UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`AMNEAL PHARMACEUTICALS, LLC
`Petitioner
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`v.
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`ENDO PHARMACEUTICALS INC.
`Patent Owner
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`_____________________
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`CASE IPR2014-00360
`U.S. Patent 8,329,216 B2
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`PETITIONER’S REPLY BRIEF ON 35 U.S.C. § 315(b)
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`AMNEAL PHARMACEUTICALS, LLC
`Petitioner
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`v.
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`ENDO PHARMACEUTICALS INC.
`Patent Owner
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`_____________________
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`CASE IPR2014-00360
`U.S. Patent 8,329,216 B2
`_____________________
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`PETITIONER’S REPLY BRIEF ON 35 U.S.C. § 315(b)
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`IPR2014-00360
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`Patent Owner’s argument that the Petition is time-barred under 35 U.S.C. §
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`315(b) lacks any legal or factual support. It is black letter law that a complaint
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`needs to have been filed and served in order to trigger the time-bar for filing a
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`petition for inter partes review. Here, the only pleading filed and served on
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`January 9, 2013 was Patent Owner’s motion for leave to amend its complaint.
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`Indeed, Patent Owner did not even have the legal right to file or serve the Second
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`Amended Complaint (“SAC”) until the District Court granted it leave to do so on
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`January 14, 2013. Pursuant to the Court’s Order, Patent Owner subsequently filed
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`and served the SAC on January 17, 2013, less than one year before the petition was
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`filed. Accordingly, Patent Owner’s § 315(b) argument is without merit.
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`Factual Background
`On November 7, 2012, Patent Owner filed a complaint against Petitioner in
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`the Southern District of New York alleging infringement of certain patents not at
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`issue in this inter partes review. EX2001. On November 14, 2012, Patent Owner
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`filed an Amended Complaint. EX2002. On January 9, 2013, Patent Owner filed
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`and served an Unopposed Motion to Amend Complaint Under Rule 15(a) seeking
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`leave from the Court to allege infringement of U.S. Patent No. 8,329,216 (“the
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`‘216 patent”). EX2004. Patent Owner attached as Exhibit 1, a document described
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`as the “Proposed” SAC, to that motion. EX2008, at 17. On January 14, 2013, the
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`Court granted the motion and ordered the plaintiffs to “file the [SAC] promptly.”
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`IPR2014-00360
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`EX2006. On January 17, 2013, Patent Owner filed and served the SAC. Petitioner
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`then filed its Petition on January 16, 2014, less than one year after service of the
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`complaint. See Papers 1 and 4.
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`I.
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`Argument
`The SAC Could Not Have Been Filed And Served Until The
`District Court Granted Leave To Patent Owner To Do So
`The one-year period under § 315(b) for filing the Petition did not begin until
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`January 17, 2013, the date that Patent Owner filed and served the SAC alleging
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`infringement of the ‘216 patent. This conclusion is dictated by the plain language
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`of the statutory text, which provides in operative part that an inter partes review
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`“may not be instituted if the petition requesting the proceeding is filed more than 1
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`year after the date on which the petitioner … is served with a complaint alleging
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`infringement of the patent.” (emphasis added). The Board has interpreted §315(b)
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`to “limit its applicability to when the patent owner brings a civil action for patent
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`infringement.” Amkor Tech,. Inc. v. Tessera, Inc., IPR2013-00242, Paper 98 at 8-9.
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`It is a basic principle of law that a “civil action is commenced by filing a complaint
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`with the court.” Fed. R. Civ. P. 3. And § 315(b) requires that a complaint be filed
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`and served before the one-year time period for filing an inter partes review is
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`triggered. Motorola Mobility LLC v. Arnouse, IPR2013-00010, Paper 20 at 6.
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`Patent Owner attempts to invoke § 315(b) by arguing that it triggered the
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`one-year time period on January 9, 2013, by merely filing a motion to amend and
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`IPR2014-00360
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`attaching its Proposed SAC. But what Patent Owner neglects to mention is that it
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`did not have the legal right to file or serve the new complaint until after the
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`District Court granted it leave to do so.
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`“In general, if an amendment that cannot be made as of right is served
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`without obtaining the court’s leave or the opposing party’s consent, it is without
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`legal effect and any new matter it contains will not be considered unless the
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`amendment is resubmitted for the court’s approval.” Wright & Miller, 6 Fed. Prac.
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`& Proc. Civ. § 1484 (3d ed. 2014). Thus, Patent Owner’s Proposed SAC was
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`“without legal effect” until the Court gave it leave to file and serve the SAC and
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`Patent Owner actually filed and served the SAC on January 17, 2013. Gaumont v.
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`Warner Bros. Pictures, 2 F.R.D. 45, 46 (S.D.N.Y. 1941). Patent Owner cites no
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`authority to the contrary.
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`The fact that Patent Owner required leave of the Court before filing the SAC
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`is dispositive here. Fed. R. Civ. P. 15 which governs the amending of pleadings
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`permits a party to file an amended pleading “once as a matter of course,” Fed. R.
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`Civ. P. 15(a)(1), and requires that “in all other cases, a party may amend its
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`pleading only with the opposing party’s written consent or court’s leave.”
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`(emphasis added). Fed. R. Civ. P. 15(a)(2). Because Patent Owner had amended
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`the complaint once already (see EX2002), it required the Court’s leave under Rule
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`15(a)(2) before it could amend the complaint again. And it was under this rule that
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`IPR2014-00360
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`Patent Owner filed a motion asking the Court for leave to amend its complaint, set
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`forth the reasons why the Court should grant its motion and attached the Proposed
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`SAC as an exhibit to its motion. Once the District Court granted Patent Owner’s
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`motion, Patent Owner filed and served the SAC. Carter v. Church, 791 F. Supp.
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`297, 298 (M.D. Ga. 1992) (holding that Rule 15 “must be read to require that an
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`amended complaint be filed after leave to amend is granted”).
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`II.
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`Fed. R. Civ. P. 5(d)(1) and The Southern District of New York’s
`Rules Are Inapplicable To This Situation
`Patent Owner’s citations to Fed. R. Civ. P. 5(d)(1) and SDNY’s rules are
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`merely red herrings. Rule 5(d)(1) allows certain papers to be filed after being
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`served and would be applicable here only if Patent Owner had actually served the
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`SAC when it served its motion to amend. But as discussed supra, Patent Owner did
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`not effect service of the SAC until after the court granted it leave to do so.
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`Similarly, the SDNY’s rules on electronic filing (EX2009 at §9.1) concern
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`only the method of electronic service and are not relevant to the dispute here.
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`Petitioner does not dispute that on January 9, 2013, Patent Owner served its motion
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`and attached the Proposed SAC as an exhibit. But the filing and service of a
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`motion to amend cannot and did not trigger § 315(b) for the above reasons.
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`Section 315(b) Is Not Based on the Notice Function
`III.
`Contrary to Patent Owner’s contention, Section 315(b) is not based on a
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`mere notice function. (See POPR at 11). The Board has previously examined the
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`IPR2014-00360
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`relevant legislative history and concluded that the statute should be interpreted in a
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`way that would allow the defendant in an action “sufficient time to analyze the
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`patent claims so that they can decide whether to challenge the patentability of the
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`claims in an inter partes review.” Motorola, Paper 20, at 5. Consequently, the
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`Board has previously rejected the argument that the “mere receipt of a complaint
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`initiates the one-year time period.” Id. at 3.
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`In the present case, the District Court could have delayed ruling on Patent
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`Owner’s motion for weeks or even denied the motion. Patent Owner’s construction
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`of the statute would have “effectively shorten[ed] the one-year time period that the
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`Congress had carefully negotiated during the legislative process” for the Petitioner.
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`Id. at 6. Moreover, Patent Owner could have changed its mind and decided never
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`to file the SAC even after seeking leave of the Court. In that case, under Patent
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`Owner’s construction, the one-year bar against Petitioner would have begun even
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`though the ‘216 patent was never part of the civil action. Such a conclusion would
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`be completely inconsistent with legislative intent.
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`Respectfully submitted,
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`Date: May 15, 2014
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`STERNE, KESSLER, GOLDSTEIN
`& FOX P.L.L.C.
`1100 New York Avenue, N.W.
`Washington, D.C. 20005 - 3934
`(202) 371-2600
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`/Eldora L. Ellison/
`Eldora L. Ellison
`Lead Attorney for Petitioner Amneal
`Registration No. 39,967
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`IPR2014-00360
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`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
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`The undersigned hereby certifies that the above-captioned Amneal
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`Pharmaceuticals’ PETITIONER’S REPLY BRIEF ON 35 U.S.C. § 315(b) was
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`served in its entirety on May 15, 2014, upon the following parties by email:
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`jmahoney@mayerbrown.com
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`ejpalmer@mayerbrown.com
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` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
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`Date: May 15, 2014
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`1100 New York Avenue, N.W.
`Washington, D.C. 20005 - 3934
` (202) 371-2600
`1849521_1.DOC
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`/Eldora L. Ellison/
`Eldora L. Ellison
`Lead Attorney for Petitioner Amneal
`Registration No. 39,967
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