DCT

1:22-cv-00311

Impossible Foods Inc v. Motif FoodWorks Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-00311, D. Del., 07/03/2023
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because both Defendants are incorporated in Delaware and thus reside in the district.
  • Core Dispute: Plaintiff alleges that Defendant Motif’s plant-based meat products containing its HEMAMI ingredient, and the genetically engineered yeast developed by Defendant Ginkgo to produce it, infringe seven patents related to using heme proteins to create meat-like flavors and aromas in food and the methods for producing those proteins.
  • Technical Context: The technology lies in food science and biotechnology, specifically concerning the use of heme proteins to make plant-based meat substitutes that more accurately replicate the sensory experience of cooking and eating animal meat.
  • Key Procedural History: This Third Amended Complaint follows prior complaints in the same litigation, indicating an ongoing and evolving dispute. The complaint references Motif's April 2021 GRAS (Generally Recognized as Safe) submission and its December 2021 Color Additive Petition to the U.S. Food and Drug Administration, which contain technical descriptions of the accused HEMAMI ingredient and its production process.

Case Timeline

Date Event
2013-01-11 Priority Date for '096, '306, '761, '250, '241 Patents
2015-05-11 Priority Date for '492, '656 Patents
2016-01-01 Impossible Foods releases IMPOSSIBLE BURGER
2018-04-17 U.S. Patent No. 9,943,096 Issues
2018-08-07 U.S. Patent No. 10,039,306 Issues
2019-01-01 Motif spins out of Ginkgo Bioworks
2019-04-30 U.S. Patent No. 10,273,492 Issues
2020-06-23 U.S. Patent No. 10,689,656 Issues
2020-12-15 U.S. Patent No. 10,863,761 Issues
2021-04-01 Motif submits GRAS Notice to FDA for myoglobin ingredient
2021-05-25 U.S. Patent No. 11,013,250 Issues
2021-06-01 Motif partners with Coolgreens to sell meat replica products
2021-12-01 Motif submits Color Additive Petition to FDA
2021-12-01 Motif demonstrates meat replica at Plant Based World Expo
2022-01-18 U.S. Patent No. 11,224,241 Issues
2023-07-03 Plaintiff files Third Amended Complaint

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

U.S. Patent No. 10,039,306 - "Methods and Compositions for Consumables"

  • Patent Identification: U.S. Patent No. 10,039,306, entitled "Methods and Compositions for Consumables," issued August 7, 2018.

The Invention Explained

  • Problem Addressed: The patent describes a central problem in the food industry: existing plant-based meat substitutes "largely fail to replicate the experience of cooking and eating meat," particularly the aromas and flavors generated during cooking (’306 Patent, col. 1:56-65).
  • The Patented Solution: The invention is a method for imparting a "beef-like aroma" to a plant-based meat replica. This is achieved by adding a non-animal heme-containing protein, within a specific concentration range (0.01%-5% by weight), to a "meat replica matrix" that also contains plant proteins, a sugar, and a sulfur compound. The patent explains that upon cooking, this combination generates volatile compounds that create a meat-associated aroma. (’306 Patent, Abstract; col. 23:23-24:9).
  • Technical Importance: This method provided a technical pathway to address the key sensory deficiencies that had historically limited the mainstream appeal of plant-based meat alternatives (Compl. ¶16, ¶17).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (’306 Patent, Compl. ¶81).
  • The essential elements of claim 1 include:
    • A method for imparting a beef-like aroma to a meat replica matrix.
    • The matrix comprises one or more plant proteins, a selected sugar, and a selected sulfur-containing compound.
    • The method comprises adding 0.01%-5% by weight of a non-animal heme-containing protein to the matrix.
    • Upon cooking, at least two volatile compounds associated with a beef-like aroma are generated.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

U.S. Patent No. 10,273,492 - "Expression Constructs and Methods of Genetically Engineering Methylotrophic Yeast"

  • Patent Identification: U.S. Patent No. 10,273,492, entitled "Expression Constructs and Methods of Genetically Engineering Methylotrophic Yeast," issued April 30, 2019.

The Invention Explained

  • Problem Addressed: The complaint notes that while heme proteins like leghemoglobin can be harvested from natural sources such as soy plants, this process is "too inefficient for commercial production" (Compl. ¶18). The patent addresses the need for efficient, scalable methods of producing recombinant proteins in host cells like methylotrophic yeast (’492 Patent, col. 1:29-34).
  • The Patented Solution: The invention is a genetically engineered methylotrophic Pichia yeast cell designed for enhanced protein production. The cell is modified to contain two key expression constructs: one encoding the desired heme-containing protein, and a second encoding at least one polypeptide involved in the natural heme biosynthesis pathway. Both constructs are operably linked to a promoter and a specific transcriptional activator sequence (Mxr1) from P. pastoris, which creates a positive feedback loop to boost expression. (’492 Patent, Abstract; col. 1:44-50).
  • Technical Importance: This technology creates a biological factory for producing the crucial heme ingredient at a scale and efficiency suitable for the mass-market food industry (Compl. ¶18).

Key Claims at a Glance

  • The complaint asserts at least independent claim 1 (’492 Patent, Compl. ¶96).
  • The essential elements of claim 1 include:
    • A methylotrophic Pichia yeast cell comprising:
    • A first nucleic acid molecule encoding a heme-containing protein, operably linked to a P. pastoris promoter element and a Mxr1 transcriptional activator sequence.
    • A second nucleic acid molecule encoding at least one polypeptide involved in heme biosynthesis, also operably linked to a P. pastoris promoter element and a Mxr1 transcriptional activator sequence.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

Multi-Patent Capsules

  • U.S. Patent No. 9943096 ('096 Patent): Issued April 17, 2018, and titled "Methods and Compositions for Affecting the Flavor and Aroma Profile of Consumables." This patent claims a food flavor additive composition comprising an isolated heme-containing protein, a sugar compound, and a sulfur-containing compound. The composition contains no animal products and, when cooked, produces at least two volatile compounds with a meat-associated aroma. (Compl. ¶66). The complaint asserts at least claim 1 (Compl. ¶67). The accused features are the Infringing Products containing HEMAMI (Compl. ¶67).
  • U.S. Patent No. 10689656 ('656 Patent): Issued June 23, 2020, and titled "Expression Constructs and Methods of Genetically Engineering Methylotrophic Yeast." This patent claims a methylotrophic yeast cell containing a recombinant nucleic acid molecule that expresses both a methanol expression regulator (Mxr1) and a separate heterologous polypeptide, each linked to a methanol-inducible promoter. The patent also covers methods of using this cell to produce the polypeptide. (Compl. ¶110). The complaint asserts at least claims 1 and 16 (Compl. ¶111). The accused features are the Infringing Yeast used to produce HEMAMI (Compl. ¶111).
  • U.S. Patent No. 10863761 ('761 Patent): Issued December 15, 2020, and titled "Methods and Compositions for Consumables." This patent claims a beef replica product comprising two separate components: a "muscle replica" containing a heme-containing protein, sugar, and sulfur; and a "fat tissue replica" containing plant oil and denatured plant protein. These two replicas are assembled to approximate the physical organization of meat. (Compl. ¶125). The complaint asserts at least claim 1 (Compl. ¶126). The accused features are the Infringing Products containing HEMAMI (Compl. ¶126).
  • U.S. Patent No. 11013250 ('250 Patent): Issued May 25, 2021, and titled "Methods and Compositions for Consumables." This patent claims a meat replica matrix comprising plant proteins, a sugar, a sulfur compound, and 0.01%-5% of a non-animal heme-containing protein. Upon cooking, this matrix generates at least two volatile compounds associated with a beef-like aroma. (Compl. ¶140). The complaint asserts at least claim 1 (Compl. ¶141). The accused features are the Infringing Products containing HEMAMI (Compl. ¶141).
  • U.S. Patent No. 11224241 ('241 Patent): Issued January 18, 2022, and titled "Methods and Compositions for Affecting the Flavor and Aroma Profile of Consumables." This patent claims a meat-like food product produced by a method of combining plant proteins with a heme-containing protein, sugars, and sulfur compounds. The product is free of animal heme-containing protein, generates meat-associated aroma upon cooking, and is in a specified form such as a burger, sausage, or ground meat. (Compl. ¶155). The complaint asserts at least claim 22 (Compl. ¶156). The accused features are the Infringing Products containing HEMAMI (Compl. ¶156).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are Defendant Motif’s food ingredient HEMAMI, the "Infringing Products" which are meat replica products containing HEMAMI (e.g., Motif BeefWorks™ Plant-Based Burger Patties), and the "Infringing Yeast" used to produce HEMAMI. Defendant Ginkgo is accused of infringing with the same "Infringing Yeast" it allegedly develops for Motif. (Compl. ¶39, 44, 51, 60).

Functionality and Market Context

HEMAMI is described as a liquid flavoring preparation containing bovine myoglobin produced via fermentation from a genetically modified strain of Pichia pastoris yeast (Compl. ¶35, 37). Motif markets HEMAMI as an ingredient for meat alternatives that provides the "real umami flavors, appearance and aromas of meat," purportedly because it uses a "naturally occurring heme protein" (Compl. ¶33). A screenshot from Motif's website shows the product advertised as providing "Taste" described as "Rich, satisfying flavors and aromas" (Compl. ¶30). The complaint alleges that Motif has touted HEMAMI as a substitute for Impossible Foods’ patented technology and that Ginkgo's CEO described a strategy to "brew up the next 100 hemes" to compete with Impossible Foods (Compl. ¶47, 50).

IV. Analysis of Infringement Allegations

'306 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for imparting a beef-like aroma to a meat replica matrix... Motif's Infringing Products are made by a method for making a meat replica matrix having a beef-like aroma. ¶81 col. 23:23-24
...wherein the meat replica matrix comprises one or more plant proteins, a sugar selected from [a list], and a sulfur-containing compound selected from [a list]... The Infringing Products are made from a meat replica matrix that comprises one or more plant proteins, a sugar, and a sulfur-containing compound from the lists in the claim. ¶81 col. 23:25-33
...the method comprises adding 0.01%-5% (by weight of the meat replica matrix) of a non-animal heme-containing protein to the meat replica matrix... Motif's method adds HEMAMI, which contains bovine myoglobin (a heme-containing protein produced in a non-animal yeast source), to the meat replica matrix. ¶35, 39, 81 col. 23:34-38
...wherein, upon cooking of the meat replica matrix, at least two volatile compounds are generated that are associated with a beef-like aroma, thereby imparting a beef-like aroma to the meat replica matrix. Cooking the Infringing Products allegedly generates volatile compounds that impart a beef-like aroma. ¶81 col. 23:38-43

'492 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A methylotrophic Pichia yeast cell comprising: The Infringing Yeast are alleged to be methylotrophic Pichia yeast. ¶96 col. 27:37-38
a nucleic acid molecule encoding a heme-containing protein operably linked to a promoter element from P. pastoris and a Mxr1 transcriptional activator sequence from P. pastoris; Based on Motif's FDA submissions, the Infringing Yeast is a modified strain of P. pastoris expressing a myoglobin protein, which is a heme-containing protein. ¶35, 37, 96 col. 27:39-43
and a nucleic acid molecule encoding at least one polypeptide involved in heme biosynthesis operably linked to a promoter element from P. pastoris and a Mxr1 transcriptional activator sequence from P. pastoris. The Infringing Yeast is alleged to comprise a nucleic acid molecule for at least one polypeptide involved in heme biosynthesis, linked as required by the claim. ¶96 col. 27:44-49

Identified Points of Contention

  • Scope Questions: A central dispute for the '306 Patent (and the '096, '250, and '241 patents) may be the construction of the term "non-animal heme-containing protein." The complaint alleges Motif’s HEMAMI ingredient contains bovine myoglobin produced via yeast fermentation (Compl. ¶35). This raises the question of whether a protein with an amino acid sequence from an animal (Bos taurus) but produced recombinantly in a non-animal host (yeast) falls within the scope of the claim term.
  • Technical Questions: For the '492 Patent (and '656 Patent), the infringement allegations are made on "information and belief" (Compl. ¶96, ¶111). A primary issue will be evidentiary: what technical evidence will be adduced to demonstrate that the accused "Infringing Yeast" contains the specific, multi-element genetic constructs recited in the claims, such as the nucleic acid molecule encoding a polypeptide involved in heme biosynthesis or the specific linkage to an Mxr1 activator sequence?

V. Key Claim Terms for Construction

  • The Term: "non-animal heme-containing protein" (’306 Patent, Claim 1)

  • Context and Importance: This term's definition is critical. If it is construed to mean a protein whose amino acid sequence is not derived from an animal, then Motif's use of bovine myoglobin would likely not infringe. If it is construed to mean a protein that is not produced inside an animal (i.e., it can be of animal origin but produced recombinantly), infringement may be possible. Practitioners may focus on this term because it appears to be the central point of non-infringement for several of the asserted composition and method patents.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent’s background section discusses the goal of creating "non-animal based replicas of animal-based food products" (’306 Patent, col. 1:26-27). This focus on the final product's "non-animal" nature could support an interpretation where the method of production (recombinant yeast), not the ultimate genetic origin of the protein sequence, is the defining characteristic.
    • Evidence for a Narrower Interpretation: The plain language of the term itself points to the nature of the protein. "Bovine myoglobin" is, by definition, an animal protein. The specification does not appear to explicitly define "non-animal heme-containing protein" in a way that would unambiguously include recombinantly produced animal proteins.

  • The Term: "operably linked to a promoter element from P. pastoris and a Mxr1 transcriptional activator sequence from P. pastoris" (’492 Patent, Claim 1)

  • Context and Importance: This limitation requires a specific genetic architecture inside the yeast cell. Infringement requires proving not just the presence of certain genes, but their specific functional linkage as claimed. The dispute may turn on whether the accused yeast, as engineered by Ginkgo, possesses this precise configuration.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent describes the invention in terms of a functional outcome: creating a "positive feedback loop" to increase expression from the AOX1 promoter (’492 Patent, col. 1:47-50). A plaintiff may argue that any genetic arrangement achieving this functional linkage infringes.
    • Evidence for a Narrower Interpretation: Claim 1 requires two separate nucleic acid molecules, each with this specific linkage. Defendants may argue that their yeast employs a different, non-infringing genetic architecture to achieve protein expression, or that it lacks the second claimed construct for heme biosynthesis entirely.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Motif induces and contributes to infringement by providing HEMAMI to business partners with the intent that they make infringing meat replica products (Compl. ¶71, 73). It further alleges Ginkgo induces and contributes by making and providing the Infringing Yeast to Motif, knowing it is for use in infringing methods and products (Compl. ¶175, 177, 190, 192).
  • Willful Infringement: Willfulness allegations are based on Defendants' alleged pre-suit knowledge of Impossible Foods' technology and patents. The complaint cites public statements by Defendants' CEOs and news articles that explicitly reference Impossible Foods' use of "heme" and describe a strategy to compete directly, suggesting Defendants were aware of and disregarded Plaintiff's patent rights. (Compl. ¶47-50, 62-63, 77).

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

  • A core issue will be one of definitional scope: can the term "non-animal heme-containing protein," central to multiple patents-in-suit, be construed to cover a protein with an animal's amino acid sequence (Bos taurus myoglobin) that is produced recombinantly in a non-animal host such as yeast?
  • A key evidentiary question will be one of technical proof: for the patents directed to specific genetic constructs in yeast, can the Plaintiff obtain and present sufficient evidence to prove that the proprietary "Infringing Yeast" developed by Ginkgo and used by Motif contains the precise, multi-part genetic architecture required by the claims?
  • A central theme of the case will be one of knowing conduct: does the evidence of Defendants' public statements and business strategy, which explicitly reference competing with Plaintiff's "heme" technology, rise to the level of willful infringement, potentially exposing Defendants to enhanced damages?