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Case: 18-2142 Document: 20 Page: 1 Filed: 08/21/2018 Appeal Nos. 2018-2142, -2143 IN THE UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT SANDOZ INC., v. ABBVIE BIOTECHNOLOGY LTD, Appellant, Appellee. Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board, in Nos. IPR2017-01824 and IPR2018-00002 APPELLEE S REPLY TO APPELLANT SANDOZ INC. S RESPONSE TO ORDER TO SHOW CAUSE WILLIAM G. MCELWAIN AMY K. WIGMORE THOMAS G. SAUNDERS JOSHUA L. STERN WILMERHALE WILLIAM B. RAICH MICHAEL J. FLIBBERT CHARLES COLLINS-CHASE SYDNEY R. KESTLE FINNEGAN, HENDERSON, FARABOW, 1875 Pennsylvania Avenue, NW GARRETT & DUNNER, LLP Washington, DC 20006 901 New York Avenue, NW (202) 663-6000 Washington, DC 20005-4413 (202) 408-4000 August 21, 2018 Attorneys for Appellee AbbVie Biotechnology Ltd

Case: 18-2142 Document: 20 Page: 2 Filed: 08/21/2018 CERTIFICATE OF INTEREST Counsel for the appellee AbbVie Biotechnology Ltd certifies the following (use None if applicable; use extra sheets if necessary): 1. The full name of every party represented by me is: AbbVie Biotechnology Ltd 2. Name of the Real Party in interest (Please only include any real party in interest NOT identified in Question 3) represented by me is: AbbVie Biotechnology Ltd 3. Parent corporations and publicly held companies that own 10 % or more of the stock of the party: AbbVie Bahamas Ltd.; AbbVie Limited; Pharmacyclics Switzerland GmbH; AbbVie Overseas S.à. r.l.; AbbVie International S.à r.l.; AbbVie (Gibraltar) Holdings Limited Luxembourg S.C.S.; Pharmacyclics LLC; AbbVie (Gibraltar) Holdings Limited; AbbVie (Gibraltar) Limited; and AbbVie Inc. 4. The names of all law firms and the partners or associates that appeared for the party or amicus now represented by me in the trial court or agency or are expected to appear in this court (and who have not or will not enter an appearance in this case) are: Maureen D. Queler Jessica L.A. Marks 5. The title and number of any case known to counsel to be pending in this or any other court or agency that will directly affect or be directly affected by this court s decision in the pending appeal. See Fed. Cir. R. 47.4(a)(5) and 47.5(b). (The parties should attach continuation pages as necessary). N/A

Case: 18-2142 Document: 20 Page: 3 Filed: 08/21/2018 TABLE OF CONTENTS INTRODUCTION... 1 ARGUMENT... 3 I. No Statute Confers Jurisdiction on This Court to Review the Board s Non-Institution Decisions... 3 A. Sandoz Fails to Identify Any Statute Affirmatively Conferring Jurisdiction to Review Non-Institution Decisions... 3 B. Sandoz Fails to Address St. Jude, Which Held That This Court Lacks Jurisdiction to Review IPR Non-Institution Decisions... 6 II. Section 314(d) Independently Bars Sandoz s Appeals... 7 III. Sandoz s Policy Arguments Likewise Fail to Confer Jurisdiction...11 A. An APA Challenge Is Not an Independent Basis for Jurisdiction...12 B. The Board s Decisions Were Neither Arbitrary Nor Capricious...14 CONCLUSION...17 i

Case: 18-2142 Document: 20 Page: 4 Filed: 08/21/2018 TABLE OF AUTHORITIES Page(s) Cases Altaire Pharms. Inc. v. Paragon Bioteck, Inc., 889 F.3d 1274 (Fed. Cir. 2018)... 13 Aqua Products, Inc. v. Matal, 872 F.3d 1290 (Fed. Cir. 2017) (en banc)... 13 Bandag, Inc. v. Al Bolser s Tire Stores, Inc., 750 F.2d 903 (Fed. Cir. 1984)... 14 Bowman Transp., Inc. v. Arkansas-Best Freight Sys., Inc., 419 U.S. 281 (1974)... 14 Califano v. Sanders, 430 U.S. 99 (1977)... 5, 6, 13 Cuozzo Speed Technologies, LLC v. Lee, 136 S. Ct. 2131 (2016)... 6, 7, 8 In re Dominion Dealer Sols., LLC, 749 F.3d 1379 (Fed. Cir. 2014)... 7 In re Gartside, 203 F.3d 1305 (Fed. Cir. 2000)... 14 Graham v. John Deere Co. of Kan. City, 383 U.S. 1 (1966)... 10 GTNX, Inc. v. INTTRA, Inc., 789 F.3d 1309 (Fed. Cir. 2015)... 5, 13 Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359 (Fed. Cir. 2016)... 15 PGBA, LLC v. United States, 389 F.3d 1219 (Fed. Cir. 2004)... 14 In re Power Integrations, Inc., F.3d, 2018 WL 3892996 (Fed. Cir. Aug. 16, 2018)... 2, 10, 11, 16 ii

Case: 18-2142 Document: 20 Page: 5 Filed: 08/21/2018 Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc., F.3d, 2018 WL 3484448 (Fed. Cir. July 20, 2018)... 8 Sandoz Inc. v. AbbVie Biotech. Ltd, IPR2018-01166 (P.T.A.B. June 5, 2018)... 15 SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018)... 6, 14 St. Jude Med., Cardiology Div., Inc. v. Volcano Corp., 749 F.3d 1373 (Fed. Cir. 2014)...passim Trudeau v. Fed. Trade Comm n, 456 F.3d 178 (D.C. Cir. 2006)... 5 Ultratech, Inc. v. Caption Call, LLC, 872 F.3d 1267 (Fed. Cir. 2017)... 13 Wi-Fi One, LLC v. Broadcom Corp., 878 F.3d 1364 (Fed. Cir. 2018) (en banc)... 7, 8, 9 Statutes 5 U.S.C. 704... 4 28 U.S.C. 1295(a)(4)(A)... 4, 5 35 U.S.C. 102... 9 35 U.S.C. 102(b)... 9 35 U.S.C. 103... 9, 10 35 U.S.C. 141(c)... 1, 3, 4, 5 35 U.S.C. 142... 4, 5 35 U.S.C. 311... 9 35 U.S.C. 311-13... 9 35 U.S.C. 311(b)... 9 35 U.S.C. 312(a)(3)... 15 iii

Case: 18-2142 Document: 20 Page: 6 Filed: 08/21/2018 35 U.S.C. 314... 8 35 U.S.C. 314(a)... 8, 9, 10, 11 35 U.S.C. 314(d)...passim 35 U.S.C. 315... 9 35 U.S.C. 315(b)... 9 35 U.S.C. 318(a)... 1, 3, 4, 5 35 U.S.C. 319... 1, 3, 4 Regulations 37 C.F.R. 42.6(a)(3)... 11 37 C.F.R. 42.24(a)... 11 37 C.F.R. 42.51(b)... 17 37 C.F.R. 42.104(b)(2), (5)... 15 37 C.F.R. 42.108(c)... 17 iv

Case: 18-2142 Document: 20 Page: 7 Filed: 08/21/2018 INTRODUCTION Sandoz purports to appeal from decisions of the Patent Trial and Appeal Board denying institution of inter partes review proceedings and denying a request for rehearing. In response to Sandoz filing two Notices of Appeal, the USPTO filed a Notice of Non-Filing of Certified List Due to Lack of Jurisdiction, which explained why this Court lacks jurisdiction to hear Sandoz s appeals. The Court then ordered Sandoz to show cause why these appeals should not be dismissed. AbbVie agrees with the USPTO that this Court lacks jurisdiction over Sandoz s appeals. To AbbVie s knowledge, this Court has never exercised jurisdiction over an appeal from a non-institution decision. Sandoz s response to the Order to Show Cause provides no reason for a contrary ruling. Most fundamentally, Sandoz identifies no statutory basis for jurisdiction. It does not address 35 U.S.C. 141(c) and 319, which permit an appeal only from a final written decision of the Board under 318(a). Section 318(a) provides that, if an IPR is instituted, the Board shall issue a final written decision. These statutes plainly limit appeals to cases in which the Board has (1) instituted an IPR and then (2) issued a final written decision. As this Court held in St. Jude: The final written decision is the only decision that the statute authorizes a dissatisfied party to appeal to this [C]ourt. St. Jude Med., Cardiology Div., Inc. v. Volcano Corp., 749 F.3d 1

Case: 18-2142 Document: 20 Page: 8 Filed: 08/21/2018 1373, 1374 (Fed. Cir. 2014) (emphasis added). Even though this Court s Order to Show Cause cited St. Jude, which is controlling, Sandoz fails to address it. Further, this Court explained in St. Jude that the statutory scheme does not merely omit an affirmative right to appeal from a non-institution decision; it also contains a broadly worded bar on appeal in 314(d). Id. at 1376. At minimum, 314(d) bars review of the Board s decision not to institute, as well as matters closely related to that decision. Sandoz s attempt to circumvent that broadly worded bar depends on its untenable proposition that whether a petitioner has proven that a reference qualifies as publicly accessible prior art is unrelated to whether it has established a reasonable likelihood of proving unpatentability. This Court has expressly rejected Sandoz s theory. In re Power Integrations, Inc., F.3d, 2018 WL 3892996, at *5 (Fed. Cir. Aug. 16, 2018) (concluding that a challenge to a noninstitution decision based on a printed publication ruling involves no issues extraneous to the application of patent law principles of unpatentability based on printed publications ). Failing to address the most relevant statutes and case law, Sandoz devotes virtually its entire response to advancing a series of unsupported policy arguments and criticisms of the USPTO. E.g., Resp. at 1 ( The IPRs that are the subject of this appeal are casualties of the Board s broken practice.... ), 23 ( This attempt by the Board to appoint itself judge, jury and executioner should not stand. ). The Court 2

Case: 18-2142 Document: 20 Page: 9 Filed: 08/21/2018 should disregard these criticisms, which cannot overcome Sandoz s failure to demonstrate that this Court has jurisdiction. Because the Board never instituted inter partes review, much less issued a final written decision in either of these cases, the Court should dismiss the appeals. See 35 U.S.C. 141(c), 314(d), 318(a), 319; St. Jude Med., 749 F.3d at 1374-76 (holding that the statutory scheme provides no authorization to appeal a noninstitution decision and dismissing an appeal from a non-institution decision). ARGUMENT I. No Statute Confers Jurisdiction on This Court to Review the Board s Non-Institution Decisions A. Sandoz Fails to Identify Any Statute Affirmatively Conferring Jurisdiction to Review Non-Institution Decisions Sandoz filed two deficient IPR petitions that failed to establish that certain asserted references were prior art printed publications. Dkt. 19-4; Dkt. 19-8. 1 The Board accordingly denied institution based on Sandoz s failure to establish a reasonable likelihood that any challenged claim was unpatentable. Dkt. 19-17 at 6-10; Dkt. 19-19 at 7-15. Sandoz seeks to appeal from those non-institution decisions and from the Board s denial of rehearing in one proceeding. Dkt. 1-2. 1 Appeal numbers 2018-2142 and 2018-2143 have been consolidated, with all entries added to the docket for 2018-2142. Docket numbers accordingly refer to the docket entries for Appeal No. 2018-2142. 3

Case: 18-2142 Document: 20 Page: 10 Filed: 08/21/2018 Although Sandoz cited several statutes in its Notices of Appeal that it contended confer jurisdiction on this Court to hear appeals from non-institution decisions, Sandoz has abandoned nearly all of those statutory arguments in its response to the Order to Show Cause. Specifically, Sandoz makes no mention of 35 U.S.C. 141(c) or 142, 28 U.S.C. 1295(a)(4)(A), or 5 U.S.C. 704, all of which were cited in the Notices of Appeal. Dkt. 1-2 at 1. Indeed, except for passing references to select provisions of the Administrative Procedure Act (APA), Sandoz has relinquished reliance on every statute identified in its Notices of Appeal. Sandoz has thus waived any jurisdictional arguments based on these statutes. Sandoz s abandonment of these statutory arguments is for good reason: no statute confers jurisdiction on this Court to review a non-institution decision. The statutes governing inter partes review do not permit appeals from non-institution decisions. Under 35 U.S.C. 141(c) and 319, a dissatisfied party may appeal only from a final written decision of the Board under 318(a). Section 318(a) provides that, if an IPR is instituted, the Board shall issue a final written decision. Thus, appeals from IPR proceedings are limited to cases in which the Board has (1) instituted an IPR and then (2) issued a final written decision. Because neither of those jurisdictional predicates exists here, the Court lacks jurisdiction. Sandoz does not contend otherwise or even cite these controlling statutes. 4

Case: 18-2142 Document: 20 Page: 11 Filed: 08/21/2018 35 U.S.C. 142 likewise fails to confer jurisdiction. It simply states that an interested party must file a notice of appeal with the USPTO if an appeal is taken. It does not authorize an appeal from a non-institution decision. Nor does 28 U.S.C. 1295(a)(4)(A) confer jurisdiction to review a non-institution decision. It provides that the Court may review an IPR decision, but that review must comport with the other provisions of Title 35, including 314(d) and 141(c). St. Jude, 749 F.3d at 1376. As this Court held in St. Jude, 1295(a)(4)(A) is most naturally read to refer precisely to the Board s final written decision under 318(a) on the merits of the IPR, after the Board has conducted the proceeding that it instituted. Id. Under that reading, the statutory grant of jurisdiction to this Court matches the appeal right in Chapter 31 and 141(c), and an appeal from a non-institution decision is outside both. Id. Accordingly, 1295(a)(4)(A) does not authorize Sandoz s appeals. Id. The APA also provides no basis for jurisdiction. The APA is not a jurisdictionconferring statute. E.g., Califano v. Sanders, 430 U.S. 99, 105-07 (1977) ( We thus conclude that the APA does not afford an implied grant of subject-matter jurisdiction permitting federal judicial review of agency action. ); see Trudeau v. Fed. Trade Comm n, 456 F.3d 178, 183 (D.C. Cir. 2006). For this reason, this Court has held in the materially similar post-grant review context that the APA does not provide a ground of jurisdiction to review a non-institution decision. GTNX, Inc. v. INTTRA, 5

Case: 18-2142 Document: 20 Page: 12 Filed: 08/21/2018 Inc., 789 F.3d 1309, 1313 (Fed. Cir. 2015) (citing Califano, 430 U.S. at 105-07). Sandoz fails to address this case law holding that the APA does not provide a basis for federal jurisdiction. Thus, despite an order from this Court directing Sandoz to show cause why these appeals should not be dismissed for lack of jurisdiction, Sandoz has failed to identify any jurisdiction-conferring statute authorizing review of the Board s noninstitution decisions. This failure warrants dismissal of Sandoz s appeals. B. Sandoz Fails to Address St. Jude, Which Held That This Court Lacks Jurisdiction to Review IPR Non-Institution Decisions This Court already expressly resolved the question raised by these appeals, holding that it does not have jurisdiction to review IPR non-institution decisions. St. Jude, 749 F.3d at 1375-76 (dismissing appeal from a non-institution decision for lack of jurisdiction). The USPTO cited the St. Jude decision in its Notice of Non- Filing of Certified List Due to Lack of Jurisdiction, Dkt. 17, and this Court identified St. Jude in its Order to Show Cause, Dkt. 18 at 2. Yet, in the face of this controlling precedent, Sandoz fails to distinguish (or even mention) the St. Jude decision. As the Court explained in St. Jude, the statute provides for appeals only from the Board s final written decisions. St. Jude, 749 F.3d at 1375-76. AbbVie is aware of no case contradicting St. Jude, and Sandoz has directed this Court to none. Importantly, the appeals in each of SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348, 1354 (2018), Cuozzo Speed Technologies, LLC v. Lee, 136 S. Ct. 2131, 2138-39 (2016), 6

Case: 18-2142 Document: 20 Page: 13 Filed: 08/21/2018 and Wi-Fi One, LLC v. Broadcom Corp., 878 F.3d 1364, 1371 (Fed. Cir. 2018) (en banc) all arose from final written decisions. None of those cases identified a basis for the Court to exercise jurisdiction over an appeal in the absence of a final written decision. St. Jude s holding that a dissatisfied petitioner may not appeal from an IPR non-institution decision thus forecloses Sandoz s appeals here. Having failed to even address this controlling precedent, Sandoz has waived any arguments to the contrary. The Court should therefore dismiss these appeals for lack of jurisdiction. St. Jude, 749 F.3d at 1375-76; see In re Dominion Dealer Sols., LLC, 749 F.3d 1379, 1380-81 (Fed. Cir. 2014) (denying writ of mandamus because no right to relief existed in light of statutory scheme precluding review of IPR non-institution decisions) (citing St. Jude, 749 F.3d at 1376). II. Section 314(d) Independently Bars Sandoz s Appeals Sandoz s failure to identify any affirmative basis for this Court to exercise jurisdiction is sufficient standing alone to require dismissal of these appeals. Its appeals are also independently barred by 35 U.S.C. 314(d), which states that the determination by the Director whether to institute an inter partes review under this section shall be final and unreviewable. That broadly worded bar on appeal precludes review of non-institution decisions. St. Jude, 749 F.3d at 1376; see also Cuozzo, 136 S. Ct. at 2141 ( Congress has told the Patent Office to determine 7

Case: 18-2142 Document: 20 Page: 14 Filed: 08/21/2018 whether inter partes review should proceed, and it has made the agency s decision final and nonappealable. Our conclusion that courts may not revisit this initial determination gives effect to this statutory command. ). As this Court noted in Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc., [i]f the Director decides not to institute, for whatever reason, there is no review. In making this decision, the Director has complete discretion to decide not to institute review. F.3d, 2018 WL 3484448, at *3 (Fed. Cir. July 20, 2018). Sandoz acknowledges that 314(d) precludes appeals that are closely related to the 314(a) determination whether to institute. Resp. at 9-11; see Cuozzo, 136 S. Ct. at 2141-42; Wi-Fi One, 878 F.3d at 1369-70, 1373. But Sandoz contends that the question of whether a reference qualifies as prior art is separate and distinct from the 314 analysis. Resp. at 10. Sandoz s attempt to circumvent 314(d) fails. In denying institution, the Board recited the standard for institution under 314(a) and stated: Applying that standard,... we deny the Petition and do not institute an inter partes review. Dkt. 19-17 at 3; Dkt. 19-19 at 3. It later reiterated that Petitioner fails to demonstrate a reasonable likelihood of prevailing at trial as to any challenged claim. Dkt. 19-17 at 11; Dkt. 19-19 at 15. The Board thus made abundantly clear that its decisions not to institute were based on 314(a). The fact that these decisions were based on a determination that Sandoz had failed to prove that its references were printed publications for purposes of 35 U.S.C. 8

Case: 18-2142 Document: 20 Page: 15 Filed: 08/21/2018 102(b) and 311(b) does not establish that the Board s decisions were not closely related to 314(a). Dkt. 19-17 at 10; Dkt. 19-19 at 14. In Wi-Fi One, the Court held that it had jurisdiction over a challenge to the time-bar provision in 315(b) in an appeal from a final written decision, but noted that 315 contrasts with many of the preliminary procedural requirements stated in 311-13, which relate to the Director s ability to make an informed preliminary patentability determination pursuant to 314(a). 878 F.3d at 1374-75. Sandoz fails to address the fact that 311(b) the provision on which the Board made its printed-publication determinations and on which Sandoz bases its appeals, see Dkt. 1-2 at 2; Dkt. 19-17 at 6 (citing 311(b)); Dkt. 19-19 at 7 (same) is one of the sections that the Court expressly identified as relating to the institution decision under 314(a). Wi-Fi One, 878 F.3d at 1374. Moreover, 314(a) expressly refers to 311 as forming part of the institution decision. Section 314(a) states that institution will be based on the sufficiency of the information presented in the petition filed under 311, and specifically on the determination of whether that information shows a reasonable likelihood that the petitioner would prevail as to at least one challenged claim. Section 311(b) further defines the scope of the unpatentability grounds that may be raised in an IPR under 102 and 103 and limits the potential prior art to patents or printed publications. 9

Case: 18-2142 Document: 20 Page: 16 Filed: 08/21/2018 Thus, the institution decision under 314(a) specifically incorporates the question of whether an asserted reference qualifies as printed publication prior art. It is unsurprising that the statute governing the threshold institution decision on obviousness incorporates the subsidiary question of whether a petitioner has established that the asserted references are publicly accessible printed publications. This inquiry is part and parcel of the 103 determination, which involves not only the ultimate legal question of validity, but also the underlying factual question of the scope and content of the prior art. See, e.g., Power Integrations, 2018 WL 3892996, at *5 (concluding that a challenge to a non-institution decision based on a printed publication ruling involves no issues extraneous to the application of patent law principles of unpatentability based on printed publications ); see also Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 17 (1966) ( While the ultimate question of patent validity is one of law... the 103 condition... lends itself to several basic factual inquiries. Under 103, the scope and content of the prior art are to be determined.... ). Sandoz thus is wrong when it argues that the question of whether a reference qualifies as a prior-art printed publication is not closely related to the threshold patentability determination under 314(a). Resp. at 9-11. Accordingly, the Court also lacks jurisdiction over Sandoz s appeals because the Board s threshold merits determinations concerning the printed publication prior art issues 10

Case: 18-2142 Document: 20 Page: 17 Filed: 08/21/2018 were closely related to its non-institution decisions, which are unreviewable on appeal. The relief Sandoz seeks in these appeals makes clear that its complaints about the Board s analyses are actually challenges to the Board s non-institution decisions under 314(a). In its Docketing Statement filed with the Court, for example, Sandoz states the relief it seeks is [r]eversal of the PTAB s decisions denying institution of inter partes review. Dkt. 6 at 1. Thus, as in Power Integrations, Sandoz s arguments are designed to obtain a ruling from this court that will ultimately result in overturning the Board s non-institution decision. And, as to that relief, the bar to appeal [under 314(d)] is fatal.... 2018 WL 3892996, at *5; accord id. at *3 ( this Court has no reviewing authority over the agency s non-institution decision. ) III. Sandoz s Policy Arguments Likewise Fail to Confer Jurisdiction Unable to identify support for its contention that the Court has jurisdiction to hear its appeals, Sandoz resorts to policy arguments and unfounded criticisms of the USPTO. Resp. at 11-23. Sandoz argues, for example, that the Board somehow acted arbitrarily and capriciously in this case based on its decisions in other cases involving different parties and different facts. Resp. at 11-18. Referring to the Board s conclusions that Sandoz failed to follow the Board s well-established rules governing the contents of IPR petitions (e.g., 37 C.F.R. 42.6(a)(3) and 42.24(a)), Sandoz argues that the Board willfully ignored record evidence based on some 11

Case: 18-2142 Document: 20 Page: 18 Filed: 08/21/2018 purported requirement of a special incantation in the petition. Resp. at 21. The Court should reject these unsupported criticisms, which amount to no more than Sandoz s dissatisfaction with the Board s decisions not to institute review and are insufficient to establish jurisdiction. A. An APA Challenge Is Not an Independent Basis for Jurisdiction Both of Sandoz s petitions asserted obviousness based on a combination of five asserted prior-art references, several of which Sandoz failed to establish were publicly accessible printed publications. Dkt. 19-4; Dkt. 19-8. After AbbVie pointed to those failures in its Patent Owner Preliminary Responses (Dkt. 19-7 at 50-58; Dkt. 19-12 at 62-73), Sandoz sought to remedy the shortcomings of its petitions by seeking leave to file a reply to address public accessibility and by requesting an opportunity to take discovery from AbbVie regarding whether the public had access to two of the asserted references. The Board denied Sandoz s requests in both inter partes review proceedings. Dkt. 19-14; Dkt. 19-16 (denying-in-part with respect to public availability). It explained that Sandoz failed to establish good cause to file a reply because it could have reasonably foreseen the public-accessibility issue, particularly given that the statute specifies that a petitioner bears the burden of establishing unpatentability based exclusively on patents or printed-publication prior art. Dkt. 19-14 at 3-4; Dkt. 19-16 at 4-5. The Board denied Sandoz s request to take discovery as premature. Dkt. 19-14 at 4-6. The Board later declined to institute 12

Case: 18-2142 Document: 20 Page: 19 Filed: 08/21/2018 review in either case because Sandoz had not shown a reasonable likelihood of establishing that any challenged claim was unpatentable. Dkt. 19-17 at 6-10; Dkt. 19-19 at 7-15. From its own failures, Sandoz now concocts an apparent APA challenge, contending that the Board s decisions were arbitrary and capricious. See Resp. at 11-23. Sandoz further argues that this alleged error somehow establishes that this Court has jurisdiction over the Board s non-institution decisions. As explained above, however, the APA is not a jurisdiction-conferring statute. See supra I.A (discussing Califano, 430 U.S. at 105-107 and GTNX, 789 F.3d at 1313). It thus cannot provide an independent basis for this Court to review the Board s noninstitution decisions. Id. Further, none of the cases Sandoz cites stands for the proposition that a losing petitioner can establish this Court s jurisdiction over a non-institution decision merely by arguing that the Board acted arbitrarily and capriciously. Resp. at 20, 22. Indeed, the Altaire, Aqua Products, and Ultratech cases relied on by Sandoz were all appeals from final written decisions, and thus were authorized by statute. Altaire Pharms. Inc. v. Paragon Bioteck, Inc., 889 F.3d 1274, 1280 (Fed. Cir. 2018); Aqua Products, Inc. v. Matal, 872 F.3d 1290, 1296 (Fed. Cir. 2017) (en banc); Ultratech, Inc. v. Caption Call, LLC, 872 F.3d 1267, 1270 (Fed. Cir. 2017). Sandoz s apparent APA challenge thus cannot provide a basis for jurisdiction here. 13

Case: 18-2142 Document: 20 Page: 20 Filed: 08/21/2018 B. The Board s Decisions Were Neither Arbitrary Nor Capricious In any event, the Board s determinations were neither arbitrary nor capricious. The scope of review under the arbitrary and capricious standard is a narrow one. Bowman Transp., Inc. v. Arkansas-Best Freight Sys., Inc., 419 U.S. 281, 285 (1974). As this Court has recognized, this highly deferential standard is met only when a reviewing court concludes, with a definite and firm conviction, that the court or agency below committed a clear error of judgment. PGBA, LLC v. United States, 389 F.3d 1219, 1223-24 (Fed. Cir. 2004) (quoting Bandag, Inc. v. Al Bolser s Tire Stores, Inc., 750 F.2d 903, 917 (Fed. Cir. 1984)); see also In re Gartside, 203 F.3d 1305, 1312 (Fed. Cir. 2000). Sandoz identifies nothing arbitrary or capricious in the Board s decisions. Sandoz instead relies on several unrelated cases addressing the public-accessibility of different references on different factual records, which it contends illuminate the Board s alleged error. See Resp. at 11-23. But those cases stand for no more than the unremarkable proposition that the Board will deny institution when petitioners fail to meet their threshold burden, and that the Board will look more probingly at issues presented at institution when they are disputed by the parties. 2 See SAS Institute, 138 2 To the extent that Sandoz contends it is prejudiced by the Board s decisions in other cases, see Resp. at 19 n.12, Sandoz was aware of those cases and of its burden to establish public accessibility under this Court s well-established legal standards for proving printed publication art. Thus, far from establishing any legal error by the Board, those cases should have put Sandoz on notice of the appropriate ways that it 14

Case: 18-2142 Document: 20 Page: 21 Filed: 08/21/2018 S. Ct. at 1356 ( Nothing suggests the Director enjoys a license to depart from the petition and institute a different inter partes review ); Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016) ( It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify with particularity the evidence that supports the grounds for the challenge to each claim. (quoting 312(a)(3))); see also 37 C.F.R. 42.104(b)(2), (5). The cases Sandoz cites thus have no bearing on the propriety of the Board s conclusion that Sandoz failed to show a reasonable likelihood of success because it failed to establish that certain asserted references were publicly accessible printed publications. That Sandoz failed to meet its burden, and that the Board consequently denied institution, does not make either Board decision arbitrary. On the contrary, in another inter partes review that Sandoz filed against an AbbVie patent, the Board concluded that Sandoz s petition sufficiently established the public accessibility of the very same reference at issue in Sandoz s appeals. Sandoz Inc. v. AbbVie Biotech. Ltd, IPR2018-01166 (Paper 11) (P.T.A.B. June 5, 2018). 3 There, Sandoz submitted and cited additional information in support of its printed publication position. Id. at could have made a threshold showing of public accessibility. Instead, Sandoz adopted a de minimis approach falling well short of this guidance, failing to submit and cite adequate evidence. Dkt. 19-7 at 50-58; Dkt. 19-12 at 62-73. 3 The Board denied institution for other reasons. 15

Case: 18-2142 Document: 20 Page: 22 Filed: 08/21/2018 8-13. This belies any argument of arbitrariness and underscores the deficiencies in Sandoz s petitions here. Sandoz also erroneously contends that the Board s denials of its requests for a reply and for additional discovery compounded the arbitrary and capricious nature of the Board s decisions. Resp. at 19-22. As this Court noted in Power Integrations, however, entertaining these types of procedural complaints would amount to no more than a transparent means of avoiding the statutory prohibition on appellate review of agency institution decisions. 2018 WL 3892996, at *4. The Court thus reasoned that: A disappointed petitioner cannot by-pass the statutory bar on appellate review simply by directing its challenge to asserted procedural irregularities rather than to the substance of the non-institution ruling. Nothing in section 314(d) suggests that the prohibition on review applies only to the merits of the Board s non-institution decisions and leaves this court free to review the Board s decisions for perceived flaws in the way the Board analyzed the evidence before it. Id. The Court concluded that [t]o draw such a distinction would inevitably lead to this court s examination of the correctness of the Board s legal and factual conclusions, which is just what Congress sought to prohibit. Id. Moreover, Sandoz is incorrect that the Board committed any error. The Board reviewed all information and arguments in Sandoz s petitions and, consistent with the statute and regulations, issued thorough and well-reasoned decisions declining 16

Case: 18-2142 Document: 20 Page: 23 Filed: 08/21/2018 to institute review because Sandoz failed to meet its threshold burden. See Dkt. 19-17 at 6-10; Dkt. 19-19 at 7-15. The Board is not required to allow a petitioner to supplement a deficient petition in response to arguments raised in a patent owner preliminary response. 4 Indeed, a petitioner must show good cause to justify a reply, and discovery is limited under Board practice, with non-routine discovery granted only in the interests of justice. 37 C.F.R. 42.51(b), 42.108(c). The Board reasonably held that public accessibility was a foreseeable dispute and moreover that it considered the evidence of record on public accessibility. Dkt. 19-14 at 3-6; Dkt. 19-16 at 4-5. There was nothing arbitrary or capricious in the Board s decisions not to help Sandoz remedy its failures. CONCLUSION For these reasons, AbbVie respectfully requests that this Court dismiss Sandoz s appeals for lack of jurisdiction. 4 Further, to the extent Sandoz contends that justice demands taking discovery of AbbVie, Sandoz did not require discovery to submit public accessibility arguments in IPR2018-01166. See Resp. at 20. Sandoz was in a position to submit information and argument; it chose not to do so here. It must bear the consequences of its decisions. 17

Case: 18-2142 Document: 20 Page: 24 Filed: 08/21/2018 WILLIAM G. MCELWAIN AMY K. WIGMORE THOMAS G. SAUNDERS JOSHUA L. STERN WILMERHALE 1875 Pennsylvania Avenue, NW Washington, DC 20006 (202) 663-6000 Date: August 21, 2018 /s/ William B. Raich WILLIAM B. RAICH MICHAEL J. FLIBBERT CHARLES COLLINS-CHASE SYDNEY R. KESTLE FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP 901 New York Avenue, NW Washington, DC 20005-4413 (202) 408-4000 Attorneys for Appellee AbbVie Biotechnology Ltd 18

Case: 18-2142 Document: 20 Page: 25 Filed: 08/21/2018 CERTIFICATE OF SERVICE I hereby certify that a copy of the foregoing Appellee s Reply to Appellant Sandoz Inc. s Response to Order to Show Cause was served on counsel of record on August 21, 2018, by electronic means via the Court s CM/ECF system. William B. Raich Name of Counsel /s/ William B. Raich Signature of Counsel FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, L.L.P. 901 New York Avenue, NW Washington, DC 20001-4413 Phone: (202) 408-4210 Fax #: (202) 408-4400 E-Mail Address: william.raich@finnegan.com

Case: 18-2142 Document: 20 Page: 26 Filed: 08/21/2018 CERTIFICATE OF COMPLIANCE WITH TYPE-VOLUME LIMITATION, TYPEFACE REQUIREMENTS, AND TYPE STYLE REQUIREMENTS 1. This brief complies with the type-volume limitation of Federal Rule of Appellate Procedure 32(a). This brief contains 4,148 words, excluding the parts of the brief exempted by Federal Rule of Appellate Procedure 32(f) and Federal Circuit Rule 32(b). 2. This brief complies with the or typeface requirements of Federal Rule of Appellate Procedure 32(a)(5) and the type style requirements of Federal Rule of Appellate Procedure 32(a)(6). This brief has been prepared in a proportionally spaced typeface using Microsoft Word 2010 in 14 point font, Times New Roman. /s/ William B. Raich William B. Raich Attorney for Appellee AbbVie Biotechnology Ltd August 21, 2018