_____________________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
_____________________
_____________________
Case IPR: Unassigned
_____________________
PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 7,895,059
UNDER 35 U.S.C. 311319 AND 37 C.F.R. 42.1.80, 42.100.123
II.
III.
IV.
OVERVIEW .................................................................................................... 2
V.
VI.
A.
B.
C.
B.
C.
B.
2.
2.
3.
Claim 2 ...................................................................................... 32
4.
5.
Claim 5 ...................................................................................... 34
6.
Claim 6 ...................................................................................... 34
7.
Claim 9 ...................................................................................... 34
8.
Claim 12 .................................................................................... 35
-i-
C.
D.
9.
Claim 13 .................................................................................... 35
10.
Claim 14 .................................................................................... 36
11.
12.
Claim 1 ...................................................................................... 40
2.
Claim 2 ...................................................................................... 49
3.
4.
Claim 5 ...................................................................................... 50
5.
Claim 6 ...................................................................................... 50
6.
Claim 9 ...................................................................................... 51
7.
Claim 12 .................................................................................... 51
8.
Claim 13 .................................................................................... 52
9.
Claim 14 .................................................................................... 52
10.
11.
CONCLUSION.............................................................................................. 60
-ii-
and seeks cancellation of claims 1-16 of U.S. Patent No. 7,895,059 (the 059
patent) (PAR1001). According to Office records, the 059 patent is assigned to
Jazz Pharmaceuticals, Inc.
Published materials used in an FDA Advisory Committee Meeting (the
Advisory Committee Art or ACA) render obvious every limitation of the
challenged claims more than a year before the 059 patents earliest effective filing
date, as set forth in Ground 1. In addition, and alternatively, other drug distribution
systems in public use long before the 059 patents earliest effective filing date also
would have rendered the challenged claims obvious to a person of ordinary skill in
the art (POSA), as set forth in Ground 2.
For the reasons explained below, Par is at least reasonably likely to prevail
on the asserted Grounds 1 and/or 2 with respect to the challenged claims. Par
requests that this Board institute IPR and cancel each of challenged claims 1-16 of
the 059 patent.
II.
OVERVIEW
A.
in
Xyremsodium
oxybate,
the
sodium
salt
of
gamma
Against this backdrop, Jazz obtained the 059 patent. The 059 patent relates
to [a] drug distribution system and method [that] utilizes a central pharmacy and
database to track all prescriptions for a sensitive drug. (PAR1001, Abstract.)
According to the 059 patent, prescription patterns by physicians and patients are
monitored for abuse using an exclusive central database. Further, physician
eligibility to prescribe the drug is verified via a database, including determining
whether any corrective or approved disciplinary actions have been brought against
the physician. (Id., 1:48-56.) Prior to shipping the prescription drug, the central
pharmacy confirms whether the patient has been educated about the prescription,
and only ships the prescription drug when no abuse is found related to the patient
and prescribing doctor. (Id., 1:59-63 and 8:62-65.) Reports are then generated to
evaluate potential diversion patterns. (Id., 2:19-21.)
The 059 patent claims are directed to a method of distributing a prescription
drug from an exclusive central pharmacy that comprises: (1) receiving in a
computer processor all prescription requests for any and all patients only at the
exclusive central pharmacy, entering information from the prescription requests
into an exclusive computer database associated with the exclusive central
pharmacy and processing the prescription requests only by the exclusive central
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CLAIM CONSTRUCTION
Unless otherwise construed herein, the terms of claims 1-16 are to be given
Exclusive
Database
Central
Pharmacy
and
Exclusive
Computer
Claims 116 all recite (either explicitly or through incorporation from the
independent claims) the terms exclusive central pharmacy and exclusive
-9-
Claims 113 all recite (either explicitly or through incorporation from the
independent claims) the limitation generating with the computer processor
periodic reports via the exclusive computer database. (PAR1001, 9:1-3.) The 059
patent discloses that [s]everal queries and reports are run against the database
to provide information which might reveal potential abuse of the sensitive drug,
such as early refills. (Id., 2:19-21).) Moreover, the 059 patent discloses that
reports are obtained by running queries against the central database. (Id., 8:22-29.)
Further, the 059 patent describes different types of queries that are run to obtain
information such as prescriptions written by physician, prescriptions by patient
name, prescriptions by frequency, and prescriptions by dose. (Id., 7:53-67.)
Accordingly, querying the central database at least meets the limitation of
generating periodic reports, as would be understood by a POSA. (PAR1007,
38.) Hence, under the broadest reasonable construction of the term, generating
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Claims 7, 10, and 15 recite the limitation the central pharmacy authorizing
the prescription drug to be dispensed to the patient by another pharmacy. The
059 patent does not provide a definition for dispensed. Further, the only support
in the 059 patent for another pharmacy (i.e., not the exclusive central pharmacy)
having any involvement in distributing the drug is where the 059 patent states,
[i]n one embodiment, the drug may be shipped to another pharmacy for patient
pickup. (PAR1001, 2:4-5.) Hence, under the broadest reasonable interpretation,
dispensed to the patient by another pharmacy would be understood by a POSA
and should be construed to mean making the prescription drug that was dispensed
by the central pharmacy available for pick-up by the patient at another pharmacy.
(PAR1007, 45.)
VI.
IDENTIFICATION OF CHALLENGE
IPR of the challenged claims of the 059 patent is requested on the grounds
for unpatentability listed below. Copies of the references are filed herewith. 37
C.F.R. 42.6(c). The proposed grounds in this Petition are supported by the
Declaration of Dr. Robert Valuck, Ph.D., R.Ph. (PAR1007).
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35 USC
103(a)
103(a)
Claims
Index of References
1-16
1-16
For each asserted ground, Par demonstrates below where each limitation
either exists in the prior art or is rendered obvious, by evaluating the scope and
contents of the prior art, any differences between the art and the challenged claims,
the knowledge of person of ordinary skill in the art, and any available objective
indicia of nonobviousness in accordance with Graham v. John Deere Co., 383 U.S.
1 (1966) and KSR Intl Co. v. Teleflex, Inc., 550 U.S. 398 (2007).
A.
Each of the references cited in this petition is available as prior art under the
basis for qualification provided for by 35 U.S.C. 311(b). The 059 patent was
filed on February 11, 2010 and claims the benefit of the 730 patent, filed on
December 17, 2002. (See PAR1001.) Patent Owner has not established any earlier
date of invention. Accordingly, December 17, 2002 is its earliest effective filing
date. Each cited prior art reference qualifies independently as (1) having published
before December 17, 2002 or (2) having been publicly disclosed more than a year
prior to the application for patent in the United States.
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Drugs
Advisory
Committee
docket
site
at
The Federal Advisory Committee Act also required that the records,
Internet
Archive:
Wayback
Machine
(located
at
The Board has not precluded the use of Documents from the Wayback
Machine when making institution decisions. See, e.g., IPR2013-00142, Paper 11,
*9-10 (Aug. 7, 2013).
-16-
Talk About Sleep (hereinafter TAS) is entitled to the 102(b) prior art date
of its publication: February 12, 2001. Honigfeld is entitled to the 102(b) prior art
date of its publication: March 31, 1998. (PAR1034, 3), Elsayed is entitled to the
102(b) prior art date of its issue: April 4, 2000. (PAR1035, front page.) Lilly is
entitled to a 102(e) prior art date of November 14, 2001, the filing date of its
earliest provisional application. See, e.g., In re Giacomini, 612 F.3d 1380 (Fed.
Cir. 2010) (PAR1036, front page).
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-20-
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Claim 2
Claim 2 depends from claim 1, and further specifies that the exclusive
central pharmacy controls the exclusive computer database. (PAR1001, 9:4-5.)
ACA discloses this feature as discussed above, stating that the single national
specialty pharmacy (i.e., exclusive central pharmacy) controls the central data
repository (i.e., exclusive computer database). (See PAR1003, Tr. 177:24-178:11,
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Claims 3 and 4
Claim 5
Claim 5 depends from claim 1, and further specifies that the prescription
drug comprises gamma hydroxy butyrate (GHB). The active ingredient in
Xyrem, the focus of ACA, was known as GHB. (See, e.g., PAR1003, Tr., 9:1217; PAR1007, 91; see also generally PAR1004; PAR1005; PAR1006.)
6.
Claim 6
Claim 9
Claim 12
The limitations of claim 12 are similar to the limitations of claim 9. The only
difference is that instead of providing GHB to the patient, as recited by claim 9,
claim 12 requires mailing or sending by courier GHB to the patient. (PAR1001,
11:9.) This difference does not change the application of ACA to the claims, and
ACA discloses mailing or sending GHB by courier to the patient. (See PAR1003,
Tr., 178:5-6 and 182:17-23; Slides, pg. 146; PAR1004, pg. 109 and 115;
PAR1005, pg. 302, 304, and 311; PAR1006, V10 00:40-V11 00:31; PAR1007,
95.) As such, the ACA discloses and renders obvious all steps of claim 12.
9.
Claim 13
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Claim 14
The limitations of claim 14 are similar to those of claim 6 with the exception
being that claim 14 does not require the step of generating with the computer
processor periodic reports via the exclusive computer database to evaluate
potential diversion patterns, recited by claim 6. (PAR1001, 9:49-51.) Thus the
ACA discloses and renders obvious all steps of claim 14. (See VI.B.6; PAR1007,
100.)
11.
Each of claims 7, 10, and 15 require that the central pharmacy authorizes the
prescription drug to be dispensed to the patient by another pharmacy.5 (PAR1001,
9:52-55, 10:35-38, and 12:37-40.) The ACA explicitly discloses shipping the
prescription GHB from the exclusive central pharmacy to another pharmacy for
patient pick-up. (PAR1004, pg. 110; PAR1007, 102.) Additionally, it is
envisioned that mechanisms will be put in place to verify[] the second pharmacys
ability to protect against diversion of GHB before shipping. (Id.) Therefore, the
benefits of preventing diversion and illicit use discussed in the disclosed
5
would be understood by a POSA to mean making the prescription drug that was
dispensed by the central pharmacy available for pick-up by the patient at another
pharmacy.
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Claims 8, 11, 16
Claims 8, 11, and 16 depend from claims 7, 10, and 15, respectively, and
further specify that another pharmacy places controls on the distribution of the
prescription drug or GHB. (PAR1001, 9:56-58; 10:39-40; 12:41-43.) The controls
are selected from the group consisting of:
confirming with the patient that the educational material has been
received and/or read by the patient, confirming receipt of the
prescription drug by the patient, contacting the patients insurance
company, questioning early refill requests by the patient, flagging
repeat instances of lost, stolen, destroyed or spilled prescriptions,
flagging that the patient paid cash for the prescription drug, flagging
early requests to refill the prescription drug, and limiting the
prescription to a supply of limited duration.
(PAR1001, 9:59-67, 10:41-50, 12:44-52.)
The ACA implicitly discloses that another pharmacy places controls on the
distribution. For example, the ACA discloses that the central pharmacy may
authorize another pharmacy to provide the prescription drug while putting in place
a mechanism for verifying the second pharmacys ability to protect against
-37-
Claim 1
(AMN1036) filed November 14, 2001. The limitations disclosed by Lilly are
disclosed by the 807 application. Thus, Lilly qualifies as prior art to the claims
under 35 U.S.C. 102(e) as of the 807 applications filing date.
-46-
-47-
Claim 2
Claim 2 depends from claim 1, and further specifies that the exclusive
central pharmacy controls the exclusive computer database. (PAR1001, 9:4-5.)
TAS discloses that all prescriptions for Xyrem will be sent to a single specialty
pharmacy that will fill the prescription requests. (PAR1033, 9.) Elsayed discloses
that the pharmacy may maintain patient information in the database. (PAR1035,
4:6066). And as TAS discloses that all prescriptions for Xyrem will be sent to a
central pharmacy, the central pharmacy would be best positioned to control the
databases disclosed in Honigfeld, Elsayed, and Lilly (See PAR1007, 139).
3.
Claims 3 and 4
-49-
Claim 5
Claim 5 depends from claim 1, and further specifies that the prescription
drug comprises gamma hydroxy butyrate (GHB). TAS discloses the distribution
of Xyrem, which contains GHB. (See, e.g., PAR1003, 1: 8, 9; PAR1007, 142.)
5.
Claim 6
-50-
Claim 9
Claim 12
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Claim 13
The only difference between claims 12 and 13 is that claim 13 recites the
additional steps of manufacturing GHB; and providing manufactured GHB only
to the exclusive central pharmacy. TAS discloses that Xyrem, which contains
GHB, will be manufactured and provided to one single pharmacy for distribution.
(See PAR1033, 1: 9; PAR1007, 147.) Accordingly, the prior art also discloses all
of the remaining limitations of claim 13. (PAR1007, 147.)
9.
Claim 14
The limitations of claim 14 are similar to those of claim 6 with the exception
being that claim 14 does not require the step of generating with the computer
processor periodic reports via the exclusive computer database to evaluate
potential diversion patterns, as recited by claim 6. (PAR1001, 9:49-51.) As such,
TAS in view of Elsayed, Honigfeld, and Lilly discloses all of the limitations of
claim 14 because it discloses all steps of claim 6. (See VI.C.6; PAR1007, 147.)
10.
Each of claims 7, 10, and 15 require that the central pharmacy authorizes the
prescription drug to be dispensed to the patient by another pharmacy.7 (PAR1001,
7
to mean making the prescription drug that was dispensed by the central pharmacy
available for pick-up by the patient at another pharmacy. (See IV.C.)
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Claims 8, 11, 16
Claims 8, 11, and 16 depend from claims 7, 10, and 15, respectively, and
further specify that another pharmacy places controls on the distribution of the
prescription drug or GHB. (PAR1001, 9:56-58; 10:39-40; 12:41-43.) The controls
are selected from the group consisting of:
confirming with the patient that the educational material has been
received and/or read by the patient, confirming receipt of the
prescription drug by the patient, contacting the patients insurance
company, questioning early refill requests by the patient, flagging
repeat instances of lost, stolen, destroyed or spilled prescriptions,
flagging that the patient paid cash for the prescription drug, flagging
early requests to refill the prescription drug, and limiting the
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-54-
Real
Party-In-Interest
(37
C.F.R.
42.8(b)(1))
is:
Par
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Back-Up Counsel
Bradford C. Frese (Reg. #69,772)
ARENT FOX LLP
1717 K Street NW
Washington, DC 20036-5342
202.857.6496 (telephone)
202.857.6395 (facsimile)
Bradford.Frese@arentfox.com
CONCLUSION
For the reasons above, Par requests that the Board institute IPR of all claims
of the 059 patent, and cancel those claims. Attached are a Power of Attorney, an
Exhibit List, and copies of the references per 42.10(b), 42.63(e), and 42.6(c).
The required fees are to be paid via withdrawal from Deposit Account No. 01-2300
(Customer ID No. 04372), and the Office is authorized to charge fee deficiencies
and credit overpayments to the same account.
Respectfully Submitted,
Aziz Burgy
Registration No. 51,514
Attorney for Petitioner
-60-
F. Dominic Cerrito
Eric C. Stops
Gabriel P. Brier
QUINN EMANUEL URQUHART &
SULLIVAN LLP
51 Madison Avenue
22nd Floor
New York, NY 10010
Richard G. Greco
RICHARD G. GRECO PC
90 State Street, Suite 700
Albany, New York 12207
John V. Biernacki
Jones Day
North Point
901 Lakeside Avenue
Cleveland, OH 44114
Aziz Burgy
Registration No. 51,514
Attorney for Petitioner