DCT

4:10-cv-40003

Centocor Ortho BIOTECH, INC. v. Abbott GmbH & CO., KG

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 4:10-cv-40003, D.D.C., 08/28/2009
  • Venue Allegations: Venue is alleged under statutes governing judicial review of patent interference decisions and actions against foreign patentees (35 U.S.C. §§ 146, 293) and the general federal venue statute (28 U.S.C. § 1391(d)).
  • Core Dispute: Plaintiff seeks judicial review of a U.S. Patent and Trademark Office (USPTO) patent interference decision, challenging the validity of Defendant's patent and asserting its own priority of invention for human antibodies that bind to human IL-12.
  • Technical Context: The technology concerns fully human monoclonal antibodies designed to neutralize interleukin-12 (IL-12), a cytokine implicated in autoimmune and inflammatory diseases, offering a potential therapeutic approach with reduced immunogenicity compared to non-human antibodies.
  • Key Procedural History: This action is an appeal under 35 U.S.C. § 146 from Interference No. 105,592, a proceeding initiated by the USPTO to determine which party first invented the subject matter common to Centocor's patent application and Abbott's issued patent. The USPTO's Board of Patent Appeals and Interferences (the "Board") awarded priority of invention to Abbott, finding it had achieved an "actual reduction to practice" before Centocor. The Board also denied Centocor's motion that Abbott's patent claims were unpatentable. Centocor now asks the district court to reverse these findings.

Case Timeline

Date Event
1999-03-25 Priority Date for U.S. Patent No. 6,914,128 (’128 Patent)
2005-07-05 U.S. Patent No. 6,914,128 Issued
2007-12-12 USPTO Declares Interference No. 105,592
2009-06-30 Oral Hearing Held before the USPTO Board
2009-08-06 USPTO Board issues final decision awarding priority to Abbott
2009-08-28 Complaint for Review of Patent Interference Decision Filed

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

U.S. Patent No. 6,914,128 - HUMAN ANTIBODIES THAT BIND HUMAN IL-12 AND METHODS FOR PRODUCING

  • Patent Identification: U.S. Patent No. 6,914,128, issued July 5, 2005.

The Invention Explained

  • Problem Addressed: The patent describes the therapeutic challenge of using antibodies derived from non-human sources (e.g., mice) in human patients. Such antibodies can provoke a "human anti-murine antibody" (HAMA) response, where the patient's immune system attacks the therapeutic antibody, limiting its efficacy and potentially causing adverse reactions, especially with long-term treatment (Compl. ¶6; ’128 Patent, col. 2:25-44).
  • The Patented Solution: The invention is a fully human antibody that specifically binds to and neutralizes human interleukin-12 (IL-12), a key protein in inflammatory pathways. By using a fully human antibody, the invention seeks to avoid the HAMA response and provide a more durable therapeutic agent for diseases like Crohn's disease and rheumatoid arthritis (’128 Patent, Abstract; col. 2:51-61). The patent claims antibodies defined by both their structure (specific amino acid sequences in their binding regions) and function (a specific, high-affinity binding to IL-12, measured by a dissociation rate constant) (’128 Patent, col. 385:9-15).
  • Technical Importance: Developing fully human therapeutic antibodies was a significant goal in biotechnology, as it promised to create safer and more effective long-term treatments for chronic inflammatory and autoimmune diseases by overcoming the immunogenicity of earlier-generation antibody therapies (’128 Patent, col. 2:45-53).

Key Claims at a Glance

  • The complaint states that the "Count" of the interference proceeding, which defines the contested invention, corresponds to Claim 1 of the ’128 Patent (Compl. ¶8). Centocor challenges the patentability of claims 1-15, 27-40, and 50-64 (Compl. ¶9).
  • Independent Claim 1 (as corrected):
    • An isolated human antibody, or an antigen-binding portion thereof,
    • that binds to human IL-12 and
    • dissociates from human IL-12 with a kd constant of 1x10-2 s-1 or less, as determined by surface plasmon resonance.

III. Analysis of Patentability and Priority Allegations

This case is not a standard infringement action but a review of a USPTO priority decision. As such, the complaint does not allege infringement. Instead, it makes two primary arguments against the USPTO Board's ruling.

  • Unpatentability Over Prior Art: Centocor alleges that the Board erred in denying its motion (Centocor Motion 1) to find Abbott's claims unpatentable as obvious under 35 U.S.C. § 103(a) (Compl. ¶¶9, 20). The complaint asserts that the Board's finding was based on "multiple errors of law" and "erroneous fact findings" (Compl. ¶20). The prior art cited in this motion includes scientific articles (e.g., Valiante et al., Chizzonite et al.) and other U.S. patents (e.g., Gately U.S. Patent No. 5,780,597) that Centocor argues would have rendered the invention of the ’128 Patent obvious to a person of ordinary skill in the art (Compl. ¶9).
  • Priority of Invention: The central dispute is who invented the subject matter first. The Board granted Abbott's motion for priority (Abbott Motion 7), finding that Abbott had an "actual reduction to practice of the subject matter of the Count prior to any date offered by Centocor" (Compl. ¶17). Centocor alleges the Board's decision was erroneous and that the court should find Centocor was the first to invent (Compl. ¶21). Centocor also alleges that it had requested the exclusion of Abbott's priority evidence on the grounds that "Abbott suppressed or concealed the invention," an argument that can defeat a claim of priority even if a party was technically the first to invent (Compl. ¶13).

No probative visual evidence provided in complaint.

IV. Key Claim Terms for Construction

  • The Term: "isolated human antibody"

    • Context and Importance: This term is foundational to the claimed invention. The definition of "isolated" and "human" distinguishes the invention from naturally occurring antibodies or those derived from non-human species. The parties' respective proofs of "reduction to practice" will depend on whether their experimental antibodies meet the definitions of these terms.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The patent defines "isolated antibody" as "substantially free of other antibodies having different antigenic specificities," which does not require absolute purity (’128 Patent, col. 27:45-49). This may allow for preparations that contain other non-antibody components.
      • Evidence for a Narrower Interpretation: The definition of "human antibody" is tied to antibodies having "variable and constant regions corresponding to human germline immunoglobulin sequences" (’128 Patent, col. 25:56-60). This could be interpreted to exclude antibodies that are merely "humanized" (i.e., originally from a non-human source with certain parts grafted to be more human-like).

  • The Term: "dissociates from human IL-12 with a kd constant of 1x10-2 s-1 or less"

    • Context and Importance: This functional limitation defines the required binding affinity of the antibody. Proving priority requires demonstrating an antibody that met this specific quantitative threshold. The dispute will likely focus on the reliability and timing of the experimental data (from "surface plasmon resonance" assays) that each party presents to prove when they first created an antibody with this characteristic.
    • Intrinsic Evidence for Interpretation:
      • Evidence for a Broader Interpretation: The claim requires a constant of 1x10-2 s-1 "or less," establishing a floor for the binding affinity but not a ceiling. Any antibody with a slower dissociation rate (a smaller kd value) would meet the limitation.
      • Evidence for a Narrower Interpretation: The patent is highly specific that this value must be "determined by surface plasmon resonance" (’128 Patent, col. 385:14-15). A party might argue that data derived from other measurement techniques is insufficient to meet the claim limitation as written, potentially narrowing the scope of acceptable evidence for reduction to practice. Practitioners may also focus on the use of "kd constant" (from the certificate of correction) with units of s-1, which clarifies it is a dissociation rate constant (koff), not an equilibrium dissociation constant (KD), which has units of Molarity.

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

This case centers on a review of a USPTO priority contest, presenting distinct questions from a typical infringement suit. The outcome will likely depend on the court's resolution of the following issues:

  • A core question will be one of evidentiary sufficiency: Did the USPTO Board err in concluding that Abbott's evidence established an "actual reduction to practice"—the creation of a physical antibody meeting every limitation of the claim's "Count"—before Centocor did? This will involve a detailed, fact-intensive review of each party's lab notebooks and experimental data.
  • A related legal and factual question is one of patentability: Independent of who was first, did the Board err in finding Abbott's claims non-obvious? The court will have to re-evaluate whether the prior art, which discloses elements related to IL-12 and antibody engineering, would have motivated a skilled artisan to create the specific human antibody claimed in the ’128 Patent with a reasonable expectation of success.
  • Finally, the court may need to address a question of diligence and conduct: Even if Abbott was the first to conceive and reduce the invention to practice, did it "suppress or conceal" the invention for a period of time, as Centocor alleges? Such a finding could potentially cause Abbott to lose its priority rights to Centocor.