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I.  INTRODUCTION

Amneal Pharmaceuticals, LLC (“Amneal”) and Par Pharmaceutical,

Inc. (“Par Inc.”) (together “Petitioner”), filed a Petition requesting an inter

 partes review of claims 1–28 (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

Basis

Challenged

Claims

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 XyremVideo and Transcript (Ex. 1006)4 

§ 103(a) 1–7 and 9–23

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 “AdvisoryCommittee Art” or “ACA.” 2  FDA Peripheral & Central Nervous System Drugs Advisory Committee,

Briefing Information, Division of Neuropharmacological Drug ProductsPreliminary 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 DrugAdministration (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.

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Reference[s] Statutory

Basis

Challenged

Claims

Advisory Committee Art (Exs. 1003–1006)

and Korfhage (Ex. 1037)5 

§ 103(a) 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 ComputerPublishing (1997). Ex. 1037.6  The ’963 patent issued from a series of continuation applications, theearliest of which is U.S. Patent Application No. 10/322,348 (“the ’348

application”) filed December 17, 2002. Ex. 1001.

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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, abuseor 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 forabuse, 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, storinginformation 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 showthat 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 patientthrough 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 throughthe 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 Exhibit1028, 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 VideoTranscript”).10 We note there is no Exhibit 1018 in the record as reflected in PRPS.

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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 December2002, the earliest effective filing date of the ’963 patent. Pet. 2–6.

Petitioner describes one of ordinary skill as someone holding a Bachelor’s orDoctor of Pharmacy degree and registered as a pharmacist with 3–5 years of

relevant work experience, or someone holding computer science degree orequivalent 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 asecure 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 “ownedinventory”. This is the point at which Xyrem is “sold” by

Orphan Medical to the specialty pharmacy. This transfer ofownership allows the specialty pharmacy to collect confidential

data such as patient names and medication doses. This isinformation that Orphan Medical will not have, but the

specialty pharmacy can collect because of thedoctor/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.

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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-basedinventory 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 arenot sufficiently commensurate with, or sufficiently addressed to, the specific

recitations of Element 1.6

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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

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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.

2. 

 Elements 1.7 and 1.8: [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;” [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

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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 appropriate pharmacist intervention can occur.”

Ex. 1003 184:24–185:7. Petitioner argues that one of ordinary skill would

have been motivated to track cash payments as a means to identify possible

abuse or diversion and “would understand that implicit in these control

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mechanisms is that the specialty pharmacy will be able to identify and . . .

notify the physician interrelated with the cash paying narcoleptic patient.”

Pet. 32–34 (citing Ex. 1007 ¶ 93).

The ACA’s disclosure of tracking all GHB prescriptions, “even cash-

 paying patients,” does not necessarily disclose a database query directed to

identifying cash-paying patients as an indicator of potential misuse, abuse,

or diversion of the prescription drug. The additional ACA disclosures cited

 by Petitioner, moreover, also do not necessarily provide a link between cash

 payers and the potential for abuse. Petitioner’s attempt to link pharmacist

identification of cash paying patients to the exemplary list of duplicate

 prescriptions, over-prescribing, and over-use, in order to trigger notification

of a prescribing physician, also is not persuasive as the necessary or natural

result of identifying cash-paying patients. Even if the recited database query

and intervention with prescribing physicians were possible, or even

 probable, as a result of identifying cash-paying patients, the cited ACA

evidence still would be insufficient to support a conclusion of inherent

disclosure of Elements 1.7 and 1.8. See Par Pharm., 773 F.3d at 1195

(“Inherency, however, may not be established by probabilities or

 possibilities. The mere fact that a certain thing may result from a given set

of circumstances is not sufficient.”) (quoting In re Oelrich, 666 F.2d at 581).

Claims 2–7 and 9–22 all depend, directly or indirectly, on claim 1.

Claim 23 contains limitations 1.6, 1.7, and 1.8. Therefore, for the reasons

given above, we determine Petitioner has not shown a reasonable likelihood

of prevailing in its assertion that claims 1–7 and 9–23 are unpatentable for

obviousness over the ACA under 35 U.S.C. § 103.

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 D. 

 Asserted Obviousness of Claims 8 14 and 24–28 of the ’963 Patent

Independent claim 24 of the ’963 patent recites a computer-

implemented system similar to that of claim 1, except claim 24 omits

Elements 1.6, 1.7, and 1.8 and recites several other elements. Claim 25

depends from claim 24 and includes Elements 1.7 and 1.8. Claim 28

depends from claim 24 and recites a modified version of Element 1.6

(“current inventory is cycle counted and reconciled with database quantities

 before shipments for a day or other time period are sent”). Therefore, for the

reasons stated in Section II.C. of this Decision, we determine Petitioner has

not satisfied its burden with respect to claims 25 and 28. We address claims

24, 26, and 27 below.

1. 

 Asserted Obviousness of Claims 24, 26, and 27 over the ACA

and Korfhage 

Claim 24 recites “a central computer database . . . for receiving

 prescriptions from any and all patients being prescribed the company’s

 prescription drug . . . having a database schema that contains and interrelates 

 prescription fields, patient fields, and prescriber fields.” Ex. 1001, 11:12–19

(emphasis added). Claim 24 also recites “one or more database queries that

operate over data related to the prescription fields, prescriber fields, and

 patient fields . . . [to] check[] for abuse within the central computer

database.”  Id. at 11:34–12:2. The quoted “database” limitations are similar

to Elements 1.1 and 1.5.

14  Because claim 8 depends from claim 1, we determine Petitioner has notshown a reasonable likelihood of prevailing in its assertion of obviousness of

claim 8 for the same reasons stated in Section II.C. of this Decision.

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The ACA discloses a single national pharmacy for receiving and

storing prescription, patient, and physician information in a “central data

repository.” Pet. 23–24, 51 (citing Ex. 1003, 177:24–178:11, 184:24–185:7,

Slides 146, 147; Ex. 1005, 310; Ex. 1006, 6 n.24; Ex. 1007 ¶ 75). “Every

 patient and prescribing physician will be registered . . . [i]n a secure

database.”  Id. at 24 (citing Ex. 1004, 110; see also Ex. 1003, 16:4–7, 259:3– 

5; Ex. 1007 ¶ 76). The ACA also discloses the capability of obtaining the

 prescription, patient, and prescriber information stored in the central

database.  Id. at 24–26 (citing Ex. 1004, 110 (“From this database it will be

 possible to obtain . . . [p]rescriptions by physician specialty . . . by patient

name . . . by volume (frequency) . . . by dose.”), 114 (“[P]atient registry

application . . . is to contain . . . [p]atient name, address, telephone number,

. . . [p]hysician name, specialty, clinic name and address.”); Ex. 1005, 308

(“Prescribing information, including frequency and dosing data, can be

accessed from a single source.); Ex. 1006, 4 n.14 (“closed-loop distribution

system . . . will also be able to generate data, recording prescribers, patients

and dosing that could provide information for any possible investigations”),

6 n.24 (“it’s possible to keep all the data about inventory, physicians,

reimbursement, patients, and delivery in one efficient and quickly-accessible

location”), 7 n.25; Ex. 1007 ¶¶ 76–79). The ACA further discloses the

capability for a pharmacist to check for abuse within the database and

intervene if potential abuse is identified.  Id. at 34–35, 51 (citing Ex. 1003,

184:24–185:7, Slide 158; Ex. 1004, 110; Ex. 1005, 306–309; Ex. 1006, 8

n.29, 9 n.38; Ex. 1007 ¶¶ 98, 100, 141–143).

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Based on the ACA disclosures referenced above and on this record,

Petitioner has provided adequate evidence to support a reasonable likelihood

of showing the asserted disclosure of the database limitations in the ACA.

Claim 24 further recites a “central computer database being

distributed over multiple computers.” Ex. 1001, 11:19–20. Dependent

claim 26 recites a similar limitation.  Id. at 12:23–24. Korfhage discloses a

database that can be distributed over multiple computers to accommodate

“[c]ost, efficiency, and the [sheer] number of documents.” Pet. 52 (citing

Ex. 1037, 276 [294], Ex. 1007 ¶ 144). Korfhage also discloses that a single

query can operate over the distributed database computers to accommodate a

user preference “to view the system as accessing a single logical database in

response to a query, even when the system must consult multiple physical

databases.” Ex. 1007, 294. Petitioner argues that one of ordinary skill

would have had ample motivation to distribute the central database of the

ACA over multiple computers (“multiple physical databases”) to increase

efficiency of drug distribution by the central pharmacy. Pet. 52 (citing Ex.

1007 ¶ 144; Ex. 1037, 276). 

Based on the present record, and for the reasons stated by Petitioner,

we determine Petitioner has provided adequate evidence to support its

assertion that one of ordinary skill would have been motivated by Korfhage

to modify the ACA system to include multiple computers for reasons of

efficiency in distributing a sensitive prescription drug from a central

 pharmacy using a central computer database, with a reasonable expectation

of success.

Claim 27 depends from claim 24 and adds “wherein the current

 pattern or the anticipated pattern [of abuse] are identified using periodic

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reports generated from the single computer database.” Ex. 1001, 12:31–33.

Petitioner relies on Dr. Valuck’s Declaration testimony that it would have

 been obvious to one of ordinary skill to use database queries for periodically

generating reports for analysis and determination of patterns of abuse. Pet.

41–43, 54 (citing Ex. 1007 ¶¶ 120–122). Based on the present record, we

determine Petitioner has provided adequate evidence to support its assertion

of obviousness of claim 27.

For the reasons given above, on the present record we are persuaded

Petitioner has shown a reasonable likelihood of prevailing in its assertion of

unpatentability of claims 24, 26, and 27 as obvious over the ACA in view of

Korfhage.

III. 

CONCLUSION

Petitioner has demonstrated a reasonable likelihood of prevailing with

respect to claims 24, 26, and 27 of the ’963 patent challenged in this

Petition. Petitioner has not demonstrated a reasonable likelihood of

 prevailing with respect claims 1–23, 25, and 28 of the ’963 patent

challenged in this Petition. At this stage of the proceeding, the Board has

not made a final determination as to the patentability of claims 24, 26, and

27.

IV.  ORDER

Accordingly, it is

ORDERED that pursuant to 35 U.S.C. § 314, an inter partes review of

the ’963 patent is instituted on the following ground:

Claims 24, 26, and 27 as obvious over the ACA and Korfhage;

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FURTHER ORDERED that inter partes review is commenced on the

entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R.

§ 42.4, notice is hereby given of the institution of a trial; and

FURTHER ORDERED that the inter partes review is limited to the

ground of unpatentability listed above, and no other grounds of

unpatentability are authorized for inter partes review.

For PETITIONERS:

Aziz Burgyaziz.burgy@arentfox.com

Bradford C. Frese bradford.frese@arentfox.com

For PATENT OWNER:

F. Dominic Cerrito

nickcerrito@quinnemanuel.com

John V. Biernacki jvbiernacki@jonesday.com