DCT

2:18-cv-02015

Chen v. Jung

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
    • Plaintiff: Degui Chen, Ph.D. (People's Republic of China)
    • Defendant: Michael E. Jung, Ph.D. (California); Charles L. Sawyers, M.D. (New York)
    • Plaintiff’s Counsel: Amin Talati Upadhye, LLP; Clinton & Clinton
  • Case Identification: 2:18-cv-02015, C.D. Cal., 03/12/2018
  • Venue Allegations: Venue is based on the assertion that a substantial part of the events or omissions giving rise to the claim, including the conception of the inventions at issue, occurred in the Central District of California at UCLA, and that Defendants are subject to personal jurisdiction in the district.
  • Core Dispute: Plaintiff alleges he was improperly omitted as a joint inventor on three patents related to androgen receptor modulators for treating prostate cancer and seeks judicial correction of inventorship pursuant to 35 U.S.C. § 256.
  • Technical Context: The patents relate to small-molecule chemical compounds designed to inhibit the androgen receptor, a key target in treating advanced prostate cancer, particularly castration-resistant forms of the disease.
  • Key Procedural History: The complaint alleges that Plaintiff, through counsel, contacted The Regents of the University of California, the assignee of the patents-in-suit, on multiple occasions beginning in November 2013 to request correction of inventorship, but that no corrective action was taken. The subject matter of the patents-in-suit has been commercialized as the FDA-approved drug Erleada®.

Case Timeline

Date Event
2004-08-XX Group meeting where the idea of creating a heterocyclic six-membered ring compound was allegedly discussed
2004-10-XX Plaintiff and Dr. Ouk allegedly met and decided to use compound RD37 as a starting point
2005-01-23 Dr. Ouk allegedly synthesized the new compound, A51
2005-02-15 Plaintiff allegedly performed tests establishing the therapeutic biological activity of A51
2006-03-27 Earliest Priority Date Claimed (U.S. Provisional App. No. 60/785,978)
2013-05-21 U.S. Patent No. 8,445,507 Issues
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 issues final approval for Janssen Biotech to market Erleada®, the subject matter of the patents-in-suit
2018-03-12 Complaint 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"

  • Patent Identification: 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: Advanced prostate cancer is often treated with androgen deprivation therapy, but the cancer can become "hormone refractory" and progress despite these treatments. A key mechanism for this resistance is the overexpression of the Androgen Receptor (AR), which can cause existing anti-androgen drugs like Bicalutamide to paradoxically act as agonists, stimulating cancer growth. (’507 Patent, col. 1:15-50).
  • The Patented Solution: The patent discloses a new class of non-steroidal compounds, including thiohydantoins, that modulate the function of the AR. These compounds are designed to have potent antagonistic (inhibitory) activity and minimal agonistic (stimulatory) activity, even when the AR is overexpressed, thereby providing a more effective treatment for hormone-refractory prostate cancer. (’507 Patent, col. 1:51-col. 2:12; Abstract).
  • Technical Importance: The development of AR inhibitors that remain effective antagonists in the high-AR environment of castration-resistant prostate cancer represented a significant advance in treating the fatal stage of the disease. (Compl. ¶22).

Key Claims at a Glance

  • The complaint asserts contribution to claims 1-3, 10, 16-18, 20-21, and 24-28. (Compl. ¶59). Independent claim 1 is representative:
  • A compound having the formula:
    • NC. N S CH3 or NC. N S F O NH CH3
    • F3C N O F3C N O
    • 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"

  • Patent Identification: 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: The patent addresses the same technical problem as the ’507 Patent: the need for improved AR modulators to treat hormone-refractory prostate cancer where AR overexpression renders existing therapies ineffective or even counterproductive. (’689 Patent, col. 1:53-col. 2:4).
  • The Patented Solution: The patent claims methods of treating diseases related to AR activity, specifically prostate cancer, by administering a therapeutically effective amount of a compound from the same chemical class described in the ’507 Patent. The solution focuses on the therapeutic application of these novel AR antagonists. (’689 Patent, col. 2:42-50; Abstract).
  • Technical Importance: This patent family provides a method-of-use framework for the novel compounds, securing intellectual property rights over not just the chemical entities but also their specific application in treating prostate cancer. (Compl. ¶¶17-21).

Key Claims at a Glance

  • The complaint asserts contribution to claims 1-2, 7-9, and 11-19. (Compl. ¶63). Independent claim 1 is representative:
  • A method for treating a disease or disorder related to nuclear receptor activity in a subject, comprising administering a compound, or a pharmaceutically acceptable salt thereof, to the subject in need of such treatment, the compound having the formula:
    • Wherein "Het" is a heterocyclic unit of 6 atoms.
    • And "A is sulfur and B is oxygen."
    • And R1, R2, and R3 define other parts of the chemical structure.

Multi-Patent Capsule

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

  • Patent Identification: U.S. Patent No. 9,388,159, "Substituted Diazaspiroalkanes As Androgen Receptor Modulators," issued July 12, 2016.
  • Technology Synopsis: This patent is a continuation of the family and claims a class of compounds, methods of use, and pharmaceutical compositions related to the same core technology of non-steroidal AR modulators for treating conditions like prostate cancer. The claims are structurally similar to those in the parent patents. (’159 Patent, Abstract; col. 1:8-25).
  • Asserted Claims: The complaint asserts contribution to claims 1-2, 4, 6-13, 15-16, 18-19, 21-22, 24-25, and 27-33. (Compl. ¶67).
  • Accused Features: This is an inventorship action; the allegation is that Plaintiff contributed to the conception of the claimed inventions. (Compl. ¶67).

III. Subject Matter of the Patented Inventions

Product Identification

  • The complaint alleges that the claimed subject matter of the ’507, ’689, and ’159 patents is marketed under the trade name Erleada®. (Compl. ¶46).

Functionality and Market Context

  • Erleada® is a drug indicated for the treatment of patients with certain forms of prostate cancer. (Compl. ¶¶17, 21-22). The complaint notes that on February 14, 2018, the FDA issued final approval to Janssen Biotech, Inc., a subsidiary of Johnson & Johnson, to market Erleada® following a New Drug Application. (Compl. ¶46). The patents-in-suit are licensed to Johnson & Johnson. (Compl. ¶45).

IV. Analysis of Inventorship Allegations

The complaint does not allege infringement but instead seeks to correct inventorship, alleging that Dr. Chen made significant contributions to the conception of the claimed inventions. The core factual allegations supporting this claim are summarized below.

Alleged Contribution to Conception Factual Allegation in Complaint Complaint Citation
Conception of the core chemical structure modification In an August 2004 meeting, Dr. Chen was part of a group that discussed creating a novel compound by replacing a carbon atom with a nitrogen atom in the ring structure of a known series of compounds (the "RD series"), thereby creating a heterocyclic ring. ¶28
Identification of the starting material In an early October 2004 meeting, Dr. Chen and Dr. Samedy Ouk jointly concluded that the compound RD37 would be the appropriate starting point for synthesizing the new hypothetical compound. ¶29
Establishment of therapeutic utility After the new compound (A51) was synthesized, the complaint alleges that "no one yet knew or could have predicted any utility and biological activity of A51." On February 15, 2005, Dr. Chen allegedly performed tests that "conclusively established that A51 had therapeutic biological activity and thus could be developed into a drug for prostate cancer." The chemical structure for A51 is depicted in the complaint (Compl. ¶33). ¶¶34-35
  • Identified Points of Contention:
    • Contribution to Conception vs. Reduction to Practice: A primary legal question may be whether Dr. Chen's alleged contributions rise to the level of "conception" of the claimed invention. Defendants may argue that discussing a general idea (a heterocyclic ring) or identifying a starting compound are routine steps, or that testing A51's biological activity constitutes a reduction to practice, which does not, by itself, confer inventorship status.
    • Corroboration: A central factual question will be what evidence, beyond Dr. Chen's own declaration, exists to corroborate his alleged contributions to the conception of the claimed compounds. The court will likely require evidence to substantiate the substance of the alleged August and October 2004 meetings.

V. Key Claim Terms for Construction

  • The Term: "a compound having the formula" (or "a compound of formula II")
  • Context and Importance: This term defines the entire scope of the claimed chemical entities. The dispute over inventorship is a dispute over who conceived of a compound falling within this claimed formula. Practitioners may focus on whether Dr. Chen's alleged conceptual contributions—specifically, the idea of creating a heterocyclic ring by replacing a carbon with a nitrogen in a related structure—is a significant contribution to the conception of the final, claimed formula.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification describes Formula II and its constituent parts (Het, R1, R2, R3, etc.) with a range of possible substituents, suggesting the formula is intended to cover a class of related compounds, not just the specific embodiment A51. (’507 Patent, col. 2:20-col. 8:65). This may support an argument that an early, foundational idea about the core heterocyclic structure was a contribution to the entire class.
    • Evidence for a Narrower Interpretation: The specification provides specific synthesis examples and biological data for compounds A51 and A52. (’507 Patent, col. 11:1-col. 14:30; FIGS. 1-6). A party might argue that the "invention" was not the general idea of a heterocyclic ring but the conception and creation of these specific, operative compounds, and that inventorship should be limited to those who conceived of the final, complete structures.

VI. Key Allegations Regarding Inventorship Standard

  • No Deceptive Intent: The complaint repeatedly alleges that the error in failing to list Dr. Chen as a joint inventor "arose without any deceptive intent on Dr. Chen's part." (Compl. ¶¶ 47, 61, 65, 69). This is a statutory requirement for a court to order correction of an issued patent under 35 U.S.C. § 256, and this allegation is necessary to state a valid claim for relief.

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

  • A central issue will be one of contribution to conception: Does the combination of allegedly proposing a core structural idea (the heterocyclic ring) and confirming the biological utility of the resulting compound (A51) constitute a significant contribution to the "definite and permanent idea of the complete and operative invention," as required for joint inventorship, or do these actions fall short of that legal standard?
  • A key evidentiary question will be one of corroboration: What independent, corroborating evidence will be presented to substantiate Plaintiff's alleged conceptual contributions during the 2004 meetings and his subsequent testing in 2005, which are the factual pillars of his claim to be a joint inventor?