PTAB

IPR2015-01903

Par Pharmaceutical Inc v. Jazz Pharmaceuticals Inc

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Key Events
Petition

1. Case Identification

2. Patent Overview

  • Title: Drug Distribution System and Method
  • Brief Description: The ’963 patent discloses a computer-implemented system for the controlled distribution of sensitive drugs prone to abuse, specifically referencing the drug Xyrem (sodium oxybate). The system utilizes an exclusive central pharmacy and a single computer database to track patients, prescribers, and prescriptions to monitor for and prevent potential misuse or diversion.

3. Grounds for Unpatentability

Ground 1: Claims 1-7 and 9-23 are obvious over the Advisory Committee Art (ACA)

  • Prior Art Relied Upon: ACA (a collection of publicly available materials from a 2001 FDA Advisory Committee Meeting concerning the approval and distribution of Xyrem).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the ACA, taken as a whole, disclosed all elements of the claimed drug distribution system. The ACA described a proposed "closed distribution system" for Xyrem, a drug for narcolepsy with a known potential for abuse, to be managed through a single, exclusive specialty pharmacy. This system featured a "central data repository" or "secure database" for registering every patient and physician, which Petitioner equated to the ’963 patent’s "single computer database." The ACA further taught that this database would be used to store prescription, patient, and prescriber data to monitor for suspicious behavior, such as early refill requests or duplicate prescriptions, and explicitly noted the need to track "cash-paying patients" as an indicator of potential diversion. Petitioner asserted that implementing this large-scale data registry and monitoring system on a computer was an obvious design choice for a person of ordinary skill in the art (POSITA) at the time.
    • Motivation to Combine: The ACA materials were presented as a single, cohesive disclosure, as they were all prepared for and discussed at a single FDA meeting regarding the same proposed risk management program. A POSITA would therefore naturally consider the documents together to understand the complete system.
    • Expectation of Success: A POSITA would have a high expectation of success in implementing the ACA’s proposed system. The system relied on conventional pharmacy practices and well-understood computer database technology to solve the known problem of prescription drug diversion.

Ground 2: Claims 8 and 24-28 are obvious over the ACA in view of Korfhage

  • Prior Art Relied Upon: ACA (as described in Ground 1) and Korfhage (a 1997 publication on information systems).
  • Core Argument for this Ground:
    • Prior Art Mapping: This ground addressed claims that specifically require the "single computer database" to be "distributed among multiple computers." Petitioner argued that while the ACA taught a logically single, centralized database, Korfhage taught that distributing a single logical database across multiple physical computers was a standard and well-known design paradigm. Korfhage explained this approach was used to improve system efficiency, handle large volumes of data, and reduce costs.
    • Motivation to Combine: A POSITA tasked with implementing the large-scale national database described in the ACA would be motivated to use Korfhage's conventional distributed architecture. The goals of efficiency, scalability, and cost-effectiveness, as taught by Korfhage, are universal engineering objectives that a POSITA would seek to apply to the ACA system.
    • Expectation of Success: The combination was argued to be a predictable application of a standard database architecture (Korfhage) to a specific system (ACA). A POSITA would expect to achieve the well-understood benefits of a distributed system—namely, improved performance and scalability—without any unexpected results.

4. Key Claim Construction Positions

  • Term: "periodic reports generated from the single computer database" (recited in claims 14 and 27).
  • Petitioner's Proposed Construction: Petitioner argued the term should be construed to mean "information obtained from querying the single computer database, such as, prescriptions by physician, prescriptions by patient name, prescriptions by frequency, and prescriptions by dose." This construction, based on disclosures in the ’963 patent’s specification, was central to Petitioner’s argument that the ACA’s teaching of querying its central database for abuse patterns met this claim limitation.

5. Relief Requested

  • Petitioner requests institution of an inter partes review and cancellation of claims 1-28 of Patent 8,731,963 as unpatentable under 35 U.S.C. §103.