DCT

1:13-cv-00407

University Of Florida Research Foundation Inc v. Lee

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:13-cv-00407, E.D. Va., 03/29/2013
  • Venue Allegations: Venue is asserted to be proper in the Eastern District of Virginia pursuant to 35 U.S.C. § 154(b)(4)(A), which provides for civil action against the Director of the USPTO.
  • Core Dispute: Plaintiff seeks judicial review of the USPTO's calculation of the Patent Term Adjustment (PTA) for its patent, alleging the USPTO improperly interpreted federal statutes, resulting in a shorter patent term than legally mandated.
  • Technical Context: The patent relates to novel iron chelator compounds designed to treat chronic iron overload, a condition often resulting from repeated blood transfusions for diseases like thalassemia.
  • Key Procedural History: The complaint is filed amidst a circuit split on the central legal issue. Plaintiff cites recent, conflicting district court decisions (Exelixis I and Novartis vs. Exelixis II) concerning the proper calculation of "B Delay" patent term adjustment when a Request for Continued Examination (RCE) is filed more than three years after the application filing date.

Case Timeline

Date Event
2005-04-04 Earliest Priority Date Claimed ('458 Patent)
2007-10-04 '458 Patent Application Filing Date
2011-06-27 Request for Continued Examination (RCE) Filed
2012-10-02 '458 Patent Issue Date
2013-03-29 Complaint Filing Date

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

U.S. Patent No. 8,278,458 - "Desferrithiocin Polyether Analogues"

The Invention Explained

  • Problem Addressed: The patent addresses the need for improved treatments for chronic iron overload, a condition that can arise from repeated blood transfusions. (Compl. ¶11; '458 Patent, col. 1:24-41). The background notes that the standard treatment, desferrioxamine B, is not ideal because it is inefficient and requires parenteral (non-oral) administration, which can lead to poor patient compliance. ('458 Patent, col. 1:42-54).
  • The Patented Solution: The invention provides novel iron-chelating compounds, specifically desferrithiocin polyether analogues, designed to be more effective and suitable for oral administration. ('458 Patent, Abstract). These compounds feature a core structure for chelating iron and polyether side chains that can be modified to improve properties like organ distribution and to reduce kidney toxicity by shifting clearance to the liver. ('458 Patent, col. 4:11-24).
  • Technical Importance: The development of orally active iron chelators with favorable toxicity profiles represents a significant advance for patients requiring long-term chelation therapy. ('458 Patent, col. 1:42-54, col. 2:1-6).

Key Claims at a Glance

The complaint does not assert specific patent claims for an infringement analysis. The lawsuit's focus is on the statutory calculation of the patent's term, not the scope or infringement of its claims.

III. The Accused Instrumentality

Product Identification

The "accused instrumentality" in this case is not a commercial product but the USPTO's final determination of the Patent Term Adjustment (PTA) for the '458 Patent. (Compl. ¶1).

Functionality and Market Context

The USPTO calculated and granted a PTA of 843 days for the '458 Patent. (Compl. ¶33). This adjustment is intended to compensate the patentee for certain administrative delays during prosecution at the USPTO.

The dispute centers on the calculation of one component of PTA, known as "B Delay," which compensates for the USPTO's failure to issue a patent within three years of its filing date. (Compl. ¶17). The complaint alleges the USPTO improperly truncated the accrual of B Delay upon the filing of a Request for Continued Examination (RCE) on June 27, 2011. (Compl. ¶¶35, 41).

Plaintiff alleges that the USPTO's calculation only credited 265 days of B Delay (from the three-year anniversary to the day before the RCE filing), whereas the correct calculation should have credited 729 days (from the three-year anniversary to the patent's issue date). (Compl. ¶¶40-41). This discrepancy of 254 days (1097 total days sought vs. 843 days granted, after accounting for overlaps and applicant delay) forms the basis of the suit. (Compl. ¶¶47, 50).

IV. Analysis of Infringement Allegations

The complaint does not allege patent infringement and therefore does not contain claim charts. The core allegations concern the interpretation of patent statute 35 U.S.C. § 154 and its implementing regulations.

The Plaintiff's primary legal theory is that the USPTO has misinterpreted 35 U.S.C. § 154(b)(1)(B). (Compl. ¶49). This statute guarantees an extension of a patent's term for each day the USPTO takes beyond three years to issue the patent. (Compl. ¶17). The statute excludes from this period "any time consumed by continued examination of the application requested by the applicant." (Compl. ¶20).

Plaintiff argues that because its RCE was filed after the three-year pendency period had already expired, the filing of the RCE does not terminate the accrual of B Delay. (Compl. ¶24). The complaint alleges the USPTO's contrary interpretation, which permanently cuts off B Delay upon an RCE filing regardless of timing, is based on an invalid regulation (37 C.F.R. § 1.703(b)(1)) and is contrary to the plain language of the statute. (Compl. ¶¶19, 25). The complaint cites favorable district court precedent from Exelixis I and Novartis to support its position. (Compl. ¶¶27, 29). No probative visual evidence provided in complaint.

V. Key Claim Terms for Construction

This section is not applicable, as the dispute centers on statutory construction, not claim construction.

VI. Other Allegations

  • Violation of the Fifth Amendment (Count Two): The complaint alleges that the USPTO's allegedly improper calculation of the PTA, which shortens the patent's enforceable term, constitutes a "taking of Plaintiff's property without just compensation, in violation of the Fifth Amendment of the Constitution of the United States." (Compl. ¶¶53, 56).
  • Violation of the Administrative Procedure Act (Count Three): The complaint seeks a declaratory judgment that the USPTO's determination of the PTA and its promulgation of the regulation at 37 C.F.R. § 1.703(b)(1) were "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law" and in excess of statutory authority, making them reviewable and invalid under the APA. (Compl. ¶¶59-61).

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

This case presents a pure question of law regarding the mechanics of patent term adjustment calculations, rather than a typical fact-intensive infringement dispute. The outcome will likely turn on the following central questions:

  • A core issue will be one of statutory interpretation: Does the phrase "not including any time consumed by continued examination" in 35 U.S.C. § 154(b)(1)(B) act to toll the accrual of B Delay only for the period of the RCE itself, or does it permanently terminate the accrual of B Delay from the date the RCE is filed?
  • A key question of administrative law will be whether the USPTO's regulation (37 C.F.R. § 1.703(b)(1)), which implements its interpretation, is entitled to deference or is an unreasonable interpretation of the statute that is "contrary to law" under the Administrative Procedure Act.
  • A secondary constitutional question is whether an incorrect calculation of patent term by the USPTO can rise to the level of a Fifth Amendment taking, entitling the patentee to a remedy on constitutional grounds in addition to statutory review.