United States Court of Appeals 

for the Federal Circuit ______________________ 

JAZZ PHARMACEUTICALS, INC.,

Appellant

v.

AMNEAL PHARMACEUTICALS, LLC,

Appellee

______________________ 

2017-1671, 2017-1673, 2017-1674, 2017-1675, 2017-1676, 

2017-1677, 2017-2075

______________________ 

Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. 

IPR2015-00545, IPR2015-00546, IPR2015-00547, 

IPR2015-00548, IPR2015-00551, IPR2015-00554, 

IPR2015-01903.

______________________ 

Decided: July 13, 2018 

______________________ 

 KATHLEEN M. SULLIVAN, Quinn Emanuel Urquhart & 

Sullivan, LLP, New York, NY, argued for appellant. Also 

represented by F. DOMINIC CERRITO, GABRIEL P. BRIER,

FRANK CHARLES CALVOSA, EVANGELINE SHIH, ERIC C.

STOPS; DAVID B. COCHRAN, Jones Day, Cleveland, OH.

 STEVEN ARTHUR MADDOX, Maddox Edwards, PLLC, 

Washington, DC, argued for appellee Also represented by 

MATTHEW C. RUEDY. 
2 JAZZ PHARM., INC. v. AMNEAL PHARM., LLC

______________________ 

Before NEWMAN, LOURIE, and REYNA, Circuit Judges.

LOURIE, Circuit Judge. 

Jazz Pharmaceuticals, Inc. (“Jazz”) appeals from six

inter partes review (“IPR”) decisions of the United States 

Patent and Trademark Office Patent Trial and Appeal 

Board (the “Board”).1 Collectively, the decisions held 

certain claims of Jazz’s U.S. Patents 7,668,730 (“’730 

patent”), 7,765,106, 7,765,107, 7,895,059, 8,589,182, 

8,457,988 (“’988 patent”), and 8,731,963 (“’963 patent”)

(together, the “patents in suit”) invalid as obvious. Because the Board did not err in its conclusions of obviousness, we affirm. 

BACKGROUND

The patents in suit are members of a family of patents 

owned by Jazz relating to a drug distribution system for 

tracking prescriptions of a “sensitive drug.” ’730 patent 

 

1 Amneal Pharm., LLC v. Jazz Pharm., Inc., No. 

IPR2015-01903, 2017 WL 1096638 (P.T.A.B. Mar. 22, 

2017) (“’963 Decision”); Amneal Pharm., LLC v. Jazz 

Pharm., Inc., No. IPR2015-00545, 2016 WL 7985452

(P.T.A.B. Dec. 22, 2016); Par Pharm., Inc. v. Jazz Pharm., 

Inc., No. IPR2015-00546, 2016 WL 7985429 (P.T.A.B. Dec. 

22, 2016); Par Pharm., Inc. v. Jazz Pharm., Inc., No. 

IPR2015-00547, 2016 WL 7985454 (P.T.A.B. Dec. 22, 

2016); Par Pharm., Inc. v. Jazz Pharm., Inc., No. 

IPR2015-00548, 2016 WL 7985430 (P.T.A.B. Dec. 22, 

2016); Par Pharm., Inc. v. Jazz Pharm., Inc., Nos. 

IPR2015-00551, IPR2015-00554, 2016 WL 7985458

(P.T.A.B. July 27, 2016) (“’730/’988 Decision”). 
JAZZ PHARM., INC. v. AMNEAL PHARM., LLC 3

Abstract.2 “A sensitive drug is one which can be abused, 

or has addiction properties or other properties that render 

the drug sensitive.” ’730 patent col. 3 ll. 14–16. 

One such sensitive drug is Xyrem®. Jazz exclusively

markets Xyrem®, which the U.S. Food and Drug Administration (“FDA”) has approved to treat symptoms associated with narcolepsy. However, the active ingredient in 

Xyrem®, gamma-hydroxybutyrate (“GHB”), may also be 

illicitly used as a “date-rape drug.” See Hillory J. Farias 

and Samantha Reid Date-Rape Drug Prohibition Act of 

2000, Pub. L. No. 106-172, 114 Stat. 7 (2000). Accordingly, under the Controlled Substances Act any approved

drug product containing GHB is classified as a Schedule 

III depressant. 21 C.F.R. § 1308.13. Because of its potential for abuse, the FDA approved Xyrem® under “restricted distribution regulations contained in [21 C.F.R. 

§ 314.500] (Subpart H) to assure safe use of the product.” 

J.A. 11055; see 21 C.F.R. § 314.520. 

During the regulatory review process for Xyrem®, the 

FDA scheduled an advisory committee meeting for June 

6, 2001. The meeting was announced in a May 14, 2001 

Federal Register Notice, which stated that the meeting 

was open to the public and that “[a] main focus of the 

deliberations will be on risk management issues” associated with Xyrem®. Meeting Notice, 66 Fed. Reg. 24,391

(May 14, 2001) (“Notice”). The Notice also provided a 

hyperlink to an FDA website where background material 

would be posted before the meeting, and the meeting 

minutes, transcript, and slides would be posted after the 

meeting. Id. Collectively, the Board referred to the

background materials and the meeting minutes, transcript, and slides on the FDA website as the Advisory 

 

2 As the patents in suit share a substantially identical specification, for ease of reference we cite only the 

’730 patent.
4 JAZZ PHARM., INC. v. AMNEAL PHARM., LLC

Committee Art (“ACA materials”). Each of the Board’s 

obviousness determinations relied on the ACA materials 

as prior art. The primary issue on appeal is whether the 

ACA materials were sufficiently accessible to the public to 

constitute prior art. 

I 

The claimed invention of the patents in suit involves 

tracking prescriptions of a sensitive drug through a 

database. ’730 patent Abstract. Claim 1 of the ’730 

patent is illustrative, and recites:

1. A computerized method of distributing a prescription drug under exclusive control of an exclusive central pharmacy, the method comprising:

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; 

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;

checking with the computer processor the credentials of the any and all doctors to determine the 

eligibility of the doctors to prescribe the prescription drug;
JAZZ PHARM., INC. v. AMNEAL PHARM., LLC 5

confirming with a patient that educational material has been read prior to shipping the prescription drug;

checking the exclusive computer database for potential abuse of the prescription drug;

mailing 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;

confirming receipt by the patient of the prescription drug; and

generating with the computer processor periodic 

reports via the exclusive computer database to 

evaluate potential diversion patterns. 

Id. col. 8 l. 37–col. 9 l. 3 (emphases added).

Of particular relevance to this appeal are the “exclusive computer database,” “information identifying,” and 

“periodic reports” terms, italicized above. The specification describes an “exclusive central database” as including

all data relevant to distribution of a sensitive drug, “including patient, physician and prescription information.” 

Id. col. 2 ll. 10–12. Several types of such information are 

listed in the description of figure 2. “The prescriber 

information contains standard contact information as well 

as license number, DEA number and physician specialty. 

Patient and prescription information includes name, 

social security number, date of birth, gender, contact 

information, drug identification, patient’s appropriate 

dosage, and number of refills allowed . . . .” Id. col. 4 ll. 

18–23. 

Reports may be run against information in the database to “reveal potential abuse of the sensitive drug, such 

as early refills.” Id. col. 2 ll. 14–15. An early refill report

is made when a specific event occurs: a patient requests a 
6 JAZZ PHARM., INC. v. AMNEAL PHARM., LLC

prescription refill prior to the scheduled refill date. Id. 

col. 6 ll. 36–42. If the physician does not approve the 

early refill, the patient must wait until the next scheduled 

refill date. Id. col. 6 ll. 43–44. Other types of reports are 

created at set time points, for example, at “a predetermined number of days or product remaining.” Id. col. 6 ll. 

12–13. Likewise, the specification discusses “sample 

reports” that have “an associated frequency or frequencies.” Id. col. 8 ll. 22–29. While claim 1 refers to “periodic 

reports,” that specific term does not appear elsewhere in 

the written description.

II

Amneal Pharmaceuticals, LLC (“Amneal”) petitioned 

for IPR of the seven patents in suit.3 The Board instituted review of all petitioned claims for each patent except 

for the ’963 patent, where the Board partially instituted 

review of a subset of the petitioned claims, see Amneal 

Pharm., LLC v. Jazz Pharm., Inc., IPR2015-01903, slip 

op. at 2 (P.T.A.B. Mar. 25, 2016), Paper No. 10. Also, in 

several of its institution decisions, the Board instituted 

review on fewer than all grounds raised in the petition. 

E.g., Amneal Pharm., LLC v. Jazz Pharm., Inc., IPR2015-

00551, IPR2015-00554, slip op. at 42 (P.T.A.B. July 28, 

2015), Paper No. 20. 

 

3 Amneal filed several of its petitions for IPR jointly 

with Par Pharmaceutical, Inc. (“Par”). Jazz and Par 

reached a settlement during the pendency of this appeal, 

and accordingly Par is no longer a party. See Jazz 

Pharm., Inc. v. Amneal Pharm., LLC, No. 17-1671 (Fed. 

Cir. Jan. 19, 2018), ECF No. 51. In discussing the proceedings before the Board, we refer to the petitioners 

collectively as “Amneal.” 
JAZZ PHARM., INC. v. AMNEAL PHARM., LLC 7

The Board issued six final written decisions regarding 

the patents in suit.4 The parties’ current dispute centers 

on the Board’s determination that the ACA materials 

were publicly accessible. The ACA materials consist of 

four documents associated with the public meeting held 

by the Xyrem® advisory committee: (1) the FDA advisory 

committee meeting transcript and slides; (2) an FDA 

preliminary clinical safety review of Xyrem®; (3) a Xyrem® 

briefing booklet; and (4) a video and transcript regarding 

a proposed distribution system for Xyrem®. ’730/’988 

Decision, 2016 WL 7985458, at *2; Appellant Br. 9. The 

Board determined that the ACA materials were publicly 

accessible on an FDA website listed in the Notice no later 

than October 4, 2001, over two months prior to the critical 

date of December 17, 2001. ’730/’988 Decision, 2016 WL 

7985458, at *11, *14.

Next, the Board turned to whether a person of ordinary skill exercising reasonable diligence would have 

been able to locate the ACA materials. Id. at *14–16. It

found that a person of ordinary skill in the art was a 

pharmacist or computer scientist having familiarity with 

computerized drug distribution procedures. Id. at *4–5. 

Furthermore, the Board agreed with Amneal that a 

person of ordinary skill “would have been familiar with 

the Federal Register and motivated to look for notices

related to drug distribution, safety, or abuse prevention,”

and that a skilled artisan would have known that Xyrem® 

contained an active ingredient susceptible to abuse. Id.; 

see also id. at *15. According to the Board, this provided a 

person of ordinary skill with “sufficient motivation to 

have located the Federal Register Notice and FDA web-

 

4 For simplicity, unless otherwise noted we cite only 

the Board’s final written decision concerning the ’730 and 

’988 patents, which is representative of the other decisions on appeal. See Appellant Br. 9 n.5.
8 JAZZ PHARM., INC. v. AMNEAL PHARM., LLC

site for Xyrem.” Id. at *15. Given that motivation, the 

Board found that a person of ordinary skill would have 

been capable of locating the Notice, as the Notice expressly stated that a “main focus of the deliberations will be on 

risk management issues” related to Xyrem®, and the basic 

purpose of the Federal Register is to provide “notice to 

interested individuals of the actions of federal agencies.” 

Id. (internal quotation marks omitted). 

The parties also dispute two of the Board’s claim constructions and its obviousness analysis. First, the Board 

construed “periodic reports” to “refer to reports that are 

generated at regular intervals or intermittently,” id. at 

*8, rejecting Jazz’s argument that the term only included 

reports generated at regular frequencies, id. at *7. Second, the Board construed “information identifying patients” as “information identifying a patient,” and not 

limited to the information listed in the specification or 

requiring all listed types of information. Id. at *8. Similarly, the Board construed “information identifying . . . 

various credentials of the any and all medical doctors” as 

“information identifying various credentials, i.e., at least 

two different types of credentials, of the prescribing 

doctor,” and not limited to the information listed in the 

specification or requiring all listed types of information. 

Id. at *9. 

Applying the above constructions, the Board held all 

instituted claims of the patents in suit unpatentable as 

obvious over the ACA materials alone or in combination 

with Robert R. Korfhage, Information Storage and Retrieval (1997) (“Korfhage”). The Board found that a 

person of ordinary skill would have been motivated to 

combine the ACA materials, id. at *16, and that the ACA 

materials collectively taught or suggested all limitations 

of the claims, e.g., id. at *22, except for claims 2 and 10 of 

the ’988 patent and claims 24, 26, and 27 of the ’963 

patent. The Board held those latter five claims obvious 
JAZZ PHARM., INC. v. AMNEAL PHARM., LLC 9

over the ACA materials and Korfhage. Id. at *25; ’963 

Decision, 2017 WL 1096638, at *12, *14. 

Claims 2 and 10 of the ’988 patent depend from independent claims 1 and 9, respectively, and recite an exclusive central database “distributed over multiple 

computers, and wherein a query operates over all data in 

all the distributed databases relating to the prescriptions, 

the doctors, and the narcoleptic patients.” ’988 patent col. 

9 ll. 14–16. The Board found that Korfhage disclosed a 

database that can be distributed over multiple computers 

for cost and efficiency reasons, and that a person of ordinary skill “would have been motivated to modify the 

[ACA] distribution system to include multiple computers 

in a distributed database system for reasons of cost, 

efficiency, and the anticipated volume of prescriptionrelated information to be received, entered, and queried.” 

’730/’988 Decision, 2016 WL 7985458, at *24. The Board 

credited Amneal’s expert’s testimony that distributed 

systems “were well-known in the art and that information 

systems were being driven toward distributed databases.” 

Id. Accordingly, the Board held claims 2 and 10 unpatentable as obvious because implementing a database 

system on multiple computers “would have been a predictable use of a known distributed data system according 

to its established function.” Id. at *25 (citing KSR Int’l 

Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007)). 

The Board conducted a similar obviousness analysis 

with respect to claims 24, 26, and 27 of the ’963 patent. 

These claims also recite a “central computer database 

being distributed over multiple computers.” ’963 patent

col. 11 ll. 19–20; id. col. 12 ll. 23–24. Again, the Board 

found that a person of ordinary skill “would have been 

motivated to distribute the ACA’s single, centralized 

computer database over multiple computers, for reasons 

of cost, efficiency, and the anticipated volume of prescription-related information to be received, entered, and 

queried.” ’963 Decision, 2017 WL 1096638, at *9. The 
10 JAZZ PHARM., INC. v. AMNEAL PHARM., LLC

Board later noted that the ACA materials disclose “a 

single, centralized database for controlling distribution of 

Xyrem.” Id. at *12. It did so in the context of rejecting 

Jazz’s argument that Korfhage emphasized systems 

having multiple databases. Crediting Amneal’s expert, 

the Board explained that Korfhage also disclosed single 

database systems, consistent with the ACA system. Id. 

As with the other instituted claims of the patents in suit, 

the Board held claims 24, 26, and 27 unpatentable as 

obvious. Id. at *12, *14.

Jazz appealed, challenging the Board’s holding that 

the ACA materials are prior art and its claim constructions and obviousness analysis. We consider each issue in 

turn. 

DISCUSSION

I. Jurisdiction

We must first address whether we have jurisdiction 

over the entirety of Jazz’s appeal. The Supreme Court 

recently decided that 35 U.S.C. § 318(a) prohibits the 

Board from instituting IPR of fewer than all claims challenged in a petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 

1348, 1353 (2018) (“The agency cannot curate the claims 

at issue but must decide them all.”). However, following 

its pre-SAS regulation, see 37 C.F.R. § 42.108(a), the 

Board here did partially institute IPR. For the ’963 

patent, the Board instituted review of fewer than all 

claims challenged in the petition. And for several of the 

other patents, the Board did not institute review of each 

ground asserted in the petition. See PGS Geophysical AS 

v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (“Equal 

treatment of claims and grounds for institution purposes

has pervasive support in SAS.”). Nonetheless, on appeal 

neither party has requested a remand for the Board to 

consider non-instituted claims or grounds, or any other 

SAS-based relief.
JAZZ PHARM., INC. v. AMNEAL PHARM., LLC 11

We recently addressed a similar scenario in PGS. In 

PGS, the Board had instituted IPR of only some of the 

claims and grounds raised by the petitioner. Id. at 1358. 

But neither party on appeal “ask[ed] for any SAS-based 

action.” Id. at 1359. Despite the Board’s partial institution, we held that: (1) “the combination of the noninstitution decisions and the final written decisions on the 

instituted claims and grounds ‘terminated the IPR proceeding[s]’” so as to satisfy the finality requirement that 

this court has read to be incorporated in 28 U.S.C. 

§ 1295(a)(4)(A), id. at 1361 (alteration in original) (quoting Arthrex, Inc. v. Smith & Nephew, Inc., 880 F.3d 1345, 

1348 (Fed. Cir. 2018)); and (2) any error committed by the 

Board under the Administrative Procedure Act in partially instituting IPR was waivable, so we could decide the 

appeal from the Board’s final written decision absent a 

request by a party for SAS-based relief, id. at 1362–63. 

Confronted with indistinguishable partially instituted 

IPRs and a lack of any request by either party for SASbased action, we conclude that PGS controls this case. 

Under PGS, we have jurisdiction over Jazz’s appeal under 

28 U.S.C. § 1295(a)(4)(A) and are not obliged to reopen 

non-instituted claims or grounds. Id. at 1362. And we 

likewise see no reason to exercise any discretion to remand the non-instituted claims or grounds sua sponte. 

See id. at 1362–63. 

II. Public Accessibility of the ACA Materials

Having concluded that we have jurisdiction over 

Jazz’s appeal, we turn to the merits. We review the 

Board’s legal determinations de novo, In re Elsner, 381 

F.3d 1125, 1127 (Fed. Cir. 2004), but we review the 

Board’s factual findings underlying those determinations 

for substantial evidence, In re Gartside, 203 F.3d 1305, 

1316 (Fed. Cir. 2000). A finding is supported by substantial evidence if a reasonable mind might accept the evi-
12 JAZZ PHARM., INC. v. AMNEAL PHARM., LLC

dence as adequate to support the finding. Consol. Edison 

Co. v. NLRB, 305 U.S. 197, 229 (1938).

Jazz principally argues on appeal that the ACA materials are not prior art, so all of the Board’s decisions 

relying on the ACA materials should be reversed. According to Jazz, the Board erred in concluding otherwise “by 

equating the constructive notice provided by the Federal 

Register with the law governing public accessibility of 

prior art.” Appellant Br. 17. Emphasizing the substantial length of the annual Federal Register, Jazz asserts 

that the Board failed to make the requisite finding that a 

person of ordinary skill exercising reasonable diligence 

could have located the ACA materials. Id. Nor could the 

Board have made such a finding, Jazz contends, as under 

the facts of this case “searchability or indexing [is] required to conclude that the ACA [m]aterials are prior art,” 

Reply Br. 10, and Amneal failed to submit any evidence of 

searchability or indexing. 

Amneal responds that the ACA materials were widely 

disseminated, and that substantial evidence supports the 

Board’s finding that a person of ordinary skill would have 

been motivated to find the ACA materials. Amneal 

further argues that neither indexing nor searchability is 

required under relevant case law. 

This court and its predecessor have interpreted the 

“printed publication” provision of 35 U.S.C. § 102(b)

(2006)5 in light of its purpose “to prevent withdrawal by 

an inventor . . . of that which was already in the possession of the public.” Medtronic, Inc. v. Barry, 891 F.3d 

 

5 Because the applications for each of the patents in 

suit were filed before March 16, 2013, the pre-LeahySmith America Invents Act version of § 102 applies. See

Pub L. No. 112-29, 125 Stat. 284 (2011); 35 U.S.C. § 102 

(2006).
JAZZ PHARM., INC. v. AMNEAL PHARM., LLC 13

1368, 1380 (Fed. Cir. 2018) (alteration in original) (quoting In re Wyer, 655 F.2d 221, 226 (CCPA 1981)). “Because 

there are many ways in which a reference may be disseminated to the interested public, ‘public accessibility’ has 

been called the touchstone in determining whether a 

reference constitutes a ‘printed publication’ . . . .” In re 

Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986). A reference 

is considered 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.” Wyer, 

665 F.2d at 226. “If accessibility is proved, there is no 

requirement to show that particular members of the 

public actually received the information.” Constant v. 

Advanced Micro-Devices, Inc., 848 F.2d 1560, 1569 (Fed. 

Cir. 1988).

Whether a reference qualifies as a “printed publication” under § 102(b) is a legal conclusion based on underlying factual findings. E.g., Suffolk Techs., LLC v. AOL 

Inc., 752 F.3d 1358, 1364 (Fed. Cir. 2014). As relevant to 

this issue, Jazz appeals only from the Board’s underlying 

determination that the ACA materials were publicly 

accessible. Public accessibility is a question of fact that 

we review for substantial evidence. In re NTP, Inc., 654 

F.3d 1279, 1296 (Fed. Cir. 2011). As the IPR petitioner, 

Amneal had the burden to prove that a particular reference is a printed publication. Medtronic, 891 F.3d at 

1380. 

We agree with Amneal that substantial evidence supports the Board’s finding that the ACA materials were 

publicly accessible. At the outset, we note that whether a 

reference is a “printed publication” is a “case-by-case 

inquiry into the facts and circumstances surrounding the 

reference’s disclosure to members of the public.” In re 

Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). We 

thus review the pertinent facts here. 
14 JAZZ PHARM., INC. v. AMNEAL PHARM., LLC

On May 14, 2001, the FDA announced a meeting of 

the Peripheral and Central Nervous System Drugs Advisory Committee through the Notice in the Federal Register. Notice, 66 Fed. Reg. 24,391 (May 14, 2001). The 

Notice stated that the meeting would be about “the safety 

and efficacy of . . . Xyrem,” and that “[a] main focus of the 

deliberations will be on risk management issues.” Id. 

The meeting would be “open to the public,” and permit

interested persons to “present data, information, or views, 

orally or in writing, on issues pending before the committee.” Id. 

The Notice also included a hyperlink to an FDA website where background material from the drug sponsor 

and the FDA would be posted before the meeting, and the 

meeting minutes, transcript, and slides would be posted 

after the meeting. Id. Furthermore, the Notice provided 

specific instructions on how to access the meeting materials on the FDA website: “Click on the year 2001 and 

scroll down to the Peripheral and Central Nervous Systems Drugs meetings.” Id. Consistent with the guidance 

provided in the Notice, the Board found that the ACA 

materials were accessible on the hyperlinked public FDA 

website no later than October 4, 2001, over two months 

prior to the critical date of the patents in suit. ’730/’988 

Decision, 2016 WL 7985458, at *9, *11, *14. Jazz does not 

challenge that finding on appeal. 

This is not the first time we have considered whether 

materials disclosed in association with meetings or conferences were “printed publications.” In Massachusetts 

Institute of Technology v. AB Fortia (“MIT”), the reference 

at issue was a paper orally presented at a scientific conference attended by between 50 and 500 cell culturists. 

774 F.2d 1104, 1108 (Fed. Cir. 1985). A copy of the paper 

was given to the head of the conference and to no more 

than six other persons, without restrictions, who requested the paper. Id. at 1108–09. We held that the paper was 

prior art because “between 50 and 500 persons interested 
JAZZ PHARM., INC. v. AMNEAL PHARM., LLC 15

and of ordinary skill in the subject matter were actually 

told of the existence of the paper and informed of its 

contents by the oral presentation, and the document itself 

was actually disseminated without restriction to at least 

six persons.” Id. at 1109. 

Similarly, in Klopfenstein, several researchers presented slides at two scientific meetings for a total of 

approximately three days. 380 F.3d at 1347, 1350. At the 

meetings “[t]he reference was shown to a wide variety of 

viewers, a large subsection of whom possessed ordinary 

skill in the art.” Id. at 1350. As in MIT, the slides were 

presented “with no stated expectation that the information would not be copied or reproduced by those viewing it.” Id. After considering multiple factors, including 

the length of the display, the expertise of the intended 

audience, whether the presenters had a reasonable expectation that the materials would not be copied, and the 

ease or simplicity of copying the materials, we held that 

the slide presentation was sufficiently publicly accessible 

to count as a printed publication. Id. at 1350–52. We so 

held even though the slides were never distributed to the 

public and never indexed. Id. at 1350. 

In Cordis Corp. v. Boston Scientific Corp., a medical 

resident presented a scientific monograph to several 

physicians and other colleagues, and gave copies of the 

paper to approximately six of his teachers. 561 F.3d 1319, 

1333 (Fed. Cir. 2009). Unlike in MIT and Klopfenstein, 

“[t]he record . . . contain[ed] clear evidence that . . . academic norms gave rise to an expectation that disclosures 

will remain confidential.” Id. at 1334. Accordingly, in the 

context of a “distribution to a limited number of entities,” 

we held that the resident’s distribution of his monograph 

to academic and research colleagues did not make the 

monograph a prior art printed publication. Id. 

Most recently, in Medtronic we considered whether 

distribution of a video and slides at several scientific 
16 JAZZ PHARM., INC. v. AMNEAL PHARM., LLC

meetings on spinal surgery were prior art printed publications. Medtronic, 891 F.3d at 1379. A CD containing the 

video was distributed at three meetings, and the slides at 

two of those meetings. Id. As in Klopfenstein, there was 

no evidence that either the video or the slides were stored 

for public access after the meetings. Id. at 1381. The first 

meeting was limited to members of a certain professional 

organization, but the second and third meetings were

open to other surgeons. Id. at 1379. Roughly 20 and 55 

surgeons attended the second and third meetings, respectively. Id. The Board had held that the video and slides 

were not prior art, but neither distinguished the limited

from the open meetings, nor addressed whether the video 

and slides were distributed with a reasonable expectation 

that they would remain confidential. Id. at 1382. As “the 

size and nature of the meetings[,] . . . whether they are 

open to people interested in the subject matter[,]” and 

“whether there is an expectation of confidentiality between the distributor and the recipients of the materials” 

are important factors in assessing public accessibility, we 

vacated the Board’s finding that the video and slides were 

not prior art and remanded for further considerations. Id. 

at 1382–83. 

Comparing the facts of this case to those in MIT, 

Klopfenstein, and Medtronic confirms that the ACA materials were disseminated more broadly and for a longer 

duration to persons of ordinary skill than the materials 

disclosed at individual meetings in those cases. In addition, unlike in Cordis, disclosure through public domain 

sources such as the Federal Register and a public federal 

agency website plainly indicates that there was no reasonable expectation that the ACA materials would remain 

confidential. As we explain below, each of these factors 

supports the Board’s finding that the ACA materials were 

publicly accessible printed publications. 

First, the breadth of the dissemination here to persons of ordinary skill is significant. “[A] printed publica-
JAZZ PHARM., INC. v. AMNEAL PHARM., LLC 17

tion need not be easily searchable after publication if it 

was sufficiently disseminated at the time of its publication.” Suffolk, 752 F.3d at 1365. Unlike meetings of at 

most several hundred persons as in the cases above,6 the 

Notice in the Federal Register widely disseminated the 

ACA materials through a hyperlink to a public FDA 

website where the ACA materials could be accessed. The 

Notice explained what materials were located on the FDA 

website, approximately when they would be available, 

and how to navigate to them. 

Whether the disseminated material is addressed to or 

of interest to persons of ordinary skill is also relevant to

the public accessibility inquiry. See, e.g., Klopfenstein, 

380 F.3d at 1351 (considering whether the reference “goes 

direct to those whose interests make them likely to observe and remember whatever it may contain that is new 

and useful”) (internal quotation marks omitted)). The 

Board found, unchallenged on appeal, that a person of 

ordinary skill “would have been familiar with the Federal 

Register and motivated to look for notices related to drug 

distribution, safety, or abuse prevention.” ’730/’988 

Decision, 2016 WL 7985458, at *4–5; see also id. at *15. 

In making that finding, the Board credited Amneal’s 

expert, id. at *5, *15, and found that Jazz’s expert’s 

testimony was not to the contrary under the proper 

standard for a person of ordinary skill in the art, id. at 

 

6 The record in this case lacks any details regarding 

the FDA meeting itself—who attended and whether they 

were persons of ordinary skill, how long the meeting 

lasted, and whether copies of the ACA materials were 

distributed. Consequently, the Board did not address 

whether any potential distribution of the ACA materials 

at the meeting alone satisfied the “public accessibility” 

standard, and we do not address that possibility here in 

the first instance.
18 JAZZ PHARM., INC. v. AMNEAL PHARM., LLC

*15. As relevant here, wide dissemination of a reference 

through a publication like the Federal Register that those 

of ordinary skill would be motivated to examine is a factor 

strongly favoring public accessibility. See Suffolk, 752 

F.3d at 1365; Cordis, 561 F.3d at 1333 (distinguishing 

case from situations involving “widespread distribution so 

that the public could easily obtain copies of the publication”); see also Klopfenstein, 380 F.3d at 1348 (“[A] public 

billboard targeted to those of ordinary skill in the art that 

describes all of the limitations of an invention and that is 

on display for the public for months may be neither ‘distributed’ nor ‘indexed’—but it most surely is ‘sufficiently 

accessible to the public interested in the art’ and therefore 

. . . a ‘printed publication.’”). 

Second, the ACA materials were available online for a 

substantial time before the critical date of the patents in 

suit. “[T]he longer a reference is displayed, the more 

likely it is to be considered a ‘printed publication.’” 

Klopfenstein, 380 F.3d at 1351. In Klopfenstein, three 

days of slide presentations between two scientific meetings were enough. Id. at 1351–52. Here, the ACA materials were available on a public FDA website for at least 

two months before the critical date of the patents in suit. 

As with the breadth of dissemination, the length of time 

the ACA materials were available supports the Board’s 

public accessibility finding. 

Third, the ACA materials were distributed via public 

domain sources with no possible expectation that the 

materials would remain confidential or not be copied. We 

have consistently emphasized the importance of such 

expectations in determining whether a reference is publicly accessible. See Medtronic, 891 F.3d at 1382; Cordis, 

561 F.3d at 1333–34; Klopfenstein, 380 F.3d at 1351; MIT, 

774 F.2d at 1108–09. There can be no dispute that materials disclosed in the Federal Register and available 

online on a public FDA website have no expectation of 

confidentiality. This case bears no resemblance to Cordis, 
JAZZ PHARM., INC. v. AMNEAL PHARM., LLC 19

where “academic norms gave rise to an expectation that 

disclosures will remain confidential.” 561 F.3d at 1334. 

Like the factors considered above, the FDA’s and drug 

sponsor’s lack of any reasonable expectations of confidentiality support the Board’s finding of public accessibility.

In sum, after considering the relevant factors identified in our public accessibility cases, the record here 

demonstrates that the ACA materials were widely disseminated to persons of ordinary skill for a substantial 

time with no reasonable expectation of confidentiality. 

They were “in the possession of the public,” Wyer, 655 

F.2d at 226, and cannot be withdrawn from it. 

Jazz asserts that the Board’s finding of public accessibility must be reversed because evidence of “searchability 

or indexing [is] required to conclude that the ACA 

[m]aterials are prior art,” Reply Br. 10, and Amneal did 

not submit such evidence. Because neither indexing nor 

searchability was required, we reject Jazz’s argument.

We have consistently held that indexing or searchability is unnecessary for a reference to be a printed publication under § 102(b). Medtronic, 891 F.3d at 1381 (“We 

have stated that a printed publication ‘need not be easily 

searchable after publication if it was sufficiently disseminated at the time of its publication.’” (quoting Suffolk, 752 

F.3d at 1365)); Klopfenstein, 380 F.3d at 1350 

(“[D]istribution and indexing are not the only factors to be 

considered in a § 102(b) ‘printed publication’ inquiry.”); 

accord MIT, 774 F.2d at 1108–09 (holding paper distributed at conference publicly accessible without considering 

indexing). Jazz has presented no persuasive argument for 

us to impose an indexing or searchability requirement 

here. Following our precedent, we decline to do so.

Moreover, even assuming that indexing is relevant to 

this case, the Federal Register was meaningfully in-
20 JAZZ PHARM., INC. v. AMNEAL PHARM., LLC

dexed.7 The Notice was published on May 14, 2001, in

issue 93 of the 66th annual volume of the Federal Register. 66 Fed. Reg., No. 93 (May 14, 2001). Consistent with 

its governing regulation, 1 C.F.R. § 6.1 (“Each daily issue 

of the Federal Register shall be appropriately indexed.”), 

issue 93 included a five-page table of contents organized 

alphabetically by agency; each agency’s rules, proposed 

rules, and notices are then listed in that order. Table of 

Contents, 66 Fed. Reg., No. 93, at III (May 14, 2001). 

FDA notices appear on the third page, with three entries 

in total. Id. at V. The last entry refers to the Notice at 

issue in this case. It includes the title of the Notice, 

“Meetings: Peripheral and Central Nervous Systems 

Drugs Advisory Committee,” and provides the page number. Id. 

Accepting the Board’s unchallenged findings that a 

person of ordinary skill has a degree in either pharmacy 

or computer science, “was interested in drug distribution, 

safety, and abuse,” and “would have had reason to look to 

the Federal Register and FDA Advisory Committee meeting notices,” ’730/’988 Decision, 2016 WL 7985458, at *4–

5, *15, we are unpersuaded by Jazz’s argument that the 

2001 Federal Register “could be reviewed only page-bypage in paper format,” Reply Br. 12, because the Federal 

Register was indexed with a table of contents organizing 

notices by agency. Thus, considering the multiple factors 

discussed above favoring public accessibility, Jazz’s 

emphasis that the annual edition of the 2001 Federal 

Register was a lengthy 67,702 pages does not demonstrate 

the Board erred in finding that the ACA materials were 

publicly accessible. 

Jazz also argues that the Board erred by “equating 

the constructive notice provided by the Federal Register 

 

7 “The contents of the Federal Register shall be judicially noticed . . . .” 44 U.S.C. § 1507 (2012). 
JAZZ PHARM., INC. v. AMNEAL PHARM., LLC 21

with the legal standard for prior art.” Appellant Br. 21. 

We disagree. In response to Jazz’s argument that a 

person of ordinary skill would have been incapable of 

finding the Notice, the Board observed that “[t]he Federal 

Register provides notice to interested individuals of the 

actions of federal agencies,” and that a skilled artisan

would have been motivated to seek out FDA meeting 

notices regarding drug abuse. ’730/’988 Decision, 2016 

WL 7985458, at *15 (citing Aris Gloves, Inc. v. United 

States, 154 F. Supp. 203, 209 (Cust. Ct. 1957)

(“[C]ongress, by statutory enactment, has designated the 

‘Federal Register’ as the official publication in which 

notices by departments of the Federal Government shall 

appear . . . .”)). We do not interpret the Board’s decision 

as applying a per se rule that every notice in the Federal 

Register satisfies the requirements for prior art, nor do 

we endorse such a rule that would supplant the case-bycase inquiry consistently applied throughout our case law. 

Nor do we discern any error in the Board’s sensible observation that the purpose of the Federal Register is to 

provide notice of government action such as the advisory 

committee meeting here. 

However, we do reiterate that “[i]f accessibility is 

proved, there is no requirement to show that particular 

members of the public actually received the information.” 

Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560,

1569 (Fed. Cir. 1988); see also In re Lister, 583 F.3d 1307, 

1313–14 (Fed. Cir. 2009) (“[O]nce accessibility is shown, it 

is unnecessary to show that anyone actually inspected the 

reference.”). As we have explained, the ACA materials 

were publicly accessible because they were broadly disseminated to interested persons of ordinary skill for a 

substantial time with no expectations of confidentiality. 

The Board did not need to find that specific persons 

actually received or examined the materials. 

For the foregoing reasons, we hold that substantial 

evidence supports the Board’s finding that the ACA
22 JAZZ PHARM., INC. v. AMNEAL PHARM., LLC

materials were publicly accessible to persons of ordinary 

skill exercising reasonable diligence before the critical 

date of the patents in suit. Hence, they qualify as printed 

publications under § 102(b). 

III. Claim Construction

We now turn to Jazz’s claim construction arguments. 

Claim construction is a question of law that may involve 

underlying factual inquiries. Teva Pharm. USA, Inc. v. 

Sandoz, Inc., 135 S. Ct. 831, 841 (2015). We review the 

Board’s claim construction based solely on intrinsic evidence de novo, while we review subsidiary factual findings 

regarding extrinsic evidence for substantial evidence. 

HTC Corp. v. Cellular Commc’ns Equip., LLC, 877 F.3d 

1361, 1367 (Fed. Cir. 2017). The Board construed the 

claims on appeal according to their “broadest reasonable 

interpretation in light of the patent specification.” E.g., 

’730/’988 Decision, 2016 WL 2985458, at *5 (citing Cuozzo 

Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 

(2016)).

A. “periodic reports” 

Jazz asserts that the Board erred in construing “periodic reports,” as recited in claim 1 of the ’730 patent, 

among others. According to Jazz, “periodic” as used in the 

claims means at regular frequencies, Appellant Br. 18, 

and the Board’s construction renders the word superfluous.

Amneal responds that the Board properly construed 

“periodic reports” as including reports generated at irregular frequencies, and Jazz’s proposed construction improperly adds limitations without support in the intrinsic 

or extrinsic evidence. 

We agree with Amneal that the Board did not err in 

construing “periodic reports” to encompass reports generated at both regular and irregular intervals. ’730/’988 

Decision, 2016 WL 7985458, at *8. We begin with the 
JAZZ PHARM., INC. v. AMNEAL PHARM., LLC 23

language of the claim itself. The claim does not define the 

word “periodic,” nor does the written description ever use 

it. The Board considered dictionary definitions, some of 

which indicated “periodic” required regular intervals, 

while others suggested broader meanings of “repeated,” 

“intermittent,” or “occurring repeatedly from time to 

time.” Id. at *7. While not decisive, the ordinary meaning of “periodic reports” is consistent with reports generated at irregular intervals. And although the meaning of 

“periodic” is broad, the word is not superfluous; a report 

that by its nature could only be generated once would not 

be “periodic.” 

We also look to the specification in interpreting the 

claims. The disclosure of the patents in suit further 

supports the Board’s construction. The specification 

discloses two types of reports: reports made in response 

to a specific event that may occur at irregular intervals, 

such as early refill requests, ’730 patent fig. 4B; id. col. 2 

ll. 14–15; id. col. 6 ll. 33–37, and reports generated at 

regular frequencies, id. col. 6 ll. 12–13. Jazz argues that 

“periodic reports” refers only to the latter, and that the 

former reports are unclaimed embodiments. Appellant 

Br. 34. But Jazz provides no persuasive support in either 

the plain meaning of “periodic” or in the written description to exclude an embodiment repeatedly highlighted in 

the specification. 

In addition, the prosecution history supports the 

Board’s construction. During prosecution, the patent 

applicant pointed to several parts of the specification as 

providing written description support for the claim limitation “generating periodic reports via the exclusive computer database to evaluate potential diversion patterns.” 

J.A. 14966. The cited disclosures referred specifically to 

early refill reports, J.A. 14993, and to the procedure for

early refill requests, J.A. 15000, but not to reports generated at regular intervals. By indicating that the specification’s disclosure of early refill reports provides written 
24 JAZZ PHARM., INC. v. AMNEAL PHARM., LLC

description support for the “periodic reports” term, the 

prosecution history lends further support to the Board’s 

construction that does not exclude reports generated at 

irregular frequencies from the scope of the claims. 

Because the totality of the evidence supports the 

Board’s construction of “periodic reports” but not Jazz’s, 

we affirm the Board’s construction.

B. “information identifying”

 Jazz also argues that the Board erred in construing 

the various terms reciting “information identifying” 

patients and physicians, as recited in claim 1 of the ’730 

patent, among others. Contrary to the Board’s construction, Jazz contends that the specification identified examples of such information, and those examples set forth the 

minimum content needed to satisfy the “information 

identifying” term because the specification uses the words 

“contains” and “includes.” Appellant Br. 43. 

Amneal responds that the Board properly construed 

the “information identifying” claim terms as potentially 

including the types of information listed in the specification, but not limited to those types of information and not 

requiring all types of that information. Again, Amneal 

argues that Jazz’s construction improperly imports limitations from the specification into the claims.

We agree with Amneal that the Board did not err in 

rejecting Jazz’s request to read into the claims a minimum set of identifying information. The claim language 

simply refers to “prescription requests containing information identifying patients, the prescription drug, and 

various credentials of the any and all medical doctors.” 

E.g., ’730 patent col. 8 ll. 45–48 (emphasis added). It 

recites no specific types of identifying information. The 

specification does list various kinds of identifying information in discussing figure 2, id. col. 4 ll. 18–25, but 

never indicates that such information must be included in 
JAZZ PHARM., INC. v. AMNEAL PHARM., LLC 25

the claimed “information identifying” a patient or physician. We decline to read such limitations into the broad 

claim language based on the specification’s use of the 

word “contains” or “includes” in the context of describing a 

certain embodiment. Jazz cites no authority persuading 

us to do so. Thus, we affirm the Board’s constructions of 

the claim terms reciting “information identifying.” 

IV. Obviousness

We finally consider Jazz’s challenge to the Board’s obviousness analysis. Obviousness is a question of law with 

underlying factual issues, including the scope and content 

of the prior art, differences between the prior art and the 

claims at issue, the level of ordinary skill, and relevant 

evidence of secondary considerations. Graham v. John 

Deere Co., 383 U.S. 1, 17–18 (1966). Whether a skilled 

artisan would have been motivated to combine references 

is a question of fact. Apple Inc. v. Samsung Elecs. Co., 

839 F.3d 1034, 1051 (Fed. Cir. 2016) (en banc). 

Jazz argues that the Board’s finding that a person of 

ordinary skill would have been motivated to modify the 

ACA materials with the distributed system disclosed in 

Korfhage lacks substantial evidence with respect to 

claims 2 and 10 of the ’988 patent and claims 24, 26, and 

27 of the ’963 patent. First, Jazz argues that the Board’s 

decisions regarding the ’963 and ’988 patents are contradictory, so both cannot be right. Appellant Br. 47–48. 

Second, Jazz asserts that the Supreme Court’s decision in 

KSR International Co. v. Teleflex Inc., 550 U.S. 398 

(2007), requires that every finding of a motivation to 

combine be premised on subsidiary findings of “(1) whether there was a problem to be solved; and (2) whether there 

were a finite universe of possible options.” Appellant Br. 

49. Jazz contends that the Board failed to make such 

findings, so its decisions must be reversed. 

Amneal responds that the Board’s decisions are not 

contradictory, and that Jazz’s reading of KSR would 
26 JAZZ PHARM., INC. v. AMNEAL PHARM., LLC

impose “the exact sort of ‘rigid preventative [rule] that 

[denies] factfinders recourse to common sense’ the Court 

rejected.” Appellee Br. 41 (alteration in original) (quoting 

KSR, 550 U.S. at 421). 

We agree with Amneal that the Board’s decisions are 

consistent. The Board made the same essential finding in 

both decisions that a person of ordinary skill would have 

been motivated to run the ACA materials’ distribution 

system over multiple computers, as taught in Korfhage. 

Compare ’730/’988 Decision, 2016 WL 7985458, at *24 

(“[O]ne of ordinary skill would have been motivated to 

modify the [ACA materials’] distribution system to include multiple computers in a distributed database system for reasons of cost, efficiency, and the anticipated 

volume of prescription-related information to be received, 

entered, and queried.”), with ’963 Decision, 2017 WL 

1096638, at *9 (“[A] [person of ordinary skill] would have 

been motivated to distribute the ACA’s single, centralized 

computer database over multiple computers, for reasons 

of cost, efficiency, and the anticipated volume of prescription-related information to be received, entered, and 

queried.”). When the Board discussed a “distributed 

database system” or “distributed databases,” we understand it to have referred to a database implemented over 

multiple computers, consistent with the ’988 patent itself, 

see ’988 patent col. 10 ll. 29–34 (reciting “an exclusive 

central database . . . distributed over multiple computers,” 

then referring to that system as “distributed databases”). 

We also agree with Amneal that Jazz misinterprets 

both the Supreme Court’s decision in KSR and this court’s 

obviousness precedent. KSR did not impose a rigid requirement to identify both a problem to be solved in the 

art and a finite universe of potential options. Rather, the 

Supreme Court rejected the teaching, suggestion, or 

motivation test, because the Court considered that the 

test was a “[r]igid, preventative rule[] that den[ies] factfinders recourse to common sense.” KSR, 550 U.S. at 421. 
JAZZ PHARM., INC. v. AMNEAL PHARM., LLC 27

Furthermore, the Supreme Court also rejected the “assumption that a person of ordinary skill attempting to 

solve a problem will be led only to those elements of prior 

art designed to solve the same problem.” Id. at 420. We 

have similarly recognized that persons of ordinary skill 

have diverse motivations, including “[t]he normal desire 

. . . to improve upon what is already generally known.” In 

re Ethicon, Inc., 844 F.3d 1344, 1351 (Fed. Cir. 2017); see 

also Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 

1291 (Fed. Cir. 2012) (“New compounds may be created 

from theoretical considerations rather than from attempts 

to improve on prior art compounds.”). 

KSR did state that “[w]hen there is a design need or 

market pressure to solve a problem and there are a finite 

number of identified, predictable solutions, a person of 

ordinary skill has good reason to pursue the known options within his or her technical grasp.” KSR, 550 U.S. at 

421. But it did not set forth such factors as part of a 

mandatory formula. To treat them as such would be 

inconsistent with KSR’s holding and our own case law. 

Thus, the Board did not err in concluding that implementing the ACA materials’ centralized database system on 

multiple computers “would have been a predictable use of 

a known distributed data system according to its established function.” ’730/’988 Decision, 2016 WL 7985458, at 

*25 (citing KSR, 550 U.S. at 417). As Jazz has presented 

no other arguments challenging the Board’s finding of a 

motivation to modify, we affirm its holdings with respect 

to claims 2 and 10 of the ’988 patent and claims 24, 26, 

and 27 of the ’963 patent.

CONCLUSION

We have considered Jazz’s remaining arguments, and 

find them unpersuasive. For the foregoing reasons, we 

affirm the Board’s decisions. 

AFFIRMED