DCT

1:17-cv-07104

Institut Pasteur v. Abbott Laboratories

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-07104, N.D. Ill., 10/02/2017
  • Venue Allegations: Venue is asserted based on Defendant Abbott Laboratories having its principal place of business in the Northern District of Illinois.
  • Core Dispute: Plaintiffs allege that Defendant’s in vitro diagnostic kits for detecting HIV-2 antibodies infringe a patent covering methods and kits for such diagnosis.
  • Technical Context: The technology addresses the need for reliable diagnostic tests for Human Immunodeficiency Virus Type 2 (HIV-2), a distinct retrovirus from the more common HIV-1, which required different detection methods to ensure the safety of the blood supply.
  • Key Procedural History: The complaint alleges that Defendant Abbott was a former licensee of the patent-in-suit. Plaintiffs claim this license was terminated on March 7, 2017, due to an alleged failure by Abbott to pay royalties. This prior relationship is central to the allegations of knowledge and willful infringement.

Case Timeline

Date Event
1986-01-22 Earliest Priority Date for ’728 Patent
1991-10-15 Alleged effective date of License Agreement with Abbott
2003-04-08 ’728 Patent Issue Date
2015-06-30 Abbott allegedly ceased paying royalties
2016-12-22 Bio-Rad allegedly notified Abbott of material breach
2017-03-07 Bio-Rad allegedly terminated the License Agreement
2017-10-02 Complaint Filing Date

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

U.S. Patent No. 6,544,728 - Methods and Kits for Diagnosing Human Immunodeficiency Virus Type 2 (HIV-2), Proteins of HIV-2, and Vaccinating Agents for HIV-2 (Issued April 8, 2003)

The Invention Explained

  • Problem Addressed: By 1986, scientists had identified HIV-2 as a cause of AIDS, distinct from the previously discovered HIV-1. Because of structural differences between the viruses, existing diagnostic tests for HIV-1 could not be relied upon to detect HIV-2 infection. This created an "urgent need for methods to detect the presence of antibodies against HIV-2" to screen patients and blood bank supplies (Compl. ¶12; ’728 Patent, col. 2:38-44).
  • The Patented Solution: The patent discloses methods and kits for detecting HIV-2 antibodies in a biological sample. The core of the invention is the use of "isolated polypeptide expression products of HIV-2," specifically man-made versions of proteins like the polymerase (pol) and envelope (env) proteins, to act as antigens that bind to HIV-2 antibodies if they are present in the sample (’728 Patent, Abstract; col. 6:20-34). These man-made polypeptides are described as having advantages over naturally-occurring proteins, such as greater safety because they are free from contaminating viruses (Compl. ¶14).
  • Technical Importance: This technology provided the specific biological tools necessary to create reliable and safe diagnostic assays for HIV-2, addressing a critical public health gap in screening and diagnosis that HIV-1 tests could not fill (Compl. ¶12-13).

Key Claims at a Glance

  • The complaint asserts independent claims 4 and 6.
  • Independent Claim 4 (Method Claim):
    • An in vitro diagnostic method for detecting antibodies that bind to HIV-2 antigens, comprising:
    • (a) contacting a biological sample with one or more isolated polypeptide expression products of HIV-2 selected from the group consisting of polymerase and env protein; and
    • (b) detecting the formation of an antigen-antibody complex.
  • Independent Claim 6 (Kit Claim):
    • An in vitro diagnostic kit for detecting antibodies that bind to HIV-2 antigens, comprising:
    • one or more isolated polypeptide expression products of HIV-2 selected from the group consisting of polymerase and env protein;
    • reagents for detecting the formation of the antigen-antibody complex;
    • a biological reference sample lacking antibodies recognized by said products;
    • wherein the components are present in an amount sufficient to detect the complex.
  • The complaint does not explicitly reserve the right to assert dependent claims but refers to the asserted claims "or [their] equivalent" (Compl. ¶¶21, 23).

III. The Accused Instrumentality

Product Identification

The complaint names two accused products: the "ABBOTT PRISM HIV O Plus" and the "ARCHITECT HIV Ag/Ab Combo" (collectively, the "Accused Products") (Compl. ¶15).

Functionality and Market Context

Both products are described as in vitro diagnostic assays or kits designed to detect the presence of antibodies to HIV-2 (among other things) in human plasma or serum specimens (Compl. ¶¶19, 27). The complaint alleges their operation involves contacting a sample with a "recombinant env expression product" attached to microparticles. The subsequent detection of any resulting antigen-antibody complexes is allegedly accomplished using additional reagents that produce a chemiluminescent signal (Compl. ¶¶20, 28).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

U.S. Patent No. 6,544,728 Infringement Allegations (Method Claim 4)

Claim Element (from Independent Claim 4) Alleged Infringing Functionality Complaint Citation Patent Citation
An in vitro diagnostic method for detecting the presence or absence of antibodies that bind to antigens of a Human Immunodeficiency Virus Type 2 (HIV-2), comprising: The Accused Products are described as assays for detecting the presence or absence of antibodies in human plasma or serum specimens that bind to antigens of HIV-2. ¶19, ¶27 col. 36:20-24
(a) contacting a biological sample with one or more isolated polypeptide expression products of HIV-2 selected from the group consisting of polymerase and env protein; Use of the Accused Products allegedly involves contacting a human plasma or serum specimen with a "recombinant env expression product" (e.g., "gp36") attached to microparticles. ¶20, ¶28 col. 36:25-29
(b) detecting the formation of antigen-antibody complex between said polypeptide expression products and antibodies present in the biological sample. Detection is allegedly performed using a biotinylated HIV-2 peptide probe and an acridinium-labelled anti-biotin conjugate that binds to the complex and emits a chemiluminescent signal. ¶20, ¶28 col. 36:30-33

U.S. Patent No. 6,544,728 Infringement Allegations (Kit Claim 6)

Claim Element (from Independent Claim 6) Alleged Infringing Functionality Complaint Citation Patent Citation
An in vitro diagnostic kit...comprising: one or more isolated polypeptide expression products of HIV-2 selected from the group consisting of polymerase and env protein; The Accused Products are alleged to comprise a "recombinant env expression product" (e.g., "gp36" for the ARCHITECT product) attached to microparticles. ¶39, ¶48 col. 36:41-43
reagents for detecting the formation of antigen-antibody complex between said polypeptide expression products and antibodies present in the biological sample; The kits allegedly include a biotinylated HIV-2 peptide probe and an acridinium-labelled anti-biotin conjugate, which together detect the complex by emitting a signal. ¶40, ¶49 col. 36:44-46
a biological reference sample lacking antibodies recognized by said polypeptide expression products; The kits are allegedly sold with controls, including a "Negative Control" comprising human plasma that is nonreactive for anti-HIV-2. ¶41, ¶50 col. 36:47-49
wherein said polypeptide expression products, reagents and biological reference material are present in an amount sufficient to detect the formation of antigen-antibody complex. The complaint alleges that the components of the Accused Products are present in an amount sufficient to detect the antigen-antibody complex. ¶42, ¶51 col. 36:50-53

Identified Points of Contention

  • Scope Questions: A central question will be whether the specific "recombinant env expression product" (e.g., "gp36") used in the Accused Products falls within the scope of the claimed "isolated polypeptide expression products of HIV-2 selected from the group consisting of polymerase and env protein." The defense may argue that its specific protein is structurally or functionally different from what is described and enabled by the patent.
  • Technical Questions: What evidence demonstrates that Abbott's detection mechanism, which involves a multi-step process with a peptide probe and a labeled conjugate, meets the limitation of "detecting the formation of antigen-antibody complex between said polypeptide expression products and antibodies" as required by claim 4? The court may need to determine if this indirect detection method satisfies the claim language.

V. Key Claim Terms for Construction

  • The Term: "isolated polypeptide expression products" (Claim 4 and 6)
  • Context and Importance: This term defines the core antigen component of the invention. The infringement case hinges on whether the specific recombinant proteins used by Abbott are encompassed by this term. Practitioners may focus on this term because any distinction Abbott can draw between its proteins and the patented "products" could be a basis for a non-infringement argument.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patent specification refers generally to polypeptides encoded by the HIV-2 genome and kits that operate through "immunodiagnostic detection of polypeptides unique to the HIV-2 virus" (’728 Patent, col. 2:56-62). This could support a reading that covers any lab-made polypeptide derived from the specified HIV-2 genes (pol or env).
    • Evidence for a Narrower Interpretation: The complaint itself highlights "significant structural and functional differences" between naturally-occurring proteins and the "man-made polypeptides of the invention," such as being free of contaminating viruses and lacking the dimer/trimer structure of natural proteins (Compl. ¶14). The patent makes a similar distinction (’728 Patent, col. 4:14-22). An argument could be made that the term is limited to polypeptides exhibiting these specific distinguishing characteristics.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Abbott induces infringement of method claim 4 by selling the Accused Products with package inserts that contain directions for use, thereby encouraging end-users to perform the patented method (Compl. ¶¶26, 34). It also alleges contributory infringement, stating the products are a material part of the invention and have no substantial non-infringing use (Compl. ¶¶23, 31).
  • Willful Infringement: Willfulness is alleged based on Abbott’s pre-suit knowledge of the ’728 Patent, which Plaintiffs claim is demonstrated by the prior license agreement between the parties (Compl. ¶¶24, 32, 35, 58). The infringing conduct is alleged to have begun on March 7, 2017, the same day the license was purportedly terminated, and to have continued since (Compl. ¶17).

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

  • A core issue will be one of definitional scope: can the term "isolated polypeptide expression products...selected from the group consisting of polymerase and env protein" be construed to cover the specific recombinant "gp36" protein and other reagents used in Abbott's diagnostic kits? The outcome will depend on the technical evidence presented regarding the nature of Abbott's proteins versus the teachings of the ’728 Patent.
  • A key legal and factual question will be the impact of the prior license agreement. The history between the parties will be central to Plaintiffs' willfulness claim and could significantly influence the potential for enhanced damages if infringement is found. The circumstances surrounding the termination of that agreement will likely be a major point of contention.
  • A third question concerns claim satisfaction: does Abbott's multi-step detection system, which uses a secondary peptide probe and a labeled conjugate to generate a signal, meet the claim limitation of "detecting the formation of [the] antigen-antibody complex" directly, or is there a functional or structural mismatch that could support a non-infringement defense?