`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Filed: February 8, 2017
`
`
`
`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
`
`
`
`U.S. Patent No. 8,822,438 to Auerbach et al.
`
`
`
`Inter Partes Review IPR2017-00853
`
`
`
`MOTION FOR JOINDER WITH RELATED INSTITUTED INTER PARTES
`REVIEW OF U.S. PATENT NO. 8,822,438 PURSUANT TO 35 U.S.C. §
`315(c), 37 C.F.R. 42.22 AND 42.112(b)
`
`
`
`
`
`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`
`Page
`
`STATEMENT OF PRECISE RELIEF REQUESTED ................................... 1
`
`STATEMENT OF MATERIAL FACTS ........................................................ 2
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED ........................ 5
`
`A.
`
`B.
`
`Joinder is timely. ................................................................................... 5
`
`Joinder is appropriate. ........................................................................... 5
`
`1.
`
`2.
`
`Legal Standard. ........................................................................... 5
`
`Joinder Is Appropriate Because Both IPRs Present
`Exactly The Same Grounds And Evidence Of
`Obviousness Concerning The Same Claims. .............................. 6
`
`3.
`
`Joinder will not impact the existing trial schedule. .................... 6
`
`IV. CONCLUSION ................................................................................................ 8
`
`
`
`
`
`
`
`i
`
`
`
`
`
`
`
`Cases
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Amerigen Pharms. Ltd. v. Janssen Oncology, Inc.,
`IPR2016-00286 (P.T.A.B.) ....................................................................... 2, 3, 7, 9
`
`Argentum Pharms. LLC v. Janssen Oncology, Inc.,
`IPR2016-01317 (P.T.A.B.) ................................................................................... 3
`
`Ariosa Diagnostics v. Isis Innovation Limited,
`IPR-2013-00250, 2013 WL 6514079 (P.T.A.B. Sept. 3, 2013) ....................... 5, 6
`
`BTG Int’l Ltd. v. Actavis Labs. FL, Inc.,
`No. 15-cv-5909-KM-JBC (D.N.J.) ....................................................................... 3
`
`BTG Int’l Ltd. v. Amerigen Pharms., Inc.,
`No. 16-cv-02449-KM-JBC (D.N.J.) ..................................................................... 3
`
`BTG Int’l Ltd. v. Glenmark Pharms. Inc., USA,
`No. 16-cv-03743-KM-JBC (D.N.J.) ..................................................................... 3
`
`BTG International LTD v. Actavis Laboratories FL, Inc.,
`15-cv-05909 (July 31, 2015) ................................................................................. 4
`
`Dell Inc. v Network-1 Security Solutions, Inc.,
`Decision on Motion for Joinder, IPR2013-00385, Paper 17 (July
`29, 2013) ............................................................................................................... 5
`
`Janssen Biotech, Inc. v. Mylan Pharms. Inc.,
`No. 15-cv-00130-IMK (N.D.W. Va.) ................................................................... 3
`
`Jiawei Technology (HK) Ltd. et al. v. Richmond,
`IPR2015-00580 (P.T.A.B. Feb. 13, 2015) ............................................................ 2
`
`Motorola Mobility LLC v. SoftView LLC,
`IPR2013-00256, Paper 10 (P.T.A.B. June 20, 2013) ........................................... 8
`
`Mylan Pharmaceuticals Inc. v. Janssen Oncology, Inc.,
`IPR2016-01332 (P.T.A.B.) ..........................................................................passim
`
`ii
`
`
`
`
`
`Wockhardt Bio AG v. Janssen Oncology, Inc.,
`IPR2016-01582 (P.T.A.B.) ................................................................................... 3
`
`Statutes
`
`35 U.S.C. § 103 .......................................................................................................... 4
`
`35 U.S.C. § 315(c) ..................................................................................................... 5
`
`Other Authorities
`
`37 C.F.R. § 42.5(c)(1) ................................................................................................ 2
`
`37 C.F.R. § 42.22 ....................................................................................................... 5
`
`37 C.F.R. § 42.122 ..................................................................................................... 5
`
`37 C.F.R. § 42.122(b) ................................................................................................ 5
`
`USPTO, Board’s Frequently Asked Questions, at H5 available at
`http://www.uspto.gov/ip/boards/bpai/prps.jsp ...................................................... 5
`
`
`
`
`
`
`
`iii
`
`
`
`
`
`I.
`
`STATEMENT OF PRECISE RELIEF REQUESTED
`
`Petitioners 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”) hereby
`
`move for joinder and/or consolidation of its today-filed petition for Inter Partes
`
`Review (“IPR”) of claims 1-20 of U.S. Patent No. 8,822,438 (“the ʼ438 patent”) with
`
`a previously instituted and currently pending IPR by Mylan Pharmaceuticals Inc.,
`
`v. Janssen Oncology, Inc. case number IPR2016-01332 (“Mylan IPR”).
`
`The Mylan IPR was instituted on January 10, 2017, on the same patent and
`
`the same claims as Petitioners’ Petition (the “Petition”) filed today. Further, the
`
`Petition and supporting expert declarations are identical to the petition and
`
`declarations submitted in the Mylan IPR. Petitioners here assert that the same claims
`
`are obvious over the same prior art based on the same arguments presented by the
`
`same experts as the Mylan IPR petitioner.
`
`The Mylan IPR petitioner has informed Petitioners that it supports joinder and
`
`that it will coordinate with Petitioners to avoid duplicative briefing on overlapping
`
`issues. Joinder will not cause any delay in the resolution of the Mylan IPR. Joinder,
`
`therefore, is appropriate because it will promote the efficient and consistent
`
`1
`
`
`
`
`
`resolution of the same validity issues of the same single ʼ438 patent, it will not delay
`
`the Mylan IPR trial schedule, and the parties in the Mylan IPR will not be prejudiced.
`
`In light of the condensed schedule set in the Mylan IPR, Petitioners
`
`respectfully request that the Board to expedite Patent Owner’s preliminary response
`
`period using its authority under 37 C.F.R. § 42.5(c)(1). See Jiawei Technology (HK)
`
`Ltd. et al. v. Richmond, IPR2015-00580 (P.T.A.B. Feb. 13, 2015) (shortening
`
`preliminary response period to accommodate a time-sensitive motion for joinder). A
`
`shortened preliminary response schedule would facilitate an earlier review of both
`
`the Petition and this concurrent motion for joinder so that Petitioners, at the latest,
`
`could join the Mylan IPR prior to its Oral Argument (if requested). In the meantime,
`
`Petitioners agree to abide by and adopt all of the actions and proceedings in the
`
`Mylan IPR that may occur prior to the Board reaching its decision on the instant
`
`Petition and motion for joinder.
`
`II.
`
`STATEMENT OF MATERIAL FACTS
`
`1.
`
`Janssen Oncology, Inc. (“Patent Owner”) purportedly owns the ʼ438
`
`patent.
`
`2.
`
`Petitioners are not aware of any reexamination certificates or pending
`
`prosecution concerning the ʼ438 patent. The following litigation or inter partes
`
`reviews related to the ʼ438 patent are pending:
`
`2
`
`
`
`
`
`
`
`Amerigen Pharms. Ltd. v. Janssen Oncology, Inc., IPR2016-00286
`
`(P.T.A.B.);
`
`
`
`Argentum Pharms. LLC v. Janssen Oncology, Inc., IPR2016-01317
`
`(P.T.A.B.);
`
`
`
`BTG Int’l Ltd. v. Actavis Labs. FL, Inc., No. 15-cv-5909-KM-JBC
`
`(D.N.J.);
`
`
`
`BTG Int’l Ltd. v. Amerigen Pharms., Inc., No. 16-cv-02449-KM-JBC
`
`(D.N.J.);
`
`
`
`BTG Int’l Ltd. v. Glenmark Pharms. Inc., USA, No. 16-cv-03743-KM-
`
`JBC (D.N.J.); and
`
`
`
`Janssen Biotech, Inc. v. Mylan Pharms. Inc., No. 15-cv-00130-IMK
`
`(N.D.W. Va.).
`
`
`
`Mylan Pharmaceuticals Inc. v. Janssen Oncology, Inc., IPR2016-
`
`01332 (P.T.A.B.).
`
`
`
`Wockhardt Bio AG v. Janssen Oncology, Inc., IPR2016-01582
`
`(P.T.A.B.).
`
`3.
`
`On June 30, 2016, Mylan Pharmaceuticals, Inc., filed a petition
`
`challenging claims 1-20 of the ʼ438 patent in Mylan Pharmaceuticals Inc., v.
`
`Janssen Oncology, Inc. case number IPR2016-01332.
`
`3
`
`
`
`
`
`4.
`
`On January 10, 2017, the U.S. Patent Trial and Appeal Board (“Board”)
`
`granted institution of Inter Partes Review. Mylan IPR, paper 21.
`
`5.
`
`The Board instituted the Mylan IPR on two grounds: (1) Claims 1-20
`
`as obvious under 35 U.S.C. § 103 over O’Donnell and Gerber; and (2) Claims 1-4
`
`and 6-11 as obvious under 35 U.S.C. § 103 over Barrie and Gerber.
`
`6.
`
`Along with
`
`their Motion for Joinder, Petitioners here have
`
`simultaneously filed a Petition for Inter Partes Review, No. IPR2017-00853, which
`
`argues, inter alia, that exactly the same claims of the ’438 patent are obvious over
`
`exactly the same grounds and reasons set out in the Mylan IPR. The Petition is also
`
`supported by expert declarations of Marc B. Garnick, M.D., and Ivan T. Hofmann,
`
`the same experts who submitted identical declarations in support of the Mylan IPR
`
`petition.
`
`7.
`
`The grounds proposed in the present Petition are therefore the same
`
`grounds of invalidity on which the Board instituted the Mylan IPR, and the Petition
`
`does not contain any additional arguments or evidence in support of the invalidity
`
`of claims 1-20 of the ’438 patent.
`
`8.
`
`The ʼ438 patent is asserted against both the petitioner in the Mylan
`
`IPR and Petitioners here in the consolidated action, BTG International LTD v.
`
`Actavis Laboratories FL, Inc., 15-cv-05909 filed July 31, 2015, in the United
`
`States District for the District of New Jersey.
`
`4
`
`
`
`
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`
`A.
`
`Joinder is timely.
`
`Pursuant to 37 C.F.R. §§ 42.22, 42.122(b), this motion for joinder is timely
`
`because it is submitted within one month of the date the Mylan IPR was instituted.
`
`The Mylan IPR was instituted on January 10, 2017, and this motion has been filed
`
`on February 8, 2017.
`
`B.
`
`Joinder is appropriate.
`
`1.
`
`Legal Standard.
`
`The Board has discretion to, and should, join Petitioners’ IPR with the Mylan
`
`IPR. See 35 U.S.C. § 315(c); 37 C.F.R. § 42.122; Ariosa Diagnostics v. Isis
`
`Innovation Limited, IPR-2013-00250, 2013 WL 6514079, at *2 (P.T.A.B. Sept. 3,
`
`2013). In considering a motion for joinder, the Board considers the following
`
`factors: (1) the reasons why joinder is appropriate; (2) new grounds of
`
`unpatentability asserted in the petition; (3) the impact (if any) joinder would have on
`
`the trial schedule for the existing review; and (4) how briefing and discovery may
`
`be simplified. See Dell Inc. v Network-1 Security Solutions, Inc., Decision on
`
`Motion for Joinder, IPR2013-00385, Paper 17 at 4 (July 29, 2013); Board’s
`
`Frequently
`
`Asked
`
`Questions,
`
`at
`
`H5
`
`available
`
`at
`
`http://www.uspto.gov/ip/boards/bpai/prps.jsp. All of the foregoing factors here
`
`weigh in favor of joinder.
`
`5
`
`
`
`
`
`2.
`
`Joinder Is Appropriate Because Both IPRs Present Exactly
`The Same Grounds And Evidence Of Obviousness
`Concerning The Same Claims.
`
`Joinder is appropriate here because the Petition asserts exactly the same
`
`grounds and relies exactly on the same evidence for invalidity that formed the basis
`
`for institution in the Mylan IPR. Specifically, the Petition relies on the same
`
`combinations of prior art references. Moreover, the same experts, Dr. Garnick and
`
`Mr. Hofmann, have submitted identical supporting declarations in both IPRs. And
`
`the arguments in both petitions are identical; there are no new grounds of
`
`unpatentability asserted in the Petition. Accordingly, the Board will need to decide
`
`the same issues in both IPRs—the Petition will not add any additional dimension to
`
`the substantive issues in the Mylan IPR.
`
`Since the parties will be presenting, and the Board will be determining, the
`
`same issues in both IPRs, joinder is the most efficient and economical manner to
`
`proceed. See, e.g., Ariosa Diagnostics v. Isis Innovation Limited, IPR2013-00250,
`
`2013 WL 6514079, at *1 (P.T.A.B. Sept. 3, 2013) (granting motion for joinder where
`
`the second petition involved the same parties, the same patent, and much of the same
`
`prior art).
`
`3.
`
`Joinder will not impact the existing trial schedule.
`
`Joinder will not introduce any new prior art, experts, or grounds for
`
`unpatentability into the Mylan IPR, so joining Petitioners’ proceeding will not add
`
`6
`
`
`
`
`
`any procedural complications or delay the progress of resolving the substantive
`
`issues already pending in the Mylan IPR. Petitioners will not request any alterations
`
`to the schedule in the Mylan IPR based on the requested joinder. Accordingly,
`
`joinder will not at all impact the trial schedule for existing review of the Mylan IPR
`
`or otherwise unfairly prejudice the Patent Owner.1 Additionally, the petitioner in
`
`the Mylan IPR has informed Petitioners here that it supports joinder and that it will
`
`coordinate with Petitioners.
`
`4.
`
`Joinder would simplify briefing and discovery.
`
`Since the prior art and bases for unpatentability in the petitions in both this
`
`IPR and the Mylan IPR are the same, the same arguments will be made by both
`
`groups of petitioners. Without joinder, largely duplicative briefs and other papers
`
`would be filed in parallel IPRs. Also, both Petitioners and the Mylan IPR petitioner
`
`
`1 Petitioners understand that the Board set a “condensed schedule” in the Mylan IPR
`
`to allow for resolution of the Mylan IPR and the IPR in Amerigen Pharmaceuticals,
`
`Ltd. v. Janssen Oncology, Inc., IPR2016-00286 (the “Amerigen IPR”) in relative
`
`proximity to each other. Mylan IPR, paper 21 at 11. For the same reasons, joinder
`
`of the Petition with the Mylan IPR will also not impact the trial schedule for existing
`
`review of the Amerigen IPR.
`
`7
`
`
`
`
`
`have retained the same experts to support identical arguments. Joinder would
`
`eliminate duplicative expert discovery and trial testimony.
`
`The Mylan IPR petitioner has represented that it will coordinate with
`
`Petitioners here to facilitate the elimination of repetitive briefs and testimony.
`
`Petitioners and the Mylan IPR petitioner have also agreed that Petitioners will
`
`maintain a secondary role in the proceeding, if joined. Petitioners will assume a
`
`primary role only if the Mylan IPR petitioner ceases to participate in the IPR. These
`
`agreements remove any potential “complication or delay” caused by joinder, while
`
`providing the parties an opportunity to address all issues that may arise and avoiding
`
`any undue burden on Patent Owner, the Mylan IPR petitioner, and the Board. See,
`
`e.g., Motorola Mobility LLC v. SoftView LLC, IPR2013-00256, Paper 10 at 8-9
`
`(P.T.A.B. June 20, 2013). Therefore, briefing and discovery would be significantly
`
`simplified if joinder were granted.
`
`IV. CONCLUSION
`
`For the foregoing reasons, Petitioners 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, respectfully request
`
`that the Board institute its Petition for Inter Partes Review of U.S. Patent No.
`
`8
`
`
`
`
`
`8,822,438 and join this proceeding with Mylan Pharmaceuticals Inc., v. Janssen
`
`Oncology, Inc., case number IPR2016-01332.
`
`Respectfully submitted,
`
`/s/ Samuel S. Park
`Samuel S. Park
`Reg. No. 59,656
`
`Lead Counsel for Petitioners
`
`
`Dated: February 8, 2017
`
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`Telephone: (312) 558-7931
`Fax: (312) 558-5700
`E-mail: spark@winston.com
`
`9
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105, I certify that I caused to be
`
`served a true and correct copy of the foregoing: Motion for Joinder with Related
`
`Instituted Inter Partes Review of U.S. Patent 8,822,438 Pursuant to 35 U.S.C. §
`
`315(c), 37 C.F.R. 42.22 and 42.112(b) by Federal Express Next Business Day
`
`Delivery on this day on the Patent Owner’s correspondence address of record for
`
`the subject patent as follows:
`
`Janssen Oncology, Inc.
`10990 Wilshire Blvd., Suite 1200
`Los Angeles, CA 90024
`
`
`
`
`Johnson & Johnson,
`Attn: Joseph F. Shirtz
`One Johnson & Johnson Plaza
`New Brunswick, NJ 08933-7003
`
`and by email to the service addresses for Patent Owner listed in Paper No. 14 in
`
`IPR2016-01332:
`
`
`
`Date: February 8, 2017
`
`delderkin@akingump.com
`bmullin@akingump.com
`rmunoz@akingump.com
`ZytigaIPRTeam@sidley.com
`
`/s/ Samuel S. Park
`Samuel S. Park
`
`Lead Counsel for Petitioners
`
`
`
`
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