throbber
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 IPR2015-00551 (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
`
`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 evaluate potential diversion
`
`patterns,” 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 1:24–29, 2:13–
`
`15. 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 6:33–39, Fig. 4B (406, 432, 434, 436). The ability of a
`
`pharmacist or other user to evaluate 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.
`
`In our Decision on Institution, we construed the phrase “generating
`
`with the computer processor periodic reports via the exclusive computer
`
`database [to evaluate potential diversion patterns]” to mean “querying the
`
`exclusive computer database via the computer processor to generate periodic
`
`reports containing prescriber, patient, and/or prescription related information
`
`that permits evaluation of potential diversion, misuse, or abuse of a
`
`prescription drug.” Dec. on Inst. 22–23.
`
`
`
`15
`
`

`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`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. 26. 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 26–27 (citing Ex. 2046
`
`¶¶ 30–38; Ex. 2047 ¶¶ 28–35). In support, Patent Owner points to the
`
`specification of the ’730 patent, such as Figures 13A–C, and where the
`
`specification states “[e]ach report has an associated frequency or
`
`frequencies.” Id. at 27; Ex. 1001, 8:26–27.
`
`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 2:49–51 (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 refer 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
`
`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 28–29 (citing Ex. 2046 ¶¶ 33, 36;
`
`Ex. 2047 ¶¶ 31–33, 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
`
`
`
`16
`
`

`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`“periodic” reports as recited in the challenged claims. PO Resp. 28–29
`
`(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 ’730 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,
`
`6:9–7:2; Reply 13–14 (citing Ex. 1047, 6; Ex.1048, 9 (ll. 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. 28 (citing Ex. 2043, 3). Petitioner points us to several other
`
`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”).
`
`
`
`17
`
`

`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`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 ’730
`
`patent limits “periodic reports” to those generated only at regular intervals,
`
`as Patent Owner contends. PO Resp. 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. “the prescription requests [for GHB] containing information
`identifying patients”
`
`Patent Owner contends that the phrase “prescription requests [for
`
`GHB] containing information identifying patients” in the challenged claims
`
`means, “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. 30–33
`
`(citing Ex. 2046 ¶¶ 39–44; Ex. 1001, 4:8–22, 8:4–5, 40–44, 10:20–23; Ex.
`
`2044, 97:11–98:5, 99:18–100:10). For example, Patent Owner contends that
`
`the specification of the ’730 patent describes receiving at a central pharmacy
`
`all prescription requests, such as enrollment forms, which include patients’
`
`“name, social security number, date of birth, gender, [and] contact
`
`information,” as identified in Figure 9 of the specification. PO Resp. at 31
`
`(citing Ex. 1001, 4:20–22, 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
`
`
`
`18
`
`

`
`IPR2015-00551 (Patent 8,457,988 B1)
`IPR2015-00554 (Patent 7,668,730 B2)
`
`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 ’730 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 infor

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket