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
`
`_______________
`
`PETITIONER’S MOTION FOR JOINDER
`
`37 C.F.R. § 42.122(b)
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`137812109v1
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`_______________
`
`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
`
`_______________
`
`PETITIONER’S MOTION FOR JOINDER
`
`37 C.F.R. § 42.122(b)
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`137812109v1
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`IPR2019-00789
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`Motion for Joinder
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`I.
`
`A STATEMENT OF THE PRECISE RELIEF REQUESTED
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`Sawai USA, Inc. and Sawai Pharmaceutical Co., Ltd. (“Sawai” or
`
`“Petitioners”) submit, concurrently with this motion, a petition for inter partes
`
`review (“Petition”) of claims 1-20 of U.S. Patent No. 8,399,514 (“the ’514 patent”)
`
`(Ex. 1001), assigned to Biogen MA Inc. (“Patent Owner”). Sawai respectfully
`
`requests joinder pursuant to 35 U.S.C. § 315(c) and 37 C.F.R. § 42.122(b) of the
`
`concurrently filed Petition with a pending inter partes review filed by Mylan
`
`Pharmaceuticals, Inc. (“Mylan”), Mylan Pharmaceuticals Inc. v. Biogen MA Inc.,
`
`IPR2018-01403 (“Mylan IPR”). Joinder is appropriate because it will promote an
`
`efficient and consistent resolution of the validity of a single patent and will not
`
`prejudice any of the parties to the Mylan IPR. Sawai’s request for joinder is timely
`
`because it was filed “no later than one month after the institution date of any inter
`
`partes review for which joinder is requested.” 37 C.F.R. § 42.122(b). Sawai’s IPR
`
`Petition is timely under 37 C.F.R. § 42.122, which provides that the time period set
`
`forth in 37 C.F.R. § 42.101(b) shall not apply when the petition is accompanied by
`
`a request for joinder. See also 35 U.S.C. § 315(b) (“The time limitation set forth in
`
`the preceding sentence shall not apply to a request for joinder under subsection
`
`(c).”).
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`IPR2019-00789
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`II.
`
`BACKGROUND
`
`Motion for Joinder
`
`On July 13, 2018, Mylan filed a petition for inter partes review challenging
`
`claims 1-20 of U.S. Patent No. 8,399,514, which was assigned Case No. IPR2018-
`
`01403. On February 6, 2019, the Board instituted review of claims 1-20 on 4
`
`grounds: (1) Claims 1-20 of the ’514 patent as obvious over the January 2006
`
`Biogen Press Release in view of the Schimrigk 2004 Abstract; (2) Claims 1-20 of
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`the ’514 patent as obvious over Kappos 2006 in view of the Schimrigk 2004
`
`Abstract; (3) Claims 1-20 of the ’514 patent as obvious over Kappos 2006 in view
`
`of WO ’342; and (4) Claims 1-20 of the ’514 patent are obvious over Kappos
`
`2006, Clinical Trials, Joshi ’999, and ICH. IPR2018- 01403, Paper 12.
`
`Today, concurrent with the instant motion for joinder, Sawai filed an IPR
`
`petition under Case No. IPR2019-00789 asserting the same grounds of
`
`unpatentability against the same patent claims as instituted in the Mylan IPR.
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`III. ARGUMENT
`
`A.
`
`Legal Standard
`
`The Board has authority to join as a party any person who properly files a
`
`petition for inter partes review to an instituted inter partes review.
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`35 U.S.C. § 315(c). A motion for joinder must be filed within one month of
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`institution of any inter partes review for which joinder is requested.
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`37 C.F.R. § 42.122(b). In deciding whether to grant a motion for joinder, the
`
`Board considers several factors including: (1) the reasons why joinder is
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`IPR2019-00789
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`Motion for Joinder
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`appropriate; (2) whether the party to be joined has presented any new grounds of
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`unpatentability; (3) what impact, if any, joinder would have on the trial schedule
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`for the existing review; and (4) how briefing and discovery may be simplified.
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`See, e.g., Hyundai Motor Co. v. Am. Vehicular Sciences LLC, IPR2014-01543,
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`Paper 11 at 3 (Oct. 24, 2014); Macronix Int’l Co. v. Spansion, IPR2014-00898,
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`Paper 15 at 4 (Aug. 13, 2014) (quoting Kyocera Corp. v. Softview LLC,
`
`IPR2013-00004, Paper 15 at 4 (April 24, 2013)).
`
`B.
`
`The Relevant Factors Weigh in Favor of Joinder
`
`Each of the four factors considered by the Board weighs in favor of joinder.
`
`1.
`
`Joinder Is Appropriate
`
`Joinder with IPR2018-01403 is appropriate because the Petition is limited to
`
`the same grounds instituted in the IPR2018-01403 petition. It also relies on the
`
`same prior art analysis and expert analysis submitted by Mylan. Indeed, the
`
`Petition raises grounds identical to those raised in the IPR2018-01403 petition, and
`
`does not include any new grounds not raised in that petition.
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`In order to further simplify the proceeding, Sawai will rely on the same
`
`declarants as Mylan, Dr. John R. Corboy, Dr. Leslie Z. Benet, Ms. Rock, and Dr.
`
`Ian McKeague, should Mylan permit it. If Mylan allows Sawai to use the same
`
`declarants, then Sawai will withdraw the declarations of Dr. Baumhefner, Dr.
`
`Bainbridge, Ms. Rock, and Dr. Marks, and rely solely on the declarations and
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`Motion for Joinder
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`testimonies of Mylan’s declarants: Dr. John R. Corboy, Dr. Leslie Z. Benet, Ms.
`
`Rock and Dr. Ian McKeague. The Board has previously acknowledged that such
`
`concessions on the part of a party seeking to join are sufficient to minimize the
`
`impact on the original proceeding. See SAP America Inc. v. Clouding IP, LLC,
`
`IPR2014-00306, Paper 13 at 4 (May 19, 2014). Further, Dr. Baumhefner, Dr.
`
`Bainbridge, Ms. Rock and Dr. Marks declarations submitted in support of the
`
`present Petition present substantively identical testimony to that of Dr. John R.
`
`Corboy, Dr. Leslie Z. Benet, Ms. Jennifer Rock, and Dr. Ian McKeague,
`
`respectively, thus streamlining the issues for trial even if Mylan does not permit
`
`Sawai to rely directly on Dr. John R. Corboy, Dr. Leslie Z. Benet, Ms. Rock, and
`
`Dr. Ian McKeague.
`
`Joinder is also appropriate because it will promote the just, speedy, and
`
`inexpensive resolution of patentability issues, including the determination of
`
`validity of the challenged claims of the ’514 patent. For example, a final written
`
`decision on the validity of the ’514 patent has the potential to minimize issues and
`
`potentially resolve any litigation altogether with respect to the ’514 patent.
`
`2.
`
`No New Grounds Are Presented
`
`The Petition does not present any new ground of unpatentability. As
`
`mentioned above, the Petition presents for review only grounds from the petition in
`
`the Mylan IPR that have been instituted. The present Petition is based on the same
`
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`IPR2019-00789
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`Motion for Joinder
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`prior art analysis submitted by Mylan, and Dr. Baumhefner’s, Dr. Bainbridge’s,
`
`Ms. Mark’s and Dr. Marks’ testimony in support of these grounds is substantively
`
`identical to that of Dr. John R. Corboy’s, Dr. Leslie Z. Benet’s, Ms. Jennifer
`
`Rock’s, and Dr. Ian McKeague’s expert testimony in the Mylan IPR, which further
`
`weighs in favor of joinder. See, e.g., Hyundai, IPR2014-01543, Paper 11 at 2-4;
`
`Sony Corp. of Am. v. Network-1 Sec. Solutions, Inc., IPR2013-00495, Paper 13 at
`
`5-9 (Sep. 16, 2013); Dell Inc. v. Network-1 Solutions, Inc., IPR2013- 00385, Paper
`
`17 at 6-10 (Jul. 29, 2013); Motorola Mobility LLC v. Softview LLC, IPR2013-
`
`00256, Paper 10 at 4-10 (June 20, 2013).
`
`3.
`
`Joinder Will Not Negatively Impact the IPR2018-01403
`Trial Schedule
`
`Because the Petition copies grounds raised in the IPR2018-01403 petition,
`
`including the prior art analysis and expert testimony provided by Mylan, joinder
`
`will have no substantial effect on the parties, or prevent the Board from issuing a
`
`final written decision in a timely manner. Moreover, as discussed below, Sawai is
`
`willing to participate in the proceeding as an understudy to Mylan, only assuming
`
`an active role in the event of termination of Mylan as a party. Sawai does not
`
`believe that any extension of the trial schedule will be required as a result of
`
`joinder.
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`4.
`
`Discovery and Briefing Can Be Simplified
`
`Given that the Petition is substantively identical to the IPR2018-01403
`
`petition, the Board may adopt procedures similar to those used in other cases to
`
`simplify briefing and discovery during trial including those advocated by Mylan in
`
`its past efforts to seek joinder. See e.g., Mylan Pharmaceuticals, Inc. v. Anacor
`
`Pharmaceuticals, Inc., IPR2018-01358, Paper 11 at 4 (Oct. 11, 2018); Hyundai,
`
`IPR2014-01543, Paper 11 at 5; Dell, IPR2013-00385, Paper 17 at 8-10; Motorola,
`
`IPR2013-00256, Paper 10 at 8-10.
`
`Specifically, as long as Mylan remains a party, the Board may order
`
`petitioners to consolidate filings and to limit Sawai to no additional filings in its
`
`understudy role. As long as Mylan remains a party, Sawai will not submit any
`
`separate filings unless it disagrees with Mylan’s position (which it is not
`
`anticipated), and in the event of such disagreement it will request prior
`
`authorization from the Board to submit a short separate filing directed only to
`
`points of disagreement with Mylan. The Board may allow the Patent Owner a
`
`corresponding number of pages to respond to any separate filings. See Dell,
`
`IPR2013-00385, Paper 17 at 8-9. Moreover, Sawai will pose no questions at any
`
`depositions or argue at oral hearing without the prior permission of the Board.
`
`Petitioner also is willing to abide by additional conditions as the Board deems
`
`appropriate.
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`IPR2019-00789
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`Motion for Joinder
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`Further, so long as Mylan agrees to allow Sawai to retain and/or rely on Dr.
`
`John R. Corboy, Dr. Leslie Z. Benet, Ms. Rock’s and Dr. Ian McKeague, no
`
`additional depositions will be needed prior to Due Date 1 of the Mylan IPR, and
`
`the depositions will be completed within ordinary time limits. As discussed above,
`
`if Mylan allows Sawai to retain the declarants, then Sawai will withdraw its
`
`declarations of Dr. Baumhefner, Dr. Bainbridge, Ms. Rock, and Dr. Marks and
`
`rely, for purposes of the Petition, solely on the declaration and testimony of
`
`Mylan’s declarants, Dr. John R. Corboy, Dr. Leslie Z. Benet, Ms. Rock and Dr. Ian
`
`McKeague. The Board has previously acknowledged that such concessions on the
`
`part of a party seeking to join sufficiently simplifies the impact of joinder on the
`
`original proceeding. SAP America, IPR2014-00306, Paper 13 at 4.1
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`1 To the extent Patent Holder or Petitioner Mylan argue that permitting joinder
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`would frustrate the possibility of settlement as other panels have previously noted:
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`“The possible chilling effect of joinder on settlement is a factor present in most, if
`
`not all, joinder situations, and must be weighed together with all of the other facts.
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`We are persuaded that the similarities in issues, lack of any impact on the existing
`
`trial schedule, and fact that Petitioner consents to procedural protections that will
`
`maintain [primary petitioner’s] control over the proceeding outweigh any potential
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`IPR2019-00789
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`IV. CONCLUSION
`
`Motion for Joinder
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`For the foregoing reasons, Sawai respectfully requests that this motion be
`
`granted and inter partes review of the challenged claims 1-20 of the ’514 patent be
`
`instituted based on the same grounds authorized and for the same reasons
`
`discussed in the Institution Decision of IPR2018-01403, and that this proceeding
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`be joined with IPR2018-01403.
`
`Respectfully submitted,
`
`Dated: March 5th, 2019
`
` /s/ Brian Sodikoff
`Brian Sodikoff
`
`effect on settlement.” Global Foundries U.S. Inc. v. Godo Kaisha IP Bridge 1,
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`IPR2017-00925 and IPR2017-00926, Paper 12 at 10 (June 9, 2017).
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`IPR2019-00789
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`Motion for Joinder
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`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: PETITIONER’S MOTION FOR
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`JOINDER, by Federal Express (or equivalent) Next Business Day Delivery on this
`
`day on the Patent Owner’s correspondence address of record for the subject patent
`
`as follows:
`
`Jones Day
`C/o Counsel for Biogen MA Inc.
`250 Vessey Street
`New York, NY 10281-1047
`
`Courtesy copies of the PETITIONER’S MOTION FOR JOINDER, have been sent
`
`by Federal Express (or equivalent) Next Business Day Delivery on this day to Patent
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`Owner’s counsel of record in the matters identified in Section II.B of the Petition
`
`and Patent Owner’s Amended Mandatory Notices as follows:
`
`Biogen MA Inc.
`Chief Intellectual Property Officer
`250 Binney St.
`Cambridge, MA 02142
`
`Barbara C. McCurdy
`Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
`901 New York Ave., N.W.
`Washington, D.C. 20001
`
`A courtesy copy of has been sent by Federal Express (or equivalent) Next Business
`
`Day Delivery on this day to Mylan Pharmaceuticals, Inc.’s counsel of record as
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`follows:
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`IPR2019-00789
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`Motion for Joinder
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`Brandon M. White
`Registration No. 52,354
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`
`Dated: March 5th 2019
`
` /s/ Brian Sodikoff
`Brian Sodikoff
`
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