DCT

1:17-cv-00922

Idorsia Pharma Ltd v. Hon Joseph Matal

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00922, E.D. Va., 06/15/2018
  • Venue Allegations: Plaintiff alleges venue is proper in the Eastern District of Virginia pursuant to the Leahy-Smith America Invents Act.
  • Core Dispute: Plaintiff alleges the U.S. Patent and Trademark Office incorrectly calculated the Patent Term Adjustment (PTA) for its patent related to P2Y12 receptor antagonists, and seeks a judicial correction of the patent's expiration date.
  • Technical Context: The patent covers phosphonic acid derivatives used as P2Y12 receptor antagonists, a class of anti-platelet agents critical in treating and preventing thrombotic diseases.
  • Key Procedural History: The complaint details a multi-year dispute with the U.S. Patent and Trademark Office (PTO) over the correct PTA for the patent-in-suit. The dispute centers on two main issues: (1) whether the first two of three "Requirements for Restriction" issued by the PTO during prosecution were legally sufficient to stop the accrual of PTA "A-delay," as Plaintiff alleges they were defective and subsequently withdrawn; and (2) whether the PTO acted properly by retroactively changing the application's national stage commencement date, which further reduced the PTA calculation. This action follows a prior lawsuit on the same matter which was remanded to the PTO, after which the PTO issued a final decision maintaining a PTA of 311 days, which Plaintiff now challenges.

Case Timeline

Date Event
2007-11-29 Earliest Priority Date for ’912 Patent Application
2010-05-28 U.S. National Stage Application Filed
2010-05-29 Original National Stage Commencement Date Used by PTO
2010-06-01 Revised National Stage Commencement Date Used by PTO
2012-03-14 PTO Issues First Requirement for Restriction
2012-04-18 PTO Issues Second Requirement for Restriction
2012-06-21 PTO Issues Third Requirement for Restriction
2013-08-27 U.S. Patent No. 8,518,912 Issues
2015-10-01 Prior Civil Action Filed (Actelion v. Lee)
2016-03-02 Court Remands Prior Action to PTO
2017-02-16 PTO Issues Second Final Decision on PTA (subject of this action)
2018-06-15 Amended Complaint Filed

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

  • Patent Identification: U.S. Patent No. 8,518,912, Phosphonic acid derivates and their use as P2Y12 receptor antagonists, issued August 27, 2013.

The Invention Explained

  • Problem Addressed: The patent's background describes the challenge of preventing thrombosis (blood clotting) and notes the limitations of existing antiplatelet agents like aspirin. It identifies the P2Y12 receptor as a key mediator in platelet activation and aggregation, making it an important target for new antithrombotic drugs (ʼ912 Patent, col. 1:24-54).
  • The Patented Solution: The invention provides a class of phosphonic acid derivatives that act as P2Y12 receptor antagonists. The specification asserts that these specific compounds exhibit "significantly improved biological properties compared to the corresponding carboxylic acid derivatives previously known to one skilled in the art," suggesting an advancement over prior art chemical structures (ʼ912 Patent, col. 2:10-14).
  • Technical Importance: P2Y12 receptor antagonists represent a major class of antithrombotic drugs used clinically to prevent cardiovascular and cerebrovascular events such as heart attacks and strokes (ʼ912 Patent, col. 1:46-54).

Key Claims at a Glance

  • The complaint does not assert specific claims for infringement, as the dispute concerns the patent's term. Independent claim 1 is representative of the patented subject matter.
  • Independent Claim 1 covers:
    • A compound of formula I, or a pharmaceutically acceptable salt thereof.
    • Formula I defines a core 2-phenyl-pyrimidine chemical structure substituted with multiple variable groups, including a piperazine ring connected to a phosphonic acid motif (P(O)R⁵R⁸).
    • The claim defines the scope of permissible substituents for various positions on the core structure, such as R¹, W, R², Ra, and Rb.
  • The complaint does not explicitly reserve the right to assert dependent claims.

VI. Summary of Legal Allegations

  • Action for Adjustment of Patent Term (35 U.S.C. § 154(b)): The complaint alleges the PTO’s final PTA determination of 311 days is incorrect and should be 413 days (or alternatively, 410 days) (Compl. ¶¶67, 72). The primary contention is that the PTO improperly stopped the "A-delay" clock upon issuing a first Requirement for Restriction, which Plaintiff argues was defective, not susceptible to a compliant response, and subsequently withdrawn (Compl. ¶¶57-58). Plaintiff contends that only the third Requirement for Restriction, issued on June 21, 2012, was a valid notification sufficient to toll A-delay accrual (Compl. ¶58). A secondary basis for the alleged miscalculation is the PTO's retroactive change of the national stage commencement date from May 29, 2010, to June 1, 2010, which reduced the PTA by three days (Compl. ¶¶59-61).
  • Administrative Procedures Act Claim: Plaintiff alleges that the PTO’s actions were "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law" (Compl. ¶74). The complaint argues the PTO applied "different, non-publicly available standards" to determine which of the three restriction requirements was sufficient to stop the A-delay clock (Compl. ¶66). It further alleges the PTO's conclusion regarding the national stage commencement date was made "without any publicly-available basis in statute, regulation or administrative guidance" (Compl. ¶80).
  • Fifth Amendment Claim: The complaint alleges that the PTO's improper determination of the PTA constitutes a permanent deprivation of Plaintiff's property—the full and correct patent term—without due process of law and just compensation, in violation of the Fifth Amendment (Compl. ¶¶85-88). This alleged deprivation is described as the result of an "arbitrary and inconsistent process" (Compl. ¶88).

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

This case does not involve infringement but rather presents a direct challenge to the administrative process of calculating a patent's term. The outcome will likely depend on the court's interpretation of patent statutes and administrative law.

  • A central legal question will be one of statutory interpretation: does a Requirement for Restriction that is later withdrawn by the PTO as defective constitute a valid "notification" under 35 U.S.C. § 132 sufficient to stop the accrual of "A-delay" under the Patent Term Adjustment statute?
  • A second key issue concerns agency procedure: did the PTO act arbitrarily and capriciously, in violation of the Administrative Procedures Act, by retroactively changing the national stage commencement date for PTA calculation based on its interpretation of how to handle deadlines falling on a weekend or holiday, particularly where it allegedly lacks a clear, publicly promulgated rule on the matter?