Amneal v. Endo (IPR2014-00360): A Proposed Amended Complaint Does Not Start the § 315(b) Clock

Under 35 U.S.C. § 315(b), an inter partes review may not be instituted on a petition filed more than one year after the petitioner, its real party in interest or a privy “is served with a complaint alleging infringement of the patent.” Amneal Pharmaceuticals, LLC v. Endo Pharmaceuticals Inc., IPR2014-00360, addressed what counts as that service when a patent is added to an existing lawsuit by amendment. Paper 15, entered June 27, 2014, carries a notation that it was designated on January 10, 2018, and it is listed here with the Board’s informative decisions.

Background

Endo sued Amneal in the Southern District of New York in November 2012 on other patents. Endo’s U.S. Patent No. 8,329,216 issued on December 11, 2012. The key dates that followed were:

Date	Event
January 9, 2013	Endo filed and electronically served an unopposed motion for leave to amend, attaching a proposed second amended complaint adding the ’216 patent
January 14, 2013	The court granted the motion, directed Endo to file the amended complaint “promptly” and set a response date
January 17, 2013	Endo filed the second amended complaint
January 16, 2014	Amneal filed its IPR petition

If service of the motion on January 9, or the court’s order on January 14, counted as service of a complaint, the petition was a few days late. If the clock started on January 17, it was timely. The Board ordered additional briefing on the question.

What the Board decided

The Board held that § 315(b) did not bar the petition. The decision addressed only the time bar, leaving institution on the merits for a separate decision.

• A proposed complaint is not a complaint. On January 9, Endo had only asked for permission to file. The attachment was a proposed pleading, and Amneal was not yet a defendant as to the ’216 patent. Under Federal Rule of Civil Procedure 15(a)(2), Endo needed consent or leave to amend, and it had chosen to seek the court’s leave, leaving the matter in the court’s hands.
• The order granting leave was not service either. The January 14 order told Endo to file promptly; it did not treat the complaint as filed or served on that date or retroactively. Endo could have filed sooner but chose January 17.
• Formal process is the trigger. The Board relied on its earlier statement in Motorola Mobility v. Arnouse that Congress did not intend the period to start before a petitioner is officially a defendant, and on the Supreme Court’s “bedrock principle” in Murphy Bros. v. Michetti Pipe Stringing (1999) that a named defendant need not engage in litigation until brought under the court’s authority by formal process.

Amneal became obliged to litigate the ’216 patent on January 17, 2013, so a petition filed January 16, 2014 was within the one-year period.

Why it matters

The § 315(b) bar is strict, and a single day can decide whether a petition can be heard. Amneal gives a clear rule for the common situation in which a newly issued patent is added to pending litigation: the clock runs from service of the operative amended complaint, not from service of a motion seeking leave to file it. The decision is also a reminder that the bar runs from service on the petitioner, any real party in interest or any privy, so petitioners should track every relevant complaint. See also the basics of an IPR petition.

Later developments

The Federal Circuit, sitting en banc on the point in Click-to-Call Technologies, LP v. Ingenio, Inc. (Fed. Cir. 2018), held that the § 315(b) period is triggered by service of a complaint even if the action is later voluntarily dismissed without prejudice. In Thryv, Inc. v. Click-To-Call Technologies, LP (2020), the Supreme Court held that the Board’s application of § 315(b) when instituting review cannot be challenged on appeal. See the Oracle v. Click-to-Call note. Designations can change, so readers should check the USPTO’s list of precedential and informative decisions.

Key takeaways

• In Amneal v. Endo, IPR2014-00360, Paper 15, the Board held the petition was not time-barred.
• Serving a motion for leave with a proposed amended complaint attached is not service of a complaint under § 315(b).
• An order granting leave to amend did not start the period either; filing and service of the amended complaint did.
• Under Thryv (2020), the Board’s time-bar rulings at institution are not appealable, so the Board’s reading is usually final.