UNITED STATES PATENT AND TRADEMARK OFFICE
`___________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
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`SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`SUN PHARMA GLOBAL FZE, and
`AMNEAL PHARMACEUTICALS LLC,
`Petitioners,
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`v.
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`ASTRAZENECA AB,
`Patent Owner.
`__________
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`Case IPR2016-01104
`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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`SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`SUN PHARMA GLOBAL FZE, and
`AMNEAL PHARMACEUTICALS LLC,
`Petitioners,
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`v.
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`ASTRAZENECA AB,
`Patent Owner.
`__________
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`Case IPR2016-01104
`Patent No. RE44,186
`__________
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`PATENT OWNER’S OPPOSITION TO JOINDER
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`TABLE OF CONTENTS
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`Case No. IPR2016-01104
`Patent No. RE44,186
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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 Sun and
`Amneal Had No Independent Right to Bring an IPR ................. 7
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`B.
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`Sun’s and Amneal’s Motion for Joinder Is Statutorily Barred ............. 8
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`1.
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`2.
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`35 U.S.C. § 315(b) ...................................................................... 8
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`37 C.F.R. § 42.122(b) ...............................................................10
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`C.
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`If Joinder Is Granted, the Board Should Impose Meaningful
`Safeguards ...........................................................................................11
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`IV. CONCLUSION ..............................................................................................11
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`TABLE OF AUTHORITIES
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`FEDERAL CASES
`Lannett Company, Inc. v. AstraZeneca AB,
`IPR2015-01629, Paper 14 (PTAB, Jan. 27, 2016) ............................................ 10
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`Microsoft Corp. v. Surfcast, Inc.,
`IPR2014-00271, Paper 20 (PTAB June 13, 2014) ........................................... 7, 8
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`Mylan Pharms. Inc., v. AstraZeneca AB,
`IPR2015-01340, Paper 3 (PTAB June 4, 2015) ................................................... 3
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`Mylan Pharms. Inc., v. AstraZeneca AB,
`IPR2015-01340, Papers 12 (PTAB Dec. 9, 2015) ................................................ 3
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`Mylan Pharms. Inc., v. AstraZeneca AB,
`IPR2015-01340, Papers 15 (PTAB May 2, 2016) ................................................ 3
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`Mylan Pharms. Inc., v. AstraZeneca AB,
`IPR2015-01340, Papers 16 (PTAB May 2, 2016) ................................................ 3
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`Samsung Elec. Co. Ltd. v. Arendi S.A.R.L.,
`IPR2014-01142, Paper 11 (PTAB Oct. 2, 2014) .......................................... 3, 4, 7
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`Samsung Elec. Co., Ltd. v. Arendi S.A.R.L.,
`IPR2014-01518, Paper 10 (PTAB Mar. 18, 2015) ............................................. 11
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`Teva Pharms. USA Inc. v. Viiv Healthcare Co.,
`IPR2015-00550, Paper 11 (PTAB June 25, 2015) ....................................... 4, 5, 7
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`Unified Patents, Inc. v. Personal Web Tech., LLC,
`IPR2014-00702, Paper 12 (PTAB July 24, 2014) ............................................ 6, 7
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`FEDERAL STATUTES
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`35 U.S.C. § 311 .................................................................................................... 9, 10
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`35 U.S.C. § 315(b) ................................................................................... 2, 7, 8, 9, 11
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`35 U.S.C. § 315(c) ................................................................................. 4, 8, 9, 10, 11
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`REGULATIONS
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`Case No. IPR2016-01104
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`37 C.F.R. § 42.1(b) .................................................................................................... 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, 10
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`I.
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`Introduction
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`Sun Pharmaceutical Industries Ltd., Sun Pharma Global FZE (together,
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`“Sun”), and Amneal Pharmaceuticals LLC’s
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`(“Amneal”)
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`(collectively,
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`“Petitioners”) petition for inter partes review (“IPR”) and their corresponding
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`motion to join the instituted Mylan Pharms. Inc., v. AstraZeneca AB IPR
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`(IPR2015-01340; “Mylan IPR”) should be denied because their participation will
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`unnecessarily complicate, disrupt, and delay the Mylan IPR, and their petition is
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`otherwise statutorily time-barred.
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`This is not a case where Amneal and Sun agree to take no substantive roll.
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`Indeed, Petitioners reserve the right to change position and provide new evidence if
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`Mylan is no longer a party or there is a disagreement. Amneal, Sun, and Mylan are
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`direct competitors, and Petitioners acknowledge the parties’ potentially divergent
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`interests when they propose to add briefing when Petitioners “disagree” with
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`Mylan. Paper 4 (Sun’s and Amneal’s Motion for Joinder, “Mot.”) at 11. 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, there is no “public interest in obtaining a speedy and efficient
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`resolution of all the patentability issues of the ’186 patent in a single proceeding.”
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`Id. at 10. After all, Sun’s and Amneal’s petition “does not assert any grounds of
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`unpatentability additional to those asserted in the Mylan IPR.” Id. at 7. Further,
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`absent joinder, Sun’s and Amneal’s petition is time-barred. 35 U.S.C. § 315(b).
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`Petitioners have no independent right to file an IPRhaving been sued for
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`infringing AstraZeneca’s RE 44,186 patent (“the ’186 patent”) almost 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 joinder will lead to a speedy and efficient resolution of the
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`issues.
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`II. Background
`On June 4, 2014, AstraZeneca served Amneal with a Complaint for
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`infringement of the ’186 patent based on Amneal’s submission of ANDAs to
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`market its generic version of AstraZeneca’s pharmaceutical products ONGLYZA®
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`and KombiglyzeTM XR. Ex. 2001 at 3, D.I. 1 (Complaint entered June 2, 2014);
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`Ex. 2007 (Amneal served on June 4, 2014). On June 5, 2014, AstraZeneca served
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`Sun with a Complaint for infringement of the ’186 patent based on Sun’s
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`submission of ANDAs
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`to market
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`its generic version of AstraZeneca’s
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`pharmaceutical products ONGLYZA® and KombiglyzeTM XR. Ex. 2002 at 4, D.I.
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`1 (Complaint entered June 2, 2014); Ex. 2008 (Sun served on June 5, 2014). These
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`cases are now consolidated with six sets of defendants, including Amneal, Sun, and
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`Mylan. Ex. 2003 at 15 (Remark entered Oct. 8, 2014). Trial is set for September
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`19, 2016, in the U.S. District Court for District of Delaware. Ex. 2003 at 15
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`(Order entered 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 (denying IPR on December 9, 2015),
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`15-16 (instituting IPR on May 2, 2016).
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`Almost two years after being served with a Complaint in the district court
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`action, Sun and Amneal filed their petition for IPR and motion for joinder. Paper 3
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`(Sun and Amneal Petition) at 17, n.1 (Petitioners acknowledging passage of over
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`one year), Paper 4 (Sun and Amneal Motion for Joinder).
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`III. Argument
`Joinder Should Be Denied
`A.
`Petitioners have the burden of proof to show they are entitled to join the
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`Mylan IPR. 37 C.F.R. §§ 42.20(c), 42.122(b). A motion for joinder should: (1)
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`set forth 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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`While Sun and Amneal claim that they have agreed to adopt any papers
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`submitted by Mylan and to rely on any testimony from the same expert witness(es)
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`as Mylan (Mot. at 9), the reality remains that joinder will complicate the Mylan
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`IPR.
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`Petitioners say that they will take a “secondary role” (id. at 10-11); however,
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`as Sun and Amneal define these roles, the proceedings will become more, not less,
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`complicated. For example, Sun and Amneal leave wide-open the issue of whether
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`they will attempt to cross examine AstraZeneca’s expert or present argument at
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`oral hearings. Without an affirmative representation to the contrary, there is a real
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`possibility that joinder will complicate the Mylan IPR. See id.
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`The Board has denied joinder where there is no evidence that the two
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`petitioners “agreed to, or will, work together.” Samsung Elec. Co. Ltd. v. Arendi
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`S.A.R.L., IPR2014-01142, Paper 11 at 5 (PTAB Oct. 2, 2014) (internal citation
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`omitted); see also Teva Pharms. USA Inc. v. Viiv Healthcare Co., IPR2015-00550,
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`Paper 11 at 6 (PTAB June 25, 2015). In part, this is because without agreement to
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`consolidate filings “every paper filed by Petitioner” could be subject to additional
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`pages of briefing by Mylan “plus additional responsive briefing by Patent Owner.”
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`Teva Pharms., IPR2015-00550, Paper 11 at 6 (denying motion for joinder and
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`denying institution of IPR). Here, Sun and Amneal have not fully rejected the
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`notion of more briefing or other complicating activities. Indeed, Sun’s and
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`Amneal’s agreement to adopt Mylan’s papers and experts are contingent, i.e., for
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`only “as long as Mylan is a party.” Mot. at 9. If Mylan exits this IPR, Petitioners
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`no longer agree to be bound to Mylan’s positions and evidence. And, additional
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`briefing is precisely what Petitioners seek in the event there is a “procedural issue
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`or statement by Mylan in the joined IPR with which Petitioner[s] disagree.” Id. at
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`11.
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`The likelihood that Sun and Amneal “disagree” with Mylan is not far-
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`fetched. For instance, Petitioners assert that their “substantive interests completely
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`align with Mylan’s” (id. at 9), but that is not necessarily true. Sun, Amneal, and
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`Mylan are direct competitors with independent agendas that are advancing
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`different substantive positions in the district court litigation with different lead
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`compound theories, different prior art, and different expert witnesses. See Ex.
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`2004 at ¶ 1 (Sun and Amneal rely on the same expert as Wockhardt, i.e., Dr. James
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`C. Powers). Sun and Amneal could disagree with statements made by Mylan in
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`the IPR to the extent they conflict with positions taken by Sun’s and Amneal’s
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`expert in the district court litigation.
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`Petitioners try to mask the complications that joinder would create by
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`focusing on the similarities between the two petitions (Mot. at 8), but that position
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`is 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 now more real than ever before, as
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`Petitioners are now but one of four parties seeking joinder.
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`There is no question that Sun, Amneal, and other defendants seek to join the
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`Mylan IPR so that they may be party to any potential settlement resulting from the
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`IPR. Petitioners admitted as much, stating that its participation in the Mylan IPR
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`“may allow Petitioner[s] and AstraZeneca to resolve the underlying litigation
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`between the parties in a cost-effective, expeditious manner even if Mylan seeks to
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`terminate its participation in the Mylan IPR based on settlement or other factors.”
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`Mot. at 9. The purpose of an IPR proceeding, however, is to provide an alternative
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`to litigation, not to create leverage in an ongoing litigation. See Unified Patents,
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`IPR2014-00702, Paper 12 at 2 (explaining that the American Invents Act (“AIA”)
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`created new administrative trial proceedings, including IPR, “as an efficient,
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`streamlined, and cost-effective alternative to district court litigation”) (emphasis
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`added).
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`2.
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`Joinder Will Not Enhance Efficiencies Because Sun and
`Amneal 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 Sun and Amneal had no independent right to seek an IPR.
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`Absent joinder, Sun’s and Amneal’s petition is time-barred because it was filed
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`more than one year after Sun and Amneal were served with complaints for
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`infringement of the ’186 patent. 35 U.S.C. §315(b). The Board has repeatedly
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`denied joinder for an otherwise time-barred petition. Teva Pharms., IPR2015-
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`00550, Paper 11; Samsung Elec., IPR2014-01142, Paper 11; Microsoft Corp. v.
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`Surfcast, Inc., IPR2014-00271, Paper 20 at 7 (PTAB June 13, 2014).
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`Petitioners argue that any prejudice or burden to AstraZeneca is outweighed
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`by “the public interest in obtaining a speedy and efficient resolution of all the
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`patentability issues of the ’186 patent in a single proceeding.” Mot. at 10. The
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`argument lacks merit: Sun and Amneal are already parties to a single proceeding
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`addressing the patentability of the ’186 patentthe consolidated district court
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`action in Delaware. Sun and Amneal are not without opportunity to challenge the
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`’186 patent. They just lost their right to do so in an IPR proceeding before the
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`Board.
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`B.
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`Sun’s and Amneal’s Motion for Joinder Is Statutorily Barred
`1.
`Because Sun’s and Amneal’s untimeliness precludes institution under 35
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`35 U.S.C. § 315(b)
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`U.S.C. § 315(b), it should also preclude joinder under Section 315(c). Section
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`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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`The Board has interpreted the last sentence of Section 315(b) to mean that
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`“the one-year time bar does not apply” if a party filing a time-barred petition also
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`requests joinder. See Microsoft, IPR2014-00271, Paper 20 at 7. AstraZeneca
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`respectfully disagrees, and preserves the issue should it become appealable.
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`The AIA, and indeed Section 315 itself, distinguishes between petitions for
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`IPR and requests for joinder. A literal reading of the last sentence of Section
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`315(b) provides an exception to the one-year bar only for filing a request for
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`joinder, not for filing a petition for IPR. Thus, the one-year bar continues to apply
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`to all petitions, even in the joinder context. The request-for-joinder exception of
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`Section 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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`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. 2005 at 4), which particularly applies to parties like Amneal and Sun and
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`other defendants in the district court action who each have had ample opportunity
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`to present their validity challenges in that venue and each have had ample
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`opportunity to file a 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. 2006 at 7 (emphasis added). Section
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`315(c) is consistent with this view, because it requires compliance with 35 U.S.C.
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`§ 311, which in turn requires compliance with the other provisions of Title 35,
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`Chapter 31 of the U.S. Code, including the timeliness provisions. 35 U.S.C. § 311
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`(“Subject to the provisions of this chapter, a person who is not the owner of a
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`patent may file with the Office a petition to institute an inter partes review of the
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`patent.”).
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`37 C.F.R. § 42.122(b)
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`2.
`Sun’s and Amneal’s motion for joinder should also be denied under the plain
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`language of Rule 42.122(b):
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`Request for joinder. Joinder may be requested by a
`patent owner or petitioner. Any request for joinder must
`be filed, as a motion under § 42.22, no later than one
`month after the institution date of any inter partes review
`for which joinder is requested. The time period set forth
`in § 42.101(b) shall not apply when the petition is
`accompanied by a request for joinder.
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`Within its discretion, the Board has given Petitioners a filing date of June 3,
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`2016. Paper 8 at 1. As this is more than one month after the Mylan IPR institution
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`date of May 2, 2016, Sun’s and Amneal’s petition for joinder is time-barred under
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`Rule 42.122(b). See e.g., Lannett Company, Inc. v. AstraZeneca AB, IPR2015-
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`01629, Paper 14 (PTAB, Jan. 27, 2016) (petition time-barred for filing one-day
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`late).
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`Under the plain language of Sections 315(b) and (c) and Rule 42.122(b),
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`joinder of Sun’s and Amneal’s untimely petition is prohibited.
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`C.
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`If Joinder Is Granted, the Board Should Impose Meaningful
`Safeguards
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`To the extent the Board considers granting Petitioner’s motion for joinder,
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`AstraZeneca requests it impose real safeguards that guarantee Petitioner’s passive
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`role. These safeguards should ensure that Petitioners will not file additional
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`papers, not present any new, additional, or supplemental arguments, not cross-
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`examine AstraZeneca’s expert or attempt to offer a rebuttal expert of their own,
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`and not present any arguments at oral hearings. See e.g., Samsung Elec. Co., Ltd.
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`v. Arendi S.A.R.L., IPR2014-01518, Paper 10 at 6 (PTAB Mar. 18, 2015) (allowing
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`joinder where movants takes a “limited understudy role” without a separate
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`opportunity to actively participate). Nor should Petitioners be permitted to change
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`position and submit new evidence if Mylan is no longer a party.
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`IV. CONCLUSION
`For the reasons above, the Board should deny Sun’s and Amneal’s motion
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`for joinder.
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`Respectfully submitted,
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`By: /Anthony A. Hartmann /
`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
`
`John D. Livingstone, Reg. No. 59,613
`Finnegan, Henderson, Farabow, Garrett &
`Dunner, L.L.P.
`271 17th Street, NW, Suite 1400
`Atlanta, GA 30363
`
`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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`Dated: June 15, 2016
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`12
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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 June 15,
`
`2016, in its entirety on the following:
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`Samuel S. Park
`Winston & Strawn LLP
`35 W. Wacker Drive
`Chicago IL 60601
`spark@winston.com
`
`
`Andrew R. Sommer
`Winston & Strawn LLP
`1700 K Street NW
`Washington, DC 20006
`asommer@winston.com
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`Dated: June 15, 2016
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`/Sheila Y. West/
`
`Sheila Y. West
`Litigation Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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