DCT

0:17-cv-01899

Pharmgate LLC v. Zoetis Inc

Log In
Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 0:17-cv-01899, D. Minn., 06/05/2017
  • Venue Allegations: Plaintiffs allege venue is proper in the District of Minnesota because Defendant Zoetis directed activities to the state by sending an infringement allegation letter to Plaintiff ProtaTek, a Minnesota-based company.
  • Core Dispute: This is a declaratory judgment action in which Plaintiffs seek a declaration that their porcine circovirus vaccines do not infringe eleven of Defendants' patents, and/or that those patents are invalid.
  • Technical Context: The patents relate to vaccines for Porcine Circovirus Type 2 (PCV2), a virus associated with Piglet Weight Loss Disease (PWD), a significant cause of economic loss in the swine industry.
  • Key Procedural History: The complaint was filed in response to a May 25, 2017, letter from Defendants alleging that Plaintiffs' vaccines infringe the eleven asserted patents. This letter was preceded by a May 20, 2017, conversation between executives of the companies in which Plaintiffs were notified of the impending infringement allegations.

Case Timeline

Date Event
1997-12-05 Earliest Priority Date for all Asserted Patents
2004-03-09 U.S. Patent No. 6,703,023 Issues
2007-05-29 U.S. Patent No. 7,223,407 Issues
2007-05-29 U.S. Patent No. 7,223,594 Issues
2008-08-05 U.S. Patent No. 7,407,803 Issues
2009-10-20 U.S. Patent No. 7,604,808 Issues
2010-05-25 U.S. Patent No. 7,722,883 Issues
2010-06-22 U.S. Patent No. 7,740,866 Issues
2010-07-20 U.S. Patent No. 7,758,865 Issues
2011-05-31 U.S. Patent No. 7,951,907 Issues
2012-02-28 U.S. Patent No. 8,124,723 Issues
2014-05-06 U.S. Patent No. 8,715,690 Issues
2017-05-20 Defendants' executive notifies Plaintiffs' CEO of impending infringement letter
2017-05-25 Defendants send letter to Plaintiffs alleging infringement
2017-06-05 Complaint for Declaratory Judgment Filed

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

U.S. Patent No. 6,703,023 - “Circovirus Sequences Associated with Piglet Weight Loss Disease (PWD)”

  • Issued: March 9, 2004 (’023 Patent)

The Invention Explained

  • Problem Addressed: The patent describes Piglet Weight Loss Disease (PWD) as a significant ailment in swine farming with an unknown cause, for which no effective vaccine existed ( ’023 Patent, col. 3:20-23). The lack of a specific diagnostic tool or vaccine hampered efforts to control the disease ( ’023 Patent, col. 3:12-17).
  • The Patented Solution: The invention claims to have isolated and sequenced a new circovirus, designated Porcine Circovirus Type B (PCVB), identified as the etiological agent for PWD (’023 Patent, Abstract). The patent discloses the nucleotide sequences of this virus, such as SEQ ID No. 25, and claims vaccines comprising these sequences (or close homologues) combined with a pharmaceutical carrier to induce a protective immune response in pigs (’023 Patent, col. 3:45-53).
  • Technical Importance: The identification and sequencing of the specific virus allegedly responsible for PWD provided the basis for developing the first targeted vaccines and diagnostic tests to combat the disease (’023 Patent, col. 3:40-44).

Key Claims at a Glance

  • The complaint specifically references independent claim 1 (Compl. ¶27).
  • The essential elements of claim 1 are:
    • A vaccine comprising a nucleic acid having a nucleotide sequence with at least 90% sequence identity to SEQ. ID. No. 25
    • and an acceptable pharmaceutical vehicle,
    • wherein said nucleic acid encodes an immunogenic protein that induces a protective response effective against infection by a piglet weight loss disease circovirus.
  • The complaint seeks a declaration of non-infringement for all claims of the patent, suggesting the dispute may extend to dependent claims as well (Compl. ¶32).

U.S. Patent No. 7,223,407 - “Circovirus Sequences Associated with Piglet Weight Loss Disease (PWD)”

  • Issued: May 29, 2007 (’407 Patent)

The Invention Explained

  • Problem Addressed: The patent addresses the same problem as the ’023 Patent: the need for effective vaccines and diagnostics for PWD caused by a porcine circovirus (’407 Patent, col. 3:22-26).
  • The Patented Solution: This patent focuses on the tools for producing the immunogenic components of a vaccine. It claims a vector, such as a baculovirus, that has been modified to include the circovirus DNA sequence. This vector can then be used to transform a host cell (e.g., an insect cell), turning it into a factory for producing the viral protein needed for the vaccine (’407 Patent, Abstract; col. 17:5-17).
  • Technical Importance: Using recombinant vectors provides a potentially safer and more scalable method for producing large quantities of a viral protein for vaccines, without having to cultivate the actual pathogenic virus (’407 Patent, col. 18:12-19).

Key Claims at a Glance

  • The complaint asserts non-infringement of the "claims '407 patent" without specifying any particular claim (Compl. ¶37). Independent claim 1 is representative.
  • The essential elements of claim 1 are:
    • A vector capable of expressing at least one polypeptide encoded by a nucleic acid sequence
    • comprising a sequence having at least 80% sequence identity to SEQ ID NO: 25.
  • The complaint seeks a declaration of non-infringement for all claims of the patent (Compl. ¶38).

U.S. Patent No. 7,223,594 - “Circovirus Sequences Associated with Piglet Weight Loss Disease (PWD)”

  • Issued: May 29, 2007
  • Technology Synopsis: This patent claims a host cell (such as an insect cell) that has been transformed with a vector containing the PWD-associated circovirus DNA sequence. These transformed cells are engineered to produce the immunogenic viral protein for use in vaccines.
  • Asserted Claims: All claims are implicated by the request for a declaratory judgment of non-infringement (Compl. ¶43).
  • Accused Features: The complaint suggests that Plaintiffs' manufacturing process, which uses ProtaTek technology, is what Defendants would accuse of infringement (Compl. ¶15).

U.S. Patent No. 7,407,803 - “Circovirus Sequences Associated with Piglet Weight Loss Disease (PWD)”

  • Issued: August 5, 2008
  • Technology Synopsis: This patent claims an immunogenic composition comprising a specific polypeptide from the PWD-associated circovirus (ORF2 of PCVB) and a pharmaceutically acceptable carrier. The claims are directed to the vaccine composition itself, focusing on the protein component.
  • Asserted Claims: All claims are implicated (Compl. ¶49).
  • Accused Features: The composition of Plaintiffs' Circogard™ and Circo/Mycogard™ vaccines are the accused instrumentalities (Compl. ¶6, ¶14).

For brevity, the following related patents, which are also asserted, share the same core technology and are summarized below.

  • U.S. Patent No. 7,604,808: Claims a method of producing the circovirus polypeptide using a baculovirus vector to transform a host cell (Compl. ¶55).
  • U.S. Patent No. 7,722,883: Claims a vaccine comprising an isolated circovirus polypeptide (PCVB) with at least 90% sequence identity to SEQ ID NO:26 (Compl. ¶61).
  • U.S. Patent No. 7,740,866: Claims a method for preparing a vaccine composition by expressing the ORF2 protein in host cells and recovering it (Compl. ¶67).
  • U.S. Patent No. 7,758,865: Claims a vaccine composition comprising an expression vector containing the circovirus nucleic acid sequence (Compl. ¶73).
  • U.S. Patent No. 7,951,907: Claims a vaccine comprising an isolated circovirus polypeptide (PCVB) with at least 95% sequence identity to SEQ ID NO:26 (Compl. ¶79).
  • U.S. Patent No. 8,715,690: Claims a method for protecting piglets by administering a vaccine containing the ORF2 protein produced via a baculovirus expression system (Compl. ¶85).
  • U.S. Patent No. 8,124,723: Claims an isolated polypeptide expressed from a baculovirus vector, where the polypeptide has at least 90% identity to the circovirus sequence ORF2 (SEQ ID NO:26) (Compl. ¶91).

III. The Accused Instrumentality

Product Identification

  • Plaintiffs’ Circogard™ and Circo/Mycogard™ vaccines (collectively, "the Accused Vaccines") (Compl. ¶14).

Functionality and Market Context

  • The Accused Vaccines are used to immunize swine against diseases associated with porcine circovirus type 2 (PCV2) (Compl. ¶6). The complaint states they are manufactured by Plaintiff ProtaTek International Inc. (Compl. ¶15). According to Defendants' allegations as recited in the complaint, the infringement theory is based on a ProtaTek patent application that describes a PCV2 ORF2 capsid antigen having "a 99% sequence identity" with SEQ. ID. No. 25, which is a sequence claimed in the Asserted Patents (Compl. ¶16). The parties are alleged to be direct competitors in the animal vaccine market (Compl. ¶8). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not provide a formal claim chart but summarizes the Defendants' infringement allegations from a pre-suit letter. The central technical basis for the infringement allegation is the high sequence identity between the antigen in Plaintiffs' vaccines and the patented sequence.

U.S. Patent No. 6,703,023 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A vaccine comprising a nucleic acid having a nucleotide sequence with at least 90% sequence identity to SEQ. ID. No. 25 The infringement allegation is based on the assertion that Plaintiffs' vaccines contain a PCV2 ORF2 capsid antigen derived from a nucleotide sequence having "a 99% sequence identity" to the patented SEQ. ID. No. 25. ¶16 col. 166:61-64
and an acceptable pharmaceutical vehicle, The Accused Vaccines are described as injectable veterinary medicines, which would require a pharmaceutical vehicle. ¶6, ¶14 col. 26:7-12
wherein said nucleic acid encodes an immunogenic protein The complaint does not provide sufficient detail for analysis of this element, though it is implied by the product's function as a vaccine. N/A col. 167:1-2
that induces a protective response effective against infection by a piglet weight loss disease circovirus. The Accused Vaccines are marketed to immunize pigs against diseases associated with porcine circovirus type 2. ¶6 col. 167:2-4

Identified Points of Contention

  • Factual Question: A primary factual dispute will be whether the nucleic acid sequence used to produce the antigen in the commercial Accused Vaccines actually falls within the claimed "at least 90% sequence identity" to SEQ ID No. 25. The complaint notes that Defendants' allegation is based on a separate ProtaTek patent application, not direct analysis of the accused product (Compl. ¶16).
  • Scope Question: The complaint raises invalidity defenses, suggesting a challenge to the patents' scope. Plaintiffs allege the claims cover patent-ineligible subject matter (a law of nature) and are obvious over prior art related to the isolation of PCV2 (Compl. ¶¶28, 29). This suggests Plaintiffs may argue the claims are invalid and therefore cannot be infringed.

V. Key Claim Terms for Construction

The Term: "at least 90% sequence identity"

  • Context and Importance: This term is the quantitative heart of the infringement allegation and appears in various forms (e.g., 80%, 95%) across the asserted patents. The methodology for calculating this percentage will be critical to determining infringement.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: Parties may argue that any scientifically accepted alignment algorithm that results in a value meeting the threshold should suffice, unless a specific method is mandated. The specification describes the term generally before pointing to a specific software package (’023 Patent, col. 7:45-64).
    • Evidence for a Narrower Interpretation: The specification explicitly provides a detailed method for calculation, including reference to a specific program: "the Wisconsin Genetics Software Package, Genetics Computer Group (GCG)" (’023 Patent, col. 7:30-34). A party may argue that this reference limits the scope of the term to calculations performed using that specific algorithm or its direct equivalents.

The Term: "a protective response"

  • Context and Importance: This functional language requires that the vaccine achieve a particular result. Whether the accused vaccines induce such a response, and how that response is measured, could become a point of contention.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: A party may argue that any demonstrable immunological effect that leads to a reduction in disease severity qualifies as a "protective response." The specification broadly describes the goal as preventing and/or treating viral infections (’023 Patent, Abstract).
    • Evidence for a Narrower Interpretation: A party could argue that the term must be limited by the results shown in the patent's own examples, such as the specific measurements of "daily mean gains" and reduction of hyperthermia demonstrated in vaccinated pigs versus a control group (’023 Patent, Example 5; FIG. 10, FIG. 11).

VI. Other Allegations

  • Indirect Infringement: The complaint seeks a declaration of non-infringement both "directly or indirectly" for all asserted patents (e.g., Compl. ¶32, ¶38). However, it does not recite any specific facts from the Defendants' pre-suit communications that would form the basis of an indirect infringement claim, such as inducement or contributory infringement.
  • Willful Infringement: This is a declaratory judgment action filed by the accused infringer, so willfulness is not formally alleged. However, the complaint establishes that Plaintiffs were on notice of the asserted patents and Defendants' infringement allegations at least as of the May 25, 2017 letter, and potentially as early as the May 20, 2017 conversation (Compl. ¶¶11, 12). This evidence could be used by Defendants to support a counterclaim for willful infringement.

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

The dispute as framed by the complaint will likely focus on two central battlegrounds: patent validity and the factual basis for infringement.

  • A core issue will be one of patent eligibility: Do the claims, which recite a specific viral nucleic acid sequence with high similarity to a naturally occurring virus, combined with a conventional pharmaceutical carrier, constitute a patent-ineligible "product of nature" under 35 U.S.C. § 101, as Plaintiffs allege?
  • A key evidentiary question will be one of factual infringement: Does the antigen in Plaintiffs' commercially sold vaccines actually derive from a nucleic acid sequence that meets the specific percentage "sequence identity" thresholds recited in the patent claims, or was the Defendants' allegation, based on a patent application, factually incorrect as applied to the marketed products?
  • A secondary but significant issue will be obviousness: Did the prior art isolation and characterization of the PCV2 virus make it obvious to one of ordinary skill in the art to create a vaccine using its genetic sequence, as Plaintiffs contend, potentially rendering the claims invalid under 35 U.S.C. § 103?