No. 21-202

Mylan Laboratories Ltd. v. Janssen Pharmaceutica, N.V., et al.

Lower Court: Federal Circuit
Docketed: 2021-08-12
Status: Denied
Type: Paid
Amici (3)Relisted (2)
Tags: 35-usc-314 35-usc-315 administrative-law appellate-jurisdiction inter-partes-review judicial-review nhk-fintiv-rule patent-trial-and-appeal-board patent-trial-and-appeals-board statutory-interpretation
Key Terms:
AdministrativeLaw Patent Trademark JusticiabilityDoctri
Latest Conference: 2022-01-14 (distributed 2 times)
Question Presented (AI Summary)

Does 35 U.S.C. § 314(d) categorically preclude appeal of all decisions not to institute inter partes review?

Question Presented (OCR Extract)

QUESTIONS PRESENTED The Director of the U.S. Patent and Trademark Office (acting through the Patent Trial and Appeals Board) has created a six-factor test known as the NHK-Fintiv Rule to determine whether to institute inter partes review in light of parallel infringement litigation pending in district court. Under NHKFintiv, the Board may deny a petition if it believes that the parallel litigation has may proceed too far for IPR to be of any efficient use. That is true even if the IPR petition is timely filed within one year of the petitioner being served with a patent-infringement complaint, 35 U.S.C. § 315(b), and otherwise complies with Congress’s express limitations related to co-pending litigation in other fora. The practical import of the NHK-Fintiv Rule is that it allows the Director to truncate the explicit time limit created by Congress. Indeed, the Board has wielded the NHK-Fintiv Rule to terminate scores of timely filed petitions since March 2020. Worse, this “rule” is not the product of a formal rulemaking, despite Congress’s command that the Director “prescribe regulations” setting forth the standards and rules governing the institution of IPR. 35 U.S.C. § 316(a). NHK-Fintiv is instead a creature of two precedential Board decisions from which it takes its name. It has never faced public comment, let alone judicial review. In this case, Petitioner appealed non-institution of its IPR petition under NHK-Fintiv because the rule exceeds the substantive and procedural limitations placed on the Director’s authority by Congress. Notwithstanding the general prohibition on appellate ii review of IPR institution decisions, 35 U.S.C. § 314(d), review is available to rein in the Director’s overreach, SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1359 (2018). The Federal Circuit refused to hear the appeal. But instead of deciding whether this case fell within the scope of SAS’s exception to the appellate bar, it construed § 314(d) as establishing a categorical rule that all non-institution decisions are nonappealable—in direct conflict with SAS. In light of this, the panel below said it had no jurisdiction under 28 U.S.C. § 1295(a)(4)(A), which otherwise provides the Federal Circuit authority to review an “appeal” from a “decision” of the Board “with respect to ... inter partes review.” The questions presented are: 1. Does 35 U.S.C. § 314(d) categorically preclude appeal of all decisions not to institute inter partes review? 2. Is the NHK-Fintiv Rule substantively and procedurally unlawful?

Docket Entries

2022-01-18
Petition DENIED. Justice Alito took no part in the consideration or decision of this petition.
2021-12-29
DISTRIBUTED for Conference of 1/14/2022.
2021-11-23
Rescheduled.
2021-11-16
DISTRIBUTED for Conference of 12/3/2021.
2021-11-16
Reply of petitioner Mylan Laboratories Ltd. filed. (Distributed)
2021-11-02
Brief of Federal Respondent in opposition filed.
2021-11-02
Brief of respondent Janssen Pharmaceutica NV in opposition filed.
2021-10-01
Motion to extend the time to file a response is granted and the time is further extended to and including November 2, 2021, for all respondents.
2021-09-30
Motion to extend the time to file a response from October 12, 2021 to November 2, 2021, submitted to The Clerk.
2021-09-13
Brief amicus curiae of Association for Accessible Medicines filed.
2021-09-13
Brief amicus curiae of Intel Corporation filed.
2021-08-25
Brief amicus curiae of Jeremy C. Doerre in support of neither party filed.
2021-08-19
Motion to extend the time to file a response is granted and the time is extended to and including October 12, 2021, for all respondents.
2021-08-18
Motion to extend the time to file a response from September 13, 2021 to October 12, 2021, submitted to The Clerk.
2021-08-09
Petition for a writ of certiorari filed. (Response due September 13, 2021)

Attorneys

Andrew Hirshfeld
Elizabeth B. PrelogarSolicitor General, Respondent
Elizabeth B. PrelogarSolicitor General, Respondent
Association for Accessible Medicines
Matthew S. HellmanJenner & Block LLP, Amicus
Matthew S. HellmanJenner & Block LLP, Amicus
Intel Corporation
Donald B. Verrilli Jr.Munger, Tolles & Olson LLP, Amicus
Donald B. Verrilli Jr.Munger, Tolles & Olson LLP, Amicus
Janssen Pharmaceutica NV
Pratik Arvind ShahAkin Gump Strauss Hauer & Feld, LLP, Respondent
Pratik Arvind ShahAkin Gump Strauss Hauer & Feld, LLP, Respondent
Jeremy C. Doerre
Jeremy Cooper DoerreTillman Wright, PLLC, Amicus
Jeremy Cooper DoerreTillman Wright, PLLC, Amicus
Mylan Laboratories Ltd.
Robert Thomas SmithKatten Muchin Rosenman LLP, Petitioner
Robert Thomas SmithKatten Muchin Rosenman LLP, Petitioner