IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________________________
`
`FAMY CARE LIMITED
`Petitioner
`v.
`ALLERGAN, INC.
`Patent Owner
`U.S. Patent No. 8,648,048 B2 to Acheampong et al.
`Issue Date: February 11, 2014
`Title: Methods of Providing Therapeutic Effects Using Cyclosporin Components
`________________________________
`
`Inter Partes Review Trial No. 2017-00566
`________________________________
`
`PETITIONER’S MOTION FOR JOINDER
`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. §§ 42.22 AND 42.122(b)
`
`
`
`
`
`

`
`
`
`
`I.
`
`II.
`
`
`
`TABLE OF CONTENTS
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 1
`
`STATEMENT OF MATERIAL FACTS ........................................................ 2
`
`III.
`
`STATEMENT OF REASONS FOR RELIEF REQUESTED ........................ 5
`
`A.
`
`Reasons Why Joinder Is Appropriate .................................................... 7
`
`1.
`
`2.
`
`Identical Grounds and Similar Petitions ..................................... 8
`
`Consolidated Discovery .............................................................. 9
`
`No New Grounds of Unpatentability .................................................. 10
`
`No Impact on IPR Trial Schedule ....................................................... 11
`
`Joinder Will, on Balance, Simplify Discovery.................................... 12
`
`Joinder Will Not Prejudice Patent Owner or Mylan ........................... 13
`
`B.
`
`C.
`
`D.
`
`E.
`
`IV. PROPOSED ORDER .................................................................................... 14
`
`V.
`
`CONCLUSION .............................................................................................. 15
`
`
`
`
`
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`
`
`
`

`
`TABLE OF AUTHORITIES
`
`
`Cases
`Amneal Pharma., Inc. v. Yeda Res. and Dev. Co., Ltd.,
`IPR2015-01976 ....................................................................................................... 2
`
`Apotex Inc. and Mylan Pharmaceuticals Inc., v. Novartis AG and Mitsubishi
`Pharma Corp, IPR2015-00518 ..............................................................................10
`
`Dell, Inc. v. Network-1 Security Solutions, Inc.,
`IPR2013-00385 ....................................................................................................... 6
`
`Kyocera Corp. et al. v. Softview LLC,
`IPR2013-0004 ......................................................................................................... 1
`
`Microsoft Corp. v. Proxyconn, Inc., IPR2013-00109 ................................................... 7
`
`Motorola Mobility LLC v. Softview LLC,
`IPR2013-00256 ....................................................................................................... 2
`
`Mylan Pharmaceuticals, Inc. v. Allergan, Inc.,
`IPR2016-01131 .................................................................................................1, 14
`
`Torrent Pharmaceuticals Ltd. v. Novartis AG and Mitsubishi Pharma Corp,
`IPR2014-00784 .....................................................................................................11
`
`Statutes
`
`35 U.S.C. § 315(b) ...................................................................................................12
`
`35 U.S.C. § 315(c) ..................................................................................................1, 5
`
`35 U.S.C. § 316(b) ..................................................................................................... 6
`
`Other Authorities
`
`37 C.F.R. § 42.1(b) .................................................................................................... 6
`
`37 C.F.R. § 42.122(b) ......................................................................................... 1, 2, 5
`
`37 C.F.R. § 42.22 ............................................................................................... 1, 2, 5
`
`
`
`ii
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`

`
`Treatises
`
`157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) .................................................... 8
`
`
`
`
`
`iii
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`

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`I.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`Petitioner Famy Care Limited (“Famy Care” or “Petitioner”) filed the present
`
`petition for inter partes review (“the Famy Care IPR”) and respectfully submits this
`
`Motion for Joinder. Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22, and
`
`42.122(b), Famy Care requests institution of an inter partes review concerning U.S.
`
`Patent No. 8,648,048 B2, which issued on February 11, 2014, to Acheampong et al.
`
`(“the ’048 patent”) and joinder with the inter partes review concerning the same
`
`patent in Mylan Pharmaceuticals, Inc. v. Allergan, Inc., assigned Case No. IPR2016-
`
`01131, (the “Mylan IPR”), which was instituted on December 8, 2016.
`
`In accordance with the Board’s Representative Order identifying matters to be
`
`addressed in a motion for joinder (Kyocera Corp. et al. v. Softview LLC, Paper No. 15,
`
`IPR2013-0004, Apr. 24, 2013), Petitioner submits that: (1) joinder is appropriate
`
`because it will promote efficient determination of the validity of the ‘048 patent
`
`without prejudice to the prior petitioners, Mylan Pharmaceuticals, Inc. (“Mylan”), or
`
`to the owners of the ‘048 patent, Allergan, Inc. (“Allergan” or “Patent Owner”); (2)
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`Famy Care’s Petition raises virtually the same grounds of unpatentability over the
`
`same prior art references as those instituted by the Board in the Mylan IPR; (3) joinder
`
`would not affect the pending schedule in the Mylan IPR nor unduly increase the
`
`complexity of that proceeding, thereby minimizing costs; and (4) Petitioner is willing
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`to agree to consolidated discovery of Patent Owner witnesses with Mylan to minimize
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`
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`1
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`

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`the burden and the impact on the schedule. Famy Care will coordinate with Mylan
`
`whenever possible and strive to avoid any duplication or additional burden. See, e.g.,
`
`Motorola Mobility LLC v. Softview LLC, Paper No. 10, IPR2013-00256 (June 20,
`
`2013) and Amneal Pharm., LLC v. Yeda Res. & Dev. Co., Ltd., Paper No. 9, IPR2015-
`
`01976 (Dec. 28, 2015).
`
`As this Motion is submitted within one month of December 8, 2016, the date of
`
`institution for the Mylan IPR, it is timely under 37 C.F.R. §§ 42.22 and 42.122(b).
`
`II.
`
`STATEMENT OF MATERIAL FACTS
`
`1.
`
`Allergan served Famy Care with a complaint asserting infringement
`
`of the ‘048 patent and related patents no earlier than April 15, 2016. Allergan, Inc.
`
`v. Famy Care Ltd., Civ. A. No. 2:16cv0401 (Eastern District of Texas, filed April
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`12, 2016).
`
`2. On December 8, 2016, the Board instituted trial on claims 1-23 of the
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`‘048 patent in the Mylan IPR.
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`3.
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`The Mylan IPR was instituted based on the following grounds for
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`unpatentability:
`
`Ground Claims
`
`1
`
`2
`
`1-10, 12-14,
`16-20, 22, 23
`11 and 21
`
`Statutory
`Basis
`§ 103
`
`Reference(s)
`
`Ding ’979 and Sall
`
`§ 103
`
`Ding ’979, Sall, and Acheampong
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`
`
`2
`
`

`
`3
`
`15
`
`§ 103
`
`Ding ’979, Sall, and Glonek1
`
`
`
`4.
`
`The Famy Care IPR presents grounds for unpatentability nearly
`
`identical to those in the Mylan IPR, challenging all of claims 1-23, and relying on
`
`the same prior art references and combinations in three listed Grounds. The only
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`difference between the grounds is that the Famy Care IPR includes claims 11, 15,
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`and 21 in Ground 1, where Mylan does not. However, both the Mylan IPR and the
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`Famy Care IPR include claims 11 and 21 in Ground 2 and claim 15 in Ground 3.
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`Thus, in terms of the claims challenged, the grounds for unpatentability and the
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`cited prior references, the Famy Care IPR and the Mylan IPR are nearly identical.
`
`5.
`
`In the Institution Decision for the Mylan IPR, the panel noted that
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`Allergan heavily relied on declaration testimony to argue secondary considerations
`
`supported patentability; and that the lack of declarant cross-examination rendered
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`1 Mylan’s IPR Petition requests institution on Ground 3 based on the Ding ’979,
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`Sall, and Glonek references. (See Mylan Petition, IPR2016-01131, Paper No. 1 at
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`12-13). However, the Institution Decision also includes the Acheampong
`
`reference in this ground. It appears that the Decision erroneously listed
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`Acheampong as included in Ground 3, given that Mylan did not present or argue
`
`that reference in Ground 3, and the decision did not analyze it against the claim at
`
`issue. (IPR2016-01131, Paper No. 8 at 6, 19-22).
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`3
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`it “more appropriate to allow further evidence regarding any alleged unexpected
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`results … to be developed during trial.” (IPR2016-01131, Paper No. 8 at 18-19).
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`To provide one reason that Famy Care’s IPR petition is not identical to Mylan’s
`
`IPR, Famy Care has provided additional specific analysis demonstrating why
`
`Allergan’s proffered secondary considerations evidence does not support finding
`
`unexpected results, including by (1) explaining why the evidence was unavailable
`
`to guide the expectations of the person of ordinary skill in the art; and (2) citing
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`specific statements from Allergan’s published, prior art clinical trial reports that
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`contradict the statements of Allergan’s declarants based on unpublished data. (See,
`
`e.g., Famy Care IPR at 56-77). Even if Mylan’s declarants are not permitted to
`
`rely on such evidence during trial, Famy Care’s experts, who have included this
`
`testimony in their Declarations, should be permitted to do so. But this difference
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`should not have a material adverse impact on the nature and scope of discovery.
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`Instead, it will provide the Board additional analysis to inform its considered
`
`judgment. Famy Care will seek to coordinate with Mylan to avoid duplication in
`
`discovery and testimony.
`
`6.
`
`Famy Care’s IPR contains declarations from two experts who did not
`
`submit declarations in the Mylan IPR. One of the Famy Care experts, however, is
`
`a distinguished clinician with considerable experience treating ocular diseases,
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`
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`4
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`

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`providing another useful perspective for the Board to consider regarding the state
`
`of the art and the validity of the challenged patents.
`
`7.
`
`Famy Care’s arguments, while worded differently, are otherwise
`
`substantively very similar to the Mylan IPR. The Famy Care and Mylan IPR
`
`petitions contain similar invalidity analyses based on the identical prior art. The
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`terms presented for claim construction, the definition of the person of ordinary skill
`
`in the art, and the proposed claim constructions are substantially similar.
`
`8.
`
`The exhibits to the two petitions, particularly the technical exhibits,
`
`are largely identical. Specifically, Exhibits 1001, 1004-1022 and 1024 from the
`
`Famy Care IPR match exhibits in the Mylan IPR. The remaining exhibits
`
`(including the expert declarations and CVs) are distinct.
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`Famy Care respectfully requests that the Board exercise its discretion to
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`grant joinder of the Famy Care IPR and the Mylan IPR proceedings under 35
`
`U.S.C. § 315(c), 37 C.F.R. § 42.22, and 37 C.F.R. § 42.122(b). In support of this
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`motion, Famy Care proposes consolidated discovery, and will coordinate with
`
`Mylan whenever possible to avoid any duplication; and will use best efforts to
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`consolidate briefing with Mylan with shared page limits wherever possible.
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`5
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`The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes
`
`review proceedings. The statutory provision governing joinder of inter partes
`
`review proceedings is 35 U.S.C. § 315(c), which reads as follows:
`
`(c) JOINDER.—If the Director institutes an inter partes review, the
`
`Director, in his or her discretion, may join as a party to that inter
`
`partes review any person who properly files a petition under section
`
`311 that the Director, after receiving a preliminary response under
`
`section 313 or the expiration of the time for filing such a response,
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`determines warrants the institution of an inter partes review under
`
`section 314.
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`When exercising its discretion to grant joinder, the Board considers the
`
`impact of substantive and procedural issues on the proceedings, as well as other
`
`considerations, while being “mindful that patent trial regulations, including the
`
`rules for joinder, must be construed to secure the just, speedy, and inexpensive
`
`resolution of every proceeding.” See Dell, Inc. v. Network-1 Security Solutions,
`
`Inc., IPR2013-00385, Paper No. 17, at 3 (July 29, 2013). The Board should
`
`consider “the policy preference for joining a party that does not present new issues
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`that might complicate or delay an existing proceeding.” Id. at 10. Under this
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`framework, the joinder of the Famy Care IPR with the Mylan IPR would be
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`6
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`appropriate to conserve Board and party resources, and facilitate the efficient and
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`speedy resolution of both proceedings.
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`“A motion for joinder should: (1) set forth the reasons why joinder is
`
`appropriate; (2) identify any new grounds of unpatentability asserted in the
`
`petition; (3) explain what impact (if any) joinder would have on the trial schedule
`
`for the existing review; and (4) address specifically how briefing and discovery
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`may be simplified.” Id. at 4. Each of these is addressed fully below.
`
`A. Reasons Why Joinder Is Appropriate
`Joinder is appropriate in this case because it is the most expedient way to
`
`secure the just, speedy, and inexpensive resolution of the two related proceedings.
`
`See 35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b). The Famy Care IPR is nearly
`
`identical to the Mylan IPR in terms of the grounds instituted, the claims
`
`challenged, and the prior art references relied upon for each ground, which avoids
`
`multiplying the issues before the Board while expediting resolution of the Famy
`
`Care proceedings. Famy Care presents arguments similar to the Mylan IPR, but
`
`for the differences noted above in the statement of material facts. Indeed, the
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`Board has held that joinder is appropriate even in instances (unlike here) where
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`there is merely an “overlap” in the cited prior art, rather than a complete
`
`duplication. See, e.g., Microsoft Corp. v. Proxyconn, Inc., Paper No. 15, at 4,
`
`IPR2013-00109 (February 25, 2013) (concerning a second petition brought by the
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`
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`7
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`

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`same petitioner). Given the duplication of the art and the grounds, joinder of the
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`related proceedings is appropriate and conserves Board resources. As noted above,
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`Famy Care will agree to consolidated discovery, and agree to be bound by the
`
`schedule set forth by the Board in the Mylan proceedings.
`
`Identical Grounds and Similar Petitions
`
`1.
`The Mylan IPR challenges the same patent claims, contains the same
`
`
`
`instituted grounds of unpatentability, and relies upon the same prior art references
`
`for each ground of unpatentability. In these key respects, the two petitions are
`
`virtually identical. The only, very minor, difference, are three claims challenged in
`
`Ground 1, as discussed above in the statement of material facts. However, these
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`claims are included in other grounds in both the Mylan IPR and the Famy Care
`
`IPR, as discussed above. In addition, the Famy Care IPR is substantively similar to
`
`the Mylan IPR, but for the differences noted above in the statement of material
`
`facts. The petitions contain similar analysis and largely identical exhibits. Given
`
`that the Board has already instituted trial in the Mylan IPR (Paper No. 8), the Famy
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`Care IPR will not require additional Board resources to determine whether
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`institution is appropriate here on virtually the same grounds as in the Mylan IPR
`
`
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`8
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`

`
`institution decision.2 Accordingly, maintaining the Famy Care IPR proceeding
`
`separate from the Mylan IPR would duplicate effort and resources, and could
`
`produce inconsistent results. See 157 CONG. REC. S1376 (daily ed. Mar. 8, 2011)
`
`(statement of Sen. Kyl) (“The Office anticipates that joinder will be allowed as of
`
`right—if an inter partes review is instituted on the basis of a petition, for example,
`
`a party that files an identical petition will be joined to that proceeding, and thus
`
`allowed to file its own briefs and make its own arguments.”)
`
`Consolidated Discovery
`
`2.
`Because the grounds of unpatentability and the prior art relied on in the
`
`Famy Care IPR and the Mylan IPR are the same, the case is amenable to
`
`consolidated discovery.
`
`Consolidated discovery is appropriate given that Famy Care and Mylan are
`
`asserting the same grounds for unpatentability, against the same claims, using the
`
`same prior art references. Famy Care will agree to work with Mylan in the
`
`conduct of discovery, for example, Famy Care would agree to designate an
`
`attorney in coordination with Mylan to conduct the cross-examination of any given
`
`
`2 Nor did Allergan, in responding to Mylan’s IPR, rely on the particular elements
`
`in Famy Care’s added claims as patentable distinctions, obviating any burden.
`
`
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`9
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`

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`witness produced by Allergan, within the timeframe normally allotted by the rules
`
`for one party.
`
`Famy Care does not at present have consent from Mylan to consolidate
`
`document filings. As noted above, Famy Care will use its best efforts to cooperate
`
`with Mylan, and present consolidated papers wherever possible.3 However, even
`
`without consolidated filings, Famy Care believes consolidating the proceedings
`
`will lead to increased efficiencies for the Board, should the Board grant the Famy
`
`Care’s IPR petition, by avoiding an entirely separate and largely duplicative
`
`proceeding. Famy Care will endeavor to coordinate with Mylan to avoid
`
`duplicative filings and testimony wherever possible.
`
`B. No New Grounds of Unpatentability
`The Famy Care IPR contains the virtually same five grounds of
`
`unpatentability instituted in the Mylan IPR, with the minor caveat noted above.
`
`In Ground 1, Famy Care includes claims 11, 15, and 19, which Mylan does not;
`
`however, Allergan did not argue in the Mylan IPR a separate patentable distinction
`
`for claims 11, 15, and 19. Claims 11, 15, and 19 also are included in other grounds
`
`
`3 An exception may be where there is an issue unique to Famy Care that Mylan is
`
`not in a position to address, or where Allergan would object to the issue being
`
`addressed by Mylan but not Famy Care.
`
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`10
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`in both the Mylan IPR and the Famy Care IPR. The Famy Care petition does not
`
`contain any additional new “grounds” of unpatentability. The grounds of
`
`unpatentability are otherwise identical, including the prior art references relied
`
`upon.
`
`As noted above in the statement of material facts, Famy Care’s petition
`
`includes some additional arguments concerning secondary considerations, some
`
`different wording, a few additional exhibits, and two expert declarations not
`
`presented in the Mylan IPR. However, the additional documents and discussion of
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`secondary considerations are all directed to the same three grounds of
`
`unpatentability, concerning the same claims, and relying on the same prior art
`
`references as those in the Mylan IPR. Indeed, the Board has previously instituted
`
`joinder where a second IPR petition relied on a different expert declaration. (See,
`
`e.g., Apotex Inc. and Mylan Pharmaceuticals Inc., v. Novartis AG and Mitsubishi
`
`Pharma Corp, Paper No. 8, at 3, IPR2015-00518 (February 25, 2015); Torrent
`
`Pharmaceuticals Ltd. v. Novartis AG and Mitsubishi Pharma Corp, Paper No. 17 at 2,
`
`IPR2014-00784 (February 4, 2015)(a related proceeding to Apotex v. Mylan).
`
`C. No Impact on IPR Trial Schedule
`The difference between the filing date of the Famy Care IPR and the Mylan
`
`IPR is without consequence should the proceedings be joined. The trial schedule
`
`for the Mylan IPR need not be delayed to effect joinder based on Patent Owners’
`
`
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`11
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`preliminary response and later-filed Famy Care IPR. Indeed, given that the Famy
`
`Care IPR asserts virtually identical grounds of unpatentability as those instituted in
`
`the Mylan IPR, there should be no need for the Patent Owners to submit a
`
`preliminary response. The Mylan IPR institution decision did not address
`
`Allergan’s secondary considerations evidence on the merits, but rather recognized
`
`such evidence was better assessed at trial. Allergan has full control over the scope
`
`of secondary considerations evidence it wishes to present and rely upon during
`
`trial. The joint proceeding would allow the Board and parties to focus on the
`
`merits in one consolidated proceeding without unnecessary duplication of effort,
`
`and in a timely manner.
`
`Joinder Will, on Balance, Simplify Discovery.
`
`D.
`As discussed above, Petitioner is amenable to a consolidated discovery
`
`schedule and consolidated discovery, which will simplify the discovery process.
`
`Famy Care will work to eliminate duplicative discovery and duplicative briefing.
`
`Should the Board deny joinder, the instant Petition remains timely filed,
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`because the Famy Care IPR was filed less than one year after April 15, 2016. 35
`
`U.S.C. § 315(b). If the Board institutes the Famy Care IPR but denies joinder, the
`
`parties will move forward separately towards two separate trials on the same
`
`grounds of unpatentability based on the same art. This result may unnecessarily
`
`consume additional time and resources from the Board and the Patent Owner.
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`12
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`Joinder Will Not Prejudice Patent Owner or Mylan
`
`E.
`Famy Care proposes joinder to streamline the proceedings and reduce the
`
`costs and burdens on both the parties and the Board. Famy Care believes joinder
`
`will achieve these goals for several reasons. First, joinder will reduce the time and
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`expense for depositions and other discovery required in separate proceedings.
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`Second, joinder eliminates the possibility of conflicting rulings concerning the
`
`same claims, based on the same grounds. Third, joinder creates case management
`
`efficiencies for the Board and parties without prejudice to Patent Owners.
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`If the Famy Care IPR is instituted, but joinder denied, Patent Owners would
`
`be required to engage in duplicative discovery to defend against both IPR petitions,
`
`perhaps requiring (for example) the same witnesses to testify twice on the same
`
`issues. Patent Owners (and the Board) could well be required to participate in two
`
`separate hearings on the same grounds. Joinder would eliminate the need for
`
`Patent Owners to participate in duplicative proceedings.
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`Given that Famy Care is willing to coordinate briefing with Mylan as
`
`discussed above, Mylan will not be prejudiced, as Mylan will be able to present its
`
`written arguments in the same way it would have if joinder was not instituted.
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`Again, Famy Care will coordinate with Mylan to avoid duplication and reduce any
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`burden on either Mylan or Patent Owners whenever possible; and expects that if an
`
`issue is briefed separately, it will be due to, e.g., issues unique to Famy Care that
`
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`13
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`Mylan is not in a position to address, or where Allergan would object to the issue
`
`being addressed by Mylan but not Famy Care.
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`IV. PROPOSED ORDER
`Petitioner proposes a joinder order for consideration by the Board as
`
`follows:
`
`• The Famy Care IPR will be instituted and joined with the Mylan IPR,
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`including on the same grounds as those for which review was
`
`instituted in the Mylan IPR.
`
`• The scheduling order for the Mylan IPR will apply to the joined
`
`proceeding.
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`• Famy Care, Mylan and Allergan will cooperate to avoid duplicative
`
`discovery and testimony.
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`14
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`V. CONCLUSION
`For the foregoing reasons, Famy Care respectfully requests that its Petition
`
`for inter partes review of U.S. Patent No. 8,648,048 B2 be instituted and that the
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`proceeding be joined with Mylan Pharmaceuticals, Inc. v. Allergan, Inc., IPR2016-
`
`01131. Although no additional fee is believed to be required for this Motion, the
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`Commissioner is hereby authorized to charge any additional fees which may be
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`required for this Motion to Deposit Acct. No. 503626.
`
`Respectfully submitted,
`
`/Deanne M. Mazzochi/
`Deanne M. Mazzochi (Reg. No. 50,158)
`dmazzochi@rmmslegal.com
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`6 West Hubbard Street, Suite 500
`Chicago, Illinois 60654
`Telephone: (312) 222-6305
`Facsimile: (312) 222-6325
`
`
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`
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`Dated: January 6, 2017
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`15
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`CERTIFICATE OF SERVICE
`
`I, Deanne M. Mazzochi, hereby certify that on this 6th day of January, 2017,
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`I caused to be served a true and correct copy of the foregoing Petitioner’s Motion
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`for Joinder Pursuant to 35 U.S.C. § 315(c) and 37 C.F.R. §§ 42.22 and 42.122(b) in
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`its entirety by Federal Express®, which is a means at least as fast and reliable as
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`U.S. Express Mail, on the following:
`
`ALLERGAN, INC.
`2525 Dupont Drive, T2-7H
`Irvine, CA 92612-1599
`
`I also caused to be served a courtesy copy of the foregoing via Electronic Mail,
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`upon the following litigation counsel for Allergan, Inc.:
`
`
`
`Jonathan E. Singer
`FISH & RICHARDSON P.C.
`60 South Sixth Street, #3200
`Minneapolis, MN 55402
`Telephone: (612) 335-5070
`Facsimile: (612) 288-969
`singer@fr.com
`
`
`Dated: January 6, 2017.
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`/Deanne M. Mazzochi/
`Deanne M. Mazzochi
`Registration No. 50,158
`6 West Hubbard, Suite 500
`Chicago, IL
`(312) 222-6305 (telephone)
`(312) 222-6325 (facsimile)
`dmazzochi@rmmslegal.com
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`Attorney for Petitioner