DCT

1:17-cv-00776

Intra Cellular Therapies Inc v. Honorable Joseph Matal

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:

  • Case Identification: 1:17-cv-00776, E.D. Va., 07/07/2017

  • Venue Allegations: Venue is alleged to be proper in the Eastern District of Virginia pursuant to the Leahy-Smith America Invents Act and 35 U.S.C. § 154(b)(4)(A), which provides for civil action against the USPTO Director in this district.

  • Core Dispute: Plaintiff challenges the U.S. Patent and Trademark Office's calculation of the Patent Term Adjustment (PTA) for its '077 Patent, arguing that the PTO improperly assessed 21 days of "applicant delay" and seeking a judicial order to correct the patent term from 264 to 285 days.

  • Technical Context: The patent-in-suit concerns stable crystalline salt forms of a pharmaceutical compound used for treating disorders of the central nervous system.

  • Key Procedural History: The dispute arises from the patent prosecution history. After receiving a Final Office Action, the Plaintiff (then-applicant) filed a response. The PTO issued an Advisory Action acknowledging the response partially overcame rejections but did not lead to immediate allowance. In its final PTA calculation, the PTO assessed a 21-day period of "applicant delay" related to this response. Plaintiff administratively challenged this calculation via a Request for Recalculation and a Request for Reconsideration, both of which were denied by the PTO, leading to this civil action.

Case Timeline

Date Event
2008-03-12 '077 Patent Priority Date
2010-09-10 '056 Application (leading to '077 Patent) Filing Date
2013-04-17 PTO mails Final Office Action
2013-07-17 ITI files Response to Final Office Action
2013-07-26 PTO mails Advisory Action
2013-08-07 ITI files Response to Advisory Action
2013-08-20 PTO mails Notice of Allowance
2014-02-11 '077 Patent Issue Date
2015-09-10 PTO issues Redetermination of Patent Term Adjustment
2017-01-09 PTO issues Final Decision on PTA, denying reconsideration
2017-07-07 Complaint Filing Date

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

U.S. Patent No. 8,648,077 - "4-((6BR,10AS)-3-METHYL-2,3,6B,9,10,10A-HEXAHYDRO-1H-PYRIDO[3',4':4,5]PYRROLO [1,2,3-DE]QUINOXALIN-8(7H)-YL)-1-(4-FLUOROPHENYL)-1-BUTANONE TOLUENESULFONIC ACID ADDITION SALT AND SALT CRYSTALS"

The Invention Explained

  • Problem Addressed: The patent's background explains that certain therapeutic compounds, known as substituted heterocycle fused gamma-carbolines, exist as liquids in their "free base" form and are susceptible to degradation, which could make them undesirable for use as pharmaceutical products (U.S. Patent No. 8,648,077, col. 1:58-62). While creating a salt can improve stability, the prior art disclosed a large number of potential salts without identifying one with optimal physical properties for drug development ('077 Patent, col. 2:7-19).
  • The Patented Solution: The invention is the discovery that a specific toluenesulfonic acid (tosylate) salt of a particular gamma-carboline compound can be formed into a stable crystal ('077 Patent, Abstract). This specific crystalline salt form is described as being "especially stable and preferred for galenic and/or therapeutic use," addressing the problem of instability and making the compound suitable for pharmaceutical formulations ('077 Patent, col. 2:21-39).
  • Technical Importance: Identifying a stable, solid, crystalline form of an active pharmaceutical ingredient is a critical step in drug development, as it directly impacts the compound's purity, shelf-life, solubility, and bioavailability ('077 Patent, col. 2:9-19).

Key Claims at a Glance

  • This action does not allege infringement of any patent claims. However, to provide technical context, independent claim 1 is representative of the patented subject matter.
  • Independent Claim 1:
    • A toluenesulfonic acid addition salt crystal of a specific chemical compound: 4-((6bR, 10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3', 4':4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone.
    • The salt crystal exhibits an X-ray powder diffraction pattern with at least two peaks selected from a specific list of 2-theta values.
    • The diffraction data is collected on a diffractometer using a copper anode with a nickel filter.
  • The complaint does not reserve the right to assert any specific claims for infringement purposes, as this is not an infringement action.

III. The Accused Instrumentality

Product Identification

The challenged "instrumentality" is not a commercial product but rather the U.S. Patent and Trademark Office's Final Decision on the Petition for Patent Term Adjustment for the '077 Patent, issued on January 9, 2017 (Compl. ¶29).

Functionality and Market Context

  • The function of the PTO's Final Decision was to definitively set the Patent Term Adjustment for the '077 Patent at 264 days (Compl. ¶29). This calculation was based on the PTO's determination that the patent applicant had accrued 142 days of "Applicant's delay" during prosecution, which reduced the total term extension (Compl. ¶33).
  • The complaint challenges a specific component of this calculation: the assessment of a 21-day period of applicant delay stemming from the applicant's response to a Final Office Action (Compl. ¶¶34, 37). The commercial context is the value of market exclusivity for a patented pharmaceutical; the 21 days of patent term at issue are alleged to be a valuable property right (Compl. ¶71-73).

IV. Analysis of Disputed Agency Action

This action does not involve patent infringement; therefore, the following table summarizes the central administrative dispute in lieu of a claim chart.

No probative visual evidence provided in complaint.

Disputed Regulatory Issue Plaintiff's (ITI's) Stated Argument Defendant's (PTO's) Stated Rationale Complaint Citation
Whether ITI's July 17, 2013 response stopped the accrual of "applicant delay" under 37 C.F.R. § 1.704(b). The response was a "bona fide" and "reasonable effort" that advanced prosecution by overcoming rejections, as shown by the PTO's subsequent Advisory Action, and thus should have stopped the delay clock. The PTO's Final Decision stated the response "fails to constitute a proper reply" because it did not comply with 37 C.F.R. § 1.113 (placing the application in condition for allowance) and therefore was not treated as a "reply" for PTA purposes. ¶¶ 36, 42, 46
Whether the response contained an "omission" under 37 C.F.R. § 1.704(c)(7). The response did not contain an "omission" because the PTO was able to, and did, promptly act on its merits in an Advisory Action. Citing the MPEP, ITI argues this rule is for replies with defects that prevent substantive review, which was not the case here. As an alternative basis, the PTO's Final Decision found that even if it were a valid "reply," it had an "omission" because it "did not place the application in condition for allowance." This finding also supported the 21-day delay calculation. ¶¶ 39, 44, 46

Identified Points of Contention

  • Legal Question: What constitutes a "reply" sufficient to toll the "applicant delay" clock under 35 U.S.C. § 154(b)(2)(C)? Does the statute's "reasonable efforts" standard require a response to a final rejection to place the application in a condition for immediate allowance? (Compl. ¶41).
  • Regulatory Interpretation Question: Does a reply to a final rejection that advances prosecution but falls short of immediate allowance contain an "omission" under 37 C.F.R. § 1.704(c)(7)? The complaint suggests a conflict between the PTO's application of the rule and the PTO's own guidance in the MPEP regarding the rule's purpose (Compl. ¶¶44-46).

V. Key Regulatory Terms for Interpretation

The dispute centers on the interpretation of regulatory terms, not patent claim terms.

The Term: "reply" (within the meaning of 37 C.F.R. § 1.704(b))

  • Context and Importance: The determination of whether ITI's July 17, 2013 submission was a "reply" is critical, as filing a "reply" stops the applicant delay clock from running. The PTO found it was not a "reply" for PTA purposes, which is the primary basis for the disputed 21 days of delay (Compl. ¶36).
  • Evidence for a Broader Interpretation: The complaint argues that the controlling statute only requires "reasonable efforts to conclude prosecution" (Compl. ¶41). It further argues that a response which substantively addresses every rejection and advances prosecution—as evidenced by the PTO entering amendments and suggesting a path to allowance—meets this standard and must be considered a "reply" (Compl. ¶42, 46).
  • Evidence for a Narrower Interpretation: The complaint states the PTO's position was that the submission was not a "proper reply" because it failed to comply with the procedural requirements of 37 C.F.R. § 1.113 for responses after a final action (Compl. ¶36). This suggests a narrower interpretation where a "reply" must place the application in condition for allowance or appeal to stop the delay clock.

The Term: "omission" (within the meaning of 37 C.F.R. § 1.704(c)(7))

  • Context and Importance: The PTO used this as an alternative justification for the 21-day delay. Defining what constitutes an "omission" is central to determining if this alternative justification is valid (Compl. ¶39).
  • Evidence for a Broader Interpretation: The complaint alleges the PTO found an "omission" simply because the response "did not place the application in condition for allowance" (Compl. ¶39). This implies a broad interpretation where any failure to achieve immediate allowance, even if prosecution is advanced, constitutes an "omission."
  • Evidence for a Narrower Interpretation: The complaint cites the MPEP to argue that this provision is intended for situations where a reply has a defect that "requires the Office to issue an action... before the initial reply... can be treated on its merits" (Compl. ¶44). Because the PTO promptly issued an Advisory Action on the merits of ITI's response, ITI argues there could not have been an "omission" as the term is meant in the regulations (Compl. ¶46).

VI. Other Allegations

  • Violation of the Administrative Procedure Act (Count 2): The complaint alleges that the PTO's Final Decision on PTA is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law" (Compl. ¶64). The basis for this allegation is that the PTO's interpretation of its own regulations is inconsistent with the plain language of the PTA statute and contravenes the PTO's own published guidance in the MPEP (Compl. ¶¶63-65).
  • Violation of the Fifth Amendment (Count 3): The complaint alleges that the patent term is a property right and that the PTO's improper calculation amounts to a permanent deprivation of that property without due process and a taking for public use without just compensation, in violation of the Fifth Amendment (Compl. ¶¶70-73).

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

  • A central issue will be one of statutory interpretation: to satisfy the "reasonable efforts" requirement of 35 U.S.C. § 154(b)(2)(C) and stop the accrual of applicant delay, must an applicant's response to a final rejection place the application in condition for immediate allowance, or does a bona fide response that substantively advances prosecution suffice?
  • A key question of regulatory scope will be the definition of an "omission" under 37 C.F.R. § 1.704(c)(7). Does the term encompass any failure to secure immediate allowance, as the PTO allegedly determined, or is it limited to procedural deficiencies that prevent the PTO from substantively reviewing a response on its merits, as the complaint argues?
  • Finally, the case raises the question of agency deference: to what extent must the court defer to the PTO's interpretation of its own PTA regulations, particularly where that interpretation is alleged to be inconsistent with both the governing statute and the agency's own procedural manual (the MPEP)?