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
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`_____________________
`
`Case IPR: Unassigned
`_____________________
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 7,765,107
`UNDER 35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.1-.80, 42.100-.123
`
`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`TABLE OF CONTENTS
`
`I. 
`
`II. 
`
`Introduction ..................................................................................................... 1 
`
`Grounds for standing (37 C.F.R. § 42.104(a)) ............................................... 1 
`
`III. 
`
`Statement of the precise relief requested and the reasons therefore .............. 1 
`
`IV.  Overview ......................................................................................................... 2 
`
`A. 
`
`B. 
`
`C. 
`
`Person of ordinary skill in the art (“POSA”) ........................................ 2 
`
`State of the art ........................................................................................ 3 
`
`The ’107 patent ...................................................................................... 6 
`
`V. 
`
`Claim construction .......................................................................................... 8 
`
`A. 
`
`B. 
`
`“Exclusive central pharmacy” ............................................................... 8 
`
`“Periodic reports generated” ................................................................. 8 
`
`VI. 
`
`Identification of challenge .............................................................................. 9 
`
`A. 
`
`Each cited reference is available prior art ........................................... 10 
`
`1. 
`
`2. 
`
`The ACA (AMN1003–AMN1006) qualifies as a
`“printed publication” ................................................................ 10 
`
`(AMN1033), Honigfeld
`Sleep
`Talk About
`(AMN1035)
`and Lilly
`(AMN1034), Elsayed
`(AMN1010) .............................................................................. 15 
`
`B. 
`
`Ground 1: Claims 1-6 are obvious over ACA ..................................... 16 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`Claim 1 would have been obvious ........................................... 17 
`
`Claim 4 ..................................................................................... 34 
`
`Claims 2 and 5 .......................................................................... 34 
`
`Claims 3 and 6 .......................................................................... 35 
`
`ii
`
`

`
`C. 
`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`Ground 2: Claims 1-6 would have been obvious over Talk
`About Sleep, in view of Honigfeld and Elsayed, and further
`in view of Lilly. ................................................................................... 36 
`
`1. 
`
`1. 
`
`2. 
`
`3. 
`
`Claim 1 ..................................................................................... 37 
`
`Claim 4 ..................................................................................... 54 
`
`Claims 2 and 5 .......................................................................... 55 
`
`Claims 3 and 6 .......................................................................... 55 
`
`D. 
`
`Secondary considerations do not rebut the prima facie case. ............. 56 
`
`VII.  Conclusion .................................................................................................... 58 
`
`VIII.  Mandatory notices (37 C.F.R. § 42.8(a)(1)) ................................................. 58 
`
`
`
`iii
`
`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`
`I.
`
`Introduction
`
`Amneal Pharmaceuticals LLC and Par Pharmaceutical, Inc.’s (collectively
`
`“Petitioners”) submit this Petition for Inter Partes Review (“Petition”) seeking
`
`cancellation of claims 1-6 of U.S. Patent No. 7,765,107 (“the ’107 patent”)
`
`(AMN1001) as unpatentable under 35 U.S.C. § 103(a) in view of the prior art.
`
`For example, published materials that were used in an FDA Advisory
`
`Committee Meeting (the “Advisory Committee Art” or “ACA”) renders obvious
`
`every limitation of the challenged claims more than a year before the ’107 patent’s
`
`earliest effective filing date, as set forth in Ground 1. In addition, Ground 2
`
`demonstrates that other drug distribution systems in public use long before the
`
`’107 patent’s earliest effective filing date also would have rendered the challenged
`
`claims obvious to a person of ordinary skill in the art (“POSA”).
`
`For the reasons explained below, Petitioners are at least reasonably likely to
`
`prevail on the asserted Grounds 1 and/or 2 with respect to the challenged claims.
`
`Petitioners request that this Board institute IPR and cancel each of challenged
`
`claims 1-6 of the ’107 patent.
`
`II. Grounds for standing (37 C.F.R. § 42.104(a))
`Petitioners certify that the ’107 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.
`
`1
`
`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`§§ 42.1-.80 and 42.100-42.123, and cancel claims 1-6—all claims—of the ’107
`
`patent as unpatentable under 35 U.S.C. § 103.
`
`IV. Overview
`A.
`Person of ordinary skill in the art (“POSA”)
`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. (AMN1007, ¶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, 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
`
`2
`
`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`available before the earliest effective filing date of ’107 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.)
`
`State of the art
`
`B.
`The ’107 patent generally pertains to centralizing the distribution of
`
`hazardous or abuse-prone drugs. The ’107 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
`
`oxybate, the sodium salt of gamma hydroxybuyrate (“GHB”)—was well-known in
`
`the prior art as being susceptible to diversion and abuse. (AMN1007, ¶41.) 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 ’107 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 ’107 patent.
`
`Aside from the explicit disclosure of the ’107 patent’s claimed methods in
`
`the prior art, the general mitigation of risks associated with the distribution of
`
`3
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`

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`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`potentially hazardous drugs was well-established in the art before the earliest
`
`effective filing date of the ’107 patent. (Id., ¶22.) For example, in 1982, Hoffman-
`
`La Roche (“Roche”) gained approval for Accutane® (isotretinoin), a potent
`
`teratogen that caused birth defects. (Id.) To address that risk, Roche developed a
`
`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. (Id.) 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.)
`
`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
`
`4
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`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`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 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
`
`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.)
`
`Consequently, it would have been obvious to a POSA in view of the prior art
`
`to develop the centralized distribution systems claimed in the ’107 patent to
`
`5
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`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`minimize the risks associated with the distribution of hazardous prescription drugs.
`
`(Id., ¶28.)
`
`C. The ’107 patent
`Against this backdrop, Jazz obtained the ’107 patent, which relates to a
`
`“drug distribution system and method [that] utilizes a central pharmacy and
`
`database to track all prescriptions for a sensitive drug.” (AMN1001, Abstract.)
`
`According to the ’107 specification, multiple controls are imposed on the
`
`prescription drug distribution. (Id., 1:56-58.) Physician and patient prescription
`
`patterns are monitored for abuse using an exclusive central database. (Id., 2:16-21.)
`
`Physician eligibility to prescribe the drug is verified via a database, including
`
`determining whether disciplinary actions have been brought against the physician.
`
`(Id., 1:48-56.) Prior to shipping the prescription drug, the central pharmacy
`
`confirms whether the patient has been educated, and only ships when no abuse is
`
`found related to the patient and prescribing doctor. (Id., 1:59-67.) The prescription
`
`drug is then delivered to the patient. (Id., 1:59-2:1-3.)
`
`During prosecution of the ’107 patent’s parent application (which issued as
`
`U.S. Patent No. 7,668,730), the independent claims were amended to add the
`
`following limitations to overcome prior art rejections: (1) “all prescriptions for the
`
`sensitive drug are processed only by the exclusive central pharmacy using only the
`
`exclusive computer database;” and (2) “mailing the sensitive drug to the patient
`
`6
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`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`only if no potential abuse is found by the patient to whom the sensitive drug is
`
`prescribed and the doctor prescribing the sensitive drug.” (AMN1016, 241-248,
`
`8/8/06 Amdt; 303-334, 7/18/07 Appeal Brief; 442, 11/2/09 Amdt.) Applicants
`
`argued that the prior art did not teach these limitations. (Id., 449, 11/2/09 Amdt.)
`
`Applicants also argued that “checking the exclusive computer database for
`
`potential abuse of the sensitive drug” was not taught in the prior art. (Id.) The cited
`
`art was found to teach all other claim limitations. (Id., at 258-262, 10/18/06 Final
`
`Rejection; and at 420-433, 8/31/09 Decision on Appeal.)
`
`Subsequently, in the Notice of Allowance for the ’107 patent’s parent
`
`application, the Examiner relied on the same limitations, stating: “the closest prior
`
`art of record does not teach or fairly suggest that all prescriptions for GHB are
`
`processed only by the exclusive central pharmacy using only the exclusive
`
`computer database. The exclusive computer database is checked for potential GHB
`
`abuse and GHB is provided/mailed only if no potential abuse is found by the
`
`patient to whom GHB is prescribed and the doctor/authorized prescriber of the
`
`GHB.” (Id., at 475-476, Notice of Allowance, p. 11.) The ’107 patent claims rely
`
`on similar limitations for patentability. (See AMN1002, Notice of Allowance,
`
`mailed March 10, 2010.)
`
`However, as this petition demonstrates, none of these alleged “novel”
`
`limitations were novel. Using the claimed “exclusive central pharmacy,”
`
`7
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`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`“computer processor,” and “central database” were well-known in the prior art, and
`
`certainly obvious. (See §§ VI.B.1 and VI.C.1.) For example, the same art also
`
`discloses authorizing
`
`the
`
`filling, using
`
`the exclusive central computer
`
`system/exclusive computer database, of a prescription that has been subjected to
`
`multiple controls. (Id.)
`
`V. Claim construction
`Unless otherwise construed herein, the terms of claims 1-6 are to be given
`
`their broadest reasonable interpretation, as understood by one of ordinary skill in
`
`the art in view of the ’107 patent’s specification. See 37 C.F.R. § 42.100(b).
`
`“Exclusive central pharmacy”
`
`A.
`The claims recite the term “exclusive central pharmacy”. During prosecution
`
`of U.S. Patent No. 7,668,730 (“the ’730 patent”), of which the ’107 patent is a
`
`divisional, the applicants defined the term “exclusive” as “single or sole.”
`
`(AMN1016, 402, 12/3/07 Reply Brief) Therefore, the term “exclusive central
`
`pharmacy” should be construed to mean a “single or sole pharmacy”. (AMN1007,
`
`¶37.)
`
`“Periodic reports generated”
`
`B.
`The claims recite the limitation of “periodic reports generated.” (AMN1001,
`
`8:60-61.) The ’107 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.” (Id., 2:19-21 (emphasis added).) The ’107
`
`8
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`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`patent also discloses that reports are obtained by running queries against the central
`
`database. (Id., 8:22-29.) The ’107 patent describes different types of queries run to
`
`obtain information, such as prescriptions by physician, patient name, frequency,
`
`and dose. (Id., 7:53-8:3.) Accordingly, “periodic reports generated” should be
`
`construed to mean “information obtained from querying the computer database,
`
`such as, prescriptions by physician, prescriptions by patient name, prescriptions by
`
`patient name, prescriptions by frequency, and prescriptions by dose.” (AMN1007,
`
`¶38.)
`
`VI.
`
`Identification of challenge
`
`Petitioners request IPR of all claims of the ’107 patent. Per 37 C.F.R. §
`
`42.6(d), copies of the references accompany the Petition. The Grounds for
`
`unpatentability are further supported by the accompanying declaration of Dr.
`
`Robert Valuck, Ph.D., R.Ph. (“Valuck Dec.”) (AMN1007), an expert in the fields
`
`of drug safety, drug abuse prevention, and prescription drug distribution.
`
`Ground
`
`35 USC
`
`Claims
`
`Index of References
`
`1
`
`2
`
`§ 103(a)
`
`1-6
`
`Advisory Committee Art (AMN1003-1006)
`
`§ 103(a)
`
`1-6
`
`Talk About Sleep (AMN1033) in view of
`Honigfeld (AMN1034) further in view of
`Elsayed (AMN1035), and further in view of
`Lilly (AMN1010)
`
`For each asserted ground, Petitioners demonstrate below where each
`
`9
`
`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`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 person of ordinary skill in the art, and any
`
`available objective 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).
`
`A. Each cited reference is available prior art
`The ’107 patent claims benefit to U.S. Patent No. 7,668,730 (“the ’730
`
`patent”), filed on December 17, 2002 (See AMN1001.), which serves as its 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.
`
`1.
`
`The ACA (AMN1003–AMN1006) qualifies as a “printed
`publication”
`
`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 published more than one year prior to the earliest
`
`effective filing date of the ’107 patent—either teaches or renders obvious every
`
`limitation of the challenged claims. The ACA materials comprise four parts: (1) the
`
`10
`
`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`Advisory Committee Transcript and Slides (AMN1003), (2) Preclinical Safety
`
`Review (AMN1004), (3) the Briefing Booklet (AMN1005), and (4) the Xyrem
`
`Video and Transcript (AMN1006).
`
` “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)).
`
`Electronic publications can qualify as “printed publications” as long they
`
`have been disseminated or otherwise made available to a POSA exercising
`
`reasonable diligence. EMC Corp. v. PersonalWeb Techs. LLC, IPR2013-00084
`
`(Paper 14), at *20-21. 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)). Moreover, institution of proceedings cannot be denied because an
`
`electronic reference is not accompanied by a declaration from an author or with
`
`other evidence that someone accessed and received the reference prior to the
`
`critical date. Rackspace US, Inc. v. PersonalWeb Techs. LLC, IPR2014-00059
`
`(Paper 9), at *34 (Board Apr. 15, 2014). Petitioners need only provide sufficient
`
`11
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`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`evidence to demonstrate that the reference was disseminated publicly or otherwise
`
`available. Id. at *34-35 (citing In re Wyer, 665 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 materials (AMN1003-AMN1006) are 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
`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.
`
`(AMN1015 (emphasis added).) 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-
`
`12
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`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`00059, Paper 9, *34 (Apr. 15, 2014) (citing In re Hall, 781 F.2d 897, 899 (Fed.
`
`Cir. 1988)).1 Therefore, based on the stated timelines, the Xyrem Video and
`
`Transcript (AMN1006), the Briefing Booklet (AMN1005), and the Preclinical
`
`Safety Review (AMN1004) were approximately available on the FDA’s website as
`
`of June 5, 2001, while the Advisory Committee Transcript and Slides (AMN1003)
`
`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) prior art. (AMN1017 (relevant bullet point highlighted).)
`
`Notably, the Preclinical Safety Review (AMN1004) 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 (AMN1005) states on its cover that it is
`
`“AVAILABLE FOR PUBLIC DISCLOSURE WITHOUT REDACTION.” There
`
`can be no question that these materials were readily accessible to a POSA. Cf.
`
`
`1 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. 7,765,107
`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).2 The Wayback Machine demonstrates that, at the
`
`latest, a link to the “Briefing Information” (i.e., the Xyrem Video and Transcript
`
`(AMN1006), the Briefing Booklet (AMN1005), and the Preclinical Safety Review
`
`(AMN1004)) was available online on June 17, 2001. (AMN1018, pg. 5, 6/6
`
`Meeting.) Following this link demonstrates that this art was all available on July 1,
`
`2001, at the latest. (AMN1019.) And the Advisory Committee Transcript and
`
`Slides (AMN1003) were available by October 4, 2001, at the latest—one year prior
`
`to December 17, 2002. (AMN1020, pg. 8, 6/6 Meeting.)
`
`Additionally, a POSA “exercising reasonable diligence” would have been
`
`able to locate the ACA. (AMN1007, ¶42; AMN1015.) 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.” (AMN1007,
`
`
`2 The Board has not precluded the use of Documents from the Wayback Machine
`
`when making institution decisions. See, e.g., IPR2013-00142, Paper 11, *9-10
`
`(Aug. 7, 2013).
`
`14
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`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`¶42; AMN1015.) Moreover, the Federal Register also points a POSA to where the
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`ACA would be located before and after the meeting. (AMN1007, ¶42; AMN1015.)
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`A POSA would have known to look in the Federal Register and on the FDA’s
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`website to obtain information related to existing and proposed risk management
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`programs. (AMN1007, ¶42.)
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`Additionally, ACA would have been available via a Freedom of Information
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`Act request, as they were part of an Advisory Committee meeting, indexed and
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`easily identifiable by reference to that meeting, and publicly available as a result.3
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`5 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
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`(AMN1004) contains redactions marked “(b)(4),” which are a specific reference to
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`5 U.S.C. § 552(b)(4) (allowing for redaction of trade secret information). The
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`Briefing Booklet (AMN1005) also states that it was available for public disclosure
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`without redaction.
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`In sum, the ACA was a collection of publicly available, printed publications
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`that were disseminated together for the same purpose, which would have been
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`available to and readily located by a POSA more than one year prior to the priority
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`benefit date of the ’107 patent. (AMN1028.)
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`2.
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`Talk About Sleep (AMN1033), Honigfeld (AMN1034),
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`3 See note 1, supra.
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`15
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`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`Elsayed (AMN1035) and Lilly (AMN1010)
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`Talk About Sleep (hereinafter “TAS”) is entitled to the §102(b) prior art date
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`of its publication: February 12, 2001. Honigfeld is entitled to the 102(b) prior art
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`date of its publication: March 31, 1998. Elsayed is entitled to the §102(b) prior art
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`date of its issue: April 4, 2000. Lilly is entitled to a § 102(e) prior art date of
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`November 14, 2001, the filing date of its earliest provisional application. See, e.g.,
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`In re Giacomini, 612 F.3d 1380 (Fed. Cir. 2010).
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`B. Ground 1: Claims 1-6 are obvious over ACA
`As supported by the declaration of Dr. Valuck, claims 1-6 of the ’107 patent
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`would have been obvious over the ACA (AMN1003-1006). The ACA qualifies as
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`prior art to the claims of the ’107 patent. (See § VI.A.1) These materials were
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`disseminated together for use in the FDA’s Advisory Committee Meetings for
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`Xyrem® and is a written public record of what transpired at the meeting. And, as
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`announced in the Federal Register, each publication was readily accessible to the
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`public from a central location on the FDA’s website more than one year before the
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`earliest effective filing date of the ’107 patent. (AMN1019.)
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`A POSA would have had more than ample reason to combine these ACA
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`materials4—(1) Advisory Committee Transcript and Slides (AMN1003), (2)
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`4 The ACA can also constitute a single disclosure, because the Xyrem FDA
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`Webpage has a menu that lists all of the documents pertaining to the same June 6,
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`16
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`Petition for Inter Partes Review
`of U.S. Patent No. 7,765,107
`Preclinical Safety Review (AMN1004), (2) Briefing Booklet (AMN1005), and (4)
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`Xyrem Video and Transcript (AMN1006)— because items 2-4 were all distributed
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`together for a single meeting before the FDA seeking approval for prescription
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`Xyrem®, and item 1 was a public transcript of the meeting itself. (AMN1007,
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`¶45.) Moreover, a POSA would also have had a reasonable expectation of success
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`when combining each of these materials to arrive at the claims 1-6 because they
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`clearly relate to the same restricted distribution program which the meeting was
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`convened to discuss. (AMN1007, ¶45.) Further, the Xyrem Video and Transcript
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`(AMN1006) is incorporated by reference into the Advisory Committee Transcript
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`and Slides (AMN1003), and into the Briefing Booklet (AMN1005). (See
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`AMN1003; AMN1005.) And, each of the ACA is all linked from a single web
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`page. (AMN1027), giving more reason to combine the individual references.
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`(AMN1007, ¶45.)
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`Claim 1 would have been obvious
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`1.
`As supported by the declaration of Dr. Valuck, each limitation of claim 1 is
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`found in the ACA and/or rendered obvious. (See AMN1007, ¶¶45-75.)
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`2001 Meeting of the Peripheral and Central Nervous System Drugs Advisory
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`Committee (held to discuss risk management issues relating to Xyrem), which
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`also was available more than one year before the patent’s priority date.
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`(AMN1027.)
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`17
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`Petitionn for Inter
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`Partes Reeview
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`of UU.S. Patent
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`No. 7,7655,107
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`TThe ’107 paatent proviides severaal flow diaagrams, toggether desccribing eacch of
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`claim 1’s limitations. The ffigure beloow has beeen producced based
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`figures of the ’1077 patent forr ease of uunderstandiing each limmitation.
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`The preammble of thhe ’107 paatent’s indeependent cclaim 1 re
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`Preamble:
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`preamble is a claiim limitatiion (whichh it is not),, the ACA
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`the disttribution. ((AMN10033, Slide, ppg. 146, reeproduced
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`discloses
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`computeriizing
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`below wiith annotaation;
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`AMN10006, Tr., pgg. 10 n.42;; V55 00:166-00:27, VV7 00:00-000:16; AMNN1007, ¶477.)
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`5 Citations to thee Xyrem VVideo (AMMN1006)
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`will be prrovided ass VX YY::YY,
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`Petitionn for Inter
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`Partes Reeview
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`of UU.S. Patent
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`No. 7,7655,107
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`ACCA: Figuree shows
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`phaarmacist att single
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`utillizing a co
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`TTo the extent the Boaard determiines that thhe ACA is
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`a POSAA would haave found
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`it obvious
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`that the AACA’s clossed distribuution systeem is
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`computerized. (AAMN1007,, ¶48.) TThe ACAA disclose
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`potentiaally thousaands of preescription rrequests att the singlee national
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`enteringg that data
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`259:4;
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`AMN10055, cover lletter; AMMN1007, ¶¶48.) The
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`collected
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`data provvides
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`pharmacyy and
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`24:21-24,, and
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`“centrallly locatedd, real-timme data [thhat] will bbe invaluaable to iddentificationn of
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`suspicioous [behavvior].” (AMMN1005, ppgs. 304 annd 311; AMMN1007, ¶¶48.) A POOSA
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