Par Pharma IPR against Jazz

UNITED STATES PATENT AND TRADEMARK OFFICE _____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD

_____________________

PAR PHARMACEUTICAL, INC. Petitioner

v.

JAZZ PHARMACEUTICALS, INC. Patent Owner

_____________________

Case IPR: Unassigned _____________________

PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 7,895,059 UNDER 35 U.S.C. § 311–319 AND 37 C.F.R. § 42.1–.80, 42.100–.123

Mail Stop “PATENT BOARD” Patent Trial and Appeal Board U.S. Patent and Trademark Office P.O. Box 1450 Alexandria, VA 22313-1450

IPR Petition of U.S. Patent No. 7,895,059

-i-

TABLE OF CONTENTS

I. INTRODUCTION AND STATEMENT OF RELIEF REQUESTED (37 C.F.R. § 42.22(a)) ...................................................................................... 1

II. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a)) ................................. 1

III. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE REASONS THEREFOR ................................................................................. 1

IV. OVERVIEW .................................................................................................... 2

A. Person of Ordinary Skill In The Art ....................................................... 2

B. State of the Art ....................................................................................... 3

C. The ’059 patent ....................................................................................... 7

V. CLAIM CONSTRUCTION ............................................................................ 9

A. “Exclusive Central Pharmacy” and “Exclusive Computer Database” ................................................................................................ 9

B. “Generating with the computer processor periodic reports via the exclusive computer database” ........................................................ 10

C. “Dispensed to the patient by another pharmacy” ................................. 11

VI. IDENTIFICATION OF CHALLENGE ........................................................ 11

A. EACH OF THE REFERENCES CITED IS AVAILABLE PRIOR ART. ........................................................................................ 12

1. The ACA (PAR1003 – PAR1006) qualifies as “printed publications.” ............................................................................ 13

2. Talk About Sleep, Honigfeld, Elsayed and Lilly ...................... 17

B. Ground 1: Claims 1-16 are obvious over the ACA .............................. 18

1. Comparison of the ’059 Patent Claims to the Prior Art. ........... 19

2. Claim 1 Would Have Been Obvious Over the ACA. ............... 20

3. Claim 2 ...................................................................................... 32

4. Claims 3 and 4 ........................................................................... 33

5. Claim 5 ...................................................................................... 34

6. Claim 6 ...................................................................................... 34

7. Claim 9 ...................................................................................... 34

8. Claim 12 .................................................................................... 35


-ii-

9. Claim 13 .................................................................................... 35

10. Claim 14 .................................................................................... 36

11. Claims 7, 10, and 15 ................................................................. 36

12. Claims 8, 11, 16 ........................................................................ 37

C. Ground 2: Claims 1-16 would have been obvious over TAS, in view of Honigfeld and Elsayed, and further in view of Lilly. ............. 39

1. Claim 1 ...................................................................................... 40

2. Claim 2 ...................................................................................... 49

3. Claims 3 and 4 ........................................................................... 49

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. Claims 7, 10, and 15 ................................................................. 52

11. Claims 8, 11, 16 ........................................................................ 53

D. Secondary considerations do not rebut the prima facie case. .............. 54

VII. IT IS MORE LIKELY THAN NOT THAT PETITIONER WILL PREVAIL WITH RESPECT TO AT LEAST ONE OF THE CHALLENGED CLAIMS ............................................................................ 58

VIII. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1)) .................................... 58

IX. CONCLUSION .............................................................................................. 60


-1-

I. INTRODUCTION AND STATEMENT OF RELIEF REQUESTED (37 C.F.R. § 42.22(a))

Par Pharmaceutical, Inc. (“Par”) petitions for inter partes review (“IPR”)

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 patent’s 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 patent’s 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. GROUNDS FOR STANDING (37 C.F.R. § 42.104(a))

Par certifies that the ’059 patent is available for IPR and Par is not barred or

estopped from requesting IPR of any of the challenged claims.

III. STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE


-2-

REASONS THEREFOR

The Office should institute IPR under 35 U.S.C. §§ 311-319 and 37 C.F.R.

§§ 42.1-.80 and 42.100-42.123, and cancel claims 1-16—all claims—of the ’059

patent as unpatentable under 35 U.S.C. § 103.

IV. OVERVIEW

A. Person of Ordinary Skill In The Art

A POSA is a hypothetical person who is presumed to be aware of all

pertinent art, thinks along conventional wisdom in the art, and is a person of

ordinary creativity. A POSA may work as part of a multi-disciplinary team and

draw upon not only his or her own skills, but also take advantage of certain

specialized skills of others in the team, to solve a given problem. (PAR1007, ¶21.)

For example, a POSA would hold a Bachelor’s or Doctor of Pharmacy degree and

a license as a registered pharmacist with 3-5 years of relevant work experience, or

a computer science undergraduate degree or equivalent work experience and work

experience relating to business applications, for example, including familiarity

with drug distribution procedures. Alternatively, a POSA may have a blend of

computer science and pharmacy drug distribution knowledge and/or experience.

For example, such a POSA may have computer science education qualifications

and experience relating to computerized drug distribution systems, or pharmacy

education qualifications and experience relating to computerized drug distribution

systems. (Id.) A POSA would have had knowledge of the literature concerning


-3-

pharmacy practice and prescription drug distribution, such as the prior art

presented herein, that was available before the earliest effective filing date of ’059

patent, including knowledge about methods employed in the art. (Id.) Accordingly,

a POSA would have been well aware of techniques related to the mitigation of the

risk associated with the distribution of potentially hazardous, but therapeutically

beneficial prescription drugs. (Id.)

B. State of the Art

The ’059 patent generally pertains to centralizing the distribution of

hazardous or abuse-prone drugs. The ’059 patent is listed in the United States Food

and Drug Administration’s electronic publication, known as the “Orange Book”

(“OB”), in connection with the prescription drug product Xyrem®. The active

ingredient in Xyrem®—sodium oxybate, the sodium salt of gamma

hydroxybuyrate (“GHB”)—was well-known in the prior art as being susceptible to

diversion and abuse. (PAR1007, ¶47.) So, as a prerequisite to FDA approval, the

sponsor of Xyrem®, with assistance and direction from an FDA advisory

committee, agreed to employ a centralized distribution program to attempt to

reduce abusive and illicit uses of Xyrem®, now known as the Xyrem® Success

Program. By listing the ’059 patent in the FDA’s OB for Xyrem®, Jazz is asserting

that the Xyrem® Success Program is an embodiment of at least one claim of the

’059 patent.


-4-

Aside from the explicit disclosure of the ’059 patent’s claimed methods in

the prior art, the mitigation of risks associated with the distribution of potentially

hazardous drugs was well-established in the art before the earliest effective filing

date of the ’059 patent. For example, in 1982, Hoffman-La Roche (“Roche”)

gained approval for Accutane® (isotretinoin), which became known to be a potent

teratogen that was responsible for birth defects. (PAR1007, ¶22.) Under pressure to

respond, Roche developed a Pregnancy Prevention Program for Accutane®. (Id.)

The program included informed consent forms to be completed by the patient and

prescriber, along with patient counseling on the teratogenic risk of Accutane®, the

need to avoid pregnancy, and the use of proper birth control methods. Finally, this

program required that women of childbearing potential must test serum negative

for a pregnancy before beginning treatment. (Id.)

Following in the footsteps of Accutane®, in 1990, Clozaril® (clozapine)

entered the United States market for use with treatment-resistant schizophrenia.

(PAR1007, ¶23.) However, Clozaril® use was associated with agranulocytosis, a

potentially fatal blood disorder resulting in white blood cell loss. (Id.) To mitigate

these risks and control the distribution of Clozaril®, the manufacturer implemented

a national registry system that limited distribution of the drug. (Id.) The

distribution system required registration in an integrated computerized database—

collecting information identifying the patient and the physician—and measuring


-5-

the patient’s white blood cell count before filling a prescription. (Id.) If a patient or

physician was non-compliant with the program, the national registry took

corrective action, such as contacting and re-educating the prescribing physician

and/or discontinuing supply of the prescription to the patient. (Id.) Overall, the

Clozaril® distribution system resulted in 97% compliance over its first five years

of implementation. (Id.) While the use of a computer differentiated the Clozaril®

system from the Accutane® system, the use of computers was not novel to

prescription drug distribution, because by 1990 pharmacies had long been using

computers to aid in filling prescriptions. (Id., ¶24.)

Based on the experiences of patients and doctors with Accutane® and

Clozaril®, in 1999, the manufacturers of prescription thalidomide—a known

teratogen—developed a hybrid system, combining the computerized registry

system of Clozaril® and the pregnancy monitoring/prevention, and informed

consent requirements of Accutane®. (Id., ¶25.) This combination of computerized

registry system and preventative testing served to monitor and control the

distribution of the drug. (Id.)

Thus, by 1999, at least three systems for the restricted distribution of

effective, yet hazardous prescription drugs were known in the art and implemented

across the industry. Moreover, while risk management programs were developing

during the 1980s through 1990s, pharmacies had already been using computerized


-6-

systems for the distribution of controlled substances, i.e., drugs with potential for

abuse. (Id., ¶¶26, 27.) Aiming to reduce time for dispensing, improve accuracy and

accountability, and streamline record keeping, the distribution of controlled

substances veered toward automation via the implementation of computerized

systems of distribution. (Id., ¶27) Computerized systems were helpful in generating

reports tracking patients who were receiving excessive supplies of controlled

substances. (Id.) Distribution of controlled substances could be tied to information

identifying the patient, the prescribing doctor, the quantity of the drug dispensed,

and the hospital inventory of a drug. (Id.) And, the systems could be queried to

provide data, such as prescriptions by doctor and patient. (Id.) These systems

allowed for detecting patterns of abuse. (Id.)

Given the proclivity for diversion and abuse of GHB, the FDA held advisory

committee meetings as a prerequisite to granting approval to the Xyrem® New

Drug Application (“NDA”). A collection of materials that were used in that

meeting (the “Advisory Committee Art” or “ACA”)—all of which published more

than one year prior to the earliest effective filing date of the ’059 patent—discloses

every limitation of the challenged claims.

Consequently, prior to the earliest effective filing date of the ’059 patent,

prior art existed that would have led a POSA to develop the centralized distribution

systems claimed in the ’059 patent to minimize the risks associated with the


-7-

distribution of hazardous prescription drugs. (Id., ¶28.)

C. The ’059 patent

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


-8-

pharmacy using only the exclusive computer database; (2) checking for patterns of

abuse using the exclusive computer database; (3) only providing the prescription

drug to the patient if no abuse is found; and (4) generating periodic reports to

evaluate potential diversion patterns.

During prosecution of the ’059 patent’s parent application, the independent

claims were amended to add the following limitations to overcome prior art

rejections: (1) “all prescriptions for the sensitive drug are processed only by the

exclusive central pharmacy using only the exclusive computer database”; and (2)

“mailing the sensitive drug to the patient only if no potential abuse is found by the

patient to whom the sensitive drug is prescribed and the doctor prescribing the

sensitive drug.”1 (PAR1016, 442 (Amdt. & Reply filed Nov. 2, 2009; see also

PAR1016, 241-248 (Amdt. & Reply filed Aug. 8, 2006) and 303-334 (Appeal

Brief filed July 18, 2007).) Applicants argued that these limitations were not taught

by the cited prior art. (PAR1016, 449 (Amdt. & Reply, filed Nov. 2, 2009).) All

other limitations of the claims were found to have been taught by the cited prior

art. (Id. at 258-262 (Final Rejection, Oct. 18, 2006) and at 420-433 (Decision on

Appeal, Aug. 31, 2009).)

Subsequently, in the Notice of Allowance for the ’059 patent’s parent

application, the Examiner pointed to the above-noted limitations when allowing the

1 Emphasis added throughout unless otherwise noted.


-9-

claims, stating: “the closest prior art of record does not teach or fairly suggest that

all prescriptions for GHB are processed only by the exclusive central pharmacy

using only the exclusive computer database. The exclusive computer database is

checked for potential GHB abuse and GHB is provided/mailed only if no potential

abuse is found by the patient to whom GHB is prescribed and the

doctor/authorized prescriber of the GHB.” (Id. at 475-476 (Notice of Allowance)

(emphasis in original).) The’059 patent claims similarly rely on these limitations

for purposes of patentability. However, as demonstrated in this petition, all of these

alleged “novel” limitations were, in fact, not novel. Use of an “exclusive central

pharmacy” and “exclusive computer database” were well-known in the art. (See

§§ VI.B–C.) And the same art also discloses checking the exclusive computer

database for patterns of abuse by both the doctors and patients and only providing

the prescription drug to the patient if no abuse is found. (Id.)

V. CLAIM CONSTRUCTION

Unless otherwise construed herein, the terms of claims 1-16 are to be given

their broadest reasonable interpretation, as understood by one of ordinary skill in

the art in view of the ’059 patent’s specification. See 37 C.F.R. § 42.100(b).

A. “Exclusive Central Pharmacy” and “Exclusive Computer Database”

Claims 1–16 all recite (either explicitly or through incorporation from the

independent claims) the terms “exclusive central pharmacy” and “exclusive


-10-

computer database.” During prosecution of the ’730 patent, of which the ’059

patent is a continuation, the applicants defined the term “exclusive” as “single or

sole.” (PAR1016, 402 (Reply Brief, filed Dec. 3, 2007).) Therefore, the terms

“exclusive central pharmacy” and “exclusive computer database” should be

construed to mean a “single or sole pharmacy” and a “single or sole database,”

respectively. (PAR1007, ¶37.)

B. “Generating with the computer processor periodic reports via the exclusive computer database”

Claims 1–13 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


-11-

… periodic reports,” should be construed to mean “querying the computer database

to obtain information, such as, prescriptions by physician, prescriptions by patient

name, prescriptions by frequency, and prescriptions by dose.” (Id,)

C. “Dispensed to the patient by another pharmacy”

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).


-12-

Ground 35 USC Claims Index of References

1 § 103(a) 1-16 Advisory Committee Art (PAR1003-1006)

2 § 103(a) 1-16 Talk About Sleep in view of Honigfeld further in view of Elsayed and further in view of Lilly.

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 Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007).

A. EACH OF THE REFERENCES CITED IS AVAILABLE PRIOR ART.

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.


-13-

1. The ACA (PAR1003 – PAR1006) qualifies as “printed publications.”

“[T]he determination of whether a given reference qualifies as a prior art

‘printed publication’ involves a case-by-case inquiry into the facts and

circumstances surrounding the reference’s disclosure to members of the public.”

CBM2013-00047, Paper 11, *16 (Feb. 18, 2014) (citing In re Klopfenstein, 380

F.3d 1345, 1350 (Fed. Cir. 2004)). And “[a] 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.” Id. (quoting Kyocera

Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed. Cir. 2008)).

Electronic publications can qualify as “printed publications” as long they

have been disseminated or otherwise made available to a POSA exercising

reasonable diligence. IPR2013-00084, Paper 14, *20-21 (May 17, 2013). And

while indexing is “often relevant to public accessibility, evidence of indexing is not

an absolute prerequisite to establishing online references [] as printed publications

within the prior art.” Id., at *21 (quoting Voter Verified, Inc. v. Premier Election

Solutions, Inc., 698 F.3d 1374, 1380 (Fed. Cir. 2012)). Moreover, institution

cannot be denied because an electronic reference is not accompanied by a

declaration from an author or with other evidence that someone accessed and

received the reference prior to the critical date. IPR2014-00059, Paper 9, *34 (Apr.


-14-

15, 2014). Par need only provide sufficient evidence to demonstrate that the

reference was disseminated publicly or otherwise available. Id. at *34-35 (citing In

re Wyer, 655 F.2d 221, 226 (C.C.P.A. 1981) (finding that no evidence concerning

actual viewing or dissemination of a reference was required when a reference is

deemed to have been “sufficiently accessible to the public and to persons skilled in

the pertinent art”)).

Examination of the ACA materials (PAR1003-PAR1006) demonstrates that

it is a collection of publicly available, printed publications. Orphan Medical

submitted for publication the Xyrem Video and Transcript, the Briefing Booklet,

and the Preclinical Safety Review as briefing materials to the FDA before the

Advisory Committee met on June 6, 2001. Indeed, according to the Federal

Register notice announcing this meeting:

Background material from the sponsor and FDA will be posted 24

hours before the meeting at the Peripheral and Central Nervous

System Drugs Advisory Committee docket site at

http://www.fda.gov/ohrms/dockets/ac/acmenu.htm (Click on the year

2001 and scroll down to the Peripheral and Central Nervous Systems

Drugs meetings.) This is the same website where you can find the

minutes, transcript, and slides from the meeting. This material is

generally posted about 3 weeks after the meeting.

(PAR1015 (emphasis added).) Such “competent evidence of the [FDA’s] general []

practice may be relied upon to establish an approximate time” the ACA would


-15-

have become available to a POSA exercising reasonable diligence. IPR2014-

00059, Paper 9, *34 (Apr. 15, 2014) (citing In re Hall, 781 F.2d 897, 899 (Fed.

Cir. 1988)).2 Therefore, based on the stated timelines, the Xyrem Video and

Transcript (PAR1006), the Briefing Booklet (PAR1005), and the Preclinical Safety

Review (PAR1004) were approximately available on the FDA’s website as of June

5, 2001, while the Advisory Committee Transcript and Slides (PAR1003) were

available as of June 27, 2001. Both dates are more than one year prior to December

17, 2002. Additionally, the FDA website that hosts these documents demonstrates

that they were all available by July 13, 2001, at the latest, also qualifying them as

102(b) prior art. (PAR1017 (relevant bullet point highlighted).) And because the

ACA was listed on an FDA website, the address of which was provided in the

Federal Register, the ACA was indexed and accessible to persons of ordinary skill.

The Preclinical Safety Review (PAR1004) contains redactions of the name

of the proposed specialty pharmacy for distribution of Xyrem®—further evidence

that these materials would be, and were intended to be, available to the public,

while small portions, immaterial here, containing confidential information were

2 The Federal Advisory Committee Act also required that “the records,

reports, transcripts, minutes … or other documents which were made available to

or prepared for or by each advisory committee shall be available for public

inspection.” 5 U.S.C. App 2 §10(b) (2001).


-16-

hidden. And the Briefing Booklet (PAR1005) states on its cover that it is

“AVAILABLE FOR PUBLIC DISCLOSURE WITHOUT REDACTION”—

confirming that a POSA would have easily been able to obtain it. Cf. IPR2013-

00458, Paper 12, *27 (Jan. 16, 2014) (finding that statements of confidentiality on

a document suggest it was not publicly available).

Other evidence corroborating the public availability of the ACA comes from

the Internet Archive: Wayback Machine (located at

https://archive.org/web/web.php).3 The Wayback Machine demonstrates that, at the

latest, a link to the “Briefing Information” (i.e., the Xyrem Video and Transcript

(PAR1006), the Briefing Booklet (PAR1005), and the Preclinical Safety Review

(PAR1004)) was available online on June 17, 2001. (PAR1018, pg. 5, 6/6

Meeting.) Following this link demonstrates that this art was all available on July 1,

2001, at the latest. (PAR1019.) And the Advisory Committee Transcript and Slides

(PAR1003) were available by October 4, 2001, at the latest—more than one year

prior to December 17, 2002. (PAR1020, pg. 8, 6/6 Meeting.)

Additionally, a POSA “exercising reasonable diligence” would have been

able to locate the ACA. (PAR1007, ¶48; PAR1015.) Notice of the Advisory

3 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).


-17-

Committee Meeting was posted in the Federal Register, which indicated that “[a]

main focus of the deliberations will be on risk management issues.” (PAR1007,

¶48; PAR1015.) Moreover, the Federal Register also points a POSA to where the

ACA would be located before and after the meeting. (PAR1007, ¶48; PAR1015.)

A POSA would have known to look in the Federal Register and on the FDA’s

website to obtain information related to existing and proposed risk management

programs. (PAR1007, ¶48.)

In sum, the ACA was a collection of publicly available, printed publications

because it would have been available to and readily located by a POSA exercising

reasonable diligence. Moreover, it was available more than one year prior to the

priority benefit date of the ’059 patent. (PAR1028.)

2. Talk About Sleep, Honigfeld, Elsayed and Lilly

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).


-18-

B. Ground 1: Claims 1-16 are obvious over the ACA

As supported by the declaration of Dr. Valuck, claims 1-16 of the ’059

patent would have been obvious over the ACA—Advisory Committee Transcript

and Slides (PAR1003), Preclinical Safety Review (PAR1004), Briefing Booklet

(PAR1005), and Xyrem Video and Transcript (PAR1006). The ACA qualifies as

prior art to the claims of the ’059 patent. (See § VI.A.1) Each publication was

either submitted to the FDA prior to the meeting or is a record of what transpired at

the meeting. And, as announced in the Federal Register, each publication was

readily accessible to the public from a central location on the FDA’s website more

than one year before the priority date for the ’059 patent. (PAR1019.)

A POSA would have had more than ample reason to combine these ACA

materials. The Preclinical Safety Review (PAR1004), Briefing Booklet

(PAR1005), and Xyrem Video and Transcript (PAR1006) were all distributed

together for a single meeting before the FDA seeking approval for prescription

Xyrem®, and the Advisory Committee Transcript and Slides (PAR1003) were a

public transcript of and presentation given at the meeting itself. Moreover, a POSA

would also have had a reasonable expectation of success when combining each of

these materials to arrive at claims 1-16 because they clearly relate to the same

restricted distribution program, which the meeting was convened to discuss.

(PAR1007, ¶52.) Further, the Xyrem Video and Transcript (PAR1006) is


-19-

incorporated by reference into the Advisory Committee Transcript and Slides

(PAR1003), and into the Briefing Booklet (PAR1005). (See PAR1003; PAR1005.)

Not only that, but each of the references are all linked from a single page. The

links specify with particularity each of the documents. So, even if they are

considered to be separate references, the base menu page effectively incorporates

by reference each of the different documents, making them obvious to combine.

1. Comparison of the ’059 Patent Claims to the Prior Art.

Independent claim 1 of the ’059 patent recites the following:

A computerized method of distributing a prescription drug under

exclusive control of an exclusive central pharmacy, the method

comprising:

[1.1] receiving in a computer processor all prescription requests,

for any and all patients being prescribed the prescription drug, only at

the exclusive central pharmacy from any and all medical doctors

allowed to prescribe the prescription drug, the prescription requests

containing information identifying patients, the prescription drug, and

various credentials of the any and all medical doctors;

[1.2] requiring entering of the information into an exclusive

computer database associated with the exclusive central pharmacy for

analysis of potential abuse situations, such that all prescriptions for

the prescription drug are processed only by the exclusive central

pharmacy using only the exclusive computer database;

[1.3] checking with the computer processor the credentials of the

any and all doctors to determine the eligibility of the doctors to


-20-

prescribe the prescription drug;

[1.4] confirming with a patient that educational material has been

received and/or read prior to shipping the prescription drug;

[1.5] checking the exclusive computer database for potential abuse

of the prescription drug;

[1.6] mailing or sending by courier the prescription drug to the

patient only if no potential abuse is found by the patient to whom the

prescription drug is prescribed and the doctor prescribing the

prescription drug;

[1.7] confirming receipt by the patient of the prescription drug; and

[1.8] generating with the computer processor periodic reports via

the exclusive computer database to evaluate potential diversion

patterns.

(PAR1001, 8:37-9:3 (numbering added for ease of reference to claim limitations).)

The remaining independent claims of the ’059 patent (claims 6, 9, 12, 13,

and 14) recite substantially similar subject matter as claim 1 with slight

differences, i.e, excluding certain limitations, rewording of certain claim terms,

and/or the claims being directed specifically to the distribution of GHB.

2. Claim 1 Would Have Been Obvious Over the ACA.

As explained by Dr. Valuck—an expert in drug safety, drug abuse

prevention, and prescription drug distribution with two decades of experience in

the area—in his accompanying declaration, each limitation of claim 1 is found in

the ACA. (See PAR1007, ¶¶53-85.) For ease of reference, claim 1 is also recited


-21-

in its entirety at Section VI.B.1 above.

The ’059 patent provides several flow diagrams, together describing each of

claim 1’s limitations. The representative figure below has been produced based on

those flow diagrams and maps each limitation of claim 1 to a representative flow

diagram step from the figures of the ’059 patent for ease of understanding each

limitation.

Preamble: The ACA explicitly teaches a method of distributing a

prescription drug under exclusive control of an exclusive central pharmacy, as

recited by the preamble of claim 1. For example, ACA discloses distributing the

prescription drugs Xyrem® through a closed distribution system. (PAR1003, Tr.,

177:24-178:11; PAR1007, ¶54.) The ACA’s closed distribution system includes


-22-

manufacturing Xyrem® at a single manufacturing facility and providing Xyrem®

to a single national pharmacy that will be its exclusive distributor. (See PAR1003,

Tr., 177:24-178:11 and 183:12-16; PAR1004, pg. 108; PAR1005, pgs. 302, 306,

309, and 311; PAR1006, Tr., pg. 4 n.13; PAR1007, ¶54.)

As discussed in § V.A., the patentee argued during prosecution that

“exclusive” meant “single or sole.” As such, a POSA would have understood that

the “single national specialty pharmacy” described by the ACA with respect to

Xyrem® is synonymous with the claimed “exclusive central pharmacy” in the ’059

patent. (PAR1007, ¶54.) ACA discloses benefitting from using a single national

specialty pharmacy because the prescription drugs are distributed from a central

location and all controls and records are in one place, i.e., at the single national

specialty pharmacy. (See PAR1003, Tr., 177:24-178:11; PAR1005, pg. 299 and

306; PAR1007, ¶¶54, 55.) Accordingly, a POSA would have immediately

appreciated that the ACA’s distribution of Xyrem® is under the exclusive control

of the single or exclusive national specialty pharmacy. (PAR1007, ¶¶54-56.)

ACA: Figure shows pharmacist at single specialty pharmacy utilizing a computer.


-23-

Moreover, ACA teaches and illustrates that the distribution of the

prescription drugs under the exclusive control of the single or exclusive national

specialty pharmacy is computerized, as claimed. (See PAR1003, Slides, pg. 146,

reproduced above w/annotation; PAR1006, Tr., pg. 10 n.42; V5 00:09-00:27,4 V7

00:00-00:16; PAR1007, ¶55.) To the extent the Board concludes that the

illustration is not an explicit teaching—and Par posits that it is—ACA at least

nevertheless implicitly teaches how its closed distribution system is computerized.

For example, ACA teaches receiving data from prescription requests (which can be

thousands of requests) at the specialty pharmacy and entering the data into a

registry. (See PAR1003, Tr., 16:4-7, 24:21-25, 259:4; PAR1005, cover letter, pg.

1; PAR1007, ¶55, emphasis added).)

The collected data provide “centrally located, real-time data [that] will be

invaluable to identification of suspicious [behavior].” (PAR1005, pg. 304 and 311;

PAR1007, ¶55.) From this disclosure, a POSA would have immediately envisaged

that the single national pharmacy utilized a computer so that prescription

information could be collected and physician prescribing patterns and patient

activity could be monitored in real-time. (PAR1007, ¶55.) Accordingly, a POSA

would have understood that ACA teaches a computerized method of distributing a

4 Citations to the Xyrem Video (PAR1006) will be provided as VX YY:YY,

where VX = PAR1006, Video, part X.


-24-

prescription drug from a central location—because the need to enter, access, and

store large amounts of information would be accelerated and, thus, facilitated by

using a computer. (PAR1007, ¶56.)

Step 1.1: Step 1.1 recites, in part, “receiving in a computer processor all

prescription requests....” ACA discloses that the single national pharmacy receives

“a number of unique prescribing forms for Xyrem® which will be necessary in

order for the prescription to be filled.” (See PAR1003,Tr. 180:6-16; Slides, pg.

151; PAR1005, pg. 310; PAR1006, Tr., pg. 5 n.20; V7 00:00-00:16; PAR1007,

¶58.) A POSA would have immediately recognized that the unique prescribing

forms are synonymous with the claimed prescription requests. (PAR1007, ¶58.)

Further, a POSA would have understood that the single national pharmacy receives

the prescribing forms for all patients being prescribed the prescription drug. (Id.)

Moreover, ACA explicitly teaches that the unique prescribing forms are

received from any and all medical doctors allowed to prescribe the prescription

drug. For example, ACA discloses that once the single national pharmacy receives

the prescription form, the central pharmacy checks the eligibility of the prescribing

doctor to prescribe Xyrem® and also checks the patient’s eligibility to receive the

prescription. (See PAR1003, Tr., 181:1-22; Slides, pg.152-153; PAR1004, pg. 109;

PAR1005, pgs. 310; PAR1006, Tr., pg. 6 n.21; PAR1007, ¶59.) As explained by

ACA, these eligibility checks ensure (1) that the physician has a valid medical


-25-

license, prescribing privileges, and no actions pending against him; and (2) the

veracity of the patient’s identity and receipt of a prescription for GHB. (See

PAR1003, Tr., 181:1-22; Slides pg. 152-153; PAR1004, pg. 109; PAR1005, pg.

306; PAR1006, Tr., pg. 6 n.21 and n.24; PAR1007, ¶59.)

A POSA reviewing the ACA would have known that in order to perform the

eligibility checks, the special prescription forms would be received from any and

all doctors and would include “information identifying patients, the prescription

drug, and various credentials of the any and all medical doctors,” as recited in

claim 1. (PAR1007, ¶¶59, 60.) It is with this information in hand that the single

national pharmacy described by ACA would (1) cross-reference the external DEA

National Technical Information Services database and state medical board records

to identify doctors allowed to prescribe the prescription drug; (2) check the

veracity of the patient and his prescription; and (3) determine what drug to

dispense and when to do so. (Id., ¶60.)

Additionally, as discussed above, ACA teaches that the distribution process

of the single national pharmacy could be performed using a computer. (See

PAR1003, Slides, pg. 146; PAR1006, Tr., pg. 10 n.42; V5 00:09-00:27, V7 00:00-

00:16; PAR1007, ¶61.) For the same reason, ACA teaches that the prescription

requests are received in a computer processor, if not explicitly, at least implicitly.

(PAR1007, ¶¶55, 61.) For example, ACA recognizes the necessity of collecting


-26-

data for a significant number of patients, thus implying utilizing a conventional

computer to accelerate processing of prescriptions. (PAR1003, Tr., 24:21-25;

PAR1005, cover letter, pg. 1; PAR1007, ¶61.) Moreover, ACA discloses

registering “every patient and prescribing physician” in “a secure database”

(PAR1004, pg. 110; PAR1007, ¶61.) and ACA shows that the pharmacy staff

receives a prescription request and enters the prescription request into a computer.

(See PAR1006, V7 00:00-00:16; PAR1007, ¶61.) Therefore, ACA discloses that

“all prescriptions from any and all doctors for any and all patients” are received in

the computer processor.

Furthermore, a POSA would have immediately envisaged using a computer

to receive and organize prescription requests, as pharmacies were doing this prior

to the effective filing date of the ’059 patent, and computers are shown in ACA.

(PAR1007, ¶¶24, 61.) And POSA would have known that a secure database, which

could house information for a large number of patients, as described by ACA,

would normally be accessed using a computer. (Id., ¶61) Here, a POSA would

have at once envisaged that ACA teaches that prescription requests are entered into

the secure database that is accessible via a computer. A POSA likewise would have

at once envisaged that achieving the disclosed benefits of using an exclusive

central pharmacy would be more realized through the use of the disclosed

computer, allowing for quicker entry, access, compiling and analysis of data.


-27-

(PAR1007, ¶¶61-62.)

Step 1.2: ACA explicitly describes an exclusive computer database

associated with the exclusive central pharmacy. (Id., ¶69.) As discussed above,

ACA discloses a centralized location for all prescription controls and records. (See

PAR1003, Tr., 177:24-178:11; Slides, pg. 146-147; PAR1005, pg. 306; PAR1006,

Tr., pg. 6 n.24; PAR1007, ¶64.) And ACA further explains that such controls and

records are kept in a “central data repository.” (Id.) A POSA would have

understood this “central data repository” to be synonymous with the claimed

“exclusive computer database” in the ’059 patent, because all the controls and

records are kept at a single location (i.e., exclusive), namely the central data

repository. (PAR1007, ¶64.) Prior to filling a prescription, the central data

repository allows for the identification of potential abuse situations, such as any

duplicate prescriptions, any attempts of over-prescribing, or any attempts at over-

use by patients. (See PAR1003, Tr., 184:24-185:6; Slides, pg. 158; PAR1005, pgs.

311; PAR1006, Tr., pg. 7 n.25 and pg. 8 n.29; PAR1007, ¶65.)

ACA also discloses that information from the prescription request is entered

into the exclusive computer database. As discussed earlier, ACA discloses

registering every patient and prescribing physician in the database. (See PAR1003,

Tr., 16:4-7, 259:4; PAR1004, pg. 110; PAR1007, ¶66.) The information that is

registered in the database includes the physician’s name, address, telephone and


-28-

facsimile numbers, DEA and state license numbers and prescribing frequency.

(PAR1004, p. 110; PAR1005, p. 306; PAR1006, Tr., pg. 6; PAR1007, ¶66.)

Utilizing the database allows for ready access to this information, organized

according to prescriptions by physician, patient, frequency, and/or dose. (See

PAR1004, pp. 110, 114; PAR1005, pg. 304; PAR1006, Tr., pg. 4 n.13-14 and pg. 7

n.25; PAR1007, ¶66.) Further, ACA discloses that upon receiving the unique

prescription request forms at the single national pharmacy, the pharmacy collects

data that aids in determining proper timing for prescription refills. (See PAR1003,

Tr. 259:4-11; Slides, pg. 158; PAR1004, pg. 110; PAR1006, Tr., pg. 4 n.13-14 and

pg. 7 n.25; PAR1007, ¶¶64, 66.) A POSA, therefore, would have at once envisaged

that to achieve the benefits described by ACA (e.g., analysis of potential abuse

situations), the information from the prescription forms would have been collected

and entered into the disclosed central data repository (i.e., exclusive computer

database). (PAR1007, ¶67.)

Step 1.3: ACA explicitly discloses performing a number of checks to

determine if the prescribing physician is eligible to administer prescriptions upon

receiving a prescription request at the single national pharmacy. These checks

include checking the relevant external DEA database and the appropriate state

medical board specific to the prescriber in question. (See PAR1003, Tr., 181:1-22;

Slides pg. 152-153; PAR1004, pg. 109; PAR1005, pg. 306 and 310; PAR1006, Tr.,


-29-

pg. 6 n.21 and n.24; PAR1007, ¶69.) A POSA also would have immediately

envisaged performing such credential checking using a computer, because doing so

would make it easier to check sources such as the DEA’s National Technical

Information Services. (PAR1007, ¶69.)

Step 1.4: ACA explains that “each patient, when they get their first

prescription of Xyrem® will receive a multi-faceted educational program called

the Xyrem Patient Success Program[.]” (PAR1003, Transcript, 182:3-8; PAR1007,

¶71.) Notably, by listing the ’059 patent in the Orange Book for Xyrem®, Jazz is

asserting that the Xyrem® Success Program is a commercial embodiment of at

least one of the ’059 patent claims. ACA also describes modifying the distribution

system to confirm with a patient that educational material has been received and/or

read prior to shipping the prescription drug. (See PAR1003, Tr., 371:10-12 and

374:7-20; PAR1004, pg. 115; PAR1007, ¶72.) A POSA would have understood

this teaching to explicitly disclose confirming that the patient received and/or read

educational materials before shipping the prescription drug. (PAR1007, ¶72.)

Step 1.5: ACA explicitly describes checking for potential abuse. As

explained above, ACA’s central data repository “allows for identification of a

number of unusual types of behavior, including any duplicate prescriptions, any

attempts of over-prescribing, or any attempts at over-use by patients.” (PAR1003,

Transcript, 184:24-185:4; PAR1007, ¶74.) Moreover, ACA discloses flagging for


-30-

monitoring and documenting “repeat instances of lost, stolen, destroyed, or spilled

prescriptions/supplies.” (PAR1004, pg. 110; PAR1007, ¶74.)

Steps 1.6-1.7: ACA explicitly discloses shipping the prescription drug to a

patient via a courier service and/or mail-order based system. (Claim 1, step 1.6;

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, ¶76.) Further, ACA explicitly discloses that the prescription drug is

only mailed or sent by courier if no potential abuse is found by the target patient

and prescribing physician based on verifying the stored information. (PAR1003,

Tr., 184:24-185:7; Slides, pgs. 158-159; PAR1005, pgs. 304, 305, and 311;

PAR1006, Tr., pg. 8 n.29 and pg. 9 n.38; PAR1007, ¶¶ 74, 77.) And the stated

benefit is that this “information is available prior to filling the prescription so

appropriate pharmacist intervention can occur.” (PAR1003, Tr., 184:24-185:7;

Slides, pgs. 158-159; PAR1006, Tr., pg. 8 n.29 and pg. 9 n.38; PAR1007, ¶77

(emphasis added).) Moreover, ACA discloses making the prescription drug

inaccessible to those who might abuse it, thus maintaining responsible distribution.

(See PAR1003, Tr., 185:9-14; Slides pg. 142; PAR1005, pgs. 298, 305, 308, and

311; PAR1007, ¶77.) Hence, a POSA would have understood the ACA to disclose

mailing or sending by courier the drug only where there is no potential for abuse.

(PAR1007, ¶77.)


-31-

Furthermore, ACA explicitly describes limitation 1.7 (confirming receipt).

ACA explains that “after the Rapid Trac System shows that the package has been

received by the patient, the specialty pharmacist will call the patient within 24

hours not only to confirm receipt of that package but also to reiterate certain

important points with the patient.” (PAR1003, Tr., 184:10-15; PAR1007, ¶79.)

Step 1.8: As discussed above in § V.B, a POSA would have understood that

the limitation of “generating…periodic reports” entails querying the computer

database to obtain prescription information organized by, for example, physician,

patient name, frequency, and/or dosage amount. In this context, ACA discloses this

limitation at least implicitly, if not explicitly. For example, ACA discloses using

the central data repository to identify patterns of abuse and diversion. (See

PAR1003, Tr., 184:24-185:7; Slides, pg. 158; PAR1005, pg. 306, 307, and 311;

PAR1007, ¶82.) And ACA describes preventing diversion and illicit use, as well as

providing assistance to “law enforcement for investigation and prosecution

efforts,” as a goal of its distribution system (PAR1003, Tr., 15:6-8; PAR1004, pg.

110; PAR1005, pp. 298, 301 and 306-308; PAR1007, ¶82.) Moreover, ACA

discloses generating data by “recording prescribers, patients, and dosing that could

provide information for any possible investigations and prosecutions for state and

federal authorities” using a computer (PAR1006, Tr., pg. 4 n.13-14; V5 00:10-

00:27; PAR1007, ¶83.) From the prescription information entered into the


-32-

database, the database can be queried to provide information such as

“[p]rescriptions by physician specialty … by patient name … by volume

(frequency) … [and] by dose.” (PAR1004, pg. 110; PAR1007, ¶83.) ACA also

discloses that the “Xyrem risk management system ensures that the centralized

pharmacy will identify patients who are attempting to duplicate prescriptions. All

data collected will be available to state and federal authorities, on whatever

timeframe they determine to be appropriate.” (PAR1005, p. 307; PAR1007, ¶83.)

At the very least, the “timeframe” referred to therein implies a periodic reporting.

(PAR1007, ¶83.) A POSA would have understood that such data generation and

querying via the central data repository is synonymous with generating periodic

reports via the exclusive computer database to evaluate potential diversion

patterns, as claimed, using a computer. (PAR1007, ¶83; see PAR1006, Tr., pg. 10

n.42; V5 00:10-00:27, V13 00:17-00:31; PAR1003, Tr., 24:21-24; PAR1005,

cover letter, pg. 1; PAR1007, ¶¶83-84.)

3. 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,


-33-

184:24-185:7; Slides, pg. 147; PAR1004, pg. 108; PAR1005, pp. 304, 306;

PAR1006, Tr., pg. 4 n.13-14 and pg. 6 n.24; V5 00:09-00:27, V7 00:00-00:16;

PAR1007, ¶87.)

4. Claims 3 and 4

Claims 3 and 4 depend from claim 1 and further specify “selectively

blocking shipment of the prescription drug to a patient.” (Claim 3; PAR1001, 9:6-

7) and blocking shipment of the prescription drug upon association of an abuse

pattern with a patient. (Claim 4; PAR1001, 9:8-10.) ACA explicitly discloses these

features by instructing to deploy appropriate pharmacist intervention, such as

contacting authorities and flagging any inappropriate prescription requests, once

potential abuse situations are identified. (See PAR1003, Tr., 184:24-185:7; Slides

pg. 158; PAR1006, Tr., pg. 8 n. 29, pg. 9 n. 38; PAR1007, ¶89.) Additionally, such

intervention includes blocking shipment of the prescription drug to a patient prior

to filling a prescription in order to make the prescription drugs inaccessible to

those who would use it inappropriately. (See PAR1003, Tr., 184:24-185:7; Slides

pp. 142, 158; PAR1005, pg. 308; PAR1007, ¶90.) Accordingly, ACA explicitly

would have taught a POSA to selectively block a shipment of the prescription drug

to a patient, because ACA emphasizes the importance of preventing drug abuse

and the discretionary ability of the pharmacist to prevent a shipment of the drug to

identified patients. (PAR1007, ¶90.)


-34-

5. 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., 9:12-

17; PAR1007, ¶91; see also generally PAR1004; PAR1005; PAR1006.)

6. Claim 6

Claim 6 is an independent claim with similar limitations to those recited in

claim 1. The only differences between claim 6 and claim 1 are: (1) the term

“medical doctors” in “any and all medical doctors allowed to prescribe a

prescription drug” in claim 1 is replaced with “authorized prescribers.” (PAR1001,

9:19.); (2) the “exclusive computer database” is “under exclusive control of the

central pharmacy,” instead of “associated with the exclusive central pharmacy”

(Id., 9:24-25.); and (3) instead of “mailing or sending by courier the prescription

drug,” as in claim 1, claim 6 requires “providing the prescription drug.” (Id., 9:42.)

These differences do not change how ACA is applied to the claims. (PAR1007,

¶93.) As explained above, ACA discloses all of the features of claim 1.

Accordingly, the ACA also discloses and renders obvious all steps of claim 6. (Id.)

7. Claim 9

Likewise, the limitations of independent claim 9 are similar to those in claim

6. The only difference is that claim 9 recites GHB as the prescription drug. As

explained above for claim 5, Xyrem®—the drug to which ACA is directed—is


-35-

GHB. (See PAR1003, Tr., 9:12-17.) Accordingly, the ACA also discloses all the

steps of claim 9. (PAR1007, ¶94.)

8. 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

“[M]anufacturing GHB and providing manufactured GHB only to the

exclusive central pharmacy”; ACA explicitly discloses that Xyrem®, known to

contain the active pharmaceutical ingredient GHB, is manufactured at one single

manufacturing facility and sent to one single national specialty pharmacy for

distribution. (See PAR1003, Tr., 178:3-5, 9:12-17; PAR1007, ¶97.)

The remaining limitations of claim 13: Each remaining limitation of claim

13 is identical to the limitations of claim 12. Accordingly, the ACA also discloses

and renders obvious all the remaining steps of claim 13. (PAR1007, ¶98.)


-36-

10. 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. Claims 7, 10, and 15

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 pharmacy’s

ability to protect against diversion of GHB before shipping.” (Id.) Therefore, the

benefits of preventing diversion and illicit use discussed in the disclosed

5 “As discussed in § IV.C., dispensed to the patient by another pharmacy”

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.”


-37-

distribution program are left intact. Thus, the ACA explicitly discloses situations

that require having another pharmacy make available the medication. One such

situation would be if mandated by the patient’s insurance provider, as described by

ACA. (PAR1004, pg. 110; PAR1007, ¶102.)

12. 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 patient’s 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 pharmacy’s ability to protect against


-38-

diversion of GHB before shipping the drug there.” (PAR1004, pg. 110; PAR1007,

¶104.) ACA also explicitly discloses various controls that are placed on the

exclusive central pharmacy, which are similar to the controls recited by claims 8,

11, and 16. Those controls include (1) confirming with the patient that the

educational material has been received and/or read by the patient; (2) confirming

receipt of the prescription drug by the patient; (3) contacting the patient’s

insurance company; (4) flagging repeat instances of lost, stolen, destroyed or

spilled prescriptions; and (5) limiting the prescription to a supply of limited

duration. (PAR1003, Tr., 184:10-15, 371:10-12; Slides, pg. 157; PAR1004, pgs.

109, 110, and 115; PAR1006, Tr., pg. 7 n.26 and pg. 9 n. 35; PAR1007, ¶105.)

A POSA would have understood that the ACA discloses placing the same

controls on the distribution of the prescription drug by the “another pharmacy.”

(PAR1007, ¶105.) Such controls placed on the “another pharmacy” would be in

line with the ACA’s express goals of preventing abuse and diversion. (PAR1003,

Tr., 184:24-185:7; Slides, pgs. 158-159; PAR1005, pgs. 304, 305, and 311;

PAR1006, Tr., pg. 8 n.29 and pg. 9 n.38; PAR1007, ¶105.) Therefore, a POSA

would have understood that ACA discloses the claimed method of the authorized

another pharmacy placing controls on the distribution of the prescription drug,

because it discloses (1) placing such controls on distribution, (2) authorizing

another pharmacy to provide the drug with a “mechanism for verifying the second


-39-

pharmacy’s ability to protect against diversion,” and (3) such a method would be in

line with the goals of the ACA’s disclosure. (PAR1007, ¶105.)

In sum, following the teachings of the combined Advisory Committee

references, a POSA would have combined the disclosed limitations as claimed

with no change to their respective functions. And the combination claimed in the

’059 patent yields nothing more than what was predicted in the Advisory

Committee references. Moreover, the claimed method steps were discussed in

detail in the prior art Advisory Committee references exactly as recited in the ’059

patent, and the art explained the techniques of reducing abuses of GHB to be had

by applying those steps. Such techniques would have been readily apparent and

predictable to a POSA, especially given the POSA’s own knowledge with drug

distribution procedures and minimizing abuses. Accordingly, the combined ACA

would have rendered claims 1-16 of the ’059 patent obvious to a POSA, even in

light of any secondary considerations (discussed in § VI.D.).

C. Ground 2: Claims 1-16 would have been obvious over TAS, in view of Honigfeld and Elsayed, and further in view of Lilly.

As supported by the declaration of Dr. Valuck, claims 1-16 of the ’059

patent would have been obvious over TAS as modified by Honigfeld, Elsayed, and

Lilly. A POSA would have had more than ample reason to combine each reference,

because TAS, Honigfeld, and Elsayed are all directed to the same endeavor—

controlled distribution of hazardous, but potentially beneficial, prescription drugs.


-40-

(PAR1007, ¶107.) And a POSA would have had a reasonable expectation of

success of combining each reference, because doing so would have been nothing

more than combining prior art methods according to known techniques in order to

yield predictable results and/or use of known techniques to improve similar

methods in the same way.

Par incorporates herein the background information on Xyrem®, GHB,

Orphan Medical, and prior art restricted distribution programs discussed above and

with respect to Ground 1, and will not repeat them here.

1. Claim 1

Preamble: TAS discloses distributing Xyrem® through a “specialty

distribution system that will utilize a central pharmacy that will handle the delivery

of medicine to the patients,” (PAR1033, 1: ¶¶1-2, 5, 8-10; PAR1007, ¶108.)

Step 1.1: TAS discloses receiving prescription requests at a single central

pharmacy controlled by the Xyrem® sponsor. (PAR1033, 1: ¶¶ 8-9; PAR1007,

¶110.) TAS states: “to order Xyrem, a physician will write a prescription and fax

that to the central pharmacy. That pharmacy will process the prescription request

… and then set up a delivery time directly to [sic] the patient so that they may

receive their medicine.” (PAR1033, 1: ¶¶ 8-9.) Moreover, a POSA would have

found it obvious to modify TAS’ central pharmacy to receive prescription requests

using a computer processor into a single computer database, because it was well-


-41-

known that pharmacies could use a single computer processor and database in

order to receive and fill prescription requests, as taught by the combination of

Honigfeld and Elsayed.

Honigfeld discloses a Clozaril National Registry (CNR) system used for the

centralized and controlled distribution of the prescription drug clozapine, “[t]he

heart” of which “is an integrated, computerized confidential database that is

maintained by the manufacturer,” (PAR1034, 6:2, ¶4; 4:2, ¶4; ; PAR1007, ¶111.),

in which all prescribers, pharmacists, and patients must be registered. (PAR1034,

4:2, ¶4; PAR1007, ¶111.) Once registered, the prescribing doctor sends the

pharmacy a prescription request, along with a reporting form that contains

information identifying the patient and the prescription drug. (See PAR1034, 5:1,

¶1; Fig. 1.; PAR1007, ¶111) Thus, Honigfeld teaches using a single computer

database to receive prescriptions and distribute prescription drugs. Moreover, a

POSA would have understood that the receipt of each prescription by CNR’s

computerized database would have been accomplished via a computer processor,

because it was well-known in the art that the transmission of data (e.g. prescription

requests) to a pharmacy, as described by Honigfeld, would have been

accomplished utilizing a computer processor. (PAR1007, ¶111)

Elsayed discloses distributing hazardous, but therapeutically beneficial

prescription drugs by registering patients, prescribers, and pharmacies in a


-42-

“computer readable storage medium.” (PAR1035, 1:13-17, 3:21-23; 4:57-60, 7:28-

32; PAR1007, ¶112.) Registration takes place via on-line transmission of

prescription information—such as the doctor’s name, address, DEA number, and

hospital affiliation; the drug being prescribed; and the patient’s name, address, and

date of birth—to an authorized recipient. (PAR1035, 4:21-41, 5:23-37, and 5:40-

53; PAR1007, ¶112.) A POSA would have known that the “[s]uitable computer

readable storage media” disclosed in Elsayed included computerized databases.

(See, e.g., PAR1034, 4:2, ¶4; PAR1007, ¶112.) It would thus have been obvious to

a POSA from Elsayed that Honigfeld’s system could utilize a similar mechanism

to allow on-line transmission of prescriptions to CNR’s single computerized

database. (PAR1007, ¶¶113–114.) Such a modification would have been nothing

more than combining steps of prior art methods to yield predictable results. (Id.)

TAS, Honigfeld, and Elsayed would thus render step 1.1 obvious to a POSA.

TAS, Honigfeld, and Elsayed are all directed to the same endeavor—controlled

distribution of prescription drugs. A POSA would have had a reason to modify the

specialty distribution system disclosed in TAS to make use of the computerized

restricted distribution methods of Honigfeld and Elsayed, because it would have

allowed for the responsible distribution and the large scale, efficient centralization

and prescription of drugs—the exact goals of TAS, Honigfeld, and Elsayed.

(PAR1033, 2: ¶10; PAR1034, Abstract, 6:2,¶3-7:1,¶2; PAR1035, 1:14-17;


-43-

PAR1007, ¶114.) And a POSA could have done so with a reasonable expectation

of success; both Honigfeld and Elsayed disclose computerized methods of

restricted distribution of a drug, and benefits that result in maintaining patient

compliance and in monitoring and controlling distribution. (See, e.g., PAR1034,

5:1, ¶2; PAR1035, 2:63-65 and 10:13-21; PAR1007, ¶114.) Furthermore, a POSA

could have applied Honigfeld and Elsayed to restrict distribution of a prescription

drug, such as Xyrem®. (See, e.g., PAR1035, 7:28-32.; PAR1007, ¶114.)

Steps 1.2 and 1.3: As discussed above for limitation 1.1, the combination of

TAS, Honigfeld and Elsayed discloses the receipt of prescription requests via a

computer processor into a single computer database of a central pharmacy. TAS as

modified by Honigfeld and Elsayed also discloses steps 1.2 and 1.3. Information

used in Honigfeld’s registration process includes the physician’s name, physician’s

DEA/ID number, and the patient’s initials, Social Security number (SSN), gender,

and date of birth. (See step 1.1 and PAR1007, ¶18.) Similarly, Elsayed discloses

registering patients and doctors in a computer readable storage medium via on-line

transmission of information—including the patient’s name, address, and date of

birth—to the drug’s distributor or an otherwise authorized recipient of such

information. (PAR1035, 4:21-41, 5:23-37, and 5:40-53, PAR1007, ¶119.) Thus,

Honigfeld and Elsayed combined teach entering the information recited by steps

1.2 and 1.3 into the single computer database.


-44-

A POSA would also have understood to combine the restricted distribution

systems in Honigfeld and Elsayed with TAS’s single pharmacy for Xyrem.

(PAR1007, ¶121.) A POSA reading TAS would have had a reason to incorporate

Honigfeld and Elsayed’s teachings of registering physicians and patients into a

centralized computer database and checking that database (i.e., the claimed

information recited by limitations 1.2 and 1.3), because doing so would have

accomplished TAS’s purpose of regulating the distribution of Xyrem. (PAR1033,

1: ¶¶8-9; PAR1007, ¶¶116–117.) Moreover, Honigfeld and Elsayed also

recognized the same need as TAS—centralizing information needed to fill

prescription requests in a secure and regulated manner. (See, e.g., PAR1034, 5:1,

¶2; PAR1035, 2:63-65 and 10:13-21.) Thus, combining the teachings of TAS,

Honigfeld, and Elsayed in a manner meeting limitations 1.2 and 1.3 would have

been nothing more than combining steps of prior art methods to yield predictable

results. (PAR1007, ¶117.)

Step 1.4: Elsayed discloses that, prior to prescribing a drug, the prescriber

may counsel the patient on the drug’s various risks and benefits. (PAR1035, 6:4–

9). Elsayed also discloses that the prescriber can provide literature materials—

such as educational brochures and patient instruction videos—for a prescription

drug, and require the patient to fill out an informed consent form acknowledging

that the patient understands the risks associated with the drug and that the patient


-45-

will behave in accordance with the prescriber’s counsel. (PAR1035, 6:26–20,

7:33–45.) It would have been obvious to a POSA to use such an “informed consent

form” to confirm the patient had received and/or read educational material.

(PAR1007, ¶124).

Steps 1.5 and 1.6: As discussed above, Honigfeld discloses screening

patients through a central computer database to prevent patients from receiving the

drug if a hazardous situation is indicated. (PAR1034, 4:2, ¶3.) Additionally, the

database provides data related to non-compliance with the drug’s distribution

system, which can result in the inability of the patient to receive the drug or the

doctor to prescribe the drug. (PAR1034, 5:1, ¶2.) Elsayed also discloses using a

computer readable storage medium to monitor and authorize distribution of

potentially hazardous prescription drugs (PAR1035, 4:50-57, 5:40-53, 5:59-61, and

10:13-17.) Likewise, Elsayed teaches checking the patient’s eligibility to receive

the drug before dispensing. (PAR1035, 9:65-10:2.) The computer readable storage

medium “may serve to deny access, dispension, or prescriptions” of hazardous

prescription drugs to patients and by doctors who fail to abide by the disclosed

methods. (PAR1035, 10:17-21.) A POSA would have found it obvious that

screening and denying access to prescription drugs (as described by Honigfeld and

Elsayed) would have included checking for abuse and not mailing (as described by

TAS) the drug to the patient if abuse was indicated. (PAR1007, ¶129.)


-46-

Further, Lilly shows such techniques were well-known in the art. In Lilly,

when a pharmacist receives a new prescription request, the pharmacist, “utilizes …

pharmaceutical computer data to compare the new prescriptive medication with

respect to the medication history of the selected prescriptive medication purchaser”

and based on the medication history the pharmacist may accept or decline to fill

the prescription. (PAR1036, ¶[0039]; see also PAR1037, pp. 3:¶¶3-6 and; 8: Table

1.6) Lilly’s system helps pharmacies and government oversight entities (e.g., the

DEA) identify “potential medication abuse by identification of needless

prescription duplications … and multi-source interstate prescriptive medication

abuse.” (PAR1036, ¶[0054]; see also PAR1037, p.3:¶¶4-7.)

A POSA would have understood that TAS, Honigfeld, Elsayed, and Lilly

were combinable in a manner to result in steps 1.5 and 1.6. (PAR1007, ¶128.) TAS

discloses receiving prescription requests for Xyrem at a central pharmacy and

Honigfeld also discloses centralizing such a process to a single location.

(PAR1033, 1: ¶¶ 8-9; PAR1034, 4:2, ¶4, 6:2, ¶4, 5:1, ¶1; Fig. 1; PAR1007, ¶127.)

Honigfeld and Elsayed both recognize the need to prevent the dispensing of

6 Lilly claims priority to U.S. Ser. No. 60/332,807 (“’807 application)

(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 application’s filing date.


-47-

prescription drugs when a patient is not in compliance with established checks and

requirements. (See, e.g., PAR1034, 5:1, ¶2; PAR1035, 2:63-65 and 10:13-2;

PAR1007, ¶129.) A POSA would recognize that one of the checks TAS’

centralized pharmacy could use would be entering, maintaining and checking

information that indicates the abuse, misuse, or diversion of the prescription drug,

as disclosed by Lilly. (PAR1036, ¶¶ [0039], [0054]; see also PAR1037 pp. 3:¶¶2–

4, 6; 4:¶¶4-7,; 5:¶¶2-3 and, Fig. 1; 6:¶4; 7: Table 2, and 8: Table 1; PAR1007,

¶129.) Such checks for abuse or diversion were well-known in the industry and

modifying the combination of TAS, Honigfeld and Elsayed with the teachings of

Lilly would have been nothing more than use of known techniques to improve

similar methods in the same way. (PAR1007, ¶¶128–129.)

Step 1.7: TAS discloses that the dispensing pharmacy will call the patient to

set up a delivery time and then deliver the drug directly to the patient so that they

may receive their medicine. (PAR1033, 1). This has the effect of confirming the

patient’s receipt of the drug because it sets up a time at which the drug will be

delivered to the patient. (PAR1007, ¶131). Further, as of 2002, commercial

shippers (e.g., UPS, the U.S. Postal Service, and Federal Express) provided

tracking and delivery confirmation, such that confirming receipt of the prescription

drug would have been implicit in the step of shipping it as TAS disclosed. (Id.)


-48-

Step 1.8: Honigfeld discloses using, “a large, full-time CNR staff is charged

with reviewing data on a retrospective basis.” (PAR1034, 5; PAR1007, ¶135.) The

staff’s “primary function is to identify discrepancies, such as missing data or low

WBCs associated with continued prescriptions.” (Id.) Elsayed discloses that

registering the patient, prescriber, and pharmacy in a computer readable medium

provides a means to monitor and authorize distribution of contraindicated drugs to

patients, and that the computer readable storage media may serve to deny access,

dispension, or prescriptions of drugs to patients, pharmacies, or prescribers who

fail to abide by the distribution program. (PAR1035, 10:13–20; PAR1007, ¶136.)

Likewise, Lilly discloses methods to prevent misuse and abuse of prescription

drugs by tracking prescriptions for drugs and/or controlled substances. (PAR1036,

¶[0032]; see also PAR1037, pp. 3:¶¶3-6 and 8: Table 1; PAR1007, ¶136). One step

for doing so is that when a patient or medication purchaser requests that the

pharmacist fill a new prescription medication, a pharmacy with a pharmacist may

use computer data to compare the new prescription with respect to the medication

history of the purchaser, and that the pharmacist may accept or decline to fill the

new prescription. (PAR1036, ¶[0039]; see also PAR1037, pp. 3:¶¶3-6 and; 8:

Table 1; ; PAR1007, ¶136) Further still, Lilly discloses that “[t]he DEA may

review [prescription] data to determine areas where violations may be occurring,”

such as abuse or misuse (PAR1036, ¶[0054]; see also PAR1037, pp. 4:¶¶4-7,;


-49-

5:¶¶2-3 and, Fig. 1,; 6:¶4; 7: Table 2, and 8: Table 1; PAR1007, ¶136.) As such,

one of ordinary skill would have recognized that reports could be generated to

determine patterns of prescription misuse, abuse, or diversion. (PAR1007, ¶137.)

2. 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,

4:60–66). 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

Claims 3 and 4 depend from claim 1 and further specify “selectively

blocking shipment of the prescription drug to a patient.” (Claim 3; PAR1001, 9:6-

7) and blocking shipment of the prescription drug upon association of an abuse

pattern with a patient. (Claim 4; PAR1001, 9:8-10.) As discussed above in steps

1.5 and 1.6, Honigfeld and Elsayed disclose selectively blocking the provision of

the drug to the patient. (See also PAR1007, ¶141.) Further still, as discussed above

with regard to step 1.8, Lilly discloses selectively blocking provision of the drug to


-50-

a patient if there are indications of abuse or misuse. (PAR1036, ¶[0039]; see also

PAR1037 pp. 3:¶¶3-4, 6 and; 8: Table 1; PAR1007, ¶141.). TAS discloses that all

prescriptions for Xyrem® will be mailed from a central pharmacy. (PAR1033,

1:¶9). It thus would have been obvious to block shipment of Xyrem® selectively if

any patient abuse or misuse is detected.

4. 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

Claim 6 is an independent claim with limitations similar to those in claim 1.

The only differences are: (1) the term “medical doctors” in “any and all medical

doctors allowed to prescribe a prescription drug” in claim 1 is replaced with

“authorized prescribers.” (PAR1001, 9:19.); (2) the “exclusive computer database”

is “under exclusive control of,” instead of “associated with,” the “exclusive central

pharmacy” (Id., 9:24-25.); and (3) instead of “mailing or sending by courier the

prescription drug only if no potential abuse is found by the patient to whom the

prescription drug is prescribed,” claim 6 requires “providing the prescription drug

only provided information in the exclusive computer database is not indicative of

potential abuse” (Id., 9:42.). These do not change how the prior art—TAS in view


-51-

of Honigfeld, Elsayed, and Lilly—are applied to the claims, and each of these

limitations is disclosed in the prior art as identified above. (PAR1007, ¶144.)

“Authorized prescribers” would include “any and all medical doctors;” having an

“exclusive computer database” under “exclusive control of the central pharmacy”

is obvious for the same reasons identified in regard to claim 2, and “mailing or

sending” the prescription drug is one method of providing the drug to a patient.

Further, the cited prior art discloses checking databases for potential abuse and

selectively blocking shipment to the patient if potential abuse is found. (See steps

1.5 and 1.6, supra; see also claims 3 and 4, supra.) As such, TAS in view of

Elsayed, Honigfeld, and Lilly renders claim 6 obvious. (PAR1007, ¶144.)

6. Claim 9

The limitations of independent claim 9 are similar to those in claim 6. The

only difference is that claim 9 recites GHB as the prescription drug. TAS discloses

the distribution of Xyrem, which contains GHB. (See, e.g., PAR1003, ¶¶8, 9;

PAR1007, ¶145.)

7. Claim 12

The limitations of claim 12 are similar to the limitations of claim 9, though

instead of “providing GHB,” as recited by claim 9, claim 12 requires “mailing or

sending by courier GHB.” (PAR1001, 11:9.) TAS discloses shipping Xyrem,

which contains GHB, to patients. (See, e.g., PAR1003, 1:¶¶8, 9; PAR1007, ¶146.)


-52-

8. 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. Claims 7, 10, and 15

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 A POSA would understand “dispensed to the patient by another pharmacy”

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.)


-53-

9:52-55, 10:35-38, and 12:37-40.) As an initial matter, both Elsayed and Honigfeld

disclose that individual pharmacies may fill prescriptions for a particular drug, so

long as those pharmacies are registered with the distribution programs disclosed

therein. (PAR1034, 4; PAR1035, 4:50-66; 5:56–64; PAR1007, ¶151.) TAS

discloses that Xyrem will be available through a specialty distribution system that

will utilize a central pharmacy to handle delivery of medicine to the patients.

(PAR1033, 1: ¶8; PAR1007, ¶151.) As such, combining TAS with Elsayed and

Honigfeld allows a POSA to arrive at a method in which a central pharmacy

delivers drugs to other registered pharmacies for pick up, rendering obvious the

limitations of claims 7, 10, and 15. (PAR1007, ¶151.)

11. 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 patient’s 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


-54-

prescription to a supply of limited duration.

(PAR1001, 9:59-67, 10:41-50, 12:44-52.) As claims 8, 11, and 16 all recite that the

controls are “selected” from this group, only one control need be selected and

disclosed in the prior art for this claim to be rendered obvious. Elsayed renders the

control of “confirming with the patient that educational material has been received

and/or read” obvious for the reasons identified above with regards to step 1.4.

(PAR1007, ¶153.) Elsayed also discloses the additional control of “limiting the

prescription to a supply of limited duration,” as it discloses that “the drug is

preferably prescribed and dispensed to the patient in a limited amount, with a

prescription amount of no more than about 28 days being preferred, and preferably

with no refills being permitted.” (PAR1035, 9:29–32). Honigfeld also limits

prescription duration to no more than one week, linked to a current white blood

cell count. (See PAR1034, 5). As such, Talk About Sleep in view of Honigfeld,

Elsayed, and Lilly renders claims 8, 11, and 16 obvious. (PAR1007, ¶¶153–155.)

D. Secondary considerations do not rebut the prima facie case.

In addition to Par’s strong prima facie obviousness showing outlined above,

secondary considerations must be taken into account, although they do not

necessarily control the obviousness conclusion. See Newell Cos., Inc. v. Kenney

Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988). And in cases where a strong prima

facie obviousness showing exists, the CAFC has repeatedly held that even relevant


-55-

secondary considerations supported by substantial evidence may not amount to a

showing of non-obviousness. See, e.g., Leapfrog Enterprises Inc. v. Fisher-Price

Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007). Moreover, objective evidence must be

attributable to the claimed invention, and aside from what is unclaimed or in the

prior art. In re Kao, 639 F.3d at 1068 (“Where the offered secondary consideration

actually results from something other than what is both claimed and novel in the

claim, there is no nexus to the merits of the claimed invention”). Jazz may argue

that secondary considerations of commercial success, long-felt but unmet need,

failure of others, copying, and unexpected superior results exist.

Jazz, by its Orange Book listing of the ’059 patent, contends that Xyrem®

must be distributed in conjunction with Xyrem®’s risk management program

claimed therein. However, Jazz cannot show that any alleged commercial success

was not due to an element in the prior art or the pharmaceutical effect of the active

ingredient. Additionally, Orphan itself indicated that the claimed risk management

program, which is disclosed in the Advisory Committee Art, would not contribute

to commercial sales because it would “eliminate[] the opportunity to ‘fill the retail

distribution pipeline.’” (PAR1005, pg. 309; PAR1007, ¶160.) Moreover,

commercial success is weak evidence in the context of products that require

regulatory approval, such as drugs. Merck & Co., Inc. v. Teva Pharms. USA, Inc.,

395 F.3d 1364, 1377 (Fed. Cir. 2005) (finding that commercial success of a drug


-56-

subject to FDA approval was weak because regulatory barriers prevented other

companies from competing).

Jazz may also argue that a long-felt but unmet need is fulfilled because

Xyrem® would not have been approved by the FDA but for the Xyrem® risk

management program. However, there was no persistent, unmet need in the art for

a controlled distribution system. (PAR1007, ¶162.) Indeed, there were already in

place various risk management programs for the controlled distribution of

hazardous prescription drugs by December of 2002, as evidenced by the

Accutane®, Clozaril®, and prescription thalidomide distribution programs that

restricted distribution to only registered pharmacies, doctors, and patients.

Even if there had been a need in the art for an improved distribution program

for prescription drugs subject to abuse and diversion, there is no evidence to

suggest that the distribution programs already in the prior art could not have

satisfied that need. (PAR1007, ¶163.) Lastly, there were no inadequacies in the

technical knowledge that prevented the development of the claimed distribution

program. (Id.) All of the limitations of the claims of the ’059 patent were in the

prior art and did not require advances in technical knowledge to put them in place

to arrive at the claimed program. Instead, the FDA required the development of the

claimed distribution program as part of the approval process for Xyrem®. Friskit,

Inc. v. Real Networks, Inc., 2009 WL 59182, *6 (Fed. Cir. 2009) (nonprecedential)


-57-

(long-felt need should be a need created by inadequacies in the technical

knowledge, not one due to business-driven market forces) (PAR1007, ¶164.)

Orphan admitted during prosecution of the parent to the ’059 patent that:

[T]he Applicant and the Food and Drug Administration (FDA) were

involved in relating to a new indication for the drug gamma hydroxyl

butyrate (GHB), and how the patent application [for the ’730 patent]

was borne out of this FDA approval process.”

(PAR1016, Amendment & Response, filed Nov. 2, 2009, pg. 9.) Similarly, Jazz

cannot point to failure of others to arrive at the claimed distribution methods. As

noted above, efficacious distribution programs for hazardous, but therapeutically

beneficial, prescription drugs were known in the art prior to December of 2002.

(Id., ¶165.) These distribution programs were successful in preventing the harms

associated with prescribing these drugs to patients. (Id.) Thus, Jazz cannot

successfully allege previous failures or long-felt but unresolved need weigh in

favor of the non-obviousness of the claims of the ’059 patent. (Id.)

Jazz cannot also argue that the development of distribution programs for

generic sodium oxybate by Par or other generic pharmaceutical companies

constitutes copying. Evidence of copying simply is not probative of non-

obviousness in the generic drug context. See Bayer Healthcare Pharms. v. Watson

Pharms., Inc., 713 F.3d 1369, 1377 (Fed. Cir. 2013).

Finally, Jazz may allege that the inventions claimed in the ’059 patent


-58-

achieve unexpected results by enabling the beneficial treatment of narcolepsy

with Xyrem®. As an initial matter, any beneficial results of Xyrem® are likely a

result of the treatment of narcoleptic patients with GHB, and not the claimed

distribution program. (PAR1007, ¶167.) And, the use of GHB to treat narcolepsy

was well-known in the art by December of 2002. (Id.) Moreover, the claimed

distribution program does not have a significant and practical advantage over the

closest prior art that discloses all of the limitations of the claimed distribution

program. In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (unexpectedly

superior results must establish that the alleged invention in the challenged claims

achieved unexpectedly superior results with respect to the results of the closest

prior art). As such, Jazz’s arguments of unexpected results fail. (PAR1007, ¶167.)

VII. IT IS MORE LIKELY THAN NOT THAT PETITIONER WILL PREVAIL WITH RESPECT TO AT LEAST ONE OF THE CHALLENGED CLAIMS

This petition, supported by the Valuck Dec. (PAR1007), amply

demonstrates that it is more likely than not that Par will prevail with respect to at

least one challenged claim.

VIII. MANDATORY NOTICES (37 C.F.R. § 42.8(a)(1))

The Real Party-In-Interest (37 C.F.R. § 42.8(b)(1)) is: Par

Pharmaceutical, Inc., (“Par”). Notice of Related Matters (37 C.F.R. §

42.8(b)(2)): Jazz has asserted the ’059 patent in two related litigations: Jazz


-59-

Pharms, Inc. v. Par Pharm., Inc., 2:13-cv-07884 (D.N.J. Dec. 27, 2013)

(consolidated with Jazz Pharms., Inc. v. Amneal Pharms., LLC, 2:13-cv-00391

(D.N.J.); and Jazz Pharms, Inc. v. Roxane Laboratories, Inc., 2:10-cv-06108

(consolidated) (D.N.J. Nov. 22, 2010). The ’059 patent is also the subject of a

Covered Business Method Patent Review Petition: Par Pharmaceutical, Inc. et al.

v. Jazz Pharms., Inc., CBM2014-00149 (filed June 24, 2014). Five related patents,

U.S. Patent 8,475,988, 7,668,730, 8,589,182, 7,765,106 and 7,765,107 are the

subject of the following respective Covered Business Method Patent Petitions:

Amneal Pharms, LLC et al. v. Jazz Pharms., Inc., CBM2014-00150 (filed July 7,

2014); Par Pharm. Inc. et al. v. Jazz Pharms, Inc., CBM2014-00151 (filed July 9,

2014) and CBM2014-00153 (filed July 9, 2014); Par Pharm. Inc. et al. v. Jazz

Pharms, Inc., CBM2014-00161 (filed August 4, 2014); and Par Pharm. Inc. et al.

v. Jazz Pharms, Inc., CBM2014-00175 (filed August 18, 2014).

Designation of Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3)):

Lead Counsel Back-Up Counsel

Aziz Burgy (Reg. #51,514) ARENT FOX LLP 1717 K Street NW Washington, DC 20036-5342 202.857.6378 (telephone) 202.857.6395 (facsimile) [email protected]

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) [email protected]

Notice of Service Information (37 C.F.R. § 42.8(b)(4)): Please direct all

correspondence to counsel at the above address. Par consents to email service at:


-60-

[email protected].

IX. 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

Date: January 8, 2015 ARENT FOX LLP 1717 K Street, NW Washington, DC 20006 202.857.6000

IPR Petition of U.S. Patent No. 7,895,059 Certificate of Service

CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))

The undersigned hereby certifies that the above-captioned “Petition for Inter

Partes Review of U.S. Patent No. 7,895,059 Under 35 U.S.C. § 311–319 and 37

C.F.R. § 42.1–.80, 42.100–.123” including its supporting evidence (EXHIBITS

1001-1039), was served in its entirety on January 8, 2015, upon the following

parties via Express Mail:

Schwegman Lundberg & Woessner/Jazz Pharmaceutical P.O. Box 2938 Minneapolis MN 55402 Patent owner’s correspondence address of record for U.S. Patent No. 7,895,059

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

Additional addresses known to Petitioner as likely to effect service

IPR Petition of U.S. Patent No. 7,895,059 Certificate of Service

Respectfully Submitted,

Aziz Burgy Registration No. 51,514 Attorney for Petitioner

Date: January 8, 2015 ARENT FOX LLP 1717 K Street, NW Washington, DC 20006 202.857.6000