UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC., SAWAI USA, INC.,
`and SAWAI PHARMACEUTICAL CO., LTD.,
`Petitioner
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner
`
`Case IPR2018-014031
`Patent 8,399,514
`
`JOINT MOTION TO TERMINATE PROCEEDING AS TO PETITIONER
`SAWAI PURSUANT TO 35 U.S.C. § 317 AND 37 C.F.R. § 42.74
`
`1 Case IPR2019-00789 has been joined with this proceeding.
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC., SAWAI USA, INC.,
`and SAWAI PHARMACEUTICAL CO., LTD.,
`Petitioner
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner
`
`Case IPR2018-014031
`Patent 8,399,514
`
`JOINT MOTION TO TERMINATE PROCEEDING AS TO PETITIONER
`SAWAI PURSUANT TO 35 U.S.C. § 317 AND 37 C.F.R. § 42.74
`
`1 Case IPR2019-00789 has been joined with this proceeding.
`
`
`
`I. INTRODUCTION
`
`Pursuant to 35 U.S.C. § 317(a), Petitioners Sawai USA Inc. and Sawai
`
`Pharmaceutical Co. Ltd. (collectively “Sawai”) and Patent Owner Biogen MA
`
`Inc. jointly request termination of the inter partes review of U.S. Patent No.
`
`8,399,514 ('514 patent), Case No. IPR2019-01403 as to Petitioner Sawai in light
`
`of Biogen and Sawai’s resolution of their dispute relating to this IPR.
`
`Biogen and Sawai have settled their disputes regarding the '514 patent.
`
`Biogen and Sawai’s settlement is memorialized in an agreement (“Settlement
`
`Agreement”), a true and correct copy of which is being filed confidentially as
`
`Exhibit 1135 (in a separate paper), as required by 35 U.S.C. § 317(b).
`
`In accordance with 37 C.F.R. § 42.20(b), on November 13, 2019, Sawai
`
`and Biogen sought authorization from the Board (via email) to file this motion to
`
`terminate and to file the Settlement Agreement as business confidential
`
`information. In an Order dated November 18, 2019 (Paper No. 90)(“Order”), the
`
`Board authorized the parties to file this joint motion to terminate and further
`
`authorized the parties to file a joint request to file the Settlement Agreement as
`
`business confidential information in a separate paper filed contemporaneously
`
`with the joint motion to terminate. Order at 3.
`
`
`
`II. TERMINATION IS APPROPRIATE
`
`Pursuant to the Order, the joint motion to terminate as to Petitioner Sawai
`
`must (1) include a brief explanation as to why termination is appropriate; (2)
`
`identify all parties in any related litigation involving the patents at issue; (3)
`
`identify any related proceedings currently before the Office; and (4) discuss
`
`specifically the current status of each such related litigation or proceeding with
`
`respect to each party to the litigation or proceeding. Order at 2.
`
`1) Explanation Why Termination is Appropriate: Biogen and Sawai have
`
`reached agreement regarding their disputes relating to the '514 patent. Pursuant to
`
`Section 1(b) of the Settlement Agreement, Patent Owner and Sawai jointly agreed
`
`to terminate Sawai from this proceeding. (Ex. 1135 at Section 1(b).) Accordingly,
`
`the parties jointly request that Sawai be terminated from this proceeding under 35
`
`U.S.C. § 317(a) and 37 C.F.R. § 42.74.The litigation between Biogen and Sawai
`
`related to this proceeding has also been settled and Biogen and Sawai filed a
`
`stipulation to dismiss the related litigation. (Ex. 1135 at Section 1(a).) Biogen
`
`International GmbH and Biogen MA Inc. v. Sawai USA, Inc. and Sawai
`
`Pharmaceutical Co. Ltd., 1:17-cv-875-MN (D. Del.) (dismissed Nov. 14, 2019).
`
`Under 35 U.S.C. § 317(a), “[a]n inter partes review instituted under this
`
`chapter shall be terminated with respect to any petitioner upon the joint request of
`
`the petitioner and the patent owner, unless the Office has decided the merits of the
`
`
`
`proceeding before the request for termination is filed.” This proceeding has been
`
`instituted but the Board has not decided on the merits of the proceeding.
`
`Strong public policy considerations favor settlement between the parties to
`
`an inter partes review proceeding. See Office Trial Practice Guide, Fed. Reg.,
`
`Vol. 77, No. 157 at 48768 (Aug. 14, 2012) (“There are strong public policy
`
`reasons to favor settlement between the parties to a proceeding.”). No public
`
`interest or other factors weigh against termination of Sawai from this proceeding.
`
`Because the underlying dispute has been resolved between Biogen and
`
`Sawai and because termination of Sawai would encourage settlement of Patent
`
`Office proceedings, consistent with federal judicial preference and the
`
`management of limited judicial and Patent Office resources, Biogen and
`
`Sawai submit that termination of this proceeding is appropriate.
`
`2) Related Litigation: The following pending litigation concerns the ’514
`
`patent:
`
`Biogen International GmbH and Biogen MA Inc. v. Amneal Pharmaceuticals, LLC
`et al., No. 1:17-cv-823-MN (D. Del.) (consolidated)
`
`Biogen International GmbH and Biogen MA Inc. v. Accord Healthcare, Inc., No.
`1:17-cv-872-MN (D. Del.)
`
`Biogen International GmbH and Biogen MA Inc. v. Alkem Labs. Limited. and S&B
`Pharma Inc., No. 1:17-cv-850-MN (D. Del.)
`
`Biogen International GmbH and Biogen MA Inc. v. Aurobindo Pharma U.S.A., Inc.
`and Aurobindo Pharma USA LLC, No. 1:17-cv-824-MN (D. Del.)
`
`
`
`Biogen International GmbH and Biogen MA Inc. v. Cipla Limited and Cipla USA
`Inc.., No. 1:17-cv-851-MN (D. Del.)
`
`Biogen International GmbH and Biogen MA Inc. v. Glenmark Pharmaceuticals
`Limited and Glenmark Pharmaceuticals Inc., USA, No. 1:17-cv-852-MN (D. Del.)
`
`Biogen MA Inc. v. Graviti Pharmaceuticals. Pvt. Limited and Graviti
`Pharmaceuticals Inc., No. 1:17-cv-846-MN (D. Del.)
`
`Biogen International GmbH and Biogen MA Inc. v. Hetero USA Inc., Hetero Labs
`Limited Unit-III and Hetero Labs Limited, No. 1:17-cv-825-MN (D. Del.)
`
`Biogen International GmbH and Biogen MA Inc. v. Lupin Atlantis Holdings SA
`and Lupin Inc., No. 1:17-cv-853-MN (D. Del.)
`
`Biogen International GmbH and Biogen MA Inc. v. Macleods Pharmaceuticals,
`Limited and Macleods Pharma USA Inc., No. 1:17-cv-857-MN (D. Del.)
`
`Biogen MA Inc. v. MSN Laboratories Private Limited and MSN Pharmaceuticals
`Inc., No. 1:17-cv-845-MN (D. Del.)
`
`Biogen International GmbH and Biogen MA Inc. v. Mylan Pharmaceuticals, Inc.,
`No. 1:17-cv-116-IMK (N.D. W. Va.)
`
`Biogen International GmbH and Biogen MA Inc. v. Pharmathen S.A., No. 1:17-cv-
`855-MN (D. Del.)
`
`Biogen International GmbH and Biogen MA Inc. v. Sandoz, Inc. and Prinston
`Pharmaceutical Inc., 1:17-cv-874-MN (D. Del.)
`
`Biogen MA Inc. v. Shilpa Medicare Limited., No. 1:17-cv-847-MN (D. Del.)
`
`Biogen MA Inc. v. Slayback Pharma LLC and Slayback Pharma India LLP, No.
`1:17-cv-828-MN (D. Del.)
`Biogen International GmbH and Biogen MA Inc. v. Torrent Pharmaceuticals
`Limited and Torrent Pharma Inc., No. 1:17-cv-854-MN (D. Del.)
`
`Biogen International GmbH and Biogen MA Inc. v. TWi Pharmaceuticals Inc. and
`TWi Pharmaceuticals USA Inc., No. 1:17-cv-856-MN (D. Del.)
`
`
`
`Biogen MA Inc. v. Windlas Healthcare, Pvt. Limited., No. 1:17-cv-849-MN (D.
`Del.)
`
`Biogen International GmbH and Biogen MA Inc. v. Zydus Pharmaceuticals (USA)
`Inc., No. 1:17-cv-954-MN (D. Del.)
`
`3 and 4) Related Proceedings before the Patent Office and Its Status:
`
`Related to the instant IPR2018-01403, initially Mylan Pharmaceuticals Inc.
`
`v. Biogen MA Inc., Patent Owner notes that on September 12, 2019, the petition
`
`against the ’514 patent in IPR2019-00789, Sawai USA, Inc. and Sawai
`
`Pharmaceutical Co., Ltd., v. Biogen MA Inc, and motion for joinder with the
`
`present IPR were granted and IPR2019-00789 was terminated. (IPR2019-00789,
`
`Paper 17 “Decision”.) On September 26, 2019, Patent Owner filed (i) a Rehearing
`
`Request and (ii) a Request for Precedential Opinion Panel Review directed to the
`
`Decision. The Request for Precedential Opinion Panel Review was denied on
`
`November 15, 2019. Paper No. 22. Otherwise, Biogen and Sawai are unaware of
`
`any other matter before the USPTO that would be affected by the settlement and
`
`termination of this proceeding.
`
`III.SUBMISSION OF THE SETTLEMENT AGREEMENTS
`
`Submitted concurrently with this Motion are the Settlement Agreements
`
`between Biogen and Sawai (Ex. 1135), as required by 35 U.S.C. § 317(b) and 37
`
`C.F.R. § 42.74(b). The parties certify that that there are no collateral agreements
`
`or understanding made in connection with, or in contemplation of, the termination
`
`
`
`of the inter partes review as to Petitioner Sawai. See 35 U.S.C. § 317(b): 37
`
`C.F.R. § 42.74(b). Therefore, Biogen and Sawai jointly request that these
`
`Settlement Agreements be treated as business confidential and be kept separate
`
`from the file of the involved patent and be made available only to Federal
`
`Government agencies on written request or to any person only on a showing of
`
`good cause pursuant to 35 U.S.C. § 317(b) and 37 C.F.R. § 42.74(c). As
`
`authorized in the Order, Biogen and Sawai are filing, concurrently herewith, a
`
`Joint Request to File the Settlement Agreements as Business Confidential
`
`Information Pursuant to 35 U.S.C. § 317.
`
`IV. CONCLUSION
`
`For the reasons stated above, Biogen and Sawai respectfully request the Board
`
`terminate this proceeding, Case No. IPR2019-01403, as to Petitioner Sawai.
`
`Dated: November 19, 2019
`
`
`
`Respectfully submitted,
`
`
`
`/Christopher B. Ferenc/
`Christopher B. Ferenc (Reg. No. 59,365)
`Counsel for Petitioners Sawai USA,
`Inc. and Sawai Pharmaceutical Co., Ltd.
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6, the undersigned certifies that on November 19,
`
`2019, a copy of the foregoing document was served upon the following, by email
`to:
`
`barbara.mccurdy@finnegan.com
`
`mark.feldstein@finnegan.com
`
`erin.sommers@finnegan.com
`
`pier.deroo@finnegan.com
`
`cora.holt@finnegan.com
`
`bmwhite@perkinscoie.com
`
`egreb@perkinscoie.com
`
`Dated: November 19, 2019
`
`
`
`/Christopher B. Ferenc/
`Christopher B. Ferenc (Reg. No. 59,365)
`Counsel for Petitioners Sawai USA,
`Inc. and Sawai Pharmaceutical Co., Ltd.
`
`
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