PTAB

IPR2015-00554

Par Pharmaceutical Inc v. Jazz Pharmaceuticals Inc

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Key Events
Petition
petition

1. Case Identification

2. Patent Overview

  • Title: Drug Distribution System and Method
  • Brief Description: The ’730 patent describes a computerized method for distributing a sensitive prescription drug (gamma-hydroxybutyrate, or GHB, sold as Xyrem®) through a controlled system. The method utilizes an exclusive central pharmacy and an exclusive computer database to track prescriptions, monitor for potential abuse or diversion by patients and physicians, and manage distribution to ensure patient safety.

3. Grounds for Unpatentability

Ground 1: Obviousness over FDA Advisory Committee Art - Claims 1-11 are obvious over the Advisory Committee Art (ACA) under 35 U.S.C. §103.

  • Prior Art Relied Upon: ACA (a collection of publicly available materials from a June 2001 FDA Advisory Committee meeting regarding the approval of Xyrem®, including the Advisory Committee Transcript and Slides, Preclinical Safety Review, Briefing Booklet, and a Xyrem Video and Transcript).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner argued that the ACA documents, which detail the risk management program for Xyrem®, collectively disclose every limitation of the challenged claims. The ACA described a "closed distribution system" using a "single national specialty pharmacy" that would be the drug's "exclusive distributor," which Petitioner equated to the claimed "exclusive central pharmacy." This system used a "central data repository" or "secure database" for registering all patients and physicians, mapping to the claimed "exclusive computer database." The ACA further disclosed processes for checking physician credentials, verifying patient education, monitoring the database for abuse patterns (e.g., duplicate prescriptions), and shipping the drug directly to the patient only if no abuse was found—all limitations recited in claim 1.
    • Motivation to Combine: A person of ordinary skill in the art (POSITA) would have been motivated to consider the ACA materials together because they were all prepared for and discussed at a single FDA meeting focused on the same subject: the proposed restricted distribution program for Xyrem®. The documents were inherently linked and intended to provide a complete picture of the program, making their combination a matter of routine review.
    • Expectation of Success: As the ACA materials all described different facets of the same cohesive program, a POSITA would have had a high expectation of success in combining their teachings to understand the complete, operational system.

Ground 2: Obviousness over Multiple Prior Art Systems - Claims 1-11 are obvious over TAS in view of Honigfeld and Elsayed, and further in view of Lilly, under §103.

  • Prior Art Relied Upon: TAS (a 2001 publication titled "Talk About Sleep"), Honigfeld (a 1998 publication), Elsayed (a 2000 publication), and Lilly (a 2001 patent application).
  • Core Argument for this Ground:
    • Prior Art Mapping: Petitioner contended that TAS disclosed a basic framework for distributing Xyrem® through a specialty distribution system using a central pharmacy. However, TAS lacked the detailed computerized controls of the claims. Petitioner argued that the remaining references supplied these well-known features. Honigfeld described the computerized "Clozaril National Registry" system, which used an "integrated, computerized confidential database" to register all participants and control the distribution of a hazardous drug. Elsayed taught registering patients and prescribers in a "computer readable storage medium" via on-line transmission to manage hazardous drug distribution. Finally, Lilly disclosed a computerized pharmacy system that compares new prescriptions against a patient's medication history to identify and prevent potential abuse. Petitioner asserted that adding the computerized database, registration, and abuse-checking functionalities of Honigfeld, Elsayed, and Lilly to the central pharmacy system of TAS would arrive at the claimed invention.
    • Motivation to Combine: A POSITA would combine these references because they all address the common problem of safely distributing abuse-prone or hazardous drugs. A POSITA would have been motivated to modify the basic central pharmacy in TAS with the established computerized techniques from Honigfeld, Elsayed, and Lilly to improve its safety, efficiency, and scalability—all predictable outcomes. Implementing such computerized controls was a known technique for improving drug distribution systems.
    • Expectation of Success: A POSITA would have had a reasonable expectation of success because the combination involved applying known, proven computerized database and abuse-monitoring techniques to a known type of drug distribution system to achieve the predictable benefits of improved control and safety.

4. Key Claim Construction Positions

  • "Exclusive Central Pharmacy" / "Exclusive Computer Database": Petitioner argued these terms should be construed to mean a "single or sole pharmacy" and a "single or sole database," respectively. This construction was based on statements made by the applicant during prosecution of the ’730 patent. The proposed construction was critical to mapping prior art that described a "single" pharmacy or a "central" database to the claim term "exclusive."
  • "Generating... periodic reports": Petitioner proposed that this phrase should be construed as "querying the computer database to obtain information" about prescription patterns (e.g., by physician, patient, frequency, or dose). This construction allowed Petitioner to argue that prior art disclosures of analyzing or querying a database for abuse patterns met the claim limitation for generating reports.

5. Relief Requested

  • Petitioner requested institution of an inter partes review and cancellation of claims 1-11 of the ’730 patent as unpatentable.