DCT

1:03-cv-00520

Eli Lilly Co v. Crabtree

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:03-cv-00520, S.D. Ind., 12/05/2005
  • Venue Allegations: Venue is asserted as proper under 28 U.S.C. § 1391.
  • Core Dispute: The United States, as intervenor, alleges that two of its former National Institutes of Health (NIH) employees were unnamed co-inventors of patents owned by Eli Lilly and seeks to correct inventorship, gain an ownership interest, and recover damages for unjust enrichment.
  • Technical Context: The patents-in-suit relate to the isolation, cloning, expression, and therapeutic use of human Protein C, a vitamin K-dependent protein that acts as a key natural anticoagulant in blood plasma.
  • Key Procedural History: The complaint states that in early 2004, the NIH investigated the work performed by its former employees and, on May 12, 2004, determined that the United States was entitled to ownership of any interest the doctors had in the inventions.

Case Timeline

Date Event
1982-06-01 Dr. Crabtree's employment with NIH begins
1983-01-01 Alleged collaboration between Dr. Crabtree and Lilly begins
1983-10-02 Dr. Plutzky's employment with NIH begins; joins collaboration
1984-10-01 Dr. Plutzky resigns from NIH
1984-12-31 Dr. Crabtree resigns from NIH; alleged collaboration ends
1985-02-08 Priority date for all patents-in-suit
1988-10-04 U.S. Patent No. 4,775,624 issues
1992-09-29 U.S. Patent No. 5,151,268 issues
1993-12-14 U.S. Patent No. 5,270,040 issues
2004-05-12 NIH issues rights determination regarding the doctors' work
2005-12-05 First Amended Complaint of Intervenor filed

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

Note: The complaint alleges incorrect inventorship for U.S. Patent No. 4,775,624; however, as the provided patent document is for an unrelated patent (U.S. Patent No. 4,755,624), it is summarized below based on information from the related patents and the complaint.

U.S. Patent No. 4,775,624 - DNA Compounds

  • Technology Synopsis: Based on its relationship to the other patents-in-suit, this patent appears to claim the fundamental DNA molecules that encode human Protein C activity. The invention provides the genetic blueprint necessary for producing the protein using recombinant DNA technology (U.S. Pat. 5,151,268, col. 1:5-8).
  • Asserted Claims: The complaint does not identify specific claims.
  • Accused Features: The complaint does not allege infringement but instead claims that NIH employees contributed to the conception of the invention itself (Compl. ¶16).

U.S. Patent No. 5,151,268 - Methods of Using Recombinant Human Protein C

The Invention Explained

  • Problem Addressed: The patent specification describes Protein C as a crucial "down-regulator of blood coagulation," noting that deficiencies can lead to severe thromboembolic episodes. Conventional anticoagulants like heparin and coumarins carry a significant risk of bleeding complications and lack specificity (’268 Patent, col. 2:26-50).
  • The Patented Solution: The invention provides methods for treating and preventing vascular disorders by administering recombinantly produced human Protein C (’268 Patent, Abstract). By using recombinant DNA methods to produce the protein in specific host cell lines (e.g., CHO-K1 or HepG-2), the invention enables a supply of Protein C for therapeutic use that is not dependent on extraction from human plasma (’268 Patent, col. 57:7-14).
  • Technical Importance: This approach provides a targeted anticoagulant therapy that is activated locally where blood clots are forming, suggesting the possibility of a wider therapeutic window and fewer systemic bleeding risks compared to conventional treatments (’268 Patent, col. 2:41-50).

Key Claims at a Glance

  • The complaint does not assert any specific claims for infringement. Independent claim 1 is representative of the invention:
  • A method of treating and preventing protein C related vascular disorders by administering an effective amount of protein C produced by the method comprising:
    • transforming a CHO-K1 or HepG-2 host cell with a recombinant DNA vector, said vector comprising:
      • a DNA sequence that provides for autonomous replication or chromosomal integration
      • a promoter and translational activating sequence functional in said host cell
      • a constructed DNA compound that comprises a DNA that encodes a polypeptide with human protein C activity
    • culturing said host cell transformed in Step A under conditions suitable for gene expression.

U.S. Patent No. 5,270,040 - Vectors and Compounds for Expression of Human Protein C

The Invention Explained

  • Problem Addressed: As a parent to the ’268 Patent, this patent addresses the same fundamental need for a reliable, large-scale source of therapeutic human Protein C to treat coagulation disorders (’040 Patent, col. 2:25-30). The specific technical problem is creating the molecular tools needed to produce the protein recombinantly.
  • The Patented Solution: The invention provides the core components for recombinant production: novel DNA compounds that encode human Protein C, recombinant DNA vectors (such as plasmids) containing these DNA compounds, and host cells transformed with these vectors (’040 Patent, Abstract). These engineered vectors and cells function as "factories" to express the desired protein (’040 Patent, col. 1:10-18).
  • Technical Importance: The invention enabled, for the first time, the synthesis of Protein C and its derivatives outside of the human body, overcoming the limitations and risks associated with purifying the protein from donated blood plasma (’040 Patent, col. 2:58-63).

Key Claims at a Glance

  • The complaint does not assert any specific claims for infringement. Independent claim 1 is representative of the invention:
  • A composition comprising a therapeutically effective amount of human protein C in admixture with a pharmaceutically acceptable carrier, said human protein C produced by the method comprising:
    • transforming a eukaryotic host cell with a recombinant DNA vector...
    • culturing said eukaryotic host cell... under conditions suitable for gene expression.

III. The Accused Instrumentality

Product Identification

  • Product Identification: Xigris® (drotrecogin alfa (activated)), a prescription drug formerly manufactured and marketed by Lilly (Compl. ¶29).

Functionality and Market Context

  • Functionality and Market Context: The complaint identifies Xigris® as the "only embodiment of the inventions claimed in the suit patents that is sold commercially in the United States" (Compl. ¶30). The product is not accused of infringement in this action. Rather, its commercial sales are the basis for the United States' claims for equitable relief, including the imposition of a constructive trust on the proceeds from those sales and compensation for lost licensing revenue (Compl. ¶¶ 34-35).

IV. Analysis of Infringement Allegations

The complaint is a claim for correction of inventorship under 35 U.S.C. § 256 and equitable relief, not patent infringement. Therefore, it contains no allegations that a product meets the limitations of any patent claim, and a claim chart summary is not applicable.

Basis for Inventorship Claim

The United States’ claim to inventorship is based on a collaboration that allegedly occurred while Drs. Crabtree and Plutzky were government employees at the NIH (Compl. ¶¶ 2, 4). The complaint alleges that Dr. Crabtree, due to his "knowledge and expertise in the fields of genetics and blood coagulation," was approached by Lilly for assistance in "isolating, cloning and expressing human Protein C" (Compl. ¶¶ 9-10). A collaboration between the doctors and Lilly allegedly continued from early 1983 through the end of 1984 (Compl. ¶11). The central allegation is that during this period, "at least Crabtree (and possibly Plutzky, as well) contributed to the conception of at least some of the inventions claimed in the suit patents" (Compl. ¶16). The complaint further alleges that some of these inventions were reduced to practice during the collaboration (Compl. ¶17).

No probative visual evidence provided in complaint.

Identified Points of Contention

  • Contribution vs. Conception: A primary factual question for the court will be whether the assistance provided by the NIH doctors constituted a contribution to the "conception" of the claimed inventions—the formation of a "definite and permanent idea of the complete and operative invention"—or whether it was limited to reducing to practice the pre-existing ideas of the named Lilly inventors.
  • Scope of Contribution: The complaint alleges contribution to "at least some of the inventions." A point of contention may be identifying which specific claimed inventions (i.e., the DNA compound, the method of use, the expression vector) the doctors allegedly co-conceived and the evidence supporting their contribution to each.

V. Key Claim Terms for Construction

The complaint, which focuses on the factual question of who contributed to conception rather than on claim scope, does not provide sufficient detail for an analysis of key claim terms for construction.

VI. Other Allegations

  • Count I – Correction of Inventorship: The complaint alleges that because Drs. Crabtree and Plutzky contributed to the conception of the claimed inventions, they are entitled to be named as inventors pursuant to 35 U.S.C. § 256 (Compl. ¶¶ 20-21). Based on an NIH rights determination and Executive Order 10,096, the complaint further alleges that the United States is entitled to an assignment of any ownership interest that the doctors obtain through the correction of inventorship (Compl. ¶22).
  • Count II – Equitable Trust: The complaint alleges that by failing to correctly name the government employees as inventors, Lilly was unjustly enriched because it "obtained exclusive use of the inventions" without having to pay royalties to the United States (Compl. ¶¶ 32-33). The complaint seeks the imposition of a constructive trust upon the proceeds of commercial sales of Xigris® and compensation for lost licensing revenue (Compl. ¶¶ 34-35).

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

The resolution of this dispute appears to hinge on three central questions:

  • A core issue will be one of evidentiary proof: What specific, corroborated evidence exists to demonstrate the nature and timing of the contributions made by Drs. Crabtree and Plutzky, and does this evidence show they contributed to the definitive conception of the claimed subject matter?
  • A key legal question will be one of joint inventorship: Do the alleged contributions, if proven, meet the legal standard for co-inventorship, which requires more than just exercising ordinary skill in the art at the direction of others?
  • A final question will be remedial: If inventorship is corrected, what is the proper legal and financial remedy for the United States' claims of unjust enrichment and lost licensing opportunities over the life of the patents?