PAR PHARMACEUTICAL, INC. v. Jazz Pharmaceuticals, Inc.

1. Case Identification

• Case #: Unassigned
• Patent #: 7,668,730
• Filed: January 8, 2015
• Petitioner(s): Amneal Pharmaceuticals, LLC. and Par Pharmaceutical, Inc.
• Patent Owner(s): Jazz Pharmaceuticals, Inc.
• Challenged Claims: 1-11

2. Patent Overview

• Title: Drug Distribution System and Method
• Brief Description: The ’730 patent discloses a computerized method and system for distributing a sensitive prescription drug. The system utilizes an exclusive central pharmacy and an exclusive computer database to track all prescriptions, verify physician credentials, and monitor for potential abuse or diversion before providing the drug to a patient.

3. Grounds for Unpatentability

Ground 1: Obviousness over Advisory Committee Art - Claims 1-11 are obvious over the Advisory Committee Art (ACA).

• Prior Art Relied Upon: Advisory Committee Art (ACA) (a collection of publicly available materials, including transcripts, slides, and briefing documents, from a June 2001 FDA Advisory Committee meeting concerning the approval of Xyrem®).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner argued that the ACA, which describes the risk management and distribution program for Xyrem®, discloses every limitation of the challenged claims. The ACA teaches a "closed distribution system" using a "single national specialty pharmacy" which Petitioner equated to the claimed "exclusive central pharmacy." This system uses a "central data repository," corresponding to the "exclusive computer database," to manage all prescriptions for the drug. The ACA further discloses receiving prescription requests, checking physician credentials against external databases, confirming patient education, monitoring the database for potential abuse (e.g., duplicate prescriptions), and mailing the drug only if no potential abuse is found by the patient or doctor. The system also generates data to identify patterns of abuse and diversion.
  • Motivation to Combine: A person of ordinary skill in the art (POSA) would have considered the ACA documents as a whole because they were all prepared for, distributed at, or created as a record of a single FDA meeting convened specifically to discuss the restricted distribution program for Xyrem®. The documents were linked from a single FDA webpage and functionally incorporate each other.
  • Expectation of Success: A POSA would have a clear expectation of success in implementing the system described across the ACA materials, as they collectively describe a single, cohesive, and comprehensive drug distribution program intended for practical implementation.

Ground 2: Obviousness over Multiple References - Claims 1-11 are obvious over Talk About Sleep (TAS) in view of Honigfeld, Elsayed, and further in view of Lilly.

• Prior Art Relied Upon: TAS (a 2001 publication), Honigfeld (a 1998 publication), Elsayed (a 2000 publication), and Lilly (’807 application).
• Core Argument for this Ground:
  • Prior Art Mapping: Petitioner asserted that TAS discloses a foundational system for distributing Xyrem® through a "specialty distribution system that will utilize a central pharmacy." To this base system, a POSA would have incorporated the teachings of the other references. Honigfeld teaches a computerized "Clozaril National Registry" system with an "integrated, computerized confidential database" to register all prescribers, pharmacists, and patients for a sensitive drug. Elsayed similarly discloses distributing hazardous drugs by registering participants in a "computer readable storage medium" via on-line data transmission. Finally, Lilly teaches using pharmaceutical computer data to compare a new prescription against a patient's medication history to identify and prevent "potential medication abuse," such as duplications. The combination of these teachings allegedly meets all limitations of the claims.
  • Motivation to Combine: A POSA would combine these references because they are all directed to the same endeavor: the controlled distribution of abuse-prone prescription drugs. A POSA would modify the central pharmacy system of TAS with the well-known computerized registry, data processing, and abuse-detection techniques taught by Honigfeld, Elsayed, and Lilly to improve its efficiency, safety, and scale. This combination would predictably achieve the shared goal of responsible drug distribution.
  • Expectation of Success: A POSA would have a reasonable expectation of success, as combining the references amounts to applying known computerized methods for ensuring patient compliance and monitoring distribution to another drug requiring a restricted distribution system. The benefits of such computerized methods were well-established and the results would be predictable.

4. Key Claim Construction Positions

• "Exclusive Central Pharmacy" / "Exclusive Computer Database": Petitioner argued that, based on statements made during prosecution of the ’730 patent, these terms should be construed to mean a "single or sole pharmacy" and a "single or sole database," respectively. This construction was central to mapping the "single national specialty pharmacy" of the ACA to the claims.
• "Generating... periodic reports": Petitioner proposed that 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 construction aligns the claim language with the data analysis capabilities described in the prior art for identifying diversion patterns.

5. Relief Requested

• Petitioner requests institution of an inter partes review (IPR) and cancellation of claims 1-11 of Patent 7,668,730 as unpatentable under 35 U.S.C. §103.