DCT

2:19-cv-04307

Degui Chen v. Michael E Jung

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:19-cv-04307, C.D. Cal., 05/17/2019
  • Venue Allegations: Venue is alleged to be proper in the Central District of California because a substantial portion of the events giving rise to the claims, including research and development at the University of California, Los Angeles (UCLA), occurred within the district.
  • Core Dispute: Plaintiff seeks correction of inventorship under 35 U.S.C. § 256 for four patents, alleging he is a joint inventor who was improperly omitted and that four of the five named inventors made no inventive contribution and should be removed.
  • Technical Context: The technology involves a class of chemical compounds known as androgen receptor modulators, which are used in the treatment of advanced prostate cancer.
  • Key Procedural History: The complaint alleges that Plaintiff, through counsel, first attempted to have inventorship corrected in a letter to the patent assignee, The Regents of the University of California, in November 2013, with subsequent follow-ups in 2016 and 2017. The patents-in-suit are listed in the FDA's "Orange Book" as covering the commercial drug Erleada® (apalutamide).

Case Timeline

Date Event
2004-10-XX Plaintiff and Defendant Ouk allegedly conceive of compound A51
2005-01-23 Defendant Ouk allegedly completes synthesis of A51
2005-02-15 Plaintiff allegedly obtains biological activity data for A51
2005-07-XX Plaintiff allegedly conceives of combining A51 and RD162 structures (related to A52)
2005-09-09 Plaintiff resigns from UCLA
2006-03-27 Earliest Priority Date ('507', '689', '159', '261' Patents)
2013-05-21 U.S. Patent No. 8,445,507 Issues
2013-11-11 Plaintiff's counsel sends first letter regarding incorrect inventorship
2014-08-12 U.S. Patent No. 8,802,689 Issues
2016-07-12 U.S. Patent No. 9,388,159 Issues
2018-02-14 FDA approves Erleada®, the drug allegedly embodying the patents-in-suit
2018-06-05 U.S. Patent No. 9,987,261 Issues
2019-05-17 Complaint for Correction of Inventorship Filed

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

U.S. Patent No. 8,445,507 - “Androgen Receptor Modulator for the Treatment of Prostate Cancer and Androgen Receptor-Associated Diseases”

  • Issued: May 21, 2013

The Invention Explained

  • Problem Addressed: The patent addresses the failure of existing anti-androgen therapies in advanced prostate cancer (Compl. ¶ 36). When the cancer becomes "hormone refractory," the Androgen Receptor (AR) is often overexpressed, which can cause conventional anti-androgens like bicalutamide to paradoxically act as agonists, stimulating rather than inhibiting cancer growth (’507 Patent, col. 1:20-col. 2:4).
  • The Patented Solution: The invention provides a new class of non-steroidal compounds, including thiohydantoins, that act as AR antagonists (’507 Patent, Abstract). These compounds are designed to potently inhibit AR activity even when it is overexpressed, thereby providing an effective treatment for both early-stage (hormone-sensitive) and advanced (hormone-refractory) prostate cancer (’507 Patent, col. 2:5-12). The patent specifically discloses the chemical structures of two such compounds, designated A51 and A52 (Compl. ¶ 24; ’507 Patent, col. 3:5-col. 4:4).
  • Technical Importance: This class of compounds represented a potential solution to a critical mechanism of drug resistance in advanced prostate cancer, a leading cause of cancer death in men (Compl. ¶ 36).

Key Claims at a Glance

  • The complaint asserts that Plaintiff contributed to the inventions claimed in claims 1-31 (Compl. ¶ 156).
  • Independent Claim 1 is a composition of matter claim directed to the specific chemical structures of compounds A51 and A52. Its essential elements are:
    • A compound having the formula [structure of A51 shown] or
    • A compound having the formula [structure of A52 shown] or
    • A pharmaceutically acceptable salt thereof.

U.S. Patent No. 8,802,689 - “Androgen Receptor Modulator for the Treatment of Prostate Cancer and Androgen Receptor-Associated Diseases”

  • Issued: August 12, 2014

The Invention Explained

  • Problem Addressed: As a continuation in the same patent family, the '689 Patent addresses the same problem of hormone-refractory prostate cancer driven by Androgen Receptor overexpression ('689 Patent, col. 1:53-col. 2:2).
  • The Patented Solution: The '689 Patent claims methods of treating prostate cancer by administering a therapeutically effective amount of a compound from the same chemical class described in the '507 Patent, including compounds A51 and A52 ('689 Patent, col. 32:3-23). The invention provides a therapeutic application for the novel compounds.
  • Technical Importance: The patent protects the use of these novel compounds as a medical treatment, a distinct and critical aspect of pharmaceutical intellectual property.

Key Claims at a Glance

  • The complaint asserts that Plaintiff contributed to the inventions claimed in claims 1-19 (Compl. ¶ 162).
  • Independent Claim 1 is a method of use claim. Its essential elements are:
    • A method for treating prostate cancer in a subject, comprising:
    • Administering to the subject a therapeutically effective amount of a specified compound or a salt thereof.
    • The compound is defined by a chemical structure that encompasses A51 and A52.

U.S. Patent No. 9,388,159 - “Substituted Diazaspiroalkanes As Androgen Receptor Modulators”

  • Issued: July 12, 2016
  • Technology Synopsis: This patent is part of the same family and addresses the same technical problem of treating prostate cancer with improved AR modulators (Compl. ¶ 6). The claims are directed to methods of using these compounds to treat androgen receptor-associated conditions.
  • Asserted Claims: Claims 1-33 (Compl. ¶ 168).
  • Accused Features: Not applicable; this is an inventorship action concerning the conception of the A-series compounds (Compl. ¶ 168).

U.S. Patent No. 9,987,261 - “Substituted Diazaspiroalkanes As Androgen Receptor Modulators”

  • Issued: June 5, 2018
  • Technology Synopsis: This patent is also part of the same family, directed to the same class of chemical compounds for treating AR-associated diseases like prostate cancer (Compl. ¶ 8). The claims cover pharmaceutical compositions containing these compounds.
  • Asserted Claims: Claims 1-21 (Compl. ¶ 174).
  • Accused Features: Not applicable; this is an inventorship action concerning the conception of the A-series compounds (Compl. ¶ 174).

III. The Alleged Conception and Reduction to Practice

  • Product Identification: The core of the patented invention is identified in the complaint as the "A" series compounds, specifically compounds A51 and A52 (Compl. ¶ 23).
  • Functionality and Market Context:
    • Compound A51 is alleged to be a novel chemical structure conceived as a modification of a prior compound, RD37. The modification involved replacing an aryl (benzene) ring with a heterocyclic (pyridine) ring to improve its properties as an AR modulator (Compl. ¶¶ 54, 57-58). A diagram in the complaint illustrates this single structural difference between the prior compound RD37 and the novel compound A51 (Compl. p. 10).
    • Compound A52 is alleged to have been conceived by combining the novel left-hand pyridine structure from A51 with the right-hand structure of a different compound, RD162, which was known to have favorable antagonist and pharmacokinetic properties (Compl. ¶ 75).
    • The subject matter of the patents-in-suit is commercialized by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson, under the trade name Erleada® for the treatment of prostate cancer (Compl. ¶ 129). The patents are listed in the FDA's "Orange Book" in connection with this drug (Compl. ¶ 130).

IV. Analysis of Inventorship Allegations

The complaint alleges that Dr. Chen is a true inventor based on his alleged conception of the claimed subject matter and that several named defendants are not because they allegedly did not contribute to conception. The legal standard for inventorship is conception, defined as the formation in the inventor's mind of a definite and permanent idea of the complete and operative invention.

  • Plaintiff's Alleged Inventive Contributions:

    • Conception of A51: The complaint alleges that in early October 2004, Plaintiff Chen and Defendant Ouk "jointly proposed making a pyridine analog of RD37, which would later be called A51" (Compl. ¶ 54). This is presented as the mental act of conceiving the novel A51 structure.
    • Reduction to Practice of A51: The complaint alleges that after Defendant Ouk synthesized A51, Plaintiff Chen performed the in vitro biological assays that first demonstrated the compound was biologically active and effective, which constitutes a reduction to practice of the invention (Compl. ¶¶ 61-62).
    • Conception of A52: The complaint alleges that in July 2005, Plaintiff Chen "envisioned a combination of the idea of A51 (left-hand side pyridine...) and RD162 (right-hand side structure...)" (Compl. ¶ 75). This is presented as the complete conception of the A52 structure by combining elements from two other molecules.

  • Allegations of Misjoinder (Improperly Named Inventors):

    • Defendants Jung and Sawyers: The complaint alleges they "did not contribute to the conception of the inventions" and should be removed from the patents (Compl. ¶ 159, 165). The narrative timeline suggests their awareness and involvement occurred well after the alleged conception by Plaintiff (Compl. ¶¶ 94-102).
    • Defendants Tran and Wongvipat: The complaint alleges they were "unaware of A51/A52 until more than a year after it was first conceived" and that their subsequent testing work "did not constitute independent or joint conceptual contributions" but was instead routine laboratory work performed at the direction of others (Compl. ¶¶ 114, 160, 166).

  • Identified Points of Contention:

    • Factual Dispute over Conception: A central question for the court will be resolving the factual dispute over who formed the "definite and permanent idea" of the A51 and A52 chemical structures. The complaint alleges Plaintiff's key role, while also describing documents allegedly created by Defendant Ouk that present a different narrative of conception (Compl. ¶¶ 103-104).
    • Corroboration of Conception: Inventorship claims require corroborating evidence. A key question will be what contemporaneous evidence (e.g., lab notebooks, emails, purchase orders, witness testimony) exists to support the dueling narratives of when and by whom the core inventive concepts were formed.
    • Standard for Joint Inventorship: The allegations raise the question of what level of contribution is required to be a joint inventor. The court may need to determine if the alleged testing activities of Defendants Tran and Wongvipat rose to the level of a conceptual contribution or were merely the work of a skilled "pair of hands" reducing an already-conceived invention to practice.

V. Key Aspects of the Claimed Invention for Inventorship Analysis

  • The 'Invention': The core of the invention, as defined by Claim 1 of the ’507 Patent, is the specific chemical structure of the A-series compounds, particularly A51 and A52 (’507 Patent, col. 30:43-60). The inventorship dispute will therefore focus on the conception of these molecular structures.
  • Context and Importance: Determining who conceived of these exact structures is the dispositive issue in the case. Practitioners may focus on the specific structural modifications that distinguish A51 and A52 from prior art compounds like RD37, as the conception of those novel modifications is the inventive act.
  • Intrinsic Evidence for the Inventive Concept:
    • Evidence for the Inventive Step: The patent describes the prior art, including non-steroidal anti-androgens, and explains the need for compounds with better antagonist activity in hormone-refractory cancer (’507 Patent, col. 1:20-col. 2:12). The inventive concept was the design of a specific molecular scaffold—a central thiohydantoin ring flanked by a substituted pyridine ring and a substituted aryl ring—that solved this problem. The complaint alleges Plaintiff conceived of this key pyridine substitution (Compl. ¶ 54).
    • Evidence of Specific Structures: The patent specification explicitly draws the structures for A51 and A52 and provides data on their biological activity (’507 Patent, col. 3:5-20; Fig. 1-3). The dispute centers on who first conceived of these exact structures that were ultimately disclosed and claimed.

VI. Other Allegations

  • Request for Exceptional Case Finding: The complaint requests that the court declare this an "exceptional case" under 35 U.S.C. § 285, which would permit an award of attorneys' fees (Compl. p. 26). This request appears to be based on allegations that, after Plaintiff's departure from UCLA, defendants engaged in conduct intended to conceal his inventive role, including the creation of allegedly false "confession letters" that misstated the timing and origin of the invention's conception (Compl. ¶¶ 90, 104-105).

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

The resolution of this inventorship dispute will likely depend on the court's determination of three central questions:

  • A core issue will be one of factual conception: Who first formed the definite and permanent mental idea of the specific chemical structures for compounds A51 and A52? The case will turn on a fact-intensive inquiry into the events of 2004 and 2005.
  • A key evidentiary question will be one of corroboration: What contemporaneous documentary and testimonial evidence can be produced to corroborate either the plaintiff's narrative of conception or the competing narrative allegedly constructed by the defendants after the plaintiff's departure?
  • A secondary legal question will be the standard of contribution: Did the alleged contributions of each named inventor, particularly the laboratory testing, rise to the level of a conceptual contribution required for joint inventorship, or did they constitute non-inventive reduction to practice at the direction of others?