DCT

1:18-cv-00147

Biogen Intl Neuroscience GmbH v. Andrei Iancu

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:18-cv-00147, E.D. Va., 02/09/2018
  • 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).
  • Core Dispute: Plaintiff alleges the U.S. Patent and Trademark Office (USPTO) improperly calculated the Patent Term Adjustment (PTA) for its patent, and seeks a judicial order to correct the patent term from zero additional days to 23 days.
  • Technical Context: The patent-in-suit relates to human anti-tau antibodies, a class of biotherapeutics developed for the treatment of neurodegenerative diseases known as tauopathies, including Alzheimer's disease.
  • Key Procedural History: The dispute arises from the prosecution of the patent application. Following a Notice of Allowance, the USPTO requested corrected drawings. Plaintiff submitted them on the same day. The USPTO ultimately assessed 43 days of "applicant delay" for this submission, running from the submission date to the patent's issue date, which resulted in a final PTA of zero days. Plaintiff administratively challenged this calculation, arguing the delay should be one day, but the USPTO maintained its position, leading to this civil action.

Case Timeline

Date Event
2012-12-21 U.S. Provisional Application Priority Date for '484 Patent
2013-12-20 PCT Application Filing Date
2015-06-19 U.S. National Stage Application Filing Date
2017-01-31 Notice of Allowance mailed by USPTO
2017-02-07 USPTO mailed Notice to File Corrected Application Papers
2017-02-07 Plaintiff submitted replacement drawings
2017-03-21 '484 Patent Issued
2017-05-18 Plaintiff filed Application for Patent Term Adjustment
2017-08-16 USPTO issued Decision denying PTA reconsideration
2017-10-10 Plaintiff filed Petition to Invoke Supervisory Authority
2017-12-26 USPTO issued final Letter denying the requested PTA
2018-02-09 Complaint Filed

II. Technology and Patent-in-Suit Analysis

U.S. Patent No. 9,598,484 - Human Anti-Tau Antibodies

The Invention Explained

  • Problem Addressed: The patent addresses the accumulation of pathologically-modified tau protein, which is a central feature of numerous neurodegenerative disorders, including Alzheimer's disease, progressive supranuclear palsy, and others (collectively "tauopathies") ('484 Patent, col. 1:43-57). Existing therapeutic strategies had limitations, creating a need for new treatments.
  • The Patented Solution: The invention provides novel human antibodies, and the genetic material (polynucleotides) that encode them, which are specifically designed to bind to pathological forms of the human tau protein ('484 Patent, col. 2:43-52). By selectively targeting these tau species, the antibodies are intended to be used in pharmaceutical compositions and methods for diagnosing and treating tauopathies ('484 Patent, Abstract). The specificity is derived from identifying and targeting novel epitopes on the tau protein that are associated with its pathological, aggregated forms ('484 Patent, col. 2:52-60).
  • Technical Importance: Developing human or humanized antibodies with high specificity for pathological protein aggregates is a key goal in biotherapeutics, as it can potentially lead to treatments with greater efficacy and fewer side effects compared to less targeted approaches.

Key Claims at a Glance

  • The complaint does not assert specific claims against an infringer, as this is a suit against the USPTO. To provide technical context, representative independent claims include Claim 1 and Claim 89.
  • Independent Claim 1 (Polynucleotide):
    • A polynucleotide encoding an immunoglobulin heavy chain or a fragment thereof comprising a VH with specific CDRs, or a light chain or fragment thereof comprising a VL with specific CDRs;
    • Wherein the VH, when paired with a VL, binds to tau.
  • Independent Claim 89 (Method of Treatment):
    • A method of treating a neurodegenerative tauopathy in a human subject in need thereof;
    • Comprising administering to the human subject a therapeutically effective amount of an anti-tau antibody or tau-binding fragment thereof;
    • Wherein the antibody comprises a heavy chain variable region (VH) and a light chain variable region (VL) with specific, enumerated complementarity determining regions (CDRs).

III. The Challenged Agency Action

  • Action Identification: The challenged action is the USPTO's final determination that U.S. Patent No. 9,598,484 is entitled to a Patent Term Adjustment of zero days (Compl. ¶¶ 26, 30).
  • Functionality and Context: Under 35 U.S.C. § 154, the term of a patent may be adjusted upward to compensate for certain administrative delays by the USPTO. This adjustment, however, is reduced by any period of "applicant delay" (Compl. ¶13). The USPTO calculated that the patentee had accrued 24 days of "A-delay" (a type of USPTO delay) but that this was entirely offset by 43 days of applicant delay, resulting in a net PTA of zero (Compl. ¶¶ 31, 35, 43). The applicant delay was assessed for the period between the filing of corrected drawings after allowance (February 7, 2017) and the date the patent issued (March 21, 2017) (Compl. ¶34).

IV. Analysis of the PTA Calculation Dispute

This action centers on the competing interpretations of "applicant delay" under the governing statute and regulations. The complaint provides a screenshot from the USPTO's PAIR system showing a "Workflow - Drawings Finished" entry dated February 7, 2017, the same day the corrected drawings were filed (Compl. ¶24, Ex. C). Plaintiff leverages this to argue that any delay attributable to its submission was minimal.

Calculation Component Plaintiff's (Biogen) Position Defendant's (USPTO) Position Complaint Citation
USPTO A-Delay 24 days 24 days ¶31
Applicant Delay 1 day 43 days ¶¶34, 36
Resulting PTA 23 days 0 days ¶¶38, 43
  • Identified Points of Contention:
    • Statutory/Regulatory Question: The core dispute concerns the proper calculation of applicant delay under 37 C.F.R. § 1.704(c)(10). This regulation states that the delay period for a submission after a notice of allowance ends on the "mailing date of the Office action or notice in response to the...paper." The complaint alleges the USPTO never mailed such a notice (Compl. ¶25, ¶32). This raises the question of how the delay period should be calculated in the absence of the event that the regulation specifies should end it.
    • Factual/Equitable Question: The complaint alleges that the USPTO arbitrarily chose the patent issue date as the end of the delay period (Compl. ¶33). It also alleges that the USPTO reviewed and accepted the corrected drawings on the same day they were submitted (Compl. ¶24). This raises the question of whether assessing a 43-day delay is a reasonable or an arbitrary application of the statute when the agency's own records suggest the applicant's submission was processed and resolved in a single day.

V. Key Statutory/Regulatory Provisions for Interpretation

  • The Provision: 37 C.F.R. § 1.704(c)(10)
  • Context and Importance: The entire case hinges on the interpretation of this regulation, which defines what constitutes applicant delay for submitting "an amendment... or other paper after a notice of allowance has been given or mailed." The regulation reduces the PTA by the number of days from when the paper was filed until the "mailing date of the Office action or notice in response to the... paper" (Compl. ¶15). The outcome of the case will depend on how the court applies this rule when the USPTO allegedly fails to mail the "notice in response."
  • Intrinsic Evidence for Interpretation:
    • Evidence for Plaintiff's Interpretation (Narrower Delay): The plain language of the regulation ties the end of the delay period to a specific event: the mailing of a responsive notice. The complaint alleges this event never occurred (Compl. ¶25). Plaintiff argues that using the patent issue date as a substitute endpoint is not supported by the regulation and results in an arbitrary penalty, especially when the submission was accepted on the day it was filed (Compl. ¶24, ¶36).
    • Evidence for Defendant's Interpretation (Broader Delay): The USPTO's position, as described in the complaint, appears to be that in the absence of a specific notice, the delay period continues to run until the next official communication, which was the patent's issuance (Compl. ¶33). The agency may argue this is a necessary gap-filling interpretation to ensure that any processing time consumed by a post-allowance submission, however long, is properly counted as applicant delay.

VI. Legal Standard for Review

  • Administrative Procedure Act (APA): The complaint is brought pursuant to 35 U.S.C. § 154(b)(4)(A), which provides for a civil action to challenge a PTA determination, and the Administrative Procedure Act (Compl. ¶2).
  • Arbitrary and Capricious Standard: Plaintiff alleges that the USPTO's determination of zero days of PTA is "arbitrary, capricious, an abuse of discretion, clear error or otherwise not in accordance with law and in excess of statutory jurisdiction, authority, or limitations, or short of statutory right" (Compl. ¶46). This language directly invokes the standard of review for agency actions under the APA, and the court will analyze the USPTO's decision through this deferential but not toothless lens.

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

The resolution of this case appears to depend on a narrow but significant question of administrative and patent law. The key questions for the court are:

  • A primary issue will be one of regulatory interpretation: When an applicant submits a paper after allowance and the USPTO fails to mail a "notice in response" as contemplated by 37 C.F.R. § 1.704(c)(10), what event properly concludes the period of "applicant delay"?
  • A related question is one of administrative reasonableness: Was the USPTO's decision to use the patent issue date as the end-point for the applicant delay period—thereby assessing 43 days of delay for a submission it allegedly accepted in one day—an "arbitrary and capricious" agency action under the APA?