DCT

1:10-cv-00164

Novartis AG v. Kappos

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:10-cv-00164, D.D.C., 01/29/2010
  • Venue Allegations: Venue is alleged to be proper in the U.S. District Court for the District of Columbia pursuant to 35 U.S.C. § 154(b)(4)(A), which provides for civil action against the Director of the USPTO in this district.
  • Core Dispute: Plaintiff seeks judicial review of a Patent Term Adjustment (PTA) determination made by the USPTO, alleging the agency miscalculated the length of the adjustment and requesting the court to order a correction from 640 days to 1,257 days.
  • Technical Context: The patent at issue relates to coumarin-based chemical compounds used as biomarkers for labeling pathological structures, such as amyloid plaques associated with Alzheimer's disease.
  • Key Procedural History: Plaintiff alleges that following the patent's issuance, it filed a Request for Reconsideration of the PTA calculation, which was dismissed by the USPTO. A Second Request for Reconsideration was pending before the PTO at the time the complaint was filed. The dispute centers on the statutory interpretation of how overlapping periods of USPTO-caused delay should be calculated.

Case Timeline

Date Event
2002-03-06 Earliest Priority Date ('337 Patent)
2004-09-02 Patent Application Filed ('381 Application)
2009-08-04 U.S. Patent No. 7,569,337 Issued
2009-10-02 Plaintiff filed first Request for Reconsideration of PTA
2009-12-22 PTO dismissed the first Request for Reconsideration
2010-01-29 Plaintiff filed Second Request for Reconsideration of PTA
2010-01-29 Complaint Filed

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

U.S. Patent No. 7,569,337 - Coumarines Useful as Biomarkers

  • Patent Identification: U.S. Patent No. 7,569,337, Coumarines Useful as Biomarkers, issued August 4, 2009.

The Invention Explained

  • Problem Addressed: The patent addresses the need for effective diagnostic tools for neurodegenerative conditions like Alzheimer's disease. A key challenge is the in-vivo (in a living organism) detection and monitoring of pathological structures, such as amyloid plaques and neurofibrillary tangles in the brain, to enable early diagnosis and track treatment efficacy (’337 Patent, col. 3:21-31).
  • The Patented Solution: The invention provides a class of novel coumarin derivative compounds. These compounds are designed to act as markers that can cross the blood-brain barrier and selectively bind to these pathological structures, allowing them to be visualized using imaging techniques like Positron Emission Tomography (PET) or Single Photon Emission Computed Tomography (SPECT) (’337 Patent, col. 3:18-27, col. 3:56-62). The core of the invention is the specific chemical structure of these compounds, which gives them their valuable properties as biomarkers (’337 Patent, col. 1:11-14; Abstract).
  • Technical Importance: The development of non-invasive biomarkers capable of imaging brain pathology represents a significant step in understanding and managing Alzheimer's disease, moving beyond diagnosis based solely on clinical symptoms (’337 Patent, col. 3:32-37).

Key Claims at a Glance

The complaint does not assert any specific claims for infringement, as the action is a challenge to the USPTO's calculation of patent term adjustment under 35 U.S.C. § 154 and not an infringement suit.

III. The Accused Instrumentality

This section is not applicable, as the complaint does not allege infringement by a product or service. The subject of the dispute is the administrative action of the USPTO in calculating the patent term adjustment.

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.

VI. Other Allegations

The complaint does not contain allegations of indirect or willful infringement. Instead, its "First Claim for Relief" centers on the administrative law ground that the USPTO's PTA determination was incorrect as a matter of statutory interpretation (Compl. ¶¶13-25).

  • Statutory Basis: The action is brought under 35 U.S.C. § 154(b)(4)(A), which permits an applicant to seek judicial review of the USPTO's PTA determination (Compl. ¶12).
  • Alleged Calculation Error: The Plaintiff alleges the USPTO incorrectly calculated the PTA by failing to properly account for two distinct types of agency delay under the statute:
    1. "A" Delay: A 731-day delay alleged under § 154(b)(1)(A) for the PTO's failure to meet statutory examination deadlines (Compl. ¶16).
    2. "B" Delay: A 702-day delay alleged under § 154(b)(1)(B) for the PTO's failure to issue the patent within three years of the application filing date (Compl. ¶17).
  • Dispute Over "Overlap": The core of the dispute is the interpretation of § 154(b)(2)(A), which states that the adjustment period cannot exceed the actual number of days the patent's issuance was delayed and that periods of delay shall not be double-counted. The Plaintiff argues that the total PTA should be the sum of "A" and "B" delays, reduced only by periods where the delays factually overlap (89 days) and by any applicant-caused delay (87 days) (Compl. ¶¶18-21).
  • Legal Allegation: The complaint concludes that the PTO's final determination of a 640-day adjustment, rather than the 1,257 days calculated by the Plaintiff, is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law" (Compl. ¶25).

No probative visual evidence provided in complaint.

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

This case does not turn on technical questions of infringement, but rather on a pure question of statutory interpretation under the Administrative Procedure Act. The key questions for the court are:

  1. A question of statutory mathematics: Under 35 U.S.C. § 154(b), when calculating patent term adjustment, how should the USPTO account for days that qualify as both "A" delay (failure to meet a specific deadline) and "B" delay (overall pendency exceeding three years)? Does the statute require simply subtracting any overlapping day counts, as Plaintiff alleges, or does it permit another methodology?
  2. A question of administrative deference: Is the USPTO’s interpretation of how to calculate overlapping delays under § 154(b)(2)(A) a reasonable construction of an ambiguous statute entitled to judicial deference, or is it an error of law that must be corrected by the court? The resolution will likely depend on the court's reading of the statute's plain language and its interplay with precedent, such as the Wyeth v. Dudas decision.