Mylan Labs. Ltd. v. Janssen Pharmaceutica, N.V.

989 F.3d 1375

MYLAN LABORATORIES LTD., Appellant

v.JANSSEN PHARMACEUTICA, N.V., Appellee

Andrew Hirshfeld, Performing the Functions and Duties of the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, Intervenor

2021-1071

United States Court of Appeals, Federal Circuit.

March 12, 2021

Deepro Mukerjee, Katten Muchin Rosenman LLP, New York, NY, argued for appellant. Also represented by Lance Soderstrom ; Johnjerica Hodge, Eric Thomas Werlinger, Washington, DC; Jitendra Malik, Charlotte, NC.

Pratik A. Shah, Akin Gump Strauss Hauer & Feld LLP, Washington, DC, argued for appellee. Also represented by Z.W. Julius Chen; Ruben H. Munoz, Philadelphia, PA; Andrew D. Cohen, Barbara Mullin, Patterson Belknap Webb & Tyler LLP, New York, NY.

Melissa N. Patterson, Appellate Staff, Civil Division, United States Department of Justice, Washington, DC, argued for intervenor. Also represented by Weili J. Shaw; Michael S. Forman, Mary L. Kelly, Thomas W. Krause, Farheena Yasmeen Rasheed, Molly R. Silfen, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA.

Before Newman, Moore, and Stoll, Circuit Judges.

ORDER

Moore, Circuit Judge.

Mylan Laboratories Ltd. appeals a Patent Trial and Appeal Board (Board) decision that denied institution of inter partes review (IPR) for U.S. Patent No. 9,439,906. Mylan Labs. Ltd. v. Janssen Pharmaceutica, N.V. , No. IPR2020-00440, 2020 WL 5580472 (P.T.A.B. Sept. 16, 2020) ( Board Decision ). It also seeks mandamus relief.¹ Janssen, the patent owner, moves to dismiss Mylan's appeal for lack of jurisdiction. The United States Patent and Trademark Office (Patent Office) intervened and supports Janssen's motion. Because we lack jurisdiction over appeals from decisions denying institution, we grant Janssen's motion to dismiss. Although we have jurisdiction over mandamus petitions challenging such decisions, Mylan has not shown it is entitled to such an extraordinary remedy. Thus, we dismiss Mylan's appeal and deny its request for mandamus.

BACKGROUND

In 2019, Janssen sued Mylan in district court for infringing certain claims in the ’906 patent. Less than six months later, Mylan petitioned for IPR of that patent. It raised four grounds for the unpatentability of certain claims, all based on 35 U.S.C. § 103. Opposing institution, Janssen claimed IPR would be an inefficient use of Board resources because of two co-pending district court actions: the suit against Mylan and another suit against Teva Pharmaceuticals USA, Inc. It argued the validity issues in those co-pending actions overlapped with Mylan's petition and that both actions would likely reach final judgment before any IPR final written decision.

The Board agreed with Janssen and denied institution. Board Decision, at *1–11. In exercising its discretion, the Board applied its six-factor standard for evaluating whether to deny institution in view of an earlier trial date in a co-pending district court proceeding. See Apple v. Fintiv , IPR2020-00019, 2020 WL 2126495 (P.T.A.B. Mar. 20, 2020) (precedential) (the Fintiv factors² ). It found substantial overlap between the issues raised in Mylan's IPR petition and the co-pending district court actions. It also found both district court actions would likely reach final judgement before any final written decision.

The Board, in part, relied on the Teva trial date, which was only a few weeks away. Thus, the Board concluded it would be an inefficient use of resources to institute IPR.

Mylan appeals. It claims "(1) that the Board's determination to deny institution ... based on the timing of a separate district-court litigation to which Petitioner is not a party, undermines Petitioner's constitutional and other due process rights; and (2) the Board's continued adoption and application of non-statutory institution standards through ad hoc proceedings lie in contrast to congressional intent." Notice of Appeal at 1. It also requests mandamus relief on the same grounds.

DISCUSSION

Janssen's motion implicates two distinct jurisdictional questions: first, whether we have jurisdiction over Mylan's direct appeal, and second, whether we have jurisdiction over Mylan's request for mandamus. We address each question in turn.

I

The jurisdiction of federal courts is limited to those cases and controversies delineated in Article III of the Constitution. And the "[j]urisdiction of the lower federal courts is further limited to those subjects encompassed within a statutory grant of jurisdiction." Ins. Corp. of Ireland v. Compagnie des Bauxites de Guinee , 456 U.S. 694, 701, 102 S.Ct. 2099, 72 L.Ed.2d 492 (1982). Because no statute grants us jurisdiction over appeals from decisions denying institution, we must dismiss Mylan's direct appeal.

Our general grant of jurisdiction, 28 U.S.C. § 1295(a)(4), and the appeal bar, 35 U.S.C. § 314(d), are most relevant here. Read together, those statutes preclude direct appeal from a decision denying institution:

• § 1295(a)(4) : [We] shall have exclusive jurisdiction ... of an appeal from a decision of [Board] with respect to ... inter partes review ....

• § 314(d) : No Appeal . The determination by the Director whether to institute an inter partes review under this section shall be final and nonappealable .

(emphases added). At a first glance, the "appeal from a decision" language in § 1295(a)(4) seems broad, perhaps broad enough to reach an appeal from a decision denying institution. But § 314(d), the more specific statute, dispels any such notion. See, e.g. , Morales v. Trans World Airlines, Inc. , 504 U.S. 374, 384, 112 S.Ct. 2031, 119 L.Ed.2d 157 (1992) ("[I]t is a commonplace of statutory construction that the specific governs the general."). Section 314(d) prevents "appeal" from a decision denying institution. Without the ability to "appeal," parties cannot make use of § 1295(a)(4) ’s jurisdictional grant.

Our decision in St. Jude Medical, Cardiology Division, Inc. v. Volcano Corp. , 749 F.3d 1373 (Fed. Cir. 2014) recognized the limits § 314(d) places on our § 1295 jurisdiction. There, we held "that we may not hear [an] appeal from the Director's denial of [a] petition for inter partes review." Id. at 1375. We relied "on the structure of the [IPR] provisions, on the language of section 314(d) within that structure, and on our jurisdictional statute read in light of those provisions." Id. Specifically, we determined that § 314(d) barred "an appeal of the non-institution decision" at issue.

Id. at 1376.³

Mylan argues the Supreme Court has undermined St. Jude , but that is not so. Every relevant Supreme Court case involved an appeal from a final written decision—not an institution decision. In that posture, 35 U.S.C. § 319 provided jurisdiction: "a party dissatisfied with the final written decision of the [Board] ... may appeal ...." So there was no reason to consider how § 314(d) affects § 1295(a)(4). When the Supreme Court discussed decisions denying institution, however, it suggested such decisions are unreviewable. In Cuozzo Speed Technologies, LLC v. Lee , ––– U.S. ––––, 136 S. Ct. 2131, 2140, 195 L.Ed.2d 423 (2016), the Court noted that decisions denying institution are "committed to agency discretion." Id. (citing 5 U.S.C. §§ 701(a)(2) and 35 U.S.C. § 314(a) ). That suggests that, consistent with St. Jude , decisions denying institution are not subject to review on direct appeal.

To be sure, the Supreme Court has recognized and relied upon the "strong ‘presumption in favor of judicial review.’ " SAS Inst. Inc. v. Iancu , ––– U.S. ––––, 138 S. Ct. 1348, 1359, 200 L.Ed.2d 695 (2018) (quoting Cuozzo , 136 S. Ct. at 2140 ). But that does not undermine St. Jude or our reasoning here. Section 314 bars direct appeal from a decision denying institution.

No other statute provides jurisdiction over Mylan's appeal. First, 35 U.S.C. § 319 is limited to "final written decisions under section 318(a)." It does cross reference other statutes, 35 U.S.C. § 141 – 44, but nothing in the cross-referenced statutes broadens § 319 ’s plain language. See id. § 141(c) (allowing appeal of "final written decision ... under section 318(a)"). This is not a final written decision. Second, the Administrative Procedure Act, 5 U.S.C. § 701 – 706, cannot confer jurisdiction over decisions denying institution. GTNX, Inc. , 789 F.3d at 1313 (holding the APA "is not a jurisdiction-conferring statute" (internal quotation omitted)). Nor could it overcome § 314(d) ’s specific bar on appeals from institution decisions. Morales , 504 U.S. at 384, 112 S.Ct. 2031 (holding "the specific governs the general").

Therefore, no statute confers jurisdiction over appeals from decisions denying institution. Without such a statute, we lack jurisdiction over those appeals. See Ins. Corp. of Ireland , 456 U.S. at 701, 102 S.Ct. 2099. Accordingly, we grant Janssen's motion and dismiss Mylan's direct appeal.

II

While there is no avenue for direct appeal of decisions denying institution, we conclude that judicial review is available in extraordinary circumstances by petition for mandamus. Mandamus is not a remedy unique to our Court. The All Writs Act provides that "the Supreme Court and all courts established by an Act of Congress may issue all writs necessary or appropriate in aid of their respective jurisdictions ...." 28 U.S.C. § 1651(a). We have long known the All Writs Act "does not expand a court's jurisdiction." See, e.g. , Cox v. West , 149 F.3d 1360, 1363 (Fed. Cir. 1998). It is, however, "well settled that ‘the authority of the appellate court is not confined to the issuance of writs in aid of jurisdiction already acquired by appeal but extends to those cases which are within its appellate jurisdiction although no appeal has been perfected.’ " Telecomms. Rsch. & Action Ctr. v. F.C.C. , 750 F.2d 70, 76 (D.C. Cir. 1984) ( TRAC ) (quoting F.T.C. v. Dean Foods Co. , 384 U.S. 597, 603–04, 86 S.Ct. 1738, 16 L.Ed.2d 802 (1966) ). "In other words, ...