DCT

1:18-cv-00129

Huvepharma EOOD v. Associated British Foods

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-00129, D. Del., 01/23/2018
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware as several defendant entities are Delaware corporations, and the foreign defendants are subject to jurisdiction in the United States.
  • Core Dispute: Plaintiff alleges that Defendants' "Quantum" and "Quantum Blue" lines of phytase products, used as animal feed additives, are produced by methods that infringe six U.S. patents related to the overexpression of phytase genes in fungal and yeast systems.
  • Technical Context: The technology involves genetically engineering microorganisms to produce phytase, an enzyme that increases the nutritional value of plant-based animal feed by releasing indigestible phosphorus, thereby improving animal growth and reducing environmental pollution from phosphate runoff.
  • Key Procedural History: The complaint alleges that Plaintiff holds an exclusive license to the patents-in-suit from the Cornell Research Foundation, Inc. Subsequent to the filing of this complaint, Inter Partes Review (IPR) proceedings were initiated against all six patents-in-suit. According to USPTO records, these IPRs resulted in the cancellation of all asserted claims of U.S. Patent Nos. 8,993,300; 6,451,572; 7,312,063; and 8,455,232, as well as the cancellation of the majority of asserted claims of U.S. Patent No. 7,026,150.

Case Timeline

Date Event
1998-06-25 Earliest Priority Date for all Patents-in-Suit
2002-09-17 U.S. Patent No. 6,451,572 Issues
2006-04-11 U.S. Patent No. 7,026,150 Issues
2007-12-25 U.S. Patent No. 7,312,063 Issues
2008 Accused "Quantum" Products Allegedly First Imported
2010-11-09 U.S. Patent No. 7,829,318 Issues
2012 Accused "Quantum Blue" Products Allegedly First Commercialized
2013-06-04 U.S. Patent No. 8,455,232 Issues
2015-03-31 U.S. Patent No. 8,993,300 Issues
2018-01-23 Complaint Filing Date
2019-01-23 IPR Petitions Filed Against Patents-in-Suit
2023-03-07 IPR Certificate Issues Cancelling Asserted Claims of ’572 Patent
2023-03-08 IPR Certificate Issues Cancelling Asserted Claims of ’063 Patent
2023-03-10 IPR Certificate Issues Cancelling Asserted Claims of ’150 Patent
2023-03-14 IPR Certificate Issues Cancelling Asserted Claims of ’232 Patent
2023-03-15 IPR Certificate Issues Cancelling Asserted Claims of ’300 Patent

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

U.S. Patent No. 8,993,300 - Overexpression of Phytase Genes in Yeast Systems

  • Patent Identification: U.S. Patent No. 8,993,300, issued on March 31, 2015.

The Invention Explained

  • Problem Addressed: The patent family addresses the problem that prior phytase enzymes used in animal feed, such as those derived from Aspergillus niger, were not sufficiently resistant to heat ("thermotolerant"). This made them susceptible to degradation during the high-temperature feed pelleting process, reducing their effectiveness (Compl. ¶36; '300 Patent, Ex. 1, col. 2:25-33).
  • The Patented Solution: The invention claims a method for producing a more thermostable phytase enzyme. The solution involves taking a polynucleotide (a gene) that encodes for a phytase from the bacterium Escherichia coli and expressing that gene in a different type of organism—specifically, fungal cells. This heterologous expression system is described as creating phytases with improved thermal stability suitable for the animal feed industry (Compl. ¶¶37-38). The '300 patent claims are directed specifically to this production method using fungal cells as the host ('300 Patent, Claim 1).
  • Technical Importance: This approach provided a method for producing phytase enzymes that could better withstand the rigors of commercial animal feed manufacturing, thereby improving phosphorus availability for livestock and reducing the need for costly supplements (Compl. ¶¶35, 37).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 11 (Compl. ¶90).
  • Essential elements of Claim 1 include:
    • A method of producing a phytase in fungal cells, comprising:
    • providing a polynucleotide encoding an Escherichia coli phytase;
    • expressing the polynucleotide in the fungal cells; and
    • isolating the expressed Escherichia coli phytase.
  • Essential elements of Claim 11 include:
    • A method of producing an Escherichia coli phytase, comprising:
    • expressing a polynucleotide encoding the Escherichia coli phytase in a fungal cell; and
    • isolating the expressed phytase, wherein the phytase retains at least 40% of its activity after heating for 15 minutes at 80 degrees C.
  • The complaint also asserts dependent claims 2, 3, 6, 7, 8, and 12 (Compl. ¶90).

U.S. Patent No. 6,451,572 - Overexpression of Phytase Genes in Yeast Systems

  • Patent Identification: U.S. Patent No. 6,451,572, issued on September 17, 2002.

The Invention Explained

  • Problem Addressed: The patent identifies the need for an efficient and simple system to economically produce phytase for the food and feed industry. It notes that while yeast can be an effective production vehicle, prior methods were insufficient ('572 Patent, col. 2:48-52).
  • The Patented Solution: The invention provides a method of producing phytase by introducing a heterologous gene—specifically, the appA gene from E. coli—into a Pichia yeast strain. The patent describes that expressing this bacterial gene in a yeast host results in a phytase enzyme with "increased thermostability" compared to the same phytase expressed in a non-yeast (e.g., bacterial) host cell ('572 Patent, Abstract; Claim 1). This use of a yeast system allows for high-level expression and secretion of the enzyme into the growth media for easier collection ('572 Patent, col. 2:34-39).
  • Technical Importance: This method provided a pathway for high-yield, cost-effective production of a more heat-stable phytase enzyme using a yeast system generally regarded as safe for food and feed applications ('572 Patent, col. 2:34-44).

Key Claims at a Glance

  • The complaint asserts independent claims 1 and 9 (Compl. ¶99).
  • Essential elements of Claim 1 include:
    • A method of producing phytase in Pichia yeast comprising:
    • providing an appA polynucleotide from Escherichia coli;
    • expressing said polynucleotide in a Pichia yeast strain; and
    • isolating the expressed protein, wherein the phytase has increased thermostability as compared to the phytase expressed in a non-yeast host cell.
  • Essential elements of Claim 9 include:
    • A method of producing a protein having phytase activity comprising:
    • providing an isolated appA polynucleotide from Escherichia coli;
    • expressing said polynucleotide in a Pichia yeast strain; and
    • isolating the expressed protein.
  • The complaint also asserts dependent claims 2-4 and 10 (Compl. ¶99).

U.S. Patent No. 7,026,150 - Overexpression of Phytase Genes in Yeast Systems

  • Patent Identification: U.S. Patent No. 7,026,150, issued April 11, 2006.
  • Technology Synopsis: This patent, part of the same family as the '572 Patent, claims methods for producing phytase by expressing a polynucleotide from a non-yeast organism (such as E. coli) in various types of yeast, including Pichia, Saccharomyces, and Kluyveromyces. The invention is directed at creating a thermostable phytase suitable for animal feed ('150 Patent, Abstract; Claim 1).
  • Asserted Claims: Independent claims 1, 6, 28, and 37 are asserted (Compl. ¶107).
  • Accused Features: The "Quantum" product line, including Quantum 2500D and 5000L, is accused of being produced by the claimed methods (Compl. ¶107).

U.S. Patent No. 7,312,063 - Overexpression of Phytase Genes in Yeast Systems

  • Patent Identification: U.S. Patent No. 7,312,063, issued December 25, 2007.
  • Technology Synopsis: This patent claims methods of producing phytase by expressing a polynucleotide from E. coli in a yeast host. The claims specify that the resulting phytase has an optimal activity at a pH of less than about 4, which is relevant for function in an animal's stomach ('063 Patent, Claim 5).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶115).
  • Accused Features: The "Quantum" product line, including Quantum 2500D and 5000L, is accused of being produced by the claimed methods (Compl. ¶115).

U.S. Patent No. 7,829,318 - Overexpression of Phytase Genes in Yeast Systems

  • Patent Identification: U.S. Patent No. 7,829,318, issued November 9, 2010.
  • Technology Synopsis: This patent claims methods of producing phytase in Pichia yeast by expressing a polynucleotide from E. coli. The claims require that the resulting phytase catalyzes the release of phosphate from phytate (’318 Patent, Claim 1).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶123).
  • Accused Features: The "Quantum" product line, including Quantum 2500D and 5000L, is accused of being produced by the claimed methods (Compl. ¶123).

U.S. Patent No. 8,455,232 - Overexpression of Phytase Genes in Yeast Systems

  • Patent Identification: U.S. Patent No. 8,455,232, issued June 4, 2013.
  • Technology Synopsis: This patent claims methods of producing phytase by providing a polynucleotide from E. coli and expressing it in a yeast. The claims cover the specific E. coli AppA phytase ('232 Patent, Claim 2).
  • Asserted Claims: Independent claim 1 is asserted (Compl. ¶131).
  • Accused Features: The "Quantum" product line, including Quantum 2500D and 5000L, is accused of being produced by the claimed methods (Compl. ¶131).

III. The Accused Instrumentality

Product Identification

The complaint accuses two product lines: the "Quantum Blue" phytase products and the "Quantum" phytase products (Compl. ¶8). Specific accused products include Quantum Blue 5G, 10G, 40P, 200P, and QBC, as well as Quantum 2500D and 5000L (Compl. ¶8).

Functionality and Market Context

  • The accused products are phytase enzymes sold as additives for animal feed to increase the digestibility of phosphorus in diets for poultry and swine (Compl. ¶¶49, 68). The complaint alleges these products are produced via the patented methods of heterologous gene expression.
  • The "Quantum Blue" products are allegedly manufactured by expressing an E. coli phytase gene in a fungal host organism, Trichoderma reesei (Compl. ¶¶45-46). Some Quantum Blue products are allegedly manufactured in the United States, while others are manufactured overseas and imported (Compl. ¶41).
  • The "Quantum" products are allegedly manufactured overseas and imported into the United States (Compl. ¶77). The complaint alleges these products are produced by fermentation of the yeast Pichia pastoris, which has been genetically modified to contain a synthetic gene from E. coli that encodes a thermotolerant phytase (Compl. ¶¶78-79).
  • A diagram in the complaint illustrates the alleged "PRODUCTION PROCESS" for Quantum Blue phytase, showing a seed fermenter, nutrient addition, processing steps such as filtering and drying, and parameters for process control (Compl. p. 20).

IV. Analysis of Infringement Allegations

8,993,300 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of producing a phytase in fungal cells, the method comprising: providing a polynucleotide encoding an Escherichia coli phytase; Defendants' Quantum Blue products are allegedly produced using an E. coli phytase gene. ¶46 col. 29:3-5
expressing the polynucleotide in the fungal cells; The E. coli polynucleotide is allegedly expressed in a fungal production organism, identified as Trichoderma reesei. ¶46, ¶51 col. 29:6-7
and isolating the expressed Escherichia coli phytase... The expressed phytase is allegedly isolated through downstream processing, which includes filtering, ultra-filtering, stabilizing, and drying methods. ¶48 col. 29:8-9
  • Identified Points of Contention:
    • Scope Questions: A potential issue may be whether the term "fungal cells" in the claims, which the specification supports with examples of filamentous fungi, is limited in any way that would exclude the specific Trichoderma reesei strain allegedly used by Defendants.
    • Technical Questions: A key factual question for the court will be whether Plaintiff can prove that the genetic source material for Defendants' Quantum Blue products is, in fact, a "polynucleotide encoding an Escherichia coli phytase," as required by the claim and alleged by the complaint.

6,451,572 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method of producing phytase in Pichia yeast comprising: providing an appA polynucleotide from Escherichia coli...; Defendants' Quantum phytase products are allegedly produced using a synthetic appA gene from E. coli as the donor organism. ¶79 col. 36:49-52
expressing said polynucleotide in a Pichia yeast strain; The appA polynucleotide is allegedly expressed through fermentation of a genetically modified strain of Pichia pastoris yeast. ¶80 col. 36:53-54
and isolating the expressed protein, wherein the phytase catalyzes the release of phosphate from phytate and has increased thermostability as compared to the phytase expressed in a non-yeast host cell. The expressed phytase enzyme is allegedly recovered from the fermentation broth through cell separation, clarification, and various filtration steps. The complaint alleges the resulting product provides increased thermostability. ¶81, ¶83 col. 36:55-61
  • Identified Points of Contention:
    • Scope Questions: Claim 1 requires that the resulting phytase has "increased thermostability as compared to the phytase expressed in a non-yeast host cell." The construction of this comparative limitation—including the specific baseline product for comparison and the metrics for measuring "increased thermostability"—may be a central point of dispute.
    • Technical Questions: What evidence does the complaint provide to support the allegation that the accused Quantum phytase demonstrates "increased thermostability" relative to the specific baseline required by the claim? The infringement analysis may turn on whether Plaintiff can produce testing data that satisfies this claim element.

V. Key Claim Terms for Construction

'300 Patent

  • The Term: "fungal cells"
  • Context and Importance: The infringement allegation against the Quantum Blue products is predicated on the use of Trichoderma reesei, a filamentous fungus, as the production host (Compl. ¶46). Practitioners may focus on this term because the scope of "fungal cells" will determine whether the specific production organism allegedly used by Defendants falls within the claims.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Claim 1 uses the general term "fungal cells" without limitation to a particular species. The patent family specification mentions that preferred hosts can include "species of yeast or filamentous fungi," and lists Aspergillus and Neurospora as preferred filamentous fungi ('572 Patent, col. 5:34-44).
    • Evidence for a Narrower Interpretation: A defendant may argue that the scope should be limited to the specific examples disclosed, such as Aspergillus and Neurospora, and might contend that Trichoderma is distinct in a legally relevant way.

'572 Patent

  • The Term: "increased thermostability as compared to the phytase expressed in a non-yeast host cell"
  • Context and Importance: This is a comparative limitation that qualifies the final product. Infringement requires not only performing the steps but also achieving a specific outcome relative to a control product. The definition of the baseline "non-yeast host cell" (e.g., E. coli) and the methodology for comparing "thermostability" will be critical to the infringement analysis.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The background section broadly describes the problem of prior art phytases being "subject to being destroyed when exposed to... heat" during feed pelleting ('572 Patent, col. 2:25-30). This context may support interpreting "increased thermostability" as any meaningful improvement in heat resistance relevant to feed production.
    • Evidence for a Narrower Interpretation: The patent specification provides specific experimental data comparing phytase produced in yeast to that produced by A. niger and showing it to be "more heat stable" ('572 Patent, col. 18:25-27). A defendant may argue that the term requires meeting the specific levels of improvement demonstrated in the patent's own examples.

VI. Other Allegations

  • Indirect Infringement: The complaint does not plead separate counts for indirect infringement (inducement or contributory infringement). The allegations focus on direct infringement under 35 U.S.C. § 271(a) for acts within the U.S. and § 271(g) for the importation, sale, or use of products made by a patented process abroad (Compl. ¶¶90-92, 99-100).
  • Willful Infringement: The complaint does not contain an explicit allegation of willful infringement and does not plead facts suggesting Defendants had pre-suit knowledge of the patents-in-suit.

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

This case presents several fundamental questions for the court, with the procedural history being of primary importance.

  • A threshold issue will be one of procedural finality: given that post-complaint Inter Partes Review proceedings resulted in the cancellation of all asserted claims for five of the six patents-in-suit and the vast majority for the sixth, can any viable infringement claims remain for adjudication?
  • A key evidentiary question would have been one of biological sourcing: can Plaintiff prove that Defendants' "Quantum Blue" products are manufactured using a polynucleotide originating from Escherichia coli, and that "Quantum" products are made using the specific appA polynucleotide, as required by the respective patent claims?
  • A central issue of claim scope for the '572 patent and its family would have been the construction of the comparative limitation "increased thermostability." The case would likely have depended on how the baseline for comparison—a "phytase expressed in a non-yeast host cell"—is defined and measured, and whether the accused products meet that standard.