UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
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`WOCKHARDT BIO AG,
`Petitioner,
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`v.
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`ASTRAZENECA AB,
`Patent Owner.
`__________
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`Case IPR2016-01029
`Patent RE44,186
`__________
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`PATENT OWNER’S PRELIMINARY RESPONSE
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`Case No. IPR2016-01029
`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. Wockhardt’s Untimely Petition Should Be Denied ........................................ 3
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`A. Wockhardt’s Petition Is Time-Barred Under 35 U.S.C. § 315(b) ........ 3
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`B. Wockhardt’s Motion for Joinder Is Not Warranted .............................. 3
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`IV. Conclusion ....................................................................................................... 6
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`Case No. IPR2016-01029
`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 ..................................................................................................... 3
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`Aurobindo Pharma U.S.A., Inc. v. AstraZeneca AB,
`IPR2016-01117 ..................................................................................................... 2
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`Medtronic, Inc. v. Endotach LLC,
`IPR2014-00695 ..................................................................................................... 3
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`Microsoft Corp. v. Surfcast, Inc.,
`IPR2014-00271 ................................................................................................. 4, 5
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`Mylan Pharms. Inc., v. AstraZeneca AB
`IPR2015-01340 ................................................................................................. 1, 2
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`Samsung Electronics Co., Ltd. v. Arendi S.A.R.L.,
`IPR2014-01142 ................................................................................................. 3, 5
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`St. Jude Med., Cardiology Div., Inc. v. Volcano Corp.,
`IPR2013-00258 ..................................................................................................... 6
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`Standard Innovation Corp. v. Lelo, Inc.,
`IPR2014-00907 ..................................................................................................... 5
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`Sun Pharm. Indus., Ltd., v AstraZeneca AB,
`IPR2016-01104 ..................................................................................................... 2
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`Statutes
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`35 U.S.C. § 315(b) ......................................................................................... 1, 3, 4, 6
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`35 U.S.C. § 315(c) ................................................................................................. 3, 4
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`Other Authorities
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`37 C.F.R. § 42.1(b) .................................................................................................... 5
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`37 C.F.R. § 42.122(b) ................................................................................................ 5
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`iii
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`

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`I.
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`Introduction
`Wockhardt’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 one year after Wockhardt was served
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`with a Complaint alleging infringement of AstraZeneca’s RE44,186 patent (“the
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`RE’186 patent”). To avoid the § 315(b) bar, Wockhardt 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 Wockhardt’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 28, 2014, AstraZeneca served Wockhardt with a Complaint for
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`infringement of the RE’186 patent based on Wockhardt’s submission of an
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`Abbreviated New Drug Application (“ANDA”) to market generic versions of
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`AstraZeneca’s pharmaceutical product ONGLYZA®. Ex. 2001 at 4, D.I. 1
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`(Complaint entered May 23, 2014), D.I. 7 (Wockhardt served on May 28, 2014).
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`Almost two years after being served with a Complaint in the district court action,
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`Wockhardt filed a Petition for IPR of the RE’186 patent and a motion to join the
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`Mylan IPR. IPR2016-01029, Paper 1 at 1, n.1 (filed May 11, 2016), Paper 3.
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`The RE’186 patent at issue in Wockhardt’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 both Wockhardt and Mylan. Ex. 2002 at 15
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`(Remark entered Oct. 8, 2014). Trial is set for September 19, 2016, in Delaware
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`District Court. Ex. 2002 at 15 (Order entered Oct. 20, 2014).
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`After Wockhardt filed its Petition, other defendants to the district court
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`action similarly filed time-barred petitions for IPR and similarly requested joinder
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`to the Mylan IPR. See Sun Pharm. Indus., Ltd., v AstraZeneca AB, IPR2016-
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`01104, Papers 3-4; Aurobindo Pharma U.S.A., Inc. v. AstraZeneca AB, IPR2016-
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`01117, Papers 1, 3. While the Petitioners in IPR2016-01340 (Mylan), IPR2016-
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`01029 (Wockhardt), and IPR2016-001104 (Sun), entered into a joint stipulation
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`regarding the level of cooperation among Petitioners in the event joinder is
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`granted, the Petitioner in IPR2016-01117 (Aurobindo) has not. IPR2015-01340,
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`Paper 23; IPR2016-01029, Paper 11; IPR2016-01104, Paper 15. Joinder is not
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`proper for the reasons provided in AstraZeneca’s respective oppositions to the
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`motions for joinder, and for the reasons below. See Wockhardt, IPR2016-01029,
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`Paper 8; Sun Pharm. Indus., IPR2016-01104, Paper 12; Aurobindo Pharma,
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`IPR2016-01117, Paper 8.
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`Patent RE44,186
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`III. Wockhardt’s Untimely Petition Should Be Denied
`A. Wockhardt’s Petition Is Time-Barred Under 35 U.S.C. § 315(b)
`There is no dispute that Wockhardt’s Petition is time-barred. Wockhardt
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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 IPR2016-01029, Paper 1 at 1, n.1
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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
`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, Wockhardt’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. Wockhardt’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 Wockhardt’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 Wockhardt’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 IPR2016-01029, 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 Wockhardt and other defendants in
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`the district court action who each had ample opportunity to file a Petition for IPR
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`Case No. IPR2016-01029
`Patent RE44,186
`within the one-year statutory deadline and who each have ample opportunity to
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`present their validity challenges in the district court trial next 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 Elecs. Co. v. Arendi S.A.R.L., IPR2014-01142, Paper 11 at 4 (PTAB Oct.
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`2, 2014).
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`Joinder will not enhance efficiencies in the Mylan IPR because Wockhardt
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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 time
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`barred). The Board has repeatedly denied joinder for an otherwise time-barred
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`petition. Teva Pharm. USA Inc. v. ViiV Healthcare Co., IPR2015-00550, Paper 11
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`(PTAB June 25, 2015); Samsung, IPR2014-01142, Paper 11(PTAB Oct. 2, 2014);
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`Microsoft, IPR2014-00271, Paper 20 at 7 (PTAB June 13, 2014).
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`Adding parties to the Mylan IPR will not simplify the proceeding. Mylan is
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`a sophisticated patent litigant capable of fully presenting its case alone. The late-
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`filing Petitioners are competitors, each with their own stakes in the litigation and
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`settlement postures. Their presence in the Mylan IPR can only complicate that
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`Case No. IPR2016-01029
`Patent RE44,186
`proceeding. Indeed, these Petitioners have not all entered into a stipulation
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`regarding streamlined, cooperative participation in the Mylan IPR in the event
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`joinder is permitted. Accordingly, adding parties to the Mylan IPR will increase
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`the complexity and cost of defending the same patent in parallel venues against
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`serial attacks. The legislative history of § 315(b) was intended to set a deadline for
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`accused infringers to ensure that the IPR is not used as a “tool[] for harassment.”
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`St. Jude Med., Cardiology Div., Inc. v. Volcano Corp., IPR2013-00258, Paper 29
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`at 3 (PTAB Oct. 16, 2013). Allowing defendants to spill over from the district
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`court action into the Mylan IPR to gain leverage in the litigation “would frustrate
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`the purpose of the section as providing quick and cost effective alternatives to
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`litigation.” See id.
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`Here, Wockhardt’s Petition is anything but an alternative to litigation.
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`Wockhardt is only a month away from its day in court to challenge the RE’186
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`patent. There is no good reason for Wockhardt to interfere with the Mylan IPR at
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`this point in time.
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`IV. Conclusion
`AstraZeneca respectfully requests that the Board deny Wockhardt’s Petition
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`for IPR of the RE’186 patent and motion for joinder.
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`Case No. IPR2016-01029
`Patent RE44,186
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`Respectfully submitted,
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`Dated: August 18, 2016
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`
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`By: / Charles E. Lipsey /
`Charles E. Lipsey, Reg. No. 28,165
`Finnegan, Henderson, Farabow, 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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`M. David Weingarten, Reg. No. 54,533
`Finnegan, Henderson, Farabow, 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, 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, Garrett &
`Dunner, L.L.P.
`901 New York Avenue, NW
`Washington, DC 20001-4413
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`Counsel for Patent Owner in IPR2016-
`01029
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`Case No. IPR2016-01029
`Patent RE44,186
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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 August 18, 2016 at the following:
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`Patrick C. Gallagher (PCGallagher@duanemorris.com)
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`Wockhardt has agreed to electronic service.
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`By: /M. David Weingarten /
`M. David Weingarten, Back-up Counsel
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`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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`8
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`Dated: August 18, 2016
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`Case No. IPR2016-01029
`Patent RE44,186
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`CERTIFICATE OF COMPLIANCE
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`The undersigned herby certifies that the foregoing Patent Owner’s
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`Preliminary Response contains 1,412 words, excluding those portions identified
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`in 37 C.F.R. § 42.24(b), as measured by the word-processing system used to
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`prepare this paper.
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`By: /M. David Weingarten /
`M. David Weingarten, Back-up Counsel
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`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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`Dated: August 18, 2016
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`9