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Amneal Pharmaceuticals, LLC v. Endo Pharmaceuticals Inc.

Paper No. 15, June 27, 2014

IPR2014-00360 (Patent 8,329,216)


On January 16, 2014, Amneal filed a Petition requesting inter partes review of U.S. Patent No. 8,329,216 (“the ‘216 patent). See Paper 15, p.2. Patent Owner Endo Pharmaceuticals filed a Preliminary Response, assert that “the Petition is time-barred under 35 U.S.C. § 315(b).” Id. 35 U.S.C. § 315(b) disallows inter partes review 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.” Id. The PTAB ordered submission of additional briefing addressing “whether Petitioner was ‘served with a complaint’ alleging infringement of the ‘216 patent more than one year before the petition was filed.” Id.

The PTAB noted that Endo filed the initial complaint against Amneal on November 7, 2012 and then filed the First Amended Complaint on November 14, 2012 in the U.S. District Court for the Southern District of New York, “alleging infringement of patents other than the ‘216 patent.” Id. at p.3. The ‘216 patent issued to Endo on December 11, 2012, and Endo filed an Unopposed Motion to Amend Complaint Under Rule 15(a), including the proposed Second Amended Complaint as an Exhibit, on January 9, 2013 to add the ‘216 patent to Endo’s allegations of infringement against Amneal. Id. The court granted Endo’s motion on January 14, 2013, issuing an Order that required Endo to “file the Second Amended Complaint promptly” and “any proposed response to the Amended Complaint is due on February 14, 2013.” Id. Endo filed the Second Amended Complaint on January 17, 2013. Id.


Amneal “was not ‘served with a complaint’ alleging infringement of the ‘216 patent for the purposes of § 315(b) before January 17, 2013.” See Paper 15, p.10. Since Amneal filed its Petition for an inter partes review within one year of that date, on January 16, 2014, § 315(b) “does not bar institution based on the Petition in this case.” Id.


“The issue before [the PTAB] is whether [Amneal] was ‘served with a complaint’ alleging infringement of the ‘216 patent prior to January 16, 2013, which would bar petition under 35 U.S.C. § 315(b).” See Paper 15, p.4. In particular, the PTAB addressed whether the Motion to Amend Complaint on January 9, 2013 or the court Order granting the Motion on January 14, 2013 “constituted service of a ‘complaint,’ thereby triggering the one-year time bar under § 315(b).” Id. Endo argued that Amneal was served with a complaint on January 9, 2013, more than a year before January 16, 2014 – the date Amneal filed the Petition for inter partes review. Id. “[T]he district court provided a Notice of Electronic Filing (‘NEF’), via electronic mail, on January 9, 2013,” relating to the Motion to Amend Complaint. Id. at p.4-5. Endo pointed to a district court rule (Local Rule 9.1) on electronic filing, which provides that the “transmission of the NEF constitutes service upon all Filing and Receiving Users who are listed as recipients of notice by electronic mail.” Id. at p.5. Therefore, according to Endo, when the district court electronically mailed the Motion to Amend Complaint and Exhibit to Amneal, it “effected service of the Second Amended Complaint on January 9, 201[3].” Id. For the purposes of 35 U.S.C. § 315(b), Endo maintained that it only mattered that the Complaint was served on Amneal, and it do not matter that the Second Amended Complaint was not filed until January 17, 2013. Id.

Amneal responded that “filing and service of that Motion and Exhibit ‘cannot and did not trigger § 315(b).’” Id. Amneal argued that Endo did not have “the legal right to file or serve the Second Amended Complaint until the District Court granted it leave to do so on January 14, 2013.” Id. at p.5-6. Citing FRCP 15(a)(2), Amneal noted that a party is permitted to file an amended pleading “once as a matter of course,” but is required “in all other cases . . . [to] amend its pleading only with the opposing party’s written consent or court’s leave.” Id. at p.6. Amneal therefore contended that the one-year period under 35 U.S.C. § 315(b) did not begin until January 17, 2013, when Endo actually filed and served it Second Amended Complaint. Id.

In response, Endo pointed to cases from other district courts “that have based ‘service-dependent deadlines on the date the court granted the motion to amend’ a complaint, where the potion attached a ‘proposed’ amended complaint.” Id. According to Endo, “it properly served its [Second Amended Complaint] on [Amneal] when it served a copy of the proposed amended complaint on [Amneal] on January 9, 2013.” Id. Endo further contented that, as of January 14, 2013, “the Second Amended Complaint had legal effect because the court ordered [Amneal] to respond to it by February 14, 2013, . . . despite [Amneal’s] request to be given one month from the date of filing of the Second Amended Complaint to answer.” Id. Finally, Endo argued that service of the Second Amended Complaint was authorized because Amneal expressly consented to its filing. Id. at p.6-7.

The PTAB determined, in view of the record before it, that “on January 9, 2013, [Endo] served [Amneal] with a Motion to Amend Complaint seeking permission to file its Second Amended Complaint, but did not serve a ‘complaint’ for the purposes of § 315(b). Id. at p.7. The PTAB held that it did not believe “Congress intended to have the one-year time period start before a petitioner is officially a defendant in a law suit,” and as of January 9, 2013, Amneal was not yet formally a defendant in the law suit. Id. at p.8. The PTAB noted, for the purposes of FRCP 15(a)(2), Endo did not require Amneal’s written consent, since it had received the court’s leave to amend the pleading a second time. Id. Additionally, the court’s Order on January 14, 2013 that Endo had to file the Second Amended Complaint promptly “did not indicate that the Second Amended Complaint was filed or served on [Amneal] as of January 14, 2013, or retroactively on January 9, 2013.” Id. at p.9. Endo chose to file the complaint on January 17, 2013, and that was the date when Amneal was “brought under a court’s authority, by formal process, [and became] obligated to engage in litigation” in relation to the ‘216 patent. Id.

A copy of the PTAB order can be found here.