Trials@uspto.gov Paper 70
`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 IPR2015-00547
`Patent 7,765,107 B2
`______________
`
`
`
`
`
`Before JACQUELINE WRIGHT BONILLA, BRIAN P. MURPHY, and
`JON B. TORNQUIST, Administrative Patent Judges.
`
`BONILLA, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`I.
`
`INTRODUCTION
`Amneal Pharmaceuticals, LLC, and Par Pharmaceutical, Inc. (“Par
`Inc.”) (together, “Petitioner”), filed a Petition requesting an inter partes
`review of claims 1–6 of U.S. Patent No. 7,765,107 B2 (Ex. 1001, “the ’107
`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 1–6 of the
`’107 patent based on an obviousness ground. 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 challenges 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. 18–22, 26–36, 38–47. Patent
`Owner also presents a responsive Affidavit of Christopher Butler dated
`November 4, 2015 (Ex. 2052, “Butler Second Affidavit”). PO Resp. 8–9.
`
`
`
`2
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`
`In addition, Petitioner also filed a Motion to Exclude seeking to
`exclude certain evidence (Paper 56, “Mot. Excl.”), 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 this proceeding and Cases IPR2015-
`00545, IPR2015-00546, IPR2015-00548, IPR2015-00551, and IPR2015-
`00554 was held on April 19, 2016; a transcript of the hearing is included in
`the record (Paper 69, “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 that Petitioner has shown by a
`preponderance of the evidence that claims 1–6 of the ’107 patent are
`unpatentable. Petitioner’s Motion to Allow Late Filing of Evidence
`Objections and Motion to Exclude are dismissed as moot.
`A. Grounds of Unpatentability at Issue
`Petitioner contends that the challenged claims are unpatentable under
`35 U.S.C. § 103 based on the ground that claims 1–6 are obvious over
`Advisory Committee Art (Exs. 1003–1006, collectively called “the ACA”),
`
`
`
`3
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`including FDA Advisory Committee Transcript and Slides (Ex. 1003),1
`Preliminary Clinical Safety Review (Ex. 1004),2 Briefing Booklet (Ex.
`1005),3 and Xyrem Video and Transcript (Ex. 1006).4 Pet. 1, 9–34, 56–58.
`B. Related Proceedings
`The parties identify the following as related district court proceedings
`regarding the ’107 patent: Jazz Pharms., Inc. v. Par Pharm., Inc., No. 2:13-
`cv-07884 (D.N.J. Dec. 27, 2013); Jazz Pharms., Inc. v. Amneal Pharms.,
`LLC, No. 2:13-cv-00391 (consolidated) (D.N.J. Jan. 18, 2013); Jazz
`Pharms., Inc. v. Roxane Labs., Inc., No. 2:10-cv-06108 (consolidated)
`(D.N.J. Nov. 22, 2010); Jazz Pharms., Inc. v. Ranbaxy Labs. Ltd., No. 2:14-
`cv-4467 (D.N.J. July 15, 2014); Jazz Pharms., Inc. v. Watson Labs., Inc.,
`No. 2:14-cv-7757 (D.N.J). Pet. 59–59; Paper 8, 1–2.
`The parties also identify the following cases as involving Petitions for
`inter partes review of patents related to the ’107 patent: IPR2015-00545
`(Patent 8,589,182 B1); IPR2015-00546 (Patent 7,765,106 B2); IPR2015-
`
`
`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, Briefing Information, 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 (Feb. 2, 2001) (“Xyrem Video and Transcript”) (Ex. 1006).
`4
`
`
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`00548 (Patent 7,895,059 B2); IPR2015-00551 (Patent 8,457,988 B1); and
`IPR2015-00554 (Patent 7,668,730 B2). Pet. 59; Paper 8, 2. The parties also
`identify the following cases as involving Petitions for covered business
`method patent review (“CBM”) regarding the ’107 patent and related
`patents: CBM2014-00149 (Patent 7,895,059 B2); CBM2014-00150 (Patent
`8,457,988 B1); CBM2014-00151 (Patent 7,668,730 B2, “the ’730 patent”);
`CBM2014-00153 (Patent 8,589,182 B1); CBM2014-00161 (Patent
`7,765,106 B2); and CBM2014-00175 (the ’107 patent). Pet. 59; Paper 8, 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 ’107 patent in
`IPR2015-01820, as well as five additional Petitions challenging claims in the
`other patents at issue in the related inter partes review cases 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 IPR2015-01820, in relation to the ’107 patent). After the oral
`hearing took place, however, upon the parties’ joint request (Paper 66), 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 67). Paper 68.
`Patent Owner identifies the following pending U.S. patent
`applications claiming priority benefit from U.S. Patent Application No.
`10/322,348, which the ’107 patent also claims the benefit of: U.S. Patent
`
`
`
`5
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`Application No. 14/196,603, filed on March 4, 2014, U.S. Patent
`Application No. 14/219,904, filed on March 19, 2014, and U.S. Patent
`Application No. 14/219,941 filed on March 19, 2014. Paper 8, 3.
`C. The ’107 Patent
`The ’107 patent, titled “Sensitive Drug Distribution System and
`Method,” issued July 27, 2010, from a divisional application of an
`application filed December 17, 2002. Ex. 1001. The ’107 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, 1:44–50.
`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, 1:48–50.
`Figures 2A, 2B, and 2C comprise flow charts representing “an initial
`prescription order entry process for a sensitive drug.” Id. at 4:13–14. 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 4:13–31, 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 4:32–34.
`The “pharmacy” workflow includes verification of the prescribing
`physician’s credentials. Id. at 5:15–31, 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
`
`
`
`6
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`drug, and daily cycle counting and inventory reconciliation. Id. at 5:31–6:4.
`Steps 240, 242, 246, and 258–266 of Figure 2C are reproduced below.
`
`. . .
`
`
`
`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
`
`
`
`
`
`7
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`infusion program (CHIP) for Xyrem®.”5 Id. at 4:34–39. 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 6:37–41, Fig. 4B (step 436).
`D. Illustrative Claims
`The ’107 patent contains two independent claims (1 and 4) and four
`dependent claims (2, 3, 5, and 6), of which claim 1 is illustrative and
`reproduced below:
`1. A computerized method to control abuse of a prescription
`drug comprising:
`controlling with a computer processor the distribution of said
`prescription drug via an exclusive central pharmacy that
`maintains a central database that tracks all prescriptions of
`said prescription drug and analyzes for potential abuse
`situations;
`receiving in the 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;
`processing with the computer processor all prescriptions for
`the prescription drug only by the exclusive central pharmacy
`using only the central database;
`determining with the computer processor current and
`anticipated patterns of potential prescription abuse of said
`prescription drug from periodic reports generated only by
`the central database based on prescription request data from
`a particular medical doctor and further based on filling of
`
`5 Xyrem® is the brand name for gamma hydroxy butyrate (“GHB”),
`indicated for the treatment of cataplexy (excessive daytime sleepiness) in
`narcoleptic patients. Ex. 1001, 3:20–27. Xyrem® is a sensitive prescription
`drug prone to potential abuse or diversion. Id.
`8
`
`
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`
`prescriptions by a particular patient, wherein said request
`data contain information identifying the patient, the drug
`prescribed, and credentials of the medical doctor; and
`selecting with the computer processor multiple controls for
`distribution by said exclusive central pharmacy, the controls
`comprising communicating prescriptions from a physician to
`the central pharmacy; identifying the physician’s name,
`license, and DEA (Drug Enforcement Agency) registration
`information; verifying the prescription; obtaining patient
`information; verifying the physician is eligible to prescribe
`the prescription drug by consulting the National Technical
`Information Services to determine whether the physician has
`an active DEA number and to check on whether any actions
`are pending against the physician; providing comprehensive
`printed materials to the physician; contacting the patient's
`insurance company if any; verifying patient registry
`information; providing comprehensive education
`information to the patient; verifying the patient has reviewed
`the educational materials; verifying the home address of the
`patient; shipping via US postal service or a commercial
`shipping service; receiving the name of an at least 18 year
`old designee to receive the drug; confirming receipt of an
`initial shipment of the drug to the patient returning the drug
`to the pharmacy after two attempts to deliver; launching an
`investigation when a shipment is lost; shipping to another
`pharmacy for delivery; requiring manufacture at a single
`location; releasing inventory in a controlled manner to the
`central pharmacy; questioning early refills; flagging repeat
`instances of lost, stolen, destroyed, or spilled prescriptions;
`limiting the prescription to a one month supply; requiring
`rewriting of the prescription periodically; and making the
`database available to the DEA for checking for abuse
`patterns in the data, for cash payments, and for inappropriate
`questions.
`Ex. 1001, 8:36–9:25 (emphases added). Dependent claim 2 (and claim 5,
`which depends from independent claim 4) of the ’107 patent recite certain
`“initially selected controls.” Id. at 9:26–44, 10:39–59. Dependent claim 3
`
`
`
`9
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`(and claim 6, which depends from independent claim 4) of the ’107 patent
`“further comprises consulting a separate database to verify that the medical
`doctor is eligible to prescribe the drug.” Id. at 9:45–47, 10:60–62.
`
`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 id. at
`¶ 20 (Dr. Valuck stating that he “at least meet[s] the criteria of a POSA” as
`outlined in ¶ 21 of his Declaration). 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.” Id. 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. 15 (citing Ex. 1007 ¶ 42).
`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. 16–24. Patent Owner’s challenge
`
`
`
`10
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`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 ’107 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, 1:11–
`27. 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 ’107 patent priority date. Pet. 3–6; see also Ex. 1001, Related
`Application, 1:6–9 (indicating earliest priority date for the ’107 patent).
`Xyrem® is a sensitive prescription drug prone to potential abuse or
`diversion. Ex. 1001, 3:20–27. 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 of 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
`
`
`
`11
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`disorder, was controlled using a national registry system and computerized
`database for identifying patients and physicians. Id. (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—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 ¶¶ 21, 41); Ex. 1007 ¶¶ 21–28.
`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. 19–20. 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. 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 ’107 patent, and with
`
`
`
`12
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`prior art of record, such as Talk About Sleep (Ex.1033),6 Honigfeld (Ex.
`1034),7 Elsayed (Ex. 1035),8 and Lilly (Ex. 1010)9. See Okajima v.
`Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating the prior art itself
`can reflect the appropriate level of ordinary skill in the art).
`B. Claim Construction
`We interpret claims in an unexpired patent according to the broadest
`reasonable construction in light of the specification of the patent in which
`they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs. LLC v. Lee, 136
`S.Ct. 2131, 2144–46 (2016). Claim terms are 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 with reasonable clarity, deliberateness, and precision. In re
`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`Claim 1 of the ’107 patent recites a “computerized method to control
`abuse of a prescription drug” by: (1.1) “controlling with a computer
`processor the distribution of said prescription drug via an exclusive central
`
`
`6 Talk About Sleep, “An Interview with Orphan Medical about Xyrem®,”
`available at http://www.talkaboutsleep.com/an-interview-with-orphan-
`medical-about-xyrem/ (Feb. 12, 2001) (“Talk About Sleep”) (Ex. 1033).
`7 Honigfeld et al., “Reducing Clozapine-Related Morbidity and Mortality: 5
`Years of Experience with the Clozaril National Registry,” J. Clin. Psych. 59
`(suppl. 3): 3-7 (1998) (“Honigfeld”) (Ex. 1034).
`8 Elsayed et al., U.S. Patent No. 6,045,501, filed Aug. 28, 1998, issued Apr.
`4, 2000 (“Elsayed”) (Ex. 1035).
`9 Lilly et al., U.S. Patent Appl. Pub. No. 2004/0176985, filed Mar. 18, 2004,
`published Sept. 9, 2004 (“Lilly”) (Ex. 1010).
`13
`
`
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`pharmacy that maintains a central database that tracks all prescriptions . . .
`and analyzes for potential abuse situations;” (1.2) “receiving in the computer
`processor all prescription requests . . . only at the exclusive central
`pharmacy;” (1.3) “processing with the computer processor all prescriptions
`for the prescription drug only by the exclusive central pharmacy using only
`the central database;” (1.4) “determining with the computer processor
`current and anticipated patterns of potential prescription abuse of said
`prescription drug from periodic reports generated only by the central
`database;” and (1.5) “selecting with the computer processor multiple
`controls for distribution by said exclusive central pharmacy.” Ex. 1001,
`8:36–9:25. The claim as a whole recites controlling distribution of a
`prescription drug to patients to guard against potential abuse.
`Both Petitioner and Patent Owner present constructions for several
`claim terms. Pet. 8–9; PO Resp. 24–36; Reply 12–18. We discuss the
`different terms in turn below.
`1. “exclusive central pharmacy”
`In our Decision on Institution, we construed the term “exclusive
`central pharmacy” to mean “single or sole pharmacy.” Dec. on Inst. 20–21.
`Our constructions are consistent with those proposed by Petitioner, and
`Patent Owner takes no position regarding Petitioner’s arguments in this
`regard. Pet. 8; PO Resp. 24 n.8. Based on our review of the complete
`record, we do not perceive any reason or evidence that now compels any
`deviation from that interpretation.
`
`
`
`14
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`
`2. “determining with the computer processor . . . patterns of potential
`prescription abuse . . . from periodic reports generated only by the
`central database”
`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. 8 (citing Ex. 1001, 2:19–21). Figure 7 of the ’107 patent
`reflects prescriber, patient, prescription, and insurance information input into
`the database, and Figures 13A–13C reflect various types of reports that may
`be generated, including reports regarding “pharmacy,” “inventory,”
`“reimbursement,” “patient care,” and “drug information.” Ex. 1001, 7:41–
`48, 8:22–29, Figs. 7, 13A–C. A user generates reports by running various
`queries through the exclusive computer database to obtain information of the
`type illustrated. Id.
`The recited use of the reports is to determine “current and anticipated
`patterns of potential prescription abuse,” such as when a patient requests the
`same prescription from multiple doctors, a patient requests an early
`prescription refill, or a prescriber writes multiple prescriptions for a patient.
`Id. at 1:31–36, 2:19–21. Figure 4B illustrates a refill request process that
`permits a pharmacist to identify an early refill request, generate a “risk
`diversion report,” and evaluate “possible product diversion, misuse or over-
`use” of a prescription drug. Id. at 6:37–41, Fig. 4B (406, 432, 434, 436).
`The ability of a pharmacist or other user to determine potential diversion
`patterns from the generated reports, in order to prevent product diversion,
`misuse, or abuse, necessarily informs the types of reports generated and
`must be reflected in the claim construction.
`
`
`
`15
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`
`In our Decision on Institution, we construed the phrase “determining
`with the computer processor . . . patterns of potential prescription abuse . . .
`from periodic reports generated only by the central database” to mean “using
`the central database via the computer processor to generate periodic reports
`containing prescriber, patient, and/or prescription related information, which
`permits evaluation of potential abuse of a prescription drug.” Dec. on Inst.
`22.
`
`Patent Owner indicates that it generally agrees with that construction,
`but proposes that the construction is incomplete in relation to the term
`“periodic reports.” PO Resp. 25. Patent Owner contends that “periodic
`reports” should be construed to mean “at regular frequencies or intervals, as
`opposed to intermittently or upon request.” Id. at 25–26 (citing Ex. 2046 ¶¶
`30–38; Ex. 2047 ¶¶ 28–35). In support, Patent Owner points to the
`specification of the ’107 patent, such as Figures 13A–C, and where the
`specification states “[e]ach report has an associated frequency or
`frequencies.” Id. at 26–27; Ex. 1001, 8:22–28.
`The cited portions of the specification, however, describe Figures
`13A–C as “descriptions of sample reports obtained by querying a central
`database having fields represented in Fig. 7.” Ex. 1001, 8:22–24 (emphasis
`added); see also id. at 2:55–57 (also describing Figs. 13A–C as describing
`“sample reports”); Reply 13. Thus, we do not agree that the specification
`indicates that “periodic reports” as recited in the claims refers only to reports
`obtained at regular frequencies or intervals, even if the term includes such
`reports.
`Patent Owner also responds to testimony by Petitioner’s expert, Dr.
`Valuck, who states that “periodic reports” can be generated on either “an ad
`
`
`
`16
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`hoc basis or on a regular basis.” PO Resp. 28 (quoting Ex. 2044, 184:8–16).
`Patent Owner argues that a POSA “would understand that ad hoc reports are
`done for a particular purpose,” and, therefore, a “POSA would not consider
`‘ad hoc’ reports to be ‘periodic.’” Id. at 27 (citing Ex. 2046 ¶¶ 33, 37; Ex.
`2047 ¶¶ 31, 34, Ex. 1001, Figs. 4B, 13A–C)). Patent Owner also argues that
`Figure 4B illustrates generating “ad hoc” reports prepared for the particular
`purpose of investigating specific early refill requests, and not “periodic”
`reports as recited in the challenged claims. PO Resp. 27–28 (citing Ex. 2046
`¶ 36; Ex. 2047 ¶ 33).
`We are not persuaded by Patent Owner’s arguments or the testimony
`of Dr. DiPiro and Dr. Bergeron in support thereof. Patent Owner does not
`explain adequately why generating a report for a particular purpose or “ad
`hoc” precludes it from being a report generated periodically. See, e.g., PO
`Resp. 28 (citing Ex. 2046 ¶ 33 (testimony by Dr. DiPiro stating that “POSA
`would not consider ‘ad hoc’ reports to be ‘periodic’ because they are not
`generated with any regular frequency.”); Ex. 2047 ¶ 31 (testimony by Dr.
`Bergeron stating same). As noted above, the specification does not limit
`“periodic reports” to those generated with “regular frequency.” Moreover,
`to the extent that Figure 4B in the ’107 patent illustrates generating “ad hoc”
`reports, as Patent Owner contends, such disclosure supports a construction
`that the recited “periodic reports” include such “ad hoc” reports. Ex. 1001,
`6:13–7:3; Reply 13–14 (citing Ex. 1047, 6; Ex. 1048, 9:12–19, Fig. 4, 436).
`Patent Owner also points us to a Merriam-Webster’s Collegiate
`Dictionary definition of the term “periodic,” which defines the term as
`“occurring or recurring at regular intervals,” or something that is “repeated.”
`PO Resp. 27 (quoting Ex. 2043, 3). Petitioner points us to several other
`
`
`
`17
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`dictionary definitions, which define “periodic” as also including
`“intermittent.” Reply 15 (citing Ex. 1049, 3 (defining “periodic” as
`including “occurring repeatedly from time to time”); Ex. 1050, 3 (defining
`“periodic” as including “[t]aking place now and then” or
`“INTERMITTENT”); Ex. 1051, 3 (defining “periodic” as including
`“[h]appening or appearing now and then” or “intermittent, occasional”).
`Upon considering all of the evidence before us, we are not persuaded that
`the plain and ordinary meaning of “periodic” in the context of the ’107
`patent limits “periodic reports” to those generated only at regular intervals,
`as Patent Owner contends. PO Resp. 26–28. Rather, the term includes
`reports generated at regular intervals and reports generated “now and again”
`or “intermittently,” without any particular regularity in time between events.
`Thus, we construe “periodic reports” as recited in the challenged
`claims to refer to reports that are generated at regular intervals or
`intermittently, i.e., now and again, including those not generated at regular
`intervals.
`3. “wherein said [prescription] request data contain information
`identifying the patient”
`Patent Owner construes the phrase “wherein said [prescription]
`request data contain information identifying the patient” to mean, “at a
`minimum: the prescription requests [for GHB] containing the patient’s
`name, social security number, date of birth, sex, and complete address
`information, including city, state and zip code.” PO Resp. 29–33 (citing Ex.
`2046 ¶¶ 39–44; Ex. 1001, 4:14–28, 8:4–5, 39–42, 10:50–53; Ex. 2044,
`97:11–98:5, 99:18–100:10). For example, Patent Owner contends that the
`specification of the ’107 patent describes receiving at a central pharmacy all
`prescription requests, such as enrollment forms, which include patients’
`18
`
`
`
`

`

`IPR2015-00547
`Patent 7,765,107 B1
`
`“name, social security number, date of birth, gender, [and] contact
`information,” as identified in Figure 9 of the specification. PO Resp. at 30
`(citing Ex. 1001, 4:26–28, 8:4–5; Ex. 2044, 97:11–23, 99:18–100:10).
`Petitioner responds that “information identifying the patient” is not
`limited to the extent that it must include all of the specific information
`identified by Patent Owner. Reply 15–17. Petitioner also argues that Patent
`Owner’s construction improperly reads limitations as disclosed in Figure 9
`into the claims. Id. We agree.
`The specification of the ’107 patent indicates that “[a]n example of
`one prescription and enrollment form is shown at 900 in FIG. 9.” Ex. 1001,
`8:4–5 (emphasis added). Thus, the enrollment form of Figure 9 describes
`one example of the type of information that may be information identifying
`a patient. The specification does not indicate, however, that “information
`identifying the patient,” as recited in the claims, necessarily includes each
`and every piece of information in the enrollment form of Figure 9.
`Similarly, nothing in the specification suggests that excluding one or more
`pieces of information in the list of a “patient’s name, social security number,
`date of birth, sex, and complete address information, including city, state and
`zip code,” as proposed by Patent Owner, means that a prescription fails to
`contain “information identifying