Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`Paper 21
`Date: September 1, 2020
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`TEVA PHARMACEUTICALS USA, INC. AND WATSON
`LABORATORIES, INC.,
`Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`_____________
`
`IPR2020-01045
`Patent 7,326,708 B2
`_______________
`
`Before SHERIDAN K. SNEDDEN, ROBERT A. POLLOCK, and
`TIMOTHY G. MAJORS, Administrative Patent Judges.
`
`MAJORS, Administrative Patent Judge.
`
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. §314
`Granting Motion for Joinder
`35 U.S.C. § 315(c); 37 C.F.R. § 42.122
`
`
`
`
`
`
`
`

`

`IPR2020-01045
`Patent 7,326,708 B2
`
`
`INTRODUCTION
`I.
`Teva Pharmaceuticals USA, Inc. and Watson Laboratories, Inc.
`(collectively “Petitioner”), 1 on June 10, 2020, filed a Petition to institute
`inter partes review of claims 1–4, 17, 19, and 21–23 of U.S. Patent
`No. 7,326,708 B2 (Ex. 1001, “the ’708 patent”). Paper 3 (“Pet.” or
`“Petition”). Petitioner also filed a Motion for Joinder (Paper 4, “Mot.” or
`“Motion”) with Mylan Pharmaceuticals Inc. v. Merck Sharp & Dohme
`Corp., IPR2020-00040, in which Mylan is challenging the patentability of
`those same claims of the ’708 patent (“Mylan IPR”). We instituted inter
`partes review of the Mylan IPR on May 12, 2020. Mylan IPR, Paper 21.
`On July 7, 2020, Merck Sharp & Dohme Corp. (“Patent Owner” or
`“Merck”) filed an Opposition (“Opp.” or “Opposition”) to Petitioner’s
`Motion for Joinder. Paper 9. Petitioner filed a Reply in support of the
`Motion. Paper 13 (“Mot. Reply”). And, on August 14, 2020, Patent Owner
`filed a Preliminary Response to the Petition. Paper 16 (“Prelim. Resp.”).
`
`Related Proceedings
`A.
`The parties identify several proceedings where the ’708 patent is
`being asserted, including: Merck Sharp & Dohme Corp. v. Mylan Pharm.
`Inc. et al., 1:19:-cv-00101 (N.D. W. Va); Merck Sharp & Dohme Corp. v.
`Mylan Pharm. Inc. et al., 1:19-cv-01489 (D. Del.); Merck Sharp & Dohme
`Corp. v. Watson Pharmaceuticals, Inc., 1:19-cv-00317 (D. Del.), and Merck
`Sharp & Dohme Corp. v. Teva Pharmaceuticals USA, Inc., 1:19-cv-00318
`(D. Del.). Pet. 6–7 (listing cases); Paper 7, 2–3 (Patent Owner’s Mandatory
`
`
`1 Petitioner identifies Teva Pharmaceutical Industries, Ltd., Teva
`Pharmaceuticals USA, Inc., and Watson Laboratories, Inc. as the real
`parties-in-interest. Pet. 6.
`
`2
`
`
`

`

`IPR2020-01045
`Patent 7,326,708 B2
`
`Notices). As Merck has explained, its lawsuits against several generic drug
`companies related to the ’708 patent, including those suits identified above,
`have been consolidated for pretrial purposes in a multidistrict litigation. See
`Mylan IPR, Paper 10, 10 (identifying In re Sitagliptin Phosphate (’708 &
`’921) Patent Litig. C.A. No. 19-md-2902-RGA (D. Del.)).
`In addition to the Mylan IPR, Patent Owner identifies the following
`related administrative matters before the Patent Office: Dr. Reddy’s
`Laboratories, Inc. v. Merck Sharp & Dohme Corp., IPR2020-01060; and
`Sun Pharmaceuticals Industries, Ltd. v. Merck Sharp & Dohme Corp.,
`IPR2020-01072. Paper 7, 3. 2
`
`
`
`
`2 Petitioners in these related matters filed their petitions at or about the same
`time as the present Petition. Those other petitioners similarly move for
`joinder with the Mylan IPR. See, e.g., IPR2020-1060, Paper 3.
`3
`
`
`

`

`IPR2020-01045
`Patent 7,326,708 B2
`
`
`
`
`Reference(s)/Basis
`WO ’4984
`
`Asserted Grounds
`B.
`Petitioner asserts six grounds of unpatentability (Pet. 13) as set forth
`in the table below:
`Claim(s) Challenged 35 U.S.C. §
`1–3, 17, 19, 21–23
`1023
`
`102
`
`1–3, 17, 19, 21–23
`
`the ’871 patent5
`
`3, 17, 19, 21–23
`
`1–3, 17, 19, 21–23
`
`4
`
`4
`
`103
`
`103
`
`103
`
`103
`
`WO ’498
`
`WO ’498, Bastin6
`
`WO ’498, Bastin, Brittain7
`
`WO ’498, Brittain
`
`
`3 The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284
`(2011) (“AIA”), amended 35 U.S.C. §§ 102 and 103. Because the
`challenged claims of the ’708 patent have an effective filing date before the
`effective date of the applicable AIA amendments, we refer to the pre-AIA
`versions of 35 U.S.C. §§ 102 and 103 in this Decision.
`4 Edmondson et al., WO 03/004498 A1, published Jan. 16, 2003 (Ex. 1004,
`“WO ’498”). WO ’498 published from Application No. PCT/US02/21349,
`filed July 5, 2002, which claims priority to US Provisional Application No.
`60/303,474, filed July 6, 2001 (Ex. 1012).
`5 Edmondson et al., US 6,699,871 B2, issued Mar. 2, 2004 (Ex. 1007, “the
`’871 patent”). The ’871 patent issued from an application filed July 5, 2002,
`and claims priority to US Provisional Application No. 60/303,474, filed July
`6, 2001 (Ex. 1012).
`6 Richard J. Bastin et al., Salt Selection and Optimisation Procedures for
`Pharmaceutical New Chemical Entities, 4 ORGANIC PROCESS RESEARCH &
`DEVELOPMENT 427–435, 2000 (Ex. 1006, “Bastin”).
`7 Polymorphism in Pharmaceutical Solids, Harry G. Brittain ed., 1999
`(Ex. 1005, “Brittain”).
`
`4
`
`
`

`

`IPR2020-01045
`Patent 7,326,708 B2
`
`Petitioner also cites the declaration of Dr. Leonard Chyall (Ex. 1002),
`but has indicated that it will withdraw Dr. Chyall’s declaration, and will rely
`instead on the testimony of Mylan’s declarant, Dr. Mukund Chorghade, in
`the Mylan IPR if permitted. Pet. 13; Mot. 5.
`
`II.
`
`INSTITUTION OF INTER PARTES REVIEW
`
`The Petition advances the same grounds of unpatentability that are
`included in the instituted Mylan IPR. Compare Pet. 13–71, with Mylan IPR,
`Paper 1, 12–69; see also Mylan IPR, Paper 21, 4–5, 64 (Institution
`Decision). Indeed, Petitioner asserts that “Teva’s Petition is a ‘Me-Too’
`petition filed within one month of the Board’s May 12, 2020 Order
`instituting trial” in the Mylan IPR, that “Teva’s Petition raises no issues
`which are not raised in Mylan’s petition,” and that the only differences
`between the petitions are minor and non-substantive. Pet. 1 n.1 (noting, for
`example, differences in party names and typographical changes).
`Merck filed a Preliminary Response, agreeing that “[t]he Petition at
`issue is a ‘Me-Too’ petition,” that was filed with a timely motion for joinder.
`Prelim. Resp. 1. 8 Merck notes the preliminary arguments it raised in
`response to the petition in the Mylan IPR. Id. But, recognizing that the
`Board granted institution in the Mylan IPR notwithstanding those
`arguments, Merck, “[f]or efficiency and to conserve judicial resources,”
`does not specifically raise or restate those arguments at this time. Id. at 2
`
`
`8 Patent Owner’s Preliminary Response does not include page numbers, but
`we treat as though it includes pages 1–4, with page 1 beginning after the
`caption page.
`
`5
`
`
`

`

`IPR2020-01045
`Patent 7,326,708 B2
`
`(reserving its rights to make argument and address the grounds further in any
`instituted and/or joined trial proceeding).
`We grant joinder as explained below, and because we determined that
`the preliminary arguments raised by Patent Owner in the Mylan IPR were
`insufficient to avoid institution in that case, we likewise grant institution
`here. 9 For the reasons set forth in our Institution Decision in the Mylan IPR,
`we determine that Petitioner has met its burden to demonstrate a reasonable
`likelihood that it would prevail in showing at least one of the challenged
`claims are unpatentable. See generally Mylan IPR, Paper 21. Accordingly,
`we institute inter partes review on the grounds raised by Petitioner here,
`which are the same as in the instituted Mylan IPR.
`
`III. GRANT OF MOTION FOR JOINDER
`As discussed above, we instituted trial in the Mylan IPR on May 12,
`2020. Mylan IPR, Paper 21. Petitioner filed its Motion for Joinder on June
`10, 2020, and the motion is, therefore, timely. 37 C.F.R. § 42.122(b) (2020)
`(requiring any joinder motion be filed “no later than one month after the
`institution date of any inter partes review for which joinder is requested”).
`The statutory provision governing joinder in inter partes review
`proceedings is 35 U.S.C. § 315(c), which reads:
`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
`
`9 Because we grant joinder, we do not reach Patent Owner’s alternative
`argument that the Petition is time barred under 35 U.S.C. § 315(b). Prelim.
`Resp. 2–3; 37 C.F.R. § 42.122(b) (“The time period set forth in § 42.101(b)
`[related to the one-year time bar under 35 U.S.C. § 315(b)] shall not apply
`when the petition is accompanied by a request for joinder.”); see also
`35 U.S.C. § 315(c).
`
`6
`
`
`

`

`IPR2020-01045
`Patent 7,326,708 B2
`
`section 311 that the Director, after receiving a preliminary
`response under section 313 or the expiration of the time for filing
`such a response, determines warrants the institution of an inter
`partes review under section 314.
`Furthermore, a motion for joinder should (1) set forth 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 may be simplified. See Kyocera Corp. v. Softview
`LLC, IPR2013-00004, Paper 15, (PTAB Apr. 24, 2013). Petitioner
`addresses these considerations in its Motion, and we generally agree with
`Petitioner’s assertions in favor of joinder. Mot. 4–9. We discuss further
`below.
`The Petition raises the same unpatentability grounds on which we
`instituted review in the Mylan IPR, and no others. Mot. 1–2 (“The instant
`Petition is the same as the Mylan IPR: it involves the same patent, claims,
`grounds of unpatentability, and evidence (including the same prior art
`combinations) as the Mylan IPR.”). Patent Owner provides no persuasive
`argument to the contrary. Thus, this inter partes review does not present any
`ground not already at issue in the Mylan IPR.
`Petitioner’s challenge to the ’708 patent is “essentially identical” to
`the challenge presented in the Mylan IPR. Mot. 4. Moreover, Petitioner
`persuades us that it has agreed to, in effect, play the “silent understudy” role
`to Mylan in the joined proceeding—agreeing to conditions like those
`regularly cited in other Board cases where joinder of a me-too petition was
`granted. Mot. 4, 7–8 (agreeing, for example, to rely on and be bound by the
`testimony of Mylan’s expert); see also Mot. Reply 2–3 (identifying
`
`7
`
`
`

`

`IPR2020-01045
`Patent 7,326,708 B2
`
`conditions that the parties have agreed to with respect to Petitioner’s role in
`the joined proceeding). Petitioner’s limited role in the joined proceeding
`helps to streamline matters and mitigate inefficiencies so that the Board can
`focus on the merits in reaching a final written decision that addresses the
`same patentability challenges raised here and in the Mylan IPR. These
`considerations favor joinder.
`Patent Owner initially opposed joinder, arguing that Petitioner’s role
`in the proceeding was uncertain and that Petitioner had not agreed to play
`the role of a true understudy. Opp. 7–13. Later, however, the parties
`apparently reached agreement on the conditions of Petitioner’s participation
`if joined as a party. See Mot. Reply 1–2 (“Correspondence already of record
`shows that Joinder Petitioners [which include Petitioners here and petitioners
`in IPR2020-01060 and IPR2020-1072] explicitly agreed to Merck’s
`conditions”); see also Mylan IPR, Ex. 1018, 9:1–4 (Patent Owner’s counsel
`representing that “Merck can report that we see that there is agreement
`amongst Merck and the Joinder Petitioners on the understudy role that the
`Joinder Petitioners would play.”). 10 Petitioner persuades us its participation
`will be limited to that of the silent understudy, and we appreciate the parties’
`efforts to reach agreement in that regard.
`As to joinder’s potential impact on the existing trial and briefing
`schedule, based on the facts known to us at present, we conclude that such
`impact is likely to be insubstantial and otherwise manageable. Mot. 5–6.
`For example, Petitioner, in its role as silent understudy, is not permitted to
`
`
`10 Exhibit 1018 in the Mylan IPR is a transcript of an August 10, 2020,
`conference call between the Board and counsel for the parties in IPR2020-
`00040, IPR2020-01045, IPR2020-01060, and IPR2020-01072.
`8
`
`
`

`

`IPR2020-01045
`Patent 7,326,708 B2
`
`make its own filings in the Mylan IPR, nor may it pursue discovery from
`Patent Owner, or provide its own argument at oral hearing (if requested). To
`the contrary, Mylan is the lead petitioner, and Petitioner will be bound in this
`proceeding by the papers filed and representations made by Mylan in the
`Mylan IPR. 11 Petitioner’s agreement to withdraw the declaration of their
`own expert will also help streamline discovery here. Id. at 6.
`In its Opposition, Merck states that it “opposes joinder to the extent it
`precludes Merck from discovery to which it is otherwise entitled from
`Joinder Petitioners.” Opp. at 3–5. 12 Merck then cites a foreign patent office
`proceeding where data that allegedly conflicts with Petitioner’s present
`challenge to the patentability of the ’708 patent’s claims was submitted.
`Opp. 5–6. We need not decide at this point whether Merck is entitled to
`discovery from Petitioner on that particular matter. But Merck is not
`precluded from pursuing it, and, if the parties reach an impasse after
`exhausting good faith efforts, asking for the Board’s help in promptly
`resolving the dispute.
`
`
`11 Although Petitioners are bound by all substantive filings made by Mylan,
`that does not extend to filings or representations unique to Mylan, such as
`matters related to potential or actual settlement.
`12 We agree with Petitioner that the cases cited by Patent Owner on this point
`are inapposite. The discovery issue in Unified Patents related to a dispute
`about identification of all real parties-in-interest, and in ZTE the joinder
`petitioner did not file an identical petition—in each case, injecting new and
`substantive party specific issues. See Unified Patents, Inc. v. Personalweb
`Techs., IPR2014-00702, Paper 12, 5 (PTAB July 24, 2014); ZTE Corp. v.
`Adaptix, Inc., IPR2015-01184, Paper 10, 4–6 (PTAB July 24, 2015). Not so
`here. Even accepting Patent Owner’s characterization of the discovery, it
`relates to an issue already in the Mylan IPR—the stoichiometry of the
`claimed DHP salt. See Mylan IPR, Paper 21, 50–51.
`9
`
`
`

`

`IPR2020-01045
`Patent 7,326,708 B2
`
`
`We also note that, although Merck initially opposed joinder based on
`an alleged need for discovery from Petitioner before the due date for the
`Patent Owner Response in the Mylan IPR, and potential schedule disruption
`without it (Opp. 8–10), Merck more recently signaled that it no longer
`opposed joinder on that basis. Merck indicated it was, instead, reserving its
`right to seek discovery if joinder is ordered. See generally Mylan IPR,
`Ex. 1018, 10:3–12:18. Merck may pursue discovery as noted above. We
`remind the parties, however, that, consistent with the purposes of the Leahy-
`Smith America Invents Act, discovery in IPR proceedings is not the same as
`available in district court and under the Federal Rules of Civil Procedure.
`Consistent with our rules and precedents, IPR discovery is more limited and
`requests must, inter alia, be narrowly targeted to specific documents or
`information. See Garmin Int’l, Inc. v. Cuozzo Speed Tech. LLC, IPR2012-
`00001, Paper 26, 3–7 (PTAB Mar. 5, 2013) (precedential) (discussing limits
`with respect to both routine and additional IPR discovery). We are not
`convinced that discovery issues requiring the Board’s intervention will arise.
`But if they do, there is no adequate basis to conclude that such issues cannot
`be addressed promptly and fairly within the confines of the current schedule.
`On balance, we agree with Petitioner that joinder with the Mylan IPR
`is appropriate under the circumstances. Petitioner’s Motion for Joinder is,
`thus, granted.
`
`IV. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that, pursuant to 35 U.S.C. § 314(a), inter partes review of
`claims 1–4, 17, 19, and 21–23 of U.S. Patent No. 7,326,708 B2 is instituted
`in IPR2020-01045;
`
`10
`
`
`

`

`IPR2020-01045
`Patent 7,326,708 B2
`
`FURTHER ORDERED that the Motion for Joinder with IPR2020-
`00040 is granted, and Petitioner is joined as a party to IPR2020-00040;
`FURTHER ORDERED that all further filings by Petitioner and Patent
`Owner, except for those which concern a request for rehearing of this
`decision, shall be made only in IPR2020-00040;
`FURTHER ORDERED that, subsequent to joinder, the grounds and
`claims for trial in IPR2020-00040 remain unchanged;
`FURTHER ORDERED that, subsequent to joinder, the Scheduling
`Order for IPR2020-00040 (Papers 22 and 39) remains unchanged, subject to
`any change already made by stipulation between the parties or otherwise
`ordered by the Board;
`FURTHER ORDERED that Petitioner shall, absent the Board’s
`permission, make no filing in the joined proceeding unless (1) Mylan settles
`with Patent Owner, and a Motion to Terminate Mylan from the joined
`proceeding has been filed by Mylan, or (2) the filing is a motion to terminate
`the proceeding with respect to Petitioner, a settlement agreement between
`Petitioner and Patent Owner, or a request to keep settlement agreement
`separate under 37 C.F.R. § 42.74(c);
`FURTHER ORDERED that the case caption in IPR2020-00040 shall
`be changed in accordance with the attached example; and
`FURTHER ORDERED that a copy of this Decision shall be entered
`into the record of IPR2020-00040.
`
`
`
`
`11
`
`
`

`

`IPR2020-01045
`Patent 7,326,708 B2
`
`
`FOR PETITIONER:
`Keith A. Zullow
`Sarah J. Fischer
`GOODWIN PROCTER LLP
`kzullow@goodwinprocter.com
`sfischer@goodwinprocter.com
`
`Jitendra Malik
`Alissa M. Pacchioli
`Christopher W. West
`Heike S. Radeke
`KATTEN MUCHIN ROSEMAN LLP
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`christopher.west@katten.com
`heike.radeke@katten.com
`
`FOR PATENT OWNER:
`Stanley E. Fisher
`Jessamyn S. Berniker
`Shaun P. Mahaffy
`Anthony H. Sheh
`WILLIAMS & CONNOLLY LLP
`sfisher@wc.com
`jberniker@wc.com
`smahaffy@wc.com
`asheh@wc.com
`
`
`12
`
`
`

`

`Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`
`
`Paper 21
`Date: September 1, 2020
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS
`USA, INC., WATSON LABORATORIES, INC., DR. REDDY’S
`LABORATORIES, INC., DR. REDDY’S LABORATORIES, LTD., and
`SUN PHARMACEUTICALS INDUSTRIES LTD.Petitioner,
`
`v.
`
`MERCK SHARP & DOHME CORP.,
`Patent Owner.
`_____________
`
`IPR2020-000401
`Patent 7,326,708 B2
`_______________
`
`
`
`
`
`
`
`
`
`
`
`1 Teva Pharmaceuticals USA, Inc. and Watson Laboratories, Inc. were
`joined as a party to this proceeding via Motion for Joinder in IPR2020-
`01045; Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd.
`were joined as a party to this proceeding via a Motion for Joinder in
`IPR2020-01060; and Sun Pharmaceuticals Industries Ltd. was joined as a
`party to this proceeding via Motion for Joinder in IPR2020-01072.
`
`