Par Pharmaceutical is petitioning for IPR (inter partes review) and seeking cancellation of claims 1-16 as U.S. Patent No. 7,895,059 is already assigned to Kyle Bass’s Jazz Pharmaceuticals.
Kyle Bass Fights Over Patent With Par Pharmaceutical
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
PAR PHARMACEUTICAL, INC.
JAZZ PHARMACEUTICALS, INC.
Case IPR: Unassigned
PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 7,895,059
UNDER 35 U.S.C. § 311–319 AND 37 C.F.R. § 42.1–.80, 42.100–.123
Introduction And Statement Of Relief Requested (37 C.F.R. § 42.22(a))
Par Pharmaceutical, Inc. (“Par”) petitions for inter partes review (“IPR”) and seeks cancellation of claims 1-16 of U.S. Patent No. 7,895,059 (“the ’059 patent”) (PAR1001). According to Office records, the ’059 patent is assigned to Jazz Pharmaceuticals, Inc.
Published materials used in an FDA Advisory Committee Meeting (the “Advisory Committee Art” or “ACA”) render obvious every limitation of the challenged claims more than a year before the ’059 patent’s earliest effective filing date, as set forth in Ground 1. In addition, and alternatively, other drug distribution systems in public use long before the ’059 patent’s earliest effective filing date also would have rendered the challenged claims obvious to a person of ordinary skill in the art (“POSA”), as set forth in Ground 2.
For the reasons explained below, Par is at least reasonably likely to prevail on the asserted Grounds 1 and/or 2 with respect to the challenged claims. Par requests that this Board institute IPR and cancel each of challenged claims 1-16 of the ’059 patent.
II. Grounds For Standing (37 C.F.R. § 42.104(a))
Par certifies that the ’059 patent is available for IPR and Par is not barred or estopped from requesting IPR of any of the challenged claims.
III. Statement Of The Precise Relief Requested And The Reasons Therefor
The Office should institute IPR under 35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.1-.80 and 42.100-42.123, and cancel claims 1-16—all claims—of the ’059 patent as unpatentable under 35 U.S.C. § 103.
A. Person of Ordinary Skill In The Art
A POSA is a hypothetical person who is presumed to be aware of all pertinent art, thinks along conventional wisdom in the art, and is a person of ordinary creativity. A POSA may work as part of a multi-disciplinary team and draw upon not only his or her own skills, but also take advantage of certain specialized skills of others in the team, to solve a given problem. (PAR1007, ¶21.) For example, a POSA would hold a Bachelor’s or Doctor of Pharmacy degree and a license as a registered pharmacist with 3-5 years of relevant work experience, or a computer science undergraduate degree or equivalent work experience and work experience relating to business applications, for example, including familiarity with drug distribution procedures. Alternatively, a POSA may have a blend of computer science and pharmacy drug distribution knowledge and/or experience. For example, such a POSA may have computer science education qualifications and experience relating to computerized drug distribution systems, or pharmacy education qualifications and experience relating to computerized drug distribution systems. (Id.) A POSA would have had knowledge of the literature concerning pharmacy practice and prescription drug distribution, such as the prior art presented herein, that was available before the earliest effective filing date of ’059 patent, including knowledge about methods employed in the art. (Id.) Accordingly, a POSA would have been well aware of techniques related to the mitigation of the risk associated with the distribution of potentially hazardous, but therapeutically beneficial prescription drugs. (Id.)
B. State of the Art
The ’059 patent generally pertains to centralizing the distribution of hazardous or abuse-prone drugs. The ’059 patent is listed in the United States Food and Drug Administration’s electronic publication, known as the “Orange Book” (“OB”), in connection with the prescription drug product Xyrem®. The active ingredient in Xyrem®—sodium oxybate, the sodium salt of gamma hydroxybuyrate (“GHB”)—was well-known in the prior art as being susceptible to diversion and abuse. (PAR1007, ¶47.) So, as a prerequisite to FDA approval, the sponsor of Xyrem®, with assistance and direction from an FDA advisory committee, agreed to employ a centralized distribution program to attempt to reduce abusive and illicit uses of Xyrem®, now known as the Xyrem® Success Program. By listing the ’059 patent in the FDA’s OB for Xyrem®, Jazz is asserting that the Xyrem® Success Program is an embodiment of at least one claim of the ’059 patent.
See full PDF below.