1:10-cv-00131
Cephalon Inc v. Kappos
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Cephalon, Inc. (Delaware)
- Defendant: Hon. David J. Kappos, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO)
- Plaintiff’s Counsel: Fish & Richardson P.C.
- Case Identification: 1:10-cv-00131, D.D.C., 01/22/2010
- Venue Allegations: Venue is asserted under 35 U.S.C. § 154(b)(4)(A), which provides for remedy by a civil action against the Director of the USPTO in the U.S. District Court for the District of Columbia.
- Core Dispute: Plaintiff seeks a judicial order to increase the Patent Term Adjustment (PTA) for its U.S. Patent No. 7,566,805, alleging that the USPTO's calculation of 107 days is erroneous and should be at least 149 days.
- Technical Context: The patent-in-suit concerns pharmaceutical compositions of modafinil, a wakefulness-promoting agent, specifically focusing on co-crystals designed to improve the drug's physical properties such as stability and dissolution rate.
- Key Procedural History: The complaint was filed shortly after the Federal Circuit’s decision in Wyeth v. Kappos, which addressed the proper method for calculating PTA, particularly how to account for overlapping periods of USPTO delay. Plaintiff alleges the USPTO’s PTA calculation is in conflict with the methodology affirmed in that decision.
Case Timeline
| Date | Event |
|---|---|
| 2003-09-04 | Earliest Priority Date Claimed ('805 Patent) |
| 2004-09-04 | International (PCT) Application Filing Date |
| 2006-03-03 | U.S. National Stage Commencement Date |
| 2007-05-04 | Start of Alleged 153-day USPTO Delay (14 months post-filing) |
| 2007-10-04 | Mailing Date of First Office Action |
| 2009-03-04 | Start of Alleged 146-day USPTO Delay (3 years post-filing) |
| 2009-04-16 | Start of Alleged 103-day USPTO Delay (4 months post-issue fee payment) |
| 2009-07-28 | '805 Patent Issue Date |
| 2010-01-22 | Complaint Filing Date |
II. Technology and Patent(s)-in-Suit Analysis
- Patent Identification: U.S. Patent No. 7,566,805, "Modafinil Compositions", issued July 28, 2009.
The Invention Explained
- Problem Addressed: The patent's background describes how the physical properties of an active pharmaceutical ingredient (API) can significantly affect a drug's formulation, stability, bioavailability, and therapeutic effect. APIs can exist in various physical forms, such as polymorphs, and it is advantageous to develop forms with improved properties, such as enhanced stability or dissolution ('805 Patent, col. 2:25-53).
- The Patented Solution: The invention is directed to co-crystals and solvates of modafinil, a drug used to treat sleep disorders ('805 Patent, col. 2:65-67). A co-crystal is a crystalline structure containing the API (modafinil) and another molecule (a "co-crystal former") in the same crystal lattice ('805 Patent, col. 10:24-30). By forming co-crystals, the invention claims to modulate and improve important physicochemical properties of modafinil, potentially leading to better drug products ('805 Patent, Abstract; col. 2:43-49).
- Technical Importance: The development of novel crystalline forms like co-crystals is a significant strategy in pharmaceutical development to overcome challenges with existing API forms and to create new intellectual property.
Key Claims at a Glance
- The complaint does not identify specific claims, as the dispute is not over infringement but over patent term. However, the patent's independent claims define the core invention.
- Independent Claim 1:
- A co-crystal comprising modafinil and a co-crystal former
- wherein the co-crystal former is selected from a specified group of acids (malonic acid, glycolic acid, etc.).
No probative visual evidence provided in complaint.
III. The Accused Instrumentality
This section is not applicable. The complaint does not allege infringement by a product or service but rather challenges a determination made by a government agency, the USPTO. The challenged action is the USPTO's calculation of the patent term adjustment for the ’805 patent (Compl. ¶1, ¶15).
IV. Analysis of Infringement Allegations
This section is not applicable. The complaint does not contain allegations of patent infringement.
V. Key Claim Terms for Construction
This section is not applicable. The dispute centers on the statutory interpretation of 35 U.S.C. § 154(b), not the construction of patent claim terms.
VI. Other Allegations
This section is not applicable. The complaint does not allege indirect or willful infringement. The action is a statutory challenge to a USPTO determination.
VII. Analyst’s Conclusion: Key Questions for the Case
This case presents a focused legal dispute over the interpretation of patent statute, not a technical dispute over infringement. The key questions for the court appear to be:
A core issue will be one of statutory interpretation: Does the methodology for calculating Patent Term Adjustment affirmed by the Federal Circuit in Wyeth v. Kappos apply to the facts of this case? Specifically, the question is how to calculate the total period of USPTO delay when "A-delay" (e.g., failure to issue a patent within 4 months of the issue fee payment) and "B-delay" (failure to issue a patent within 3 years of the application filing date) have occurred, and how to account for any temporal overlap between them (Compl. ¶18, ¶22).
A secondary question may concern factual accuracy in calculation: The complaint presents a detailed calculation of PTO and applicant delay to arrive at a proposed 149-day adjustment (Compl. ¶16-21). The court will need to review whether Plaintiff's accounting of the specific periods of "A-delay," "B-delay," overlapping delay, and applicant delay is correct under the statute and supported by the patent's prosecution history. The complaint contains a minor internal inconsistency regarding the applicant delay period, citing both 149 and 150 days, which may require clarification (Compl. ¶20-21).