DCT

1:20-cv-00514

Huvepharma EOOD v. Koninklijke DSM NV

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:20-cv-00514, D. Del., 04/15/2020
  • Venue Allegations: Venue is asserted based on Defendant DSM Nutritional Products, LLC being a Delaware corporation and the other defendants being foreign entities, rendering Delaware a proper and convenient forum.
  • Core Dispute: Plaintiff alleges that Defendants' imported animal feed additives are produced using a patented process for manufacturing phytase enzymes, thereby infringing its process patent under 35 U.S.C. § 271(g).
  • Technical Context: The technology concerns the biotechnological production of phytase, an enzyme added to animal feed to increase phosphorus absorption, enhance animal growth, and reduce environmental pollution from manure.
  • Key Procedural History: Plaintiff is the exclusive licensee of the patent, originally assigned to Cornell Research Foundation, Inc. Subsequent to the filing of this complaint, all asserted claims of the '300 patent were cancelled in an Inter Partes Review proceeding (IPR2019-00577), with the cancellation certificate issued on March 15, 2023.

Case Timeline

Date Event
1998-06-25 '300 Patent Priority Date
2012-01-01 Alleged commencement of accused product manufacturing
2015-03-31 '300 Patent Issue Date
2016-01-01 Alleged commencement of U.S. importation and sales
2020-04-15 Complaint Filing Date

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, “Overexpression of Phytase Genes in Yeast Systems,” issued March 31, 2015.

The Invention Explained

  • Problem Addressed: The patent addresses the inability of simple-stomached animals, such as swine and poultry, to digest phosphorus from phytate, a compound common in plant-based feeds. This necessitates costly phosphorus supplementation and leads to environmental pollution from excreted, undigested phytate-P. (’300 Patent, col. 1:36-49). Furthermore, previously available microbial phytases were often not sufficiently stable to withstand the heat of the feed manufacturing process. (’300 Patent, col. 2:42-49).
  • The Patented Solution: The invention describes a method for producing more effective and thermostable phytase enzymes. The method involves expressing a polynucleotide that encodes for an Escherichia coli phytase within a heterologous host, specifically a fungal cell system like yeast. (’300 Patent, Abstract; col. 10:11-19). This heterologous expression system is designed to produce the enzyme economically and with improved biochemical properties, such as thermal stability. (’300 Patent, col. 10:29-34).
  • Technical Importance: The described method offers a way to produce phytase enzymes that are both more effective in animal digestive tracts and more resilient to industrial feed production processes, using a host system (yeast) that is considered safe and efficient for food applications. (’300 Patent, col. 2:52-65).

Key Claims at a Glance

  • The complaint asserts claims 1-9 of the ’300 Patent (Compl. ¶57). Independent claim 1 is representative.
  • The essential elements of independent claim 1 are:
    • A method of producing a phytase in fungal cells, the method comprising:
    • providing a polynucleotide encoding an Escherichia coli phytase;
    • expressing the polynucleotide in the fungal cells; and
    • isolating the expressed Escherichia coli phytase wherein the Escherichia coli phytase catalyzes the release of phosphate from phytate.
  • The complaint notes that its infringement contentions are exemplary and not intended to be limiting. (Compl. ¶59).

III. The Accused Instrumentality

Product Identification

The accused instrumentalities are phytase animal feed products sold under the trade names Ronozyme® HiPhos M, Ronozyme® HiPhos GT, and Ronozyme® HiPhos L. (Compl. ¶9).

Functionality and Market Context

The accused products are phytase enzymes used as additives in animal feed to increase the availability of phosphorus from plant-based diets. (Compl. ¶54). The complaint alleges these products are manufactured outside the United States by a third party, Novozymes, for the Defendants, and are then imported, distributed, and sold within the United States. (Compl. ¶¶41-42). A flowchart included in the complaint illustrates the alleged manufacturing process, which involves fermentation, purification, and formulation steps. (Compl. p. 14). The complaint alleges the accused products are produced in the filamentous fungus Aspergillus oryzae using a gene derived from E. coli. (Compl. ¶¶46, 49).

IV. Analysis of Infringement Allegations

'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: The accused phytase is allegedly produced in the filamentous fungus Aspergillus oryzae, which are fungal cells. ¶45, ¶49 col. 36:27-29
providing a polynucleotide encoding an Escherichia coli phytase; The manufacturing process allegedly uses a polynucleotide encoding an AppA phytase derived from E. coli, which Plaintiff states was confirmed by laboratory testing. ¶46, ¶47 col. 36:30-31
expressing the polynucleotide in the fungal cells; and The E. coli-derived gene is allegedly expressed in the Aspergillus oryzae fungal cells. ¶48, ¶49 col. 36:32-33
isolating the expressed Escherichia coli phytase wherein the Escherichia coli phytase catalyzes the release of phosphate from phytate. The accused manufacturing process allegedly includes multi-step purification to isolate the enzyme, which is then used to release phosphate from phytate in animal feed. ¶51, ¶53 col. 36:34-37

Identified Points of Contention

  • Scope Questions: The complaint itself raises a potential factual dispute regarding the origin of the phytase-encoding gene. It alleges the gene is from E. coli but also acknowledges a Defendant document stating the gene is from Citrobacter braakii. (Compl. ¶47). This raises the question: Does the accused process use a polynucleotide encoding an 'Escherichia coli' phytase as required by the claim, or does it use a gene from a different, albeit related, bacterium?
  • Technical Questions: A technical question may arise regarding the claim term "fungal cells." The patent is titled "Overexpression of Phytase Genes in Yeast Systems," which could suggest a narrower scope than the plain language of the claim. This raises the question: Can the term "fungal cells", in the context of the patent as a whole, be construed to cover the filamentous fungus Aspergillus oryzae allegedly used in the accused process, or is it limited to yeast systems?

V. Key Claim Terms for Construction

The Term: "fungal cells"

  • Context and Importance: This term defines the required host organism for the patented method. The infringement allegation hinges on the accused process using Aspergillus oryzae, a filamentous fungus, which must fall within the scope of "fungal cells" for the claim to be met. Practitioners may focus on this term because of the potential tension between the broad claim language and more specific descriptions in the patent.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification explicitly states that preferred host cells "include yeast or filamentous fungi," and names Aspergillus niger as a preferred filamentous fungus. (’300 Patent, col. 10:16-18).
    • Evidence for a Narrower Interpretation: The patent's title, “Overexpression of Phytase Genes in Yeast Systems,” and abstract, which focuses on production "in a yeast system," could be used to argue that the invention is specific to yeast and that "fungal cells" should be construed more narrowly in that context. (’300 Patent, Title; Abstract).

The Term: "Escherichia coli phytase"

  • Context and Importance: This term defines the specific enzyme to be produced. Its construction is critical because the complaint notes conflicting evidence regarding the genetic source of the enzyme in the accused product (E. coli vs. Citrobacter braakii). (Compl. ¶47).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party could argue the term encompasses phytases with high homology to the E. coli AppA protein described in the patent, regardless of the exact bacterial source. The patent characterizes the enzyme by its properties, such as its optimal pH and molecular mass. (’300 Patent, col. 10:11-14).
    • Evidence for a Narrower Interpretation: The claim language is specific to "Escherichia coli phytase." The specification consistently describes the method as using a polynucleotide "isolated from bacterial cells, i.e., from E. coli." (’300 Patent, col. 10:11-12). This may support an interpretation that strictly requires the gene to originate from the E. coli species.

VI. Other Allegations

Indirect Infringement

The complaint does not contain specific factual allegations supporting induced or contributory infringement under 35 U.S.C. § 271(b) or (c). The action is premised on direct infringement arising from the importation of a product made by a patented process under 35 U.S.C. § 271(g). (Compl. ¶57).

Willful Infringement

The complaint does not allege facts to support a claim of willful infringement, such as pre-suit knowledge of the patent or egregious conduct. The prayer for relief includes a request for a determination that the case is "exceptional" under 35 U.S.C. § 285, but the complaint body does not plead the factual basis for such a finding. (Compl. p. 16, ¶C).

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

  • A central threshold issue is one of case viability: given that all asserted claims of the '300 patent were cancelled in an Inter Partes Review proceeding after the complaint was filed, the court must first address the legal standing of an infringement action based on claims that are no longer valid.
  • A core factual dispute will be one of genetic origin: does the accused manufacturing process utilize a polynucleotide encoding an 'Escherichia coli' phytase as claimed, or does it originate from a different bacterium like Citrobacter braakii, as a defense document suggests?
  • A key question for claim construction will be one of host scope: does the term "fungal cells," in the context of a patent titled for "Yeast Systems," encompass the filamentous fungus Aspergillus oryzae allegedly used in the accused process, or is the claim scope limited by the more specific embodiments described?