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
`
`DECLARATION OF TATSUFUMI HIRAMATSU IN SUPPORT OF
`
`PETITIONERS’ RESPONSE REGARDING THE IDENTIFICATION OF
`
`REAL PARTY-IN-INTEREST
`
`Sawai (IPR2019-00789) EX. 1060, p. 001
`
`Sawai (IPR2019-00789) Ex. 1060, p. 001
`
`
`
`
`
`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
`
`DECLARATION OF TATSUFUMI HIRAMATSU IN SUPPORT OF
`
`PETITIONERS’ RESPONSE REGARDING THE IDENTIFICATION OF
`
`REAL PARTY-IN-INTEREST
`
`Sawai (IPR2019-00789) EX. 1060, p. 001
`
`Sawai (IPR2019-00789) Ex. 1060, p. 001
`
`
`
`I, Tatsufumi Hiramatsu, declare as follows:
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`1.
`
`I either have personal knowledge of the facts
`
`stated in this
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`Declaration or believe them to be true based on my experience, review of
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`business records, or information I have otherwise received in the course of my
`
`duties.
`
`2.
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`Sawai Pharmaceutical Co. Ltd. (“Sawai Japan”) is a publicly traded
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`Japanese company.
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`3.
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`Sawai, USA, Inc. (“Sawai USA”) is incorporated in the state of
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`Delaware. Sawai USA is a wholly owned subsidiary of Sawai Japan. Sawai
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`USA is the holder of Abbreviated New Drug Application No. 210285 (“ANDA
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`210285,” “Sawai USA’s ANDA,” or the “ANDA”), which seeks marketing
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`approval in the United States for delayed release dimethyl fumarate capsules.
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`4.
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`Sawai America Holdings, Inc. (“Sawai America Holdings”) is a
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`Delaware corporation. Sawai America Holdings is a wholly owned subsidiary of
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`Sawai Japan.
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`5.
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`Sawai America, LLC (“Sawai America”) is a Delaware limited
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`liability company. Sawai America is a wholly owned subsidiary of Sawai
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`America Holdings.
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`6.
`
`7.
`
`Stason Pharmaceuticals, Inc. (“Stason”) is a California corporation.
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`Upsher—Smith Laboratories, LLC (“Upsher-Smith”) is a Minnesota
`
`2 S
`
`awai (IPR2019-00789) EX. 1060, p. 002
`
`Sawai (IPR2019-00789) Ex. 1060, p. 002
`
`
`
`limited liability company. Upsher-Smith is a wholly owned subsidiary of Sawai
`
`America.
`
`8.
`
`Sumitomo Corporation is a publicly traded Japanese company. To
`
`the best of my knowledge, Sumitomo Corporation has a number of wholly
`
`owned subsidiaries, one of which is Sumitomo Corporation of Americas
`
`(“SCOA”).
`
`9.
`
`Sawai America Holdings is the majority owner (80%) of Sawai
`
`America. SCOA is the minority owner (20%) of Sawai America.
`
`10.
`
`I am Senior Director, Corporate Strategy for Uspher-Smith LLC.
`
`(“Upsher-Smith”). Upsher—Smith currently pays my salary. Before December
`
`11th, 2017, I was Specialist for “Sawai Japan”.
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`Sawai USA’s ANDA and the Delaware Litigation
`
`11.
`
`Sawai USA, through its agent Stason, submitted ANDA No. 210285
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`seeking to market
`
`in the United States dimethyl
`
`fumarate delayed release
`
`capsules. Sawai USA was (and continues to be) the sole named applicant for, and
`
`owner of all right and title to, Sawai USA’sANDA.
`
`12. As part of filing the ANDA, Sawai USA submitted a Paragraph IV
`
`Certification to the FDA, indicating that US. Patent Nos. 6,509,376; 7,320,999;
`
`7,619,001; 7,803,840; 8,759,393; and 8,399,514 (“the ’514 patent”) are invalid
`
`and not infringed. In connection with that Certification, Sawai USA, by its
`
`3
`
`Sawai (IPR2019-00789) EX. 1060, p. 003
`
`Sawai (IPR2019-00789) Ex. 1060, p. 003
`
`
`
`outside counsel, served, among others, Biogen MA, Inc. (“Biogen”) with a
`
`Paragraph IV Notice Letter, which provided a detailed legal and factual basis
`
`supporting the invalidity of the 6,509,376; 7,320,999; 7,619,001; 7,803,840;
`
`8,759,393; and 8,399,514 patents. Stason was named in Sawai USA’s ANDA
`
`and the Paragraph IV Notice Letter as an agent in the United States authorized to
`
`accept service of process for Sawai USA in connection with ANDA No. 210285 .
`
`Stason also had a role in the development of the products described in ANDA
`
`No. 210285.
`
`13.
`
`On June 30, 2017,
`
`in response to the Paragraph IV Notice Letter,
`
`Biogen sued both Sawai USA and Sawai Japan in the US. District Court for the
`
`District of Delaware, alleging infringement of, among other patents, the ’514
`
`patent (the “Delaware Litigation”).
`
`14.
`
`On October 16, 2017, Sawai USA and Sawai Japan filed their
`
`Answer and Counterclaims asserting, among other things, that the ’5 14 patent is
`
`invalid and not
`
`infringed. The Delaware Litigation remains pending against
`
`Sawai USA and Sawai Japan. All aspects of the Delaware Litigation are
`
`controlled, overseen and paid for by either Sawai Japan or Sawai USA.
`
`The Pending IPR Proceeding
`
`15.
`
`On or about February 2019, Sawai Japan and Sawai USA decided to
`
`prepare a petition for inter partes review of the ’514 patent. That decision was
`
`4
`
`Sawai (IPR2019-00789) EX. 1060, p. 004
`
`Sawai (IPR2019-00789) Ex. 1060, p. 004
`
`
`
`solely made by Sawai Japan and Sawai USA. Neither Sumitomo Corporation
`
`nor SCOA had any involvement in that decision making process.
`
`16.
`
`On March 5, 2019, Sawai Japan and Sawai USA filed: (i) a petition
`
`for inter partes review of the ’514 patent; and (ii) a motion for joinder with a
`
`pending inter partes review filed by Mylan Pharmaceuticals,
`
`Inc., Mylan
`
`Pharmaceuticals, Inc. v. Biogen MA, Inc, IPR2018-01403 (together the “IPR
`
`Proceeding"). All aspects the IPR Proceeding are controlled, overseen and paid
`
`for by Sawai Japan.
`
`17.
`
`It is my understanding that on April 5, 2019, Biogen MA, Inc. filed
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`an Opposition to the Motion for Joinder, wherein it cited a press release (Ex.
`
`2001) and website (Ex. 2002), alleging that Sumitomo Corporation “meets the
`
`criteria of an RPI as it has ‘management participationm in Upsher-Smith. Biogen
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`Opposition, p. 9.
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`Neither Sumitomo Corporation Nor SCOA Have Any Role in Sawai USA’s
`ANDA, the Delaware Litigation, or the IPR Proceeding
`
`18. Neither Sumitomo Corporation nor SCOA have any control,
`
`influence, decision-making authority, or otherwise participate in any actions
`
`regarding Sawai USA’s ANDA, the Delaware Litigation, or the IPR Proceeding.
`
`19.
`
`In January 2018, SCOA — not Sumitomo Corporation — became a
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`20% minority owner of Sawai America. Sawai America is in turn the 100%
`
`owner of Upsher—Smith.
`
`5
`
`Sawai (IPR2019-00789) EX. 1060, p. 005
`
`Sawai (IPR2019-00789) Ex. 1060, p. 005
`
`
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`20.
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`Sawai Japan and Sawai USA are n_ot owned or controlled in any
`
`way by Upsher-Smith, SCOA, or Sumitomo Corporation.
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`21.
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`Upsher—Smith is wholly owned by Sawai America. Sawai America
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`is owned by a majority owner (Sawai America Holdings - 80%) and a minority
`
`owner (SCOA - 20%). Sumitomo Corporation owns 100% of SCOA. Sawai
`
`Japan owns 100% of Sawai America Holdings. Upsher-Smith does not control,
`
`nor does it have the ability to control, in any way the decision making process of
`
`either Sawai Japan or Sawai USA in the Delaware Litigation or the IPR
`
`Proceeding. Nor does Upsher-Smith pay any bills relating to these proceedings.
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`Rather, Sawai USA intends to engage Upsher-Smith in the future through a
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`license and supply agreement to sell the products approved under Sawai USA’s
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`ANDA No. 210285.
`
`22. Sawai Japan or Sawai USA are, and continue to be, the only entities
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`responsible for directing, controlling, and funding all aspects of the Delaware
`
`Litigation and the IPR Proceeding. Every decision relating to these proceedings
`
`was, and is, under the control and direction of either Sawai Japan or Sawai USA.
`
`Sawai Japan remains the only entity that has paid and pays all filing fees or legal
`
`expenses associated with the Delaware Litigation and the IPR Proceeding.
`
`23. Neither Sumitomo Corporation nor SCOA Sumitomo has ever
`
`exercised any control over the Delaware Litigation and the IPR Proceeding.
`
`6
`
`Sawai (IPR2019-00789) EX. 1060, p. 006
`
`Sawai (IPR2019-00789) Ex. 1060, p. 006
`
`
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`24.
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`There are no unified actions between Sawai USA, Sawai Japan and
`
`either Sumitomo Corporation or SCOA with respect to either the Delaware
`
`Litigation or the IPR Proceeding.
`
`25. No Sumitomo Corporation or SCOA officer or director,
`
`in their
`
`capacity as such, has ever acted on behalf of Sawai USA or Sawai Japan in
`
`connection with the Delaware Litigation or
`
`the IPR Proceeding. Neither
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`Sumitomo Corporation nor SCOA has ever paid any of the legal fees associated
`
`with Delaware Litigation or the IPR Proceeding and is not obligated to provide
`
`either Sawai USA or Sawai Japan with any legal support for these matters.
`
`26.
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`I hereby declare that all statements made herein of my own
`
`knowledge are true and that all statements made on information and belief are
`
`believed to be true; and that these statements were made with the knowledge that
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`willful false statements are punishable under Section 1001 of Title 18 of the US.
`
`Code.
`
`7
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`Sawai (IPR2019-00789) EX. 1060, p. 007
`
`Sawai (IPR2019-00789) Ex. 1060, p. 007
`
`
`
`Dated:
`
`'1“ {7V
`
`lél’lfl
`
`10[6{
`
`Tfl—L ‘ W fiU“ 'k\( 6'1»
`
`Tatsufumi Hiramatsu
`
`8 S
`
`awai (IPR2019-00789) EX. 1060, p. 008
`
`Sawai (IPR2019-00789) Ex. 1060, p. 008
`
`
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