Trials@uspto.gov Paper 69
`Tel: 571-272-7822
`
`Entered: July 27, 2016
`
`
`
`
`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 IPR2015-00545
`Patent 8,589,182 B1
`______________
`
`
`Before JACQUELINE WRIGHT BONILLA, BRIAN P. MURPHY, and
`JON B. TORNQUIST, Administrative Patent Judges.
`
`
`MURPHY, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`Tel: 571-272-7822
`
`Entered: July 27, 2016
`
`
`
`
`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 IPR2015-00545
`Patent 8,589,182 B1
`______________
`
`
`Before JACQUELINE WRIGHT BONILLA, BRIAN P. MURPHY, and
`JON B. TORNQUIST, Administrative Patent Judges.
`
`
`MURPHY, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`
`
`
`IPR2015-00545
`Patent 8,589,182 B1
`
`
`I.
`
`INTRODUCTION
`
`Amneal Pharmaceuticals, LLC (“Amneal”) and Par Pharmaceutical,
`
`Inc. (“Par Inc.”) (together, “Petitioner”) filed a Petition requesting an inter
`
`partes review of claims 1–26 (all claims) of U.S. Patent No. 8,589,182 B1
`
`(Ex. 1001, “the ’182 patent”). Paper 4 (“Petition” or “Pet.”). Jazz
`
`Pharmaceuticals, Inc. (“Patent Owner”) filed a Preliminary Response to the
`
`Petition. Paper 10. As authorized (Paper 11), Petitioner filed a response
`
`directed solely to real party in interest issues raised in the Preliminary
`
`Response (Paper 12), and Patent Owner filed a reply to that paper (Papers
`
`17/18). Upon considering those submissions, we instituted inter partes
`
`review of claims 1–26 of the ’182 patent. Paper 25 (“Dec. on Inst.”).
`
`After institution, Patent Owner filed a Response (Paper 46, “PO
`
`Resp.”), and Petitioner filed a Reply (Paper 50, “Reply”). Petitioner
`
`supports its challenge with a Declaration by Robert J. Valuck, Ph.D., R.Ph.
`
`(“Valuck Declaration”) (Ex. 1007) and the Affidavit of Christopher Butler
`
`(“Butler First Affidavit”) (Ex. 1028). Pet. 9, 15. Petitioner also presents
`
`another Affidavit of Mr. Butler (Ex. 1058, “Butler Third Affidavit”) with its
`
`Reply. Reply 7.
`
`With its Response, Patent Owner presents the Declarations of Joseph
`
`T. DiPiro, Pharm.D. (Ex. 2046, “DiPiro Declaration”), Bryan Bergeron,
`
`MD, FACMI (Ex. 2047, “Bergeron Declaration”), Craig F. Kirkwood,
`
`Pharm.D. (Ex. 2053, “Kirkwood Declaration”), David A. Holdford, Ph.D.,
`
`FAPhA (Ex. 2056, “Holdford Declaration”), and Lyndsey J. Przybylski (Ex.
`
`2057, “Przybylski Declaration”). PO Resp. 17–22, 27–29. Patent Owner
`
`also presents a responsive Affidavit of Christopher Butler dated November
`
`4, 2015 (Ex. 2052, “Butler Second Affidavit”). PO Resp. 7–8.
`
`
`
`2
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`IPR2015-00545
`Patent 8,589,182 B1
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`Petitioner filed a Motion to Exclude seeking to exclude certain
`
`evidence (Paper 56), along with a Motion to Allow Late Filing of Evidence
`
`Objections (Paper 58). Patent Owner filed an Opposition to Petitioner’s
`
`Motion to Exclude (Paper 63) and an Opposition to Petitioner’s Motion to
`
`Allow Late Filing of Evidence Objections (Paper 61). Petitioner filed a
`
`Reply to Patent Owner’s Opposition to the Motion to Exclude (Paper 64). In
`
`addition, Patent Owner filed a Notice Regarding New Arguments and
`
`Evidence in Petitioner’s Reply (Paper 52), to which Petitioner filed a
`
`Response (Paper 53).
`
`A combined oral hearing in Cases IPR2015-00545, IPR2015-00546,
`
`IPR2015-00547, IPR2015-00548, IPR2015-00551, and IPR2015-00554 was
`
`held on April 19, 2016; a transcript of the hearing is included in the record.
`
`(Paper 68, “Tr.”).
`
`We have jurisdiction under 35 U.S.C. § 6(c). We issue this Final
`
`Written Decision pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For
`
`the reasons that follow, we determine Petitioner has shown by a
`
`preponderance of the evidence that claims 1–26 of the ’182 patent are
`
`unpatentable. Petitioner’s Motion to Allow Late Filing of Evidence
`
`Objections and Motion to Exclude are dismissed as moot.
`
`A. Ground of Unpatentability at Issue
`
`Petitioner contends that claims 1–26 of the ’182 patent are
`
`unpatentable under 35 U.S.C. § 103 as obvious over Advisory Committee
`
`Art (Exs. 1003–1006, collectively called “the ACA”), including the Food
`
`and Drug Administration (“FDA”) Advisory Committee Transcript and
`
`
`
`3
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`IPR2015-00545
`Patent 8,589,182 B1
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`Slides (Ex. 1003),1 FDA Preliminary Clinical Safety Review (Ex. 1004),2
`
`Briefing Booklet (Ex. 1005),3 and Xyrem Video and Transcript (Ex. 1006).4
`
`Pet. 1, 9–37, 56–58.
`
`B. Related Proceedings
`
`The parties identify the following as related district court proceedings
`
`regarding the ’182 patent: Jazz Pharmaceuticals, Inc. v. Roxane
`
`Laboratories, Inc., 2:10-cv-6108 (D.N.J.); Jazz Pharmaceuticals, Inc. v.
`
`Amneal Pharmaceuticals, LLC, 2:13-cv-391(consolidated) (D.N.J.); Jazz
`
`Pharmaceuticals, Inc. v. Par Pharmaceutical., Inc., 2:13-cv-07884 (D.N.J.);
`
`Jazz Pharmaceuticals, Inc. v. Ranbaxy Laboratories Ltd., 2:14-cv-4467
`
`(D.N.J.); and Jazz Pharmaceuticals, Inc. v. Watson Laboratories, Inc., 2:14-
`
`cv-7757 (D.N.J). Pet. 59; Paper 7, 1–2. Patent Owner identifies two other
`
`district court proceedings concerning patents related to the ’182 patent: Jazz
`
`Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, 2:14-cv-3235
`
`
`1 FDA Peripheral & Central Nervous System Drugs Advisory Committee,
`Transcript and Slides (June 6, 2001) (“Advisory Committee Transcript and
`Slides”) (Ex. 1003).
`
`2 Ranjit B. Mani, FDA Peripheral & Central Nervous System Drugs
`Advisory Committee, Division of Neuropharmacological Drug Products,
`Preliminary Clinical Safety Review of NDA 21-196 (May 3, 2001)
`(“Preliminary Clinical Safety Review”) (Ex. 1004).
`
`3 Xyrem® (sodium oxybate) oral solution NDA #21-196: Briefing Booklet
`for the FDA Peripheral & Central Nervous System Drugs Advisory
`Committee (May 3, 2001) (“Briefing Booklet”) (Ex. 1005).
`
`4 FDA Peripheral & Central Nervous System Drugs Advisory Committee,
`Briefing Information, Xyrem Prescription and Distribution Process Video
`and Transcript (February 2, 2001) (“Xyrem Video and Transcript”) (Ex.
`1006).
`
`
`
`4
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`IPR2015-00545
`Patent 8,589,182 B1
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`(D.N.J.) and Jazz Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc., 2:14-
`
`cv-5139 (D.N.J.). Paper 7, 2.
`
`The parties identify the following as Petitions for inter partes review
`
`of patents related to the ’182 patent: IPR2015-00546 (Patent 7,765,106);
`
`IPR2015-00547 (Patent 7,765,107); IPR2015-00548 (Patent 7,895,059);
`
`IPR2015-00551 (Patent 8,457,988); and IPR2015-00554 (Patent 7,668,730).
`
`Pet. 59; Paper 7, 2. The parties also identify the following as Petitions for
`
`covered business method patent review regarding the ’182 patent and related
`
`patents: CBM2014-00149 (Patent 7,895,059); CBM2014-00150 (Patent
`
`8,457,988); CBM2014-00151 (Patent 7,668,730); CBM2014-00153 (the
`
`’182 patent); CBM2014-00161 (Patent 7,765,106); and CBM2014-00175
`
`(Patent 7,765,107). Pet. 59; Paper 7, 2. The Board has denied institution in
`
`all six of the above-mentioned CBM cases.
`
`In addition, a different Petitioner, Wockhardt Bio AG (“Petitioner
`
`Wockhardt”), filed a Petition for inter partes review of the ’182 patent in
`
`IPR2015-01813, as well as five additional Petitions challenging claims in the
`
`other patents at issue in the related inter partes review proceedings noted
`
`above. Petitioner Wockhardt also filed Motions for Joinder in all six cases
`
`in relation to the corresponding earlier filed Petitions. We originally
`
`instituted review in those cases and granted Petitioner Wockhardt’s Joinder
`
`Motions. See, e.g., Paper 44 (granting institution and Petitioner
`
`Wockhardt’s Motion for Joinder in IPR2015-01813, in relation to the ’182
`
`patent). After the oral hearing took place, however, upon the parties’ joint
`
`request (Paper 65), we ordered the termination of all six proceedings as to
`
`Petitioner Wockhardt, and granted the parties’ joint request to treat the
`
`
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`5
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`underlying settlement agreement as business confidential information (Paper
`
`66). Paper 67.
`
`C. The ’182 Patent
`
`The ’182 patent, titled “Sensitive Drug Distribution System and
`
`Method,” issued November 19, 2013, from an application filed August 27,
`
`2012. Ex. 1001.5 The ’182 patent is directed to a method for controlling
`
`access to a sensitive prescription drug prone to potential abuse or diversion,
`
`by utilizing a central database to track all prescriptions for the sensitive drug.
`
`Id. at Abstract, 1:48–52. Information regarding all physicians authorized to
`
`prescribe the drug and all patients receiving the drug is maintained in the
`
`database. Id. Abuses are identified by monitoring the database for
`
`prescription patterns by physicians and prescriptions obtained by patients.
`
`Id. at Abstract, 1:52–54.
`
`Figures 2A, 2B, and 2C comprise flow charts representing “an initial
`
`prescription order entry process for a sensitive drug.” Id. at 4:17–18. In
`
`overview, a physician submits prescriber, patient, and prescription
`
`information for the sensitive drug to a pharmacy team, which enters the
`
`information into a computer database. Id. at 4:17–35, Fig. 2A (steps 202–
`
`210). The pharmacy team then engages in “intake reimbursement” (Fig.
`
`2A), which includes verification of insurance coverage or the patient’s
`
`willingness and ability to pay for the prescription drug. Id. at 4:36–38.
`
`The pharmacy workflow also includes verification of the prescribing
`
`physician’s credentials. Id. at 5:19–34, Fig. 2B (steps 274–280). Filling the
`
`
`5 The ’182 patent claims priority, through a chain of continuations, from
`patent application US 10/322,348 (“the ’348 application”) filed December
`17, 2002. Ex. 1001, Related U.S. Application Data (63), 1:6–13.
`
`
`
`6
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`IPR2015-00545
`Patent 8,589,182 B1
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`prescription includes confirming the patient has read educational materials
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`regarding the sensitive drug, confirming the patient’s receipt of the sensitive
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`drug, and daily cycle counting and inventory reconciliation. Id. at 5:35–6:3.
`
`Steps 240, 242, 246, and 258–266 of Figure 2C are reproduced below.
`
`. . .
`
`
`
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`7
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`IPR2015-00545
`Patent 8,589,182 B1
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`Figure 2C, above, depicts a portion of a prescription fulfillment flow
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`diagram. Id. at Fig. 2C. The “CHiPS” system, referenced in steps 260 and
`
`266, is an application database “used to maintain a record of a client home
`
`infusion program (CHIP) for Xyrem®.”6 Id. at 4:38–43. If a patient requests
`
`an early prescription refill, for example, the pharmacist generates a report
`
`evaluating “the patient’s compliance with therapy or possible product
`
`diversion, misuse or over-use.” Id. at 6:42–44, Fig. 4B (step 436).
`
`D. Illustrative Claim
`
`The ’182 patent contains multiple independent claims (1, 8, 15 and
`
`19) and several dependent claims, of which claim 1 is illustrative and
`
`reproduced below:
`
`1. 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 approval for distribution of the
`prescription drug, comprising:
`
`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;
`
`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;
`
`
`6 Xyrem® (or Xyrem) is the brand name for gamma hydroxy butyrate
`(“GHB”), indicated for the treatment of cataplexy (excessive daytime
`sleepiness) in narcoleptic patients. Ex. 1001, 3:24–29. Xyrem is a sensitive
`prescription drug prone to potential abuse or diversion. Id.
`
`
`
`8
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`IPR2015-00545
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`
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`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;
`
`entering and maintaining, using the computer processor, in
`the single computer database information that indicates
`that the narcoleptic patient or prescriber has abused,
`misused, or diverted the company's prescription drug;
`and
`
`checking for abuse, using the computer processor and the
`single computer database, and authorizing filling of the
`prescriptions for the company's prescription drug only if there is no
`record of incidents that indicate abuse, misuse, or diversion by the
`narcoleptic patient and prescriber, and if there is a record of such
`incidents, the single computer database indicates that such incidents
`have been investigated, and the single computer database indicates
`that such incidents do not involve abuse, misuse or diversion.
`
`
`II. ANALYSIS
`
`A. Level of Ordinary Skill in the Art
`
`Relying on testimony by Dr. Valuck, Petitioner contends that a person
`
`of ordinary skill in the relevant art (hereafter “POSA”) includes someone
`
`with 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.” Pet. 2 (citing Ex. 1007 ¶ 21); see also Ex.
`
`1007 ¶ 20 (Dr. Valuck stating that he “at least meet[s] the criteria of a
`
`
`
`9
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`IPR2015-00545
`Patent 8,589,182 B1
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`POSA”). Alternatively, according to Petitioner, a POSA “may have a blend
`
`of computer science and pharmacy drug distribution knowledge and/or
`
`experience,” including “computer science education qualifications and
`
`experience relating to computerized drug distribution systems, or pharmacy
`
`education qualifications and experience relating to computerized drug
`
`distribution systems.” Pet. 2. Petitioner also asserts that 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. Pet. 14–15 (citing Ex. 1007 ¶ 47).
`
`In its Response, Patent Owner challenges the sufficiency of
`
`Petitioner’s evidence that a POSA would have been familiar with the Federal
`
`Register and motivated to look for notices related to drug distribution,
`
`safety, or abuse prevention. PO Resp. 15–17. Patent Owner’s challenge
`
`amounts to an attack on the knowledge and skill level of a hypothetical
`
`person of ordinary skill in the art. We are not persuaded by Patent Owner’s
`
`argument.
`
`We begin with the premise that a hypothetical POSA is presumed to
`
`be aware of the pertinent art in the field of endeavor at the time of the
`
`invention, and to be a person of ordinary creativity. KSR Int’l Co. v. Teleflex
`
`Inc., 550 U.S. 398, 407-09, 420-21 (2007). As the title, field of the
`
`invention, and background discussion in the ’182 patent make clear, the
`
`relevant field of endeavor is the distribution of sensitive prescription drugs
`
`prone to abuse or causing serious adverse reactions. Ex. 1001, Title (54),
`
`1:15–31. Petitioner provides substantial evidence of the state of the art of
`
`such sensitive drug distribution systems as of December 17, 2001, one year
`
`
`
`10
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`IPR2015-00545
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`before the ’182 patent priority date. Pet. 3–6; Ex. 1001, Related U.S.
`
`Application Data (63).
`
`Xyrem is a sensitive prescription drug prone to potential abuse or
`
`diversion. Ex. 1001, 3:24–29. Prior to Xyrem, sensitive prescription drugs
`
`such as Accutane, Clozaril, and thalidomide were known to use controlled
`
`distribution systems to protect against potential side effects, abuse, and
`
`diversion. Pet. 4–5 (citing Ex. 1007 ¶¶ 22–25). Accutane, a prescription
`
`drug from the 1980s that could cause birth defects, was distributed under a
`
`program requiring i) informed consent forms completed by patient and
`
`physician, ii) patient counseling to avoid pregnancy and use birth control,
`
`and iii) a negative blood serum test for pregnancy prior to beginning
`
`treatment. Id. at 4 (citing Ex. 1007 ¶ 22). Distribution of Clozaril, indicated
`
`for treating schizophrenia but also capable of causing a fatal blood disorder,
`
`was controlled using a national registry system and computerized database
`
`for identifying patients and physicians. Id. at 4–5 (citing Ex. 1007 ¶ 23). In
`
`1999, the manufacturers of thalidomide developed a system that combined
`
`the computerized registry of Clozaril with the controls imposed by the
`
`Accutane distribution system. Id. at 5 (citing Ex. 1007 ¶ 25). Based on such
`
`prior art activity, we find that by December 2002 a person of ordinary skill
`
`would have known the active ingredient in Xyrem – sodium oxybate, the
`
`sodium salt of gamma hydroxybutyrate – was a sensitive drug susceptible to
`
`abuse and diversion, and such person would have known of several available
`
`techniques to control and mitigate the risks associated with Xyrem’s
`
`distribution. Id. at 2–3 (citing Ex. 1007 ¶¶ 21, 46); Ex. 1007 ¶¶ 21–28, 46.
`
`In its Response, and during the oral hearing, counsel for Patent Owner
`
`argued that a person of ordinary skill in the art was “a person of three to five
`
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`11
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`years’ experience, a pharmacist, a person who sits behind the counter at
`
`Walgreens [and] is not worried about preapproved drugs.” Tr. 30:17–31:9;
`
`PO Resp. 19–20. Counsel for Patent Owner further argued that a person of
`
`ordinary skill would not have had an interest nor “a focus on restricted
`
`distribution of products that don’t even exist yet.” Tr. at 31:1–32:1.
`
`In view of the claims at issue here, we are not persuaded that the level
`
`of ordinary skill in the art is limited to the level of skill or interest of a
`
`pharmacist that dispenses FDA-approved drugs, such as one that “sits behind
`
`the counter at Walgreens.” Id. at 31:1–5. We adopt the level of ordinary
`
`skill in the art as described by Petitioner and its witness, Dr. Valuck, because
`
`it is consistent with the subject matter before us, the ’182 patent, and with
`
`prior art of record, such as Talk About Sleep (Ex.1033), Honigfeld (Ex.
`
`1034), Elsayed (Ex. 1035), and Lilly (Ex. 1010). See Okajima v. Bourdeau,
`
`261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that the prior art itself can
`
`reflect the appropriate level of ordinary skill in the art).
`
`B. Claim Construction
`
`For inter partes review, claim terms in an unexpired patent are given
`
`their broadest reasonable interpretation in light of the patent specification.
`
`37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131,
`
`2144–46 (2016). Claim terms are generally given their ordinary and
`
`customary meaning, as would be understood by one of ordinary skill in the
`
`art in the context of the entire disclosure. In re Translogic Tech., Inc.,
`
`504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definition for a claim
`
`term must be set forth in the specification with reasonable clarity,
`
`
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`12
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`deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir.
`
`1994).
`
`The independent claims of the ’182 patent recite, in relevant part:
`
`(i)
`
`(ii)
`
`(iii)
`
`(iv)
`
`A method of treating a “narcoleptic patient” with a
`prescription drug “that has a potential for misuse, abuse or
`diversion . . . comprising;”
`“receiving, using a computer processor, into a single
`computer database . . . from any and all patients . . . all
`prescriptions for the . . . prescription drug” (“Step 1.1”);
`“entering, using the computer processor, into the single
`computer database information sufficient to identify the
`narcoleptic patient” (“Step 1.2”);
`“entering, using the computer processor, into the single
`computer database information sufficient to identify any and
`all physicians or other prescribers . . . authorized to
`prescribe the . . . prescription drug” (“Step 1.3 ”);
`“entering and maintaining . . . in the single computer
`database information that indicates that the narcoleptic
`patient or prescriber has abused, misused, or diverted the . . .
`prescription drug” (“Step 1.4”); and
`“checking for abuse, using . . . the single computer database,
`and authorizing filling of the prescriptions . . . only if there
`is no record of incidents that indicate abuse, misuse, or
`diversion by the narcoleptic patient and prescriber” (“Step
`1.5”).
`Ex. 1001, 8:38–12:10 (see independent claims 1, 8, 15, and 19).
`
`(v)
`
`(vi)
`
` Of note, the ’182 patented method requires a “single computer
`
`database” to receive “all prescriptions” “from any and all patients” (Step
`
`1.1) in addition to storing the identifying information for the “patient” and
`
`“all physicians or other [authorized] prescribers” of the prescription drug
`
`(Steps 1.2 and 1.3). The single computer database is used to store and
`
`maintain information on whether a patient or prescriber “has abused,
`
`misused, or diverted” the prescription drug (Step 1.4). The single computer
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`13
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`database is used to check for abuse such that authorizing the filling of
`
`prescriptions occurs only if there is no record of incidents indicating abuse,
`
`misuse, or diversion by the patient and prescriber (Step 1.5).
`
`Petitioner argues for the broadest reasonable interpretation of the
`
`claims as understood by one of ordinary skill in the art in light of the ’182
`
`patent specification. Id. at 8. Petitioner does not propose to construe any
`
`particular claim terms or phrases, but argues that the preamble language in
`
`independent claims 1, 8, 15, and 19 is not limiting. Id. at 8–9. In support,
`
`Petitioner argues that, although framed as “method of treatment” claims,
`
`none of the ’182 patent claims recites a method step directed to treating a
`
`narcoleptic patient. Id. (citing Ex. 1007 ¶ 37).
`
`Patent Owner does not address the substance of the preamble
`
`language in the independent claims. PO Resp. 23–25. Patent Owner argues
`
`that dependent claims 7, 14, and 25, which depend from independent claims
`
`1, 8, and 19 either directly or indirectly, do recite administration of a
`
`compound for therapeutic effect, based on the recited wherein clause:
`
`“wherein said GHB drug product treats cataplexy in said narcoleptic
`
`patient.” Id. at 24. We address the parties’ arguments below.
`
`First, we agree with Petitioner that the preamble language “[a] method
`
`of treatment of a narcoleptic patient” in the independent claims is not
`
`“necessary to give life, meaning, and vitality” to the claims of the ’182
`
`patent. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305
`
`(Fed. Cir. 1999). The claims recite method steps for controlling distribution
`
`of a prescription drug prone to abuse, misuse, or diversion; the claims do not
`
`recite treating a patient, administering a compound or drug product for
`
`therapeutic effect, or other treatment-related method steps. See, Ex. 1007
`
`
`
`14
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`¶ 37. Therefore, we determine the preamble language “[a] method of
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`treatment of a narcoleptic patient” to be non-limiting.
`
`Second, the wherein clause at issue does not recite a method step.
`
`Independent claims 1, 8, and 19 consistently recite method steps using the
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`present participle verb form, “receiving,” “entering,” “checking,” and
`
`“authorizing.” The wherein clause, however, recites the GHB drug product
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`“treats” cataplexy, rather than reciting a method step of “treating” cataplexy.
`
`The absence of the present participle verb form and the use of a wherein
`
`clause indicate an intended use or inherent property of the GHB drug
`
`product to treat cataplexy, not a method step. See Credle v. Bond, 25 F.3d
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`1566, 1572 (Fed. Cir. 1994) (“[B]efore each clause containing an undisputed
`
`present participle designating the method steps—‘providing an insert;’
`
`‘joining two opposed webs’ . . . there is a comma, indicating the beginning
`
`of a new, distinct step . . . . There is no such comma preceding ‘flexibly
`
`securing.’ This suggests that ‘securing’ is not a present participle signifying
`
`a distinct method step.”).
`
`Third, the last step in the claimed methods of independent claims 1, 8,
`
`and 19 recites “checking for abuse . . . and authorizing filling of the
`
`prescriptions . . . only if there is no record of incidents” that may indicate
`
`abuse, misuse, or diversion. Ex. 1001, 8:65–9:1; 9:49–52, 12:2–5 (emphasis
`
`added). Claims 7 and 14 depend directly from claims 6 and 13,
`
`respectively.7 Claims 6 and 13 (and independent claim 19) do not recite an
`
`additional method step, such as mailing, providing, or delivering the GHB
`
`
`7 Claim 25 depends directly from independent claim 19.
`
`15
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`Patent 8,589,182 B1
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`drug product to the patient. Ex. 1001, claims 6, 13, and 24.8 Thus, each
`
`method recited in claims 7, 14, and 25 ends with the step of authorizing a
`
`GHB prescription after checking for possible abuse. Steps for mailing,
`
`providing, or delivering the GHB drug product to the patient and/or for
`
`confirming receipt, precursor method steps to any purported treating of the
`
`patient within the context of the claims, are not recited.
`
`Fourth, the ’182 patent specification does not describe method of
`
`treatment steps for treating cataplexy with GHB. The references to
`
`treatment are brief general statements in the Prescription and Enrollment
`
`Form of Figure 9 and the Background section of the patent. Ex. 1001, 1:32–
`
`35 (“Certain agents, such as gamma hydroxy buterate (GHB) are also
`
`abused, yet also are effective for therapeutic purposes such as treatment of
`
`daytime cataplexy in patients with narcolepsy.”), Fig. 9 (“Xyrem is approved
`
`for the treatment of cataplexy in patients with narcolepsy”). Those limited
`
`descriptions further support our determination that the wherein clause at
`
`issue recites only an intended use or inherent property of GHB. Neither the
`
`Summary of the Invention, the Drawing flowcharts, the Detailed Description
`
`of the Invention, nor the claims describe a method step for treating a patient
`
`as part of the claimed invention. Ex. 1001.
`
`Considering the claim language as a whole in light of the
`
`specification, we conclude that the wherein clause recited in dependent
`
`claims 7, 14, and 25 is not a method step in the claimed method. The
`
`wherein clause, like the preamble, recites only an intended use or inherent
`
`
`8 Dependent claims 2, 9, and 20 each recite “delivering the prescription drug
`to the narcoleptic patient in order to treat the narcoleptic patient,” but this
`“delivering” step is not a step in the methods of claims 7, 14, and 25.
`
`
`
`16
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`property of the GHB drug product to treat cataplexy in a narcoleptic patient.
`
`Therefore, we determine the wherein clause in dependent claims 7, 14, and
`
`25 is not entitled to patentable weight. See Catalina Mktg. Int’l v.
`
`Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (a preamble is not
`
`limiting “where a patentee defines a structurally complete invention in the
`
`claim body and uses the preamble only to state a purpose or intended use for
`
`the invention.”).
`
`C. Public Accessibility of Exhibits 1003–1006
`
`The priority date of the ’182 patent is December 17, 2002. Ex. 1001,
`
`1 (63). Petitioner asserts that Exhibits 1003–1006 (the “Advisory
`
`Committee Art” or “ACA”) were publicly accessible printed publications
`
`under 35 U.S.C. § 102(b), in connection with the Xyrem Advisory
`
`Committee meeting held on June 6, 2001. Pet. 10–15. Patent Owner
`
`counters that Petitioner’s evidence is insufficient to show that (1) Exhibits
`
`1004–1006 were publicly accessible more than one year prior to December
`
`17, 2002, or that (2) a POSA would have been “capable of locating or
`
`learning of the existence and potential relevance” of Exhibits 1003–1006.
`
`PO Resp. 3–23.
`
`The key inquiry is whether a reference was made “sufficiently
`
`accessible to the public interested in the art” before the critical date, here
`
`December 17, 2001. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989).
`
`“A given 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.” Bruckelmyer v. Ground
`
`Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006). Indexing of a reference
`
`
`
`17
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`is not “a necessary condition for a reference to be publicly accessible,” but it
`
`is one among various factors that may bear on public accessibility. In re
`
`Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009). “Whether a reference is
`
`publicly accessible is determined on a case-by-case basis based on the ‘facts
`
`and circumstances surrounding the reference’s disclosure to members of the
`
`public.’” Voter Verified, Inc., v. Premier Election Solutions, Inc., 698 F.3d
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`1374, 1380 (Fed. Cir. 2012) (quoting In re Lister, 583 F.3d 1307, 1311 (Fed.
`
`Cir. 2009)). With these principles in mind, we consider the parties’
`
`arguments below.
`
`1. Accessibility of Exhibits 1003–1006 on FDA’s Website
`
`a. Summary timeline
`
`A summary timeline of events, before and after the June 6, 2001 FDA
`
`Advisory Committee Meeting concerning Xyrem® (or “Xyrem”), provides
`
`helpful context. Orphan Medical is the company that developed Xyrem and
`
`prepared the drug sponsor’s Briefing Booklet for the Xyrem Advisory
`
`Committee Meeting, in accordance with the Federal Advisory Committee
`
`Act (“FACA”). Ex. 1005, 1; Pet. 12–13 (citing Ex. 1005; 5 U.S.C. App 2
`
`§ 10(b) (2001)); Reply 2–3 (citing Ex. 1005, 1; Ex. 1057, 2; 5 U.S.C. App 2
`
`§ 10(b) (2001)). FDA reviewers also prepared briefing information,
`
`including the Preliminary Clinical Safety Review of the Xyrem New Drug
`
`Application (“Safety Review”). Ex. 1004. The June 6, 2001 meeting was
`
`transcribed. Ex. 1003. We provide a summary timeline below.
`
`May 3, 2001: FDA Safety Review of Xyrem completed (Ex. 1004, 1)
`
`May 3, 2001: Sponsor’s Xyrem Briefing Booklet submitted to
`Advisory Committee (Ex. 1005, 1)
`
`
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`18
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`May 3, 2001: Sponsor’s video of Xyrem prescription process
`submitted to Advisory Committee (Ex. 1005, 2 ¶ 5, 14, 312; Ex. 1006)
`
`May 14, 2001: Federal Register Notice of Xyrem Advisory
`Committee Meeting (Ex. 1015, Col. 2–3)
`
`June 6, 2001: Xyrem Advisory Committee Meeting (Ex. 1003)
`
`June 17, 2001: Internet Archive of FDA website for Xyrem Advisory
`Committee (Ex. 1018, 5)
`
`July 1, 2001: Internet Archive of FDA website for Xyrem Advisory
`Committee (Ex. 1019)
`
`October 4, 2001: Internet Archive of FDA website for Xyrem
`Advisory Committee (Ex. 1020, 8–9)
`
`December 17, 2002: ’182 patent application priority date
`
`August 30, 2003: Internet Archive printout of Ex. 1006 “Video Script
`2/2/01” (Ex. 2052, 1–2 (¶¶ 6, 9), 482–492, 501)
`
`September 13, 2011: Internet Archive printout of Ex. 1005 “Briefing
`Booklet” (Ex. 2052, 1–2 (¶¶ 6, 8), 128–481, 498)
`
`November 21, 2011: Internet Archive printout of Ex. 1004
`“Preliminary Clinical Safety Review” (Ex. 2052, 1–2 (¶¶ 6, 7), 5–127,
`495).
`
`
`The Advisory Committee Meeting was convened to discuss Xyrem,
`
`with the “main focus of the deliberations . . . on risk management issues.”
`
`Pet. 14 (citing Ex. 1015; Ex. 1007 ¶ 47); Ex. 1003, 5:23–6:3. The above
`
`timeline and cited exhibits confirm Petitioner’s unopposed contention that
`
`Exhibits 1004–1006 were prepared for and made available to the Xyrem
`
`Advisory Committee before the June 6, 2001 Xyrem Advisory Committee
`
`Meeting. Reply 2–3. The transcript of the Xyrem Advisory Committee
`
`Meeting contains several references to the “briefing documents” and
`
`
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`19
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`“materials” distributed prior to the meeting, al
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