Case: 17-1671
`
`Document: 61-1
`
`Page:1_
`
`Filed: 07/13/2018
`
`(1 of 30)
`
`Gnited States Court of Appeals
`for the federal Circuit
`
`JAZZ PHARMACEUTICALS,INC.,
`Appellant
`
`Vv.
`
`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.
`TPR2015-00545,
`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.
`
`

`

`Case: 17-1671
`
`Document: 61-1
`
`Page:2
`
`Filed: 07/13/2018
`
`(2 of 30)
`
`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”).! 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 membersof 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”).
`
`

`

`Case: 17-1671
`
`Document: 61-1
`
`Page:3
`
`Filed: 07/13/2018
`
`(3 of 30)
`
`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 GHBis 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.
`Jd. 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.
`
`

`

`Case: 17-1671
`
`Document:61-1
`
`Page:4
`
`Filed: 07/13/2018
`
`(4 of 30)
`
`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
`patentis illustrative, andrecites:
`
`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 andall 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;
`
`

`

`Case: 17-1671
`
`Document: 61-1
`
`Page:5
`
`Filed: 07/13/2018
`
`(5 of 30)
`
`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 drugto 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.
`
`Td. col. 8 1. 37-col. 9 1. 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.”
`Td. 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 numberofrefills 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.” Jd. col. 2 1. 14-15. An early refill report
`is made whena specific event occurs: a patient requests a
`
`

`

`Case: 17-1671
`
`Document: 61-1
`
`Page:6
`
`Filed: 07/13/2018
`
`(6 of 30)
`
`6
`
`JAZZ PHARM., INC. v. AMNEAL PHARM., LLC
`
`Id.
`prescription refill prior to the scheduled refill date.
`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. 48-44. Other types of reports are
`created at set time points, for example, at “a predeter-
`mined numberof days or product remaining.” Jd. 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.2 The Board institut-
`ed review ofall 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., IPR2015-019038, 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 Amnealfiled severalof 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.”
`
`

`

`Case: 17-1671
`
`Document: 61-1
`
`Page:7
`
`Filed: 07/13/2018
`
`(7 of 30).
`
`JAZZ PHARM., INC. v. AMNEAL PHARM., LLC
`
`7
`
`The Board issuedsix 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 nolater
`than October 4, 2001, over two monthspriorto 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. Jd. 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-
`
`For simplicity, unless otherwise noted wecite only
`4
`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. 9n.5.
`
`

`

`Case: 17-1671
`
`Document:61-1
`
`Page:8
`
`Filed: 07/13/2018
`
`(8 of 30)
`
`8
`
`JAZZ PHARM., INC. v. AMNEAL PHARM., LLC
`
`site for Xyrem.” Jd. 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. Gnternal 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, i1.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
`
`

`

`Case: 17-1671
`
`Document: 61-1
`
`Page:9
`
`Filed: 07/13/2018
`
`(9 of 30)
`
`JAZZ PHARM., INC. v. AMNEAL PHARM., LLC
`
`9
`
`over the ACA materials and Korfhage.
`Decision, 2017 WL 1096638, at *12, *14.
`
`Id. at *25; 963
`
`Claims 2 and 10 of the ’988 patent depend from inde-
`pendentclaims 1 and 9, respectively, and recite an exclu-
`sive
`central
`database
`“distributed
`over multiple
`computers, and wherein a query operates overall data in
`all the distributed databases relating to the prescriptions,
`the doctors, and the narcoleptic patients.” ’988 patentcol.
`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 ofordi-
`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-knownin 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.” Jd. at *25 (citing KSR Inti
`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 volumeof prescrip-
`tion-related information to be received, entered, and
`queried.”
`’963 Decision, 2017 WL 1096638, at *9. The
`
`

`

`Case: 17-1671 Page:10_Filed: 07/13/2018Document: 61-1 (10 of 30)
`
`
`
`
`
`
`
`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
`Jazzs 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
`
`J. 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 JInst., Inc. v. Iancu, 138 S. Ct.
`1348, 1853 (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 7963
`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.
`
`

`

`Case: 17-1671
`
`Document: 61-1
`
`Page:11
`
`Filed: 07/13/2018
`
`(11 of 30)
`
`JAZZ PHARM., INC. v. AMNEAL PHARM., LLC
`
`11
`
`Werecently addressed a similar scenario in PGS. In
`PGS, the Board had instituted IPR of only some of the
`claims and groundsraised by the petitioner. Jd. 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-basedrelief, 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
`Jazzs 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, Jn 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-
`
`

`

`Case: 17-1671
`
`Document: 61-1
`
`Page:12
`
`Filed: 07/13/2018
`
`(12 of 30)
`
`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 evidenceof
`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
`
`Because the applications for each of the patents in
`5
`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).
`
`

`

`Case: 17-1671
`
`Document: 61-1
`
`Page:13
`
`Filed: 07/13/2018
`
`(13 of 30)
`
`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, 13864 (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 Amnealthat 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.”
`Jn re
`Klopfenstein, 380 F.3d 1345, 13850 (Fed. Cir. 2004). We
`thus review the pertinent facts here.
`
`

`

`Case: 17-1671
`
`Document: 61-1
`
`Page:14_
`
`Filed: 07/13/2018
`
`(14 of 30)
`
`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
`andefficacy 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. Jd. 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 500cell 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 personsinterested
`
`

`

`Case: 17-1671
`
`Document: 61-1
`
`Page:15
`
`Filed: 07/13/2018
`
`(15 of 30)
`
`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 documentitself
`was actually disseminated without restriction to at least
`six persons.” Id. at 1109.
`
`in Klopfenstein, several researchers pre-
`Similarly,
`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.” Jd. at 1334. Accordingly, in the
`context of a “distribution to a limited numberofentities,”
`we held that the resident’s distribution of his monograph
`to academic and research colleagues did not make the
`monographa prior art printed publication. Id.
`
`Most recently, in Medtronic we considered whether
`distribution of a video and slides at several scientific
`
`

`

`Case: 17-1671
`
`Document: 61-1
`
`Page:16
`
`Filed: 07/13/2018
`
`(16 of 30)
`
`16
`
`JAZZ PHARM., INC. v. AMNEAL PHARM., LLC
`
`meetings on spinal surgery wereprior 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. Jd. at 1381. Thefirst
`meeting was limited to membersof a certain professional
`organization, but the second and third meetings were
`open to other surgeons. Jd. 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 remandedfor 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-
`
`

`

`Case: 17-1671 Page:17_Filed: 07/13/2018Document: 61-1 (17 of 30)
`
`
`
`
`
`
`
`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,® 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
`
`The record in this case lacks any details regarding
`6
`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.
`
`

`

`Case: 17-1671 Page:18_Filed: 07/13/2018Document: 61-1 (18 of 30)
`
`
`
`
`
`
`
`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 1s 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 Klopf