DCT

4:23-cv-00088

Bayer CropScience LP v. Pierce

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 4:23-cv-00088, E.D. Mo., 01/25/2023
  • Venue Allegations: Venue is alleged to be proper as Defendant resides and operates his farming business in the judicial district, the infringing acts occurred there, and a licensing agreement executed by Defendant designated the district as the exclusive forum.
  • Core Dispute: Plaintiffs allege that Defendant’s farming operation infringed patents on genetically modified soybean technology by saving seeds from one harvest and planting them in subsequent seasons, in violation of a single-use license.
  • Technical Context: The technology involves soybean seeds genetically engineered to tolerate herbicides, specifically glyphosate and dicamba, which allows for simplified and effective weed control in agriculture.
  • Key Procedural History: The complaint alleges that Defendant executed a Technology Stewardship Agreement (TSA) in 2017, which constitutes a limited use license for the patented seed technology and expressly prohibits the saving of harvested seed for replanting. This agreement is central to the allegations of unauthorized use and willfulness.

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-XX-XX Defendant executes Technology Stewardship Agreement (TSA)
2018-04-17 '945 Patent Issue Date
2020–2022 Alleged Infringement Period during soybean seasons
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: The patent’s background describes the agricultural importance of developing crops with tolerance to herbicides like glyphosate. It also notes that when a new gene is inserted into a plant’s genome, its location can significantly affect its expression and the plant's characteristics. Therefore, there is a need to identify and characterize specific, high-performing "transgenic events" and develop reliable methods for detecting their presence for regulatory, commercial, and breeding purposes ('945 Patent, col. 1:26-40, col. 2:1-19).
  • The Patented Solution: The invention is the specific transgenic soybean event designated MON89788, which results from the insertion of a gene conferring glyphosate tolerance (CP4 EPSPS) into a specific location in the soybean genome. The patent claims the resulting unique DNA sequences that span the junction between the inserted transgene and the soybean's native "flanking" DNA, which serve as a unique fingerprint for the MON89788 event ('945 Patent, Abstract; FIG. 1).
  • Technical Importance: The MON89788 event provided farmers with a commercially valuable glyphosate-tolerant soybean line, enabling the use of Roundup® herbicide for effective weed control without damaging the crop ('945 Patent, col. 1:31-40).

Key Claims at a Glance

  • The complaint asserts independent claim 1 and dependent claims 3, 5, and 7 (Compl. ¶40).
  • The essential elements of independent claim 1 are:
    • A transgenic soybean plant, seed, or plant part
    • comprising a DNA molecule
    • comprising SEQ ID NO: 3
    • flanking a glyphosate tolerant 5-enolpyruvyl-3-phosphoshikimate 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: The patent addresses the challenge of engineering plants to be tolerant to the herbicide dicamba. An enzyme known as dicamba monooxygenase (DMO) can detoxify dicamba, but for it to function effectively in a plant cell, it must be transported into the chloroplasts where necessary co-factors are located. The patent notes that simply expressing the DMO gene is insufficient, as the resulting protein may not be correctly localized or processed, leading to reduced efficacy and potential regulatory hurdles due to the presence of unintended protein variants ('729 Patent, col. 5:23-44, col. 5:58-col. 6:7).
  • The Patented Solution: The invention provides specific DNA sequences that encode chloroplast transit peptides (CTPs). A CTP is a short molecular "address label" that, when attached to the DMO enzyme, directs it to the chloroplast. Once inside, the CTP is cleaved off, leaving a correctly sized, fully active DMO enzyme in the proper cellular compartment to neutralize dicamba ('729 Patent, Abstract; col. 6:8-21).
  • Technical Importance: By enabling the efficient localization and processing of the DMO enzyme, this invention was a critical step in creating commercially viable dicamba-tolerant crops, such as the Xtend® and XtendFlex® soybean lines ('729 Patent, col. 6:53-62).

Key Claims at a Glance

  • The complaint asserts independent claim 29 and dependent claim 30 (Compl. ¶49).
  • The essential elements of independent claim 29 are:
    • 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.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are soybean seeds containing Plaintiffs' patented Roundup Ready 2 Yield®, Roundup Ready 2 Xtend®, and/or XtendFlex® genetic technologies, which Defendant allegedly saved from a prior harvest for planting in subsequent years (Compl. ¶¶ 1, 34).

Functionality and Market Context

  • The seeds are genetically engineered to produce plants that are tolerant to glyphosate herbicide (the trait in Roundup Ready 2 Yield® and the '945 Patent) and, in the case of Xtend® and XtendFlex® seeds, also tolerant to dicamba herbicide (the trait enabled by the '729 Patent) (Compl. ¶¶ 14, 17, 20-21). This technology allows farmers to apply these herbicides directly to their fields to control weeds without harming the soybean crop, which the complaint describes as offering "significant economic benefits" and having achieved "widespread adoption" (Compl. ¶15). The core of the alleged infringement is the unauthorized replication of this technology by saving and replanting seeds (Compl. ¶¶ 32, 36).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint alleges that Defendant directly infringed the patents-in-suit by "making" new patented seeds when he planted and grew a crop, and by "using" the patented invention when he planted those saved seeds in subsequent seasons without authorization (Compl. ¶¶ 32, 34, 40, 49).

'945 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A transgenic soybean...seed... Defendant allegedly made, used, and sold soybean seed saved from a prior year's harvest. ¶40 col. 38:58-62
...comprising a DNA molecule comprising SEQ ID NO: 3 flanking a glyphosate tolerant...EPSPS coding sequence. The saved seed allegedly contained Plaintiffs' Roundup Ready 2 Yield®, Xtend®, and/or XtendFlex® technology, which embodies the MON89788 event defined by the patent's claimed DNA sequences. ¶40 col. 8:31-34

'729 Patent Infringement Allegations

Claim Element (from Independent Claim 29) Alleged Infringing Functionality Complaint Citation Patent Citation
A dicamba tolerant seed... Defendant allegedly made, used, and sold soybean seed containing Roundup Ready 2 Xtend® and/or XtendFlex® technology, which confers tolerance to dicamba. ¶49 col. 3:32-34
...comprising a DNA encoding a chloroplast transit peptide of SEQ ID NO:1 operably linked to a DNA encoding dicamba monooxygenase. The saved seed containing Xtend® and/or XtendFlex® technology allegedly embodies the patented invention, which uses a CTP to enable dicamba tolerance. ¶49 col. 5:10-13
  • Identified Points of Contention:
    • Factual Proof: A central issue will be whether Plaintiffs can prove that Defendant in fact planted saved seeds containing the patented genetic traits. This raises an evidentiary question regarding what proof (e.g., genetic testing of field samples, purchase records, witness testimony) will be offered to substantiate the allegations of making and using unauthorized seed.
    • Patent Exhaustion: The dispute raises the question of patent exhaustion as it applies to self-replicating technologies. While the sale of a patented seed to a farmer exhausts the patentee's rights with respect to that purchased seed, the Supreme Court has held this does not grant the purchaser a license to "make" new patented articles by planting the seed and harvesting the progeny for replanting. The complaint's theory appears to align with this precedent, framing the saving and replanting of seed as an infringing act of "making" (Compl. ¶32).

V. Key Claim Terms for Construction

The complaint does not provide sufficient detail for analysis of specific claim terms that may be in dispute. The core of the lawsuit appears to be factual—whether Defendant planted saved seeds containing the patented technology—rather than a dispute over the meaning of claim language. The asserted claims recite specific biological products (a seed), traits (dicamba tolerant), and components (a specific DNA sequence), which are defined with a high degree of specificity in the patent, suggesting a limited basis for construction disputes.

VI. Other Allegations

  • Indirect Infringement: While the prayer for relief seeks a judgment of direct and indirect infringement, the factual allegations in the body of the complaint and the specific infringement counts focus exclusively on Defendant's own acts of "making, using, offering to sell, and/or selling saved...soybean seed," which constitute allegations of direct infringement (Compl. ¶¶ 40, 49, 63A).
  • Willful Infringement: The complaint alleges that Defendant's infringement was knowing, intentional, and willful (Compl. ¶¶ 32-33, 44). This allegation is based on alleged pre-suit knowledge of the patents and the terms of the single-use license. This knowledge is purportedly established by Defendant’s execution of the Technology Stewardship Agreement (TSA) in 2017, annual updates to that agreement, and patent notices on product bags and a virtual marking website (Compl. ¶¶ 27-28, 31).

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

  • A primary issue for the court will be one of factual evidence: Can Plaintiffs present sufficient evidence, such as genetic testing of plant tissue from Defendant's fields or purchase records, to prove that Defendant planted soybean seeds that (a) were saved from a prior harvest and (b) contained the specific patented genetic events claimed in the '945 and '729 patents?
  • A second key question will concern willfulness and damages: Does the evidence of Defendant’s execution of the Technology Stewardship Agreement (TSA), which explicitly prohibits saving seed, establish that the alleged infringement was undertaken with full knowledge of the patents and the limited scope of the license, thereby constituting willful infringement and justifying a potential award of enhanced damages?