UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`AMNEAL PHARMACEUTICALS LLC and
`PAR PHARMACEUTICAL, INC.
`Petitioners
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`Patent Owner
`
`
`_____________________
`
`Case IPR: Unassigned
`_____________________
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,589,182
`UNDER 35 U.S.C. §§ 311-319 and 37 C.F.R. §§ 42.1-.80, 42.100-.123
`
`
`
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`

`

`
`
`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`TABLE OF CONTENTS
`
`V. 
`VI. 
`
`I. 
`Introduction ...................................................................................................... 1 
`Grounds for standing (37 C.F.R. § 42.104(a)) ................................................ 1 
`II. 
`Statement of the precise relief requested and the reasons therefore ............... 2 
`III. 
`IV.  Overview .......................................................................................................... 2 
`A. 
`Person of ordinary skill in the art (“POSA”) ......................................... 2 
`B. 
`State of the art ......................................................................................... 3 
`C. 
`The ’182 patent ....................................................................................... 6 
`Claim construction ........................................................................................... 8 
`Identification of challenge (37 C.F.R. § 42.104(b)) ........................................ 9 
`A. 
`Each cited reference is available prior art. ........................................... 10 
`1. 
`The ACA (AMN1003 – AMN1006) qualifies as a
`“printed publication.” ................................................................ 10 
`Talk About Sleep (AMN1033), Honigfeld (AMN1034),
`Elsayed (AMN1035) and Lilly (AMN1010) ............................ 15 
`Ground 1: Claims 1-26 would have been obvious over ACA ............. 16 
`1. 
`Comparison of the ’182 patent claims to the prior art. ............. 17 
`2. 
`Claim 1 would have been obvious ............................................ 19 
`3. 
`Claim 2 ...................................................................................... 27 
`4. 
`Claim 3 ...................................................................................... 28 
`5. 
`Claims 4 and 5 ........................................................................... 28 
`6. 
`Claims 6 and 7 ........................................................................... 29 
`7. 
`Claim 8 ...................................................................................... 30 
`8. 
`Claims 9-14 ............................................................................... 30 
`
`2. 
`
`B. 
`
`i
`
`

`

`C. 
`
`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`Claim 15 .................................................................................... 30 
`9. 
`10.  Claims 16-18 ............................................................................. 32 
`11.  Claim 19 .................................................................................... 32 
`12.  Claims 20-25 ............................................................................. 35 
`13.  Claim 26 .................................................................................... 36 
`Ground 2: Claims 1-26 would have been obvious over TAS, in
`view of Honigfeld and Elsayed, and further in view of Lilly. ............. 37 
`1. 
`Claim 1 ...................................................................................... 38 
`2. 
`Claim 2 ...................................................................................... 49 
`3. 
`Claim 3 ...................................................................................... 49 
`4. 
`Claims 4 and 5 ........................................................................... 49 
`5. 
`Claims 6 and 7 ........................................................................... 50 
`6. 
`Claim 8 ...................................................................................... 51 
`7. 
`Claims 9-14 ............................................................................... 51 
`8. 
`Claim 15 .................................................................................... 51 
`9. 
`Claims 16-18 ............................................................................. 52 
`10.  Claim 19 .................................................................................... 52 
`11.  Claims 20-25 ............................................................................. 55 
`12.  Claim 26 .................................................................................... 55 
`Secondary considerations do not rebut the prima facie case. .............. 56 
`D. 
`VII.  Conclusion ..................................................................................................... 59 
`VIII.  Mandatory notices (37 C.F.R. § 42.8(a)(1)) .................................................. 59 
`
`
`
`
`ii
`
`

`

`I.
`
`Introduction
`
`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`
`Amneal Pharmaceuticals LLC and Par Pharmaceutical, Inc. (collectively
`
`“Petitioners”) submit this Petition for Inter Partes Review (“Petition”) seeking
`
`cancellation of claims 1-26 of U.S. Patent No. 8,589,182 (“the ’182 patent”)
`
`(AMN1001) as unpatentable under 35 U.S.C. §103(a) in view of the prior art.
`
`Published materials used in an FDA Advisory Committee Meeting (the
`
`“Advisory Committee Art” or “ACA”) renders obvious every limitation of the
`
`challenged claims more than a year before the ’182 patent’s earliest effective filing
`
`date, as set forth in Ground 1. In addition, and alternatively, Ground 2
`
`demonstrates that other drug distribution systems in public use long before the
`
`’182 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 1-26 of the ’182 patent.
`
`II. Grounds for standing (37 C.F.R. § 42.104(a))
`Petitioners certify that the ’182 patent is available for IPR and Petitioners are
`
`not barred or estopped from requesting IPR of any of the challenged claims.
`
`1
`
`

`

`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.
`
`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`
`§§ 42.1-.80 and 42.100-42.123, and cancel claims 1-26—all claims—of the ’182
`
`patent as unpatentable under 35 U.S.C. § 103.
`
`IV. Overview
`A.
`Person of ordinary skill in the art (“POSA”)
`A POSA is a hypothetical person who is presumed to be aware of all
`
`pertinent art, thinks along conventional wisdom in the art, and is a person of
`
`ordinary creativity. A POSA may work as part of a multi-disciplinary team and
`
`draw upon not only his or her own skills, but also take advantage of certain
`
`specialized skills of others in the team, to solve a given problem. (AMN1007, ¶21.)
`
`For example, a POSA would hold a Bachelor’s or Doctor of Pharmacy degree and
`
`a license as a registered pharmacist with 3-5 years of relevant work experience, or
`
`a computer science undergraduate degree or equivalent work experience and work
`
`experience relating to business applications, including familiarity with drug
`
`distribution procedures. (Id.) Alternatively, a POSA may have a blend of computer
`
`science and pharmacy drug distribution knowledge and/or experience. (Id.) Such a
`
`POSA may have computer science education qualifications and experience relating
`
`to computerized drug distribution systems, or pharmacy education qualifications
`
`and experience relating to computerized drug distribution systems. (Id.)
`
`2
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`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 ’182 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 ’182 patent generally pertains to centralizing the distribution of
`
`hazardous or abuse-prone drugs. The ’182 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. (Id., ¶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 Program. By listing the ’182 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 ’182 patent.
`
`3
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`Aside from the explicit disclosure of the ’182 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 ’182 patent. For example, in 1982, Hoffman-La Roche
`
`gained approval for Accutane® (isotretinoin), a potent teratogen that caused birth
`
`defects. (Id., ¶22.) To address that risk, Roche developed a special Pregnancy
`
`Prevention Program for Accutane® as part of its distribution in pharmacies. (Id.)
`
`The program included informed consent forms to be completed by the patient and
`
`prescriber, along with patient counseling on the teratogenic risk of Accutane®, the
`
`need to avoid pregnancy, and the use of proper birth control methods. Finally, this
`
`program required that women of childbearing potential must test serum negative
`
`for a pregnancy before the drug could be distributed to them. (Id.)
`
`Another drug, Clozaril® (clozapine), was approved in the U.S. in 1990 for
`
`the treatment of refractory schizophrenia. (Id., ¶23.) Similar to Accutane®,
`
`Clozaril®’s manufacturer sought to mitigate these risks associated with Clozaril®
`
`by implementing a national registry system that limited distribution of the drug.
`
`(Id.) The distribution system required registration of patient and physician
`
`information in an integrated computerized database. (Id.) If a patient or physician
`
`was non-compliant with the program, the national registry took corrective action,
`
`such as contacting and re-educating the prescribing physician and/or discontinuing
`
`4
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`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., ¶24.)
`
`On the heels of the Accutane® and Clozaril® restricted distribution systems,
`
`in 1999, the manufacturers of prescription thalidomide—yet another known
`
`teratogenic drug—developed a hybrid system, combining the computerized
`
`registry system of Clozaril® and the pregnancy monitoring/prevention, and
`
`informed consent requirements of Accutane® to monitor and control the
`
`distribution of the drug. (Id., ¶25.)
`
`Thus, by 1999, at least three systems for the restricted distribution of
`
`effective, yet hazardous prescription drugs were known in the art and successfully
`
`implemented across the industry. (Id., ¶26.) Moreover, while risk management
`
`programs were developing during the 1980s through 1990s, pharmacies had
`
`already been using computerized systems for the distribution of narcotics and other
`
`controlled substances, i.e., drugs with potential for abuse. (Id., ¶27.) Computerized
`
`systems were also helpful in generating reports tracking patients, physicians, the
`
`quantity of the drug dispensed, and the hospital inventory of a drug , allowing for
`
`the detection of abuse patterns. (Id.)
`
`Consequently, it would have been obvious to a POSA in view of the prior art
`
`5
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`to develop the centralized distribution systems claimed in the ’182 patent to
`
`minimize the risks associated with the distribution of hazardous prescription drugs.
`
`(Id., ¶28.)
`
`C. The ’182 patent
`Against this backdrop, Jazz obtained the ’182 patent. The ’182 patent relates
`
`to “[a] drug distribution system and method [that] utilizes a central pharmacy and
`
`database to track all prescriptions for a sensitive drug.” (AMN1001, Abstract.)
`
`According to the ’182 patent, prescription patterns by physicians and patients are
`
`monitored for abuse using an exclusive central database. (Id., 2:20-25.) 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., 1:54-60.) Prior to shipping the prescription
`
`drug, the central pharmacy checks whether the patient has been educated about the
`
`prescription, and only ships the prescription drug when no abuse is found related to
`
`the patient and prescribing doctor. (Id., 1:63-66 and 5:25-34.) Reports are then
`
`generated to evaluate potential diversion patterns. (Id., 2:23-25.)
`
`During prosecution of the ’182 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
`
`6
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`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 (AMN1016, 442
`
`(Amdt. & Reply filed Nov. 2, 2009; see also Id., 241-248 (Amdt. & Reply filed
`
`Aug. 8, 2006) and 303-334 (Appeal Brief filed July 18, 2007).) Applicants argued
`
`that these limitations were not taught by the cited prior art. (Id., 449 (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 258-262 (Final Rejection, Oct. 18, 2006)
`
`and at 420-433 (Decision on Appeal, Aug. 31, 2009).)
`
`Indeed, when allowing the claims in the parent application, the Examiner
`
`expressly emphasized these new limitations, stating: “the closest prior art of record
`
`does not teach or fairly suggest that all prescriptions for GHB are processed only
`
`by the exclusive central pharmacy using only the exclusive computer database.
`
`The exclusive computer database is checked for potential GHB abuse and GHB is
`
`provided/mailed only if no potential abuse is found by the patient to whom GHB is
`
`prescribed and the doctor/authorized prescriber of the GHB.” (Id. at 475-476
`
`(Notice of Allowance) (emphasis in original).)
`
`Yet, nowhere does the ’182 patent recite the “the exclusive central pharmacy
`
`
`1 Emphasis added throughout unless otherwise noted.
`
`7
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`or “exclusive computer database” limitations, instead reciting merely a “computer
`
`processor” and a “single computer database.” By omitting the “exclusive central
`
`pharmacy” and “exclusive computer database” limitations, the ’182 patent claims
`
`cannot even rely on the Examiner’s reasoning from the parent application to
`
`establish patentability. But even if it could, as demonstrated in this petition, use of
`
`a “single computer database” for a company that obtained approval for a
`
`prescription drug was well-known in the art and would have been obvious to a
`
`POSA. (See, e.g., AMN1007, ¶¶53-63 and 98-111.) And the same art also
`
`discloses checking the 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. (See, e.g. id., ¶¶64-67 and 112-121.)
`
`V. Claim construction
`Unless otherwise construed herein, the terms of claims 1-26 are to be given
`
`their broadest reasonable interpretation, as understood by one of ordinary skill in
`
`the art in view of the ’182 patent’s specification. See 37 C.F.R. § 42.100(b).
`
`The preamble of claims 1, 8, 15, and 19 all recite a “method of treatment” of
`
`a narcoleptic patient. However the “methods of treatment” recited in claims 1-26
`
`do not contain any steps actually directed to treatment of a narcoleptic patient, such
`
`as administering a quantity of a particular drug to a patient. (AMN1007, ¶37.) As
`
`such, framing the claims as methods of treatment is meaningless, and does not
`
`8
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`create any substantive limitations on the scope of the claim, the prescription drug,
`
`or its use. These claims recite methods of distribution. In short, the preamble of
`
`each challenged claim is not limiting.
`
`VI.
`
`Identification of challenge (37 C.F.R. § 42.104(b))
`
`Petitioners request IPR of all claims of the ’182 patent. Per 37 C.F.R. §
`
`42.6(d), copies of the references accompany the Petition. The Grounds for
`
`unpatentability are further supported by the accompanying declaration of Dr.
`
`Robert Valuck, Ph.D., R.Ph. (“Valuck Dec.”) (AMN1007), an expert in the fields
`
`of drug safety, drug abuse prevention, and prescription drug distribution.
`
`Ground
`
`35 USC
`
`Clai
`ms
`
`Index of References
`
`1
`
`2
`
`§ 103(a)
`
`1-26
`
`§ 103(a)
`
`1-26
`
`Advisory Committee Art (AMN1003-
`1006)
`
`Talk About Sleep(AMN1033) in view
`of Honigfeld (AMN1034) further in
`view of Elsayed (AMN1035) and
`further in view of Lilly (AMN1010)
`
`
`
`For each asserted ground, Petitioners demonstrate below where each
`
`limitation either exists in the prior art or is rendered obvious, by evaluating the
`
`scope and contents of the prior art, any differences between the art and the
`
`challenged claims, the knowledge of person of ordinary skill in the art, and any
`
`available objective indicia of nonobviousness in accordance with Graham v. John
`
`9
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`Deere Co., 383 U.S. 1 (1966) and KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398
`
`(2007).
`
`A. Each cited reference is available prior art.
`The ’182 patent claims benefit to U.S. Patent No. 7,668,730 (“the ’730
`
`patent”), filed on December 17, 2002 (See AMN1001.), which serves as its earliest
`
`possible effective filing date. Each cited prior art reference qualifies independently
`
`as (1) having published before December 17, 2002 or (2) having been publicly
`
`disclosed more than a year prior to December 17, 2002..
`
`1.
`
`The ACA (AMN1003 – AMN1006) qualifies as a “printed
`publication.”
`
`In view of GHB’s known susceptibility for diversion and abuse and its
`
`experience in restricted distribution of certain dangerous drugs, the FDA held
`
`advisory committee meetings as a prerequisite to granting approval to Xyrem®. A
`
`collection of materials that were used in that meeting (the “Advisory Committee
`
`Art” or “ACA”)—all of which published more than one year prior to the earliest
`
`effective filing date of the ’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 (AMN1003), (2) Preclinical Safety
`
`Review (AMN1004), (3) the Briefing Booklet (AMN1005), and (4) the Xyrem
`
`Video and Transcript (AMN1006).
`
`“A reference is publicly accessible upon a satisfactory showing that such
`
`10
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`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 evidence of actual viewing or
`
`dissemination was not required when a reference is deemed to have been
`
`“sufficiently accessible to the public and to persons skilled in the pertinent art”)).
`
`The ACA materials (AMN1003-AMN1006) are a collection of publicly
`
`11
`
`

`

`available, printed publications. Orphan Medical, Patent Owner Jazz’s predecessor-
`
`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`
`in-interest, submitted to the FDA for publication before the Advisory Committee
`
`met on June 6, 2001 the Xyrem® Video and Transcript, the Briefing Booklet, and
`
`the Preclinical Safety Review. In fact, according to the Federal Register notice
`
`announcing this meeting:
`
`Background material from the sponsor and FDA will be posted 24
`hours before the meeting at the Peripheral and Central Nervous
`System Drugs Advisory
`Committee
`docket
`site
`at
`http://www.fda.gov/ohrms/dockets/ac/acmenu.htm (Click on the year
`2001 and scroll down to the Peripheral and Central Nervous Systems
`Drugs meetings.) This is the same website where you can find the
`minutes, transcript, and slides from the meeting. This material is
`generally posted about 3 weeks after the meeting.
`
`(AMN1015 (emphasis added).) Such “competent evidence of the [FDA’s] general
`
`[] practice may be relied upon to establish an approximate time” the ACA would
`
`have become available to a POSA exercising reasonable diligence. IPR2014-
`
`00059, Paper 9, *34 (Apr. 15, 2014) (citing In re Hall, 781 F.2d 897, 899 (Fed.
`
`Cir. 1988)).2 Therefore, based on the stated timelines, the Xyrem Video and
`
`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
`
`
`
`12
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`Transcript (AMN1006), the Briefing Booklet (AMN1005), and the Preclinical
`
`Safety Review (AMN1004) were approximately available on the FDA’s website as
`
`of June 5, 2001, while the Advisory Committee Transcript and Slides (AMN1003)
`
`were available as of June 27, 2001. Both dates are more than one year prior to
`
`December 17, 2002. Additionally, the FDA website that hosts these documents
`
`demonstrates that they were all available by July 13, 2001, at the latest, also
`
`qualifying them as 102(b) prior art. (AMN1017 (relevant bullet point highlighted).)
`
`Notably, the Preclinical Safety Review (AMN1004) contains redactions of
`
`the name of the proposed specialty pharmacy for distribution of Xyrem®—further
`
`evidence that these materials would be, and were intended to be, available to the
`
`public. And the Briefing Booklet (AMN1005) states on its cover that it is
`
`“AVAILABLE FOR PUBLIC DISCLOSURE WITHOUT REDACTION.” There
`
`can be no question that these materials were readily accessible to a POSA. Cf.
`
`IPR2013-00458, Paper 12, *27 (Jan. 16, 2014) (finding that statements of
`
`confidentiality on a document suggest it was not publicly available).
`
`Other evidence corroborating the public availability of the ACA comes from
`
`the
`
`Internet
`
`Archive:
`
`Wayback
`
`Machine
`
`(located
`
`at
`
`
`inspection.” 5 U.S.C. App 2 §10(b) (2001).
`
`13
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`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
`
`(AMN1006), the Briefing Booklet (AMN1005), and the Preclinical Safety Review
`
`(AMN1004)) was available online on June 17, 2001. (AMN1018, pg. 5, 6/6
`
`Meeting.) Following this link demonstrates that this art was all available on July 1,
`
`2001, at the latest. (AMN1019.) And the Advisory Committee Transcript and
`
`Slides (AMN1003) were available by October 4, 2001, at the latest—one year prior
`
`to December 17, 2002. (AMN1020, pg. 8, 6/6 Meeting.)
`
`Additionally, a POSA “exercising reasonable diligence” would have been
`
`able to locate the ACA. (AMN1007, ¶47; AMN1015.) Notice of the Advisory
`
`Committee Meeting was posted in the Federal Register, which indicated that “[a]
`
`main focus of the deliberations will be on risk management issues.” (AMN1007,
`
`¶47; AMN1015.) Moreover, the Federal Register also points a POSA to where the
`
`ACA would be located before and after the meeting. (AMN1007, ¶47; AMN1015.)
`
`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
`
`
`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
`
`

`

`programs. (AMN1007, ¶47.)
`
`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`
`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
`
`available “subject to section 552 of title 5[.]” The Preclinical Safety Review
`
`(AMN1004) 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 (AMN1005) also states that it was available for public disclosure
`
`without redaction.
`
`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 ’182 patent. (AMN1028.)
`
`2.
`
`Talk About Sleep (AMN1033), Honigfeld (AMN1034),
`Elsayed (AMN1035) and Lilly (AMN1010)
`
`
`
`Talk About Sleep (hereinafter “TAS”) is entitled to the §102(b) prior art date
`
`of its publication: February 12, 2001. Honigfeld is entitled to the 102(b) prior art
`
`date of its publication: March 31, 1998. Elsayed is entitled to the §102(b) prior art
`
`4 See note 2, supra.
`
`15
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`date of its issue: April 4, 2000. Lilly is entitled to a § 102(e) prior art date of
`
`November 14, 2001, the filing date of its earliest provisional application. See, e.g.,
`
`In re Giacomini, 612 F.3d 1380 (Fed. Cir. 2010).
`
`B. Ground 1: Claims 1-26 would have been obvious over ACA
`As supported by the declaration of Dr. Valuck, claims 1-26 of the ’182
`
`patent would have been obvious over the ACA (AMN1003-1006). (AMN1007,
`
`¶¶50-94.) The ACA qualifies as prior art to the claims of the ’182 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 ’182 patent.
`
`(AMN1019.)
`
`A POSA would have had more than ample reason to combine these ACA
`
`materials5—(1) Advisory Committee Transcript and Slides (AMN1003), (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
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`Preclinical Safety Review (AMN1004), (3) Briefing Booklet (AMN1005), and (4)
`
`Xyrem Video and Transcript (AMN1006)—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. (AMN1007,
`
`¶50.) Moreover, a POSA would also have had a reasonable expectation of success
`
`when combining each of these materials to arrive at the claims 1-26 because they
`
`clearly relate to the same restricted distribution program, which the meeting was
`
`convened to discuss. (Id.) Further, the Xyrem Video and Transcript (AMN1006) is
`
`incorporated by reference into the Advisory Committee Transcript and Slides
`
`(AMN1003), and into the Briefing Booklet (AMN1005). (See AMN1003;
`
`AMN1005.) And, each of the ACA is all linked from a single web page
`
`(AMN1027), giving more reason
`
`to combine
`
`the
`
`individual references.
`
`(AMN1007, ¶50.)
`
`1.
`Independent claim 1 of the ’182 patent recites the following:
`
`Comparison of the ’182 patent claims to the prior art.
`
`A method of treatment of a narcoleptic patient with a prescription drug
`that has a potential for misuse, abuse or diversion, wherein the
`prescription drug is sold or distributed by a company that obtained
`
`also was available more than one year before the patent’s priority date.
`
`(AMN1027.)
`
`17
`
`

`

`Petition for Inter Partes Review
`of U.S. Patent No. 8,589,182
`
`
`approval for distribution of the prescription drug, comprising:
`
`[1.1] receiving, using a computer processor, into a single computer
`database of the company that obtained approval for distribution of the
`prescription drug, from any and all patients being prescribed the
`company's prescription drug, all prescriptions for
`the company's
`prescription drug with the potential for abuse, misuse or diversion;
`[1.2] entering, using the computer processor, into the single computer
`
`database information sufficient to identify the narcoleptic patient for
`whom the company's prescription drug is prescribed;
`[1.3] entering, using the computer processor, into the single computer
`
`database information sufficient to identify any and all physicians or other
`prescribers of the company's prescription drug and information to show
`that the physicians or other prescribers are authorized to prescribe the
`company's prescription drug;
`[1.4]