DCT
4:23-cv-00083
Bayer CropScience LP v. Irions
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Bayer CropScience LP (Delaware/Missouri) and Monsanto Technology LLC (Delaware/Missouri)
- Defendant: Brian G. Irions d/b/a Brian Irions Farms and/or Irions Farms (Missouri)
- Plaintiff’s Counsel: Thompson Coburn LLP
- Case Identification: 4:23-cv-00083, E.D. Mo., 01/25/2023
- Venue Allegations: Venue is alleged to be proper as Defendant resides and operates his farming business within the judicial district, the infringing acts allegedly occurred there, and a licensing agreement executed by Defendant allegedly designates the district as the exclusive forum.
- Core Dispute: Plaintiff alleges that Defendant’s farming practices, specifically the planting of saved soybean seed and the subsequent application of unapproved herbicides to the resulting crops, infringe patents related to genetically modified, herbicide-tolerant seed technology.
- Technical Context: The technology involves genetically engineering soybean plants to tolerate specific herbicides (glyphosate and dicamba), enabling farmers to control weeds over-the-top of the crop without causing damage.
- Key Procedural History: The complaint alleges Defendant entered into a "Technology Stewardship Agreement" (TSA) in 2010, which governs the licensed use of the patented seed technology and allegedly prohibits the saving of seed for replanting.
Case Timeline
| Date | Event |
|---|---|
| 2005-05-27 | ’945 Patent Priority Date |
| 2007-02-26 | ’729 Patent Priority Date |
| 2010-01-01 | Defendant allegedly enters into Technology Stewardship Agreement (TSA) |
| 2010-11-23 | ’729 Patent Issue Date |
| 2018-04-17 | ’945 Patent Issue Date |
| 2020-01-01 | Alleged infringement begins during the 2020 soybean season |
| 2021-01-01 | Alleged infringement continues during the 2021 soybean season |
| 2022-01-01 | Alleged infringement continues during the 2022 soybean season |
| 2022-06-30 | Alleged application of dicamba herbicide after Missouri's regulatory cut-off date |
| 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," Issued April 17, 2018
The Invention Explained
- Problem Addressed: When developing transgenic plants, it is necessary to screen a large number of individual "events" (unique insertions of a gene into a plant's genome) to identify one with optimal expression of the desired trait. For regulatory, breeding, and intellectual property purposes, it is critical to have a method to definitively identify the presence of a specific, commercialized event and distinguish it from all others (ʼ945 Patent, col. 2:5-25).
- The Patented Solution: The invention provides the specific, unique DNA sequences that span the junction between the inserted transgene and the soybean's native genomic DNA for the particular event MON89788. These junction sequences act as a molecular fingerprint, allowing for the creation of precise tests (like PCR assays) to confirm the presence of this specific event in a biological sample (ʼ945 Patent, Abstract; col. 3:5-24).
- Technical Importance: This technology provides a definitive method for identifying a specific, commercially valuable genetic trait, which is crucial for enforcing patent rights, ensuring regulatory compliance, and integrating the trait into new plant varieties through conventional breeding programs (ʼ945 Patent, col. 2:26-31).
Key Claims at a Glance
- The complaint asserts independent claim 1 and dependent claims 3, 5, and 7 (Compl. ¶92).
- Claim 1 recites:
- 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," Issued November 23, 2010
The Invention Explained
- Problem Addressed: The enzyme Dicamba Monooxygenase (DMO) provides herbicide tolerance by degrading dicamba. For DMO to function effectively in a plant cell, it must be transported to the chloroplast, where its necessary co-factors (reductase and ferredoxin) are located. Simply expressing the DMO gene is insufficient; it requires a molecular "shipping label" to guide it to the correct subcellular location. Some of these labels, known as chloroplast transit peptides (CTPs), can be inefficient, resulting in incompletely processed or inactive enzymes, which reduces herbicide tolerance (ʼ729 Patent, col. 1:26-40; col. 2:1-7).
- The Patented Solution: The invention identifies and claims specific CTPs that, when fused to the DMO enzyme, efficiently guide the enzyme to the chloroplast and are then cleanly cleaved off. This process yields a correctly formed, fully functional DMO enzyme inside the chloroplast, leading to improved and more reliable dicamba tolerance in the plant (ʼ729 Patent, Abstract; col. 4:4-21).
- Technical Importance: The invention enables the creation of robustly dicamba-tolerant crops by ensuring the herbicide-degrading enzyme is delivered to the precise subcellular compartment required for maximum efficacy, a key step in developing commercially viable herbicide tolerance technology (ʼ729 Patent, col. 4:41-47).
Key Claims at a Glance
- The complaint asserts independent claims 1 and 23, among others (Compl. ¶¶101, 108).
- Claim 1 recites:
- 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.
- Claim 23 recites:
- 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 (1) soybean seeds saved from a prior harvest that contain Plaintiff's patented Roundup Ready 2 Yield®, Roundup Ready 2 Xtend®, and/or XtendFlex® technologies, and the plants grown therefrom; and (2) the method of applying unapproved dicamba herbicides to those plants (Compl. ¶¶1-2, 82-84).
- Functionality and Market Context: The complaint alleges the saved seeds contain patented genetic traits that confer tolerance to glyphosate and dicamba herbicides (Compl. ¶¶1, 15-18). This allows a farmer to spray these herbicides directly onto a field of growing crops to eliminate weeds without harming the soybeans. The complaint alleges Defendant planted these saved seeds over hundreds of acres in Missouri for at least the 2020, 2021, and 2022 growing seasons (Compl. ¶¶1, 80). The complaint further alleges Defendant applied unapproved, higher-volatility dicamba formulations to the resulting crops, in some instances after a state-mandated cut-off date (Compl. ¶¶2, 83-84).
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 comprising | Defendant allegedly made, used, and planted saved soybean seed from a prior year's harvest. | ¶¶82, 92 | col. 2:56-60 |
| a DNA molecule comprising SEQ ID NO: 3 flanking a glyphosate tolerant 5-enolpyruvyl-3-physphoshikimate synthase (EPSPS) coding sequence. | The saved seeds allegedly contain the Roundup Ready 2 Yield®, Xtend®, and/or XtendFlex® technology, which embodies the MON89788 event defined by the patent's sequence identifiers, including SEQ ID NO:3. | ¶¶90, 92 | col. 7:5-10 |
- ’729 Patent Infringement Allegations (Saved Seed - Claim 1)
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A recombinant DNA molecule comprising... | The saved soybean seeds allegedly contain the patented recombinant DNA molecule as part of their genome. | ¶101 | col. 5:10-15 |
| a DNA sequence encoding a chloroplast transit peptide...wherein the DNA sequence...encodes SEQ ID NO:1 | The accused Roundup Ready 2 Xtend® and XtendFlex® technologies allegedly utilize the claimed chloroplast transit peptide to target the DMO enzyme. | ¶¶18, 101 | col. 5:11-13; SEQ ID NO:1 |
| operably linked to a DNA sequence encoding dicamba monooxygenase | The accused technologies allegedly function by expressing the DMO enzyme to confer dicamba tolerance. | ¶¶18, 101 | col. 1:19-24 |
- ’729 Patent Infringement Allegations (Herbicide Application - Claim 23)
| 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 allegedly planted the saved seeds, which grew into soybean plants containing the patented technology as described in claim 16. | ¶¶82, 108 | col. 20:4-14 |
| comprising applying to the crop growing environment an amount of dicamba herbicide effective to control weed growth. | Defendant allegedly applied unapproved dicamba herbicides over the top of his soybean crops to control weeds. | ¶¶83-84, 108 | col. 4:6-14 |
- Identified Points of Contention:
- Factual Proof: The central questions appear to be factual rather than legal or definitional. The case may turn on Plaintiff’s ability to prove through evidence (e.g., genetic testing of samples from Defendant's fields) that the seeds Defendant planted were in fact saved seeds containing the specific patented genetic events (MON89788 and the CTP-DMO construct).
- Scope Questions: A potential question for the court is whether the act of applying an unapproved herbicide formulation, as alleged in Count III, constitutes practicing the claimed "method for controlling weed growth." While the claim requires applying an "effective" amount, it does not specify the formulation must be one approved for use by regulators.
V. Key Claim Terms for Construction
The Term: "soybean event MON89788" (from '945 Patent, Claim 1 and patent title)
- Context and Importance: This term defines the entire scope of the '945 patent. Infringement requires proof that Defendant's seeds contain this exact, specific genetic insertion. The dispute is less likely to be about the term's definition and more about whether the accused seeds meet that definition.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The complaint does not provide sufficient detail for analysis of this element.
- Evidence for a Narrower Interpretation: The patent specification provides a highly specific definition, stating the invention "provides a soybean transgenic event designated MON89788...having representative seed deposited with American Type Culture Collection (ATCC) with accession No. PTA-6708" (ʼ945 Patent, col. 2:56-60). The event is further defined by the specific junction sequence of SEQ ID NO:3, as recited in Claim 1. This evidence strongly suggests the term is limited to a single, precisely defined genetic event.
The Term: "chloroplast transit peptide" (from ’729 Patent, Claim 1)
- Context and Importance: The scope of this term is foundational to the ’729 patent. Asserted Claim 1 narrows this term to a specific DNA sequence encoding SEQ ID NO:1, making the infringement analysis for that claim highly specific. Practitioners may focus on this term if other claims with broader CTP language are asserted later.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification suggests a broader concept, stating, "A chloroplast transit peptide from any gene that is encoded in the nucleus and the product of which targets a polypeptide to the chloroplast can be tested" (ʼ729 Patent, col. 5:3-7).
- Evidence for a Narrower Interpretation: Asserted Claim 1 explicitly limits the scope to a CTP encoded by a sequence for "SEQ ID NO:1" (ʼ729 Patent, col. 19:48-52). The specification provides the explicit amino acid sequence for SEQ ID NO:1, tying the claim to a specific molecular structure (ʼ729 Patent, col. 27:13-28).
VI. Other Allegations
- Indirect Infringement: The complaint does not contain specific counts for indirect infringement.
- Willful Infringement: The complaint alleges willful infringement based on Defendant’s alleged pre-suit knowledge of the patents and the prohibitions on saving seed (Compl. ¶¶93, 102, 111). This knowledge is allegedly based on Defendant having signed a Technology Stewardship Agreement (TSA) in 2010, receiving subsequent annual updates to the TSA and associated Technology User Guides (TUGs), and the presence of statutory patent notices on seed bag labeling (Compl. ¶¶73-74, 79).
VII. Analyst’s Conclusion: Key Questions for the Case
- A central issue will be one of factual verification: can Plaintiff produce sufficient evidence, such as genetic analysis of samples from Defendant's fields, to prove that the soybeans planted by Defendant in 2020-2022 were in fact saved seed containing the specific patented genetic traits of MON89788 and the CTP-DMO construct as claimed in the patents-in-suit?
- A key legal question, though likely settled by precedent, is one of patent exhaustion: does the authorized sale of the first generation of seeds exhaust the patentee's rights, or does the creation of a new generation of seeds by planting and harvesting constitute an infringing "making" of the invention, as established in Bowman v. Monsanto? The complaint is structured to align with the latter interpretation.
- A third core issue will be one of willfulness: does the evidence of Defendant's assent to the Technology Stewardship Agreement (TSA) and the patent markings on seed bags establish a level of pre-suit knowledge sufficient to support a finding of willful infringement and potential enhanced damages?