1:17-cv-01153
Mayo Foundation for Medical Education Research v. Hon Joseph Matal
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Mayo Foundation for Medical Education and Research (Minnesota)
- Defendant: Hon. Joseph Matal, Performing the Functions and Duties of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office
- Plaintiff’s Counsel: Fish & Richardson P.C.
- Case Identification: 1:17-cv-01153, E.D. Va., 10/13/2017
- 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 patent, seeking an increase from the granted 604 days to a requested 723 days based on a differing interpretation of statutory delay provisions.
- Technical Context: The patent-in-suit relates to B7-H1 antibodies and their use in co-stimulating T-cell immune responses, a foundational area of modern immunotherapy.
- Key Procedural History: The dispute centers on the calculation of "B-delay," which compensates for PTO examination pendency beyond three years. The patent application was subject to both a Request for Continued Examination (RCE) filed by the applicant and a subsequent interference proceeding declared by the PTO. The core issue is whether the time consumed by the interference proceeding should be excluded from the patent term adjustment calculation as "time consumed by continued examination requested by the applicant."
Case Timeline
| Date | Event |
|---|---|
| 1999-11-30 | U.S. Patent No. 8,981,063 Earliest Priority Date |
| 2009-04-09 | Application for '063 Patent Filed |
| 2011-09-14 | Request for Continued Examination (RCE) Filed |
| 2012-02-09 | Interference Proceeding Declared by PTO |
| 2014-02-19 | Board of Patent Appeals and Interferences Issues Judgment |
| 2014-04-23 | Interference Proceeding Terminated |
| 2014-11-03 | Notice of Allowance Issued |
| 2015-03-17 | U.S. Patent No. 8,981,063 Issues |
| 2015-09-17 | Plaintiff Files Application for Patent Term Adjustment |
| 2016-05-26 | PTO Issues First Decision on Redetermination of PTA |
| 2016-10-26 | Plaintiff Files Request for Reconsideration of PTA |
| 2017-07-12 | PTO Issues Final Decision on Request for Reconsideration |
| 2017-10-13 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,981,063 - "B7-H1 Antibodies"
- Issued: March 17, 2015
The Invention Explained
- Problem Addressed: The patent describes the need to regulate mammalian T lymphocyte responses, which recognize antigenic peptides on the surface of antigen-presenting cells (APCs) and are central to the immune system's function ('063 Patent, col. 1:31-41).
- The Patented Solution: The invention provides novel polypeptides, designated B7-H1, that can "co-stimulate" a T-cell, meaning they enhance the T-cell's response upon activation ('063 Patent, Abstract; col. 3:41-46). The patent discloses the human and mouse versions of the B7-H1 protein, the DNA molecules that encode them, and antibodies that bind to them, providing tools to modulate T-cell activity ('063 Patent, col. 2:42-65).
- Technical Importance: The ability to modulate T-cell co-stimulation is foundational to immunotherapy, offering a pathway to either enhance immune responses against targets like cancer cells or suppress responses in the context of autoimmune diseases ('063 Patent, col. 13:17-36).
Key Claims at a Glance
- While no claims are asserted for infringement, the patent's value, and thus the value of its term, is defined by its claims. The complaint concerns the term of the patent as a whole (Compl. ¶1).
- Representative Independent Claim 1 includes the following essential elements:
- An isolated antibody that binds specifically to a B7-H1 polypeptide, where the polypeptide comprises:
- amino acids having the sequence set forth in SEQ ID NO:1; or
- amino acids that are encoded by a polynucleotide comprising nucleotides having the sequence set forth in SEQ ID NO:2.
III. The Accused Instrumentality
This section is not applicable, as the lawsuit challenges a decision by a government agency regarding patent term calculation, not a product or service.
IV. Analysis of Infringement Allegations
This section is not applicable, as the complaint does not allege patent infringement. No probative visual evidence provided in complaint.
V. Key Claim Terms for Construction
This section is not applicable, as the dispute does not involve claim construction.
VI. Other Allegations
The complaint alleges that the PTO's final determination of a 604-day PTA is "arbitrary, capricious, an abuse of discretion, clear error or otherwise not in accordance with law" (Compl. ¶50). The core of this allegation is a disagreement over the calculation of "B-delay" under 35 U.S.C. § 154(b).
The parties agree on the total pendency (2169 days) and the three-year statutory deadline (1097 days) (Compl. ¶35). The dispute focuses on the amount of time that should be excluded from B-delay calculation. The PTO determined that 1147 days, the entire period from the filing of a Request for Continued Examination (RCE) to the Notice of Allowance, constituted "time consumed by continued examination requested by the applicant" and was therefore excludable (Compl. ¶33, ¶35).
Plaintiff alleges this is an incorrect interpretation of the statute. It argues that the "continued examination requested by the applicant" concluded when the PTO declared an interference proceeding (Compl. ¶36, ¶38, ¶40). This period, from the RCE filing to the interference declaration, was 148 days (Compl. ¶38). Plaintiff further argues that the subsequent 805-day interference proceeding is separately excludable under a different statutory provision and that the two periods cannot overlap for the purpose of B-delay calculation (Compl. ¶36, ¶39, ¶41). Therefore, Plaintiff contends that the excludable "time consumed by continued examination" was only 148 days, not the 1147 days calculated by the PTO, which would result in 119 days of B-delay and a total PTA of 723 days (Compl. ¶41, ¶42).
VII. Analyst’s Conclusion: Key Questions for the Case
This case presents a focused question of statutory interpretation under the Patent Term Adjustment framework, rather than a typical infringement dispute. The outcome will likely depend on the court's resolution of the following key issues:
A primary issue is one of statutory interpretation: For the purpose of calculating B-delay, when does the excludable period of "time consumed by continued examination requested by the applicant" under 35 U.S.C. § 154(b)(1)(B)(i) end if the PTO suspends examination to declare an interference? Does it end, as Plaintiff argues, upon the declaration of interference, or does it continue through the interference and any subsequent prosecution until allowance, as the PTO determined?
A related procedural question is one of causation and characterization of delay: Was the PTO's sua sponte decision to reopen prosecution after the interference was terminated a part of the "continued examination requested by the applicant," or was it a new period of PTO-initiated delay that should not be excluded from the B-delay calculation?