UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`WOCKHARDT BIO AG
`Petitioner
`
`
`
`
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`______________________
`
`Case IPR: Unassigned
`______________________
`
`
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 7,668,730
`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. 7,668,730
`
`TABLE OF CONTENTS
`
`
`Introduction And Statement Of Relief Requested (37 C.F.R. §
`42.22(a)) .......................................................................................................... 1 
`
`Grounds for standing (37 C.F.R. § 42.104(a)) ................................................ 2 
`
`Statement of the precise relief requested and the reasons therefore ................ 2 
`
`
`
`I. 
`
`II. 
`
`III. 
`
`IV.  Overview ......................................................................................................... 2 
`
`A. 
`
`B. 
`
`C. 
`
`Person of ordinary skill in the art (“POSA”) ......................................... 2 
`
`State of the art ........................................................................................ 3 
`
`The ’730 patent ...................................................................................... 7 
`
`V. 
`
`Claim construction ........................................................................................ 10 
`
`A. 
`
`B. 
`
`“Exclusive central pharmacy” and “exclusive computer
`database” .............................................................................................. 10 
`
`“Generating with the computer processor periodic reports via
`the exclusive computer database” ....................................................... 10 
`
`VI. 
`
`Identification of challenge (37 C.F.R. § 42.104) .......................................... 11 
`
`A. 
`
`Each of the references cited is available prior art ................................ 12 
`
`1. 
`
`The ACA (Ex. 1003 – Ex. 1006) qualify as “printed
`publications” ............................................................................ 12 
`
`B. 
`
`Ground 1: Claims 1-11 would have been obvious over the
`ACA ..................................................................................................... 18 
`
`1. 
`
`2. 
`
`3. 
`
`4. 
`
`Comparison of the ’730 patent claims to the prior art .............. 19 
`
`Claim 1 ..................................................................................... 21 
`
`Claim 2 ..................................................................................... 33 
`
`Claim 3 ..................................................................................... 33 
`
`
`
`-i-
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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
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`5. 
`
`6. 
`
`7. 
`
`8. 
`
`9. 
`
`Claims 4 and 5 .......................................................................... 34 
`
`Claim 6 ..................................................................................... 34 
`
`Claim 7 ..................................................................................... 35 
`
`Claim 8 ..................................................................................... 36 
`
`Claim 9 ..................................................................................... 37 
`
`10.  Claim 10 ................................................................................... 37 
`
`11.  Claim 11 ................................................................................... 37 
`
`C. 
`
`Secondary considerations do not rebut the prima facie case. .............. 38 
`
`VII.  Conclusion .................................................................................................... 43 
`
`VIII.  Mandatory notices (37 C.F.R. § 42.8(a)(1)) .................................................. 43 
`
`
`
`
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`-ii-
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`

`
`Introduction And Statement Of Relief Requested (37 C.F.R. § 42.22(a))
`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`
`
`I.
`
`On July 28, 2015, the Board instituted Inter Partes Review (“IPR”) of
`
`claims 1-11 of U.S. Patent No. 7,668,730 (“the ’730 patent”) (Ex. 1001) in
`
`IPR2015-00554. 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 1-11 of the ’730 patent more than a year before the ’730 patent’s earliest
`
`effective filing date. See IPR2015-00554, Paper 20 at 30-36.
`
`Wockhardt Bio AG (“Wockhardt”) submits this Petition for IPR (“Petition”)
`
`also seeking cancellation of claims 1-11 of the ’730 patent as unpatentable under
`
`35 U.S.C. §103(a) over the Advisory Committee Art. This petition presents the
`
`same arguments, based on the same prior art presented in the IPR2015-00554
`
`Petition (IPR2015-00554, Paper 1), and on which the Board instituted IPR in
`
`IPR2015-00551, along with a Motion for Joinder to join this Petition with the
`
`IPR2015-00551 proceedings. Indeed, this petition is an almost verbatim copy of
`
`the petition in IPR2015-00551, 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 IPR2015-00554, Wockhardt is reasonably likely to prevail on Ground 1
`
`with respect to the challenged claims. Wockhardt requests that this Board institute
`
`1
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`

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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`IPR and cancel each of claims 1-11 of the ’730 patent.
`
`II. Grounds for standing (37 C.F.R. § 42.104(a))
`Wockhardt certifies that the ’730 patent is available for IPR and Wockhardt
`
`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 1-11—all claims—of the ’730
`
`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,
`
`¶20.) For example, a POSA would hold a Bachelor’s or Doctor of Pharmacy
`
`degree and a license as a registered pharmacist with 3-5 years of relevant work
`
`experience, or a computer science undergraduate degree or equivalent work
`
`experience and work experience relating to business applications, for example,
`
`including familiarity with drug distribution procedures. Alternatively, a POSA
`
`may have a blend of computer science and pharmacy drug distribution knowledge
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`2
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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`and/or experience. For example, such a POSA may have computer science
`
`education qualifications and experience relating to computerized drug distribution
`
`systems, or pharmacy education qualifications and experience relating
`
`to
`
`computerized drug distribution systems. (Id.)
`
`A POSA would have had knowledge of the literature concerning pharmacy
`
`practice and prescription drug distribution, such as the prior art presented herein,
`
`that was available before the earliest effective filing date of ’730 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 ’730 patent generally pertains to centralizing the distribution of
`
`hazardous or abuse-prone drugs. The ’730 patent is listed in the United States Food
`
`and Drug Administration’s electronic publication known as the “Orange Book”
`
`(“OB”), in connection with the prescription drug product Xyrem®. The active
`
`ingredient
`
`in Xyrem®—sodium oxybate,
`
`the
`
`sodium
`
`salt of gamma
`
`hydroxybuyrate (“GHB”)—was well-known in the prior art as being susceptible to
`
`diversion and abuse. (Ex. 1007, ¶46.) So, as a prerequisite to FDA approval, the
`
`sponsor of Xyrem®, with assistance and direction from an FDA advisory
`
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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`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 ’730 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
`
`’730 patent.
`
`Aside from the explicit disclosure of the ’730 patent’s claimed methods in
`
`the prior art, the 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 ’730 patent. For example, in 1982, Hoffman-La Roche (“Roche”)
`
`gained approval for Accutane® (isotretinoin), which became known to be a potent
`
`teratogen that was responsible for birth defects. (Ex. 1007, ¶21.) Under pressure to
`
`respond, Roche developed a Pregnancy Prevention Program for Accutane®. (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 beginning treatment. (Id.)
`
`Following in the footsteps of Accutane®, in 1990, Clozaril® (clozapine)
`
`entered the United States market for use with treatment-resistant schizophrenia.
`
`(Ex. 1007, ¶22.) However, Clozaril® use was associated with agranulocytosis, a
`
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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`potentially fatal blood disorder resulting in white blood cell loss. (Id.) To mitigate
`
`these risks and control the distribution of Clozaril®, the manufacturer implemented
`
`a national registry system that limited distribution of the drug. (Id.) The
`
`distribution system required registration in an integrated computerized database—
`
`collecting information identifying the patient and the physician and measuring the
`
`patient’s white blood cell count before filling a prescription. (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.) Overall, the
`
`Clozaril® distribution system resulted in 97% compliance over its first five years
`
`of implementation. (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., ¶23.)
`
`Based on the experiences of patients and doctors with Accutane® and
`
`Clozaril®, in 1999, the manufacturers of prescription thalidomide—a known
`
`teratogen—developed a hybrid system, combining the computerized registry
`
`system of Clozaril® and the pregnancy monitoring/prevention, and informed
`
`consent requirements of Accutane®. (Id., ¶24.) This combination of computerized
`
`registry system and preventative testing served to monitor and control the
`
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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
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`distribution of the drug. (Id.)
`
`Thus, by 1999, at least three systems for the restricted distribution of
`
`effective, yet hazardous prescription drugs were known in the art and implemented
`
`across the industry. Moreover, while risk management programs were developing
`
`during the 1980s through 1990s, pharmacies had already been using computerized
`
`systems for the distribution of controlled substances, i.e., drugs with potential for
`
`abuse. (Id., ¶¶25, 26.) Aiming to reduce time for dispensing, improve accuracy and
`
`accountability, and streamline record keeping, the distribution of controlled
`
`substances veered toward automation via the implementation of computerized
`
`systems of distribution. (Id., ¶26.) Computerized systems were helpful in
`
`generating reports tracking patients who were receiving excessive supplies of
`
`controlled substances. (Id.) Distribution of controlled substances could be tied to
`
`information identifying the patient, the prescribing doctor, the quantity of the drug
`
`dispensed, and the hospital inventory of a drug. (Id.) And, the systems could be
`
`queried to provide data, such as prescriptions by doctor and patient. (Id.) These
`
`systems allowed for detecting patterns of abuse. (Id.)
`
`Given the proclivity for diversion and abuse of GHB, the FDA held advisory
`
`committee meetings as a prerequisite to granting approval to the Xyrem® New
`
`Drug Application (“NDA”). A collection of materials that were used in that
`
`meeting (the “Advisory Committee Art” or “ACA”)—all of which published more
`
`6
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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`than one year prior to the earliest effective filing date of the ’730 patent—discloses
`
`every limitation of the challenged claims.
`
`Consequently, prior to the earliest effective filing date of the ’730 patent, the
`
`prior art existed that would have led a POSA to develop the centralized distribution
`
`methods claimed in the ’730 patent to minimize the risks associated with the
`
`distribution of hazardous, but therapeutically beneficial, prescription drugs. (Id.,
`
`¶27.)
`
`C. The ’730 patent
`Against this backdrop, Jazz obtained the ’730 patent. The ’730 patent relates
`
`to “[a] drug distribution system and method [that] utilizes a central pharmacy and
`
`database to track all prescriptions for a sensitive drug.” (Ex. 1001, Abstract.)
`
`According to the ’730 patent, prescription patterns by physicians and patients are
`
`monitored for abuse using an exclusive central database. Further, 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., 1:44-50.) Prior to shipping the prescription drug, the central
`
`pharmacy confirms whether the patient has been educated about the prescription,
`
`and only ships the prescription drug when no abuse is found related to the patient
`
`or prescribing doctor. (See id., 1:52-63.) Reports are then generated to evaluate
`
`potential diversion patterns. (See id., 2:13-15.)
`
`7
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`

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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`The ’730 patent claims are directed to a method of distributing a prescription
`
`drug from an exclusive central pharmacy that comprises: (1) receiving in a
`
`computer processor all prescription requests for any and all patients only at the
`
`exclusive central pharmacy, entering information from the prescription requests
`
`into an exclusive computer database associated with the exclusive central
`
`pharmacy and processing the prescription requests only by the exclusive central
`
`pharmacy using only the exclusive computer database; (2) checking for patterns of
`
`abuse using the exclusive computer database; (3) only providing the prescription
`
`drug to the patient if no abuse is found; and (4) generating periodic reports to
`
`evaluate potential diversion patterns.
`
`During prosecution of the application that led to the ’730 patent (U.S. Patent
`
`Application No. 10/322,348 (“the ’348 application”)), 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 only if no potential abuse is found by the patient to
`
`whom the sensitive drug is prescribed and the doctor prescribing the sensitive
`
`drug.”1 (Ex. 1002, 698 (Amdt. & Reply filed Nov. 2, 2009; see also Ex. 1002,
`
`
`1 Emphasis added throughout unless otherwise noted.
`
`8
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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`401 (Amdt. & Reply filed Aug. 8, 2006) and 522 (Appeal Brief filed July 18,
`
`2007).) Applicants argued that these limitations were not taught by the cited prior
`
`art. (Ex. 1002, 699 (Amdt. & Reply, filed Nov. 2, 2009).) All other limitations of
`
`the claims were found to have been taught by the cited prior art. (Id. at 417-430
`
`(Final Rejection, Oct. 18, 2006) and at 592-604 (Decision on Appeal, Aug. 31,
`
`2009).)
`
`Subsequently, in the Notice of Allowance for the ’348 application, the
`
`Examiner pointed to the above-noted limitations when allowing the claims, 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 790 (Notice of Allowance) (emphasis in original).)
`
`However, as demonstrated in this petition, all of these alleged “novel” limitations
`
`were, in fact, not novel. Use of an “exclusive central pharmacy” and “exclusive
`
`computer database” were well-known in the art. (See § VI.B.) And the same art
`
`also discloses checking the exclusive computer database for patterns of abuse by
`
`both the doctors and patients and only providing the prescription drug to the
`
`patient if no abuse is found. (Id.)
`
`9
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`

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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`
`V. Claim construction
`Unless otherwise construed herein, the terms of claims 1-11 are to be given
`
`their broadest reasonable interpretation, as understood by one of ordinary skill in
`
`the art in view of the ’730 patent’s specification. See 37 C.F.R. § 42.100(b).
`
`“Exclusive central pharmacy” and “exclusive computer database”
`
`A.
`Claims 1–11 recite the terms “exclusive central pharmacy” and “exclusive
`
`computer database.” During prosecution of the ’730 patent, the applicants defined
`
`the term “exclusive” as “single or sole.” (Ex. 1002, 577(Reply Brief, filed Dec. 3,
`
`2007) Therefore, for purposes of this proceeding the terms “exclusive central
`
`pharmacy” and “exclusive computer database” should be construed to mean a
`
`“single or sole pharmacy” and a “single or sole database,” respectively. (Ex. 1007,
`
`¶36.)
`
`B.
`
`“Generating with the computer processor periodic reports via the
`exclusive computer database”
`
`Claims 1–10 also recite the limitation “generating with the computer
`
`processor periodic reports via the exclusive computer database to evaluate
`
`potential diversion patterns.” (Ex. 1001, 9:1-3.) The ’730 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., 2:13-15.) Moreover, the ’730 patent discloses that reports are obtained
`
`by running queries against the central database. (Id., 8:22-29.) Further, the ’730
`
`10
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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`patent describes different types of queries that are run to obtain information such as
`
`prescriptions written by physician, prescriptions by patient name, prescriptions by
`
`frequency, and prescriptions by dose. (Ex. 1001, 7:53-67.) Accordingly, “querying
`
`the central database” at least meets the limitation of “generating … periodic
`
`reports,” as would be understood by a POSA. (Ex. 1007, ¶37.) Hence, under the
`
`broadest reasonable construction of the term, “generating … periodic reports,”
`
`should be construed to mean “querying the computer database to obtain
`
`information, such as, prescriptions by physician, prescriptions by patient name,
`
`prescriptions by frequency, and prescriptions by dose.” (Id.)
`
`VI.
`
`Identification of challenge (37 C.F.R. § 42.104)
`
`Wockhardt requests IPR of all claims of the ’730 patent. Per 37 C.F.R.
`
`§ 42.6(c), 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. 1007)2, an expert in the fields of
`
`
`2 Wockhardt submits and relies upon an identical copy of the Declaration of Dr.
`
`Valuck submitted in Amneal Pharms., LLC, et al. v. Jazz Pharms., Inc., Case No.
`
`IPR2015-00554 (“the Amneal/Par IPR”). Dr. Valuck’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
`
`
`
`11
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`

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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`drug safety, drug abuse prevention, and prescription drug distribution.
`
`Ground 35 USC Claims
`
`Index of References
`
`1
`
`§ 103(a)
`
`1-11
`
`Advisory Committee Art (Ex. 1003-
`1006)
`
`A. Each of the references cited 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 35 U.S.C. § 311(b). The ’730 patent was
`
`filed on December 17, 2002. (Ex. 1001.) Patent Owner has not established any
`
`earlier date of invention. Accordingly, December 17, 2002 is its earliest 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) qualify as “printed
`publications”
`
`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
`
`does not rely upon that part of his declaration in this proceeding.
`
`12
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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`effective filing date of the ’182 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).
`
` “[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)). And “[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. 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
`
`13
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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`Solutions, Inc., 698 F.3d 1374, 1380 (Fed. Cir. 2012)). Moreover, institution
`
`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. IPR2014-00059, Paper 9, *34 (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, 655 F.2d 221, 226 (C.C.P.A. 1981) (finding that no evidence concerning
`
`actual viewing or dissemination of a reference was required when a reference is
`
`deemed to have been “sufficiently accessible to the public and to persons skilled in
`
`the pertinent art”)).
`
`Examination of the ACA materials (Ex. 1003-Ex. 1006) demonstrates that it
`
`is a collection of publicly available, printed publications. Orphan Medical
`
`submitted for publication to the FDA the Xyrem Video and Transcript, the Briefing
`
`Booklet, and the Preclinical Safety Review as briefing materials to the FDA before
`
`the Advisory Committee met on June 6, 2001. In fact, according to the Federal
`
`Register notice announcing this meeting the
`
`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
`
`14
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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`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.”
`(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)).3 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
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`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
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`that they were all available by July 13, 2001, at the latest, also qualifying them as
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`102(b) prior art. (Ex. 1017 (relevant bullet point highlighted).) And because the
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`ACA was listed on an FDA website, the address of which was provided in the
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`3 The Federal Advisory Committee Act also required that “the records, reports,
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`transcripts, minutes … or other documents which were made available to or
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`prepared for or by each advisory committee shall be available for public
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`inspection.” 5 U.S.C. App 2 §10(b) (2001).
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`15
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`

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`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`Federal Register, the ACA was indexed and accessible to persons of ordinary skill.
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`The Preclinical Safety Review (Ex. 1004) contains redactions of the name
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`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,
`
`while small portions, immaterial here, containing confidential information were
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`hidden. And the Briefing Booklet (Ex. 1005) states on its cover that it is
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`“AVAILABLE FOR PUBLIC DISCLOSURE WITHOUT REDACTION.”—
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`confirming that a POSA would have easily been able to obtain it if so desired. Cf.
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`IPR2013-00458, Paper 12, *27 (Jan 16, 2014) (finding that statements of
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`confidentiality on a document suggest it was not publicly available).
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`Other evidence corroborating the public availability of the ACA comes from
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`the
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`Internet
`
`Archive:
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`Wayback
`
`Machine
`
`(located
`
`at
`
`https://archive.org/web/web.php).4 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.)
`
`
`4 The Board has not precluded the use of Documents from the Wayback Machine
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`when making institution decisions. See, e.g., IPR2013-00142, Paper 11, *9-10
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`(Aug. 7, 2013).
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`16
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`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`Following this link from the “Briefing Information” demonstrates that this art was
`
`all available on July 1, 2001, at the latest. (Ex. 1019.) And the Advisory
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`Committee Transcript and Slides (Ex. 1003) were available by October 4, 2001, at
`
`the latest—still one year prior to December 17, 2002. (Ex. 1020, pg. 8, 6/6
`
`Meeting.)
`
`Additionally, a POSA “exercising reasonable diligence” would have been
`
`able to locate the ACA. (Ex. 1007, ¶47; 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,
`
`¶47; Ex. 1015.) Moreover, the Federal Register also points a POSA to where the
`
`ACA would be located before and after the meeting. (Ex. 1007, ¶47; Ex. 1015.)
`
`A 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, ¶47.)
`
`And even if the materials were not available on the FDA’s website, they
`
`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 U.S.C. App 2
`
`
`5 See note 3, supra.
`
`17
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`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`§10(b) states that Advisory Committee materials are to be made 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.
`
`In sum, the ACA was a collection of publicly available printed publications
`
`because it would have been available to and readily located by a POSA exercising
`
`reasonable diligence. Moreover, it was available more than one year prior to the
`
`priority benefit date of the ’730 patent. (Ex. 1028.)
`
`B. Ground 1: Claims 1-11 would have been obvious over the ACA
`As supported by the declaration of Dr. Valuck, claims 1-11 of the ’730
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`patent would have been obvious over the ACA—Advisory Committee Transcript
`
`and Slides (Ex. 1003), Preclinical Safety Review (Ex. 1004), Briefing Booklet (Ex.
`
`1005), and Xyrem Video and Transcript (Ex. 1006). The ACA qualifies as prior
`
`art to the claims of the ’730 patent. (See § VI.A.1.) Each publication was either
`
`submitted to the FDA prior to the meeting or is a 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 priority date for the ’730 patent. (Ex. 1019.)
`
`A POSA would have had more than ample reason to combine these ACA
`
`18
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`

`
`Petition for Inter Partes Review
`of U.S. Patent No. 7,668,730
`materials. The Preclinical Safety Review (Ex. 1004), Briefing Booklet (Ex. 1005),
`
`and Xyrem Video and Transcript (Ex. 1006) were all distributed together for a
`
`single meeting before the FDA seeking approval for prescription