Paper No. ___
`Date Filed: July 29, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`
`________________
`
`Case IPR2016-01332
`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)
`
`
`
`
`
`Date Filed: July 29, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`JANSSEN ONCOLOGY, INC.,
`Patent Owner
`
`________________
`
`Case IPR2016-01332
`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)
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page
`
`
`
`I.
`INTRODUCTION ........................................................................................................ 1
`FACTUAL BACKGROUND .................................................................................... 1
`II.
`III. LEGAL STANDARDS ............................................................................................... 3
`IV. ARGUMENT ................................................................................................................ 6
`a. Mylan’s IPR Petition Introduces New Evidence And Testimony That
`Would Prejudice Janssen By Unduly Complicating The Amerigen IPR
`If Joinder Is Allowed. ...................................................................................... 6
`b. Mylan’s Motion for Joinder Fails To Specify How Its Petition Differs
`From Amerigen’s Petition And How Briefing And Discovery May Be
`Simplified. .......................................................................................................... 8
`c. Mylan Cites No Board Decision Granting Joinder Where A Petitioner
`Requesting Joinder Sought To Rely On Expert Testimony From A
`Different Expert. ............................................................................................. 10
`CONCLUSION ........................................................................................................... 11
`
`V.
`
`
`
`ii
`
`
`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Dell, Inc. v. Network-1 Security Solns., Inc.,
`IPR2013-00385, Paper 17 (PTAB July 29, 2013) .............................................. 10
`
`Kyocera Corp. v. Softview LLC,
`IPR2013-00004, Paper 15 (PTAB Apr. 24, 2013) ............................................... 4
`
`Motorola Mobility LLC v. SoftView LLC,
`IPR2013-00256, Paper 10 (PTAB June 20, 2013) ............................................. 10
`
`NetApp, Inc. v. PersonalWeb Techs., LLC,
`IPR2013-00319, Paper 18 (PTAB July 22, 2013) ................................................ 5
`
`Samsung Elec. Co., Ltd. v. Arendi S.A.R.L.,
`IPR2014-01144, Paper 11 (PTAB Oct. 2, 2014) ................................ 3, 4, 5, 9, 10
`
`Sony Corp. of America, et al. v. Network-1 Security Solutions, Inc.,
`IPR2013-00386, Paper 16 (PTAB July 29, 2013) ............................................ 8, 9
`
`Toyota Motor Corp., v. Am. Vehicular Sciences LLC,
`IPR215-00261, Paper 10 (PTAB Jan. 29, 2015) ................................................... 4
`
`ZTE Corp., et al. v. Adaptix, Inc.,
`IPR 2015-01184, Paper 10 (PTAB July 24, 2015) ......................................... 4, 10
`
`
`
`iii
`
`
`
`
`
`Statutes
`
`37 C.F.R. § 42.1(b) ................................................................................................ 4, 7
`
`37 C.F.R. § 42.20(c) ................................................................................................... 4
`
`37 C.F.R. § 42.51(b)(1)(ii) ......................................................................................... 7
`
`37 C.F.R. § 42.122(b) ................................................................................................ 4
`
`35 U.S.C. § 315(c) ..................................................................................................... 3
`
`Other Authorities
`
`157 Cong. Rec. S1376, daily ed. Mar. 8, 2011 (statement of Sen. Kyl) ................... 5
`
`iv
`
`
`
`
`
`
`
`INTRODUCTION
`
`I.
`Patent Owner Janssen Oncology, Inc. (“Janssen”) respectfully requests that
`
`the Board deny Petitioner Mylan Pharmaceutical Inc.’s (“Mylan”) motion for
`
`joinder of IPR2016-01332 (the “Mylan IPR”) with IPR2016-00286 (the “Amerigen
`
`IPR”). The Mylan IPR and the Amerigen IPR are both directed to U.S. Patent No.
`
`8,822,438 (the “’438 patent”).
`
`As explained in detail below, the Board should deny Mylan’s motion
`
`because it introduces new exhibits, including two new expert declarations, that
`
`unduly complicate the Amerigen proceeding and will prejudice Janssen. Mylan
`
`also fails to specify how its petition differs from Amerigen’s petition and it cites no
`
`Board decisions to support what it seeks to do here—rely on new expert testimony
`
`to support the petition that it seeks to join.
`
`FACTUAL BACKGROUND
`
`II.
`On July 31, 2015, Janssen filed a patent infringement lawsuit against Mylan,
`
`and other defendants, in the District of New Jersey in response to Mylan’s
`
`submission of an Abbreviated New Drug Application (“ANDA”) to the United
`
`States Food and Drug Administration. Through this ANDA, Mylan seeks approval
`
`to market a generic version of Janssen’s ZYTIGA® (abiraterone acetate) Tablets
`
`
`
`
`
`
`
`drug product prior to the expiration of the ’438 Patent.1
`
`On December 4, 2015, Amerigen Pharmaceuticals Limited (“Amerigen”)
`
`filed the Amerigen IPR petition seeking review of all 20 claims of the ’438 Patent.
`
`In support of its petition, Amerigen submitted the expert declarations of Scott R.
`
`Serels, M.D. (the “Serels Declaration”) and DeForest McDuff, Ph.D. (the “McDuff
`
`Declaration.”)
`
`On May 31, 2016, the Board instituted the Amerigen IPR petition based on
`
`two grounds of unpatentability. Under Ground 1, the Board will review claims 1–
`
`20 as allegedly obvious under 35 U.S.C. § 103 over O’Donnell and Gerber. Under
`
`Ground 2, the Board will review claims 1–4 and 6–11 as allegedly obvious under
`
`35 U.S.C. § 103 over Barrie and Gerber. See Amerigen IPR, Paper 14 at p. 19.
`
`On June 30, 2016, Mylan filed the Mylan IPR petition and concurrently filed
`
`a motion for joinder. In support of its IPR petition, Mylan submitted 15 new
`
`exhibits that were not submitted in the Amerigen IPR. Among Mylan’s 15 new
`
`
`1 In addition, Janssen filed a “protective suit” against Mylan in the Northern
`
`District of West Virginia on August 4, 2015 to preserve Janssen’s right for a 30-
`
`month stay under 21 U.S.C. § 355(j)(5)(B)(iii). This litigation is stayed. Janssen
`
`Biotech, Inc. et al. v. Mylan Pharms. Inc., et al., C.A. No. 1:15-cv-00130-IMK
`
`(N.D.W.Va.).
`
`
`
`2
`
`
`
`
`
`exhibits are the new expert declarations of Marc B. Garnick, M.D. (the “Garnick
`
`Declaration”) and Ivan T. Hofmann (the “Hofmann Declaration”) that are different
`
`from the Serels Declaration and the McDuff Declaration, respectively. 2 Because
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`Mylan relies on new evidence and new expert testimony not presented in the
`
`Amerigen IPR, Janssen disputes Mylan’s Statement of Material Facts (Nos. 5 and
`
`6) recited in its motion. See Mylan’s Motion for Joinder, Paper 3 at p. 3.
`
`Janssen will address separately, in due course, the reasons why the Mylan
`
`IPR petition should be denied. In this regard, Janssen intends to file its preliminary
`
`response to the Mylan IPR petition by no later than October 12, 2016—the
`
`deadline to file its preliminary response in accordance with 37 C.F.R. § 42.107.
`
`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.
`
`
`2 Although Mylan has represented to Janssen off the record that it is willing to
`
`withdraw the Hofmann Declaration to rely solely on the McDuff Declaration,
`
`Mylan is not willing to withdraw the Garnick Declaration to rely solely on the
`
`Serels Declaration.
`
`
`
`3
`
`
`
`
`
`v. Arendi S.A.R.L., IPR2014-01144, Paper 11 at p. 7 (PTAB Oct. 2, 2014); 37
`
`C.F.R. § 42.1(b).
`
`As the moving party, a petitioner requesting joinder has the burden of proof
`
`in establishing entitlement to joinder. Samsung, IPR2014-01144, Paper 11 at p. 7;
`
`37 C.F.R. §§ 42.20(c), 42.122(b). A motion for joinder should: (1) set forth the
`
`reasons why joinder is appropriate; (2) identify any new grounds of unpatentability
`
`asserted in the petition; (3) explain what impact (if any) joinder 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).
`
`When deciding a motion for joinder, the Board has considered the following
`
`factors:
`
`• whether the new petition adds new evidence (see, e.g., ZTE Corp., et
`
`al. v. Adaptix, Inc., IPR 2015-01184, Paper 10 at pp. 2-7 (PTAB July
`
`24, 2015) (denying motion for joinder because, although petitioner
`
`purported to advance the same grounds of unpatentability as those in
`
`the instituted petition, petitioner relied on a new expert declaration to
`
`support those grounds); see also Toyota Motor Corp., v. Am. Vehicular
`
`Sciences LLC, IPR215-00261, Paper 10 at pp. 3-7 (PTAB Jan. 29,
`
`2015));
`
`
`
`4
`
`
`
`
`
`• whether joinder prejudices the non-moving party by, for example,
`
`complicating resolution of the instituted proceeding (see, e.g., NetApp,
`
`Inc. v. PersonalWeb Techs., LLC, IPR2013-00319, Paper 18 at p. 5
`
`(PTAB July 22, 2013) (denying joinder because the additional
`
`analysis and expense associated with joinder would complicate the
`
`proceeding and prejudice patent owner)); and
`
`• whether the party requesting joinder failed to address in its motion the
`
`differences between its petition and the petition that it seeks to join
`
`(see, e.g., Samsung, IPR2014-01144, Paper 11 at p. 5 (denying motion
`
`for joinder and noting that petitioner “fails to specify the differences
`
`between its [p]etition and the [p]etition [that it seeks to join]” or what
`
`it “meant by ‘substantially identical’ claim charts”).
`
` 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,
`
`and consent of the patent owner.”). Id. citing 157 Cong. Rec. S1376, daily ed.
`
`Mar. 8, 2011 (statement of Sen. Kyl) (emphasis added).
`
`
`
`5
`
`
`
`
`
`IV. ARGUMENT
`a. Mylan’s IPR Petition Introduces New Evidence And
`Testimony That Would Prejudice Janssen By Unduly
`Complicating The Amerigen IPR If Joinder Is Allowed.
`
`Despite Mylan’s representations to the contrary, the Mylan IPR petition does
`
`not advance “identical grounds” to those instituted by the Board in Amerigen’s
`
`IPR. See Mylan’s Motion for Joinder, Paper 3 at pp. 4-5. Although Mylan’s IPR
`
`petition states that it relies on the same prior art references on which the Board
`
`instituted the Amerigen IPR, Mylan seeks to introduce new evidence and new
`
`expert testimony in support of those grounds. Specifically, Mylan relies on new
`
`Exhibits 1002, 1017, and 1068-1080 to support its petition.3 Exhibits 1002 and
`
`1017 are the brand new Garnick and Hofmann Declarations, respectively. These
`
`declarations replace the corresponding exhibits in the Amerigen IPR containing the
`
`Serels and McDuff Declarations. The new testimony that Mylan seeks to introduce
`
`would necessarily and significantly complicate the Amerigen IPR to the prejudice
`
`of Janssen. Mylan’s attempt to introduce new testimony would force Janssen to
`
`
`3 In addition, Mylan appears to withdraw, and does not appear to rely, on original
`
`Exhibits 1002, 1017, 1037, 1038, 1042-44, 1052, 1056, 1058-1063, and 1067 that
`
`were submitted in the Amerigen IPR.
`
`
`
`6
`
`
`
`
`
`engage in discovery and briefing not currently contemplated in the governing
`
`scheduling order in the Amerigen IPR.
`
`At a minimum, the additional burdens imposed on Janssen if Mylan’s
`
`request for joinder were granted include: 1) the need to analyze Mylan’s new
`
`evidence and expert testimony; 2) the need to depose Dr. Garnick (in addition to
`
`Dr. Serels and Dr. McDuff); and 3) the need to respond (in Janssen’s Patent Owner
`
`Response) to the new issues that Mylan supports in its petition with the new
`
`Garnick and Hofmann declarations. All of these added complications in a joined
`
`proceeding would impose an undue burden on Janssen and are contrary to the rules
`
`governing inter partes reviews which are designed “to secure the just, speedy, and
`
`inexpensive resolution of every proceeding.” 37 C.F.R. § 42.1(b). Further,
`
`Janssen’s Patent Owner Response in IPR2016-00286 is fast approaching and
`
`depositions of Amerigen’s experts are being scheduled. Because routine discovery
`
`in an inter partes review includes cross-examination of affidavit testimony (37
`
`C.F.R. § 42.51(b)(1)(ii)), Mylan’s introduction of new experts at this stage would
`
`require taking and responding to these depositions in a shortened timeframe than
`
`would be available if the Mylan IPR continued in a separate proceeding. Thus,
`
`granting Mylan’s request for joinder threatens to affect the scheduling of IPR2016-
`
`00286. This undue complication and tightened schedule is unfairly prejudicial to
`
`Janssen and, for this reason alone, Mylan’s motion for joinder should be denied.
`
`
`
`7
`
`
`
`
`
`b. Mylan’s Motion for Joinder Fails To Specify How Its Petition
`Differs From Amerigen’s Petition And How Briefing And
`Discovery May Be Simplified.
`It is Mylan’s burden to show that it is entitled to joinder. Sony Corp. of
`
`America, et al. v. Network-1 Security Solutions, Inc., IPR2013-00386, Paper 16 at
`
`pp. 3-4 (PTAB July 29, 2013). To meet its burden, Mylan is required to “identify
`
`any new grounds of unpatentability asserted in the petition.” Id. But Mylan
`
`nowhere explains why it needs 15 new exhibits, including the Garnick and
`
`Hofmann Declarations, to support its IPR petition. Rather than identifying the new
`
`testimony and exhibits that it presents, Mylan simply states that “while the
`
`Petitioner in the Mylan IPR and the Petitioner in the Amerigen IPR have relied
`
`upon testimony from separate experts in their respective petitions, the conclusions
`
`and underlying reasoning of the experts are congruent, and therefore present no
`
`additional burden on the part of the Patent Owners to address.” See Mylan’s
`
`Motion for Joinder, Paper 3 at p. 5 (emphasis added). Mylan’s use of the ill-
`
`defined term “congruent” to describe the positions espoused in its petition, as
`
`compared to those advanced in Amerigen’s petition, is insufficient to satisfy its
`
`burden.
`
`Indeed, for all the reasons described above, if joined, Mylan’s introduction
`
`of new evidence and new testimony imposes substantial additional burden on
`
`Janssen. Furthermore, Mylan’s motion makes no specific suggestions regarding
`
`
`
`8
`
`
`
`
`
`schedule or discovery in the Amerigen IPR, as it was required to do to sustain its
`
`burden. See Sony, IPR2013-00386, Paper 16 at pp. 3-4. With regards to briefing,
`
`Mylan appears to discern no impact on the Amerigen IPR, other than to suggest
`
`allowing “the new petitioner to file seven additional pages with corresponding
`
`additional responsive pages allowed to the Patent Owner.” See Mylan’s Motion
`
`for Joinder, Paper 3 at p. 5. But, as explained in Section IV.c., the cases cited by
`
`Mylan to support its proposal are inapposite because in those cases there was no
`
`new evidence or expert testimony introduced into the joined proceeding.
`
`Mylan’s failure to point out the differences between its petition and the
`
`Amerigen IPR and the realistic impact of these differences on the trial schedule,
`
`briefing, and discovery in the Amerigen IPR are fatal to Mylan’s joinder request.
`
`Samsung, IPR2014-01144, Paper 11 at 7 (finding that “[i]n view of the facts and
`
`circumstances of th[e] case, . . . Petitioner has not met its burden to show that
`
`joinder is appropriate, consistent with the goal of securing the just, speedy, and
`
`inexpensive resolution of every proceeding. Petitioner’s motion for joinder is, thus,
`
`denied.”). Thus, for this additional reason, Mylan’s motion for joinder should be
`
`denied.
`
`
`
`9
`
`
`
`
`
`c. Mylan Cites No Board Decision Granting Joinder Where A
`Petitioner Requesting Joinder Sought To Rely On Expert
`Testimony From A Different Expert.
`
`To support its motion for joinder, Mylan relies on the Board’s decisions
`
`granting joinder in Dell, Inc. v. Network-1 Security Solns., Inc., IPR2013-00385,
`
`Paper 17 (PTAB July 29, 2013) and Motorola Mobility LLC v. SoftView LLC,
`
`IPR2013-00256, Paper 10 (PTAB June 20, 2013). Mylan fails to mention,
`
`however, that neither of these cases introduced a new expert declaration into the
`
`joined proceeding, as Mylan seeks to do here. Instead, the petitioners seeking
`
`joinder in Dell and Motorola agreed to rely on the same expert testimony that had
`
`been submitted in the proceeding that they sought to join.
`
`Mylan’s absence of persuasive authority to support its motion is not
`
`surprising. Janssen is not aware of any Board decision granting a contested motion
`
`for joinder in an IPR proceeding where the petitioner requesting joinder relied on a
`
`different expert. Instead, the Board has consistently denied motions for joinder in
`
`which the petitioner requesting joinder sought to introduce new expert testimony.
`
`See ZTE, IPR 2015-01184, Paper 10 at pp. 2-7 (denying joinder because “new
`
`issues raised by reliance on [a] different declarant…would adversely impact the
`
`IPR ‘1525 trial”); Samsung, IPR2014-01144, Paper 11 at pp. 6-7 (denying joinder
`
`where reliance on testimony of a new expert “would introduce new evidence and
`
`argument into the joint proceeding”). Nothing in Mylan’s request for joinder
`
`
`
`10
`
`
`
`
`
`suggests that the Board should deviate from its normal practice, and as a result,
`
`Mylan’s motion for joinder should be denied.4
`
`V. CONCLUSION
`For all the foregoing reasons, Mylan’s motion for joinder should be denied
`
`and the Board should proceed to an orderly and timely consideration of the
`
`Amerigen IPR.
`
`Dated: July 29, 2016
`
`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
`
`Counsel for Patent Owner
`
`
`4 Janssen has enumerated the conditions that the Board has considered appropriate
`
`to ensure the just, speedy, and inexpensive resolution of a joined proceeding in its
`
`response to a request for joinder in Argentum Pharmaceuticals LLC v. Janssen
`
`Oncology, Inc., IPR2016-01317, Paper No. 7. Indeed, under those conditions and
`
`safeguards, Janssen has not opposed joinder in that related proceeding.
`
`
`
`11
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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 July 29, 2016 by filing this document through the Patent Trial and
`
`Appeal Board End-to-End (PTAB E2E) system, as well as delivering a copy via
`
`electronic mail to counsel of record for the Petitioner at the following addresses:
`
`Brandon M. White – mbwhite@perkinscoie.com
`Bryan D. Beel – bbeel@perkinscoie.com
`
`
`
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`
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`Respectfully submitted,
`
`By: /s/Dianne B. Elderkin
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
`
`Date: July 29, 2016
`
`
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`12
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