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Amneal Pharmaceuticals, LLC v. Endo Pharmaceuticals Inc.

Paper 15, June 27, 2014

IPR2014-00360 (Patent 8,329,216 B2)


[The one-year time bar for IPR starts with filing of the amended complaint that includes patent at issue]




Patent Owner (PO) Endo Pharm. filed a complaint against Petitioner Amneal Pharm. on November 7, 2012, and then an amended complaint on November 14, 2012 in S.D. of N.Y. with respect to different patents.  The ‘216 patent issued on December 11, 2012. On January 9, 2013, PO Endo filed an “Unopposed Motion to Amend Complaint Under Rule 15(a)” (Motion), which added the ‘216 patent to the infringement suit. The court granted the Motion on January 14, 2013, authorizing the PO to file an amended complaint. Thereafter, Endo filed its Second Amended Compliant on January 17, 2013.


Amneal requested an IPR of a patent owned by Endo Pharm. on January 16, 2014.  Endo filed a Patent Owner Preliminary Response (POPR) asserting the Petition was time-barred under 35 U.S.C. § 315(b), which provides an IPR may not be instituted based on a petition “filed more than 1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent.”  After a conference call with the Board on May 7, 2014, additional briefing was provided by the parties.  Amneal filed a Reply (Paper 11) and Endo filed a Surreply (Paper 14).


Was the Petitioner “served with a complaint” alleging infringement prior to January 16, 2013? The answer is “no”.




Petitioner was not “served with a complaint” alleging infringement of the ‘216 patent for the purposes of 35 U.S.C. § 315(b) before January 16, 2014.


Various provisions of local court rules and the Federal Rules of Civil Procedure were cited.  Petitioner acknowledged that PO did not “have the legal right to file or serve the Second Amended Complaint under the district court granted it leave to do so.  Paper 15 at 5.


On January 9, 2013, PO served Petitioner with a Motion to Amend Complaint seeking permission to file its Second Amended Complaint, but did not serve a “complaint” for purposes of 315(b).  Paper 15 at 7.  When the Motion to Amend Complaint was filed, Petitioner was not yet a defendant with respect to the ‘216 patent.  Further, Petitioner was not “served with a complaint” when the district granted the PO’s Motion to Amend Complaint on January 14, 2013.



  • For an existing infringement suit, the date of the amended complaint is filed to include a patent later at issue in the IPR is the trigger date of the one-year time bar.
  • A district court’s grant of a PO Motion to Amend Complaint is not the trigger date as well. The actual filing date of the amended complaint is the trigger date.

The PTAB Order can be found here.