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 No. RE44,186
`__________
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`PATENT OWNER’S OPPOSITION TO JOINDER
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`___________
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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 No. RE44,186
`__________
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`PATENT OWNER’S OPPOSITION TO JOINDER
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`Case No. IPR2016-01029
`Patent No. RE44,186
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`TABLE OF CONTENTS
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`Introduction ...................................................................................................... 1
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`Background ...................................................................................................... 2
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`I.
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`II.
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`III. Argument ......................................................................................................... 3
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`A.
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`Joinder Should Be Denied ..................................................................... 3
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`1.
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`2.
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`Joinder Will Complicate the Proceeding and May Disrupt
`the Trial Schedule ....................................................................... 4
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`Joinder Will Not Enhance Efficiencies Because
`Wockhardt Had No Independent Right to Bring an IPR ............ 7
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`B.
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`If Joinder Is Granted, the Board Should Impose Meaningful
`Safeguards ............................................................................................. 8
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`C. Wockhardt’s Motion for Joinder Is Statutorily Barred ......................... 8
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`IV. CONCLUSION ..............................................................................................10
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`Patent No. RE44,186
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`TABLE OF AUTHORITIES
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`FEDERAL CASES
`Microsoft Corp. v. Surfcast, Inc.,
`IPR2014-00271, Paper 20 (June 13, 2014) ....................................................... 7, 9
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`Mylan Pharms. Inc., v. AstraZeneca AB,
`IPR2015-01340, Paper 3 (June 4, 2015) ............................................................... 2
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`Mylan Pharms. Inc., v. AstraZeneca AB,
`IPR2015-01340, Papers 12, 15-16 (May 2, 2016) ................................................ 3
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`Samsung Elec. Co. Ltd. v. Arendi S.A.R.L.,
`IPR2014-01142, Paper 11 (Oct. 2, 2014) ......................................................... 3, 4
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`Samsung Elec. Co., Ltd. v. Arendi S.A.R.L.,
`IPR2014-01518, Paper 10 (Mar. 18, 2015) .......................................................... 8
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`Teva Pharms. USA Inc. v. Viiv Healthcare Co.,
`IPR2015-00550, Paper 11 (June 25, 2015) ....................................................... 4, 7
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`Unified Patents, Inc. v. Personal Web Tech., LLC,
`IPR2014-00702, Paper 12 (July 24, 2014) ........................................................... 6
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`FEDERAL STATUTES
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`35 U.S.C. § 311 ........................................................................................................ 10
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`35 U.S.C. § 315(b) ................................................................................... 2, 7, 8, 9, 10
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`35 U.S.C. § 315(c) ....................................................................................... 4, 8, 9, 10
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`REGULATIONS
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`37 C.F.R. § 42.1(b) ................................................................................................ 4, 5
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`37 C.F.R. § 42.20(c) .................................................................................................. 3
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`37 C.F.R. § 42.122(b) ................................................................................................ 3
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`Case No. IPR2016-01029
`Patent No. RE44,186
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`I.
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`Introduction
`Wockhardt Bio AG’s (“Wockhardt”) petition for inter partes review (“IPR”)
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`and its corresponding motion to join the instituted Mylan Pharms. Inc., v.
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`AstraZeneca AB IPR (IPR2015-01340; “Mylan IPR”) should be denied because its
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`participation will unnecessarily complicate, disrupt, and delay the Mylan IPR, and
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`its petition is otherwise statutorily time-barred.
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`This is not a case where Wockhardt and Mylan are working together and
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`Wockhardt requests joinder to be in the game but sit on the sidelines. Wockhardt
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`and Mylan are direct competitors. They have no agreement to cooperate, no
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`agreement to consolidate filings, no agreement to use the same expert, and no
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`agreement to apportion hearing time. Wockhardt acknowledges the parties’
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`potentially divergent interests when it proposes to add briefing when “Wockhardt
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`disagrees” with Mylan, to potentially introduce a new expert if “Mylan settles with
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`AstraZeneca and contractually bind[s] [its] experts from continuing in the IPR with
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`Wockhardt,” and to take a “primary” role if “Mylan willingly seeks more
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`prominent participation from Wockhardt’s counsel.” Mot. at 11-12. These
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`proposals introduce complexity and expense to briefing, discovery, and hearings,
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`threaten to delay the existing trial schedule, and will likely increase the burden on
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`the Board.
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`In addition, denying Wockhardt’s motion will not “burden[] [the Board] by
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`having needlessly to adjudicate and preside over two proceedings” (Mot. at 9). See
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`also id. at 1. Absent joinder, Wockhardt’s petition is time-barred. 35 U.S.C.
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`§ 315(b). Wockhardt has no independent right to file an IPRhaving been sued
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`for infringing AstraZeneca’s RE 44,186 patent (“the ’186 patent”) nearly two years
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`ago and choosing to wait until now to file a petition. Under the statute, there is no
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`scenario in which the Board will be burdened with two proceedings.
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`II. Background
`On May 28, 2014, AstraZeneca served Wockhardt with a Complaint for
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`infringement of the ’186 patent based on Wockhardt’s submission of an ANDA to
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`market its generic version of AstraZeneca’s pharmaceutical product ONGLYZA®.
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`Ex. 2001 at 4, D.I. 1 (Complaint entered May 23, 2014), D.I. 7 (Wockhardt served
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`on May 28, 2014). The case is consolidated with five defendants, including both
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`Wockhardt and Mylan. Ex. 2002 at 15 (Remark entered Oct. 8, 2014). Trial is set
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`for September 19, 2016, in Delaware District Court. Ex. 2002 at 15 (Order entered
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`Oct. 20, 2014).
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`Mylan filed a petition for IPR of the same ’186 patent at issue in the district
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`court action. Mylan Pharms., IPR2015-01340, Paper 3 (June 4, 2015). The Board
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`initially denied institution but later granted Mylan’s request for rehearing and
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`instituted trial on four grounds challenging certain claims of the ’186 patent.
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`Mylan Pharms., IPR2015-01340, Papers 12, 15-16 (instituting IPR on May 2,
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`2016).
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`Almost two years after being served with a Complaint in the district court
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`action, Wockhardt filed its petition for IPR and motion for joinder. IPR2016-
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`01029, Paper 1 at 1, n.1 (Petitioner acknowledging passage of over one year),
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`Paper 3 (Mot.). Wockhardt’s petition relies on the same expert declaration of Dr.
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`David Rotella that Mylan filed with its petition. Id.; Ex. 1003. As far as
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`AstraZeneca knows, Mylan has not agreed to cooperate or consolidate joint
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`submissions with Wockhardt. Mot. at 2, 9-10.
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`III. Argument
`Joinder Should Be Denied
`A.
`Wockhardt has the burden of proof to show it is entitled to join the Mylan
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`IPR. 37 C.F.R. §§ 42.20(c), 42.122(b). A motion for joinder should: (1) set forth
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`the reasons why joinder is appropriate; (2) identify any new grounds of
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`unpatentability asserted in the petition; (3) explain what impact (if any) joinder
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`would have on the trial schedule for the existing review; and (4) specifically
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`address how briefing and discovery may be simplified. See e.g., Samsung Elec.
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`Co. Ltd. v. Arendi S.A.R.L., IPR2014-01142, Paper 11, 4 (PTAB Oct. 2, 2014).
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`The Board has discretion to grant or deny a motion for joinder consistent with the
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`goal of securing “the just, speedy, and inexpensive resolution of every
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`proceeding.” See 35 U.S.C. § 315(c), 37 C.F.R. § 42.1(b).
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`1.
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`Joinder Will Complicate the Proceeding and May Disrupt
`the Trial Schedule
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`Joinder will complicate the Mylan IPR because Wockhardt and Mylan are
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`not working together. Wockhardt admits as much, indicating that Mylan has not
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`consented to joinder or to coordinate on joint submissions. Mot., 2, 9-10. Under
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`similar circumstances, the Board has denied joinder where there is no evidence that
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`the two petitioners “agreed to, or will, work together.” Samsung Elec. Co. Ltd. v.
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`Arendi S.A.R.L., IPR2014-01142, Paper 11 at 5 (PTAB Oct. 2, 2014) (internal
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`citation omitted); see also Teva Pharms. USA Inc. v. Viiv Healthcare Co.,
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`IPR2015-00550, Paper 11 at 6 (PTAB June 25, 2015). In part, this is because
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`without agreement to consolidate filings “every paper filed by Petitioner” could be
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`subject to additional pages of briefing by Mylan “plus additional responsive
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`briefing by Patent Owner.” Teva Pharms., IPR2015-00550, Paper 11 at 6 (denying
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`motion for joinder and denying institution of IPR). Indeed, additional briefing is
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`precisely what Wockhardt seeks in the event there is a “procedural issue or
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`statement by Mylan in the joined IPR with which Wockhardt disagrees.” Mot. at
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`11.
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`The likelihood that Wockhardt “disagrees” with Mylan is not far-fetched.
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`For instance, Wockhardt asserts that its “substantive interests completely align
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`with Mylan’s” (Mot. at 9), but that is not true. Wockhardt and Mylan are direct
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`competitors with independent agendas that are advancing different substantive
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`positions in the district court litigation with different lead compound theories,
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`different prior art, and different expert witnesses. See Ex. 2002 at 36 (D.I. 325 -
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`Notice of Service of Expert Report of David P. Rotella by Mylan entered Feb. 1,
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`2016, and D.I. 326 - Notice of Service of Expert Report of James C. Powers by
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`Wockhardt entered Feb 2, 2016). Wockhardt could disagree with statements made
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`by Mylan in the IPR to the extent they conflict with positions taken by
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`Wockhardt’s expert in the litigation. The fact that Wockhardt and Mylan have
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`different experts in the litigation will complicate the IPR in the event Wockhardt is
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`“precluded from relying on Mylan’s expert,” Dr. Rotella, due to his contractual
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`agreement with Mylan, Dr. Rotella’s inclination, or settlement. Mot. at 11-12.
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`Wockhardt acknowledges this possibility and, as a necessary remedy, suggests the
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`submission of a new expert declaration in the IPR. Id. Submission of a new expert
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`declaration would significantly increase discovery costs and efforts (e.g., extra
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`depositions and briefing), which would likely force the parties to seek delays to the
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`schedule. Cf. 37 C.F.R. § 42.1(b).
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`Wockhardt tries to mask the complications that joinder would create by
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`focusing on the similarities between the two petitions, but that position is
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`misplaced. Even with nearly identical petitions, the Board has rejected the
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`argument that joinder should be granted “as a matter of right.” Unified Patents,
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`Inc. v. Personal Web Tech., LLC, IPR2014-00702, Paper 12 at 4 (PTAB July 24,
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`2014). The legislative history supports that position: “[t]he Director is given
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`discretion … over whether to allow joinder. This safety valve will allow the Office
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`to avoid being overwhelmed if there happens to be a deluge of joinder petitions in
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`a particular case.” Id. (citing 157 CONG. REC. S1376 (daily ed. Mar. 8, 2011)
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`(statement of Sen. Kyl)). This concern is real. AstraZeneca understands that at
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`least one of the other three defendants to the district court action plans to join the
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`Mylan IPR. In addition, the remaining two defendants would be incentivized to
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`follow suit and seek joinder to the Mylan IPReach having exceeded the statutory
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`time limit for filing an independent petition.
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`There is no question that Wockhardt, and potentially other defendants, seek
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`to join the Mylan IPR so that they may be party to any potential settlement
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`resulting from the IPR. Wockhardt admitted as much, stating that its participation
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`in the Mylan IPR “will allow Wockhardt and AstraZeneca to resolve the
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`underlying litigation between the parties in a cost effective, expeditious manner
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`should Mylan seek to terminate its participation in the Mylan IPR based on
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`settlement or other factors.” Mot. at 8-9. The purpose of an IPR proceeding,
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`however, is to provide an alternative to litigation, not to create leverage in an
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`ongoing litigation. See Unified Patents, IPR2014-00702, Paper 12 at 2 (explaining
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`that the American Invents Act (“AIA”) created new administrative trial
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`proceedings, including IPR, “as an efficient, streamlined, and cost-effective
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`alternative to district court litigation”) (emphasis added).
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`2.
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`Joinder Will Not Enhance Efficiencies Because Wockhardt
`Had No Independent Right to Bring an IPR
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`Joinder will not avoid duplicative efforts by the Board or enhance
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`efficiencies because Wockhardt has no independent right to seek an IPR. Absent
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`joinder, Wockhardt’s petition is time-barred because it was filed more than one
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`year after Wockhardt was served with a complaint for infringement of the ’186
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`patent. 35 U.S.C. §315(b). The Board has repeatedly denied joinder for an
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`otherwise time-barred petition. Teva Pharms., IPR2015-00550, Paper 11;
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`Samsung Elec., IPR2014-01142, Paper 11; Microsoft Corp. v. Surfcast, Inc.,
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`IPR2014-00271, Paper 20 at 7 (PTAB June 13, 2014).
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`Wockhardt argues that any prejudice or burden to AstraZeneca is
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`outweighed by “the public interest in obtaining a speedy and efficient resolution of
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`all patentability issues of the ’186 patent in a single proceeding.” Mot. at 10. The
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`argument lacks merit: Wockhardt is already party to a single proceeding
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`addressing the patentability of the ’186 patentthe consolidated district court
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`action. Wockhardt is not without opportunity to challenge the ’186 patent. It just
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`lost its right to do so in an IPR proceeding.
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`B.
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`Case No. IPR2016-01029
`Patent No. RE44,186
`If Joinder Is Granted, the Board Should Impose Meaningful
`Safeguards
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`To the extent the Board considers granting Wockhardt’s motion for joinder,
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`AstraZeneca requests it impose real safeguards that guarantee a passive role.
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`These safeguards should ensure that Wockhardt will not file additional papers, not
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`file additional pages to Mylan’s papers, not present any new, additional, or
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`supplemental arguments, not cross-examine AstraZeneca’s expert or attempt to
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`offer a rebuttal expert of its own, and not present any arguments at oral hearings.
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`See e.g., Samsung Elec. Co., Ltd. v. Arendi S.A.R.L., IPR2014-01518, Paper 10 at 6
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`(PTAB Mar. 18, 2015) (allowing joinder where movants takes a “limited
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`understudy role” without a separate opportunity to actively participate).
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`C. Wockhardt’s Motion for Joinder Is Statutorily Barred
`Because Wockhardt’s untimeliness precludes institution under § 315(b), it
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`should also preclude joinder under § 315(c). Section 315(b) 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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`Patent No. RE44,186
`The Board has interpreted the last sentence of § 315(b) to mean that “the
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`one-year time bar does not apply” if a party filing a time-barred petition requests
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`joinder. See Microsoft, IPR2014-00271, Paper 20 at 7. AstraZeneca respectfully
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`disagrees, and preserves the issue should it become appealable.
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`The AIA, and indeed § 315 itself, distinguishes between petitions for IPR
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`and requests for joinder. The last sentence of § 315(b) provides an exception to the
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`one-year bar only for a request for joinder, not for a petition for IPR. Thus, the
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`one-year bar continues to apply to all petitions, even in the joinder context. The
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`request-for-joinder exception of § 315(b) applies only when two timely petitions
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`are filed, but the request for joinder is made more than a year after being served
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`with a complaint.
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`This reading makes sense because joinder is not available until after a
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`petition has been instituted. 35 U.S.C. § 315(c). Since an institution decision can
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`take up to six months, it is likely that many requests for joinder will occur more
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`than one year after being served with a complaint. The statutory language
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`addresses this concern. It does not, however, provide a backdoor for time-barred
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`petitions to be effectively instituted through joinder. Such a view would be
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`contrary to Congress’s intent to “prevent[] the serial harassment of patent holders”
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`(Ex. 2003 at 4), which particularly applies to parties like Wockhardt and other
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`defendants in the district court action who each have ample opportunity to present
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`Case No. IPR2016-01029
`Patent No. RE44,186
`their validity challenges in that venue and each had ample opportunity to file a
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`Petition for IPR within the one-year statutory deadline.
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`Permitting untimely petitions to be instituted through joinder is also contrary
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`to the joinder statute. Under 35 U.S.C. § 315(c), a party may be joined if it has
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`“properly file[d] a petition under section 311.” Senator Kyl addressed the meaning
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`of the phrase “properly file[d],” stating that “time deadlines for filing petitions
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`must be complied with in all cases.” Ex. 2004 at 7. Section 315(c) is consistent
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`with this view, because it requires compliance with § 311, which in turn requires
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`compliance with the other provisions of Title 35, Chapter 31 of the U.S. Code,
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`including the timeliness provisions. 35 U.S.C. § 311 (“Subject to the provisions of
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`this chapter, a person who is not the owner of a patent may file with the Office a
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`petition to institute an inter partes review of the patent.”). Under the plain
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`language of § 315(b) and (c), joinder of Wockhardt’s untimely petition is
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`prohibited.
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`IV. CONCLUSION
`For the reasons above, the Board should deny Wockhardt’s petition for IPR
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`and motion for joinder.
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`Case No. IPR2016-01029
`Patent No. RE44,186
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`Respectfully submitted,
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`Dated: May 31, 2016
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`
`
`By: /John D. Livingstone/
`Charles E. Lipsey, Reg. No. 28,165
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, L.L.P.
`11955 Freedom Drive
`Reston, VA 20190
`
`Eric E. Grondahl, Reg. No. 46,741
`McCarter & English LLP
`CityPlace I
`185 Asylum St.
`Hartford, CT 06103
`
`M. David Weingarten, Reg. No. 54,533
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, L.L.P.
`3500 SunTrust Plaza
`303 Peachtree Street, N.E.
`Atlanta, GA 30308
`
`John D. Livingstone, Reg. No. 59,613
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, L.L.P.
`3500 SunTrust Plaza
`303 Peachtree Street, N.E.
`Atlanta, GA 30308
`
`Anthony A. Hartmann, Reg. No. 43,662
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, L.L.P.
`901 New York Ave., NW
`Washington, DC 20001
`
`Counsel for Patent Owner in
`IPR2016-01029
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`11
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`
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`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing PATENT OWNER’S
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`OPPOSITION TO JOINDER was served electronically via e-mail on May 31,
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`2016, in its entirety on the following:
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`Patrick Gallagher
`Duane Morris LLP
`190 South LaSalle Street
`Suite 3700 Chicago, IL 60603
`PCGallagher@duanemorris.com
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`Petitioner has agreed to electronic service.
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`By: /Sheila Y. West/
` Legal Assistant
` FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, LLP
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`
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`
`
`Dated: May 31, 2016
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