UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WOCKHARDT BIO AG
`
`Petitioner
`
`V.
`
`JAZZ PPLARMACEUTICALS, INC.
`Patent Owner
`
`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
`
`Mail Stop “PATENT BOARD ”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`

`
`TABLE OF CONTENTS
`
`Introduction ................................................................................................... .. 1
`
`II.
`
`III.
`
`Grounds for standing (37 C.F.R. § 42.lO4(a)) .............................................. .. 2
`
`Statement of the precise relief requested and the reasons therefore ............. .. 2
`
`IV.
`
`Overview ....................................................................................................... .. 2
`
`A.
`
`B.
`
`C.
`
`Person of ordinary skill in the art (“POSA”) ...................................... .. 2
`
`State of the art ..................................................................................... .. 3
`
`The ’ 107 patent ................................................................................... .. 6
`
`Claim construction ........................................................................................ .. 8
`
`A.
`
`B.
`
`“Exclusive central pharmacy” ............................................................ .. 8
`
`“Periodic reports generated” ............................................................... .. 9
`
`VI.
`
`Identification of challenge ............................................................................ .. 9
`
`A.
`
`Each cited reference is available prior art ........................................ .. l0
`
`1.
`
`The ACA (Ex. lOO3—EX. 1006) qualifies as a “printed
`publication” ............................................................................ .. l0
`
`B.
`
`Ground 1: Claims 1-6 Would have been obvious over the
`
`ACA .................................................................................................. .. I6
`
`1.
`
`2.
`
`3.
`
`4.
`
`Claim 1 ................................................................................... .. l7
`
`Claim 4 ................................................................................... .. 33
`
`Claims 2 and 5 ........................................................................ .. 34
`
`Claims 3 and 6 ........................................................................ .. 35
`
`C.
`
`Secondary considerations do not rebut the primafacie case. .......... .. 36
`
`VII.
`
`Conclusion .................................................................................................. .. 3 8
`
`VIII.
`
`Mandatory notices (37 C.F.R. § 42.8(a)(l)) ............................................... .. 38
`
`

`
`Petition for Inter Partes Review
`of US. Patent No. 7, 765,107
`
`I.
`
`Introduction
`
`On July 28, 2015,
`
`the Board instituted Inter Partes Review (“IPR”) of
`
`claims 1-6 of U.S. Patent No. 7,765,107 (“the ’lO7 patent”)
`
`(EX. 1001)
`
`in
`
`IPR20l5—00547. In its decision for institution,
`
`the Board determined that it is
`
`reasonably likely that published materials used in an FDA Advisory Committee
`
`Meeting (the “Advisory Committee Art” or “ACA”) would have rendered obvious
`
`claims l—6 of the ’l07 patent more than a year before the ’107 patent’s earliest
`
`effective filing date. See IPR2015—00547, Paper 25 at 28-35.
`
`Wockhardt Bio AG (“Wockhardt”) submits this Petition for IPR (“Petition”)
`
`also seeking cancellation of claims 1-6 of the ‘ 107 patent as unpatentable under 35
`
`U.S.C. §l03(a) over the Advisory Committee Art. This petition presents the same
`
`arguments, based on the same prior art presented in the IPR20l5—00547 Petition
`
`(IPR20l5-00547, Paper 3), and on which the Board instituted IPR in IPR20l5—
`
`00547, along with a Motion for Joinder to join this Petition with the IPR20l5—
`00547 proceedings. Indeed, this petition is an almostverbatim copy of the petition
`
`in IPR20l5—00547, but missing the discussion of uninstituted Ground 2 in that
`
`case.
`
`For the reasons explained below, and for the reasons the Board instituted
`
`IPR in IPR20l5—00547, Wockhardt is reasonably likely to prevail on Ground 1
`
`with respect to the challenged claims. Wockhardt requests that this Board institute
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`

`
`Petition for Inter Partes Review
`of US. Patent No. 7, 765,107
`
`IPR and cancel each of claims 1-6 of the ’ 107 patent.
`
`II.
`
`Grounds for standing (37 C.F.R. § 42.104(a))
`
`Wockhardt certifies that the ’ 107 patent is available for IPR and Wockhardt
`
`is 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.l00—42.l23, and cancel claims 1—6—a1l claims—of the ’l07
`
`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. (Ex. 1007, 1121.)
`
`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
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`

`
`Petition for Inter Partes Review
`of US. Patent No. 7, 765,107
`
`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 ’l07 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 ’l07 patent generally pertains to centralizing the distribution of
`
`hazardous or abuse—prone drugs. The ’l07 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. (Ex. 1007, 1141.) 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 ’l07 patent in the FDA’s
`
`OB for Xyrern®, Jazz is asserting that the Xyrem® Success Program is an
`
`Petition for Inter Partes Review
`of US. Patent No. 7, 765,107
`
`embodiment of at least one claim of the ’ 107 patent.
`
`Aside from the explicit disclosure of the ’l07 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 ’l07 patent. (Id., 1122.) 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
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`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
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`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.
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`

`
`Petition for Inter Partes Review
`of US. Patent No. 7,765,107
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`(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
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`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 to aid in filling prescriptions. (Id., 1124.)
`
`On the heels of the Accutane® and Clozaril® restricted distribution systems,
`
`in 1999,
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`the manufacturers of prescription thalidomide—yet another known
`
`teratogenic drug——deVeloped a hybrid system, combining the computerized
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`registry system of Clozaril® and the pregnancy monitoring/prevention, and
`
`informed consent
`
`requirements of Accutane® to monitor and control
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`the
`
`distribution of the drug. (Id., 1[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, 1126.) Moreover, While risk management
`
`programs were developing during the 1980s through 19905, pharmacies had
`
`already been using computerized systems for the distribution of narcotics and other
`
`controlled substances, i. e., drugs with potential for abuse. (Id., 1127.) 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
`
`Petition for Inter Partes Review
`of US. Patent No. 7, 765,107
`
`the detection of abuse patterns. (Id.)
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`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
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`minimize the risks associated with the distribution of hazardous prescription drugs.
`
`(Id., 1128.)
`
`C.
`
`The ’107 patent
`
`Against this backdrop, Jazz obtained the ’l07 patent, which relates to a
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`“drug distribution system and method [that] utilizes a central pharmacy and
`
`database to track all prescriptions for a sensitive drug.” (Ex. 1001, Abstract.)
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`According to the ’107 specification, multiple controls are imposed on the
`
`prescription drug distribution. (Id., 1:56-58.) Physician and patient prescription
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`patterns are monitored for abuse using an exclusive central database. (Id., 2:16-21.)
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`Physician eligibility to prescribe the drug is verified via a database, including
`
`determining whether disciplinary actions have been brought against the physician.
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`(Id., 1:48-56.) Prior to shipping the prescription drug,
`
`the central pharmacy
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`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
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`drug is then delivered to the patient. (Id, 1159-2: 1-3.)
`
`

`
`Petition for Inter Partes Review
`of US. Patent No. 7, 765,107
`
`During prosecution of the ’l07 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
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`only if no potential abuse is found by the patient to whom the sensitive drug is
`
`prescribed and the doctor prescribing the sensitive drug.” (Ex. 1016, 241-248,
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`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 ’l07 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
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`patient to whom GHB is prescribed and the doctor/authorized prescriber of the
`
`

`
`GHB.” (Id., at 475-476, Notice of Allowance, p. 11.) The ’l07 patent claims rely
`
`on similar limitations for patentability. (See Ex. 1002, Notice of Allowance, mailed
`
`Petition for Inter Partes Review
`of US. Patent No. 7, 765,107
`
`March 10, 2010.)
`
`However, as this petition demonstrates, none of these alleged “novel”
`
`limitations were novel. Using the claimed
`
`exclusive central pharmacy,”
`
`(6
`
`“computer processor,” and “central database” were well—known in the prior art, and
`
`certainly obvious. (See §§ VI.B.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.lO0(b).
`
`A.
`
`“Exclusive central pharmacy”
`
`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.” (Ex.
`
`1016, 402, 12/3/07 Reply Brief) Therefore, the term “exclusive central pharmacy”
`
`should be construed to mean a “single or sole pharmacy”. (Ex. 1007, 1137.)
`
`

`
`Petition for Inter Partes Review
`of US. Patent No. 7, 765,107
`
`B.
`
`“Periodic reports generated”
`
`The claims recite the limitation of “periodic reports generated.” (Ex. 1001,
`
`8:60-61.) The ’l07 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
`
`patent also discloses that reports are obtained by running queries against the central
`
`database. (Id., 8:22-29.) The ’l07 patent describes different types of queries run to
`
`obtain information, such as prescriptions by physician, patient name, frequency,
`
`and dose. (Id., 7:53-83.) 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.” (Ex. 1007,
`
`1l38.)i
`
`VI.
`
`Identification of challenge
`
`Wockhardt requests IPR of all claims of the ’l07 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.”) (Ex. l007)1, an expert in the fields of
`
`1 Wockhardt submits and relies upon an identical copy of the Declaration of Dr.
`
`

`
`drug safety, drug abuse prevention, and prescription drug distribution.
`
`Petition for Inter Partes Review
`of US. Patent No. 7, 765,107
`
`Ground
`
`Advisory Committee Art (Ex. 1003-1006)
`
`Claims
`
`Index of References
`
`A.
`
`Each cited reference is available prior art
`
`The ’l07 patent claims benefit to U.S. Patent No. 7,668,730 (“the ’730
`
`patent”), filed on December 17, 2002 (See EX. 1001), 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 (Ex. 1003—Ex. 1006) 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
`
`Valuck submitted in Amneal Pharms., LLC, et al. v. Jazz Pharms., Inc., Case No.
`
`IPR2015—00547 (“the Amneal/Par
`
`IPR”). Dr. Valucl<’s Declaration in the
`
`Amneal/Par IPR (here referred to as EX. 1007) discusses one ground of
`
`unpatentability not instituted by the Board in the Amneal/Par IPR. Wockhardt
`
`does not rely upon that part of his declaration in this proceeding.
`
`10
`
`

`
`Petition for Inter Partes Review
`of US. Patent No. 7, 765,107
`
`collection of materials that were used in that meeting (the “Advisory Committee
`
`Art” or “ACA”)-—a1l 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
`
`Advisory Committee Transcript and Slides (Ex. 1003),
`
`(2) Preclinical Safety
`
`Review (Ex. 1004), (3) the Briefing Booklet (Ex. 1005), and (4) the Xyrem Video
`
`and Transcript (Ex. 1006).
`
`“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.” [d., at *2l (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
`
`11
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`

`
`Petition for Inter Partes Review
`of US. Patent No. 7, 765,107
`
`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). Wockhardt need only provide sufficient
`
`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 (EX.
`
`1003—EX. 1006) 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
`
`12
`
`

`
`generally posted about 3 weeks after the meeting.
`
`Petition for Inter Partes Review
`of US. Patent No. 7,765,107
`
`(Ex. 1015 (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—
`
`00059, Paper 9, *34 (Apr. 15, 2014) (citing In re Hall, 781 F.2d 897, 899 (Fed.
`
`Cir. 1988))? Therefore, based on the stated timelines,
`
`the Xyrem Video and
`
`Transcript (Ex. 1006), the Briefing Booklet (Ex. 1005), and the Preclinical Safety
`
`Review (Ex. 1004) were approximately available on the FDA’s website as of June
`
`5, 2001, While the Advisory Committee Transcript and Slides (Ex. 1003) 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. (Ex. 1017 (relevant bullet point highlighted).)
`
`Notably, the Preclinical Safety Review (Ex. 1004) contains redactions of the
`
`name of the proposed specialty pharmacy for distribution of Xyrem®—further
`
`2 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 US. Patent No. 7, 765,107
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`evidence that these materials would be, and were intended to be, available to the
`
`public. And the Briefing Booklet
`
`(EX. 1005) 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
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`IPR2013—O0458, 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
`
`https2//archive.org/Web/web.php).3 The Wayback Machine demonstrates that, at the
`
`latest, a link to the “Briefing Information” (i.e., the Xyrem Video and Transcript
`
`(Ex. 1006), the Briefing Booklet (EX. 1005), and the Preclinical Safety Review
`
`(EX. 1004)) was available online on June 17, 2001. (EX. 1018, pg. 5, 6/6 Meeting.)
`
`Following this link demonstrates that this art was all available on July 1, 2001, at
`
`the latest. (EX. 1019.) And the Advisory Committee Transcript and Slides (EX.
`
`1003) were available by October 4, 2001, at the latest—-one year prior to December
`
`17, 2002. (Ex. 1020, pg. 8, 6/6 Meeting.)
`
`3 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 US. Patent No. 7,765,107
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`Additionally, a POSA “exercising reasonable diligence” would have been
`
`able to locate the ACA. (Ex. 1007, 1142; Ex. 1015.) 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.” (Ex. 1007,
`
`1142; Ex. 1015.) Moreover, the Federal Register also points a POSA to where the
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`ACA would be located before and after the meeting. (Ex. 1007, 1142; Ex. 1015.) A
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`POSA would have known to look in the Federal Register and on the FDA’s
`
`website to obtain information related to existing and proposed risk management
`
`programs. (Ex. 1007, 1142.)
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`Additionally, ACA 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.4
`
`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 (Ex.
`
`1004) 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
`
`Briefing Booklet (Ex. 1005) also states that it was available for public disclosure
`
`without redaction.
`
`4 See note 2, Supra.
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`15
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`Petition for Inter Partes Review
`of US. Patent No. 7, 765,107
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`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
`
`benefit date of the ’ 107 patent. (EX. 1028.)
`
`B.
`
`Ground 1: Claims 1-6 would have been obvious over the ACA
`
`As supported by the declaration of Dr. Valuck, claims 1-6 of the ’107 patent
`
`would have been obvious over the ACA (Ex. 1003-1006). The ACA qualifies as
`
`prior art to the claims of the ’107 patent. (See § VI.A.1) These materials were
`
`disseminated together for use in the FDA’s Advisory 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 from a central location on the FDA’s website more than one year before the
`
`earliest effective filing date of the ’ 107 patent. (Ex. 1019.)
`
`A POSA would have had more than ample reason to combine these ACA
`
`materials5—(1) Advisory Committee Transcript and Slides
`
`(EX. 1003),
`
`(2)
`
`5 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
`
`16
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`

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`Petition for Inter Partes Review
`of US. Patent No. 7, 765,107
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`Preclinical Safety Review (EX. 1004), (2) Briefing Booklet (EX. 1005), and (4)
`
`Xyrem Video and Transcript (Ex. 1006)—— because items 2-4 were all distributed
`
`together for a single meeting before the FDA seeking approval for prescription
`
`Xyrem®, and item 1 was a public transcript of the meeting itself. (EX. 1007, 1145.)
`
`Moreover, a POSA would also have had a reasonable expectation of success when
`
`combining each of these materials to arrive at the claims 1-6 because they clearly
`
`relate to the same restricted distribution program which the meeting was convened
`
`to discuss. (EX. 1007, 1145.) Further, the Xyrem Video and Transcript (EX. 1006) is
`
`incorporated by reference into the Advisory Committee Transcript and Slides (Ex.
`
`1003), and into the Briefing Booklet (EX. 1005). (See EX. 1003; EX. 1005.) And,
`
`each of the ACA is all linked from a single web page. (Ex. 1027), giving more
`reason to combine the individual references. (EX. 1007, 1145.)
`
`1.
`
`Claim 1
`
`As supported by the declaration of Dr. Valuck, each limitation of claim 1 is
`
`found in the ACA and/or rendered obvious. (See EX. 1007, 1145-75.)
`
`The ’ 107 patent provides several flow diagrams, together describing each of
`
`claim 1’s limitations. The figure below has been produced based on those flow
`
`also was available more than one year before the patent’s priority date. (Ex.
`
`1027.)
`
`17
`
`

`
`diagrams and maps each limitation of claim 1
`
`to a flow diagram step from the
`
`figures of the ’ 107 patent for ease of understanding each limitation.
`
`Petition for Inter Partes Review
`of US. Patent No. 7, 765,107
`
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`Preamble: The preamble of the ’107 patent’s independent claim 1 recites
`
`“[a] computerized method to control abuse of a prescription drug.” Even if the
`
`preamble is a claim limitation (which it is not), the ACA discloses computerizing
`
`the distribution. (EX. 1003, Slide, pg. 146, reproduced below with annotation; Ex.
`
`1006, Tr., pg. 10 n.42; V56 00:16-00:27, V7 00:00-00:16; EX. 1007, 1147.)
`
`6 Citations to the Xyrem Video (EX. 1006) will be provided as VX YY:YY, where
`
`VX = EX. 1006, Video, part X.
`
`18
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`Xyrem Closed Distribution System
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`Petition for Inter Partes Review
`of US. Patent No. 7,765,107
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`
`
`
`
`
`=....
`Single
`Manufacturing
`Facility
`
`vernight
`courier
`
`Specialty
`
`2 Pharmacy
`
`ACA: Figure shows
`pharmacist at single
`specialty pharmacy
`utilizing a computer.
`
`Patient
`
`To the extent the Board determines that the ACA is not an explicit teaching,
`
`a POSA would have found it obvious that the ACA’s closed distribution system is
`
`computerized. (EX. 1007, 1148.) The ACA discloses receiving data from potentially
`
`thousands of prescription requests at the single national pharmacy and entering that
`
`data into a registry. (See, e.g., EX. 1003, Tr., 1624-7, 24:21-24, and 259:4; EX.
`
`1005, cover letter; Ex. 1007, 1[48.) The collected data provides “centrally located,
`
`real—time data [that] will be invaluable to identification of suspicious [behaVior].”
`
`(EX. 1005, pgs. 304 and 311; Ex. 1007, 1148.) A POSA would have appreciated
`
`from this disclosure that the single national pharmacy utilized a computer to collect
`
`the prescription information and real time monitor physician prescribing patterns
`
`and patient activity. (EX. 1007, 1148.)
`
`As such, a POSA would have understood that the ACA discloses using a
`
`computer to distribute a prescription drug (Xyrem) from a central location to
`
`control abuse of the prescription drug—-—especially because the need to enter,
`
`access, and store large amounts of information would be accelerated, and thus,
`
`facilitated by using a computer. (Id. , W496 0.)
`
`Step 1.1: The ACA explicitly discloses distributing Xyrem® in a “closed
`
`19
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`

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`Petition for Inter Partes Review
`of US. Patent No. 7, 765,107
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`loop distribution system.” (Ex. 1003, Tr., 177:24—178:11; Slides, pgs. 146-147; Ex.
`
`1004, pg. 108; Ex. 1005, pgs. 300 and 304; Ex. 1006, Tr., pg. 4 n.l4 and pg. 10
`
`n.42; Ex. 1007, 1152.) That distribution system entails manufacturing Xyrem® at a
`
`single manufacturing facility and providing it to “one single national specialty
`
`pharmacy” that will be “[t]he primary and exclusive distributor.” (Ex. 1003, Tr.,
`
`177:24—l78:11 and l83:12—16;Ex. 1004, pg. 108; Ex. 1005, pgs. 306 and 309; Ex.
`
`1006, Tr., pg. 4 n.13; Ex. 1007, 1152.) As discussed above, the term “exclusive”
`
`means “single or sole.” Thus an exclusive central pharmacy is a single or sole
`
`pharmacy. (See § V.A.) As such, a POSA would have understood the “one single
`
`national specialty pharmacy” is the claimed “exclusive central pharmacy.” (Ex.
`
`1007, 1152.)
`
`The ACA also discloses that the exclusive central phar