`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
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`SAWAI USA, INC. AND
`SAWAI PHARMACEUTICAL CO., LTD.
`Petitioners,
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`v.
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`BIOGEN MA, INC.
`Patent Owner.
`
`_______________________________
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`Patent No. 8,399,514
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`_______________________________
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`Inter Partes Review IPR2019-00789
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`_______________
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`PETITIONER’S MOTION FOR JOINDER
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`37 C.F.R. § 42.122(b)
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`IPR2019-00789
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`Motion for Joinder
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`I.
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`A STATEMENT OF THE PRECISE RELIEF REQUESTED
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`Sawai USA, Inc. and Sawai Pharmaceutical Co., Ltd. (“Sawai” or
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`“Petitioners”) submit, concurrently with this motion, a petition for inter partes
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`review (“Petition”) of claims 1-20 of U.S. Patent No. 8,399,514 (“the ’514 patent”)
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`(Ex. 1001), assigned to Biogen MA Inc. (“Patent Owner”). Sawai respectfully
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`requests joinder pursuant to 35 U.S.C. § 315(c) and 37 C.F.R. § 42.122(b) of the
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`concurrently filed Petition with a pending inter partes review filed by Mylan
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`Pharmaceuticals, Inc. (“Mylan”), Mylan Pharmaceuticals Inc. v. Biogen MA Inc.,
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`IPR2018-01403 (“Mylan IPR”). Joinder is appropriate because it will promote an
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`efficient and consistent resolution of the validity of a single patent and will not
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`prejudice any of the parties to the Mylan IPR. Sawai’s request for joinder is timely
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`because it was filed “no later than one month after the institution date of any inter
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`partes review for which joinder is requested.” 37 C.F.R. § 42.122(b). Sawai’s IPR
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`Petition is timely under 37 C.F.R. § 42.122, which provides that the time period set
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`forth in 37 C.F.R. § 42.101(b) shall not apply when the petition is accompanied by
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`a request for joinder. See also 35 U.S.C. § 315(b) (“The time limitation set forth in
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`the preceding sentence shall not apply to a request for joinder under subsection
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`(c).”).
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`IPR2019-00789
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`II.
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`BACKGROUND
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`Motion for Joinder
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`On July 13, 2018, Mylan filed a petition for inter partes review challenging
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`claims 1-20 of U.S. Patent No. 8,399,514, which was assigned Case No. IPR2018-
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`01403. On February 6, 2019, the Board instituted review of claims 1-20 on 4
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`grounds: (1) Claims 1-20 of the ’514 patent as obvious over the January 2006
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`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
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`Abstract; (3) Claims 1-20 of the ’514 patent as obvious over Kappos 2006 in view
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`of WO ’342; and (4) Claims 1-20 of the ’514 patent are obvious over Kappos
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`2006, Clinical Trials, Joshi ’999, and ICH. IPR2018- 01403, Paper 12.
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`Today, concurrent with the instant motion for joinder, Sawai filed an IPR
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`petition under Case No. IPR2019-00789 asserting the same grounds of
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`unpatentability against the same patent claims as instituted in the Mylan IPR.
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`III. ARGUMENT
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`A.
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`Legal Standard
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`The Board has authority to join as a party any person who properly files a
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`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
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`Board considers several factors including: (1) the reasons why joinder is
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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,
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`IPR2013-00004, Paper 15 at 4 (April 24, 2013)).
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`B.
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`The Relevant Factors Weigh in Favor of Joinder
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`Each of the four factors considered by the Board weighs in favor of joinder.
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`1.
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`Joinder Is Appropriate
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`Joinder with IPR2018-01403 is appropriate because the Petition is limited to
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`the same grounds instituted in the IPR2018-01403 petition. It also relies on the
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`same prior art analysis and expert analysis submitted by Mylan. Indeed, the
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`Petition raises grounds identical to those raised in the IPR2018-01403 petition, and
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`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
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`declarants as Mylan, Dr. John R. Corboy, Dr. Leslie Z. Benet, Ms. Rock, and Dr.
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`Ian McKeague, should Mylan permit it. If Mylan allows Sawai to use the same
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`declarants, then Sawai will withdraw the declarations of Dr. Baumhefner, Dr.
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`Bainbridge, Ms. Rock, and Dr. Marks, and rely solely on the declarations and
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`testimonies of Mylan’s declarants: Dr. John R. Corboy, Dr. Leslie Z. Benet, Ms.
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`Rock and Dr. Ian McKeague. The Board has previously acknowledged that such
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`concessions on the part of a party seeking to join are sufficient to minimize the
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`impact on the original proceeding. See SAP America Inc. v. Clouding IP, LLC,
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`IPR2014-00306, Paper 13 at 4 (May 19, 2014). Further, Dr. Baumhefner, Dr.
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`Bainbridge, Ms. Rock and Dr. Marks declarations submitted in support of the
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`present Petition present substantively identical testimony to that of Dr. John R.
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`Corboy, Dr. Leslie Z. Benet, Ms. Jennifer Rock, and Dr. Ian McKeague,
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`respectively, thus streamlining the issues for trial even if Mylan does not permit
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`Sawai to rely directly on Dr. John R. Corboy, Dr. Leslie Z. Benet, Ms. Rock, and
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`Dr. Ian McKeague.
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`Joinder is also appropriate because it will promote the just, speedy, and
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`inexpensive resolution of patentability issues, including the determination of
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`validity of the challenged claims of the ’514 patent. For example, a final written
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`decision on the validity of the ’514 patent has the potential to minimize issues and
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`potentially resolve any litigation altogether with respect to the ’514 patent.
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`2.
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`No New Grounds Are Presented
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`The Petition does not present any new ground of unpatentability. As
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`mentioned above, the Petition presents for review only grounds from the petition in
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`the Mylan IPR that have been instituted. The present Petition is based on the same
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`prior art analysis submitted by Mylan, and Dr. Baumhefner’s, Dr. Bainbridge’s,
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`Ms. Mark’s and Dr. Marks’ testimony in support of these grounds is substantively
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`identical to that of Dr. John R. Corboy’s, Dr. Leslie Z. Benet’s, Ms. Jennifer
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`Rock’s, and Dr. Ian McKeague’s expert testimony in the Mylan IPR, which further
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`weighs in favor of joinder. See, e.g., Hyundai, IPR2014-01543, Paper 11 at 2-4;
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`Sony Corp. of Am. v. Network-1 Sec. Solutions, Inc., IPR2013-00495, Paper 13 at
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`5-9 (Sep. 16, 2013); Dell Inc. v. Network-1 Solutions, Inc., IPR2013- 00385, Paper
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`17 at 6-10 (Jul. 29, 2013); Motorola Mobility LLC v. Softview LLC, IPR2013-
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`00256, Paper 10 at 4-10 (June 20, 2013).
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`3.
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`Joinder Will Not Negatively Impact the IPR2018-01403
`Trial Schedule
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`Because the Petition copies grounds raised in the IPR2018-01403 petition,
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`including the prior art analysis and expert testimony provided by Mylan, joinder
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`will have no substantial effect on the parties, or prevent the Board from issuing a
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`final written decision in a timely manner. Moreover, as discussed below, Sawai is
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`willing to participate in the proceeding as an understudy to Mylan, only assuming
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`an active role in the event of termination of Mylan as a party. Sawai does not
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`believe that any extension of the trial schedule will be required as a result of
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`joinder.
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`4.
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`Discovery and Briefing Can Be Simplified
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`Given that the Petition is substantively identical to the IPR2018-01403
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`petition, the Board may adopt procedures similar to those used in other cases to
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`simplify briefing and discovery during trial including those advocated by Mylan in
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`its past efforts to seek joinder. See e.g., Mylan Pharmaceuticals, Inc. v. Anacor
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`Pharmaceuticals, Inc., IPR2018-01358, Paper 11 at 4 (Oct. 11, 2018); Hyundai,
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`IPR2014-01543, Paper 11 at 5; Dell, IPR2013-00385, Paper 17 at 8-10; Motorola,
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`IPR2013-00256, Paper 10 at 8-10.
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`Specifically, as long as Mylan remains a party, the Board may order
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`petitioners to consolidate filings and to limit Sawai to no additional filings in its
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`understudy role. As long as Mylan remains a party, Sawai will not submit any
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`separate filings unless it disagrees with Mylan’s position (which it is not
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`anticipated), and in the event of such disagreement it will request prior
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`authorization from the Board to submit a short separate filing directed only to
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`points of disagreement with Mylan. The Board may allow the Patent Owner a
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`corresponding number of pages to respond to any separate filings. See Dell,
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`IPR2013-00385, Paper 17 at 8-9. Moreover, Sawai will pose no questions at any
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`depositions or argue at oral hearing without the prior permission of the Board.
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`Petitioner also is willing to abide by additional conditions as the Board deems
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`appropriate.
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`Further, so long as Mylan agrees to allow Sawai to retain and/or rely on Dr.
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`John R. Corboy, Dr. Leslie Z. Benet, Ms. Rock’s and Dr. Ian McKeague, no
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`additional depositions will be needed prior to Due Date 1 of the Mylan IPR, and
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`the depositions will be completed within ordinary time limits. As discussed above,
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`if Mylan allows Sawai to retain the declarants, then Sawai will withdraw its
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`declarations of Dr. Baumhefner, Dr. Bainbridge, Ms. Rock, and Dr. Marks and
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`rely, for purposes of the Petition, solely on the declaration and testimony of
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`Mylan’s declarants, Dr. John R. Corboy, Dr. Leslie Z. Benet, Ms. Rock and Dr. Ian
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`McKeague. The Board has previously acknowledged that such concessions on the
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`part of a party seeking to join sufficiently simplifies the impact of joinder on the
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`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
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`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
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`trial schedule, and fact that Petitioner consents to procedural protections that will
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`maintain [primary petitioner’s] control over the proceeding outweigh any potential
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`IV. CONCLUSION
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`Motion for Joinder
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`For the foregoing reasons, Sawai respectfully requests that this motion be
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`granted and inter partes review of the challenged claims 1-20 of the ’514 patent be
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`instituted based on the same grounds authorized and for the same reasons
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`discussed in the Institution Decision of IPR2018-01403, and that this proceeding
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`be joined with IPR2018-01403.
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`Respectfully submitted,
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`Dated: March 5th, 2019
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` /s/ Brian Sodikoff
`Brian Sodikoff
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`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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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105, I certify that I caused to be
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`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
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`day on the Patent Owner’s correspondence address of record for the subject patent
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`as follows:
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`Jones Day
`C/o Counsel for Biogen MA Inc.
`250 Vessey Street
`New York, NY 10281-1047
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`Courtesy copies of the PETITIONER’S MOTION FOR JOINDER, have been sent
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`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
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`and Patent Owner’s Amended Mandatory Notices as follows:
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`Biogen MA Inc.
`Chief Intellectual Property Officer
`250 Binney St.
`Cambridge, MA 02142
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`Barbara C. McCurdy
`Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
`901 New York Ave., N.W.
`Washington, D.C. 20001
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`A courtesy copy of has been sent by Federal Express (or equivalent) Next Business
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`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
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`Dated: March 5th 2019
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` /s/ Brian Sodikoff
`Brian Sodikoff
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