exclusive forum in a licensing agreement.
  • Core Dispute: Plaintiffs allege that Defendant’s planting of saved soybean seeds and subsequent application of unapproved herbicides infringe patents related to genetically modified, herbicide-tolerant seed technology, in violation of both patent law and a licensing agreement.
  • Technical Context: Genetically engineered crops with herbicide-tolerance traits are a cornerstone of modern agriculture, enabling effective weed management over millions of acres and significantly impacting crop yields.
  • Key Procedural History: The complaint alleges that the Defendant entered into a Technology Stewardship Agreement (TSA), a limited use license that expressly prohibits farmers from saving harvested seed for replanting and restricts the types of herbicides that may be used on the crops; this agreement is cited as establishing Defendant’s knowledge for the purposes of willful infringement.

Case Timeline

Date Event
2005-05-27 ’945 Patent Priority Date
2007-02-26 ’729 Patent Priority Date
2010-11-23 ’729 Patent Issue Date
2017-01-01 Defendant allegedly signed Technology Stewardship Agreement (TSA)
2018-04-17 ’945 Patent Issue Date
2020-01-01 Alleged infringement began during the 2020 soybean season
2023-01-25 Complaint Filing Date

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

U.S. Patent No. 9,944,945 - "Soybean event MON89788 and methods for detection thereof"

  • Patent Identification: U.S. Patent No. 9,944,945, "Soybean event MON89788 and methods for detection thereof," issued April 17, 2018.

The Invention Explained

  • Problem Addressed: When a new gene is inserted into a plant’s genome to create a transgenic crop, its location of insertion is random. This randomness can lead to wide variations in the gene's expression, with some "events" (a specific insertion at a specific location) performing optimally while others are ineffective or detrimental. The patent notes the need to screen a large number of events to identify one with the desired level of gene expression for commercial purposes ('945 Patent, col. 2:1-14).
  • The Patented Solution: The invention is not the glyphosate-tolerance gene itself, but the specific, unique transgenic event named MON89788. The patent identifies the precise DNA sequences at the junction between the inserted foreign DNA (the transgene) and the native soybean DNA. This unique "fingerprint" allows for the precise identification of plants containing this specific, commercially valuable event and distinguishes it from all other soybean plants, including those with different glyphosate-tolerance events ('945 Patent, col. 3:56-61; Fig. 1).
  • Technical Importance: The isolation and characterization of a specific, high-performing transgenic event is a critical step in developing a commercially successful genetically modified crop, ensuring stable and predictable trait performance across generations ('945 Patent, col. 2:15-24).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 3, 5, and 7 (Compl. ¶92).
  • Independent Claim 1:
    • A transgenic soybean plant, seed, or plant part
    • comprising a DNA molecule comprising SEQ ID NO: 3
    • flanking a glyphosate tolerant 5-enolpyruvyl-3-physphoshikimate synthase (EPSPS) coding sequence.

U.S. Patent No. 7,838,729 - "Chloroplast transit peptides for efficient targeting of DMO and uses thereof"

  • Patent Identification: U.S. Patent No. 7,838,729, "Chloroplast transit peptides for efficient targeting of DMO and uses thereof," issued November 23, 2010.

The Invention Explained

  • Problem Addressed: For a plant to be made tolerant to the herbicide dicamba, it must express an enzyme called dicamba monooxygenase (DMO) that degrades the herbicide. The patent explains that the plant's own machinery for powering the DMO enzyme is located within cellular compartments called chloroplasts. Therefore, for the DMO enzyme to function efficiently and provide robust herbicide tolerance, it must be transported from where it is made into the chloroplasts (’729 Patent, col. 1:28-33).
  • The Patented Solution: The invention provides specific genetic sequences that encode a "chloroplast transit peptide" (CTP). A CTP acts like a biological shipping label; when attached to the DMO enzyme, it directs the cell's transport machinery to deliver the DMO protein to the chloroplasts. The patent claims the combination of a CTP-encoding DNA sequence operably linked to a DMO-encoding DNA sequence, creating a tool to ensure the herbicide-degrading enzyme reaches its required site of action (’729 Patent, col. 2:9-16).
  • Technical Importance: This technology enables the development of crops with effective tolerance to dicamba, giving farmers a crucial alternative for controlling weeds that may have developed resistance to other common herbicides (’729 Patent, col. 1:23-28).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 23, and dependent claims 5, 16, 29 and 30 (Compl. ¶101, ¶108).
  • Independent Claim 1 (Composition):
    • A recombinant DNA molecule comprising a DNA sequence encoding a chloroplast transit peptide
    • operably linked to a DNA sequence encoding dicamba monooxygenase,
    • wherein the DNA sequence encoding the chloroplast transit peptide encodes SEQ ID NO:1.
  • Independent Claim 23 (Method):
    • A method for controlling weed growth in a crop growing environment comprising a plant of claim 16 or a seed thereof,
    • comprising applying to the crop growing environment an amount of dicamba herbicide effective to control weed growth.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are soybean seeds containing Plaintiffs' Roundup Ready 2 Yield®, Roundup Ready 2 Xtend®, and/or XtendFlex® technologies, which Defendant allegedly saved from a prior harvest and replanted, as well as the method of applying dicamba herbicides to the resulting crops (Compl. ¶1, ¶82-84).

Functionality and Market Context

  • The accused seeds are genetically modified to express proteins that confer tolerance to herbicides. The "Roundup Ready" trait provides tolerance to glyphosate, while the "Xtend" and "XtendFlex" traits provide tolerance to both glyphosate and dicamba (Compl. ¶15, ¶18). This allows farmers to apply these herbicides "over the top" of growing crops to control weeds without harming the crop itself. The complaint characterizes these technologies as "revolutionary" and providing "significant economic benefits" by simplifying weed management (Compl. ¶15-16). The core of the accused activity is the unauthorized replication ("making") and planting ("using") of these patented seeds, an action allegedly prohibited by a license agreement signed by the Defendant (Compl. ¶1, ¶71).

IV. Analysis of Infringement Allegations

’945 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A transgenic soybean plant, seed, or plant part Defendant made and used soybean plants and seeds by saving seed from a prior harvest and planting it in subsequent seasons. ¶92 col. 33:57-61
comprising a DNA molecule comprising SEQ ID NO: 3 The saved seeds allegedly contained Plaintiffs' Roundup Ready 2 Yield®, Roundup Ready 2 Xtend®, and/or XtendFlex® technology, which embodies the patented invention. ¶92 col. 7:42-49
flanking a glyphosate tolerant 5-enolpyruvyl-3-physphoshikimate synthase (EPSPS) coding sequence. The patented technology contained within the saved seeds includes the claimed EPSPS coding sequence flanked by the specific genomic DNA of SEQ ID NO: 3. ¶92 col. 9:1-5

’729 Patent Infringement Allegations

Claim Element (from Independent Claim 23) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for controlling weed growth in a crop growing environment comprising a plant of claim 16 or a seed thereof... Defendant planted soybean seeds containing the Roundup Ready 2 Xtend® and/or XtendFlex® technology, which embodies the patented invention for dicamba tolerance. ¶108 col. 12:41-43
...comprising applying to the crop growing environment an amount of dicamba herbicide effective to control weed growth. Defendant applied unapproved and unlabeled dicamba herbicides to his soybean crop, including applications after the legally mandated "cut-off" date. ¶108-109 col. 12:43-45

Identified Points of Contention

  • Evidentiary Questions: The case may depend on factual proof. A central question will be whether Plaintiffs can produce evidence (e.g., from seed/plant tissue testing) demonstrating that the specific seeds Defendant saved and planted contained the patented MON89788 event ('945 Patent) and the claimed CTP-DMO technology ('729 Patent).
  • Scope Questions: Count III alleges infringement of a method claim by applying "unapproved and unlabeled" dicamba. This raises the question of whether the claim term "dicamba herbicide" is limited in any way by the regulatory status of the herbicide applied. The analysis may focus on whether the claim language itself contains any such limitation, or if it reads on the application of any chemical formulation of dicamba.
  • Legal Questions: The dispute invokes the legal principle of patent exhaustion. A likely question for the court is whether, under established precedent, the act of harvesting and replanting a patented seed constitutes an unauthorized "making" of a new infringing article, thereby exceeding the rights conferred to a purchaser of the original seed.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

The Term: "a soybean plant, seed, or...of soybean event MON89788"

  • (from the '945 Patent, claim 1 is tied to this via SEQ ID NO:3 which defines the event's flank).
  • Context and Importance: The entire infringement case for the '945 Patent rests on this definition. The Plaintiffs must prove that the Defendant's saved seeds fall within the scope of this term. Its construction is less about interpretation and more about factual identification.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent defines the event not by its phenotype (glyphosate tolerance) alone, but by its unique genetic structure. The specification explicitly links the event MON89788 to the specific junction sequences between the transgene and the host genome ('945 Patent, col. 3:56-61). This suggests any seed containing these precise sequences is "of" the event.
    • Evidence for a Narrower Interpretation: The definition is inherently precise and limited to the specific DNA sequences disclosed, such as SEQ ID NO:1, SEQ ID NO:2, and the overall map in Figure 1. A defense would center on arguing that any seeds tested do not contain these exact, claimed sequences, thereby falling outside the term's scope.

The Term: "applying...dicamba herbicide"

  • (from the '729 Patent, claim 23).
  • Context and Importance: This term is central to the infringement theory in Count III, where Plaintiffs allege infringement by Defendant's application of "unapproved" and "off-label" dicamba. Practitioners may focus on this term because its construction will determine whether the regulatory status of the applied herbicide is relevant to the patent infringement analysis itself.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification repeatedly discusses "dicamba" as a chemical compound and an herbicide generally, without qualification as to specific commercial formulations or regulatory approval status ('729 Patent, col. 3:32-37). This may support a construction where "dicamba herbicide" means any product containing the active ingredient dicamba.
    • Evidence for a Narrower Interpretation: A defendant could potentially argue that the patent, by teaching a system to enable the safe use of dicamba on crops, implicitly requires the term to be construed as dicamba applied in a legally permissible manner. The specification's objective is to provide "improved tolerance to dicamba" ('729 Patent, col. 1:31-32), which could be argued to imply use within the bounds of agricultural practice, not in violation of it.

VI. Other Allegations

  • Indirect Infringement: The complaint does not contain allegations of indirect infringement; it focuses on direct infringement by the Defendant for allegedly "making" and "using" the patented seeds and technology.
  • Willful Infringement: Willfulness is alleged for all patent counts (Compl. ¶96, ¶105, ¶115). The complaint bases this allegation on pre-suit knowledge, asserting that Defendant signed a Technology Stewardship Agreement (TSA) in 2017 and received subsequent annual updates which provided notice of Plaintiffs' patent rights and the express prohibition on saving seed (Compl. ¶79). The complaint also alleges that the seed bags are marked with notice of the asserted patents (Compl. ¶73-74).

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

  • A central issue will be one of evidentiary proof: Can Plaintiffs demonstrate through genetic testing or other means that the specific seeds Defendant saved and replanted in 2020-2022 in fact contained the patented MON89788 genetic event and the dicamba-tolerance technology claimed in the asserted patents?
  • The case will also turn on a foundational question of patent rights versus property rights: Does a farmer's act of harvesting and replanting a crop grown from patented seed constitute an unauthorized "making" of a new infringing article, or does the initial authorized sale of the seed exhaust the patent holder's rights with respect to subsequent generations?
  • A third question involves claim scope in a regulatory context: Does the method claim of applying "dicamba herbicide" to the patented crop cover the application of any product containing the chemical dicamba, or could the term be construed to exclude "unapproved" or "off-label" applications that violate external regulations and the patent's stated purpose of enabling effective weed control?