UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`AMNEAL PHARMACEUTICALS LLC and
`PAR PHARMACEUTICAL, INC.
`Petitioners
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`_____________________
`
`Case IPR: Unassigned
`Patent 8,731,963
`_____________________
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,731,963
`UNDER 35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.1-.80, 42.100-.123
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`TABLE OF CONTENTS
`
`V.
`
`VI.
`
`Introduction.......................................................................................................1
`I.
`Grounds for standing (37 C.F.R. § 42.104(a)) .................................................2
`II.
`Statement of the precise relief requested and the reasons therefore ................2
`III.
`IV. Overview...........................................................................................................2
`A.
`Person of ordinary skill in the art...........................................................2
`B.
`State of the art.........................................................................................3
`C.
`The ’963 patent.......................................................................................6
`Claim construction............................................................................................8
`A.
`“Periodic reports generated from the single computer database.”.........8
`Identification of challenge (37 C.F.R. § 42.104(b)).........................................9
`A.
`Each cited reference is available prior art............................................10
`1.
`The ACA (PAR1003–PAR1006) qualifies as a “printed
`publication.”.............................................................................. 11
`Korfhage is available as prior art.............................................. 16
`2.
`Ground 1: Claims 1-7 & 9-23 would have been obvious over
`the ACA................................................................................................16
`1.
`Claim 1...................................................................................... 18
`2.
`Claim 2...................................................................................... 34
`3.
`Claim 3...................................................................................... 35
`4.
`Claim 4...................................................................................... 35
`5.
`Claim 5...................................................................................... 36
`6.
`Claim 6...................................................................................... 36
`7.
`Claim 7...................................................................................... 37
`
`B.
`
`i
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`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`Claim 9...................................................................................... 37
`8.
`Claim 10.................................................................................... 39
`9.
`10. Claim 11.................................................................................... 39
`11. Claim 12.................................................................................... 40
`12. Claim 13.................................................................................... 40
`13. Claim 14.................................................................................... 41
`14. Claim 15.................................................................................... 43
`15. Claims 16–19 ............................................................................ 43
`16. Claim 20.................................................................................... 44
`17. Claims 21-22............................................................................. 46
`18. Claim 23.................................................................................... 46
`Ground 2: Claims 8 & 24-28 would have been obvious over the
`ACA in view of Korfhage ....................................................................48
`1.
`Claim 8...................................................................................... 48
`2.
`Claim 24.................................................................................... 50
`3.
`Claim 25.................................................................................... 52
`4.
`Claims 26-28............................................................................. 53
`Secondary considerations do not rebut the prima facie case. ..............54
`D.
`VII. Mandatory notices (37 C.F.R. § 42.8(a)(1)).................................................. 58
`VIII. CONCLUSION.............................................................................................. 60
`
`C.
`
`ii
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`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`
`I.
`
`Introduction
`
`Par Pharmaceutical,
`
`Inc.
`
`(“Par”) and Amneal Pharmaceuticals LLC
`
`(“Amneal”) (collectively “Petitioners”) submit this Petition for Inter Partes Review
`
`(“Petition”) seeking cancellation of claims 1-28 of U.S. Patent No. 8,731,963 (“the
`
`’963 patent”) (PAR1001) as unpatentable under 35 U.S.C. §103(a) in view of the
`
`prior art.1 According to Office records,
`
`the ’963 patent
`
`is assigned to Jazz
`
`Pharmaceuticals, Inc. (“Jazz”).
`
`Published materials used in an FDA Advisory Committee Meeting (the
`
`“Advisory Committee Art” or “ACA”) render obvious every limitation of at least
`
`claims 1–7 & 9–23 more than one year before the ’963 patent’s earliest effective
`
`filing date, as set forth in Ground 1. The additional limitations of claims 8 & 24–28
`
`would have also been rendered obvious to a person of ordinary skill in the art
`
`(“POSA”) over the ACA in combination with an additional prior art reference
`
`more than one year before the ’963 patent’s earliest effective filing date, as
`
`discussed below in Ground 2. Accordingly, claims 1–28 of the ’963 patent would
`
`1 Petitioners note that
`
`the Board recently instituted IPR trials for the
`
`following related patents to the ’963 patent on July 28, 2015: 7,668,730 (IPR2015-
`
`00554); 7,765,106 (IPR2015-00546); 7,765,107 (IPR2015-00547); 7,895,059
`
`(IPR2015-00548); 8,457,988 (IPR2015-00551); and 8,589,182 (IPR2015-00545).
`
`1
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`

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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`have been obvious to a POSA at the time of the invention—irrespective of any
`
`alleged objective indicia of nonobviousness.
`
`For the reasons explained below, Petitioners are at least reasonably likely to
`
`prevail on the asserted Grounds with respect to the challenged claims. Therfore,
`
`Petitioners respectfully request that this Board institute IPR and cancel each of
`
`challenged claims 1–28 of the ’963 patent.
`
`II. Grounds for standing (37 C.F.R. § 42.104(a))
`
`Petitioners certify that the ’963 patent is available for IPR and Petitioners are
`
`not barred or estopped from requesting IPR of any of the challenged claims.
`
`III.
`
`Statement of the precise relief requested and the reasons therefore
`
`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 1-28—all claims—of the ’963
`
`patent as unpatentable under 35 U.S.C. § 103.
`
`IV. Overview
`
`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
`
`2
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`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,
`
`including familiarity with drug
`
`distribution procedures. (Id.) Alternatively, a POSA may have a blend of computer
`
`science and pharmacy drug distribution knowledge and/or experience. (Id.) 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 the ’963 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 ’963 patent generally pertains to centralizing the distribution of
`
`hazardous or abuse-prone drugs. The ’963 patent is listed in the U.S. Food and
`
`Drug Administration’s (“FDA”) “Orange Book” (“OB”) in connection with the
`
`prescription drug product Xyrem. The active ingredient
`
`in Xyrem—sodium
`
`3
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`oxybate, the sodium salt of gamma hydroxybutyrate (“GHB”)—was well-known in
`
`the prior art as being susceptible to diversion and abuse. (Id., ¶64.) 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 ’963 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 ’963 patent.
`
`Aside from the explicit disclosure of the ’963 patent’s claimed methods in
`
`the prior art, the general mitigation of risks associated with the distribution of
`
`potentially hazardous drugs was well-established in the art before the earliest
`
`effective filing date of the ’963 patent. For example, in 1982, Hoffman-La Roche
`
`gained approval for Accutane® (isotretinoin), a potent teratogen that caused birth
`
`defects. (Id., ¶22.) To address that risk, Roche developed a special Pregnancy
`
`Prevention Program for Accutane® as part of its distribution in pharmacies. (Id.)
`
`The program included informed consent forms to be completed by the patient and
`
`prescriber, along with patient counseling on the teratogenic risk of Accutane®, the
`
`need to avoid pregnancy, and the use of proper birth control methods. Finally, this
`
`program required that women of childbearing potential must test serum negative
`
`for a pregnancy before the drug could be distributed to them. (Id.)
`
`4
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`

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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`Another drug, Clozaril® (clozapine), was approved in the U.S. in 1990 for
`
`the treatment of refractory schizophrenia. (Id., ¶23.) Similar to Accutane®,
`
`Clozaril®’s manufacturer sought to mitigate these risks associated with Clozaril®
`
`by implementing a national registry system that limited distribution of the drug.
`
`(Id.) The distribution system required registration of patient and physician
`
`information in an integrated computerized database. (Id.) If a patient or physician
`
`was non-compliant with the program, the national registry took corrective action,
`
`such as contacting and re-educating the prescribing physician and/or discontinuing
`
`supply of the prescription to the patient. (Id.) While the use of a computer
`
`differentiated the Clozaril® system from the Accutane® system,
`
`the use of
`
`computers was not novel
`
`to prescription drug distribution, because by 1990
`
`pharmacies had long been using computers (and the data processors within them)
`
`to aid in filling prescriptions. (Id., ¶24.)
`
`On the heels of the Accutane® and Clozaril® restricted distribution systems,
`
`in 1999,
`
`the manufacturers of prescription thalidomide—yet another known
`
`teratogenic drug—developed a hybrid system, combining the computerized
`
`registry system of Clozaril® and the pregnancy monitoring/prevention, and
`
`informed consent
`
`requirements of Accutane® to monitor and control
`
`the
`
`distribution of the drug. (Id., ¶25.)
`
`Thus, by 1999, at least three systems for the restricted distribution of
`
`5
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`effective, yet hazardous prescription drugs were known in the art and successfully
`
`implemented across the industry. (Id., ¶26.) Moreover, while risk management
`
`programs were developing during the 1980s through 1990s, pharmacies had
`
`already been using computerized systems for the distribution of narcotics and other
`
`controlled substances, i.e., drugs with potential for abuse. (Id., ¶27.) Computerized
`
`systems were also helpful in generating reports tracking patients, physicians, the
`
`quantity of the drug dispensed, and the hospital inventory of a drug, allowing for
`
`the detection of abuse patterns. (Id.) And, the systems could be queried to provide
`
`data, such as, prescriptions by doctor and patient. (Id.)
`
`Consequently, by December of 2002 (the earliest effective filing date of the
`
`’963 patent), multiple sources existed in the art that would have led a POSA to
`
`develop a computer-implemented and centralized distribution system that can be
`
`queried and configured to minimize the risks associated with the distribution of
`
`hazardous, but therapeutically beneficial, prescription drugs. (Id., ¶28.)
`
`C.
`
`The ’963 patent
`
`Against this backdrop, Jazz obtained the ’963 patent. The ’963 patent relates
`
`to “[a] drug distribution system and method [that] utilizes a central pharmacy and
`
`database to track all prescriptions for a sensitive drug.” (PAR1001, Abstract.)
`
`According to the ’963 patent, prescription patterns by physicians and patients are
`
`monitored for abuse using an exclusive central database. (Id., 2:20-25.) Further,
`
`6
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`physician eligibility to prescribe the drug is verified via a database, including
`
`determining whether any corrective or approved disciplinary actions have been
`
`brought against the physician. (Id., 1:54-60.) Prior to shipping the prescription
`
`drug, the central pharmacy checks whether the patient has been educated about the
`
`prescription, and only ships the prescription drug when no abuse is found related to
`
`the patient and prescribing doctor. (Id., 1:63-66, 5:25-34.) Reports are then
`
`generated to evaluate potential diversion patterns. (Id., 2:23-25.) The prescription
`
`drug is then delivered to the patient. (Id., 1:59-2:4.)
`
`The ’963 patent claims are directed to a computer implemented system used
`
`to distribute a prescription drug that has a potential for misuse, abuse, or diversion,
`
`wherein the prescription drug is sold by a company that obtained approval for
`
`distribution of the prescription drug through an exclusive central pharmacy that
`
`comprises: (1) storing in the memory of a computer (or multiple computers) a
`
`single computer database that contains prescription fields, patient fields, and
`
`prescriber fields where data from a prescription request can be entered, stored, and
`
`analyzed; (2) querying all data related to the prescription, prescriber, and patient
`
`fields within the single computer database before a prescription request
`
`is
`
`processed by the single central pharmacy; (3) checking for current or anticipated
`
`patterns of abuse, including flagging cash-paying patients or prescribers who are
`
`related to the narcoleptic patient, through periodic reports generated by querying
`
`7
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`the single computer database, (4) providing the prescription drug to the patient if
`
`no abuse is found on the part of the patient or the prescriber after querying the
`
`single computer database; and (5) reconciling inventory of the prescription drug
`
`before shipments for a day or other time period are sent by querying the database.
`
`V.
`
`Claim construction
`
`Unless otherwise construed herein, the terms of claims 1–28 are to be given
`
`their broadest reasonable interpretation, as understood by one of ordinary skill in
`
`the art in view of the ’963 patent’s specification. See 37 C.F.R. § 42.100(b).
`
`A.
`
`“Periodic reports generated from the single computer database.”
`
`Claims 14 and 27 of the ’963 patent recite the limitation “periodic reports
`
`generated from the single computer database.” (PAR1001, 9:57-58, 12:32-33.) The
`
`’963 patent discloses that “[s]everal queries and reports are run against the
`
`database to provide information which might reveal potential abuse of the
`
`sensitive drug, such as early refills.”2 (Id., 2:23-25.) The ’963 patent also discloses
`
`that reports are obtained by running queries against the central database. (Id., 8:24-
`
`31.) The ’963 patent specification describes different types of queries run to obtain
`
`information, such as prescriptions by physician, patient name, frequency, and dose.
`
`(Id., 7:55-8:2.) Accordingly, under the broadest reasonable interpretation of the
`
`term, “periodic reports generated from the single computer database” should be
`
`2 Emphasis added throughout unless otherwise noted.
`
`8
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`

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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`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.” (PAR1007, ¶50.)
`
`VI.
`
`Identification of challenge (37 C.F.R. § 42.104(b))
`
`Petitioners respectfully request IPR of all claims of the ’963 patent on the
`
`Grounds for unpatentability listed below. Per 37 C.F.R. § 42.6(d), copies of the
`
`references that petitioners rely upon in their challenge of patentability for all
`
`claims of the ’963 patent accompany the Petition. Petitioners further rely upon the
`
`accompanying declaration of Dr. Robert Valuck, Ph.D., R.Ph. (PAR1007), an
`
`expert in the fields of drug safety, drug abuse prevention, and prescription drug
`
`distribution as additional support for the Grounds for unpatentability of the ’963
`
`patent.
`
`Ground
`
`35 U.S.C.
`
`Claims
`
`Index of References
`
`1
`
`2
`
`§ 103(a)
`
`§ 103(a)
`
`1-7 & 9-
`23
`
`8 & 24-
`28
`
`ACA (PAR1003–1006)
`
`ACA (PAR1003–1006) in view
`of Korfhage (PAR1037)
`
`Petitioners demonstrate below, for each asserted Ground, where each limitation
`
`either exists in the prior art or is rendered obvious, by evaluating the scope and
`
`contents of the prior art, any differences between the art and the challenged claims,
`
`the knowledge of a person of ordinary skill in the art, and any available objective
`
`9
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`

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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`indicia of nonobviousness in accordance with Graham v. John Deere Co., 383 U.S.
`
`1 (1966) and KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). For Ground 2,
`
`Korfhage presents new and non-cumulative information about preexisting
`
`technology that was not applied or applied in the same way as discussed herein
`
`during the initial examination of
`
`the ’963 patent. This discussion and
`
`accompanying evidence, amply demonstrate that, more likely than not, the claims
`
`of the ’963 patent are unpatentable under each of the proposed Grounds.
`
`A.
`
`Each cited reference is available prior art
`
`Each of the references cited in this petition is available as prior art under the
`
`basis for qualification provided for by AIA,3 § 18(a)(1)(C)(i) and AIA, §
`
`18(a)(1)(C)(ii)(I). The ’963 patent claims benefit to U.S. Patent No. 7,668,730
`
`(“the ’730 patent”), filed on December 17, 2002 (See PAR1001.) Accordingly,
`
`December 17, 2002 is the ’963 patent’s earliest possible effective filing date. Each
`
`cited prior art reference qualifies independently as (1) having published before
`
`December 17, 2002 or (2) having been publicly disclosed more than a year prior to
`
`December 17, 2002.
`
`3 Leahy–Smith America Invents Act, 112 Pub. L. 29, 125 Stat. 284 (2011)
`
`(codified in scattered sections of 35 U.S.C.).
`
`10
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`

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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`The ACA (PAR1003–PAR1006) qualifies as a “printed
`publication.”
`
`1.
`
`In view of GHB’s known susceptibility for diversion and abuse and its
`
`experience in restricted distribution of certain dangerous drugs, the FDA held
`
`advisory committee meetings as a prerequisite to granting approval to Xyrem. A
`
`collection of materials that were used in that meeting (the “Advisory Committee
`
`Art” or “ACA”)—all of which were published more than one year prior to the
`
`earliest effective filing date of the ’963 patent—either teaches or renders obvious
`
`every limitation of the challenged claims. The ACA materials comprise four parts:
`
`(1) the Advisory Committee Transcript and Slides (PAR1003), (2) Preclinical
`
`Safety Review (PAR1004), (3) the Briefing Booklet (PAR1005), and (4) the
`
`Xyrem Video and Transcript (PAR1006).
`
`“[T]he determination of whether a given reference qualifies as a prior art
`
`‘printed publication’
`
`involves a case-by-case inquiry into the facts and
`
`circumstances surrounding the reference’s disclosure to members of the public.”
`
`CBM2013-00047, Paper 11, *16 (Feb. 18, 2014) (citing In re Klopfenstein, 380
`
`F.3d. 1345, 1350 (Fed. Cir. 2004)). “A reference is publicly accessible upon a
`
`satisfactory showing that such document has been disseminated or otherwise made
`
`available to the extent that persons interested and ordinarily skilled in the subject
`
`matter or art exercising reasonable diligence, can locate it.” Id. (quoting Kyocera
`
`Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed. Cir. 2008)).
`
`11
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`Electronic publications can qualify as “printed publications” as long they
`
`have been disseminated or otherwise made available to a POSA exercising
`
`reasonable diligence. IPR2013-00084, Paper 14, *20-21 (May 17, 2013). And
`
`while indexing is “often relevant to public accessibility, evidence of indexing is not
`
`an absolute prerequisite to establishing online references [] as printed publications
`
`within the prior art.” Id. at *21 (quoting Voter Verified, Inc. v. Premier Election
`
`Solutions, Inc., 698 F.3d 1374, 1380 (Fed. Cir. 2012)). Petitioners need only
`
`provide sufficient evidence to demonstrate that the reference was disseminated
`
`publicly or otherwise available. Id. at *34-35 (citing In re Wyer, 655 F.2d 221, 226
`
`(C.C.P.A. 1981) (finding evidence of actual viewing or dissemination was not
`
`required when a reference is deemed to have been “sufficiently accessible to the
`
`public and to persons skilled in the pertinent art”)).
`
`The ACA (PAR1003-PAR1006) is a collection of publicly available, printed
`
`publications. Orphan Medical, Patent Owner
`
`Jazz’s predecessor-in-interest,
`
`submitted to the FDA for publication before the Advisory Committee met on June
`
`6, 2001 the Xyrem Video and Transcript, the Briefing Booklet, and the Preclinical
`
`Safety Review. In fact, according to the Federal Register notice announcing this
`
`meeting:
`
`Background material from the sponsor and FDA will be posted 24
`hours before the meeting at the Peripheral and Central Nervous
`System
`Drugs
`Advisory
`Committee
`docket
`site
`at
`
`12
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`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`http://www.fda.gov/ohrms/dockets/ac/acmenu.htm (Click on the year
`2001 and scroll down to the Peripheral and Central Nervous Systems
`Drugs meetings.) This is the same website where you can find the
`minutes, transcript, and slides from the meeting. This material is
`generally posted about 3 weeks after the meeting.
`
`(PAR1015.) Such “competent evidence of the [FDA’s] general [] practice may be
`
`relied upon to establish an approximate time” the ACA would have become
`
`available to a POSA exercising reasonable diligence. IPR2014-00059, Paper 9, *34
`
`(Apr. 15, 2014) (citing In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986)).4 Therefore,
`
`based on the stated timelines, the Xyrem Video and Transcript (PAR1006), the
`
`Briefing Booklet (PAR1005), and the Preclinical Safety Review (PAR1004) were
`
`approximately available on the FDA’s website as of June 5, 2001, while the
`
`Advisory Committee Transcript and Slides (PAR1003) were available as of
`
`June 27, 2001. Both dates are more than one year prior to December 17, 2002.
`
`Additionally, the FDA website that hosts these documents demonstrates that they
`
`were all available by July 13, 2001, at the latest, also qualifying them as 102(b)
`
`4 The Federal Advisory Committee Act also required that “the records,
`
`reports, transcripts, minutes . . . or other documents which were made available to
`
`or prepared for or by each advisory committee shall be available for public
`
`inspection.” 5 U.S.C. App 2 §10(b) (2001).
`
`13
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`prior art. (PAR1017 (relevant bullet point highlighted).)
`
`Notably, the Preclinical Safety Review (PAR1004) contains redactions of
`
`the name of the proposed specialty pharmacy for distribution of Xyrem—further
`
`evidence that these materials would be, and were intended to be, available to the
`
`public. And the Briefing Booklet (PAR1005) states on its cover that
`
`it
`
`is
`
`“AVAILABLE FOR PUBLIC DISCLOSURE WITHOUT REDACTION.”
`
`Accordingly, there can be no question that these materials were readily accessible
`
`to a POSA. Cf. IPR2013-00458, Paper 12, *27 (Jan. 16, 2014) (finding that
`
`statements of confidentiality on a document suggest it was not publicly available).
`
`Other evidence corroborating the public availability of the ACA comes from
`
`the
`
`Internet
`
`Archive:
`
`Wayback
`
`Machine
`
`(located
`
`at
`
`https://archive.org/web/web.php). The Wayback Machine demonstrates that, at the
`
`latest, a link to the “Briefing Information” (i.e., the Xyrem Video and Transcript
`
`(PAR1006), the Briefing Booklet (PAR1005), and the Preclinical Safety Review
`
`(PAR1004)) was available online on June 17, 2001. (PAR1018, pgs. 5-6 (6/6
`
`Meeting).) Following this link demonstrates that this art was all available on July
`
`1, 2001, at the latest. (PAR1019.) And the Advisory Committee Transcript and
`
`Slides (PAR1003) were available by October 4, 2001, at the latest—one year prior
`
`to
`
`December
`
`17,
`
`2002.
`
`(PAR1020,
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`pgs.
`
`8-9
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`(6/6 Meeting); see also PAR1028, pg. 20.)
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`Additionally, a POSA “exercising reasonable diligence” would have been
`
`able to locate the ACA. (PAR1007, ¶64; PAR1015.) Notice of the Advisory
`
`Committee Meeting was posted in the Federal Register, which indicated that “[a]
`
`main focus of the deliberations will be on risk management issues.” (PAR1007,
`
`¶64; PAR1015.) The Federal Register also points a POSA to where the ACA
`
`would be located before and after the meeting. (PAR1007, ¶64; PAR1015.) A
`
`POSA would have known to look in the Federal Register and on the FDA’s
`
`website to obtain information on existing and proposed risk management
`
`programs. (PAR1007, ¶64.)
`
`The ACA also would have been available via a Freedom of Information Act
`
`request, as they were part of an Advisory Committee meeting, indexed and easily
`
`identifiable by reference to that meeting, and publicly available as a result.5 5
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`U.S.C. App 2 § 10(b) states that Advisory Committee materials are to be made
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`available “subject to section 552 of title 5[.]” The Preclinical Safety Review
`
`(PAR1004) contains redactions marked “(b)(4),” which are a specific reference to
`
`5 U.S.C. § 552(b)(4) (allowing for redaction of trade secret information). The
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`Briefing Booklet (PAR1005) also states that it was available for public disclosure
`
`without redaction.
`
`5 See supra note 4.
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`In sum, the ACA was a collection of publicly available, printed publications
`
`that were disseminated together for the same purpose, which would have been
`
`available to and readily located by a POSA more than one year prior to the priority
`
`date of the ’963 patent. (PAR1028.)6
`
`2.
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`Korfhage is available as prior art
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`Korfhage’s 1997 publication date qualifies it as § 102(b) prior art.
`
`(PAR1037, pg. 4.)
`
`B.
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`Ground 1: Claims 1-7 & 9-23 would have been obvious over the
`ACA
`
`As supported by the declaration of Dr. Valuck, claims 1-7 & 9-23 of the
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`’963 patent would have been obvious over the ACA (PAR1003–1006). (PAR1007,
`
`¶¶67-133.) The ACA qualifies as prior art to the claims of the ’963 patent. (See §
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`VI.A.1) These materials were disseminated together for use in the FDA’s Advisory
`
`6 Petitioners also note that the Board, in instituting trials for related patents,
`
`recognized that
`
`the dates on PAR1004–1006,
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`the Federal Register Notice
`
`(PAR1015),
`
`the Internet Archive Evidence (PAR1018–1020 and PAR1028),
`
`among others, “indicate[]
`
`that
`
`.
`
`.
`
`. Petitioner has shown sufficiently that
`
`[PAR1004–1006] were publicly accessible to one of ordinary skill more than one
`
`year before the December 17, 2002 priority date” of the ’963 patent. See, e.g.,
`
`IPR2015-00554, Paper 19, *29 (July 28, 2015).
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`16
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`Committee Meetings for Xyrem and is a written public record of what transpired at
`
`the meeting. And, as announced in the Federal Register, each publication was
`
`readily accessible to the public on the FDA’s website more than one year before
`
`the earliest effective filing date of the ’963 patent. (PAR1019.)
`
`A POSA would have had more than ample reason to combine these ACA
`
`materials7—(1) Advisory Committee Transcript and Slides (PAR1003),
`
`(2)
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`Preclinical Safety Review (PAR1004), (3) Briefing Booklet (PAR1005), and (4)
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`Xyrem Video and Transcript (PAR1006)—because items 2-4 were all distributed
`
`together for a meeting before the FDA seeking approval for prescription Xyrem,
`
`and item 1 was a transcript of the meeting itself. (PAR1007, ¶68.) Moreover, a
`
`POSA would also have had a reasonable expectation of success when combining
`
`each of these materials to arrive at claims 1-7 & 9-23 because they clearly relate to
`
`the same restricted and computer-implemented distribution program, which the
`
`meeting was convened to discuss. (Id.) Further, the Xyrem Video and Transcript
`
`7 The ACA can also constitute a single disclosure, because the Xyrem FDA
`
`Webpage has a menu that lists all of the documents pertaining to the same June 6,
`
`2001 Meeting of the Peripheral and Central Nervous System Drugs Advisory
`
`Committee (held to discuss risk management issues relating to Xyrem), which also
`
`was available more than one year before the patent’s priority date. (PAR1027.)
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`(PAR1006) is incorporated by reference into the Advisory Committee Transcript
`
`and Slides (PAR1003), and into the Briefing Booklet (PAR1005). (See PAR1003;
`
`PAR1005.) And, each of the ACA is all linked from a single web page (PAR1027),
`
`providing a further reason to combine the references. (See PAR1007, ¶68.)
`
`1.
`
`Claim 1
`
`Independent claim 1 of the ’963 patent recites the following:
`
`[Preamble] A computer-implemented system for treatment of a
`narcoleptic patient with a prescription drug that has a potential for
`misuse, abuse or diversion, comprising:
`[1.1] one or more computer memories for storing a single
`computer database having a database schema that contains and
`interrelates prescription fields, patient fields, and prescriber fields;
`[1.2] said prescription fields, contained within the database
`schema, storing prescriptions for the prescription drug with the
`potential for abuse, misuse or diversion, wherein the prescription drug
`is sold or distributed by a company that obtained approval for
`distribution of the prescription drug;
`[1.3] said patient fields, contained within the database schema,
`storing information sufficient to identify the narcoleptic patient for
`whom the company’s prescription drug is prescribed;
`[1.4] said prescriber fields, contained within the database
`schema, storing information sufficient to identify a physician or other
`prescriber of the company's prescription drug and information to show
`that the physician or other prescriber is authorized to prescribe the
`company's prescription drug;
`
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`Petition for Inter Partes Review
`of U.S. Patent No. 8,731,963
`[1. 5] a data processor configured to: process a database query
`that operates over all data related to the prescription fields, prescriber
`fields, and patient fields for the prescription drug; and
`[1.6] reco