UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________________
`SAWAI USA, INC. AND
`SAWAI PHARMACEUTICAL CO., LTD.
`Petitioners,
`
`v.
`
`BIOGEN MA, INC.
`Patent Owner.
`_______________________________
`Patent No. 8,399,514
`_______________________________
`Inter Partes Review IPR2019-00789
`_______________________________
`
`PETITIONERS’ RESPONSE TO PATENT OWNER’S OPPOSITION TO
`PETITIONERS’ MOTION FOR JOINDER
`
`
`_______________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________________
`SAWAI USA, INC. AND
`SAWAI PHARMACEUTICAL CO., LTD.
`Petitioners,
`
`v.
`
`BIOGEN MA, INC.
`Patent Owner.
`_______________________________
`Patent No. 8,399,514
`_______________________________
`Inter Partes Review IPR2019-00789
`_______________________________
`
`PETITIONERS’ RESPONSE TO PATENT OWNER’S OPPOSITION TO
`PETITIONERS’ MOTION FOR JOINDER
`
`
`
`Sawai USA, Inc. (“Sawai USA”) and Sawai Pharmaceutical Co., Ltd. (“Sawai
`
`Japan”) (collectively, “Sawai” or “Petitioners”) timely filed a Motion for Joinder. In
`
`response, Biogen MA Inc. (“Patent Owner”) filed an Opposition to Petitioners’
`
`Motion for Joinder (Paper 9) (“Opp.”). Contrary to Patent Owner’s allegations,
`
`Petitioners’ joinder to IPR2018-01403 (herein the “Mylan IPR”) will not delay that
`
`proceeding because Petitioners’ declarants will not introduce new issues and there
`
`is no real party-in-interest (“RPI”) issue that must be resolved. Therefore, Sawai’s
`
`Motion for Joinder should be granted.
`
`I.
`
`Sawai’s Declarants Will Not Introduce New Issues Into the Mylan IPR
`
`As an initial matter, Patent Owner does not identify a single “new” substantive
`
`issue that will be introduced by Petitioners’ declarants. There is none. That is why
`
`Sawai repeatedly requested Mylan’s permission to rely on Mylan’s declarants if
`
`Sawai’s Motion for Joinder were granted. Ex. 1061. After Mylan refused to provide
`
`an answer, Sawai sought guidance from the Board, and the parties received an email
`
`stating, in part, “[t]he panel understands that, if joined to the Mylan IPR (IPR2018-
`
`01403), Sawai does not intend to produce its own testifying witnesses or file
`
`substantive papers in the Mylan IPR so long as Mylan remains a party to the case.”
`
`Ex. 1062 at 1. The panel’s understanding is correct, and Sawai has notified Patent
`
`Owner and Mylan of the same. Ex. 1063 at 1; Ex. 1064. Moreover, as the panel
`
`suggested, Sawai has no objection to the panel revisiting the declarant situation
`
`- 1 -
`
`
`
`should it become an issue when deciding Sawai's Motion for Joinder. Id.
`
`Accordingly, if joined, Sawai’s Declarants will not introduce any new issues into the
`
`Mylan IPR.
`
`II.
`
`Sumitomo Is Not an RPI
`
`Patent Owner attempts to manufacture an “RPI issue” where none exists.
`
`A.
`
`Patent Owner Does Not Establish Sumitomo Has Control Over
`Petitioners Sawai Japan or Sawai USA.
`Patent Owner cites two press releases for the proposition that Sumitomo “has
`
`control over” Upsher-Smith Laboratories, LLC (“Upsher-Smith”). Opp. at 7-9. But,
`
`Upsher-Smith is not a petitioner. See, e.g., Applications in Internet Time, LLC v.
`
`RPX Corp., 897 F.3d 1336, 1351 (Fed. Cir. 2018) (“Determining whether a non-
`
`party is a ‘real party in interest’ demands a flexible approach that takes into account
`
`both equitable and practical considerations, with an eye toward determining whether
`
`the non-party is a clear beneficiary that has a preexisting, established relationship
`
`with the petitioner.”) (emphasis added). Even if it is assumed that Sumitomo has
`
`control over Upsher-Smith (it does not), there is no evidence that Upsher-Smith
`
`controls either Petitioner.
`
`While not necessary to determine the instant motion, Petitioners attach
`
`herewith the Declaration of Tatsufumi Hiramatsu (Ex. 1060), which demonstrates
`
`the following corporate relationship:
`
`2
`
`
`
`As set forth in the Declaration, Upsher-Smith is wholly owned by Sawai America,
`
`LLC (“Sawai America”). Id. at ¶ 21. Sawai America is owned by a majority owner
`
`(80%), Sawai America Holdings, Inc. (“Sawai America Holdings”), and a minority
`
`owner (20%), Sumitomo Corporation of Americas (“SCOA”). Id. Sumitomo owns
`
`100% of SCOA. Id. at ¶ 8. Accordingly, neither Petitioner Sawai Japan nor Petitioner
`
`Sawai USA are owned or controlled by Sumitomo, SCOA or Upsher-Smith. Ex.
`
`1060 at ¶¶ 20-21, 23-25.
`
`At most, Patent Owner’s “evidence” shows, consistent with the attached
`
`Declaration, part of the corporate tree reproduced above – Sumitomo’s indirect
`
`minority ownership in Upsher-Smith. Accord Ex. 2001 (stating Sumitomo owns
`
`20% of Upsher-Smith through its subsidiary). Yet, Patent Owner – a named plaintiff
`
`in the underlying litigation filed against Sawai – never named Sumitomo or Upsher-
`
`Smith as a party in that case, or sought any discovery specifically from those entities.
`
`Indeed, Patent Owner offers no precedent where a third party in Sumitomo’s relative
`
`3
`
`
`
`position to Petitioners Sawai Japan and Sawai USA was found to be a RPI. This
`
`suggests that Patent Owner is merely speculating about Sumitomo’s alleged control
`
`in an effort to manufacture an “RPI issue” that does not exist. See Daifuku Co. Ltd
`
`et al. v. Murata Machinery, Ltd., IPR2015-01538 Paper 11 at 11 (PTAB Jan. 19,
`
`2016) (“Theoretical, hypothetical, or speculative assertions about effective control,
`
`unsupported by evidence, are neither probative nor persuasive.”).
`
`Sumitomo Does Not Exercise Any Control Over Sawai’s Petition.
`B.
`Patent Owner makes no assertions and cites to no evidence that suggests
`
`Sumitomo exercises any control over Sawai’s petition. That is because no such
`
`control exists. Rather, Petitioners are in control of themselves and all aspects of their
`
`petition.
`
`Sawai USA, through its agent Stason Pharmaceuticals, Inc. (“Stason”),
`
`submitted Abbreviated New Drug Application No. 210285 (“Sawai’s ANDA”)
`
`seeking to market in the United States dimethyl fumarate delayed release capsules.
`
`Ex. 1060 at ¶ 11. Sawai USA was (and continues to be) the sole named applicant
`
`for, and owner of all right and title to, Sawai’s ANDA. Id. Patent Owner received
`
`Sawai’s Paragraph IV Notice Letter and later sued Petitioners in Delaware alleging
`
`infringement, inter alia, of U.S. Patent No. 8,399,514 (the “’514 patent”) (the
`
`“Delaware Litigation”). Id. at ¶¶ 12-13. On March 5, 2019, Petitioners sought inter
`
`partes review the ’514 patent and joinder to the Mylan IPR (the “IPR Proceeding”).
`
`4
`
`
`
`Id. at ¶ 16. Neither Sumitomo nor Upsher-Smith have any control over Sawai Japan
`
`or Sawai USA and do not have control over Sawai’s ANDA, the Delaware Litigation
`
`or the IPR Proceeding. Id. at ¶¶ 18-25. Neither Sumitomo nor Upsher-Smith pay any
`
`bills relating to these proceedings. Id. at ¶¶ 22, 25.1 Put simply, all aspects of Sawai’s
`
`ANDA, the Delaware Litigation, and the IPR Proceeding are independent of Upsher-
`
`Smith and Sumitomo, and instead controlled, overseen and paid for by either
`
`Petitioner Sawai Japan or Petitioner Sawai USA. Id. at ¶¶ 14, 16, 18, 20, 22-25.
`
`Nothing in Patent Owner’s Opposition demonstrates otherwise.
`
`In view of the above, any suggestion that Sumitomo is an RPI is baseless.
`
`Accordingly, there is no “RPI Issue” that could delay the Mylan IPR.
`
`III. CONCLUSION
`
`Petitioners respectfully request the Board grant their Motion for Joinder.
`
`Dated: May 6, 2019
`
`Respectfully submitted,
`
`By: /s/
`Brian Sodikoff
`
`1 In full disclosure, Sawai USA intends to engage Upsher-Smith in the future through
`
`a license and supply agreement so that Upsher-Smith can sell the products approved
`
`under Sawai’s ANDA. Ex. 1060 at ¶ 21. Because of this intended role, Upsher-Smith
`
`was identified as an RPI.
`
`5
`
`
`
`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: Petitioners’ Response To Patent
`
`Owner’s Opposition To Petitioner’s Motion For Joinder, by email on this day on the
`
`Patent Owner’s counsel of record as follows:
`
`barbara.mccurdy@finnegan.com;
`
`mark.feldstein@finnegan.com
`
`erin.sommers@finnegan.com; and
`
`pier.deroo@finnegan.com.
`
`A courtesy copy has been sent by Federal Express (or equivalent) Next
`
`Business Day Delivery on this day to Mylan Pharmaceuticals, Inc.’s counsel of
`
`record as follows:
`
`Brandon M. White
`Registration No. 52,354
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`
`Dated: May 6, 2019
`
` /s/
`Brian Sodikoff
`
`- 1 -
`
`
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