By Lin Yu, Ph.D. and Cary Miller, Ph.D.

In IPR2017-01054 and IPR2017-01055 (Fresenius Kabi USA, LLC v. Hospira Inc.), the PTAB denied institution of inter partes reviews of U.S. Patent Nos. 8,242,158 and 8,338,470, because Petitioner Fresenius filed the IPR petitions more than one year after being served with a patent infringement complaint; and there was no instituted IPR proceeding for Petitioner to join to save the untimely IPR petitions.

Section 315(b) bars IPR institution when an IPR petition is filed more than one year after the petitioner is served with a patent infringement complaint.  35 U.S.C. § 315(b); 37 C.F.R. § 42.101(b).  The one-year bar may not apply to an untimely filed IPR petition if it is accompanied by a timely joinder motion.  35 U.S.C. § 315(b); 37 C.F.R. § 42.122(b) (“The time period set forth in § 42.101(b) should not apply when the petition is accompanied by a request for joinder.”).

Hospira sued Amneal Pharmaceuticals LLC and Fresenius for infringing the ’158 and ’470 patents.  On January 15, 2016, Hospira served a patent infringement complaint on Fresenius.  On February 9, 2017, the PTAB instituted two IPRs filed by Amneal.  On March 8, 2017, that is, within a month of the Amneal IPR institution decisions, Fresenius filed the two IPRs, each accompanied by a timely motion to join one of the Amneal IPRs.  37 C.F.R. § 42.122(b) (“Any request for joinder must be filed . . . no later than one month after the institution date of any inter partes review for which joinder is requested.”).  The Fresenius two IPRs were filed outside the one year window imposed by Section 315(b).  On May 19 and 26, 2017, the PTAB terminated the two Amneal IPRs after Hospira settled with Amneal.  On September 6, 2017, the PTAB declined to institute the two Fresenius IPRs.

In its decisions, the PTAB first dismissed the joinder motions as moot because there were no instituted IPRs for Fresenius to join and then held that the Fresenius IPRs were statutorily barred under Section 315(b).  In a concurring opinion, Judge Fitzpatrick wrote that “I would deny the Petition as time-barred irrespective of whether the Motion for Joinder was filed, let alone granted.  The Motion for Joinder is not relevant to whether the Petition is time-barred under § 315(b).”  However, Judge Fitzpatrick’s strict reading of Section 315(b) is inconsistent with the majority opinion in Zhongshan Broad Ocean Motor Co., Ltd. v. Nidec Motor Corp., IPR2015-00762, where an expanded 5-judge panel with two judges dissenting held that the joinder statute Section 315(c) allows joinder of issues, not just parties, even when the joinder allows a petitioner to avoid the one-year deadline.  Id., Paper 16 at 6-9.

It is worth noting that the PTAB’s institution decisions based on the one-year statutory bar are final and nonappealable.  35 U.S.C. § 314(d); Achates Reference Publ’g, Inc. v. Apple Inc., 803 F.3d 652, 657-658 (Fed. Cir. 2015), cert. dismissed, 136 S.Ct. 998 (2016).  At the moment, “Achates remains good law.”  Click-to-call Technologies, LP v. Oracle Corp., No. 2015-1242 (Fed. Cir. Nov. 17, 2016).  However, an en banc decision by the Federal Circuit on whether the 1-year IPR statutory bar is appealable is expected later in 2017.  Wi-Fi One, LLC v. Broadcom Corp., No. 2015-1944, -1945, -1945 (Fed. Cir. Jan. 4, 2017).

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Dr. Cary Miller’s practice focuses on assisting life sciences clients with their patent issues. She works with clients in patent prosecution, prelitigation analysis, PTAB proceedings, and patent litigation. Prior to joining Jones Day, Cary participated in numerous biotechnology and pharmaceutical patent lawsuits including representing companies in Hatch-Waxman litigation, biosimilars litigation, and in litigation relating to DNA sequencing.