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Paper 10
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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I.

INTRODUCTION

Amneal Pharmaceuticals, LLC (Amneal) and Par Pharmaceutical,

Inc. (Par Inc.) (together Petitioner), filed a Petition requesting an inter
partes review of claims 128 (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 128 of the 963 patent as unpatentable
under 35 U.S.C. 103(a). Pet. 910. 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, 2:13cv-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 (IPR201500554); 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
Advisory Committee Art (Exs. 10031006), 103(a)
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

Challenged
Claims
17 and 923

FDA Peripheral & Central Nervous System Drugs Advisory Committee,

Transcript and Slides (Advisory Committee Transcript and Slides). Ex.
1003. Petitioner refers to Exhibits 10031006 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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Patent 8,731,963 B1
Reference[s]
Advisory Committee Art (Exs. 10031006)
and Korfhage (Ex. 1037)5

Statutory
Basis
103(a)

Challenged
Claims
8 and 2428

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, 1:4852. 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, 1:5254.
Figures 2A, 2B, and 2C comprise flow charts representing an initial
prescription order entry process for a sensitive drug. Id. at 4:1718. 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 4:1735, 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.
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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 8:69. The
pharmacy team then engages in intake reimbursement, which includes
verification of insurance coverage or the patients willingness and ability to
pay for the prescription drug. Id. at 4:3638, Fig. 2A.
The pharmacy workflow also includes verification of the
prescribing physicians credentials. Id. at 5:1936, Fig. 2B (steps 274280).
Filling the prescription includes confirming the patient has read educational
materials regarding the sensitive drug, confirming the patients receipt of the
sensitive drug, and daily cycle counting and inventory reconciliation. Id. at
5:376:7. Steps 240, 242, 246, and 258266 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 4:3843. If a patient
requests an early prescription refill, for example, the pharmacist generates a
report evaluating the patients compliance with therapy or possible product
diversion, misuse or over-use. Id. at 6:4044, 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:

Xyrem is the brand name for gamma-hydroxybutyrate (GHB), indicated

for the treatment of cataplexy (excessive daytime sleepiness) in narcoleptic
patients. Ex. 1001, 3:1419. 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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Patent 8,731,963 B1
[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, 127981 (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 10031006
The priority date of the 963 patent is December 17, 2002. Ex. 1001,
(63), 1:613. Petitioner asserts the references comprising the Advisory
Committee Art (Exs. 10031006) were publicly accessible as printed
publications in connection with an FDA Advisory Committee meeting
regarding Xyrem held on June 6, 2001. Pet. 1116. The documents at issue
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are alleged to have been published in electronic form and made available on
the FDAs website before the 963 patent priority date. Id. at 1314.
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. 1112 (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, 5:236:3. A Federal Register
Notice, dated May 14, 2001, provided public notice of the Advisory
Committee Meeting. Pet. 1112 (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, 89; Ex.
1028, 20). The cited Internet Archive page contains a Universal Resource
Locator (URL) date code of October 4, 2001. Id. Petitioners 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. Butlers Affidavit explains the URL date codes used to
determine the availability of archived internet records as of a particular date.
Ex. 1028 35. 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.

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 10041006
Petitioner considers Exhibits 10041006 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 FDAs website no later than July 1,
2001. Id. (citing Ex. 1018, 10 56; 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. Valucks
testimony, argues that one of skill in the art would have been able to locate

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.
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Exhibits 10041006 no later than July 1, 2001, by exercising reasonable
diligence and [f]ollowing this link. Id. at 1415 (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. 10041006), the Federal Register Notice
(Ex. 1015), the Internet Archive evidence (Exs. 10191020; Ex. 1028), and
Mr. Valucks Declaration testimony (Ex. 1007 64), indicates that
Petitioner has shown sufficiently that Exhibits 10041006 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
Petitioners unpatentability grounds.
C. Asserted Obviousness of claims 17 and 923 of the 963 Patent
over the Advisory Committee Art
Petitioner contends that claims 17 and 923 of the 963 patent would
have been obvious to one of ordinary skill in the art over the ACA (Exhibits
10031006). Pet. 1648.11 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. 26.
Petitioner describes one of ordinary skill as someone holding a Bachelors or
Doctor of Pharmacy degree and registered as a pharmacist with 35 years of
relevant work experience, or someone holding computer science degree or
equivalent work experience including familiarity with drug distribution
procedures. Id. at 23.
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which the meeting was convened to discuss. Id. at 17 (citing Ex. 1007
68). Petitioner further relies on Dr. Valucks Declaration testimony in
support of its argument that all of the elements recited in independent
claim 1, identified as the preamble and Elements 1.11.8, are found in the
ACA. Id. at 1819 (citing Ex. 1007 7095). Petitioner also cites to
specific disclosures in the ACA and to Dr. Valucks Declaration testimony
in support of its argument that the additional elements recited in claims 27
and 923 are disclosed in the ACA. Id. at 3448 (citing Ex. 1003; Ex. 1004;
Ex. 1005; Ex. 1006; Ex. 1007 98, 100, 102, 104, 106, 108, 110, 112, 114,
116, 118, 120122, 124, 126, 128130, 132134).
For the reasons stated below, we are not persuaded by Petitioners
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,
6:47, 6:3437, 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 7:2939, 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 6:3053.
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, 31314; see also Pet. 3031. 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, 10:68, 12:3436.
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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. Valucks 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. Valucks
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 Petitioners 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. 46; Ex. 1007 27 (citing
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the FDA Briefing Booklet and Dr. Valucks 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. 3031. 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. Valucks
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. 3031; Ex. 1007 89, 90.
The Petition relies on Dr. Valucks cited testimony to fill in the gaps
in the ACA disclosure, but neither the Petition nor Dr. Valucks 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, 56:2 157:1 1 [4:2 15:1 1]). Even so, such disclosures are
not 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 Commcns, 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 Intl Co. v. Teleflex Inc., 550
U.S. 398, 418 (2007)).
Moreover, Petitioners 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. 20151391, 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. Intl Trade Commn, 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 analysisthe 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, 119596 (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, Petitioners 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, 6:4450.
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,
7:5564, 8:47, 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 8:2431.
Petitioner argues that the recited capability of identifying the cashpaying 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. 3234 (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 overprescribing, or attempts at over-use by patients . . . is available prior to
filling the prescription so appropriate pharmacist intervention can occur.
Ex. 1003 184:24185:7. 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. 3234 (citing Ex. 1007 93).
The ACAs disclosure of tracking all GHB prescriptions, even cashpaying 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. Petitioners 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 27 and 922 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 17 and 923 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 2428 of the 963 Patent
Independent claim 24 of the 963 patent recites a computerimplemented 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 companys
prescription drug . . . having a database schema that contains and interrelates
prescription fields, patient fields, and prescriber fields. Ex. 1001, 11:1219
(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 11:3412:2. 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 not

shown 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. 2324, 51 (citing Ex. 1003, 177:24178:11, 184:24185:7,
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, 16:47, 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 2426 (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 (its 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 7679). 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 3435, 51 (citing Ex. 1003,
184:24185:7, Slide 158; Ex. 1004, 110; Ex. 1005, 306309; Ex. 1006, 8
n.29, 9 n.38; Ex. 1007 98, 100, 141143).

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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, 11:1920. Dependent
claim 26 recites a similar limitation. Id. at 12:2324. 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, 12:3133.
Petitioner relies on Dr. Valucks 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.
4143, 54 (citing Ex. 1007 120122). 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 123, 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 Burgy
aziz.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

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