DCT

1:17-cv-00922

Idorsia Pharma Ltd v. Hon Joseph Matal

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00922, E.D. Va., 08/11/2017
  • Venue Allegations: Venue is alleged as proper under the Leahy-Smith America Invents Act and 35 U.S.C. § 154(b)(4)(A), which provides for civil action against the Director of the USPTO in the U.S. District Court for the Eastern D. Virginia.
  • Core Dispute: Plaintiff alleges that the U.S. Patent and Trademark Office incorrectly calculated the patent term adjustment for a patent related to pharmaceutical compounds, and seeks a judicial order to change the adjustment from 311 days to 413 days.
  • Technical Context: The patent-in-suit concerns P2Y12 receptor antagonists, a class of drugs used as antiplatelet agents to prevent thrombosis and treat cardiovascular and cerebrovascular diseases.
  • Key Procedural History: This action follows a lengthy administrative dispute with the USPTO regarding the patent term adjustment for the patent-in-suit. Plaintiff alleges the USPTO issued two defective "Requirements for Restriction" that were subsequently superseded. A prior civil action, Actelion v. Lee, resulted in a remand to the USPTO, which then issued a second Final Decision on PTA that Plaintiff now challenges in this action.

Case Timeline

Date Event
2007-11-29 Patent Priority Date ('912 Patent)
2010-05-28 U.S. National Stage Application Filed
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 '912 Patent Issues
2015-10-01 Prior Civil Action (Actelion v. Lee) Filed
2016-03-02 Court Remands Actelion v. Lee to PTO
2017-02-16 PTO Issues Second Final Decision on PTA
2017-08-11 Complaint Filing Date

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

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 haemostasis as the natural balance between maintaining blood fluidity and forming clots to prevent blood loss after vessel injury. It notes that while antiplatelet agents are critical for treating thrombosis, widely used agents such as aspirin have efficacy limitations, creating a need for new therapeutics. The patent identifies the P2Y12 adenosine 5'-diphosphate (ADP) receptor as a key mediator in platelet activation and aggregation. (Compl. ¶9; ’912 Patent, col. 4:24-54).
  • The Patented Solution: The invention provides a class of chemical compounds—specifically 2-phenyl-pyrimidine derivatives containing a phosphonic acid motif—that act as P2Y12 receptor antagonists. The inventors assert that these phosphonic acid derivatives "surprisingly show significantly improved biological properties compared to the corresponding carboxylic acid derivatives previously known to one skilled in the art." (’912 Patent, col. 4:11-15). By blocking the P2Y12 receptor, these compounds inhibit platelet aggregation and are thus useful for treating and preventing thrombosis and related conditions. (’912 Patent, Abstract).
  • Technical Importance: The development of novel, effective, and selective P2Y12 receptor antagonists is a significant area of pharmaceutical research for managing cardiovascular and cerebrovascular diseases. (’912 Patent, col. 4:24-34, 4:60-66).

Key Claims at a Glance

  • The complaint does not assert specific claims for infringement, as the dispute concerns patent term adjustment rather than product infringement. The following analysis is of the first independent claim of the patent.
  • Independent Claim 1:
    • A compound of formula I or a pharmaceutically acceptable salt thereof, where formula I defines a specific chemical scaffold.
    • The scaffold includes a 2-phenyl-pyrimidine core.
    • The phenyl group (R¹) can be unsubstituted or substituted 1 to 3 times with specified substituents (e.g., halogen, methyl, methoxy).
    • The pyrimidine ring is attached to a piperazine ring, which in turn is connected to a phosphonic acid group.
    • The structure includes multiple variables (W, R², R³, R⁴, R⁵, R⁸, n, m, V, etc.) that define various possible substituent groups at different positions on the core scaffold.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is the final agency action of the USPTO, specifically the "Second Final Decision on PTA" dated February 16, 2017, which determined the patent term adjustment (PTA) for the ’912 Patent to be 311 days. (Compl. ¶¶47, 55).

Functionality and Market Context

  • The decision represents the USPTO's final calculation of the patent term extension owed to the patentee to compensate for administrative delays during prosecution. The complaint alleges the USPTO's calculation is based on two key legal and factual determinations. First, the USPTO determined that its mailing of the first "Requirement for Restriction" on March 14, 2012, was a sufficient notification under 35 U.S.C. § 132 to stop the accrual of "A-delay," despite Plaintiff's contention that this notification was defective and later superseded. (Compl. ¶¶45, 47). Second, the USPTO determined that the national stage commencement date for PTA calculation purposes was June 1, 2010, which Plaintiff alleges was an improper rollover from the actual deadline of May 29, 2010. (Compl. ¶¶47, 52).
  • The length of a patent's term is of critical commercial importance in the pharmaceutical industry, as it defines the period of market exclusivity for a patented drug. The 102-day difference in PTA asserted by the Plaintiff (413 days versus the PTO's 311 days) represents a significant period of potential revenue. (Compl. ¶¶2, 53).

IV. Analysis of Infringement Allegations

A standard claim chart comparing patent claims to an accused product is not applicable to this case, as the lawsuit challenges a governmental agency's administrative decision rather than alleging infringement by a commercial product. The "infringement" theory is an allegation that the USPTO's decision was arbitrary, capricious, and contrary to law under the Administrative Procedures Act and 35 U.S.C. § 154(b). (Compl. ¶¶60, 64-65).

The Plaintiff’s central arguments are as follows:

  1. Improper Stoppage of A-Delay: The complaint alleges that the A-delay clock, which compensates for PTO examination delays, should have continued to run until the PTO issued a proper office action to which the applicant could respond.

    • Plaintiff's Position: Plaintiff alleges that the first and second Requirements for Restriction issued by the PTO were "defective on their face because they failed to address all aspects of the pending claims" and were subsequently withdrawn. (Compl. ¶51). Because a compliant response was impossible, Plaintiff argues these defective notices could not qualify as notifications under 35 U.S.C. § 132 sufficient to stop the A-delay clock. (Compl. ¶50). It is alleged that only the third Requirement for Restriction, mailed June 21, 2012, was a proper notification that should have stopped the clock. (Compl. ¶51).
    • Contention: This raises the legal question of what constitutes a valid "notification" for PTA purposes and whether a defective, later-superseded notification qualifies.

  2. Incorrect National Stage Commencement Date: The complaint alleges the USPTO improperly calculated the start date for the A-delay period.

    • Plaintiff's Position: The 30-month national stage commencement date for the application was Saturday, May 29, 2010. (Compl. ¶16). The PTO, however, revised this date to the next business day, Tuesday, June 1, 2010, for its PTA calculation. (Compl. ¶17). Plaintiff argues that the PTO "does not have the authority to decide that the 30-month national stage commencement date rolls over," as the statute, 35 U.S.C. § 371(b), states the national stage "shall commence with the expiration" of the 30-month limit without providing for such an adjustment. (Compl. ¶52).
    • Contention: This raises a question of statutory interpretation regarding the PTO's authority to adjust filing or commencement dates that fall on a weekend or holiday for the specific purpose of PTA calculation.

No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

This section is not applicable, as the dispute centers on the interpretation of statutory provisions governing patent term adjustment (35 U.S.C. § 154(b) and § 371), not the construction of terms within the ’912 Patent's claims.

VI. Other Allegations

The complaint includes counts beyond the direct challenge to the PTA calculation under 35 U.S.C. § 154(b).

  • Administrative Procedures Act (Count 2): The complaint alleges that the PTO's determination of the PTA is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law" under 5 U.S.C. § 706(2)(A). (Compl. ¶¶64-65). This is based on the argument that the PTO’s decision to treat a defective and superseded restriction requirement as a valid notification is contrary to the purpose of the PTA statute. (Compl. ¶¶64, 67).
  • Fifth Amendment Violation (Count 3): The complaint alleges that the PTO's improper determination of the PTA constitutes a "permanent deprivation of Idorsia’s correct and full patent term and rights" without due process of law. (Compl. ¶72). It further alleges this action is a "taking of a property right... without just compensation," in violation of the Fifth Amendment. (Compl. ¶73).

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

This case will likely turn on questions of statutory interpretation and agency authority rather than technical patent issues. The central questions for the court appear to be:

  • A primary issue will be one of statutory interpretation: What constitutes a "notification under section 132" sufficient to stop the accrual of A-delay under 35 U.S.C. § 154(b)(1)(A)(i)? Specifically, can a Requirement for Restriction that the PTO itself later supersedes for being defective serve as a valid clock-stopping event?
  • A second key issue will be one of agency authority: Does the USPTO's general authority to adjust deadlines falling on a weekend or holiday extend to altering the statutory "commencement" date of the national stage under 35 U.S.C. § 371(b) for the purpose of calculating patent term adjustment?