DCT

1:23-cv-01105

H Lundbeck As v. United States Patent Trademark Office

Log In

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:23-cv-01105, E.D. Va., 08/18/2023
  • Venue Allegations: Venue is alleged in the U.S. District Court for the Eastern District of Virginia pursuant to 35 U.S.C. § 154(b)(4)(A), which provides for exclusive remedy by civil action against the Director of the USPTO in this district for patent term adjustment disputes.
  • Core Dispute: Plaintiff challenges the U.S. Patent and Trademark Office's calculation of zero days of Patent Term Adjustment (PTA) for its patent, arguing that the PTO improperly attributed 141 days of "applicant delay" for a formality defect that the PTO itself did not identify until months after the period for correction had allegedly begun.
  • Technical Context: The patent-in-suit concerns pharmaceutical compounds known as MAGL inhibitors, which are developed for the treatment of pain and other neurological disorders.
  • Key Procedural History: The dispute arises from the prosecution of the application leading to the patent-in-suit. The USPTO issued a pre-examination notice nearly ten months after the application's commencement date, citing "shading" in certain tables as a formality defect. Based on this defect, the PTO later determined that the applicant had failed to put the application in a condition for examination within the prescribed eight-month period, resulting in a reduction of the patent term adjustment by 141 days. Plaintiff argues this calculation is improper under the governing statute and Federal Circuit precedent, specifically Supernus Pharms., Inc. v. Iancu.

Case Timeline

Date Event
2016-11-16 '822 Patent Priority Date
2019-05-16 National stage application commencement date
2020-01-17 Eight-month deadline to provide application "in condition for examination" passes
2020-03-11 PTO sends pre-examination notice regarding "shading" in tables
2020-06-05 Plaintiff responds, removing the table shading
2020-06-12 PTO issues notice of acceptance of the application
2020-07-16 Fourteen-month deadline for PTO to issue first action passes
2020-11-27 PTO issues first substantive office action
2021-03-10 PTO issues notice of allowance
2021-07-13 U.S. Patent No. 11,059,822 issues
2021-08-25 Plaintiff requests PTA of 91 days
2022-02-07 PTO re-determines PTA to be 58 days
2022-04-13 PTO issues second re-determination, concluding PTA is 0 days
2022-11-09 Plaintiff files second request to correct PTA to 91 days
2023-02-24 PTO issues final decision denying Plaintiff's request for reconsideration
2023-08-18 Complaint filed

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

This action is a challenge to the USPTO’s calculation of Patent Term Adjustment and does not contain allegations of patent infringement against an accused product. The following analysis of the patent’s technology and claims is provided for context.

U.S. Patent No. 11,059,822 - "MAGL INHIBITORS"

The Invention Explained

  • Problem Addressed: The patent describes Monoacylglycerol lipase (MAGL) as an enzyme that hydrolyzes endocannabinoids, which are lipids involved in the nervous system (’822 Patent, col. 1:12-17). The proper regulation of these endocannabinoids is implicated in various physiological processes, including pain sensation.
  • The Patented Solution: The invention provides specific spirocyclic and fused bicyclic carbamate compounds that act as modulators of MAGL (’822 Patent, Abstract; col. 1:18-24). By inhibiting MAGL activity, these compounds are intended to be useful as medicinal agents for treating conditions such as pain and various neurological disorders (’822 Patent, col. 7:29-37). The patent discloses numerous chemical structures representing these compounds (’822 Patent, col. 4:21-6:64).
  • Technical Importance: The development of selective MAGL inhibitors represents a therapeutic strategy for managing pain and neuroinflammation by modulating the endocannabinoid system without the direct psychoactive effects associated with cannabis-based medicines (Compl. ¶4).

Key Claims at a Glance

  • The complaint asserts that the USPTO's PTA calculation is erroneous but does not assert any patent claims for infringement. Independent claim 1 is representative of the patented subject matter:
  • Independent Claim 1:
    • A compound having the structure of Formula (I), or a pharmaceutically acceptable salt thereof.
    • The formula specifies a core chemical structure with multiple variable substituents (R¹, R², R³, R⁴, R⁵, R⁶, X, Y, m, n, p, q, t) that define the scope of the claimed chemical compounds (’822 Patent, col. 17:58-18:65).

III. The Accused Instrumentality

This section is not applicable as the complaint does not allege infringement by a product, method, or service. The action challenges an administrative determination by the USPTO.

IV. Analysis of Infringement Allegations

This section is not applicable as the complaint does not contain allegations of patent infringement.

V. Key Claim Terms for Construction

This section is not applicable as the dispute does not involve claim construction for the purposes of an infringement analysis.

VI. Other Allegations

The complaint brings three counts against the Defendant related to the calculation of Patent Term Adjustment.

  • Count One (Patent Term Adjustment Under 35 U.S.C. § 154): Plaintiff alleges that the PTO failed to comply with 35 U.S.C. § 154(b)(2)(C) in reducing the patent's term adjustment (Compl. ¶55). The core of this count is the PTO's assessment of 141 days of "Applicant Delay" for failure to place the application in a condition for examination within eight months of its commencement date (Compl. ¶33). Plaintiff argues this delay was attributable to the PTO, as the PTO did not identify the alleged formality defect—"shading" in certain tables—until nearly ten months after the commencement date, by which time the eight-month period had already passed (Compl. ¶36, ¶48). The complaint includes a screenshot of a "shaded" table to illustrate the alleged defect, which Plaintiff argues provided sufficient clarity for reproduction (Compl. ¶22, Figure 1). Plaintiff contends that under the reasoning of Supernus Pharms., Inc. v. Iancu, the PTO cannot attribute delay to an applicant for a period during which the applicant could not have taken any action to advance prosecution (Compl. ¶39).

  • Count Two (Declaratory Judgment Under the Administrative Procedures Act): Plaintiff alleges that the PTO's application of its regulations, particularly 37 C.F.R. § 1.704(c)(13), is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law (Compl. ¶62). The complaint argues that the PTO's action produces an "unfair and irrational result" by depriving Lundbeck of patent term due to the PTO's own delay in processing the application (Compl. ¶62). To illustrate this point, the complaint provides a timeline graphic showing that even a hypothetical immediate response by Lundbeck would have resulted in the PTO assessing 55 days of applicant delay (Compl. p.15, Figure 10).

  • Count Three (Violation of the Fifth Amendment): Plaintiff alleges that its patent is a private property right and that the Defendant's "purposeful and deliberate diminution of the patent term" constitutes a taking of property without just compensation, in violation of the Fifth Amendment (Compl. ¶70, ¶73).

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

This case presents a dispute over the administrative rules governing patent prosecution timelines rather than a traditional infringement conflict. The outcome will likely depend on the court’s interpretation of statutory and regulatory duties.

  • A central issue will be one of statutory interpretation: can the USPTO, consistent with 35 U.S.C. § 154(b)(2)(C) and the Federal Circuit's holding in Supernus, assess "Applicant Delay" against a patentee for a period before the PTO provided any notice of an alleged application defect?
  • A key administrative law question will be whether the PTO's application of 37 C.F.R. § 1.704(c)(13) to these facts was arbitrary and capricious, particularly in light of the PTO's own delay in identifying the formality issue that triggered the reduction in patent term.
  • A predicate factual question may be whether the "shading" in the as-filed tables constituted a legitimate basis for the PTO's initial formalities rejection, or if the application was, in fact, in a condition for examination from its commencement date.