DCT

4:23-cv-01417

Bayer CropScience LP v. Calder

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: Bayer CropScience LP v. Calder, 4:23-cv-01417, E.D. Mo., 11/06/2023
  • Venue Allegations: Plaintiffs allege that venue is proper in the Eastern District of Missouri based on a forum selection clause in a Technology Stewardship Agreement (TSA) that Defendant purportedly executed, designating the district as the exclusive forum for disputes.
  • Core Dispute: Plaintiffs allege that Defendant’s planting of soybean seeds saved from a prior harvest, in violation of a single-use license, constitutes infringement of patents covering genetically modified herbicide-tolerance technologies.
  • Technical Context: The technology involves genetically engineered seeds that allow crops to survive the application of specific herbicides, which is a cornerstone of modern agricultural weed management systems.
  • Key Procedural History: The complaint alleges that Defendant signed a 2023 Technology Stewardship Agreement, a limited-use license that expressly prohibits the saving and replanting of harvested seed. This agreement is presented as the basis for Defendant's alleged knowledge of the patents and the terms of authorized use, forming a foundation for the willfulness and breach of contract claims.

Case Timeline

Date Event
2005-05-27 U.S. Patent No. 9,944,945 Priority Date
2007-02-26 U.S. Patent No. 7,838,729 Priority Date
2010-11-23 U.S. Patent No. 7,838,729 Issue Date
2018-04-17 U.S. Patent No. 9,944,945 Issue Date
2023-03-16 Defendant agrees to terms of the 2023 Technology Stewardship Agreement
2023-11-06 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

The Invention Explained

  • Problem Addressed: For regulatory, commercial, and breeding purposes, it is necessary to reliably distinguish between different genetic modification "events," particularly those created using the same gene construct but integrated at different locations in a plant's genome ('945' Patent, col. 2:26-42).
  • The Patented Solution: The invention is not the herbicide-tolerance gene itself, but a specific, stable genetic insertion event in soybeans known as MON89788. The patent identifies the unique DNA sequences (referred to as SEQ ID NO:3 and SEQ ID NO:4) that are formed at the junction between the host soybean's native DNA and the inserted genetic material ('945 Patent, col. 3:56-col. 4:4; FIG. 1). These unique junction sequences act as a definitive "fingerprint" to identify plants containing the MON89788 event.
  • Technical Importance: The creation and characterization of a specific, stable genetic event with known flanking DNA sequences is a prerequisite for commercializing a transgenic crop, as it ensures consistent expression of the desired trait and is essential for obtaining regulatory approvals worldwide ('945 Patent, col. 2:5-25).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 5.
  • 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.
  • Claim 5: A transgenic soybean plant, seed, or plant part comprising a DNA molecule comprising SEQ ID NO: 4 flanking a glyphosate tolerant 5-enolpyruvyl-3-physphoshikimate synthase (EPSPS) coding sequence.
  • The complaint reserves the right to assert dependent claims 3 and 7 (Compl. ¶40).

U.S. Patent No. 7,838,729 - CHLOROPLAST TRANSIT PEPTIDES FOR EFFICIENT TARGETING OF DMO AND USES THEREOF

The Invention Explained

  • Problem Addressed: The patent's background explains that to confer tolerance to the herbicide dicamba, a bacterial enzyme called dicamba monooxygenase (DMO) must be expressed in a plant. For the DMO enzyme to function effectively, it must be physically transported into the plant cell's chloroplasts, where necessary co-factor proteins reside ('729' Patent, col. 1:21-33). This transport is mediated by a "chloroplast transit peptide" (CTP). However, the patent notes that using a non-optimal CTP can lead to incorrect processing of the enzyme, resulting in poor DMO activity and inadequate herbicide tolerance ('729 Patent, col. 1:56-col. 2:6).
  • The Patented Solution: The invention identifies specific CTPs that, when operably linked to the DMO gene, enable efficient transport into the chloroplast and correct processing of the DMO enzyme ('729 Patent, col. 4:6-23). This optimized CTP-DMO combination results in plants with robust and commercially viable tolerance to dicamba.
  • Technical Importance: Developing a functional CTP-DMO construct was a critical step for creating dicamba-tolerant crop systems, providing farmers with an important tool for managing weeds that have developed resistance to other herbicides ('729 Patent, col. 4:1-5).

Key Claims at a Glance

  • The complaint asserts claims 29 and 30.
  • Claim 29 (Independent): A dicamba tolerant seed comprising a DNA encoding a chloroplast transit peptide of SEQ ID NO:1 operably linked to a DNA encoding dicamba monooxygenase.
  • The complaint reserves the right to assert dependent claim 30 (Compl. ¶49).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are Roundup Ready 2 Xtend® and/or XtendFlex® soybean seeds, specifically seeds that Defendant allegedly saved from a prior harvest and replanted in 2023 (Compl. ¶¶1, 32).

Functionality and Market Context

  • The complaint alleges that the accused seeds are genetically modified to contain patented technologies that confer tolerance to glyphosate and dicamba herbicides (for Roundup Ready 2 Xtend®) and additionally to glufosinate herbicide (for XtendFlex®) (Compl. ¶¶1, 14, 17). This functionality allows farmers to apply these herbicides directly to their fields to control weeds without harming the soybean crop (Compl. ¶¶20-21). The complaint characterizes these technologies as "revolutionary" and having "widespread adoption" due to the "significant economic benefits" they provide to farmers (Compl. ¶¶14, 15).

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...seed... Defendant allegedly planted saved soybean seeds in 2023, thereby "making" and "using" new seeds. ¶¶32, 40 col. 1:24-28
...comprising a DNA molecule comprising SEQ ID NO: 3 flanking a glyphosate tolerant...EPSPS coding sequence. The planted seeds are alleged to be Roundup Ready 2 Xtend® or XtendFlex® soybeans, which contain the patented MON89788 genetic event defined by the claimed unique DNA junction sequence. ¶¶1, 32, 40 col. 3:56-61

'729 Patent Infringement Allegations

Claim Element (from Independent Claim 29) Alleged Infringing Functionality Complaint Citation Patent Citation
A dicamba tolerant seed... Defendant allegedly planted saved Roundup Ready 2 Xtend® or XtendFlex® seeds, which are by definition tolerant to dicamba herbicide. ¶¶1, 14, 49 col. 3:32-35
...comprising a DNA encoding a chloroplast transit peptide of SEQ ID NO:1 operably linked to a DNA encoding dicamba monooxygenase. The planted seeds are alleged to contain the Roundup Ready 2 Xtend® or XtendFlex® technology, which embodies the patented invention of using a specific CTP to functionally express the DMO enzyme and confer dicamba tolerance. ¶¶1, 17, 49 col. 5:10-14

Identified Points of Contention

  • Factual Question: The central dispute is factual, not technical. A primary question for the court will be whether Plaintiffs can produce sufficient evidence to prove that the specific seeds planted by Defendant were in fact saved from a prior harvest, as alleged (Compl. ¶32), rather than purchased from an authorized source.
  • Legal Question (Patent Exhaustion): The complaint appears structured to preempt a patent exhaustion defense. It alleges Defendant agreed to a Technology Stewardship Agreement (TSA), which acts as a single-use license prohibiting the saving of seed (Compl. ¶¶18, 25, 31). This raises the legal question of whether the TSA constitutes an enforceable limited license that effectively conditions the sale of the seeds and prevents the exhaustion of patent rights, consistent with legal precedent.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

This case appears to turn more on the act of infringement (saving and replanting seed) than on technical claim construction. However, certain terms are foundational to the legal theories.

  • The Term: "A transgenic soybean...seed" ('945 Patent, Claim 1)

    • Context and Importance: The core infringement allegation is that Defendant "made" and "used" the patented seeds without authorization by planting a prior year's harvest (Compl. ¶¶33, 35). Practitioners may focus on this term because the act of planting a seed and growing a new plant that produces more seeds has been established by the Supreme Court as an act of "making" a new, potentially infringing, patented article. The dispute will center on whether Defendant's alleged actions fall under this precedent.
    • Intrinsic Evidence for Interpretation: The patent claims are directed to the physical seed itself as a product containing the specified DNA molecules ('945 Patent, cls. 1, 3, 5, 7). The specification consistently describes the invention as embodied in a soybean plant or seed ('945 Patent, col. 2:63-65). The legal analysis will likely depend less on the patent's definition of "seed" and more on the application of case law to the act of replanting it.

  • The Term: "operably linked" ('729 Patent, Claim 29)

    • Context and Importance: This term is critical to the functionality of the '729 Patent's invention. Practitioners may focus on this term because infringement requires not just the presence of the CTP and DMO gene sequences, but their functional connection, resulting in the expression of a properly targeted and processed enzyme that confers dicamba tolerance.
    • Evidence for a Broader Interpretation: The specification provides a general definition, stating that "operably linked" refers to the arrangement of genetic elements in a way that permits them to function in their intended manner within a genetic construct ('729 Patent, Abstract).
    • Evidence for a Narrower Interpretation: The patent's background and detailed description emphasize that the "operable" linkage for this specific invention is one that results in efficient processing and improved tolerance, not merely a theoretical linkage ('729 Patent, col. 4:6-14). Evidence that the accused seeds exhibit high levels of dicamba tolerance may be used to argue they necessarily contain a construct that is "operably linked" in this successful, narrower sense.

VI. Other Allegations

  • Indirect Infringement: The complaint’s prayer for relief makes a conclusory allegation of indirect infringement (Prayer ¶A). However, the factual allegations within the body of the complaint focus exclusively on direct infringement through Defendant’s alleged personal acts of "making" and "using" the saved seeds (Compl. ¶¶33, 35). The complaint does not allege facts to support inducement or contributory infringement, such as transferring saved seed to others.
  • Willful Infringement: The complaint alleges willfulness on two grounds. First, it alleges Defendant had constructive notice of the patents through marking on the seed bags or via a virtual marking website (Compl. ¶¶27, 28). Second, it alleges Defendant had actual notice of the patents and the licensing restrictions by agreeing to the terms of the 2023 Technology Stewardship Agreement (TSA) on March 16, 2023, prior to the alleged infringement (Compl. ¶31).

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

  • A central issue will be one of evidentiary proof: Can Plaintiffs produce sufficient factual evidence, such as genetic testing of field samples or transactional records, to demonstrate that the soybean crop grown by Defendant in 2023 originated from saved seed rather than from a new, authorized purchase?
  • A key legal question will be the enforceability of the license: Assuming the factual allegations are proven, will the Technology Stewardship Agreement (TSA) be found to be an enforceable, single-use license that validly conditions the sale of the patented seeds and contractually precludes a patent exhaustion defense?
  • A final question will be one of product identity: While the complaint identifies the accused products by their commercial names, will discovery confirm that the specific seeds planted by Defendant in fact contain the precise genetic event markers and functional gene constructs covered by the asserted claims of the '945 and '729 patents?