UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
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`AUROBINDO PHARMA U.S.A., INC.,
`Petitioner,
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`v.
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`ASTRAZENECA AB,
`Patent Owner.
`__________
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`Case IPR2016-01117
`Patent RE44,186
`__________
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`PATENT OWNER’S PRELIMINARY RESPONSE
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`___________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`AUROBINDO PHARMA U.S.A., INC.,
`Petitioner,
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`v.
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`ASTRAZENECA AB,
`Patent Owner.
`__________
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`Case IPR2016-01117
`Patent RE44,186
`__________
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`PATENT OWNER’S PRELIMINARY RESPONSE
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`Case No. IPR2016-01117
`Patent RE44,186
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`TABLE OF CONTENTS
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`Introduction ...................................................................................................... 1
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`Procedural History Relevant to 35 U.S.C. § 315(b) ........................................ 1
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`I.
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`II.
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`III. Aurobindo’s Untimely Petition Should Be Denied ......................................... 2
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`A. Aurobindo’s Petition Is Time-Barred Under 35 U.S.C. § 315(b) ......... 2
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`B. Aurobindo’s Motion for Joinder Is Not Warranted .............................. 3
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`IV. Conclusion ....................................................................................................... 6
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`Case No. IPR2016-01117
`Patent RE44,186
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`TABLE OF AUTHORITIES
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`Page(s)
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`Cases
`Atoptech, Inc. v. Synopsys, Inc.
`IPR2015-00760, Paper 14 (PTAB July 21, 2015) ................................................ 3
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`Medtronic, Inc. v. Endotach LLC,
`IPR2014-00695, Paper 18 (PTAB Sept. 25, 2014) ............................................... 3
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`Microsoft Corp. v. Surfcast, Inc.,
`IPR2014-00271, Paper 20 (PTAB June 13, 2014) ........................................... 4, 5
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`Samsung Electronics Co., Ltd. v. Arendi S.A.R.L.,
`IPR2014-01142, Paper 11 (PTAB Oct. 2, 2014) .............................................. 3, 5
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`St. Jude Med., Cardiology Div., Inc. v. Volcano Corp.,
`IPR2013-00258, Paper 29 (PTAB Oct. 16, 2013) ................................................ 6
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`Standard Innovation Corp. v. Lelo, Inc.,
`IPR2014-00907, Paper 10 (PTAB Dec. 1, 2014) ................................................. 5
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`Teva Pharm. USA Inc. v. ViiV Healthcare Co.,
`IPR2015-00550, Paper 11 (PTAB June 25, 2015) ............................................... 5
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`Statutes
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`35 U.S.C. § 311 .......................................................................................................... 3
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`35 U.S.C. § 313 .......................................................................................................... 3
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`35 U.S.C. § 314 .......................................................................................................... 3
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`35 U.S.C. § 315(b) ................................................................................................. 1-5
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`35 U.S.C. § 315(c) ..................................................................................................... 3
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`Other Authorities
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`37 C.F.R. § 42.1(b) .................................................................................................... 4
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`37 C.F.R. § 42.122(b) ................................................................................................ 5
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`iii
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`I.
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`Introduction
`Aurobindo’s Petition for inter partes review (“IPR”) is time-barred under 35
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`U.S.C. § 315(b), having been filed more than two years after Aurobindo was
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`served with a Complaint alleging infringement of AstraZeneca’s RE44,186 patent
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`(the “RE’186 patent”). To avoid the § 315(b) bar, Aurobindo proposes joinder to
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`instituted IPR2015-01340 (Mylan Pharms. Inc. v. AstraZeneca AB) (the “Mylan
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`IPR”). Joinder is not warranted here, because Aurobindo’s Petition was not timely
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`filed and its participation in the Mylan IPR is unnecessary and will only complicate
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`that proceeding.
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`II.
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`Procedural History Relevant to 35 U.S.C. § 315(b)
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`On May 29, 2014, AstraZeneca served Aurobindo with a Complaint for
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`infringement of the RE’186 patent based on Aurobindo’s submission of an
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`Abbreviated New Drug Application (“ANDA”) to market a generic version of
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`AstraZeneca’s pharmaceutical product ONGLYZA®. Ex. 2001 at 14, D.I. 1
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`(Complaint against Aurobindo filed May 23, 2014); id. at 15, D.I. 7 (Aurobindo
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`served on May 29, 2014). More than two years after being served with the
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`Complaint in the district court action, Aurobindo filed a Petition for IPR of the
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`RE’186 patent and a motion to join the Mylan IPR. IPR2016-01117, Paper 1 at 68
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`(filed June 1, 2016), Paper 3.
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`The RE’186 patent at issue in Aurobindo’s Petition is the same patent at
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`issue in the Mylan IPR and the district court action. Mylan Pharms., IPR2015-
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`01340, Paper 3 (June 4, 2015). The district court case has been consolidated with
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`five total defendants, including Aurobindo and Mylan. Ex. 2001 at 17 (Remark
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`entered Oct. 8, 2014). Trial is set for September 19, 2016, in Delaware District
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`Court. Ex. 2001 at 17-18 (Order entered Oct. 20, 2014).
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`Other defendants to the district court action similarly filed time-barred
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`petitions for IPR and similarly requested joinder to the Mylan IPR. See Wockhardt
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`Bio AG v. AstraZeneca AB, IPR2016-01029, Papers 1, 3; Sun Pharm. Indus., Ltd.
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`v. AstraZeneca AB, IPR2016-01104, Papers 3, 4. Joinder is not proper for the
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`reasons provided in AstraZeneca’s respective oppositions to those motions for
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`joinder and for the reasons below. See Wockhardt, IPR2016-01029, Paper 8; Sun
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`& Amneal, IPR2016-01104, Paper 12; Aurobindo, IPR2016-01117, Paper 8.
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`III. Aurobindo’s Untimely Petition Should Be Denied
`A. Aurobindo’s Petition Is Time-Barred Under 35 U.S.C. § 315(b)
`There is no dispute that Aurobindo’s Petition is time-barred. Aurobindo
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`filed its Petition more than one year after it was served with a complaint alleging
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`infringement of the RE’186 patent. See IPR2016-01117, Paper 1 at 16, n.2
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`(Petitioner acknowledging passage of over one year). The statute states:
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`An inter partes review may not be instituted if the
`petition requesting the proceeding is filed more than 1
`2
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`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. The time
`limitation set forth in the preceding sentence shall not
`apply to a request for joinder under subsection (c).
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`35 U.S.C. § 315(b).
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`Absent joinder, Aurobindo’s Petition must be denied. Samsung Elecs. Co.,
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`Ltd. v. Arendi S.A.R.L., IPR2014-01142, Paper 11 (PTAB Oct. 2, 2014);
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`Medtronic, Inc. v. Endotach LLC, IPR2014-00695, Paper 18 (PTAB Sept. 25,
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`2014); Atoptech, Inc. v. Synopsys, Inc., IPR2015-00760, Paper 14 (PTAB July 21,
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`2015).
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`B. Aurobindo’s Motion for Joinder Is Not Warranted
`Under § 315(c), the Board has discretion to join “any person who properly
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`files a petition under section 311 that the Director, after receiving a preliminary
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`response under section 313 or the expiration of the time for filing such a response,
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`determines warrants the institution of an inter partes review under section 314.”
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`Because Aurobindo’s untimeliness precludes institution under § 315(b), it
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`should also preclude joinder under § 315(c). The Board, however, has interpreted
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`the last sentence of § 315(b) to mean that “the one-year time bar does not apply” if
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`a party filing a time-barred petition requests joinder. See Microsoft Corp. v.
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`Surfcast, Inc., IPR2014-00271, Paper 20 at 7 (PTAB June 13, 2014). AstraZeneca
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`respectfully disagrees.
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`As discussed in greater detail in AstraZeneca’s Opposition to Aurobindo’s
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`Motion for Joinder, the America Invents Act, and § 315 itself, distinguishes
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`between petitions for IPR and requests for joinder. See IPR2016-01117, Paper 8.
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`The last sentence of § 315(b) provides an exception to the one-year bar only for a
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`request for joinder, not for a petition for IPR. The request-for-joinder exception of
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`§ 315(b) applies only when two timely petitions are filed, but the request for
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`joinder is made more than a year after being served with a complaint.
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`The statute does not provide a backdoor for time-barred petitions to be
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`effectively instituted through joinder. Such a view would be contrary to
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`Congress’s intent to “prevent[] the serial harassment of patent holders” (Ex. 2003
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`at 4), which particularly applies to parties like Aurobindo and other defendants in
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`the district court action who each had ample opportunity to file a timely petition
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`for IPR within the one-year statutory deadline, and who each have ample
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`opportunity to present their validity challenges in the district court trial this month.
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`Joinder is also not warranted in this case because it does not further the goal
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`of “securing the just, speedy, and inexpensive resolution of every proceeding.” See
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`37 C.F.R. § 42.1(b). In exercising its discretion to grant joinder, the Board is to
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`construe the rules for joinder consistent with that goal. 37 C.F.R. § 42.122(b); see
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`Samsung, IPR2014-01142, Paper 11 at 4.
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`Joinder will not enhance efficiencies in the Mylan IPR because Aurobindo
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`has no independent right to seek an IPR. See Standard Innovation Corp. v. Lelo,
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`Inc., IPR2014-00907, Paper 10 at 10 (PTAB Dec. 1, 2014) (explaining that
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`denying joinder will not result in multiple proceedings, because the Petition is
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`time-barred). The Board has repeatedly denied joinder for an otherwise time-
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`barred petition. Teva Pharm. USA Inc. v. ViiV Healthcare Co., IPR2015-00550,
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`Paper 11 (PTAB June 25, 2015); Samsung, IPR2014-01142, Paper 11 (PTAB Oct.
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`2, 2014); Microsoft, IPR2014-00271, Paper 20 at 7 (PTAB June 13, 2014).
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`Adding Aurobindo to the Mylan IPR will not simplify the proceeding.
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`Mylan is a sophisticated patent litigant capable of fully presenting its case alone.
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`The late-filing Petitioners, including Aurobindo, are competitors, each with its own
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`stake in the litigation and settlement postures. Aurobindo’s presence in the Mylan
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`IPR can only complicate that proceeding. For instance, Aurobindo has no known
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`agreement with Mylan, Wockhardt, Teva, and/or Sun/Amneal to coordinate the
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`actions of the Petitioners, if joined. Accordingly, adding Aurobindo to the Mylan
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`IPR will increase the complexity and cost of defending the same patent in parallel
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`venues against serial attacks. The legislative history of § 315(b) was intended to
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`set a deadline for accused infringers to ensure that the IPR is not used as a “tool[]
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`for harassment.” St. Jude Med., Cardiology Div., Inc. v. Volcano Corp., IPR2013-
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`00258, Paper 29 at 3 (PTAB Oct. 16, 2013). Allowing Aurobindo to spill over
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`from the district court action into the Mylan IPR to gain leverage in the litigation
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`“would frustrate the purpose of the section as providing quick and cost effective
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`alternatives to litigation.” See id.
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`Here, Aurobindo’s Petition is anything but an alternative to litigation.
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`Aurobindo is less than two weeks away from its day in court to challenge the
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`RE’186 patent. There is no good reason for Aurobindo to interfere with the Mylan
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`IPR at this point in time.
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`IV. Conclusion
`AstraZeneca respectfully requests that the Board deny Aurobindo’s Petition
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`for IPR of the RE’186 patent and motion for joinder.
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`
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`By: / Anthony A. Hartmann /
`Charles E. Lipsey, Reg. No. 28,165
`Finnegan, Henderson, Farabow,
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`Garrett & Dunner, L.L.P.
`11955 Freedom Drive
`Reston, VA 20190
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`Eric E. Grondahl, Reg. No. 46,741
`McCarter & English LLP
`CityPlace I, 185 Asylum St.
`Hartford, CT 06103
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`6
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`Respectfully submitted,
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`Dated: September 9, 2016
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`Case No. IPR2016-01117
`Patent RE44,186
`M. David Weingarten, Reg. No. 54,533
`Finnegan, Henderson, Farabow,
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`Garrett & Dunner, L.L.P.
`271 17th Street, NW Suite 1400
`Atlanta, GA 30363
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`John D. Livingstone, Reg. No. 59,613
`Finnegan, Henderson, Farabow,
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`Garrett & Dunner, L.L.P.
`271 17th Street, NW Suite 1400
`Atlanta, GA 30363
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`Anthony A. Hartmann, Reg. No. 43,662
`Finnegan, Henderson, Farabow,
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`Garrett & Dunner, L.L.P.
`901 New York Avenue, NW
`Washington, DC 20001-4413
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`Counsel for Patent Owner in IPR2016-
`01117
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`7
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`CERTIFICATE OF COMPLIANCE
` The undersigned herby certifies that the foregoing Patent Owner’s
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`Preliminary Response contains 1338 words, excluding those portions identified in
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`37 C.F.R. § 42.24(b), as measured by the word-processing system used to prepare
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`this paper.
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`By: / Anthony A. Hartmann /
`Anthony A. Hartmann, Back-up Counsel
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`FINNEGAN, HENDERSON, FARABOW,
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`GARRETT & DUNNER, LLP
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`Dated: September 9, 2016
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`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing Patent Owner’s
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`Preliminary Response was served electronically via e-mail directed to counsel of
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`record for the Petitioner on September 9, 2016 at the following:
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`
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`Sailesh K. Patel
`SCHIFF HARDIN LLP
`233 South Wacker Drive, Suite 6600
`Chicago, IL 60606
`SPatel@schiffhardin.com
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`George C. Yu
`SCHIFF HARDIN LLP
`1700 K Street NW
`One Market Plaza
`Spear Street Tower, #3200
`San Francisco, CA 94105
`GYu@schiffhardin.com
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`By: / Bradley J. Moore /
`Bradley J. Moore
`Litigation Legal Assistant
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`FINNEGAN, HENDERSON, FARABOW,
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`GARRETT & DUNNER, LLP
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`Dated: September 9, 2016
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