DCT
3:17-cv-05812
Alere Inc v. Institut Pasteur
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Alere Inc. (Delaware)
- Defendant: Institut Pasteur (France) and Bio-Rad Laboratories, Inc. (Delaware)
- Plaintiff’s Counsel: Patterson Belknap Webb & Tyler LLP; Kirkland & Ellis LLP
- Case Identification: 3:17-cv-05812, N.D. Cal., 10/10/2017
- Venue Allegations: Venue is alleged to be proper based on a license agreement between the parties designating California courts for exclusive jurisdiction, and because Defendant Bio-Rad Laboratories, Inc. has its principal place of business in the district.
- Core Dispute: Plaintiff seeks a declaratory judgment that its rapid HIV diagnostic products do not infringe two patents owned by Defendants, and that those patents are invalid.
- Technical Context: The technology concerns in vitro diagnostic methods and kits for detecting Human Immunodeficiency Virus Type 2 (HIV-2), a distinct viral strain from the more common HIV-1, which is critical for public health and blood supply safety.
- Key Procedural History: The dispute arose under a 2008 license agreement after Plaintiff Alere was acquired by Abbott Laboratories. Defendants allegedly attempted to condition consent for the change of control on Alere forfeiting its right to challenge the patents-in-suit. In response, Alere invoked its right to challenge the patents under the Lear, Inc. v. Adkins doctrine. The complaint notes that Defendants filed a separate infringement action against Abbott concerning one of the patents-in-suit in the Northern District of Illinois eight days prior to this filing.
Case Timeline
| Date | Event |
|---|---|
| 1986-03-03 | Priority Date (’728 and ’149 Patents) |
| 2001-07-24 | Issue Date (U.S. Patent No. 6,265,149) |
| 2003-04-08 | Issue Date (U.S. Patent No. 6,544,728) |
| 2008-06-22 | License Agreement entered into by parties |
| 2015-12-28 | License Agreement amended |
| 2017-10-02 | Defendants file infringement suit against Abbott Laboratories |
| 2017-10-03 | Abbott Laboratories completes acquisition of Alere |
| 2017-10-10 | Complaint for Declaratory Judgment filed |
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: The patent's background describes the discovery of a new class of human retrovirus, HIV-2, which is serologically distinct from the previously identified HIV-1. This created a diagnostic gap, as existing tests for HIV-1 were not reliably detecting HIV-2 infections, leading to potential false negatives (U.S. Patent No. 6,544,728, col. 2:5-18).
- The Patented Solution: The invention provides diagnostic methods and kits that use specific, isolated proteins of the HIV-2 virus, particularly from the polymerase (pol) and envelope (env) regions, as reagents. By using components unique to HIV-2, the patented method allows for the specific detection of antibodies against HIV-2, enabling differentiation from HIV-1 infection ('728 Patent, Abstract; col. 2:40-54).
- Technical Importance: This technology provided a basis for developing specific diagnostic assays for a newly identified major human pathogen, which was essential for accurate patient diagnosis, epidemiological tracking, and ensuring the safety of the blood supply ('728 Patent, col. 2:5-18).
Key Claims at a Glance
- The complaint identifies independent claims 4 and 6 as representative (Compl. ¶47).
- Independent Claim 4 (Method):
- 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:
- 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
- detecting the formation of antigen-antibody complex.
- Independent Claim 6 (Kit):
- An in vitro diagnostic kit for detecting the presence or absence of antibodies in a biological sample that bind to antigens of Human Immunodeficiency Virus Type 2 (HIV-2), 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 antigen-antibody complex; and
- a biological reference sample lacking antibodies recognized by said polypeptide expression products.
- The complaint does not explicitly reserve the right to assert dependent claims, as it is the party seeking a declaration of non-infringement and invalidity.
U.S. Patent No. 6,265,149 - "In vitro diagnostic methods and kits for the detection of HIV-2-specific antibodies," issued July 24, 2001
The Invention Explained
- Problem Addressed: As with the '728 patent, this patent addresses the need for reliable in vitro diagnostic tools to detect infections caused by the HIV-2 retrovirus, which could not be consistently identified using existing HIV-1 assays ('149 Patent, col. 1:44-59).
- The Patented Solution: This invention refines the diagnostic approach by using specific peptide fragments derived from HIV-2 proteins, particularly the Gag and Env proteins, as the antigenic material in diagnostic kits and methods ('149 Patent, Abstract; col. 1:4-8). The use of smaller, defined fragments aims to achieve high specificity in detecting antibodies to HIV-2.
- Technical Importance: The use of defined peptide fragments rather than whole proteins represented a step toward more precise and potentially more specific immunoassays, a common evolution in the development of viral diagnostics.
Key Claims at a Glance
- The complaint identifies claim 13 (dependent on claim 9) as representative and also contests the scope of language found in claim 5 (Compl. ¶¶ 62, 63). The relevant independent claims are 5 and 9.
- Independent Claim 5 (Method):
- A method for detecting antibodies against HIV-2 in a biological sample, comprising:
- contacting the biological sample with an antigen, comprising a peptide fragment of HIV-2 Env, wherein antibodies in AIDS patient sera bind to said peptide fragment;
- providing a control antigen;
- contacting the sample with the control antigen; and
- detecting and comparing immunological complexes formed.
- Independent Claim 9 (Kit):
- A kit for detecting anti-HIV-2 antibodies in a biological sample, said kit comprising:
- an antigen composition, comprising a peptide fragment of HIV-2 Gag, wherein antibodies in AIDS patient sera bind to said peptide fragment; and
- a buffer.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
Product Identification
- The "products at issue" are the Alere Determine™ HIV-1/2 Ag/AB Combo and the Clearview® Complete HIV 1/2 (Compl. ¶24).
Functionality and Market Context
- The accused products are described as sensitive and rapid point-of-care diagnostic tests for HIV infections (Compl. ¶¶ 24-26).
- The Alere Determine™ HIV-1/2 Ag/AB Combo is an in vitro immunoassay for the simultaneous detection of HIV-1 p24 antigen and antibodies to both HIV-1 and HIV-2 in various types of blood samples (Compl. ¶25).
- The Clearview® COMPLETE HIV 1/2 is a single-use, immunochromatographic test that detects antibodies to HIV-1 and HIV-2 viruses, providing results within 15 minutes (Compl. ¶26).
- The complaint positions Plaintiff Alere as a "world leader in rapid diagnostics at the point of care" (Compl. ¶22).
- No probative visual evidence provided in complaint.
IV. Analysis of Infringement Allegations
Plaintiff Alere alleges its products do not infringe the patents-in-suit.
’728 Patent Infringement Allegations
The complaint’s non-infringement argument for the ’728 Patent centers on the interpretation of the term "isolated polypeptide expression products."
| Claim Element (from Independent Claim 4) | Alleged Non-Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| one or more isolated polypeptide expression products of HIV-2 selected from the group consisting of polymerase and env protein | Plaintiff alleges its products use "fragments of env protein," not the full proteins allegedly required by the claim term "isolated polypeptide expression products." The complaint contends that the patent's specification and prosecution history differentiate "peptides" (fragments) from "polypeptides" (full proteins). | ¶54 | col. 36:43-45 |
’149 Patent Infringement Allegations
The complaint does not provide sufficient detail for analysis of its non-infringement theory with respect to the ’149 patent, stating only that the "products at issue have not infringed and do not directly or indirectly infringe any valid claim of the '149 patent" (Compl. ¶69).
- Identified Points of Contention:
- Scope Questions: The primary dispute for the '728 patent is one of claim scope: does the term "isolated polypeptide expression products" read on the protein "fragments" that Alere alleges are used in its products? Alere argues the term is limited to full-length proteins (Compl. ¶54).
- Technical Questions: A factual question for the court will be to determine the precise biochemical nature of the antigenic reagents used in the Alere Determine™ and Clearview® tests and whether they are properly characterized as "fragments" versus "full proteins."
V. Key Claim Terms for Construction
’728 Patent
- The Term: "isolated polypeptide expression products"
- Context and Importance: The construction of this term is dispositive for Alere's non-infringement argument regarding the '728 patent. If the term is construed to be limited to full-length proteins, and Alere's products are proven to use only protein fragments, Alere would not infringe. Practitioners may focus on this term because its interpretation appears to be the central axis of the non-infringement dispute.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states generally that the invention relates to "polypeptides containing amino acid sequences encoded by the cloned DNA sequences," which does not on its face impose a size limitation (’728 Patent, col. 1:36–38). The term "polypeptide" can be defined broadly in the art to include chains of amino acids of various lengths.
- Evidence for a Narrower Interpretation: The complaint alleges that during prosecution, the applicants differentiated between "peptides" and "polypeptides" and defined the claimed "polypeptide expression products" by referencing a list of full proteins (Compl. ¶54). Furthermore, the related ’149 patent, which stems from the same family, explicitly claims "peptide fragment" (’149 Patent, col. 35:12). The use of different terms in related patents may suggest an intended difference in scope, supporting an argument that "polypeptide expression products" in the ’728 patent was not meant to include fragments.
VI. Other Allegations
- Indirect Infringement: The complaint seeks a declaratory judgment that it is not liable for indirect infringement (Compl. ¶54; Prayer for Relief ¶B). However, it does not set forth any specific factual allegations that Defendants might raise to support such a claim (e.g., specific instructions or inducements).
- Willful Infringement: This allegation is not applicable, as willfulness is asserted by a patentee against an infringer, not by a declaratory judgment plaintiff.
VII. Analyst’s Conclusion: Key Questions for the Case
This declaratory judgment action appears to center on three fundamental questions for the court:
A core issue will be one of claim construction: Can the term "isolated polypeptide expression products" in the '728 patent, which Alere alleges refers only to full-length proteins, be construed to cover the protein "fragments" Alere claims to use in its diagnostic kits?
A second central issue will be one of validity under the doctrine of obviousness-type double patenting: Are the claims of the '728 and '149 patents patentably indistinct from the claims of earlier, now-expired patents from the same family, as Alere alleges, thereby constituting an improper extension of the patent term?
A third key question will be one of patent eligibility under 35 U.S.C. § 101: Are the claims, which are directed to diagnostic methods using naturally occurring viral proteins, invalid for being directed to a natural phenomenon without adding a sufficient inventive concept, as required by the Mayo/Ariosa framework?