DCT

1:24-cv-02344

AbbVie Inc v. Brent

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-02344, E.D. Va., 12/23/2024
  • Venue Allegations: Venue is asserted under 35 U.S.C. § 154(b)(4)(A), which provides for civil actions against the Director of the USPTO to be brought in the U.S. District Court for the Eastern District of Virginia.
  • Core Dispute: Plaintiff alleges the U.S. Patent and Trademark Office (PTO) incorrectly calculated the Patent Term Adjustment (PTA) for its '599' patent, and seeks a judicial order to correct the term by adding 129 days that it argues were improperly characterized as "applicant delay."
  • Technical Context: The patent relates to pharmaceutical formulations of the anti-cancer drug Venetoclax, specifically using a melt-extrusion process to create an amorphous solid dispersion that improves the drug's oral bioavailability.
  • Key Procedural History: The dispute arises from a sequence of events during patent prosecution. The PTO issued a "Notice of Non-Responsive Amendment," which the Plaintiff alleges was improper and which the PTO later withdrew. To avoid potential abandonment of its application while a petition to withdraw the notice was pending, Plaintiff filed a "precautionary" supplemental response. The PTO subsequently treated the time between Plaintiff's initial response and its precautionary response as applicant delay, reducing the patent term by 129 days. Plaintiff's administrative requests to reverse this calculation were denied, leading to this lawsuit. The complaint invokes recent case law, including Loper Bright Enterprises v. Raimondo, to challenge the level of deference owed to the PTO's interpretation of the PTA statute.

Case Timeline

Date Event
2010-10-07 '599 Patent Earliest Priority Date
2014-07-24 '435 Application (leading to '599 patent) Filing Date
2015-06-19 PTO issues Non-final Office Action with Restriction Requirement
2019-11-08 AbbVie files Amendment in response to an Office Action
2020-02-12 PTO issues Notice of Non-Responsive Amendment
2020-03-16 AbbVie files Petition to Withdraw Notice and a "precautionary" Amendment/Response
2020-03-19 PTO grants AbbVie's Petition to Withdraw the Notice
2022-06-28 U.S. Patent No. 11,369,599 Issues
2022-07-05 AbbVie files Application for Patent Term Adjustment
2024-02-01 PTO redetermines PTA, calculating a 129-day applicant delay
2024-07-19 PTO issues final decision denying AbbVie's request for reconsideration
2024-12-23 Complaint Filing Date

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

  • Patent Identification: U.S. Patent No. 11,369,599, "MELT-EXTRUDED SOLID DISPERSIONS CONTAINING AN APOPTOSIS-INDUCING AGENT," issued June 28, 2022.

The Invention Explained

  • Problem Addressed: The patent addresses the challenge that many promising therapeutic compounds, particularly those that inhibit Bcl-2 proteins to treat cancer, have poor aqueous solubility ('599 Patent, col. 3:19-24). This low solubility makes it difficult to formulate an oral drug (e.g., a tablet) that can be absorbed effectively by the body to reach therapeutic concentrations ('599 Patent, col. 3:32-38).
  • The Patented Solution: The invention uses a process called melt extrusion to create a "solid dispersion" of the drug ('599 Patent, Abstract). In this process, the active pharmaceutical ingredient (API) is combined with a water-soluble polymer and heated until it melts, then extruded and cooled ('599 Patent, Fig. 1; col. 6:52-67). This traps the API in an "essentially non-crystalline or amorphous" state within the polymer matrix, which enhances its dissolution and bioavailability when taken orally ('599 Patent, Abstract; col. 7:6-14).
  • Technical Importance: This formulation technology enables the development of an effective and convenient oral tablet for a potent anti-cancer compound, Venetoclax, which otherwise would face significant delivery challenges (Compl. ¶2).

Key Claims at a Glance

  • The complaint does not assert specific claims for infringement, as the dispute is over patent term. The prosecution history discussion centers on amendments to what became issued Claim 1.
  • Issued Independent Claim 1 recites:
    • An orally deliverable pharmaceutical tablet comprising a solid dispersion.
    • The solid dispersion comprises a specific parent compound (Venetoclax).
    • The parent compound is in an "essentially non-crystalline or amorphous form."
    • The solid dispersion also comprises "from 7% by weight to 95% by weight of at least one pharmaceutically acceptable water-soluble polymeric carrier."

III. The Accused Instrumentality

Product Identification

  • The accused "instrumentality" is not a commercial product but rather the final agency action of the USPTO, specifically the Director's decision of July 19, 2024, denying Plaintiff's request for reconsideration and maintaining a Patent Term Adjustment of 439 days for the '599 patent (Compl. ¶¶ 1, 40).

Functionality and Market Context

  • The challenged action is the PTO's calculation of "applicant delay" under 35 U.S.C. § 154(b)(2)(C) and its implementing regulation, 37 C.F.R. § 1.704(c)(8) (Compl. ¶¶ 4, 43, 47). The PTO determined that the 129-day period between AbbVie's filing of an amendment on November 8, 2019, and a subsequent "precautionary" amendment on March 16, 2020, constituted a failure by the applicant "to engage in reasonable efforts to conclude prosecution" (Compl. ¶¶ 38, 45).
  • The complaint alleges this calculation is improper because the March 16, 2020 filing was not a source of delay but a necessary procedural safeguard taken only after the PTO issued an improper "Notice of Non-Responsive Amendment" that placed the application at risk of abandonment (Compl. ¶¶ 32-33, 50). The commercial context is significant, as the 129-day reduction in patent term would shorten the period of market exclusivity for Venclexta®, which the complaint describes as a "lifesaving anti-cancer drug" (Compl. ¶2).

IV. Analysis of Infringement Allegations

The complaint does not allege patent infringement. Instead, it alleges that the Defendant, the Acting Director of the USPTO, has incorrectly applied U.S. patent law and administrative regulations in calculating the term of the '599 patent. The core of the dispute is the legal characterization of a 129-day period during prosecution.

The Plaintiff argues that this period should not be counted as "applicant delay" that reduces the patent term (Compl. ¶3). The Plaintiff's primary argument is that its actions during this period were reasonable and necessary efforts to conclude prosecution, particularly because they were undertaken to mitigate the effects of an alleged PTO error (Compl. ¶50). Specifically, the Plaintiff filed a petition to have the PTO withdraw an allegedly improper "Notice of Non-Responsive Amendment" and, while that petition was pending, filed a "precautionary" response to prevent the application from being abandoned (Compl. ¶¶ 32, 33). The PTO ultimately granted the petition and withdrew its notice, which the Plaintiff argues is a concession that the PTO's action was improper (Compl. ¶34, 69).

Conversely, the PTO's decision was based on its interpretation of 37 C.F.R. § 1.704(c)(8), which states that the submission of a "supplemental reply or other paper" after an initial reply has been filed can constitute applicant delay (Compl. ¶47). The PTO's position appears to be that the filing of the March 16, 2020 amendment triggered this provision, regardless of the applicant's motivation for the filing (Compl. ¶38).

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Statutory Interpretation Question: Does an applicant's filing of a "precautionary" response to avoid abandonment, while simultaneously petitioning the PTO to correct its own error, constitute a "fail[ure] to engage in reasonable efforts to conclude prosecution" under the governing statute, 35 U.S.C. § 154(b)(2)(C)(i)? (Compl. ¶¶ 50, 53).
    • Administrative Law Question: Was the PTO's application of its regulation, 37 C.F.R. § 1.704(c)(8), to penalize the applicant for a procedural step necessitated by a later-withdrawn PTO action, "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law" under the Administrative Procedure Act? (Compl. ¶¶ 51, 69).
    • Regulatory Authority Question: Does the PTO's regulation, as applied here, exceed the authority granted by Congress, which limits PTA reduction to periods when the applicant failed to engage in reasonable efforts? (Compl. ¶¶ 79-80).

V. Key Claim Terms for Construction

The complaint does not raise any issues of claim construction. The dispute is centered on the interpretation and application of the statutes and regulations governing Patent Term Adjustment.

VI. Other Allegations

The complaint does not contain allegations of indirect or willful infringement. Its core allegations are presented in three distinct legal counts against the Director of the USPTO:

  • Count 1: Action for Adjustment of Patent Term (35 U.S.C. § 154(b)): This count asserts a direct statutory right to relief, arguing that the PTO failed to comply with 35 U.S.C. § 154(b)(2)(C) by incorrectly determining the reduction period (Compl. ¶¶ 59-66). It claims that Plaintiff's actions were reasonable efforts and that the PTO's contrary finding deprived Plaintiff of 129 days of patent term to which it is entitled (Compl. ¶¶ 64-65).
  • Count 2: Final Agency Action in Violation of 5 U.S.C. § 706(2)(A): This count brings a claim under the Administrative Procedure Act (APA), alleging the PTO’s decision was "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law" (Compl. ¶¶ 67-76). The basis for this claim is that the PTO's decision penalizes the Plaintiff for taking necessary steps to address an "unwarranted" PTO action that the PTO itself later conceded was improper and withdrew (Compl. ¶69).
  • Count 3: Final Agency Action in Violation of 5 U.S.C. § 706(2)(C): This count alleges that the PTO's regulation, 37 C.F.R. § 1.704(c)(8), as promulgated and interpreted by the PTO, is "in excess of statutory jurisdiction, authority, or limitations" (Compl. ¶79). It argues that Congress did not authorize the PTO to create regulations that reduce patent term for periods where the applicant was acting reasonably to advance prosecution in the face of PTO-created obstacles (Compl. ¶80). This count also explicitly raises the Supreme Court's decision in Loper Bright, suggesting prior court decisions deferring to the PTO's rulemaking authority may no longer be appropriate (Compl. ¶81).

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

This case presents a focused legal challenge to the PTO's calculation of patent term, moving beyond typical infringement facts into the realm of administrative and statutory law. The outcome will likely depend on the court's resolution of the following questions:

  • A core issue will be one of statutory interpretation: Can an applicant’s "precautionary" filing, made solely to preserve an application against a potential abandonment caused by a PTO error that the PTO later concedes, be considered a "failure to engage in reasonable efforts to conclude prosecution" under 35 U.S.C. § 154(b)?
  • A central administrative law question will be whether the PTO’s application of its own regulation (37 C.F.R. § 1.704(c)(8)) to impose a penalty for applicant conduct that was directly precipitated by the agency's own mistake constitutes an "arbitrary and capricious" action under the APA.
  • Finally, the case will test the boundaries of judicial deference: To what extent, if any, will the court defer to the PTO's interpretation of its statutory authority to define "applicant delay," particularly in light of the Plaintiff's invocation of the Supreme Court's recent decision in Loper Bright Enterprises v. Raimondo which curtailed such deference?