Paliperidone – USA

Paliperidone – USA

On Mar. 12, 2021, Federal Circuit affirmed PTAB’s decision denying Mylan’s IPR petition based on concurrent Hatch-Waxman litigation.


Mylan filed IPR (2020-00440) for US 9,439,906 patent which is listed in Orange Book (OB) against INVEGA SUSTENNA (Paliperidone ER) injection. US’906 relates to dosing regimen associated with long acting injectable paliperidone esters. 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. It argued the validity issues in those co-pending actions overlapped with Mylan’s petition and that both actions would likely reach final judgment be-fore any IPR final written decision. PTAB agreed with Janssen & denied the institution based on Fintiv factors [Apple v. Fin-tiv, IPR2020-00019, 2020 WL 2126495 (P.T.A.B. Mar. 20, 2020)].

Mylan appealed. Mylan argued that denial of institution based on third party’s litigation undermines Petitioner’s constitutional and other due process rights. Application of non-statutory institution standards through ad hoc proceedings lie in contrast to congressional intent. Janssen’s motion implicated two distinct jurisdictional questions: first, whether CAFC has jurisdiction over Mylan’s direct appeal, and second, whether CAFC has jurisdiction over Mylan’s request for mandamus.


Jurisdiction over Mylan’s direct appeal:

Court said that 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. Moreover, St. Jude Medical, Cardiology Division, Inc. v. Volcano Corp., 749 F.3d 1373 (Fed. Cir. 2014) recognized the limits § 314(d) places on § 1295 jurisdiction. There, CAFC held that it may not hear [an] appeal from the Director’s denial of [a] petition for inter partes review.”

§ 314(d): No Appeal. The determination by the Director whether to institute an inter partes re-view under this section shall be final and non-appealable.

Court said that 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).” This is not a final written decision. Therefore, no statute confers jurisdiction over appeals from decisions denying institution.  Court thus granted Janssen’s motion and dismissed Mylan’s direct appeal.


Jurisdiction over Mylan’s request for mandamus:

Court said that statute is silent with respect to mandamus. There is no reason, therefore, to think § 314(d) also divests court of mandamus jurisdiction. In fact, when the Board denies institution, court’s mandamus jurisdiction is especially important. Court said that challenges to the denial of institution fall within the TRAC rubric. To protect future jurisdiction, this court have jurisdiction to review any petition for a writ of mandamus denying institution of an IPR. Therefore, Mylan triggered our exclusive jurisdiction by petitioning for IPR.

But the question here is that whether Mylan is entitled to mandamus relief based on its statutory and constitutional challenges. Court said that mandamus is a “drastic and extraordinary remedy reserved for really extraordinary causes.” [Cheney v. U.S. Dist. Court for D.C., 542 U.S. 367, 380 (2004)]. Only exceptional circumstances amounting to a judicial usurpation of power, or a clear abuse of discretion will justify such relief. When a mandamus petition challenges a decision denying institution, the mandamus standard will be especially difficult to satisfy. Because the scope of review of a mandamus petition over a denial of institution is very narrow. As the Supreme Court has explained, “the [Patent Office]’s decision to deny a petition is a matter committed to the Patent Office’s discretion. It is difficult to imagine a mandamus petition that challenges a denial of institution and identifies a clear and indisputable right to relief. Certainly, this is not such a petition. Mylan lacks a clear and indisputable right to review of the Patent Office’s determination to apply the Fintiv factors or the Patent Office’s choice to apply them in this case through adjudication rather than notice-and-comment rule-making. Given the limits on reviewability, Mylan’s ultra vires argument cannot be a basis for granting the petition for mandamus.


Federal Circuit thus concluded that it lacked jurisdiction over Mylan’s direct appeal over denial of institution. Though it had jurisdiction over its request for mandamus, Mylan has failed to show a clear right to relief.

Leave a Reply

Leave a Reply

Your email address will not be published. Required fields are marked *

All content provided on this blog is for informational purposes only. By using the blog, you agree that the information on this blog does not constitute legal or other professional advice on author's or on his company's behalf.

Copyrights 2024 Pharma IP Circle. All Rights Reserved