Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC , 895 F.3d 1347 ( 2018 )

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 Trade-
mark 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. Be-
cause the Board did not err in its conclusions of obvious-
ness, 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 Admin-
istration (“FDA”) has approved to treat symptoms associ-
ated 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). According-
ly, 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 poten-
tial for abuse, the FDA approved Xyrem® under “restrict-
ed 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” associ-
ated 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, tran-
script, and slides on the FDA website as the Advisory
2 As the patents in suit share a substantially iden-
tical 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 pre-
scription drug under exclusive control of an exclu-
sive 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 al-
lowed to prescribe the prescription drug, the pre-
scription requests containing information
identifying patients, the prescription drug, and
various credentials of the any and all medical doc-
tors;
requiring entering of the information into an ex-
clusive computer database associated with the ex-
clusive 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 exclu-
sive computer database;
checking with the computer processor the creden-
tials of the any and all doctors to determine the
eligibility of the doctors to prescribe the prescrip-
tion drug;
JAZZ PHARM., INC. v. AMNEAL PHARM., LLC 5
confirming with a patient that educational mate-
rial has been read prior to shipping the prescrip-
tion drug;
checking the exclusive computer database for po-
tential 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 prescrip-
tion 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 “exclu-
sive computer database,” “information identifying,” and
“periodic reports” terms, italicized above. The specifica-
tion describes an “exclusive central database” as including
all data relevant to distribution of a sensitive drug, “in-
cluding 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 data-
base 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 predeter-
mined number of days or product remaining.” Id. col. 6 ll.
12–13. Likewise, the specification discusses “sample
reports” that have “an associated frequency or frequen-
cies.” 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 institut-
ed 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 pro-
ceedings 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 ordi-
nary 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 deci-
sions 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 express-
ly 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 con-
structions 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. Sec-
ond, the Board construed “information identifying pa-
tients” 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. Simi-
larly, 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 Re-
trieval (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 inde-
pendent claims 1 and 9, respectively, and recite an exclu-
sive 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 ordi-
nary 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 prescription-
related 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 un-
patentable as obvious because implementing a database
system on multiple computers “would have been a pre-
dictable 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 prescrip-
tion-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 construc-
tions 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 chal-
lenged 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 institu-
tion, we held that: (1) “the combination of the non-
institution decisions and the final written decisions on the
instituted claims and grounds ‘terminated the IPR pro-
ceeding[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) (quot-
ing 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 partial-
ly 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 SAS-
based 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 re-
mand 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 substan-
tial 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 mate-
rials are not prior art, so all of the Board’s decisions
relying on the ACA materials should be reversed. Accord-
ing 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 substan-
tial 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] re-
quired 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 posses-
sion 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-Leahy-
Smith 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) (quot-
ing In re Wyer, 655 F.2d 221, 226 (CCPA 1981)). “Because
there are many ways in which a reference may be dissem-
inated 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 publica-
tion” under § 102(b) is a legal conclusion based on under-
lying 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 refer-
ence is a printed publication. Medtronic, 891 F.3d at
1380.
We agree with Amneal that substantial evidence sup-
ports 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 Advi-
sory Committee through the Notice in the Federal Regis-
ter. 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 commit-
tee.” Id.
The Notice also included a hyperlink to an FDA web-
site 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 materi-
als on the FDA website: “Click on the year 2001 and
scroll down to the Peripheral and Central Nervous Sys-
tems 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 con-
ferences were “printed publications.” In Massachusetts
Institute of Technology v. AB Fortia (“MIT”), the reference
at issue was a paper orally presented at a scientific con-
ference 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 request-
ed 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 pre-
sented 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 infor-
mation would not be copied or reproduced by those view-
ing it.” Id. After considering multiple factors, including
the length of the display, the expertise of the intended
audience, whether the presenters had a reasonable expec-
tation 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 . . . aca-
demic 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 publica-
tions. 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, respec-
tively. 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 be-
tween 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 mate-
rials 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 addi-
tion, 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 rea-
sonable 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 per-
sons 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 publica-
tion.” 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 ob-
serve 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 publica-
tion”); 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 ‘dis-
tributed’ 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 meet-
ings were enough. Id. at 1351–52. Here, the ACA mate-
rials 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 public-
ly 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 mate-
rials 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 confiden-
tiality support the Board’s finding of public accessibility.
In sum, after considering the relevant factors identi-
fied in our public accessibility cases, the record here
demonstrates that the ACA materials were widely dis-
seminated 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 accessi-
bility 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 searchabil-
ity is unnecessary for a reference to be a printed publica-
tion 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 dissemi-
nated 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 distrib-
uted 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 Regis-
ter. 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 num-
ber. 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 meet-
ing 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-by-
page 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 ju-
dicially 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-by-
case inquiry consistently applied throughout our case law.
Nor do we discern any error in the Board’s sensible obser-
vation 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 dis-
seminated 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 evi-
dence 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 “peri-
odic 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 superflu-
ous.
Amneal responds that the Board properly construed
“periodic reports” as including reports generated at irreg-
ular frequencies, and Jazz’s proposed construction im-
properly 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 gener-
ated 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 mean-
ing of “periodic reports” is consistent with reports gener-
ated 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 descrip-
tion 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 limita-
tion “generating periodic reports via the exclusive com-
puter 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 gener-
ated at regular intervals. By indicating that the specifica-
tion’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 construc-
tion, Jazz contends that the specification identified exam-
ples 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 specifica-
tion, 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 limi-
tations 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 mini-
mum set of identifying information. The claim language
simply refers to “prescription requests containing infor-
mation 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 infor-
mation 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 physi-
cian. 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 ob-
viousness 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 contra-
dictory, 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) wheth-
er 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 in-
clude multiple computers in a distributed database sys-
tem 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 prescrip-
tion-related information to be received, entered, and
queried.”). When the Board discussed a “distributed
database system” or “distributed databases,” we under-
stand 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 re-
quirement 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] fact-
finders 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 “as-
sumption 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 op-
tions 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 implement-
ing the ACA materials’ centralized database system on
multiple computers “would have been a predictable use of
a known distributed data system according to its estab-
lished 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