DCT

1:17-cv-00313

Kyowa Hakko Bio Co Ltd v. Ajinomoto Co Ltd

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00313, D. Del., 03/23/2017
  • Venue Allegations: Venue is alleged to be proper for U.S.-based Defendants as they are residents of or conduct business in Delaware. For non-U.S. resident Defendants, venue is asserted under 28 U.S.C. § 1391(c)(3).
  • Core Dispute: Plaintiff alleges that Defendants' process for manufacturing certain amino acids infringes a patent related to microbial fermentation and crystallization.
  • Technical Context: The lawsuit concerns industrial-scale production of amino acids, which are fundamental components in pharmaceuticals, food products, and animal feed, via fermentation processes.
  • Key Procedural History: The patent-in-suit is a reissue of U.S. Patent 7,888,078, indicating the claims were amended after the original grant. The complaint also notes that prior licensing discussions between the parties, from November 2014 to May 2016, did not result in an agreement. Plaintiff heavily invokes 35 U.S.C. § 295, seeking to shift the burden of proof for infringement to Defendants, a provision specific to products made by a patented process and imported into the U.S.

Case Timeline

Date Event
2005-04-12 ’723 Patent Priority Date (Japanese Application)
2014-11-01 Licensing discussions between Plaintiff and Defendant reportedly begin
2015-03-21 Alleged importation of L-valine by Defendant Ajinomoto Heartland
2015-04-01 Defendant Ajinomoto North America, Inc. succeeds predecessor entity
2015-10-06 U.S. Patent RE45,723 Issues
2015-12-28 Alleged importation of L-tryptophan by Defendant Ajinomoto Heartland
2016-05-31 Licensing discussions reportedly end without agreement
2016-06-06 Alleged importation of L-valine by Defendant Ajinomoto North America
2016-06-09 Plaintiff's counsel sends letter requesting process disclosure
2016-07-05 Defendant's counsel responds with non-infringement arguments
2017-03-23 Complaint Filed
2017-05-31 Scheduled completion of Defendant's L-tryptophan facility in Iowa

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

U.S. Reissue Patent No. RE 45,723 - "Process for Producing Amino Acids"

  • Patent Identification: U.S. Reissue Patent No. RE 45,723, "Process for Producing Amino Acids", issued October 6, 2015.

The Invention Explained

  • Problem Addressed: In conventional amino acid fermentation, the desired amino acid often precipitates as microcrystals. These small crystals are difficult to separate efficiently from the microorganisms in the culture, leading to low recovery yields or requiring additional, costly purification steps like redissolving the crystals (’723 Patent, col. 4:41-54).
  • The Patented Solution: The invention proposes a "Direct Crystal Precipitation" (DCP) process to control crystal formation during fermentation. The method involves adding "seed" crystals of the amino acid, with a specific average particle size, into the fermentation medium at a critical time—after the amino acid concentration has reached saturation but before spontaneous, uncontrolled crystallization begins. This seeding process encourages the formation of larger, more uniform crystals that can be easily recovered from the culture with a high recovery rate (’723 Patent, col. 8:25-40, Abstract).
  • Technical Importance: This process offers a method to increase the efficiency and yield of industrial amino acid production by simplifying the downstream purification and recovery stages (’723 Patent, col. 4:58-61).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 2, and dependent claims 7 and 8 (Compl. ¶64).
  • Independent Claim 1 recites a process comprising the steps of:
    • culturing a microorganism with the ability to produce an amino acid in a medium;
    • adding seed crystals of the amino acid with an average particle size of 7 to 50 µm to the medium at a specific time (after saturation but before natural deposition) so the crystal concentration becomes 0.5 g/l or more;
    • continuing to culture the microorganism;
    • allowing the crystals to grow to an average particle size of 30 µm or more; and
    • recovering the accumulated crystals based on the difference in particle size or specific gravity.
  • Independent Claim 2 is similar to Claim 1, but the seeding step is defined by the total surface area of the added crystals becoming 0.02 m²/l or more, rather than by concentration.
  • Dependent claims 7 and 8 specify that the amino acid is one of L-glutamine, L-valine, L-leucine, L-isoleucine, L-phenylalanine, L-tyrosine, or L-tryptophan.

III. The Accused Instrumentality

Product Identification

  • The "Accused Products" are specific amino acids (L-glutamine, L-glutamic acid, L-tryptophan, and L-valine) and monosodium glutamate, which the complaint alleges are manufactured by an infringing process and then imported, sold, or used in the U.S. by Defendants (Compl. ¶2).

Functionality and Market Context

  • The complaint alleges that Defendants use a fermentation process to produce the Accused Products (Compl. ¶115). Plaintiff alleges that this process is, in fact, the patented DCP process and provides technical analysis of impurity profiles in Defendants' products to support this claim (Compl. ¶¶ 124-125, 128). The products are sold for various applications, including animal nutrition, human food, and pharmaceuticals (Compl. ¶¶ 44-46). The complaint portrays the various defendant entities as an integrated "Ajinomoto Group" that functions as a single enterprise in the manufacture and sale of these products (Compl. ¶¶ 26-28).

IV. Analysis of Infringement Allegations

No probative visual evidence provided in complaint.

The complaint alleges that the process used by Defendants to manufacture the Accused Products meets every limitation of the asserted claims. The allegations are summarized below for the representative independent claim.

RE 45,723 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
culturing a microorganism having an ability to produce the amino acid in a medium Defendants are alleged to use a fermentation process, which involves culturing a microorganism, to produce the Accused Products. ¶115, ¶117 col. 8:47-49
adding crystals of the amino acid having an average particle size of 7 to 50 µm to the medium at some time after the amino acid concentration in the medium reaches the saturation solubility and before crystals of the amino acid deposit in the medium so that the concentration of the crystals of the amino acid becomes 0.5 g/l or more The complaint alleges a substantial likelihood that Defendants' process includes this seeding step within the claimed parameters, arguing it is more efficient than alternatives. For products where Defendants deny adding crystals, Plaintiff points to impurity fingerprints as evidence that a DCP process was used. ¶134, ¶138-¶140 col. 8:50-57
culturing the microorganism having the ability to produce the amino acid in the medium The complaint alleges a substantial likelihood that Defendants continue culturing the microorganism during crystallization due to the greater productivity of this method compared to terminating the culture. ¶141 col. 8:58-60
allowing the crystals of the amino acid to grow to crystals of the amino acid having an average particle size of 30 µm or more and accumulate in the medium The complaint alleges a substantial likelihood that Defendants' process allows crystals to grow to this size because it enables more efficient recovery in the subsequent step. ¶142 col. 8:61-63
recovering the crystals of the amino acid from the culture by separating the microorganism producing the amino acid and the accumulated crystals of the amino acid based on the difference in particle size or specific gravity between them The complaint alleges a substantial likelihood that Defendants use this recovery method because it is more efficient in terms of time and energy than alternative recovery methods for crystalline amino acids produced via a DCP process. ¶143 col. 8:64-68
  • Identified Points of Contention:
    • Factual Question: For L-tryptophan, L-valine, and L-glutamine, Defendants reportedly stated they "do not add crystals of the amino acid to the medium, as claimed" (Compl. ¶107). The central dispute will be a factual one: does the accused process practice this step? The complaint relies on indirect evidence, such as HPLC impurity fingerprints allegedly characteristic of a DCP process, to argue that the step is performed (Compl. ¶¶ 124-127).
    • Scope & Technical Question: For L-glutamic acid, Defendants allegedly admitted to adding seed crystals but contended their "average particle size... is much greater than the maximum of the range claimed" (Compl. ¶107). This raises two questions: 1) a legal question of claim construction regarding the term "average particle size," and 2) a factual question of whether the crystals used in the accused process fall within the properly construed range.

V. Key Claim Terms for Construction

  • The Term: "average particle size"
  • Context and Importance: This term is central to the dispute. For L-glutamic acid, Defendants’ primary non-infringement argument is that their seed crystals are larger than the 7-to-50 µm range required by Claim 1 (Compl. ¶107). Plaintiff alleges that Defendants’ interpretation of this term may be incorrect (Compl. ¶¶ 109-112). The construction of this term could be dispositive for infringement of at least some of the Accused Products.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification discusses adding crystals with an "average particle size of 1 to 120 µm" in its general description, a much wider range than recited in the claim (’723 Patent, col. 6:1-2). A party might argue this context suggests the specific claimed range should not be interpreted with excessive rigidity.
    • Evidence for a Narrower Interpretation: The claim itself explicitly recites the range of "7 to 50 µm" (’723 Patent, col. 8:50). The specification discloses a specific instrument for measurement, the "SK LASER MICRON SIZER LMS-24," which uses a laser diffraction and scattering method (’723 Patent, col. 8:2-5). Plaintiff suggests the proper interpretation is tied to this specific methodology, potentially giving the term a precise technical meaning that a party could argue Defendants' process meets (Compl. ¶111).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement to infringe under 35 U.S.C. § 271(b). The factual basis is the allegation that the parent company, Ajinomoto Co., Ltd. ("AJ"), specifies and controls the manufacturing methods used by its subsidiaries, and that the defendants operate as a "single business enterprise" with knowledge of the patent (Compl. ¶¶ 31, 66, 70).
  • Willful Infringement: Willfulness is alleged based on pre-suit knowledge of the ’723 patent and its parent patent (Compl. ¶133). The complaint cites licensing discussions that began in November 2014 and a June 2016 letter from Plaintiff’s counsel that specifically identified the patent and the infringing activities, followed by a substantive response from Defendants' counsel (Compl. ¶¶ 103-107, 149).

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

  • A primary issue will be the application of 35 U.S.C. § 295: will the plaintiff's proffer of indirect evidence (e.g., impurity analysis, arguments of process superiority) and its documented but unsuccessful efforts to obtain process details from the defendants be sufficient to establish a "substantial likelihood" of infringement, thereby shifting the burden of proof to the defendants to show their process is non-infringing?
  • A second core issue will be one of claim construction and factual application: how will the court construe the term "average particle size"? Will it be defined by the specific measurement techniques disclosed in the patent, and does the defendants' admitted process for making L-glutamic acid fall within that construed scope?
  • Finally, a key evidentiary question will be one of proof: for the products where defendants deny "adding crystals," can the plaintiff’s indirect technical evidence of impurity profiles convince a fact-finder, by a preponderance of the evidence, that the claimed seeding step was in fact performed?