`
`
`Paper No. ___
`Date Filed: March. 8, 2017
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`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`ACTAVIS LABORATORIES FL, INC., AMNEAL PHARMACEUTICALS LLC,
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC, DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD., SUN
`PHARMACEUTICALS INDUSTRIES, LTD., SUN PHARMACEUTICALS
`INDUSTRIES, INC., TEVA PHARMACEUTICALS USA, INC., WEST-WARD
`PHARMACEUTICAL CORP., and HIKMA PHARMACEUTICALS, LLC,
`
`Petitioners,
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`
`Patent Owner.
`
`________________
`
`Case IPR2017-00853
`Patent 8,822,438
`
`________________
`
`
`
`JANSSEN ONCOLOGY, INC.’S OPPOSITION TO MOTION FOR
`JOINDER PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b)
`
`
`
`
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`IPR2017-00853
`Patent 8,822,438
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`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION ........................................................................................... 1
`
`FACTUAL BACKGROUND .......................................................................... 1
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`
`
`
`
`I.
`
`II.
`
`III. LEGAL STANDARDS .................................................................................... 4
`
`IV. ARGUMENT ................................................................................................... 6
`A.
`The Board Should Exercise its Discretion to Discourage Late
`Requests for Joinder .............................................................................. 6
`Joinder Would Not Simplify Briefing and Discovery ........................... 8
`If Joinder is Granted, the Board Should Impose Strict
`Safeguards ........................................................................................... 10
`
`B.
`C.
`
`V.
`
`CONCLUSION .............................................................................................. 12
`
`
`
`ii
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`IPR2017-00853
`Patent 8,822,438
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`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Brinkmann Corp. v. A&J Mfg., LLC,
`IPR2015-00056, Paper 10 (PTAB March 23, 2015) ............................................ 8
`
`Int’l Bus. Machines Corp. v. Elec. & Telecomms. Research Inst.,
`IPR2014-00949, Paper 25 (PTAB Jan. 28, 2015) .............................................. 11
`
`Kyocera Corp. v. Softview LLC,
`IPR2013-00004, Paper 15 (PTAB Apr. 24, 2013) ............................................... 5
`
`Samsung Elec. Co., Ltd. v. Arendi S.A.R.L.,
`IPR2014-01144, Paper 11 (PTAB Oct. 2, 2014) .............................................. 4, 5
`
`Skimlinks, Inc. v. Linkgine, Inc.,
`CBM2015-00086, Paper 17 (PTAB Jun. 12, 2015) ........................................... 11
`
`Unified Patents, Inc. v. PersonalWeb Tech.,
`LLC, IPR2014-00702, Paper 12 (PTAB Jul. 24, 2014) ........................... 4, 5, 7, 8
`
`Statutes
`
`35 U.S.C. § 315(b) ............................................................................................. 4, 8, 9
`
`35 U.S.C. § 315(c) ............................................................................................. 4, 5, 6
`
`35 U.S.C. § 315(c) ................................................................................................... 14
`
`Other Authorities
`
`37 C.F.R. §§ 42.20(c), 42.122(b) ............................................................................... 5
`
`37 C.F.R. § 42.122(b) .............................................................................................. 14
`
`157 Cong. Rec. S1376............................................................................................ 6, 7
`
`iii
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`IPR2017-00853
`Patent 8,822,438
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`INTRODUCTION
`
`I.
`
`
`Patent Owner Janssen Oncology, Inc. (“Janssen”) respectfully requests that
`
`the Board deny Petitioners’1 motion for joinder of IPR2017-00853 (the “Actavis
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`IPR”) with IPR2016-01332 (the “Mylan IPR”). The Actavis IPR and the Mylan
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`IPR are both directed to Janssen’s U.S. Patent No. 8,822,438 (the “’438 patent”).
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`As explained below, the Board should deny Petitioners’ motion because the
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`serial challenges to the ’438 patent brought by what now amounts to 14 different
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`petitioners are prejudicial to Janssen and are the exact type of practice that the
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`Board should discourage. Rather than simplifying briefing and discovery, as
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`Petitioners suggest, joinder may further complicate discovery in an already
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`condensed schedule in the Mylan IPR.
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`FACTUAL BACKGROUND
`
`II.
`
`
`The present petition for inter partes review is the latest in a growing list of
`
`
`1 There are ten named Petitioners in this proceeding: Actavis Laboratories
`
`FL, Inc., Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York,
`
`LLC, Dr. Reddy’s Laboratories, Inc., Dr. Reddy’s Laboratories, Ltd., Sun
`
`Pharmaceuticals Industries, Ltd., Sun Pharmaceuticals Industries, Inc., Teva
`
`Pharmaceuticals USA, Inc., West-Ward Pharmaceutical Corp., and Hikma
`
`Pharmaceuticals, LLC.
`
`
`
`IPR2017-00853
`Patent 8,822,438
`
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`staggered attacks aimed at challenging the patentability of the claims of the ’438
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`patent. Amerigen Pharmaceuticals Limited (“Amerigen”) filed the first IPR
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`petition on December 4, 2015 seeking review of all 20 claims of the ’438 patent.
`
`See Amerigen Pharms. Ltd. v. Janssen Oncology, Inc., IPR2016-00286, Paper 1
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`(PTAB Dec. 4, 2015) (the “Amerigen IPR”). The Board instituted the Amerigen
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`IPR on May 31, 2016 based on two grounds of unpatentability. See Amerigen,
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`IPR2016-00286, Paper 14.
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`Half-a-year later—on June 29 and June 30, 2016, respectively—Argentum
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`Pharmaceuticals LLC (“Argentum”) and Mylan Pharmaceuticals Inc. (“Mylan”)
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`followed with their own separate IPR petitions. See Argentum Pharms. LLC v.
`
`Janssen Oncology, Inc., IPR2016-01317, Paper 2 (PTAB June 29, 2016) (the
`
`“Argentum IPR”) and Mylan Pharms. Inc. v. Janssen Oncology, Inc., IPR2016-
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`01332, Paper 1 (PTAB June 30, 2016) (the “Mylan IPR”). Concurrently with their
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`respective IPR petitions, Argentum and Mylan filed motions seeking joinder with
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`the Amerigen IPR.
`
`On August 10, 2016, Wockhardt Bio AG (“Wockhardt”) filed a fourth
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`petition seeking cancellation of all 20 claims of the ’438 patent. Wockhardt Bio AG
`
`v. Janssen Oncology, Inc., IPR2016-01582, Paper 4 (PTAB Aug. 10, 2016) (the
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`“Wockhardt IPR”).
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`
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`2
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`IPR2017-00853
`Patent 8,822,438
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`On September 19, 2016, the Board instituted the Argentum IPR and joined it
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`with the Amerigen IPR. Argentum, IPR2016-01317, Paper 9. On January 10,
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`2017, the Board denied Mylan’s motion for joinder because, among other things,
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`Mylan sought to rely on new evidence, including two new expert declarations.
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`Mylan, IPR2016-01332 , Paper 21 at p. 10 (noting that “[g]ranting joinder in view
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`of Mylan’s two different declarations and new evidence would add an additional
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`dimension to the substantive issues in the Amerigen IPR, and thus would be more
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`significant than Mylan suggests.”). On January 10, 2017, the Board instituted the
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`Mylan IPR and, in doing so, implemented a condensed schedule “to allow for
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`resolution of [the Amerigen IPR and the Mylan IPR] . . . in relative proximity to
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`each other.” Id. at p. 11.
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`On January 19, 2017, the Board instituted the Wockhardt IPR and also
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`ordered that the trial phase of this proceeding be conducted under a condensed
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`schedule. Wockhardt, IPR2016-01582, Paper 29 at p. 19. The Board has ordered
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`oral argument in both the Mylan and Wockhardt IPR proceedings on the same day,
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`May 24, 2017. Mylan, IPR2016-01332, Paper 22 at p. 6; Wockhardt, IPR2016-
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`01582, Paper 30 at p. 6. Oral argument in the Amerigen IPR took place on
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`February 16, 2017.
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`The Petitioners in the present case, a collection of ten generic
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`pharmaceutical companies, have filed the Actavis IPR as a fifth separate challenge
`
`
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`3
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`IPR2017-00853
`Patent 8,822,438
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`to the ’438 patent. Presently before the Board is Petitioners’ motion for joinder,
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`which seeks to join the Actavis IPR to the previously instituted Mylan IPR. As
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`explained below, the Board should exercise its discretion and deny Petitioners’
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`motion for joinder because the attempt by these ten additional companies to
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`serially attack the ’438 patent in staggered IPR petitions does not promote judicial
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`efficiency and is prejudicial to Janssen. Furthermore, because the present petition
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`was filed more than one year after Petitioners were served with a complaint
`
`alleging infringement of the ’438 patent, absent joinder, the Actavis IPR is time-
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`barred under 35 U.S.C. § 315(b).
`
`III. LEGAL STANDARDS
`
`
`The decision to grant joinder is discretionary. 35 U.S.C. § 315(c). When
`
`exercising that discretion, the Board should be mindful that “patent trial
`
`regulations, including the rules for joinder, must be construed to secure the just,
`
`speedy, and inexpensive resolution of every proceeding.” Samsung Elec. Co., Ltd.
`
`v. Arendi S.A.R.L., IPR2014-01144, Paper 11 at p. 7 (PTAB Oct. 2, 2014) (citing 37
`
`C.F.R. § 42.1(b)); see also Unified Patents, Inc. v. PersonalWeb Tech., LLC,
`
`IPR2014-00702, Paper 12 at p. 2 (PTAB Jul. 24, 2014) (“The America Invents Act
`
`(‘AIA’) created new administrative trial proceedings, including inter partes review,
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`as an efficient, streamlined, and cost-effective alternative to district court
`
`litigation.”). Even when there are “two proceedings with nearly identical petitions
`
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`4
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`IPR2017-00853
`Patent 8,822,438
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`. . . joinder is not automatic, particularly given the need to complete proceedings in
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`a just, speedy and inexpensive manner.” Unified Patents, IPR2014-00702, Paper
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`12 at p. 4 (citing 35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b); 157 Cong. Rec. S1376,
`
`daily ed. Mar. 8, 2011 (statement of Sen. Kyl)).
`
`As the moving party, a petitioner requesting joinder has the burden of proof
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`in establishing entitlement to joinder. See Samsung, IPR2014-01144, Paper 11 at p.
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`7; 37 C.F.R. §§ 42.20(c), 42.122(b). In this regard, a motion for joinder should:
`
`(1) set forth the reasons why joinder is appropriate; (2) identify any new grounds
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`of 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
`
`address how briefing and discovery may be simplified. See, e.g., Kyocera Corp. v.
`
`Softview LLC, IPR2013-00004, Paper 15 at p. 4 (PTAB Apr. 24, 2013).
`
`As indicated in the legislative history, “the Board will determine whether to
`
`grant joinder on a case-by-case basis, taking into account the particular facts of
`
`each case.” Samsung, IPR2014-01144, Paper 11 at p. 7. In particular, “when
`
`determining whether and when to allow joinder, the Office may consider factors
`
`including the breadth or unusualness of the claim scope, claim construction issues,
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`and consent of the patent owner.” Id. (citing 157 Cong. Rec. S1376, daily ed. Mar.
`
`8, 2011 (statement of Sen. Kyl)) (emphasis added). The Board has also indicated
`
`its intent to use its authority under § 315(c) “to encourage early requests for joinder
`
`
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`5
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`IPR2017-00853
`Patent 8,822,438
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`and to discourage late requests.” See 157 Cong. Rec. S1376, daily ed. Mar. 8, 2011
`
`(statement of Sen. Kyl).
`
`IV. ARGUMENT
`
`A. The Board Should Exercise its Discretion to Discourage Late
`Requests for Joinder
`
`
`
`35 U.S.C. § 315(c) instructs that the decision to grant or deny joinder is
`
`discretionary. The legislative history also makes clear that the Office should use its
`
`discretion to encourage the early filing of motions for joinder and to avoid an
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`onslaught of joinder petitions. See 157 Cong. Rec. S1376, daily ed. Mar. 8, 2011
`
`(statement of Sen. Kyl). The instant case presents an ideal opportunity to advance
`
`these goals. And the Board should do so by denying Petitioners’ motion for
`
`joinder.
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`As described above, the Actavis IPR is the fifth in a series of IPR attacks
`
`brought by 14 petitioners to challenge the patentability of the claims of the ’438
`
`patent. And it comes at the 11th hour. The Actavis IPR and present motion for
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`joinder were filed approximately 18 months after Petitioners were served with a
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`complaint alleging infringement of the ’438 patent. Petitioners offer no
`
`explanation for why they waited so long to file the Actavis IPR, especially
`
`considering that Petitioners contend that the Actavis IPR relies on the same
`
`unpatentability grounds, prior art references, and expert declarations as the Mylan
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`IPR. See Petitioners’ Motion for Joinder, Paper 9 at p. 6. Having chosen to wait,
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`6
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`IPR2017-00853
`Patent 8,822,438
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`Petitioners now seek to join the Mylan IPR, which is at an advanced stage due to
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`the condensed schedule ordered by the Board.
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`This type of “gang-tackling,” in which petitioners serially file IPR petitions
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`along with motions to join a previously instituted proceeding is exactly the type of
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`late request for joinder that the Board should discourage. See 157 Cong. Rec.
`
`S1376, daily ed. Mar. 8, 2011 (statement of Sen. Kyl) (“The Director is given
`
`discretion, however, over whether to allow joinder. This safety valve will allow
`
`the Office to avoid being overwhelmed if there happens to be a deluge of joinder
`
`petitions in a particular case.”). Judicial efficiency is not best served by allowing
`
`petitioners to manipulate the IPR process through such practice. In fact, the
`
`purpose of IPR— to provide “an efficient, streamlined, and cost-effective
`
`alternative to district court litigation” (Unified Patents, IPR2014-00702, Paper 12
`
`at p. 4)—is undermined by allowing time-barred serial petitions through a loophole
`
`in the joinder regulations. Granting the present motion for joinder would
`
`encourage petitioners to file multiple, staggered challenges—well after the one-
`
`year time bar—without any fear that their delay in filing might have adverse
`
`consequences, such as denial of joinder. The present motion should, therefore, be
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`denied.
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`7
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`IPR2017-00853
`Patent 8,822,438
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`B.
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`Joinder Would Not Simplify Briefing and Discovery
`
`
`
`Petitioners argue that briefing and discovery would be significantly
`
`simplified if joinder were granted because “[w]ithout joinder, largely duplicative
`
`briefs and other papers would be filed in parallel IPRs.” See Petitioners’ Motion
`
`for Joinder, Paper 9 at p. 6. Petitioners further argue that “[j]oinder would
`
`eliminate duplicative expert discovery and trial testimony.” See id. at p. 8.
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`Petitioners are wrong. Absent joinder, the Actavis IPR is time-barred; therefore, if
`
`Petitioners’ motion for joinder is denied, no IPR proceeding can be instituted.
`
`The ’438 patent is asserted against the Petitioners in BTG International LTD
`
`v. Actavis Laboratories FL, Inc.—an action that was filed on July 31, 2015 in the
`
`United States District for the District of New Jersey listing as defendants all ten
`
`Petitioners in this proceeding. Each of the ten Petitioners waived service of the
`
`summons, and Janssen filed these executed waivers in district court between
`
`August 11, 2015 and September 8, 2015. See Exs. 2002-2011. The filing date of
`
`the waiver of summons is the date that each Petitioner is deemed to have been
`
`served with a complaint for purposes of 35 U.S.C. § 315(b). See Brinkmann Corp.
`
`v. A&J Mfg., LLC, IPR2015-00056, Paper 10 at pp. 6-7 (PTAB March 23, 2015).
`
`Yet, these Petitioners waited until February 8, 2017 to file the Actavis IPR. Thus,
`
`because the Actavis IPR was filed more than one year after the Petitioners were
`
`served with a complaint alleging infringement of the ’438 patent, the Actavis IPR
`
`
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`8
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`IPR2017-00853
`Patent 8,822,438
`
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`is time-barred under 35 U.S.C. § 315(b). And, despite Petitioners’ assertions to the
`
`contrary,2 if Petitioners’ motion for joinder is denied, there would be no parallel
`
`proceeding and no threat of duplicative briefs, expert discovery, or trial testimony.
`
`
`
`Rather than simplifying briefing and discovery, joinder could potentially
`
`complicate the already condensed Mylan IPR proceeding. In their motion for
`
`joinder, Petitioners state that they will coordinate with Mylan “to facilitate the
`
`elimination of repetitive briefs and testimony.” See Petitioners’ Motion for Joinder,
`
`Paper 9 at p. 8. But, notably, Petitioners stop short of agreeing to rely on Mylan’s
`
`briefs and testimony in their entirety and, in doing so, leave open the possibility to
`
`set forth independent positions and opinions on issues that do not overlap with
`
`Mylan’s. See id. at p. 8. Because ten new Petitioners would be added to the
`
`Mylan IPR if the proceedings were joined, there is a strong likelihood that the
`
`interests of all the Petitioners may not completely align with Mylan’s interests on
`
`all issues. In that event, the Petitioners would undoubtedly seek to have their
`
`independent voices heard by advancing positions that Janssen would not have to
`
`face if it were dealing with Mylan alone. Thus, joinder would be prejudicial to
`
`Janssen and poses a real threat of complicating the already condensed Mylan IPR
`
`proceeding. And Petitioners’ motion should be denied for this additional reason.
`
`
`
`
`2 See Petitioners’ Motion for Joinder, Paper 9 at pp. 7-8.
`
`
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`9
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`IPR2017-00853
`Patent 8,822,438
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`C.
`
`If Joinder is Granted, the Board Should Impose Strict Safeguards
`
`
`
`In its motion for joinder, Petitioners represented to the Board that (1) their
`
`petition is limited to the same grounds instituted in the Mylan IPR (see Petitioners’
`
`Motion for Joinder, Paper 9 at pp. 1, 6), (2) their petition is based on the same prior
`
`art analysis as the Mylan IPR (id.), (3) their petition relies on expert declarations
`
`that are identical to those in the Mylan IPR (id.), and (4) there would be no change
`
`in the trial schedule as a result of joinder (id. at pp. 1-2, 6-7).
`
`While Janssen believes that Petitioners’ motion should be denied, in the
`
`event that the Board decides to allow joinder, Janssen respectfully requests that
`
`Petitioners be required to abide by the following conditions:
`
` Petitioners agree to “assert exactly the same grounds and rel[y]
`
`exactly on the same evidence for invalidity that formed the basis for
`
`institution in the Mylan IPR,” including “the same combinations of
`
`prior art references.” Petitioners’ Motion for Joinder, Paper 9 at p. 6;
`
`see also Ex. 2012 (Feb. 8, 2017 email from Petitioners’ counsel).
`
` Petitioners agree to rely on “the same experts, Dr. Garnick and Mr.
`
`Hofmann, [who] have submitted identical supporting declarations in
`
`both [the Actavis and Mylan] IPRs.” Petitioners’ Motion for Joinder,
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`Paper 9 at p. 6; Ex. 2012.
`
`
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`10
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`IPR2017-00853
`Patent 8,822,438
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` Petitioners agree that they “will not request any alterations to the
`
`schedule in the Mylan IPR based on the requested joinder” and that
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`“[a]ccordingly, joinder will not at all impact the trial schedule for
`
`existing review of the Mylan IPR.” Petitioners’ Motion for Joinder,
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`Paper 9 at p. 7.
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` Petitioners “agree to not submit any separate briefing on any issue
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`(unless the issue pertains specifically to one of [the Petitioners] and
`
`not to Mylan).” Ex. 2012. In Janssen’s view, such a petitioner-
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`specific issue should be strictly limited to challenges to real party-in-
`
`interest.
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` As the Board has done in other proceedings, Janssen requests that the
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`Board orders Petitioners to work together to consolidate filings
`
`without authorizing expansion of page limits beyond the regular page
`
`limits allotted by the rules. See Int’l Bus. Machines Corp. v. Elec. &
`
`Telecomms. Research Inst., IPR2014-00949, Paper 25 at pp. 3-4
`
`(PTAB Jan. 28, 2015); Skimlinks, Inc. v. Linkgine, Inc., CBM2015-
`
`00086, Paper 17 at pp. 26-27 (PTAB Jun. 12, 2015).
`
` Petitioners agree to “coordinate with [Mylan] to facilitate the
`
`elimination of repetitive . . . testimony.” Petitioners’ Motion for
`
`Joinder, Paper 9 at p. 8.
`
`
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`11
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`IPR2017-00853
`Patent 8,822,438
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` Petitioners agree to participate only as observers during depositions.
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`Ex. 2012. Petitioners further agree that no additional depositions will
`
`be needed, and that the depositions will be completed within the time
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`limits agreed upon by Janssen and Mylan.
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` Petitioners agree that they will “maintain a secondary role in the
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`proceeding, if joined,” and “will assume a primary role only if the
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`Mylan IPR petitioner ceases to participate in the IPR.” Petitioners’
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`Motion for Joinder, Paper 9 at p. 8; Ex. 2012.
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`V. CONCLUSION
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`For all the foregoing reasons, Petitioners’ motion for joinder should be
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`denied and the Board should proceed to an orderly and timely consideration of the
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`Mylan IPR.
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`Dated: March 8, 2017
`
`
`Respectfully submitted,
`
`By: /Dianne B. Elderkin/
`Dianne B. Elderkin (Reg. No. 28,598)
`Barbara L. Mullin (Reg. No. 38,250)
`Ruben H. Munoz (Reg. No. 66,998)
`AKIN GUMP STRAUSS HAUER
`& FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel: (215) 965-1200
`Fax: (215) 965-1210
`JANS-ZYTIGA@akingump.com
`
`
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`12
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`IPR2017-00853
`Patent 8,822,438
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`ZytigaIPRTeam@sidley.com
`
`Counsel for Patent Owner
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`13
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`IPR2017-00853
`Patent 8,822,438
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing JANSSEN
`
`ONCOLOGY, INC.’S OPPOSITION TO MOTION FOR JOINDER
`
`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. § 42.122(b) was served on
`
`counsel of record on March 8, 2017 by filing this document through the End-to-
`
`End System, as well as delivering a copy via electronic mail to counsel of record
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`for the Petitioners at the following addresses:
`
`Samuel S. Park – spark@winston.com
`Ryan B. Hauer – rhauer@winston.com
`Jovial Wong – jwong@winston.com
`
`
`
`Date: March 8, 2017
`
`
`
`
`
`
`
`
`
`/Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
`
`
`
`
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`14
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