Paper 10
`Trials@uspto.gov
`Tel: 571-272-7822
`
`Entered: March 25, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`AMNEAL PHARMACEUTICALS, LLC and
`PAR PHARMACEUTICAL, INC.,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`_____________
`
`Case IPR2015-01903
`Patent 8,731,963 B1
`
`
`
`______________
`Before: JACQUELINE WRIGHT BONILLA, SUSAN L. C. MITCHELL,
`and BRIAN P. MURPHY, Administrative Patent Judges.
`
`MURPHY, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`Trials@uspto.gov
`Tel: 571-272-7822
`
`Entered: March 25, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`AMNEAL PHARMACEUTICALS, LLC and
`PAR PHARMACEUTICAL, INC.,
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`_____________
`
`Case IPR2015-01903
`Patent 8,731,963 B1
`
`
`
`______________
`Before: JACQUELINE WRIGHT BONILLA, SUSAN L. C. MITCHELL,
`and BRIAN P. MURPHY, Administrative Patent Judges.
`
`MURPHY, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
`
`
`
`
`IPR2015-01903
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`INTRODUCTION
`I.
`Amneal Pharmaceuticals, LLC (“Amneal”) and Par Pharmaceutical,
`Inc. (“Par Inc.”) (together “Petitioner”), filed a Petition requesting an inter
`partes review of claims 1–28 (all claims) of U.S. Patent No. 8,731,963 B1
`(Ex. 1001, “the ’963 patent”). Paper 1 (“Petition” or “Pet.”). Jazz
`Pharmaceuticals, Inc. (“Patent Owner”) did not file a Preliminary Response
`to the Petition. We have statutory authority under 35 U.S.C. § 314(a), which
`provides that an inter partes review may not be instituted “unless . . . there is
`a reasonable likelihood that the petitioner would prevail with respect to at
`least 1 of the claims challenged in the petition.”
`Petitioner challenges claims 1–28 of the ’963 patent as unpatentable
`under 35 U.S.C. § 103(a). Pet. 9–10. Based on the information presented in
`the Petition, we are persuaded there is a reasonable likelihood Petitioner
`would prevail with respect to claims 24, 26, and 27 of the ’963 patent.
`Therefore, we institute inter partes review of the ’963 patent, limited to the
`single ground of obviousness asserted against claims 24, 26, and 27.
`A. Related Proceedings
`Petitioner identifies the following as related district court proceedings
`regarding the ’963 patent: Jazz Pharms., Inc. v. Amneal Pharms. LLC, 2:13-
`cv-00391 (consolidated) (D.N.J. Jan. 18, 2013.); Jazz Pharms., Inc. v.
`Roxane Labs., Inc., 2:10-cv-06108 (consolidated) (D.N.J. Nov. 22, 2010);
`Jazz Pharms., Inc. v. Wockhardt Bio AG., Inc., 2:14-cv-05619 (D.N.J. July
`17, 2015); and Jazz Pharms., Inc. v. Lupin Ltd., 2:2015-cv-6548 (D.N.J.
`Sept. 1, 2015). Pet. 59.
`
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`Petitioner identifies the following as petitions for inter partes review
`of patents related to the ’963 patent: U.S. Patent Nos. 7,668,730 (IPR2015-
`00554); 7,765,106 (IPR2015-00546); 7,765,107 (IPR2015-00547);
`7,895,059 (IPR2015-00548); 8,457,988 (IPR2015-00551); and 8,589,182
`(IPR2015-00545). Id. The Board has instituted inter partes reviews in all
`six of the aforementioned proceedings.
`B. Proposed Grounds of Unpatentability
`Petitioner advances two grounds of unpatentability under 35 U.S.C.
`§ 103(a) in relation to the challenged claims in the ’963 patent:
`Reference[s]
`Statutory
`Challenged
`Basis
`Claims
`§ 103(a)
`1–7 and 9–23
`
`
`Advisory Committee Art (Exs. 1003–1006),
`including FDA Advisory Committee
`Transcript and Slides (Ex. 1003),1
`Preclinical Safety Review (Ex. 1004),2
`Briefing Booklet (Ex. 1005),3 and Xyrem
`Video and Transcript (Ex. 1006)4
`
`
`1 FDA Peripheral & Central Nervous System Drugs Advisory Committee,
`Transcript and Slides (“Advisory Committee Transcript and Slides”). Ex.
`1003. Petitioner refers to Exhibits 1003–1006 collectively as the “Advisory
`Committee Art” or “ACA.”
`2 FDA Peripheral & Central Nervous System Drugs Advisory Committee,
`Briefing Information, Division of Neuropharmacological Drug Products
`Preliminary Clinical Safety Review of NDA 21-196 (“Preclinical Safety
`Review”). Ex. 1004.
`3 Peripheral & Central Nervous System Drugs Advisory Committee,
`Briefing Booklet, Orphan Medical, Inc. Presentation, Food and Drug
`Administration (June 2001), (“Briefing Booklet”). Ex. 1005.
`4 FDA Peripheral & Central Nervous System Drugs Advisory Committee,
`Briefing Information, Xyrem Prescription and Distribution Process Video
`and Transcript (“Xyrem Video and Transcript”). Ex. 1006.
`3
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`Reference[s]
`
`Advisory Committee Art (Exs. 1003–1006)
`and Korfhage (Ex. 1037)5
`
`Statutory
`Basis
`§ 103(a)
`
`Challenged
`Claims
`8 and 24–28
`
`Petitioner supports its challenge with a Declaration by Robert J.
`Valuck, Ph.D., R.Ph. (“Valuck Decl.”) (Ex. 1007).
`
`C. The ’963 Patent
`The ’963 patent, titled “Sensitive Drug Distribution System and
`Method,” issued May 20, 2014, from an application filed August 22, 2012.
`Ex. 1001.6 The ’963 patent is directed to a computer-implemented system
`for controlling access to an abuse-prone prescription drug by using a central
`pharmacy and computer database to track all prescriptions, patients, and
`prescribers. Id. at Abstract, 1:48–52. Information regarding all physicians
`authorized to prescribe the drug and all patients receiving the drug is
`maintained in the database. Id. Abuses are identified by monitoring the
`database for prescription patterns by physicians and prescriptions obtained
`by patients. Id. at Abstract, 1:52–54.
`Figures 2A, 2B, and 2C comprise flow charts representing “an initial
`prescription order entry process for a sensitive drug.” Id. at 4:17–18. In
`overview, a physician submits prescriber, patient, and prescription
`information for the sensitive drug to a pharmacy team, which enters the
`information into a computer database. Id. at 4:17–35, Fig. 2A (steps 202–
`
`
`5 Korfhage, Robert R., Information Storage and Retrieval, Wiley Computer
`Publishing (1997). Ex. 1037.
`6 The ’963 patent issued from a series of continuation applications, the
`earliest of which is U.S. Patent Application No. 10/322,348 (“the ’348
`application”) filed December 17, 2002. Ex. 1001.
`4
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`210). Figure 9 is an example of the information to be provided by the
`physician in a prescription and enrollment form. Id. at 8:6–9. The
`pharmacy team then engages in “intake reimbursement,” which includes
`verification of insurance coverage or the patient’s willingness and ability to
`pay for the prescription drug. Id. at 4:36–38, Fig. 2A.
`The “pharmacy” workflow also includes verification of the
`prescribing physician’s credentials. Id. at 5:19–36, 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
`5:37–6:7. Steps 240, 242, 246, and 258–266 of Figure 2C, are reproduced
`below.
`
`. . .
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`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®.”7 Id. at 4:38–43. If a patient
`requests an early prescription refill, for example, the pharmacist generates a
`report evaluating “the patient’s compliance with therapy or possible product
`diversion, misuse or over-use.” Id. at 6:40–44, Fig. 4B (step 436).
`D. Illustrative Claim
`The ’963 patent contains multiple independent claims (1, 23, and 24)
`and several dependent claims, of which claim 1 is illustrative and
`reproduced below (bracketed numbers added for ease of reference):
`The invention claimed is:
`
`
`7 Xyrem is the brand name for gamma-hydroxybutyrate (“GHB”), indicated
`for the treatment of cataplexy (excessive daytime sleepiness) in narcoleptic
`patients. Ex. 1001, 3:14–19. Xyrem is a prescription drug prone to potential
`abuse or diversion. Id.
`
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`1. A computer-implemented system for treatment of a narcoleptic
`patient with a prescription drug that has a potential for misuse, abuse
`or diversion, comprising:
`
`[1.1] one or more computer memories for storing a single computer
`database having a database schema that contains and interrelates
`prescription fields, patient fields, and prescriber fields;
`
`[1.2] said prescription fields, contained within the database schema,
`storing prescriptions for the prescription drug with the potential for
`abuse, misuse or diversion, wherein the prescription drug is sold or
`distributed by a company that obtained approval for distribution of the
`prescription drug;
`
`[1.3] said patient fields, contained within the database schema, storing
`information sufficient to identify the narcoleptic patient for whom the
`company's prescription drug is prescribed;
`
`[1.4] said prescriber fields, contained within the database schema,
`storing information sufficient to identify a physician or other
`prescriber of the company's prescription drug and information to show
`that the physician or other prescriber is authorized to prescribe the
`company's prescription drug;
`
`a data processor configured to:
`
`[1.5] process a database query that operates over all data related to the
`prescription fields, prescriber fields, and patient fields for the
`prescription drug; and
`
`[1.6] reconcile inventory of the prescription drug before the shipments
`for a day or other time period are sent by using said database query to
`identify information in the prescription fields and patient fields;
`
`[1.7] wherein the data processor is configured to process a second
`database query that identifies that the narcoleptic patient is a cash
`payer and a physician that is interrelated with the narcoleptic patient
`through the schema of the single computer database;
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`[1.8] said identifying that the narcoleptic patient is a cash payer by
`said second database query being an indicator of a potential misuse,
`abuse or diversion by the narcoleptic patient and being used to notify
`the physician that is interrelated with the narcoleptic patient through
`the schema of the single computer database.
`
`II. ANALYSIS
`A. Claim Construction
`In an inter partes review, we construe claim terms of an unexpired
`patent according to their broadest reasonable interpretation in light of the
`patent specification. 37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs.,
`LLC, 793 F.3d 1268, 1279–81 (Fed. Cir. 2015), cert. granted sub nom.
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 890 (mem.) (2016). Under the
`broadest reasonable interpretation standard, we assign claim terms their
`ordinary and customary meaning, as understood by one of ordinary skill in
`the art, in the context of the entire patent 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).
`We determine that no claim terms require express construction for
`purposes of this Decision.
`B. Public Accessibility of Exhibits 1003–1006
`The priority date of the ’963 patent is December 17, 2002. Ex. 1001,
`(63), 1:6–13. Petitioner asserts the references comprising the Advisory
`Committee Art (Exs. 1003–1006) were publicly accessible as printed
`publications in connection with an FDA Advisory Committee meeting
`regarding Xyrem held on June 6, 2001. Pet. 11–16. The documents at issue
`
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`are alleged to have been published in electronic form and made available on
`the FDA’s website before the ’963 patent priority date. Id. at 13–14.
`The key inquiry is whether a reference was made “sufficiently
`accessible to the public interested in the art” before the priority date. In re
`Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989) (citation omitted). Indexing
`of a reference is not “a necessary condition for a reference to be publicly
`accessible,” but it is one among various factors that may bear on public
`accessibility. In re Lister, 583 F.3d 1307, 1312 (Fed. Cir. 2009). “A given
`reference is ‘publicly accessible’ upon a satisfactory showing that such
`document has been disseminated or otherwise made available to the extent
`that persons interested and ordinarily skilled in the subject matter or art
`exercising reasonable diligence, can locate it.” Bruckelmyer v. Ground
`Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006) (citing In re Wyer, 655
`F.2d 221, 226 (CCPA 1981)); see also Voter Verified, Inc. v. Premier
`Election Solutions, Inc., 698 F.3d 1374, 1380 (Fed. Cir. 2012). With these
`principles in mind, we consider the parties’ arguments below.
`1. Exhibit 1003 Advisory Committee Meeting Transcript and
`Slides
`Exhibit 1003 is a written transcript, including presentation slides, of
`the Peripheral and Central Nervous System Drugs Advisory Committee
`meeting held June 6, 2001, in Bethesda, MD (“the Advisory Committee
`Meeting”). Pet. 11–12 (citing Ex. 1003). The Advisory Committee Meeting
`was convened to discuss Xyrem, with the “main focus of the deliberations
`. . . on risk management issues.” Ex. 1003, 5:23–6:3. A Federal Register
`Notice, dated May 14, 2001, provided public notice of the Advisory
`Committee Meeting. Pet. 11–12 (citing Ex. 1015). The notice further
`
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`identified a website for providing “[b]ackground material from the sponsor
`and FDA” and stated that “the minutes, transcript, and slides from the
`meeting” are “generally posted about 3 weeks after the meeting.” Id. at 12–
`13 (citing Ex. 1015) (emphasis omitted).
`Petitioner also cites evidence from the Internet Archive Wayback
`Machine (located at https://archive.org/web/web.php) indicating that the
`Advisory Committee Meeting transcript and presentation slides were
`available no later than October 4, 2001. Id. at 14 (citing Ex. 1020, 8–9; Ex.
`1028, 20). The cited Internet Archive page contains a Universal Resource
`Locator (“URL”) date code of October 4, 2001. Id. Petitioner’s Internet
`Archive evidence is supported by a June 15, 2012, Affidavit of Christopher
`Butler, the Office Manager of the Internet Archive at that time. Id. (citing
`Ex. 1028). Mr. Butler’s Affidavit explains the URL date codes used to
`determine the availability of archived internet records as of a particular date.
`Ex. 1028 ¶¶ 3–5.8
`The date of the Advisory Committee Meeting, the Federal Register
`Notice, and the Internet Archive evidence all support a public accessibility
`date for Exhibit 1003 of no later than October 4, 2001. Therefore, we are
`persuaded on the present record that the evidence provided by Petitioner
`indicates sufficiently that Exhibit 1003 was publicly accessible to a person
`of ordinary skill in the art, exercising reasonable diligence, no later than
`October 4, 2001.
`
`
`8 We note that the entry for the Advisory Committee Meeting on page 8 of
`Exhibit 1020 appears to be very similar to the entry on page 20 of Exhibit
`1028, except for the “5/13/2014” date appearing on the upper left-hand
`corner of each page of Exhibit 1020.
`
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`2. Exhibits 1004–1006
`Petitioner considers Exhibits 1004–1006 together, with respect to their
`public accessibility date. Exhibit 1004 is a Xyrem Preclinical Safety
`Review, asserted by Petitioner to have small portions redacted, thereby
`indicating an intent to make the document publicly available. Pet. 14. The
`cover page of the Preclinical Safety Review indicates FDA completed its
`review on May 3, 2001. Ex. 1004, 1 (“Review Completed: 5/3/01”).
`Exhibit 1005 comprises a three-page cover letter from the Xyrem sponsor,
`dated May 3, 2001, and the enclosed Briefing Booklet for the Advisory
`Committee Meeting. Pet. 14 (citing Ex. 1005). The cover page of the
`Briefing Booklet says “AVAILABLE FOR PUBLIC DISCLOSURE
`WITHOUT REDACTION.” Id. Exhibit 1006 is a Xyrem Video and
`Transcript of the video dated February 2, 2001.9 Id. (citing Ex. 1006).
`Petitioner argues that Internet Archive evidence shows Exhibits 1004–
`1006 were publicly accessible on the FDA’s website no later than July 1,
`2001. Id. (citing Ex. 1018,10 5–6; Ex. 1019). Exhibit 1019, dated July 1,
`2001, contains Portable Document Format (“pdf”) links to “Safety Review,”
`“Briefing Information,” and “Video Script 2/2/01” documents relating to the
`Advisory Committee Meeting, as well as a hyper-text file for the Xyrem
`Video. Id. (citing Ex. 1019). Petitioner, in reliance on Mr. Valuck’s
`testimony, argues that one of skill in the art would have been able to locate
`
`
`9 Petitioner has submitted Exhibit 1006 in fifteen parts, comprising fourteen
`parts of the video and the transcript of the entire video. All citations to Ex.
`1006 are citations to the transcript (“Exhibit 1006 Xyrem Video
`Transcript”).
`10 We note there is no Exhibit 1018 in the record as reflected in PRPS.
`11
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`Exhibits 1004–1006 no later than July 1, 2001, by “exercising reasonable
`diligence” and “[f]ollowing this link.” Id. at 14–15 (citing Ex. 1007 ¶ 64;
`Exs. 1003, 1015, 1019, 1020, and 1028).
`Our review of the evidence on the present record, including the dates
`on the documents themselves (Exs. 1004–1006), the Federal Register Notice
`(Ex. 1015), the Internet Archive evidence (Exs. 1019–1020; Ex. 1028), and
`Mr. Valuck’s Declaration testimony (Ex. 1007 ¶ 64), indicates that
`Petitioner has shown sufficiently that Exhibits 1004–1006 were publicly
`accessible to one of ordinary skill more than one year before the December
`17, 2002, priority date of the ’963 patent. Therefore, we proceed to consider
`Petitioner’s unpatentability grounds.
`
`C. Asserted Obviousness of claims 1–7 and 9–23 of the ’963 Patent
`over the Advisory Committee Art
`
`Petitioner contends that claims 1–7 and 9–23 of the ’963 patent would
`have been obvious to one of ordinary skill in the art over the ACA (Exhibits
`1003–1006). Pet. 16–48.11 Petitioner relies on the Declaration testimony of
`Dr. Valuck in support of its argument that a person of ordinary skill in the
`art would have had reason to combine the ACA documents because the
`documents were prepared for the Advisory Committee Meeting and “relate
`to the same restricted and computer-implemented distribution program,
`
`
`11 Petitioner describes the level of skill and state of the art as of December
`2002, the earliest effective filing date of the ’963 patent. Pet. 2–6.
`Petitioner describes one of ordinary skill as someone holding a Bachelor’s or
`Doctor of Pharmacy degree and registered as a pharmacist with 3–5 years of
`relevant work experience, or someone holding computer science degree or
`equivalent work experience including familiarity with drug distribution
`procedures. Id. at 2–3.
`
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`which the meeting was convened to discuss.” Id. at 17 (citing Ex. 1007
`¶ 68). Petitioner further relies on Dr. Valuck’s Declaration testimony in
`support of its argument that all of the elements recited in independent
`claim 1, identified as the preamble and Elements 1.1–1.8, are found in the
`ACA. Id. at 18–19 (citing Ex. 1007 ¶¶ 70–95). Petitioner also cites to
`specific disclosures in the ACA and to Dr. Valuck’s Declaration testimony
`in support of its argument that the additional elements recited in claims 2–7
`and 9–23 are disclosed in the ACA. Id. at 34–48 (citing Ex. 1003; Ex. 1004;
`Ex. 1005; Ex. 1006; Ex. 1007 ¶¶ 98, 100, 102, 104, 106, 108, 110, 112, 114,
`116, 118, 120–122, 124, 126, 128–130, 132–134).
`For the reasons stated below, we are not persuaded by Petitioner’s
`analysis and supporting evidence that there is a reasonable likelihood it
`would prevail on this ground in relation to the challenged claims.
`1. Element 1.6: “a data processor configured to: . . . reconcile
`inventory of the prescription drug before the shipments for a
`day or other time period are sent by using said database
`query to identify information in the prescription fields and
`patient fields”
`
`
`
`Claim Element 1.6 recites two requirements for reconciling inventory.
`The inventory must be reconciled (i) by using a database query to identify
`prescription and patient information, and (ii) before shipments are sent out
`for a given period of time, e.g., daily. The ’963 patent describes the process
`used to “reconcile” or account for the inventory of the sensitive prescription
`drug before shipment to a patient. All inventory is “cycle counted and
`reconciled with the database system quantities before shipments for the day
`are sent.” This provides a very precise control of the inventory. Ex. 1001,
`6:4–7, 6:34–37, Fig. 4A (426). We understand “cycle counting” to refer to
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`counting the quantity of prescription drug on hand (“all inventory”) on a
`defined cycle, e.g., daily or weekly, to account for “production inventory”
`that is segregated from consigned inventory and shipped to authorized
`patients. Id. at 7:29–39, Fig. 6.12 Any discrepancy or shortage in the
`quantity of inventory on hand, when compared and reconciled with the
`quantities reflected in the historical prescription and patient information
`stored in the database, are resolved or reported. Id. at 6:30–53.
`a. The FDA Briefing Booklet
`The FDA Briefing Booklet on which Petitioner relies discloses an
`inventory control process:
`Xyrem, once received at the specialty pharmacy, goes into a
`secure holding area dedicated solely to the storage of Xyrem
`and accessible only to authorized employees. . . . On a weekly
`basis, the specialty pharmacy determines the amount of Xyrem
`it is likely to need for fulfillment of prescriptions, and the
`appropriate amount of product is transferred to “owned
`inventory”. This is the point at which Xyrem is “sold” by
`Orphan Medical to the specialty pharmacy. This transfer of
`ownership allows the specialty pharmacy to collect confidential
`data such as patient names and medication doses. This is
`information that Orphan Medical will not have, but the
`specialty pharmacy can collect because of the
`doctor/pharmacist/patient relationship.
`
`Ex. 1005, 313–14; see also Pet. 30–31. The FDA Briefing Booklet discloses
`the steps of determining the amount of the drug needed to fill pending
`prescriptions, transferring that amount to “owned inventory,” and
`completing the sales transaction with the drug manufacturer. It does not
`
`
`12 The cycle counting technique is recited in dependent claims 20 and 28
`(“inventory is cycle counted and reconciled”). Ex. 1001, 10:6–8, 12:34–36.
`14
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`disclose the use of database queries to “reconcile” inventory prior to
`shipment for a given time period, e.g., daily or weekly.
`b. Analysis
`Although the cited passage from the FDA Briefing Booklet discloses
`the capability of the specialty pharmacy to collect confidential patient and
`prescription data, it does not link such data collection to running a database
`query to reconcile inventory on hand with inventory shipped, prior to the
`next shipment in a given time period. For example, on a given day the
`specialty pharmacy might choose to reconcile inventory by visual inspection
`without running a database query or might choose not to reconcile inventory
`prior to the next shipment of the prescription drug. The precise procedure
`contemplated is unspecified.
`Petitioner relies on Dr. Valuck’s Declaration testimony that a person
`of ordinary skill in the art “would have understood” the capability of
`reconciling inventory by querying the database “to determine that there was
`not any Xyrem missing from inventory.” Ex. 1007 ¶ 89. Dr. Valuck further
`states “it was well-known in the art for pharmacies to utilize inventory
`auditing controls for prescriptions that are prone to abuse by making sure
`that the current on-hand inventory aligns with the inventory identified as
`being present on the database.” Id. ¶ 90. The Petition and Dr. Valuck’s
`Declaration, however, do not cite any supporting evidence for the statements
`quoted in Declaration paragraphs 89 and 90 or provide a detailed analysis
`with respect to the actual language of Element 1.6.13 Petitioner’s citation to
`
`
`13 We note the Petition and Declaration do discuss computer-based
`inventory auditing as state of the art for controlling abuse-prone prescription
`drugs prior to the ’963 patent priority date. Pet. 4–6; Ex. 1007 ¶ 27 (citing
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`the FDA Briefing Booklet and Dr. Valuck’s Declaration testimony is
`insufficient, because ensuring there is sufficient drug on hand to satisfy
`pending prescription orders does not disclose, teach, suggest, or motivate
`one of ordinary skill to use a database query of the prescription and patient
`fields to perform an inventory reconciliation prior to shipment.
`With regard to the claim recitation of reconciling inventory “before
`the shipments for a day or other time period are sent,” the Petition is silent.
`Pet. 30–31. Dr. Valuck testifies that a person of ordinary skill would have
`understood to query the database “to ensure that there was sufficient Xyrem
`on hand to fulfill upcoming prescriptions or refills that were likely within the
`forthcoming period.” Ex. 1007 ¶ 89. Neither the Petition nor Dr. Valuck’s
`Declaration, however, assert that the FDA Briefing Booklet or other ACA
`documents disclose, teach, or suggest the use of database queries to
`reconcile inventory “before the shipments for a day or other time period are
`sent,” as recited in Element 1.6. Pet. 30–31; Ex. 1007 ¶¶ 89, 90.
`The Petition relies on Dr. Valuck’s cited testimony to fill in the gaps
`in the ACA disclosure, but neither the Petition nor Dr. Valuck’s testimony
`addresses why a person of ordinary skill would have understood to reconcile
`inventory by running a database query of prescription and patient
`information prior to shipping the prescription drug for a given time period.
`The Petition does not contain a textual analysis of the disclosure and
`knowledge of skilled artisans in comparison to the specific limitations of
`Element 1.6. Petitioner also does not explain why a person of ordinary skill
`
`
`Ex. 1012, 56:2 ¶ 1–57:1 ¶ 1 [4:2 ¶ 1–5:1 ¶ 1]). Even so, such disclosures are
`not sufficiently commensurate with, or sufficiently addressed to, the specific
`recitations of Element 1.6
`
`
`
`16
`
`
`
`IPR2015-01903
`Patent 8,731,963 B1
`
`
`in the art would have combined the ACA references “in the way the claimed
`invention does” with regard to Element 1.6. See ActiveVideo Networks, Inc.
`v. Verizon Commc’ns, Inc., 694 F.3d 1312, 1328 (Fed. Cir. 2012) (rejecting
`expert testimony that “is generic and . . . fails to explain why a person of
`ordinary skill in the art would have combined elements from specific
`references in the way the claimed invention does”). Without more, we are
`not persuaded Petitioner has provided a reasoned analysis based on rational
`underpinning sufficient to support its obviousness argument with regard to
`Element 1.6. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)
`(“[R]ejections on obviousness grounds cannot be sustained by mere
`conclusory statements; instead, there must be some articulated reasoning
`with some rational underpinning to support the legal conclusion of
`obviousness.”) (quoted with approval in KSR Int’l Co. v. Teleflex Inc., 550
`U.S. 398, 418 (2007)).
`Moreover, Petitioner’s reliance on what a person of ordinary skill
`“would have understood” appears to indicate reliance on a theory of inherent
`disclosure based on a combination of references. See Blue Calypso, LLC v.
`Groupon, Inc., No. 2015–1391, 2016 WL 791107, at *17 n.2 (Fed. Cir.
`March 1, 2016) (Schall, J., dissenting) (“We have stated that filling in the
`gaps in a reference by using the understanding of one skilled in the art to
`find anticipation indicates reliance on a theory of inherency.”) (citing
`Finnigan Corp. v. Int’l Trade Comm’n, 180 F.3d 1354, 1365 (Fed. Cir.
`1999)). In an obviousness context, “[a] party must . . . meet a high standard
`in order to rely on inherency to establish the existence of a claim limitation
`in the prior art in an obviousness analysis—the limitation at issue necessarily
`must be present, or the natural result of the combination of elements
`17
`
`
`
`
`
`IPR2015-01903
`Patent 8,731,963 B1
`
`
`explicitly disclosed by the prior art.” Par Pharm., Inc. v. TWI Pharms., Inc.,
`773 F.3d 1186, 1195–96 (Fed. Cir. 2014); see also In re Oelrich, 666 F2d.
`578, 581 (CCPA 1981) (“Inherency, however, may not be established by
`probabilities or possibilities.”). Any argument of inherency by Petitioner
`falls short of the high standard required, for the reasons given above.
`In sum, Petitioner’s analysis of Element 1.6 is hindsight-driven rather
`than a reasoned analysis based on the actual disclosures of the ACA
`documents and the level of skill in the art.
`Elements 1.7 and 1.8: [1.7] “wherein the data processor
`2.
`is configured to process a second database query that identifies
`that the narcoleptic patient is a cash payer and a physician that
`is interrelated with the narcoleptic patient through the schema
`of the single computer database;” [1.8] “said identifying that
`the narcoleptic patient is a cash payer by said second database
`query being an indicator of a potential misuse, abuse or
`diversion by the narcoleptic patient and being used to notify the
`physician that is interrelated with the narcoleptic patient
`through the schema of the single computer database.”
`
`
`Claim Elements 1.7 and 1.8 together recite a second database query
`that identifies (i) a narcoleptic patient who offers to pay cash for the
`prescription as an indicator of potential misuse, abuse, or diversion, and (ii)
`a physician “interrelated” with the cash-paying patient in the database. The
`identification of a cash-paying patient is used by the pharmacist to notify the
`physician “to alert them of the situation and confirm if the physician
`approves” or disapproves of filling the prescription. Ex. 1001, 6:44–50.
`The ’963 patent does not define expressly the “interrelated” nature of the
`data fields, but the patent does describe the type of information to be
`submitted on a prescription and enrollment form, which is entered into the
`
`
`
`18
`
`
`
`IPR2015-01903
`Patent 8,731,963 B1
`
`
`database and accessed via database queries to identify prescriptions “written
`by physician,” “by patient name,” “by frequency,” and “by dose.” Ex. 1001,
`7:55–64, 8:4–7, Figs. 7, 8, 9. Database queries are used to generate reports
`directed to regulatory issues such as the number of “denied physician
`registries,” “completed patient registries,” and “problem identification &
`management risk diversion reports completed.” Id. at 8:24–31.
`Petitioner argues that the recited capability of identifying the cash-
`paying patient as an indicator of potential abuse, in order to notify the
`interrelated (prescribing) physician, is “implicit” or “inherently” disclosed in
`the ACA references. Pet. 32–34 (citing, inter alia, Ex. 1007 ¶¶ 93, 95).
`The ACA discloses that the pharmacist should “carefully track[] all
`GHB prescriptions (even cash-paying patients) to see if excessive quantities
`are being prescribed.” Ex. 1004, 115. From this disclosure, and the
`disclosed collection of patient insurance information, Petitioner asserts that
`cash payers would be identified “inherently” by their presumed lack of
`insurance. Pet. 32 (citing Ex. 1004, 109; Ex. 1005, 310). Petitioner further
`argues that the collected insurance information aids in diversion prevention,
`such that the prescribing physician “will be contacted if a prescription
`appears to be a duplicate or if the dosing frequency appears unusual.” Id.
`(citing Ex. 1005, 314 (sixth paragraph)). The ACA also discloses that
`information such as “duplicate prescriptions,” “attempts of over-
`prescribing,” or “attempts at over-use by patients . . . is available prior to
`filling the prescription so
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