DCT
4:23-cv-01393
Bayer CropScience LP v. Patrick R Lovett
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bayer CropScience LP (Delaware) and Monsanto Technology LLC (Delaware)
- Defendant: Patrick R. Lovett d/b/a Pat Lovett and Lovett Farms (North Carolina)
- Plaintiff’s Counsel: Thompson Coburn LLP
- Case Identification: 4:23-cv-01393, E.D. Mo., 11/01/2023
- Venue Allegations: Venue is asserted based on a forum selection clause in a 2012 licensing agreement allegedly executed by the Defendant, which designated the Eastern District of Missouri as the exclusive forum for disputes.
- Core Dispute: Plaintiff alleges that Defendant’s planting of saved soybean seeds, harvested from a prior season's crop, constitutes infringement of patents covering genetically modified, herbicide-tolerant seed technology.
- Technical Context: The technology involves genetically modifying soybeans to tolerate specific herbicides, such as glyphosate and dicamba, which is a foundational technology for modern weed management in large-scale agriculture.
- Key Procedural History: The complaint alleges that the Defendant entered into a Technology Stewardship Agreement (TSA) in 2012 and received updates in subsequent years, which established a limited, single-use license for the patented seed technology and expressly prohibited the saving of seed for replanting.
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 |
| 2011 | Defendant enters into 2012 Technology Stewardship Agreement |
| 2018-04-17 | '945 Patent Issue Date |
| 2023 (at least) | Defendant purchases and plants accused seed |
| 2023-11-01 | 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" (issued April 17, 2018)
The Invention Explained
- Problem Addressed: The patent's background explains that when a new gene is inserted into a plant's genome, its expression level can vary significantly depending on the insertion location. For commercializing a genetically modified crop, it is critical to select a single, stable insertion "event" with optimal gene expression and to have a reliable method for detecting that specific event in subsequent generations and derived products (’945 Patent, col. 2:1-25).
- The Patented Solution: The invention is not a general concept but a specific, man-made biological article: the soybean event designated MON89788, which contains a gene conferring glyphosate tolerance. The patent claims the unique DNA sequences that span the junction between the soybean's native genome and the inserted gene cassette. This unique genetic "fingerprint," illustrated in the patent's Figure 1, allows for the precise and unambiguous detection of the MON89788 event and distinguishes it from all other soybean varieties and transgenic events (’945 Patent, Abstract; col. 3:5-15).
- Technical Importance: The creation and characterization of a specific, high-performing transgenic event like MON89788 is the final, critical step in developing a commercial GM crop, while the ability to precisely detect it is essential for intellectual property protection, regulatory compliance, and quality control throughout the supply chain (’945 Patent, col. 2:26-44).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 5 (Compl. ¶39).
- 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.
- Independent 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 also asserts dependent claims 3 and 7 (Compl. ¶39).
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: This patent addresses the challenge of engineering dicamba herbicide tolerance into plants using a bacterial enzyme, dicamba monooxygenase (DMO). For the DMO enzyme to function effectively, it must be transported into the chloroplasts within plant cells. The patent notes that simply introducing the DMO gene is insufficient, and some targeting methods can result in the creation of incorrectly processed, and thus less active or inactive, forms of the enzyme, which complicates regulatory approval and reduces efficacy (’729 Patent, col. 5:19-65).
- The Patented Solution: The invention provides specific polynucleotide sequences that encode "chloroplast transit peptides" (CTPs). These CTPs function as molecular "address labels" that, when attached to the DMO enzyme, guide it to the chloroplast. The invention identifies particular CTPs that not only ensure correct targeting but also lead to clean and complete processing of the DMO enzyme, resulting in a single, correctly-sized, and fully active protein (’729 Patent, Abstract; col. 6:1-19).
- Technical Importance: By enabling the efficient targeting and proper processing of the DMO enzyme, the invention provides a more effective and commercially viable way to produce dicamba-tolerant crops, improving both the level of herbicide tolerance and the predictability of the resulting protein product for regulatory purposes (’729 Patent, col. 6:55-63).
Key Claims at a Glance
- The complaint asserts independent claim 29 (Compl. ¶48).
- Independent Claim 29: 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 also asserts dependent claim 30 (Compl. ¶48).
III. The Accused Instrumentality
Product Identification
- Saved soybean seed containing Plaintiff’s "Roundup Ready 2 Xtend®" and/or "XtendFlex®" technology, which Defendant allegedly planted in the 2023 growing season after saving it from a prior harvest (Compl. ¶1, 33). The infringing acts are identified as the "making and/or using" of this saved seed without authorization (Compl. ¶31, 39, 48).
Functionality and Market Context
- The accused seeds are genetically modified to express proteins that confer tolerance to the herbicides glyphosate and dicamba; XtendFlex® seeds are additionally tolerant to glufosinate (Compl. ¶13, 16). This technology allows for over-the-top application of these herbicides for weed control without damaging the crop. The complaint alleges this technology is subject to a limited use license (TSA) that prohibits farmers from saving harvested seed for replanting, requiring them to purchase new seed each season from an authorized dealer (Compl. ¶17, 24).
- No probative visual evidence provided in complaint.
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 | The saved soybeans planted by Defendant, and the resulting soybean plants grown therefrom, are alleged to be transgenic seeds and plants. | ¶31, 33, 39 | col. 36:58-59 |
| comprising a DNA molecule comprising SEQ ID NO: 3 flanking a glyphosate tolerant ... EPSPS coding sequence. | The complaint alleges that the saved seed contains the Roundup Ready 2 Xtend® technology, which embodies the patented MON89788 invention and therefore contains the specific DNA junction of SEQ ID NO: 3. | ¶37, 39 | col. 36:59-63 |
- Identified Points of Contention:
- Factual Question: The central dispute will be a question of fact requiring scientific evidence: do the seeds saved and planted by the Defendant actually contain the MON89788 event, which is defined by the specific DNA junction sequences (SEQ ID NO: 3 and SEQ ID NO: 4) claimed in the patent?
- Legal Question: The case raises the established legal question of whether planting a patented seed, which then self-replicates, constitutes an infringing act of "making" a new patented article under 35 U.S.C. § 271. The complaint’s infringement theory rests on this interpretation, previously affirmed by the Supreme Court.
'729 Patent Infringement Allegations
| Claim Element (from Independent Claim 29) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A dicamba tolerant seed | The saved Roundup Ready 2 Xtend® and XtendFlex® seeds are alleged to be tolerant to the herbicide dicamba. | ¶13, 20, 48 | col. 69:15 |
| comprising a DNA encoding a chloroplast transit peptide of SEQ ID NO:1 operably linked to a DNA encoding dicamba monooxygenase. | The complaint alleges the saved seed contains technology embodying the '729 patent's invention, implying the presence of the specific genetic construct claimed to confer dicamba tolerance. | ¶21, 48 | col. 69:16-19 |
- Identified Points of Contention:
- Technical Question: Infringement will depend on whether the Roundup Ready 2 Xtend® and XtendFlex® technologies practice the specific invention of the ’729 Patent. The plaintiff will need to demonstrate that the genetic construct in the accused seeds includes the claimed chloroplast transit peptide (SEQ ID NO:1) "operably linked" to a DMO gene.
- Scope Question: The analysis will turn on whether the accused seeds fall within the scope of a "dicamba tolerant seed" that contains the specific genetic elements recited in the claim.
V. Key Claim Terms for Construction
For the '945 Patent
- The Term: "transgenic soybean plant, seed, or plant part"
- Context and Importance: While the technical meaning is clear, the legal scope of this term is central to all saved-seed litigation. The dispute will not be over the scientific definition of "transgenic," but over whether the act of planting a seed and allowing it to grow into a new plant (which produces more seeds) constitutes an infringing "making" of a new article, or is merely a permissible "use" of an article that was previously purchased.
- Intrinsic Evidence for Interpretation: The patent itself does not provide a definition that resolves this legal issue, as it is a matter of statutory interpretation under 35 U.S.C. § 271. The specification describes the initial creation of the transgenic plant via Agrobacterium-mediated transformation (’945 Patent, col. 12:1-12), but the claims cover the resulting plant and its progeny, regardless of how they are generated.
For the '729 Patent
- The Term: "operably linked"
- Context and Importance: This is a foundational term in biotechnology patents. For infringement to be found, the plaintiff must prove not only that the DNA for the CTP and the DMO enzyme are present in the accused seed, but that they are joined together in a way that allows them to function as intended—specifically, for the CTP to direct the DMO to the chloroplast. Practitioners may focus on this term because it requires proof of a functional relationship, not just the presence of DNA sequences.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification suggests a functional definition, stating that the invention provides "Chimeric DNA molecules comprising a DNA encoding a chloroplast transit peptide operably linked to a DNA encoding dicamba monooxygenase" for the purpose of expression and transport (’729 Patent, col. 6:62-65).
- Evidence for a Narrower Interpretation: A defendant could argue that the patent repeatedly emphasizes the importance of efficient and complete processing as the key advantage of the invention (’729 Patent, col. 6:8-16). This could support a narrower construction where "operably linked" requires not just any functional linkage, but one that achieves the superior processing results highlighted in the patent's examples.
VI. Other Allegations
- Indirect Infringement: The complaint’s prayer for relief includes a request for a judgment of indirect infringement (Compl., Prayer for Relief ¶A). However, the factual allegations in the body of the complaint describe conduct—a farmer planting seeds on his own farm—that exclusively supports a theory of direct infringement under 35 U.S.C. § 271(a) (Compl. ¶31, 39, 48). The complaint does not allege facts to support inducement or contributory infringement, such as selling saved seed to others.
- Willful Infringement: The complaint alleges that the defendant's infringement was willful (Compl. ¶31-33). This allegation is based on alleged pre-suit knowledge of the patents and use restrictions arising from two sources: (1) Technology Stewardship Agreements (TSAs) the defendant allegedly entered into, which explicitly prohibited saving seed and put him on notice of the patents (Compl. ¶30, 55); and (2) patent markings allegedly placed on the bags of seed, which provided statutory notice of the '945 and '729 patents (Compl. ¶26-27).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central evidentiary question of identity: Can the plaintiff prove, through DNA testing, that the seeds saved and planted by the Defendant contain the exact genetic sequences protected by the asserted claims—specifically, the MON89788 junction sequences of the ’945 patent and the CTP-DMO construct of the ’729 patent?
- A core legal question of patent rights versus exhaustion: Will the court affirm the precedent that a farmer's act of planting a patented, self-replicating seed constitutes the "making" of a new, infringing article, or will the defendant succeed in arguing that this conduct is a permissible "use" of a legally purchased product under the patent exhaustion doctrine?
- A dispositive question of willfulness: Does the evidence of signed licensing agreements and on-bag patent notices establish that the defendant had actual knowledge of the patents and the associated use restrictions, thereby exposing the defendant to a finding of willful infringement and potential enhanced damages?