DCT

1:18-cv-08059

Arcadia Biosciences Inc v. Arista Cereal Tech Pty Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-08059, S.D.N.Y., 10/26/2018
  • Venue Allegations: Plaintiff alleges venue is proper because Defendants consented to jurisdiction and venue in New York in a Non-Disclosure Agreement (NDA) that governs the dispute.
  • Core Dispute: Plaintiff alleges that Defendants misappropriated its invention related to high-amylose wheat, which was disclosed under an NDA, and then improperly filed for and obtained patents on that technology without naming the correct Arcadia scientists as inventors.
  • Technical Context: The technology involves non-transgenic methods for genetically modifying wheat to increase its amylose (resistant starch) content, which offers significant health benefits and is of high interest in the food production industry.
  • Key Procedural History: The central event alleged is the disclosure of the "Arcadia Invention" to Defendants under an NDA executed on November 13, 2009. The complaint also notes that Plaintiff is a party to an ongoing patent Interference proceeding (No. 106,094) at the U.S. Patent and Trademark Office concerning U.S. Patent No. 9,357,722.

Case Timeline

Date Event
2006-01-01 Arcadia Scientists allegedly began research on high amylose wheat technology.
2007-04-13 Alleged conception date of the "Arcadia Invention."
2009-11-13 Alleged reduction to practice date for the "Arcadia Invention."
2009-11-13 Arcadia and Vilmorin execute Non-Disclosure Agreement.
2010-03-19 Arcadia allegedly discloses its invention to Defendants at a meeting.
2010-11-04 Earliest priority date for '533 and '413 Patents.
2011-11-04 Earliest priority date for '722 Patent.
2015-06-23 U.S. Patent No. 9,060,533 issues.
2016-06-07 U.S. Patent No. 9,357,722 issues.
2017-03-07 U.S. Patent No. 9,585,413 issues.
2018-10-26 First Amended Complaint filed.

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

U.S. Patent No. 9,357,722: High Amylose Wheat-II (Issued June 7, 2016)

The Invention Explained

  • Problem Addressed: In wheat, starch is composed of amylopectin and the healthier, more slowly digested amylose (resistant starch) (Compl. ¶¶22-23). Increasing amylose content for health benefits requires reducing the activity of the SBEIIa enzyme, which produces amylopectin (Compl. ¶24). However, the complaint alleges that Defendants’ own patent filings acknowledged a belief in the field that completely eliminating SBEIIa enzyme activity would be "lethal to seed development and/or fertility," preventing the creation of viable wheat plants (Compl. ¶61).
  • The Patented Solution: The patent claims a process for producing milled wheat product from a specific type of viable, high-amylose wheat grain (’722 Patent, Abstract; ’722 Patent, col. 10:45-56). This is achieved by obtaining wheat grain with "null alleles" (mutated, non-functional versions) for all copies of the SBEIIa gene present in wheat's three distinct genomes (A, B, and D), which renders the SBEIIa protein "undetectable" (’722 Patent, Claim 1). Crucially, the resulting grain has a high amylose content (50-90%) while maintaining a high germination rate, overcoming the previously understood viability problem (’722 Patent, Claim 1). The complex genetic structure of wheat is illustrated in the complaint's Figure 6, which shows the 21 chromosome pairs across the A, B, and D genomes (Compl. ¶33).
  • Technical Importance: The invention provides a method for producing flour from a non-transgenic wheat variety with significantly increased dietary fiber, meeting consumer demand for healthier food ingredients (Compl. ¶25).

Key Claims at a Glance

  • The complaint asserts that claims in the ’722 Patent, including independent claim 1 and dependent claims 2-3, incorporate subject matter from the Arcadia Invention (Compl. ¶73).
  • Independent Claim 1 recites a process with the following essential elements:
    • (i) Obtaining a specific Triticum aestivum wheat grain comprising an embryo and starch.
    • The embryo has two identical null alleles for each of the three SBEIIa genes (SBEIIa-A, SBEIIa-B, SBEIIa-D).
    • At least one pair of these null alleles are point mutations.
    • The SBEIIa protein is undetectable in the grain.
    • The starch comprises between 50% and 90% amylose.
    • The grain has a germination rate of about 70% to 100% relative to wild-type grain.
    • (ii) Milling the grain to produce a milled product.

U.S. Patent No. 9,060,533: High Amylose Wheat (Issued June 23, 2015)

The Invention Explained

  • Problem Addressed: As with the ’722 patent, the technical challenge is to increase amylose content by suppressing starch branching enzymes without rendering the wheat plant sterile or non-viable (’533 Patent, col. 16:25-33). This patent addresses the problem by targeting two different starch branching enzymes, SBEIIa and SBEIIb.
  • The Patented Solution: The patent claims the wheat grain and plant itself, rather than a process of use (’533 Patent, Claims 1, 11). The solution involves creating loss-of-function mutations in the genes for both SBEIIa and SBEIIb proteins, such that the total activity of SBEII protein is reduced to a specific window—between 2% and 30% of the level in a wild-type grain (’533 Patent, Abstract; ’533 Patent, col. 6:1-12). This calibrated reduction in enzyme activity results in a grain with high amylose (at least 50%) that remains fertile and maintains a high germination rate (’533 Patent, Claim 11).
  • Technical Importance: This approach defines a specific genetic and biochemical profile for a viable high-amylose wheat that results from the combined, partial suppression of two related enzyme families.

Key Claims at a Glance

  • The complaint asserts that claims in the ’533 Patent, including independent claims 1 and 11, incorporate subject matter from the Arcadia Invention (Compl. ¶79).
  • Independent Claim 1 recites a wheat grain with the following essential elements:
    • A Triticum aestivum wheat grain with an embryo, endosperm, and starch.
    • A reduced level or activity of total SBEII protein (between 2% and 30% of wild-type).
    • The embryo has loss-of-function mutations in alleles of SBEIIa and SBEIIb genes.
    • (i) A specific combination of SBEIIa and SBEIIb alleles, including 5 or 6 mutated SBEIIa alleles and 2, 4, or 6 null SBEIIb alleles, where at least one SBEIIa mutation is a point mutation.
    • (ii) A germination rate between 70% and 100% relative to wild-type.
    • (iii) A starch amylose content of at least 50%.
  • Independent Claim 11 recites a wheat plant that produces the grain of Claim 1 and adds the limitation that "the wheat plant is male and female fertile."

Multi-Patent Capsule

  • Patent Identification: U.S. Patent No. 9,585,413, Food Ingredients Produced from High Amylose Wheat, issued March 7, 2017 (Compl. ¶15).
  • Technology Synopsis: The ’413 Patent claims food ingredients (such as flour or wholemeal) and processes for producing them from a high-amylose wheat grain. The grain is defined by a reduced level of SBEII protein activity (2% to 30% of wild-type) resulting from specific loss-of-function mutations in the SBEIIa genes, an amylose content of at least 60%, and a high germination rate (Compl. ¶¶83-84).
  • Asserted Claims: Independent Claims 1 and 8 (Compl. ¶¶83-84).
  • Alleged Derivation: The complaint alleges that the claimed subject matter, particularly the combination of genetic mutations leading to a viable, high-amylose, and high-germination grain suitable for processing, was derived from the Arcadia Invention (Compl. ¶85).

III. The Disputed Invention

Invention Identification

  • The complaint centers on the "Arcadia Invention," which Plaintiff alleges it conceived, reduced to practice, and disclosed to Defendants before Defendants filed the patents-in-suit (Compl. ¶¶37-40, 52).

Functionality and Context

  • The Arcadia Invention is defined as obtaining viable wheat plants and grain (Triticum aestivum) with specific genetic characteristics: homozygous null and/or loss of function mutations in all three SBEIIa genes (SBEIIa-A, -B, and -D) (Compl. ¶37). The complaint's Figure 1 provides a basic anatomical diagram of a wheat grain, identifying the endosperm where the starch modifications occur (Compl. ¶18).
  • A key feature of the alleged invention is that at least one of these mutations is a point mutation, the SBEIIa protein is undetectable, the grain's starch has an amylose content between 50% and 90%, and the grain remains viable and able to germinate (Compl. ¶37).
  • The invention is also defined to include the process of milling this specific grain to produce a milled product (Compl. ¶37).
  • The complaint further alleges that Arcadia's disclosures to Defendants included information on SBEIIb mutations and SBEIIa/SBEIIb mutant combinations (Compl. ¶59).

IV. Analysis of Inventorship Allegations

The complaint does not allege infringement by a product but rather that the claims of the patents-in-suit cover an invention first conceived and communicated by Arcadia's scientists. The central dispute is one of derivation and proper inventorship.

'722 Patent Inventorship Allegations

Claim Element (from Independent Claim 1) Alleged Inventive Contribution by Arcadia Complaint Citation Patent Citation
A process for producing a milled product, comprising the steps of (i) obtaining wheat grain (Triticum aestivum) ... wherein the embryo comprises two identical null alleles of an SBEIIa-A gene, two identical null alleles of an SBEIIa-B gene and two identical null alleles of an SBEIIa-D gene... The complaint alleges that Arcadia scientists conceived of obtaining wheat plants and grain with homozygous null and/or loss of function mutations in all three SBEIIa genes. ¶37 col. 12:35-51
...wherein either the two identical null alleles of the SBEIIa-A gene, or of the SBEIIa-B gene or of the SBEIIa-D gene are point mutations... The complaint alleges that the Arcadia Invention required that at least one of the mutations is a point mutation. ¶37 col. 8:51-54
...wherein SBEIIa protein is undetectable in the wheat grain... The complaint alleges that in the Arcadia Invention, the SBEIIa protein is undetectable in the wheat grain. ¶37 col. 12:1-3
(a) the starch comprises amylose such that the grain has an amylose content of between 50% and 90% (w/w)... The complaint alleges the Arcadia Invention resulted in a grain with an amylose content of between 50% and 90%. ¶37 col. 12:52-61
(b) the wheat grain has a germination rate of about 70% to about 100% relative to the germination rate of a wild-type wheat grain... The complaint alleges that a key aspect of the Arcadia Invention was that the resulting wheat grain germinates, indicating viability. ¶37 col. 10:35-44
(ii) milling the grain, thereby producing the milled product. The complaint alleges the Arcadia Invention also conceived of a process for producing a milled product by milling the specified grain. ¶37 col. 11:28-34

Identified Points of Contention

  • Derivation vs. Independent Conception: A primary issue will be whether the named inventors independently conceived of the subject matter of the ’722 patent claims or derived it from Arcadia's confidential disclosures. The complaint alleges that Defendants’ own patent documents admitted failures to create viable wheat with complete loss of SBEIIa function, suggesting a technical barrier that Arcadia's invention overcame (Compl. ¶61).
  • Sufficiency of Disclosure: A factual question may arise as to whether Arcadia’s alleged disclosures in 2010 were specific enough to communicate the complete invention as claimed. The dispute may turn on the content of the PowerPoint presentations and other communications referenced in the complaint (Compl. ¶¶54-57).

V. Key Claim Terms for Construction

While this is an inventorship dispute, the meaning of certain claim terms will be central to determining the scope of the alleged contribution.

  • The Term: "point mutation" (in '722 Claim 1 and '533 Claim 1)

  • Context and Importance: The requirement of a "point mutation" is a specific technical limitation. For Arcadia to prevail on its inventorship claim, it must demonstrate it contributed this specific concept, not just a general idea of creating mutations. Practitioners may focus on this term because it distinguishes the claimed invention from one using other mutation types (e.g., large deletions), and proof of contributing this specific limitation would be strong evidence of joint inventorship.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The complaint defines a point mutation as an alteration "affecting single nucleotide base pairs in the DNA" (Compl. ¶28).
    • Evidence for a Narrower Interpretation: The patent specification describes point mutations as a subset of possible mutations, contrasting them with deletions, insertions, and other types, and notes that they may result in a premature stop codon or an altered but full-length protein (’722 Patent, col. 23:13-24). The debate could center on whether Arcadia conceived of using this specific type of mutation to achieve the desired viability and high-amylose result.

  • The Term: "SBEIIa protein is undetectable" ('722 Claim 1)

  • Context and Importance: This term defines the biochemical outcome in the claimed grain. Its interpretation is critical for comparing the scope of the '722 patent with the '533 patent (which claims a 2-30% activity range) and with the evidence of what Arcadia's scientists actually achieved and disclosed. A key question for the court will be whether Arcadia's alleged contribution of a complete "knockout" of the protein is inventive over, and a contribution to, claims reciting merely a partial reduction.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The term could be interpreted functionally to mean any level below the detection limit of standard assays used in the field at the time, which may still permit trace amounts of protein.
    • Evidence for a Narrower Interpretation: The patent specifies that protein levels can be determined by Western blot analysis, which has a defined detection threshold (’722 Patent, col. 23:51-58). An argument could be made that "undetectable" means a complete absence of the protein, which may be a distinct inventive concept from the partial reduction claimed in the related '533 patent.

VI. Other Allegations

The complaint asserts several claims related to the central dispute of misappropriation and incorrect inventorship.

  • Correction of Inventorship (Counts I and IX): Plaintiff seeks a declaratory judgment under 35 U.S.C. § 256 to add its scientists as joint inventors to the '413, '533, and '722 patents, alleging they made inventive contributions to the subject matter claimed in those patents (Compl. ¶¶104, 178).
  • Breach of Contract and Related Claims: The complaint alleges that by using Arcadia’s confidential information to file patents and develop commercial products, Defendants breached the NDA (Count II), breached the implied covenant of good faith and fair dealing (Count III), engaged in unfair competition (Count IV), misappropriated confidential information (Count V), were unjustly enriched (Count VI), converted Arcadia's intellectual property (Count VII), and tortiously interfered with Arcadia's business relations (Count VIII) (Compl. ¶¶111-174).

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

  • A core issue will be one of derivation and proof: Can Arcadia provide sufficient corroborating evidence to establish that its scientists conceived of the specific combination of genetic traits, biochemical outcomes, and viability characteristics as claimed in the patents, and that this complete conception was communicated to the named inventors prior to their own conception?
  • A second key question is one of inventive contribution: Does the evidence demonstrate that Arcadia's contribution meets the legal standard for joint inventorship for each patent? This may involve parsing whether conceiving of a wheat with "undetectable" SBEIIa protein ('722 patent) constitutes an inventive contribution to claims reciting a specific range of SBEII protein activity resulting from combined SBEIIa/SBEIIb mutations ('533 patent).
  • Finally, the case presents a question of contractual breach: Independent of patent law, did Defendants' alleged use of information disclosed under the NDA to file their own patents violate the agreement's purpose, which was limited to discussions regarding a potential business relationship?