DCT
1:23-cv-01376
Oterra As v. Wild Flavors Inc
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Oterra A/S (Denmark) and Oterra, LLC (Wisconsin)
- Defendant: Wild Flavors, Inc. (Delaware) and Archer-Daniels-Midland Co. (Delaware)
- Plaintiff’s Counsel: Saul Ewing LLP
- Case Identification: 1:23-cv-01376, D. Del., 12/04/2023
- Venue Allegations: Venue is alleged to be proper in the District of Delaware on the basis that both Defendant corporations are incorporated in Delaware and are therefore deemed to reside in the district.
- Core Dispute: Plaintiff seeks a declaratory judgment that its planned importation and sale of a natural blue food colorant does not infringe Defendant's patent, and that the patent's asserted claims are invalid.
- Technical Context: The technology relates to methods for creating stable, natural food colorants, particularly blue colorants, by co-processing juice from the Genipa americana fruit with other food-grade materials containing amino acids.
- Key Procedural History: The patent-in-suit is a reissue of U.S. Patent No. 8,557,319. The complaint alleges that during the prosecution of the original patent, the patentee made narrowing amendments and arguments to disclaim coverage of processes using "pure chemicals" or "purified materials" in order to overcome prior art rejections. This alleged disclaimer is central to the plaintiff's non-infringement theory. The lawsuit was filed on the effective date of an FDA rule authorizing the use of the plaintiff's specific colorant in the U.S., following a series of letters from the defendant asserting its patent rights.
Case Timeline
| Date | Event |
|---|---|
| 2008-03-28 | Priority Date for U.S. Patent No. 8,557,319 |
| 2009-03-06 | Filing Date for U.S. Patent No. 8,557,319 |
| 2011-10-19 | Prosecution Amendment for '319 Patent |
| 2012-08-31 | Prosecution Amendment for '319 Patent |
| 2013-10-15 | Issue Date for U.S. Patent No. 8,557,319 |
| 2015-10-13 | Filing Date for Reissue Patent RE46,695 |
| 2018-02-06 | Issue Date for U.S. Reissue Patent No. RE46,695 |
| 2020-02-05 | Defendant sends letter to Plaintiff's predecessor regarding RE'695 |
| 2020-07-31 | Plaintiff's partner (Ecoflora) submits FDA Petition for jagua blue colorant |
| 2020-12-03 | Defendant sends second letter to Plaintiff's predecessor regarding RE'695 |
| 2021-02-02 | Plaintiff's predecessor responds to Defendant's letter |
| 2023-02-21 | Defendant's counsel sends letter to Plaintiff's partner (Ecoflora) |
| 2023-12-04 | FDA rule permitting use of jagua blue colorant becomes effective |
| 2023-12-04 | Complaint for Declaratory Judgment filed |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Reissue Patent No. RE46,695, “Stable Natural Color Process, Products and Use Thereof,” issued February 6, 2018 (Compl. ¶21).
- The Invention Explained:
- Problem Addressed: The patent background describes a market need for natural food colorants, particularly a stable, natural blue colorant suitable for use in food and drug applications, which was not commercially available in the U.S. or Europe at the time of the invention (RE’695 Patent, col. 4:32-44).
- The Patented Solution: The invention is a method for producing stable, natural colors by co-processing fruit juice from Genipa americana (which contains the compound genipin) with other edible juices or extracts that contain nitrogenous compounds like amino acids or proteins (RE’695 Patent, Abstract). The reaction between the genipin in the Genipa juice and the amino acids in the second component is described as creating the stable color, such as a brilliant blue when processed with watermelon (RE’695 Patent, col. 6:22-25; col. 7:51-54).
- Technical Importance: The described process provides a method for creating a commercially desirable natural blue food colorant from plant-based sources, offering an alternative to synthetic dyes (RE’695 Patent, col. 4:32-44).
- Key Claims at a Glance:
- The complaint challenges claims 45-62, all of which depend from independent claim 45 (Compl. ¶38).
- Independent Claim 45 requires, among other things:
- Forming a mixture comprising (i) Genipa americana fruit juice and (ii) "other juice or material from a suitable food-grade source" that contains an amino acid.
- Processing the mixture at a specific pH range.
- Stabilizing the mixture with a heat treatment.
- Drying the mixture.
- The complaint expressly reserves the right to assert non-infringement or invalidity of other claims (Compl. ¶41, 51).
III. The Accused Instrumentality
- Product Identification: The subject of the declaratory judgment action is a jagua blue colorant produced by Plaintiff’s partner, Ecoflora, which Plaintiff Oterra intends to import, offer for sale, and sell in the United States (Compl. ¶¶ 4, 7). The action concerns both the process of making the colorant and the resulting product.
- Functionality and Market Context: The colorant is a natural, plant-based blue colorant for the food and beverage industry (Compl. ¶¶ 2, 4). The complaint alleges that the key feature of Ecoflora's manufacturing process is the use of "pure glycine" as the amino acid source that reacts with the Genipa americana fruit juice (Compl. ¶39). This functionality is contrasted with the patent's alleged requirement to use "simple juices" rather than "pure chemicals" (Compl. ¶39). The FDA's recent approval of the colorant for use in various food categories positions it for immediate entry into the U.S. market (Compl. ¶6).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The complaint seeks a declaratory judgment of non-infringement. The following table summarizes the plaintiff's primary argument that its process does not meet a key limitation of the asserted claim.
RE46,695 Infringement Allegations
| Claim Element (from Independent Claim 45) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| a. forming a mixture comprising: (i) Genipa americana fruit juice... | The complaint does not dispute that the process uses juice from Genipa americana fruit. | ¶4, 38 | col. 14:56-62 |
| ...and (ii) other juice or material from a suitable food-grade source that contains at least one component capable of providing the desired color... wherein the food-grade source comprises an amino acid; | The complaint alleges the process uses "pure glycine," which it contends is a "pure chemical" and not a "juice or material from a suitable food-grade source" as the patentee allegedly defined the term during prosecution. | ¶39 | col. 14:63-65 |
| b. processing said mixture... at a pH of from about 3 to about 8; | The complaint does not provide sufficient detail for analysis of this element. | col. 15:1-5 | |
| c. stabilizing the mixture... by applying a heat treatment; and | The complaint does not provide sufficient detail for analysis of this element. | col. 15:6-10 | |
| d. drying the mixture... | The complaint does not provide sufficient detail for analysis of this element. | col. 15:11-14 |
- Identified Points of Contention:
- Scope Questions: The central dispute concerns the scope of the claim term "other juice or material from a suitable food-grade source." The complaint raises the question of whether this term can be interpreted to cover a purified chemical compound like "pure glycine," especially in light of alleged prosecution history disclaimer where the patentee purportedly distinguished its invention from prior art that used "pure chemicals" and "purified materials" (Compl. ¶¶ 25-27, 39).
- Technical Questions: While the complaint notes that the manufacturing process occurs outside the U.S. (Compl. ¶39), the key technical question for infringement under 35 U.S.C. § 271(g) is whether that foreign process includes all steps of the patented method. This analysis will depend almost entirely on the resolution of the scope question identified above.
V. Key Claim Terms for Construction
- The Term: "other juice or material from a suitable food-grade source" (Claim 45).
- Context and Importance: The construction of this term is the fulcrum of the non-infringement dispute. Plaintiff's case is predicated on this term being construed to exclude purified chemicals like glycine (Compl. ¶¶ 39, 45). If the term is found to cover pure glycine, Plaintiff's primary non-infringement argument may fail.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent specification discloses that the "co-process materials" can be from a "broad range of suitable edible materials" including fruits, vegetables, grains, and seeds, and that these materials "contain amino acids, polypeptides, and proteins" (RE’695 Patent, col. 5:51-58). A patentee might argue that since the source material contains amino acids, using a purified form of an amino acid is encompassed by the claim language, which itself only requires that the "food-grade source comprises an amino acid" (RE’695 Patent, col. 14:65).
- Evidence for a Narrower Interpretation: The complaint alleges that during prosecution, the patentee explicitly distinguished the invention from prior art by stating that the claimed process "does not use 'pure chemicals (including amino acids)'" and instead utilizes "fruit juices or liquified versions of the defined food-grade sources" (Compl. ¶25). Such a statement, if found to be a clear and unambiguous disclaimer, would provide strong evidence for a narrower construction that excludes purified chemical compounds.
VI. Other Allegations
- Indirect Infringement: The complaint seeks a declaration of non-infringement for both direct and indirect infringement (Compl. p. 11, Prayer A). However, the factual allegations in the body of the complaint focus exclusively on the argument that the manufacturing process does not meet the limitations of the asserted method claims, which is a direct infringement analysis.
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of prosecution history estoppel: Did the patentee, during prosecution of the original patent, make a clear and unambiguous surrender of claim scope that would preclude the asserted claims from covering a process that uses a purified chemical, such as pure glycine, as the source of amino acids? The court's interpretation of the prosecution record will be a determinative factor.
- The case will also depend on a question of claim construction: Independent of the estoppel argument, what is the proper scope of the claim phrase "other juice or material from a suitable food-grade source"? The dispute will center on whether this language, in the context of the patent's specification, inherently requires a complex, non-purified substance like a juice or extract, or whether it can be read to include a single, pure chemical compound derived from such a source.