`Tel: 571-272-7822
`
`Entered: July 27, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`PAR PHARMACEUTICAL, INC. and AMNEAL PHARMACEUTICALS,
`LLC,
`Petitioner,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`_____________
`
`Case IPR2015-00551 (Patent 8,457,988 B1)
`Case IPR2015-00554 (Patent 7,668,730 B2)1
`
`______________
`
`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
`
`
`
`
`1 This Final Written Decision addresses common issues raised in both cases.
`The patents at issue in IPR2015-00551 and IPR2015-00554 are related, and
`the arguments by Petitioner and Patent Owner are largely the same in each
`case. Therefore, we issue one Final Written Decision to be entered in each
`case. The parties are not authorized to use this caption without prior
`authorization of the Board.
`
`
`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`I.
`
`INTRODUCTION
`
`Par Pharmaceutical, Inc. (“Par Inc.”), and Amneal Pharmaceuticals,
`
`LLC (“Amneal”) (together, “Petitioner”) filed a Petition requesting an inter
`
`partes review of claims 1–11 (all claims) of U.S. Patent No. 7,668,730 B2
`
`(Ex. 1001, “the ’730 patent”). IPR2015-00554, Paper 1 (“Petition” or
`
`“Pet.”). 2 Jazz Pharmaceuticals, Inc. (“Patent Owner”) filed a Preliminary
`
`Response to the Petition. Paper 10.3 As authorized (Paper 11), Petitioner
`
`filed a response directed solely to real party in interest issues raised in the
`
`Preliminary Response (Paper 13), and Patent Owner filed a reply to that
`
`paper (Papers 17/18). Upon considering those submissions, we instituted
`
`inter partes review of claims 1–11 of the ’730 patent and claims 1–15 of the
`
`’988 patent. Paper 20 (“Dec. on Inst.”).
`
`After institution, Patent Owner filed a Response (Paper 39, “PO
`
`Resp.”), and Petitioner filed a Reply (Paper 46, “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. 11, 17–18. 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,
`
`
`2 For clarity and expediency, we treat IPR2015-00554 as representative of
`both cases. All citations are to IPR2015-00554 unless otherwise noted.
`3 Petitioner also filed a Petition requesting an inter partes review of claims
`1–15 (all claims) of U.S. Patent No. 8,457,988 B1 (“the ’988 patent”).
`IPR2015-00551, Paper 1 (“the ’551 Petition” or “’551 Pet.”). Patent Owner
`filed a Preliminary Response to that Petition. IPR2015-00551, Paper 9.
`
`
`
`2
`
`
`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`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. 18–22, 27–36, 39–49, 53–57.
`
`Patent Owner also presents a responsive Affidavit of Christopher Butler
`
`dated November 4, 2015 (Ex. 2052, “Butler Second Affidavit”). PO Resp.
`
`8.
`
`Petitioner filed a Motion to Exclude seeking to exclude certain
`
`evidence (Paper 54), along with a Motion to Allow Late Filing of Evidence
`
`Objections (Paper 57). Patent Owner filed an Opposition to Petitioner’s
`
`Motion to Exclude (Paper 61) and an Opposition to Petitioner’s Motion to
`
`Allow Late Filing of Evidence Objections (Paper 59). Petitioner filed a
`
`Reply to Patent Owner’s Opposition to the Motion to Exclude (Paper 63). In
`
`addition, Patent Owner filed a Notice Regarding New Arguments and
`
`Evidence in Petitioner’s Reply (Paper 50), to which Petitioner filed a
`
`Response (Paper 51).
`
`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 67, “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 1–11 of the ’730 patent and
`
`claims 1–15 of the ’988 patent are unpatentable. We also dismiss
`
`Petitioner’s Motions to Allow Late Filing of Objections and Motions to
`
`
`
`3
`
`
`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`Exclude as moot.
`
`A. Ground of Unpatentability at Issue
`
`Petitioner contends that claims 1–11 of the ’730 patent and claims 1,
`
`3–9, and 11–15 of the ’988 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 Slides (Ex. 1003),4 FDA Preliminary
`
`Clinical Safety Review (Ex. 1004),5 Briefing Booklet (Ex. 1005),6 and
`
`Xyrem Video and Transcript (Ex. 1006).7 Pet. 1, 9–33, 56–58. Petitioner
`
`further contends that claims 2 and 10 of the ’988 patent are unpatentable
`
`under 35 U.S.C. § 103 as obvious over the Advisory Committee Art in view
`
`of Korfhage.8
`
`B. Related Proceedings
`
`The parties identify the following as related district court proceedings:
`
`
`4 FDA Peripheral & Central Nervous System Drugs Advisory Committee,
`Transcript and Slides (June 6, 2001) (“Advisory Committee Transcript and
`Slides”) (Ex. 1003).
`
`5 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).
`
`6 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).
`
`7 FDA Peripheral & Central Nervous System Drugs Advisory Committee,
`Briefing Information, Xyrem Prescription and Distribution Process Video
`and Transcript (Feb. 2, 2001) (“Xyrem Video and Transcript”) (Ex. 1006)
`
`8 Korfhage, Information Storage and Retrieval (John Wiley & Sons, Inc.
`1997) (“Korfhage”) (IPR2015-00551, Ex. 1037).
`
`
`
`4
`
`
`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`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. 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. 58; Paper 8, 1.
`
`Patent Owner identifies two other district court proceedings: Jazz
`
`Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, 2:14-cv-3235
`
`(D.N.J.) and Jazz Pharmaceuticals, Inc. v. Par Pharmaceutical, Inc., 2:14-
`
`cv-5139 (D.N.J.). Paper 8, 2.
`
`The parties identify the following cases as involving petitions for inter
`
`partes review of patents related to the ’730 and ’988 patents: IPR2015-
`
`00545 (Patent 8,589,182); IPR2015-00546 (Patent 7,765,106); IPR2015-
`
`00547 (Patent 7,765,107); and IPR2015-00548 (Patent 7,895,059). Pet. 58–
`
`59; Paper 8, 2. The parties also identify the following cases as involving
`
`petitions for covered business method patent review regarding the ’730, ’988
`
`and related patents: CBM2014-00149 (Patent 7,895,059); CBM2014-00150
`
`(the ’988 patent); CBM2014-00151 (the ’730 patent); CBM2014-00153
`
`(Patent 8,589,182); CBM2014-00161 (Patent 7,765,106); and CBM2014-
`
`00175 (Patent 7,765,107). Pet. 58; Paper 8, 2–3. 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 petitions for inter partes review of the ’730 and ’988
`
`patents in IPR2015-01818 and IPR2015-01814, respectively, as well as four
`
`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
`
`
`
`5
`
`
`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`earlier filed Petitions. We originally instituted review in those cases and
`
`granted Petitioner Wockhardt’s Joinder Motions. See, e.g., Paper 37
`
`(granting institution and Petitioner Wockhardt’s Motion for Joinder in
`
`IPR2015-01818, in relation to the ’730 patent). After the oral hearing took
`
`place, however, upon the parties’ joint request (Paper 64), we ordered the
`
`termination of all six proceedings as to Petitioner Wockhardt and granted the
`
`parties’ joint request to treat the underlying settlement agreement as business
`
`confidential information (Paper 65). Paper 66.
`
`C. The ’730 Patent
`
`The ’730 patent, titled “Sensitive Drug Distribution System and
`
`Method,” issued February 23, 2010, from an application filed December 17,
`
`2002. Ex. 1001.9 The ’730 patent is directed to a method for controlling
`
`access to a sensitive prescription drug prone to potential abuse or diversion,
`
`by utilizing a central pharmacy and database to track all prescriptions for the
`
`sensitive drug. Id. at Abstract, 1:38–42. 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, 1:42–44.
`
`Figures 2A, 2B, and 2C comprise flow charts representing “an initial
`
`prescription order entry process for a sensitive drug.” Id. at 4:7–8. 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 4:7–25, Fig. 2A (steps 202–
`
`
`9 The ’730 patent issued from patent application US 10/322,348 (“the ’348
`application”). Ex. 1001.
`
`
`
`6
`
`
`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`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 4:26–28.
`
`The pharmacy workflow includes verification of the prescribing
`
`physician’s credentials. Id. at 5:9–26, Fig. 2B (steps 274–280). Filling the
`
`prescription includes confirming the patient has read educational materials
`
`regarding the sensitive drug, confirming the patient’s receipt of the sensitive
`
`drug, and daily cycle counting and inventory reconciliation. Id. at 5:27–67.
`
`Steps 240, 242, 246, and 258–266 of Figure 2C are reproduced below.
`
`. . .
`
`
`
`
`
`7
`
`
`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`
`
`Figure 2C, above, depicts a portion of a prescription fulfillment flow
`
`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®.”10 Id. at 4:28–33. 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 6:33–38, Fig. 4B (step 436). The ’988
`
`patent, which derives from the same priority application, contains the same
`
`disclosure as the ’730 patent.
`
`D. Illustrative Claim
`
`The ’730 patent contains multiple independent claims (1, 2, and 7–11)
`
`and several dependent claims (3–6), of which claim 1 is illustrative and
`
`reproduced below:
`
`
`
`
`10 Xyrem is the brand name for gamma hydroxy butyrate (“GHB”), indicated
`for the treatment of cataplexy (excessive daytime sleepiness) in narcoleptic
`patients. Ex. 1001, 3:14–19. Xyrem is a sensitive prescription drug prone to
`potential abuse or diversion. Id.
`
`
`
`8
`
`
`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`1. A computerized method of distributing a prescription
`drug under exclusive control of an exclusive central pharmacy,
`the method comprising:
`
`receiving in a computer processor all prescription requests,
`for any and all patients being prescribed the prescription drug,
`only at the exclusive central pharmacy from any and all medical
`doctors allowed to prescribe the prescription drug, the prescription
`requests containing information identifying patients, the prescription
`drug, and various credentials of the any and all medical doctors;
`
`requiring entering of the information into an exclusive
`computer database associated with the exclusive central
`pharmacy for analysis of potential abuse situations, such
`that all prescriptions for the prescription drug are processed
`only by the exclusive central pharmacy using
`only the exclusive computer database;
`
`checking with the computer processor the credentials of
`the any and all doctors to determine the eligibility of the
`doctors to prescribe the prescription drug;
`
`confirming with a patient that educational material has
`been read prior to shipping the prescription drug;
`
`checking the exclusive computer database for potential
`abuse of the prescription drug;
`
`mailing the prescription drug to the patient only if no
`potential abuse is found by the patient to whom the
`prescription drug is prescribed and the doctor prescribing
`the prescription drug;
`
`confirming receipt by the patient of the prescription drug;
`and
`
`generating with the computer processor periodic reports
`via the exclusive computer database to evaluate potential
`
`
`
`9
`
`
`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`diversion patterns.11
`
`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, for example, including
`
`familiarity with drug distribution procedures.” Pet. 2 (citing Ex. 1007 ¶ 20);
`
`see also Ex. 1007 ¶ 19 (Dr. Valuck stating that he “at least meet[s] the
`
`criteria of a 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. 2–3. 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
`
`
`11 The preamble of the independent claims in the ’988 patent recites a
`“method of treatment of a narcoleptic patient . . . while controlling potential
`misuse, abuse or diversion of said prescription drug, comprising . . . .”
`IPR2015-00551 Ex. 1001, 8:38–40. The method steps recited in the
`independent claims of the ’988 patent, however, are very similar to the
`method steps recited in the independent claims of the ’730 patent, such that
`the analysis concerning claim construction and the ACA grounds of
`challenge are very similar, if not identical, in the two proceedings.
`
`
`
`10
`
`
`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`programs. Pet. 17 (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. 16–17.
`
`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 ’730 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),
`
`1:4–26. Petitioner provides substantial evidence of the state of the art of
`
`such sensitive drug distribution systems as of December 17, 2001, one year
`
`before the ’730 patent priority date. Pet. 3–6: Ex. 1001, filing date (22).
`
`Xyrem is a sensitive prescription drug prone to potential abuse or
`
`diversion. Ex. 1001, 3:14–19. 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 ¶¶ 21–24). 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 of birth control,
`
`and iii) a negative blood serum test for pregnancy prior to beginning
`
`
`
`11
`
`
`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`treatment. Id. at 4 (citing Ex. 1007 ¶ 21). 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 ¶ 22). 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 ¶ 24). 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 – 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 3 (citing Ex. 1007 ¶ 20); Ex.
`
`1007 ¶¶ 21–27, 47.
`
`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
`
`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. 20. Counsel for Patent Owner further argued that a person of
`
`ordinary skill would not have had an interest or “a focus on restricted
`
`distribution of products that don’t even exist yet.” Tr. 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 ’730 patent, and with
`
`
`
`12
`
`
`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`prior art of record, such as Talk About Sleep (Ex.1033), Honigfeld (Ex.
`
`1034), Elsayed (Ex. 1035), and Lilly (Ex. 1036). 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,
`
`deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir.
`
`1994).
`
`Claim 1 of the ’730 patent claims a method of “distributing a
`
`prescription drug” under “exclusive control” of an “exclusive central
`
`pharmacy.” Ex. 1001, 8:38–40, 10:17–19. The claimed method recites
`
`receiving all prescription requests “only at the exclusive central pharmacy;”
`
`entering the physician, patient, and prescription information into an
`
`“exclusive computer database;” and utilizing a series of checks and controls
`
`to prevent “potential abuse” and “evaluate potential diversion patterns.” Id.
`
`at 8:41–9:3. The series of checks and controls are claimed as follows:
`
`“entering . . . information . . . for analysis of potential abuse situations;”
`
`“checking . . . credentials . . . to determine the eligibility of the doctors to
`
`prescribe the prescription drug;” “checking . . . for potential abuse of the
`
`
`
`13
`
`
`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`prescription drug;” “mailing the prescription drug to the patient only if no
`
`potential abuse is found by the patient . . . and the doctor;” and “generating .
`
`. . periodic reports . . . to evaluate potential diversion patterns.” Id. The
`
`claimed method steps correspond to portions of the intake, pharmacy, and
`
`prescription fulfillment workflows described in the patent. The claim as a
`
`whole recites a method for controlling access to a prescription drug to guard
`
`against potential abuse and unauthorized diversion.
`
`Both Petitioner and Patent Owner present constructions for several
`
`claim terms. Pet. 9–11; PO Resp. 24–36; Reply 12–18. We discuss the
`
`different terms in turn below.
`
`1. “exclusive central pharmacy” and “exclusive computer
`database”
`In our Decision on Institution, we construed the term “exclusive
`
`central pharmacy” to mean “single or sole pharmacy,” and the term
`
`“exclusive computer database” to mean “single or sole computer database.”
`
`Dec. on Inst. 21. Our constructions are consistent with those proposed by
`
`Petitioner, and Patent Owner takes no position regarding Petitioner’s
`
`arguments in this regard. Pet. 10; PO Resp. 25 n.8. Based on our review of
`
`the complete record, we do not perceive any reason or evidence that now
`
`compels any deviation from these interpretations.
`
`2. “generating with the computer processor periodic reports via
`the exclusive computer database [to evaluate potential
`diversion patterns]”
`
`Petitioner cites portions of the specification explaining, for example,
`
`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.” Pet. 10 (quoting Ex. 1001, 2:13–15). Figure 7 of the ’730
`
`
`
`14
`
`
`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`patent reflects prescriber, patient, prescription, and insurance information
`
`input into the database, and Figures 13A–13C reflect various types of reports
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`that may be generated, including reports regarding “pharmacy,” “inventory,”
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`“reimbursement,” “patient care,” and “drug information.” Ex. 1001, 7:41–
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`48, 8:22–29, Figs. 7, 13A–C. A user generates reports by running various
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`queries through the exclusive computer database to obtain information of the
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`type illustrated. Id.
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`The recited use of the reports is “to evaluate potential diversion
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`patterns,” such as when a patient requests the same prescription from
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`multiple doctors, a patient requests an early prescription refill, or a
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`prescriber writes multiple prescriptions for a patient. Id. at 1:24–29, 2:13–
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`15. Figure 4B illustrates a refill request process that permits a pharmacist to
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`identify an early refill request, generate a “risk diversion report,” and
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`evaluate “possible product diversion, misuse or over-use” of a prescription
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`drug. Id. at 6:33–39, Fig. 4B (406, 432, 434, 436). The ability of a
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`pharmacist or other user to evaluate potential diversion patterns from the
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`generated reports, in order to prevent product diversion, misuse, or abuse,
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`necessarily informs the types of reports generated and must be reflected in
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`the claim construction.
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`In our Decision on Institution, we construed the phrase “generating
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`with the computer processor periodic reports via the exclusive computer
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`database [to evaluate potential diversion patterns]” to mean “querying the
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`exclusive computer database via the computer processor to generate periodic
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`reports containing prescriber, patient, and/or prescription related information
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`that permits evaluation of potential diversion, misuse, or abuse of a
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`prescription drug.” Dec. on Inst. 22–23.
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`
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`15
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`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
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`Patent Owner indicates that it generally agrees with that construction,
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`but proposes that the construction is incomplete in relation to the term
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`“periodic reports.” PO Resp. 26. Patent Owner contends that “periodic
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`reports” should be construed to mean “at regular frequencies or intervals, as
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`opposed to intermittently or upon request.” Id. at 26–27 (citing Ex. 2046
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`¶¶ 30–38; Ex. 2047 ¶¶ 28–35). In support, Patent Owner points to the
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`specification of the ’730 patent, such as Figures 13A–C, and where the
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`specification states “[e]ach report has an associated frequency or
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`frequencies.” Id. at 27; Ex. 1001, 8:26–27.
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`The cited portions of the specification, however, describe Figures
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`13A–C as “descriptions of sample reports obtained by querying a central
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`database having fields represented in Fig. 7.” Ex. 1001, 8:22–24 (emphasis
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`added); see also id. at 2:49–51 (also describing Figs. 13A–C as describing
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`“sample reports”); Reply 13. Thus, we do not agree that the specification
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`indicates that “periodic reports” as recited in the claims refer only to reports
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`obtained at regular frequencies or intervals, even if the term includes such
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`reports.
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`Patent Owner also responds to testimony by Petitioner’s expert, Dr.
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`Valuck, who states that “periodic reports” can be generated on either “an ad
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`hoc basis or on a regular basis.” PO Resp. 28 (quoting Ex. 2044, 184:8–16).
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`Patent Owner argues that a POSA “would understand that ad hoc reports are
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`done for a particular purpose,” and, therefore, a “POSA would not consider
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`‘ad hoc’ reports to be ‘periodic.’” Id. at 28–29 (citing Ex. 2046 ¶¶ 33, 36;
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`Ex. 2047 ¶¶ 31–33, Ex. 1001, Figs. 4B, 13A–C)). Patent Owner also argues
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`that Figure 4B illustrates generating “ad hoc” reports prepared for the
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`particular purpose of investigating specific early refill requests, and not
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`
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`16
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`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
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`“periodic” reports as recited in the challenged claims. PO Resp. 28–29
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`(citing Ex. 2046 ¶ 36; Ex. 2047 ¶ 33).
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`We are not persuaded by Patent Owner’s arguments or the testimony
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`of Dr. DiPiro and Dr. Bergeron in support thereof. Patent Owner does not
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`explain adequately why generating a report for a particular purpose or “ad
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`hoc” precludes it from being a report generated periodically. See, e.g., PO
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`Resp. 28 (citing Ex. 2046 ¶ 33 (testimony by Dr. DiPiro stating that “POSA
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`would not consider ‘ad hoc’ reports to be ‘periodic’ because they are not
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`generated with any regular frequency.”); Ex. 2047 ¶ 31 (testimony by Dr.
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`Bergeron stating same). As noted above, the specification does not limit
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`“periodic reports” to those generated with “regular frequency.” Moreover,
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`to the extent that Figure 4B in the ’730 patent illustrates generating “ad hoc”
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`reports, as Patent Owner contends, such disclosure supports a construction
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`that the recited “periodic reports” include such “ad hoc” reports. Ex. 1001,
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`6:9–7:2; Reply 13–14 (citing Ex. 1047, 6; Ex.1048, 9 (ll. 12–19), Fig. 4
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`(436)).
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`Patent Owner also points us to a Merriam-Webster’s Collegiate
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`Dictionary definition of the term “periodic,” which defines the term as
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`“occurring or recurring at regular intervals,” or something that is “repeated.”
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`PO Resp. 28 (citing Ex. 2043, 3). Petitioner points us to several other
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`dictionary definitions, which define “periodic” as also including
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`“intermittent.” Reply 15 (citing Ex. 1049, 3 (defining “periodic” as
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`including “occurring repeatedly from time to time”); Ex. 1050, 3 (defining
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`“periodic” as including “[t]aking place now and then” or
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`“INTERMITTENT”); Ex. 1051, 3 (defining “periodic” as including
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`“[h]appening or appearing now and then” or “intermittent, occasional”).
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`17
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`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
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`Upon considering all of the evidence before us, we are not persuaded that
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`the plain and ordinary meaning of “periodic” in the context of the ’730
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`patent limits “periodic reports” to those generated only at regular intervals,
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`as Patent Owner contends. PO Resp. 28. Rather, the term includes reports
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`generated at regular intervals and reports generated “now and again” or
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`“intermittently,” without any particular regularity in time between events.
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`Thus, we construe “periodic reports” as recited in the challenged
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`claims to refer to reports that are generated at regular intervals or
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`intermittently, i.e., now and again, including those not generated at regular
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`intervals.
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`3. “the prescription requests [for GHB] containing information
`identifying patients”
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`Patent Owner contends that the phrase “prescription requests [for
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`GHB] containing information identifying patients” in the challenged claims
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`means, “at a minimum: the prescription requests [for GHB] containing the
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`patient’s name, social security number, date of birth, sex, and complete
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`address information, including city, state and zip code.” PO Resp. 30–33
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`(citing Ex. 2046 ¶¶ 39–44; Ex. 1001, 4:8–22, 8:4–5, 40–44, 10:20–23; Ex.
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`2044, 97:11–98:5, 99:18–100:10). For example, Patent Owner contends that
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`the specification of the ’730 patent describes receiving at a central pharmacy
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`all prescription requests, such as enrollment forms, which include patients’
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`“name, social security number, date of birth, gender, [and] contact
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`information,” as identified in Figure 9 of the specification. PO Resp. at 31
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`(citing Ex. 1001, 4:20–22, 8:4–5; Ex. 2044, 97:11–23, 99:18–100:10).
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`Petitioner responds that “information identifying the patient” is not
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`limited to the extent that it must include all of the specific information
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`
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`18
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`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
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`identified by Patent Owner. Reply 15–17. Petitioner also argues that Patent
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`Owner’s construction improperly reads limitations as disclosed in Figure 9
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`into the claims. Id. We agree.
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`The specification of the ’730 patent indicates that “[a]n example of
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`one prescription and enrollment form is shown at 900 in FIG. 9.” Ex. 1001,
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`8:4–5 (emphasis added). Thus, the enrollment form of Figure 9 describes
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`one example of