DCT

1:18-cv-03133

Eli Lilly Co v. Adocia SA

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-03133, S.D. Ind., 10/09/2018
  • Venue Allegations: Venue is alleged to be proper under 28 U.S.C. § 1391. The complaint alleges personal jurisdiction over the French defendant, Adocia, based on its purposeful business activities directed at the plaintiff in Indiana, including entering into collaboration agreements and supplying materials into the state.
  • Core Dispute: Plaintiff seeks a declaratory judgment that its employees are the sole and correct inventors of two patents related to rapid-acting insulin formulations, thereby preempting Defendant's alleged claims of co-inventorship arising from a prior collaboration.
  • Technical Context: The technology involves pharmaceutical formulations for rapid-acting insulin, a critical therapy for managing blood sugar levels in patients with diabetes.
  • Key Procedural History: The dispute arises from a multi-year research collaboration between the parties (2011-2017) focused on developing an ultra-rapid insulin product using Defendant's proprietary "BioChaperone®" technology. Following the collaboration's termination, Defendant allegedly asserted co-inventorship rights over Plaintiff’s patents, culminating in this declaratory judgment action by Plaintiff to affirm the listed inventorship.

Case Timeline

Date Event
2011-12-13 Lilly and Adocia enter first "Collaborative Research & License Agreement"
2013-07-XX The 2011 collaboration agreement is terminated
2014-12-16 Priority Date for U.S. Patent No. 9,993,555
2014-12-18 Lilly and Adocia enter second "Collaborative Research & License Agreement"
2015-08-27 Priority Date for U.S. Patent No. 9,901,623
2017-01-XX Research collaboration between Lilly and Adocia ends
2017-06-14 Adocia's CEO sends letter to Lilly demanding correction of inventorship
2017-06-16 Adocia files its own U.S. Patent Application
2018-02-27 U.S. Patent No. 9,901,623 Issues
2018-06-12 U.S. Patent No. 9,993,555 Issues
2018-10-09 Complaint Filed

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

U.S. Patent No. 9,901,623 - "Rapid-Acting Insulin Compositions," issued February 27, 2018

The Invention Explained

  • Problem Addressed: The patent addresses the need for insulin compositions that are absorbed more rapidly into the bloodstream after injection than existing commercial products, which can be too slow to counteract blood sugar spikes from meals (Compl. ¶13; ’623 Patent, col. 1:12-26).
  • The Patented Solution: The invention is a pharmaceutical formulation that combines an insulin analog (like insulin lispro) with specific concentrations of both citrate and a vasodilator, treprostinil. The patent states it was "surprisingly been found" that this specific combination yields a more rapid time-action profile while maintaining chemical and physical stability, which is achieved by including additional stabilizing agents like zinc and magnesium chloride (’623 Patent, Abstract; col. 2:15-28).
  • Technical Importance: Developing faster-acting insulin formulations allows for better glycemic control for diabetic patients, more closely mimicking the natural insulin response of a healthy pancreas after a meal (’623 Patent, col. 1:15-19).

Key Claims at a Glance

  • The complaint seeks a declaration of correct inventorship for the patent generally, without specifying claims (Compl. ¶¶ 45-51). Independent claim 1 is representative of the core invention.
  • Independent Claim 1: A pharmaceutical composition comprising:
    • an insulin;
    • citrate, in a concentration from about 5 to about 25 mM;
    • treprostinil, in a concentration from about 0.04 to about 20 µg/mL;
    • zinc, in a concentration sufficient to provide at least 2 zinc ions per six molecules of insulin;
    • a preservative; and
    • one or more additional stabilizing agents, selected from the group consisting of a magnesium-containing compound and sodium chloride.

U.S. Patent No. 9,993,555 - "Rapid-Acting Insulin Compositions," issued June 12, 2018

The Invention Explained

  • Problem Addressed: Similar to the ’623 Patent, this patent aims to create a faster-acting insulin. It also implicitly addresses a problem with prior art approaches that used the chelating agent EDTA, which the patent notes can cause "injection site discomfort" (’555 Patent, col. 2:1-10).
  • The Patented Solution: The invention is a pharmaceutical formulation that includes an insulin analog, specific concentrations of citrate, and zinc, but which specifically excludes EDTA. The patent asserts that this composition is stable and provides rapid pharmacokinetic action (’555 Patent, Abstract; Compl. ¶12). This invention is distinct from the ’623 patent in that it does not require treprostinil.
  • Technical Importance: This approach seeks to accelerate insulin action using citrate without relying on other agents like EDTA, potentially avoiding issues associated with those agents while still achieving the desired therapeutic effect (’555 Patent, col. 2:20-24).

Key Claims at a Glance

  • The complaint seeks a declaration of correct inventorship for the patent generally (Compl. ¶¶ 53-59). Independent claim 1 is representative.
  • Independent Claim 1: A pharmaceutical composition comprising:
    • an insulin, in a concentration of about 100 to about 200 IU/mL;
    • citrate, in a concentration from about 15 to about 35 mM;
    • zinc, in a concentration from about 0.2 to about 0.8 mM;
    • a preservative; and
    • wherein the composition does not include EDTA.

III. The Disputed Contribution

  • Source of Dispute: The inventorship dispute arises from a research collaboration between Lilly and Adocia from 2011 to 2017 (Compl. ¶¶ 21-26). Adocia has alleged that its employees should be listed as co-inventors on the patents-in-suit based on contributions made during this period (Compl. ¶38).
  • Nature of the Collaboration: The collaboration focused on the joint development of an ultra-rapid insulin ("URI") product based on Lilly's Humalog® product formulated with Adocia's proprietary "BioChaperone® technology" (Compl. ¶¶ 21, 25). Adocia's BioChaperone® technology is described as using polymers to form physical complexes with therapeutic proteins to improve their time-action profile (Compl. ¶20).
  • Plaintiff's Position on Contribution: Lilly alleges that its patented inventions were developed separately from the joint collaboration (Compl. ¶36). The complaint asserts that the patented inventions—which are based on specific concentrations of citrate, treprostinil, and other excipients—stem from Lilly's own internal research program and not from any input from Adocia (Compl. ¶¶ 16, 36). Lilly further alleges that, unlike its patented inventions, the joint collaboration with Adocia "focused only on URI products containing BioChaperone® molecules" (Compl. ¶36).

IV. Analysis of Infringement Allegations

This is an action for declaratory judgment of inventorship, not patent infringement. Therefore, this section is not applicable.
No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

While this is not an infringement case, the scope of the claims is central to determining inventorship. An inventor must have contributed to the conception of the claimed subject matter. Practitioners will focus on terms defining the novel aspects of the compositions to distinguish the patented inventions from the subject matter of the parties' collaboration.

  • For the ’623 Patent:

    • The Term: "treprostinil"
    • Context and Importance: Lilly alleges the patented invention is distinct from the collaboration, which it claims focused on Adocia's BioChaperone® polymers (Compl. ¶36). Treprostinil, a specific vasodilator, is a required element in the '623 patent's independent claims. The core inventorship question may turn on whether Adocia can produce evidence that its employees contributed to the conception of using treprostinil in combination with citrate to accelerate insulin action, or if that idea originated solely within Lilly.
    • Intrinsic Evidence for Interpretation: The patent specification defines treprostinil by its specific chemical name and CAS number and describes it as a "synthetic analog of prostacyclin" with "potent vasodilatory effects" (’623 Patent, col. 8:15-41). The patent presents the combination of citrate and treprostinil as a "surprising" discovery that provides a more rapid time-action profile (’623 Patent, col. 2:15-18). This language may be used to frame the inventive concept as the specific combination, raising the question of who conceived of that combination.

  • For the ’555 Patent:

    • The Term: "does not include EDTA"
    • Context and Importance: This negative limitation is a critical feature of the '555 patent's claims. An inventorship dispute over a claim with a negative limitation raises the question of who conceived of the absence of the element as an essential feature of the invention. The court will need to determine whether an Adocia employee contributed to the conception of a stable, rapid-acting, citrate-based insulin formulation that is specifically defined by being free of EDTA.
    • Intrinsic Evidence for Interpretation: The specification provides context for this limitation by describing prior art that used zinc chelators like EDTA but notes that such compositions "showed injection site discomfort" (’555 Patent, col. 2:1-10). The patent describes its invention as providing rapid action without requiring EDTA (’555 Patent, Abstract; Compl. ¶12). This suggests the exclusion of EDTA is a deliberate and essential part of the solution to the technical problem, making the conception of this exclusion a key point of the inventorship inquiry.

VI. Other Allegations

  • Exceptional Case and Attorneys' Fees: The complaint does not allege infringement. Instead, it preemptively seeks a declaration that Adocia's conduct renders the case "exceptional" under 35 U.S.C. § 285, entitling Lilly to an award of attorneys' fees (Compl. ¶¶ 52, 60; Prayer for Relief C). The basis for this allegation appears to be Adocia's repeated claims of inventorship and threats of legal action, which Lilly contends are baseless (Compl. ¶¶ 46-47, 54-55).

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

This case is not a standard infringement dispute but a contest over ownership and inventorship. The outcome will likely depend on the evidence presented to answer two central questions for the court:

  • A core issue will be one of evidentiary proof of conception: Can Adocia demonstrate with clear and convincing evidence that its employees contributed to the conception of the specific chemical compositions recited in the patent claims—namely the use of citrate with treprostinil (’623 patent) and the citrate-based, EDTA-free formulation (’555 patent)? Or will the evidence show, as Lilly alleges, that Adocia's contributions were confined to the separate and distinct field of BioChaperone® polymer technology?
  • A related question will be the demarcation of collaborative work: What were the actual technical boundaries of the joint research collaboration? The court will need to determine if the work that led to the patented inventions was an independent effort by Lilly, as the complaint alleges, or if it was an inseparable part of, or a direct result of, the joint development activities with Adocia.