DCT

1:19-cv-06587

Abbott Laboratories v. Grifols Diagnostic Solutions Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-06587, N.D. Ill., 10/03/2019
  • Venue Allegations: Venue is alleged to be proper because Plaintiff Abbott Laboratories resides in the district and manufactures the products that are the subject of the underlying infringement dispute within the district.
  • Core Dispute: Plaintiff seeks a declaratory judgment that Defendant's patent related to a method for replicating HIV-specific DNA is invalid on several grounds, including obviousness-type double patenting over an expired, related patent.
  • Technical Context: The technology concerns fundamental molecular biology techniques for replicating DNA from the human immunodeficiency virus (HIV), a critical step for developing diagnostic assays and research tools during the early AIDS epidemic.
  • Key Procedural History: The complaint alleges the patent-in-suit is one of thirteen patents that claim priority to a single 1984 application and that its claims are not patentably distinct from those in an earlier-issued, now-expired patent from the same family, U.S. Patent No. 5,156,949. Plaintiff had previously paid royalties to Defendants and their predecessors under a 1996 license agreement that included the patent-in-suit, but terminated that license on the day the complaint was filed.

Case Timeline

Date Event
1984-10-31 Priority Date for ’101 and ’949 Patents
1987-12-24 U.S. Patent 5,156,949 Application Filed
1992-10-20 U.S. Patent 5,156,949 Issued
1995-05-17 U.S. Patent 7,205,101 Application Filed
1996-01-01 License Agreement between Abbott and Chiron took effect
2007-04-17 U.S. Patent 7,205,101 Issued
2009-10-20 U.S. Patent 5,156,949 Expired
2019-10-03 Abbott terminates license agreement
2019-10-03 Complaint for Declaratory Judgment Filed

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

  • Patent Identification: U.S. Patent No. 7,205,101, “Human Immunodeficiency Virus (HIV) Nucleotide Sequences, Recombinant Polypeptides, and Applications Thereof,” issued April 17, 2007.

The Invention Explained

  • Problem Addressed: The patent’s background section describes the state of HIV research in the early 1980s, noting that propagating the live virus in culture was hazardous and could not produce the large quantities of viral material needed for widespread serology assays to protect the public health (’101 Patent, col. 2:1-14). Furthermore, producing viral proteins through safer recombinant DNA technology was not possible because HIV's nucleotide sequences were not yet available (’101 Patent, col. 2:30-32).
  • The Patented Solution: The invention provides the nucleotide sequences of HIV, which enables the production of recombinant polypeptides. These sequences and polypeptides can be used as diagnostic reagents for detecting HIV infection, for developing vaccines through the expression of antigenic polypeptides, and as probes to detect viral nucleic acids (’101 Patent, Abstract; col. 2:54-65).
  • Technical Importance: The ability to clone and replicate specific HIV DNA sequences provided the foundational tools for developing safer, scalable, second-generation diagnostic tests and research materials during the height of the AIDS epidemic (Compl. ¶3).

Key Claims at a Glance

  • The complaint asserts that at least Claim 1 is invalid (Compl. ¶¶45-47).
  • Independent Claim 1 contains the following essential elements:
    • A method for replicating DNA specific for HIV, which comprises:
    • (a) providing a DNA construct comprising an origin of replication recognized by a unicellular microorganism and a DNA sequence comprising at least a 20 bp sequence of a human immunodeficiency virus (HIV) genome; and
    • (b) growing a unicellular microorganism containing said DNA construct under conditions whereby said DNA sequence is replicated.
  • The complaint reserves the right to seek a declaration that all claims of the ’101 Patent are invalid (Compl. ¶44; Prayer for Relief ¶a).

III. The Accused Instrumentality

Product Identification

The complaint is a declaratory judgment action for invalidity, filed in response to infringement allegations from the Defendants. The products that are the subject of the underlying dispute are Plaintiff’s own products: the Abbott PRISM HIV O Plus assay and the Abbott ARCHITECT HIV Ag/Ab Combo assay (Compl. ¶19).

Functionality and Market Context

The complaint identifies these products as assays "used to test for HIV" (Compl. ¶19). No further technical details regarding the operation of these assays are provided. Abbott alleges that it manufactures these products at facilities within the Northern District of Illinois (Compl. ¶19, ¶27).

IV. Analysis of Infringement Allegations

The complaint is an action for a declaratory judgment of patent invalidity and does not contain infringement allegations against the Defendants. While it states that the action was precipitated by Defendants’ allegations that Plaintiff’s products infringe the ’101 Patent, it does not provide any details of the Defendants' infringement theory (Compl. ¶¶15, 17). Therefore, the complaint does not provide sufficient detail for analysis of infringement. No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

The complaint's invalidity arguments are based on broad patent law doctrines such as obviousness-type double patenting, patentable subject matter under § 101, and written description under § 112, rather than on disputes over the specific meaning of claim terms (Compl. ¶¶45-47). The complaint, therefore, does not provide a basis for identifying key claim terms that may be central to a construction dispute.

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

  • A central issue will be one of improper patent term extension: is Claim 1 of the ’101 Patent, which claims a general method for replicating HIV DNA in a microorganism, patentably indistinct from the claims of the expired ’949 Patent, which claimed a method of using recombinant HIV polypeptides for antibody detection? This will likely require the court to determine if the method claimed in the ’101 Patent was an obvious variant of, or inherent in, the invention claimed in the expired ’949 Patent.
  • A second key issue will be one of patentable scope: does the ’101 Patent, which claims priority to a 1984 disclosure describing the sequence of a single HIV strain, contain adequate written description under 35 U.S.C. § 112 to support the full scope of a method for replicating DNA from the "human immunodeficiency virus" genome generally? This may also raise a question of patent eligibility under 35 U.S.C. § 101, concerning whether the claims are directed to a naturally occurring genetic sequence without a sufficient inventive concept.