DCT

1:11-cv-02163

Organic Seed Growers Trade Association v. Monsanto Co

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:11-cv-02163, S.D.N.Y., 06/01/2011
  • Venue Allegations: Plaintiffs allege venue is proper in the Southern District of New York because Defendants are authorized to do and are doing business in the district and have sufficient contacts therein.
  • Core Dispute: A coalition of organic and non-transgenic agricultural entities seeks a declaratory judgment that they would not infringe Monsanto's patents on transgenic seeds, and that such patents are invalid and unenforceable, should their crops become inadvertently contaminated with Monsanto's patented genetic material.
  • Technical Context: The technology involves the genetic engineering of agricultural crops to create transgenic seeds that possess traits such as resistance to herbicides, which has become a dominant feature of modern industrial agriculture.
  • Key Procedural History: The complaint is predicated on Plaintiffs' fear of future litigation, based on allegations of Monsanto's history of aggressively enforcing its patents against farmers, including in cases of alleged inadvertent contamination. Plaintiffs also allege that a public "Commitment" by Monsanto not to sue over "trace amounts" of contamination is ambiguous and legally unreliable. The complaint notes that pre-suit correspondence seeking a covenant not to sue from Monsanto did not alleviate these fears, prompting this declaratory judgment action.

Case Timeline

Date Event
1983-01-17 Earliest Priority Date, U.S. Patent No. 5,352,605
1987-01-13 Earliest Priority Date, U.S. Patent No. 5,322,938
1994-06-21 U.S. Patent No. 5,322,938 Issues
1994-10-04 U.S. Patent No. 5,352,605 Issues
2011-06-01 Complaint Filing Date

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

U.S. Patent No. 5,322,938 - “DNA sequence for enhancing the efficiency of transcription,” Issued June 21, 1994

The Invention Explained

  • Problem Addressed: The patent addresses the technical challenge of achieving sufficiently high or increased levels of gene expression in transformed plants, which is necessary for producing new, commercially viable characteristics (Compl. ¶126A; ’938 Patent, col. 1:21-28). The patent notes that existing promoters vary in their transcription efficiency and that a means to enhance transcription would facilitate the production of important proteins for agricultural purposes (Compl. ¶126A; ’938 Patent, col. 1:28-33).
  • The Patented Solution: The invention provides novel DNA constructs that enhance the rate of gene transcription. The solution involves creating a "chimaeric" transcription initiation region that includes a duplicated "enhancer domain" from the Cauliflower Mosaic Virus (CaMV) 35S promoter. This tandem duplication of the enhancer sequence, when placed upstream of a promoter, significantly increases the expression of the associated gene compared to a construct with only a single enhancer copy (Compl. ¶126A; ’938 Patent, col. 2:6-20, FIG. 1).
  • Technical Importance: This method of creating a "strong enhancer" by duplicating viral promoter sequences provided a critical tool for achieving the high levels of foreign gene expression needed to develop commercially successful transgenic crops (Compl. ¶126A; ’938 Patent, col. 1:21-28).

Key Claims at a Glance

  • The complaint makes a general challenge to all claims (Compl. ¶165). Independent claim 1 is representative:
  • a chimeric transcriptional initiation region comprising as operably joined components:
    • (i) a tandemly duplicated CaMV 35S enhancer sequence comprising an AluI-EcoRV fragment of a CaMV 35S upstream region; and
    • (ii) a promoter comprising an RNA polymerase binding site and an mRNA initiation site,
    • wherein when a nucleotide sequence of interest is transcribed under the regulatory control of said chimeric transcriptional initiation region, the amount of transcription product is enhanced as compared to the amount of transcription obtained with a chimeric transcriptional initiation region comprising a single copy of said CaMV enhancer sequence and said promoter.

U.S. Patent No. 5,352,605 - “Chimeric genes for transforming plant cells using viral promoters,” Issued October 4, 1994

The Invention Explained

  • Problem Addressed: The patent background describes the fundamental difficulty in genetic engineering of expressing a foreign gene in a plant cell. It notes that for a gene to be expressed, it must have a promoter that is recognized by the cell's machinery, and that prior to this invention, no one had successfully created a functional "chimeric gene" using a plant virus promoter to drive the expression of a heterologous (foreign) structural gene in a plant cell (Compl. ¶126B; ’605 Patent, col. 1:19-31, col. 2:54-64).
  • The Patented Solution: The invention provides chimeric genes that successfully use viral promoters, specifically from the Cauliflower Mosaic Virus (CaMV), to express foreign genes in plant cells. The patented solution involves ligating a promoter region from CaMV to a heterologous coding sequence (such as a gene for antibiotic resistance) to form a chimeric gene that is demonstrably expressed in transformed plant cells, tissues, and differentiated plants (Compl. ¶126B; ’605 Patent, col. 2:54-64, FIG. 1).
  • Technical Importance: This invention was a foundational development in agricultural biotechnology, demonstrating that viral promoters could serve as powerful and reliable engines to drive foreign gene expression in plants, enabling the creation of transgenic crops with novel traits (Compl. ¶126B; ’605 Patent, col. 1:12-16).

Key Claims at a Glance

  • The complaint makes a general challenge to all claims (Compl. ¶165). Independent claim 1 is representative:
  • A chimeric gene which is expressed in plant cells comprising:
    • a promoter from a cauliflower mosaic virus, said promoter selected from the group consisting of a CaMV (35S) promoter isolated from CaMV protein-encoding DNA sequences and a CaMV (19S) promoter isolated from CaMV protein-encoding DNA sequences, and
    • a structural sequence which is heterologous with respect to the promoter.

Multi-Patent Capsules for Additional Patents-in-Suit

  • U.S. Patent No. 5,362,865, “Enhanced expression in plants using non-translated leader sequences,” Issued Nov. 8, 1994: This patent addresses the need for enhanced gene expression in plants. It discloses that specific 5' non-translated leader sequences from heat shock protein genes can be used in chimeric gene constructs to enhance expression levels of foreign proteins (Compl. ¶126C). All claims are challenged (Compl. ¶165). The patented genetic elements are alleged to be present in Monsanto's transgenic seeds (Compl. ¶126).
  • U.S. Patent No. 5,378,619, “Promoter for transgenic plants,” Issued Jan. 3, 1995: This patent relates to a promoter from the figwort mosaic virus (FMV) for use in expressing genes in transgenic plants. The invention provides a strong and uniform promoter that functions effectively in chimeric genes to drive expression across various plant tissues, particularly in floral buds (Compl. ¶126D). All claims are challenged (Compl. ¶165). The patented genetic elements are alleged to be present in Monsanto's transgenic seeds (Compl. ¶126).
  • U.S. Patent No. 5,424,412, “Enhanced expression in plants,” Issued June 13, 1995: This patent addresses the need for improved expression of chimeric genes, particularly in monocot plants. The invention provides a method of enhancing expression by including an intron derived from the 70Kd maize heat shock protein (HSP70) in the non-translated leader sequence of the gene construct (Compl. ¶126E). All claims are challenged (Compl. ¶165). The patented genetic elements are alleged to be present in Monsanto's transgenic seeds (Compl. ¶126).
  • The complaint lists eighteen additional patents (Compl. ¶126F-W), all of which are generally directed to technologies for creating and optimizing transgenic plants, including specific DNA promoters, enhancers, methods of transformation, and genes conferring traits such as glyphosate tolerance. The plaintiffs challenge all claims of these patents on the grounds of invalidity and unenforceability, and seek a declaration of non-infringement in the event of inadvertent contamination (Compl. ¶¶ 164-179).

III. The Accused Instrumentality

Product Identification

The "instrumentalities" at issue are not products sold by the Defendant, but rather the Plaintiffs' own organic and non-transgenic crops and seeds (Compl. ¶2). The action is preemptive, concerning the legal status of these crops and seeds should they become unintentionally contaminated by Monsanto's patented transgenic genetic material (Compl. ¶4). The crops identified as being at risk include corn, soybeans, cotton, sugar beets, alfalfa, and canola (Compl. ¶96).

Functionality and Market Context

The complaint alleges that Monsanto's patented transgenic traits, particularly glyphosate tolerance found in "Roundup Ready" seeds, are present in over 85-90% of certain major crops grown in the U.S. (Compl. ¶104). Plaintiffs allege that the genetic material from these crops can spread through natural processes like cross-pollination and commingling, contaminating their non-transgenic fields (Compl. ¶¶ 103, 111). Such contamination allegedly threatens the Plaintiffs' ability to maintain organic certification, lowers their crop value, and creates a risk of being accused of patent infringement by Monsanto (Compl. ¶¶ 2, 107).

IV. Analysis of Infringement Allegations

The complaint does not contain specific infringement allegations or claim charts mapping product features to claim limitations. Instead, it seeks a declaratory judgment of non-infringement based on a hypothetical future event: the inadvertent contamination of Plaintiffs' crops with Defendant's patented technology (Compl. ¶¶ 171-174). The core of the non-infringement argument is that unintentional possession of a self-replicating patented technology does not constitute infringement under the Patent Act (Compl. ¶149). Further, the complaint asserts that any patent rights Monsanto has in its transgenic seed are exhausted upon the authorized sale of that seed to its customers, arguing that subsequent contamination of Plaintiffs' fields is a reasonably foreseeable consequence of such sales (Compl. ¶150).

  • Identified Points of Contention:
    • Jurisdictional Question: A primary issue is whether the Plaintiffs' stated fear of future litigation, absent a direct threat of suit from Monsanto concerning a specific instance of contamination, constitutes a sufficient "actual controversy" to give the court jurisdiction to issue a declaratory judgment (Compl. ¶8).
    • Scope Questions: The case raises fundamental questions about the scope of patent rights for self-replicating technologies. A central question for the court may be whether the term "makes" or "uses" under 35 U.S.C. § 271(a) can be satisfied by the unintentional and unwelcomed replication of a patented gene within one's own property.
    • Legal Questions: The dispute suggests a potential conflict between the doctrine of patent exhaustion and the enforcement of patents on progeny. A key question is whether patent rights are exhausted only for the purchased seed itself, or whether exhaustion extends to subsequent generations that spread beyond the purchaser's control through natural biological processes.

V. Key Claim Terms for Construction

Because this is a declaratory judgment action focused on broad questions of validity and the applicability of infringement statutes to unintentional contamination, traditional claim construction may be secondary. However, a central pillar of the Plaintiffs' validity challenge rests on the interpretation of a statutory term from 35 U.S.C. § 101.

  • The Term: "useful"
  • Context and Importance: Plaintiffs' First Claim for Relief seeks a declaratory judgment of patent invalidity, arguing that each patent in suit is invalid because, among other things, the claimed invention is "not useful" (Compl. ¶166). This argument is critical to their case, as it asserts that Monsanto's transgenic seeds provide no net benefit to society and are instead "injurious to the well-being, good policy, or sound morals of society," thereby failing the utility requirement for patentability (Compl. ¶4).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specifications of the patents-in-suit describe specific, substantial, and credible utilities. For example, the ’938 Patent discloses "novel transcription initiation regions that provide for enhanced transcription" ('938 Patent, Abstract), and the ’605 Patent discloses "chimeric genes which are capable of being expressed in plant cells" ('605 Patent, Abstract). This evidence from the patents themselves supports the conventional interpretation of "useful" as requiring a demonstrable, practical, and technical utility, without regard to broader societal or moral considerations.
    • Evidence for a Narrower Interpretation: The complaint itself does not cite intrinsic evidence for a narrower view. Instead, it relies on an interpretation of § 101 rooted in 19th-century case law, arguing that "useful" implies a beneficial societal use (Compl. ¶4, citing Lowell v. Lewis). Plaintiffs' argument suggests that evidence of alleged negative health effects, environmental harm, and economic damage to organic farmers (Compl. ¶¶ 113-120) should inform the utility analysis, thereby narrowing the scope of "useful" inventions to only those the court finds to be societally beneficial on balance.

VI. Other Allegations

  • Patent Misuse: The complaint alleges that Monsanto has misused its patents to achieve and maintain dominant, anticompetitive market power in the seed markets for several major crops (Compl. ¶¶ 151, 176). The alleged misuse includes pursuing baseless litigation to intimidate farmers and using restrictive licensing agreements to limit competition (Compl. ¶¶ 155-156).
  • Equitable Estoppel: Plaintiffs allege that Monsanto should be equitably estopped from enforcing its patents against them (Compl. ¶177). They base this on Monsanto's public "Commitment" not to sue for "trace amounts" of inadvertent contamination, which they argue is misleadingly ambiguous and which Monsanto has allegedly violated in the past, making it unreasonable for Plaintiffs to rely on it (Compl. ¶¶ 134-135, 158-159). The complaint includes a screenshot of a March 29, 2011, statement from Monsanto’s website, which reiterates its policy not to exercise patent rights for 'trace amounts' of patented seed present due to 'inadvertent means' (Compl. Ex. 2).

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

This declaratory judgment action appears to turn on several threshold legal questions rather than a direct factual dispute over infringement. The central issues for the court may be:

  • A core issue will be one of jurisdiction: does a widely held fear among non-infringing parties, based on a patentee's litigation history and allegedly ambiguous public statements, create a "case of actual controversy" sufficient for a court to issue a declaratory judgment on patent validity and infringement?
  • A second key question will be one of infringement scope: can the act of "making" or "using" a patented invention be satisfied by the passive, unintentional, and undesired presence of self-replicating genetic technology that has spread naturally onto one's property?
  • A third dispositive issue will be a question of statutory interpretation: should the "utility" requirement of 35 U.S.C. § 101 be interpreted narrowly to include a moral or societal-benefit component, potentially invalidating patents on technologies alleged to have a net negative impact, or does it remain a purely technical and functional inquiry?