UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`
`
`
`AMNEAL PHARMACUETICALS, LLC. and
`PAR PHARMACEUTICAL, INC.,
`Petitioners
`
`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
`
`
`
`
`
`

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`IPR Petition of U.S. Patent No. 7,668,730
`
`TABLE OF CONTENTS
`
`Page
`
`B.
`
`B.
`
`I.
`
`II.
`III.
`
`V.
`
`VI.
`
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED
`(37 C.F.R. § 42.22(a)) ....................................................................................... 1
`GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)) .................................. 1
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFORE ................................................................................ 2
`IV. OVERVIEW ..................................................................................................... 2
`A.
`Person of Ordinary Skill In The Art ....................................................... 2
`B.
`State of the Art ....................................................................................... 3
`C.
`The ’730 patent ....................................................................................... 7
`CLAIM CONSTRUCTION ............................................................................. 9
`A.
`“Exclusive Central Pharmacy” and “Exclusive Computer
`Database” .............................................................................................. 10
`“Generating with the computer processor periodic reports via
`the exclusive computer database” ........................................................ 10
`IDENTIFICATION OF CHALLENGE (37 C.F.R. § 42.104) ....................... 11
`A.
`EACH OF THE REFERENCES CITED IS AVAILABLE
`PRIOR ART ......................................................................................... 12
`1.
`The ACA (PAR1003 – PAR1006) qualify as “printed
`publications” .............................................................................. 12
`Talk About Sleep, Honigfeld, Elsayed and Lilly ....................... 18
`2.
`Ground 1: Claims 1-11 would have been obvious over the ACA ....... 18
`1.
`Comparison of the ’730 Patent Claims to the Prior Art. ........... 19
`2.
`Claim 1 Would Have Been Obvious Over the ACA. ................ 21
`3.
`Claim 2 ....................................................................................... 33
`4.
`Claim 3 ....................................................................................... 33
`5.
`Claims 4 and 5............................................................................ 34
`6.
`Claim 6 ....................................................................................... 35
`7.
`Claim 7 ....................................................................................... 35
`8.
`Claim 8 ....................................................................................... 36
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`-i-
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`IPR Petition of U.S. Patent No. 7,668,730
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`C.
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`Claim 9 ....................................................................................... 37
`9.
`10. Claim 10 ..................................................................................... 37
`11. Claim 11 ..................................................................................... 38
`Ground 2: Claims 1-11 would have been obvious over TAS, in
`view of Honigfeld and Elsayed, and further in view of Lilly. ............. 38
`1.
`Claim 1 ....................................................................................... 39
`2.
`Claim 2 ....................................................................................... 48
`3.
`Claim 3 ....................................................................................... 48
`4.
`Claims 4 and 5............................................................................ 49
`5.
`Claim 6 ....................................................................................... 50
`6.
`Claim 7 ....................................................................................... 50
`7.
`Claim 8 ....................................................................................... 51
`8.
`Claim 9 ....................................................................................... 51
`9.
`Claim 10 ..................................................................................... 52
`10. Claim 11 ..................................................................................... 52
`Secondary considerations do not rebut the prima facie case. .............. 52
`D.
`IT IS MORE LIKELY THAN NOT THAT PETITIONERS WILL
`PREVAIL WITH RESPECT TO AT LEAST ONE OF THE
`CHALLENGED CLAIMS ............................................................................. 57
`VIII. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1)) ..................................... 58
`IX. CONCLUSION ............................................................................................... 59
`
`VII.
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`-ii-
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`
`
`I.
`INTRODUCTION AND STATEMENT OF RELIEF REQUESTED (37
`C.F.R. § 42.22(a))
`
`IPR Petition of U.S. Patent No. 7,668,730
`
`
`Par Pharmaceutical, Inc. (“Par”) and Amneal Pharmaceuticals, LLC
`
`(“Amneal”) (collectively, “Petitioners”) petition for Inter Partes Review (“IPR”)
`
`seeking cancellation of claims 1-11 of U.S. Patent No. 7,668,730 (“the ’730
`
`patent”) (PAR1001). According to USPTO records, the ’730 patent is assigned to
`
`Jazz Pharmaceuticals, Inc. (“Jazz”).
`
`Published materials used in an FDA Advisory Committee Meeting (the
`
`“Advisory Committee Art” or “ACA”) render obvious every limitation of the
`
`challenged claims more than a year before the ’730 patent’s earliest effective filing
`
`date, as set forth in Ground 1. In addition, and alternatively, other drug distribution
`
`systems in public use long before the ’730 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 1-11 of the ’730 patent.
`
`II. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a))
`Petitioners certify that the ’730 patent is available for IPR and Petitioners are
`
`not barred or estopped from requesting IPR of any of the challenged claims.
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`-1-
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`

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`
`
`III. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFORE
`
`IPR Petition of U.S. Patent No. 7,668,730
`
`
`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
`A POSA is a hypothetical person who is presumed to be aware of all
`
`pertinent art, thinks along conventional wisdom in the art, and is a person of
`
`ordinary creativity.
`
`A POSA may work as part of a multi-disciplinary team and draw upon not
`
`only his or her own skills, but also take advantage of certain specialized skills of
`
`others in the team, to solve a given problem. (PAR1007, ¶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 and/or experience. For
`
`example, such a POSA may have computer science education qualifications and
`
`experience relating to computerized drug distribution systems, or pharmacy
`
`-2-
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`IPR Petition of U.S. Patent No. 7,668,730
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`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. (PAR1007, ¶46.) 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
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`-3-
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`IPR Petition of U.S. Patent No. 7,668,730
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`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. (PAR1007, ¶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.
`
`(PAR1007, ¶22.) However, Clozaril® use was associated with agranulocytosis, a
`
`potentially fatal blood disorder resulting in white blood cell loss. (Id.) To mitigate
`
`these risks and control the distribution of Clozaril®, the manufacturer implemented
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`-4-
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`IPR Petition of U.S. Patent No. 7,668,730
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`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
`
`distribution of the drug. (Id.)
`
`
`
`Thus, by 1999, at least three systems for the restricted distribution of
`
`-5-
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`IPR Petition of U.S. Patent No. 7,668,730
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`
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`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
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`abuse. (Id., ¶¶25, 26.) Aiming to reduce time for dispensing, improve accuracy and
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`accountability, and streamline record keeping, the distribution of controlled
`
`substances veered toward automation via the implementation of computerized
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`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
`
`than one year prior to the earliest effective filing date of the ’730 patent—discloses
`
`every limitation of the challenged claims.
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`-6-
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`IPR Petition of U.S. Patent No. 7,668,730
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`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.” (PAR1001, 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.)
`
`
`
`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
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`-7-
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`IPR Petition of U.S. Patent No. 7,668,730
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`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
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`pharmacy and processing the prescription requests only by the exclusive central
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`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
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`drug.”1 (PAR1002, 698 (Amdt. & Reply filed Nov. 2, 2009; see also PAR1002,
`
`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. (PAR1002, 699 (Amdt. & Reply, filed Nov. 2, 2009).) All other limitations of
`
`
`1 Emphasis added throughout unless otherwise noted.
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`-8-
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`IPR Petition of U.S. Patent No. 7,668,730
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`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–C.) 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.)
`
`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
`
`-9-
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`

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`
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`the art in view of the ’730 patent’s specification. See 37 C.F.R. § 42.100(b).
`
`IPR Petition of U.S. Patent No. 7,668,730
`
`
`A.
`“Exclusive Central Pharmacy” and “Exclusive Computer
`Database”
`
`
`
`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.” (PAR1002, 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. (PAR1007,
`
`¶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.” (PAR1001, 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
`
`patent describes different types of queries that are run to obtain information such as
`
`prescriptions written by physician, prescriptions by patient name, prescriptions by
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`-10-
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`IPR Petition of U.S. Patent No. 7,668,730
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`frequency, and prescriptions by dose. (PAR1001, 7:53-67.) Accordingly, “querying
`
`the central database” at least meets the limitation of “generating … periodic
`
`reports,” as would be understood by a POSA. (PAR1007, ¶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)
`
`Petitioners request IPR of all claims of the ’730 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.”) (PAR1007), an expert in the fields of
`
`drug safety, drug abuse prevention, and prescription drug distribution.
`
`Ground
`
`35 USC
`
`Clai
`ms
`
`Index of References
`
`1
`
`2
`
`§ 103(a)
`
`1-11
`
`§ 103(a)
`
`1-11
`
`Advisory Committee Art (PAR1003-
`1006)
`
`Talk About Sleep in view of
`Honigfeld further in view of Elsayed
`and further in view of Lilly
`
`
`
`For each asserted ground, Petitioners demonstrate below where each
`
`limitation either exists in the prior art or is rendered obvious, by evaluating the
`
`-11-
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`IPR Petition of U.S. Patent No. 7,668,730
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`
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`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
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`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 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. (PAR1001.) 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 the application for patent in the United States.
`
`1.
`The ACA (PAR1003 – PAR1006) qualify as “printed
`publications”
`
`“[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
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`-12-
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`IPR Petition of U.S. Patent No. 7,668,730
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`
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`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
`
`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). Petitioners need only provide sufficient evidence to demonstrate that the
`
`reference was disseminated publicly or otherwise available. Id. at *34-35 (citing In
`
`re Wyer, 655 F.2d 221, 226 (C.C.P.A. 1981) (finding 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”)).
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`-13-
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`IPR Petition of U.S. Patent No. 7,668,730
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`Examination of the ACA materials (PAR1003-PAR1006) 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
`
`Drugs meetings.) This is the same website where you can find the
`
`minutes, transcript, and slides from the meeting. This material is
`
`generally posted about 3 weeks after the meeting.”
`
`(PAR1015.) (emphasis added). Such “competent evidence of the [FDA’s] general
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`[] practice may be relied upon to establish an approximate time” the ACA would
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`have become available to a POSA exercising reasonable diligence. IPR2014-
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`00059, Paper 9, *34 (Apr. 15, 2014) (citing In re Hall, 781 F.2d 897, 899 (Fed.
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`-14-
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`IPR Petition of U.S. Patent No. 7,668,730
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`Cir. 1988)).2 Therefore, based on the stated timelines, the Xyrem Video and
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`Transcript (PAR1006), the Briefing Booklet (PAR1005), and the Preclinical Safety
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`Review (PAR1004) were approximately available on the FDA’s website as of June
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`5, 2001, while the Advisory Committee Transcript and Slides (PAR1003) were
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`available as of June 27, 2001. Both dates are more than one year prior to December
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`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. (PAR1017 (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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`Federal Register, the ACA was indexed and accessible to persons of ordinary skill.
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`The Preclinical Safety Review (PAR1004) contains redactions of the name
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`of the proposed specialty pharmacy for distribution of Xyrem®—further evidence
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`that these materials would be, and were intended to be, available to the public,
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`while small portions, immaterial here, containing confidential information were
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`hidden. And the Briefing Booklet (PAR1005) states on its cover that it is
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`“AVAILABLE FOR PUBLIC DISCLOSURE WITHOUT REDACTION.”—
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`2 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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`IPR Petition of U.S. Patent No. 7,668,730
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`
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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
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`Archive:
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`Wayback
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`Machine
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`(located
`
`at
`
`https://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
`
`(PAR1006), the Briefing Booklet (PAR1005), and the Preclinical Safety Review
`
`(PAR1004)) was available online on June 17, 2001. (PAR1018, pg. 5, 6/6
`
`Meeting.) Following this link from the “Briefing Information” demonstrates that
`
`this art was all available on July 1, 2001, at the latest. (PAR1019.) And the
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`Advisory Committee Transcript and Slides (PAR1003) were available by October
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`4, 2001, at the latest—still one year prior to December 17, 2002. (PAR1020, pg. 8,
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`6/6 Meeting.)
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`Additionally, a POSA “exercising reasonable diligence” would have been
`
`able to locate the ACA. (PAR1007, ¶47; PAR1015.) Notice of the Advisory
`
`
`3 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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`IPR Petition of U.S. Patent No. 7,668,730
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`
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`Committee Meeting was posted in the Federal Register, which indicated that “[a]
`
`main focus of the deliberations will be on risk management issues.” (PAR1007,
`
`¶47; PAR1015.) Moreover, the Federal Register also points a POSA to where the
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`ACA would be located before and after the meeting. (PAR1007, ¶47; PAR1015.)
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`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
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`programs. (PAR1007, ¶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.4 5 U.S.C. App 2
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`§10(b) states that Advisory Committee materials are to be made available “subject
`
`to section 552 of title 5[.]” The Preclinical Safety Review (AMN1004) contains
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`redactions marked “(b)(4),” which are a specific reference to 5 U.S.C. § 552(b)(4)
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`(allowing for redaction of trade secret information). The Briefing Booklet
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`(AMN1005) 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
`
`
`4 See note 2, supra.
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`IPR Petition of U.S. Patent No. 7,668,730
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`reasonable diligence. Moreover, it was available more than one year prior to the
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`priority benefit date of the ’730 patent. (PAR1028.)
`
`Talk About Sleep, Honigfeld, Elsayed and Lilly
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`2.
`Talk About Sleep (hereinafter “TAS”) is entitled to the §102(b) prior art date
`
`
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`of its publication: February 12, 2001. (PAR1033, front page). Honigfeld is entitled
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`to the 102(b) prior art date of its publication: March 31, 1998. (PAR1034, 3),
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`Elsayed is entitled to the §102(b) prior art date of its issue: April 4, 2000.
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`(PAR1035, front page.) Lilly is entitled to a § 102(e) prior art date of November
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`14, 2001, the filing date of its earliest provisional application. See, e.g., In re
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`Giacomini, 612 F.3d 1380 (Fed. Cir. 2010) (PAR1036, front page).
`
`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
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`and Slides (PAR1003), Preclinical Safety Review (PAR1004), Briefing Booklet
`
`(PAR1005), and Xyrem Video and Transcript (PAR1006). The ACA qualifies as
`
`prior art to the claims of the ’730 patent. (See § VI.A.1.) Each publication was
`
`either