PTAB

IPR2015-00551

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 ’988 patent discloses a method and system for distributing a sensitive drug (e.g., GHB for narcolepsy) that is prone to misuse, abuse, or diversion. The system utilizes an exclusive central pharmacy and an associated exclusive computer database to process all prescriptions, monitor patients and physicians for potential abuse, and control the shipment of the drug.

3. Grounds for Unpatentability

Ground 1: Obviousness over Advisory Committee Art - Claims 1, 3-9, and 11-15 are obvious over the ACA.

  • Prior Art Relied Upon: ACA (a collection of publicly available materials from a June 2001 FDA Advisory Committee meeting regarding the approval of Xyrem®, the drug product corresponding to the ’988 patent).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the ACA materials, taken together, disclose every limitation of the challenged claims. The ACA described a proposed risk management program for Xyrem® (GHB) that utilized a single, exclusive specialty pharmacy to handle all prescriptions. This "closed distribution system" involved receiving prescription forms, entering patient and physician data into a central data repository (the claimed "exclusive computer database"), verifying physician credentials, and checking for patterns of abuse or diversion (e.g., duplicate prescriptions). The ACA explicitly taught shipping the drug only after confirming no potential abuse was found and generating data to assist law enforcement, which meets the core limitations of independent claims 1 and 9. Dependent claims were also taught, such as shipping to another pharmacy for pickup or blocking shipments if abuse was detected.
    • Motivation to Combine: A person of ordinary skill in the art (POSITA) would have been motivated to consider the various ACA documents together because they were all prepared for, or were a record of, a single FDA meeting focused on the specific topic of a safe distribution program for Xyrem®. The documents were linked from a single FDA webpage and clearly related to the same subject matter.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success in combining the teachings of the ACA materials, as they collectively described a single, coherent risk management program designed to function as a whole to safely distribute an abuse-prone drug.

Ground 2: Obviousness over TAS in view of Honigfeld, Elsayed, and Lilly - Claims 1-15 are obvious over TAS in view of Honigfeld, Elsayed, and Lilly.

  • Prior Art Relied Upon: TAS (a 2001 publication titled "Talk About Sleep"), Honigfeld (a 1998 publication on the Clozaril National Registry), Elsayed (a 2000 publication on distributing hazardous drugs), and Lilly (a 2001 provisional application on preventing medication abuse).

  • Core Argument for this Ground:

    • Prior Art Mapping: Petitioner contended that TAS disclosed the foundation of the invention: a specialty distribution system for Xyrem® using a single central pharmacy to handle prescriptions for narcoleptic patients. However, TAS did not explicitly describe a computerized database system. Honigfeld and Elsayed were argued to supply this missing element, as both taught using integrated, computerized databases for managing the distribution of other high-risk drugs (Clozapine and thalidomide, respectively). They disclosed registering all prescribers, pharmacies, and patients in a central database and using online transmission of prescription data. Lilly was cited to show that using such computer data to identify potential abuse by comparing new prescriptions to a patient's medication history was a well-known technique. The combination of these references, therefore, taught all limitations of the independent claims.
    • Motivation to Combine: A POSITA would combine these references because they all address the same problem: the controlled distribution of drugs susceptible to abuse. It would have been obvious to improve the central pharmacy system described in TAS for Xyrem® by implementing the known computerized registry and abuse-detection techniques described in Honigfeld, Elsayed, and Lilly for other controlled substances. This would have been a predictable solution to enhance the efficiency and safety of the TAS system.
    • Expectation of Success: A POSITA would have had a high expectation of success, as the combination merely involved applying known computerized database and monitoring techniques to a known centralized pharmacy model to achieve the predictable result of a more secure and efficient drug distribution system.

  • Additional Grounds: Petitioner asserted that claims 2 and 10 (requiring distributed databases) are obvious over ACA in view of Elsayed or Korfhage, and over the TAS combination in view of Korfhage. These grounds argued it would have been obvious to distribute the central database across multiple computers for reasons of cost and efficiency, as taught by Elsayed and the Korfhage treatise on information retrieval.

4. Key Claim Construction Positions

  • "Exclusive Central Pharmacy" and "Exclusive Computer Database": Petitioner argued these terms should be construed as a "single or sole pharmacy" and a "single or sole database," respectively. This construction was based on a definition provided by the applicant during the prosecution of a related patent.
  • "Generating... periodic reports": Petitioner proposed this limitation should be construed to mean "querying the computer database to obtain information, such as, prescriptions by physician, prescriptions by patient name, prescriptions by frequency, and prescriptions by dose." This was based on the patent’s description of running queries against the database to reveal potential abuse.
  • "Dispensed... by another pharmacy": Based on the specification’s only disclosure of another pharmacy’s involvement, Petitioner argued this phrase should mean "making the prescription drug that was dispensed by the central pharmacy available for pick-up by the patient at another pharmacy."

5. Relief Requested

  • Petitioner requests the institution of an inter partes review and cancellation of claims 1-15 of the ’988 patent as unpatentable under 35 U.S.C. §103.