Paper 12
`Trials@uspto.gov
`571-272-7822 Entered: August 15, 2019
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`PFIZER INC.,
`Petitioner,
`
`v.
`
`
`
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`_____________
`
`Case IPR2019-00977
`Patent 8,603,044 B2
`_____________
`
`
`Before HYUN J. JUNG, BART A. GERSTENBLITH, and
`JAMES A. TARTAL, Administrative Patent Judges.
`
`GERSTENBLITH, Administrative Patent Judge.
`
`
`DECISION
`Instituting Inter Partes Review and Granting Motion for Joinder
`35 U.S.C. §§ 314, 315(c)
`
`
`
`
`
`Trials@uspto.gov
`571-272-7822 Entered: August 15, 2019
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`PFIZER INC.,
`Petitioner,
`
`v.
`
`
`
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`_____________
`
`Case IPR2019-00977
`Patent 8,603,044 B2
`_____________
`
`
`Before HYUN J. JUNG, BART A. GERSTENBLITH, and
`JAMES A. TARTAL, Administrative Patent Judges.
`
`GERSTENBLITH, Administrative Patent Judge.
`
`
`DECISION
`Instituting Inter Partes Review and Granting Motion for Joinder
`35 U.S.C. §§ 314, 315(c)
`
`
`
`
`
`
`IPR2019-00977
`Patent 8,603,044 B2
`
`
`INTRODUCTION
`I.
`Pfizer Inc. (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting
`institution of an inter partes review of claims 11, 14, 15, 18, and 19 of
`U.S. Patent No. 8,603,044 B2 (Ex. 1002, “the ’044 patent”). Concurrently
`with its Petition, Petitioner filed a Motion for Joinder seeking to join Mylan
`Pharmaceuticals Inc. v. Sanofi-Aventis Deutschland GmbH, Case IPR2018-
`01675 (the “Mylan IPR”). Paper 3, 1.
`Sanofi-Aventis Deutschland GmbH (“Patent Owner”) waived its
`Preliminary Response. Paper 9, 1; see also Paper 8, 1 (stating “Sanofi has
`also concurrently filed a waiver of its Preliminary Response in the above
`Pfizer IPRs”). Patent Owner filed a Response to Petitioner’s Motions for
`Joinder. Paper 8. Thereafter, Petitioner filed a Reply in Support of
`Petitioner’s Motion for Joinder Under 35 U.S.C. § 315(c) and 37 C.F.R.
`§§ 42.22, 42.122(b). Paper 10.
`For the reasons below, we institute inter partes review of challenged
`claims 11, 14, 15, 18, and 19 of the ’044 patent. We also grant Petitioner’s
`Motion for Joinder and join Petitioner to IPR2018-01675. In view of the
`joinder, we terminate this proceeding.
`
`BACKGROUND
`II.
`Related Proceedings
`A.
`The parties indicate that the ’044 patent has been asserted in Sanofi-
`Aventis U.S. LLC v. Mylan GmbH, No. 2:17-cv-09105-SRC-CLW (D.N.J.);
`Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., No. 1-16-cv-
`00812-RGA-MPT (D. Del.); Sanofi-Aventis U.S. LLC v. Eli Lily and Co.,
`No. 1:14-cv-00113 (D. Del.); Sanofi-Aventis U.S. LLC v. Eli Lilly and Co.,
`
`
`
`2
`
`
`
`IPR2019-00977
`Patent 8,603,044 B2
`
`No. 1:14-cv-00884 (D. Del.); and Sanofi-Aventis U.S. LLC v. Mylan GmbH,
`No. 1:17-cv-00181 (N.D. W.Va.). Pet. 1–2; Paper 6, 2.
`The parties also indicate that the ’044 patent is challenged in Cases
`IPR2018-01675, IPR2018-01676, and IPR2019-00978. Pet. 1–2; Paper 6, 2.
`The parties additionally indicate that patents related to the ’044 patent
`are challenged in Cases IPR2018-01670, IPR2018-01677, IPR2018-01678,
`IPR2018-01679, IPR2018-01680, IPR2018-01682, IPR2018-01684,
`IPR2018-01696, IPR2019-00122, IPR2019-00979, IPR2019-00980,
`IPR2019-00981, IPR2019-00982, IPR2019-00987, IPR2019-01022, and
`IPR2019-01023. Pet. 2; Paper 6, 2–4. The parties further identify related
`patent applications and patents. Pet. 2–4; Paper 6, 4–6.
`
`Real Parties in Interest
`B.
`Petitioner identifies itself and Hospira, Inc. as real parties in interest.
`Pet. 1. Patent Owner identifies itself, Sanofi-Aventis U.S. LLC, and Sanofi
`Winthrop Industrie as real parties in interest. Paper 6, 1.
`
`Evidence Relied Upon
`C.
`Petitioner identifies the following reference as prior art in the asserted
`ground of unpatentability:
`U.S. Patent No. 6,221,046 B1, issued April 24, 2001 (Ex. 1013,
`“Burroughs”).
`In support of its challenge, Petitioner provides a Declaration of
`Mr. Charles E. Clemens (Ex. 1011). See Paper 3, 3 (the “opinions set forth
`in Mr. Clemens’s declaration are nearly identical to the opinions set forth in
`the declaration of Mr. Karl R. Leinsing filed in the Mylan IPR (Mylan IPR
`Ex. 1011)”).
`
`
`
`3
`
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`IPR2019-00977
`Patent 8,603,044 B2
`
`
`Asserted Ground
`D.
`Petitioner asserts that Burroughs would have rendered the subject
`matter of claims 11, 14, 15, 18, and 19 obvious, under 35 U.S.C. § 103, to
`one of ordinary skill in the art at the time of the invention. Pet. 5, 21–49.
`
`INSTITUTION OF INTER PARTES REVIEW
`III.
`The Petition is substantively identical to the petition in the Mylan IPR.
`Compare Pet. with Mylan IPR (Paper 2); see also Paper 3, 3 (stating that
`“the same claims of the ’044 patent are obvious over the same grounds and
`for substantially the same reasons set forth in the Mylan IPR” and that “the
`Petition does not contain any additional arguments or evidence (except for
`reliance on a different expert, as noted above) in support of the
`unpatentability of claims 11, 14, 15, 18, and 19 of the ’044 patent”). For
`substantially the same reasons discussed in the Institution Decision in the
`Mylan IPR, which we incorporate expressly herein, Petitioner demonstrates
`a reasonable likelihood of prevailing with respect to at least one of the
`challenged claims of the ’044 patent. Mylan IPR, Paper 28.
`Accordingly, we institute inter partes review of claims 11, 14, 15, 18,
`and 19 of the ’044 patent based on the asserted ground of unpatentability set
`forth in the Petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60
`(2018). At this stage of the proceeding, we have not made a final
`determination as to the unpatentability of any challenged claim or any
`underlying factual or legal issue.
`
`IV. MOTION FOR JOINDER
`Petitioner contends that its Motion for Joinder is timely “because it is
`submitted within one month of the date the Mylan IPR was instituted.”
`Paper 3, 4.
`
`
`
`4
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`IPR2019-00977
`Patent 8,603,044 B2
`
`
`“Any request for joinder must be 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). On May 2, 2019, Petitioner filed the
`Motion for Joinder requesting to join the Mylan IPR. The Board instituted
`an inter partes review in the Mylan IPR on April 2, 2019. Petitioner
`requested joinder no later than one month after the institution date of the
`Mylan IPR. Petitioner’s Motion for Joinder, therefore, is timely.
`Acting under the designation of the Director, we have discretion to
`determine whether to join a party to an instituted inter partes review.
`35 U.S.C. § 315(c); 37 C.F.R. § 42.122(a). We may
`join as a party to [an instituted] inter partes review any person
`who properly files a petition under section 311 that . . . after
`receiving a preliminary response under section 313 or the
`expiration of the time for filing such a response . . . warrants the
`institution of an inter partes review under section 314.
`35 U.S.C. § 315(c). We have explained that 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.
`Kyocera Corp. v. Softview LLC, Case IPR2013-00004, slip op. at 4 (PTAB
`Apr. 24, 2013) (Paper 15).
`As for reasons why joinder is appropriate and identifying any new
`grounds of unpatentability asserted in the Petition, Petitioner contends that it
`asserts the same grounds as in the Mylan IPR, presents nearly identical
`arguments, and relies on substantially the same evidence. Paper 3, 5–6.
`Petitioner also contends that the Board will be determining the same issues
`
`
`
`5
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`IPR2019-00977
`Patent 8,603,044 B2
`
`and joinder would be the most efficient and economical manner in which to
`proceed. Id.
`Regarding what impact, if any, joinder would have on the trial
`schedule for the existing review, Petitioner argues that joinder would not
`affect the schedule in the Mylan IPR because joinder “will not add any
`procedural complications or delay the progress of resolving the substantive
`issues already pending in the Mylan IPR,” Petitioner “will coordinate with
`the Mylan IPR petitioner,” and Petitioner “agrees to take an understudy role
`. . . if joinder is granted.” Id. at 6.
`Lastly, with respect to how briefing and discovery may be simplified,
`Petitioner argues that joinder would avoid the filing of “largely duplicative
`briefs and other papers” and that “Petitioner will maintain a secondary role
`in the proceeding, if joined.” Id. at 6–7.
`Patent Owner responds that it “does not oppose Pfizer’s Motion for
`Joinder” and “agrees that judicial economy will be served by joining Pfizer
`to the Mylan . . . IPR[].” Paper 8, 2–5. Although Patent Owner proposed an
`extension of the trial schedule in its Response to Petitioner’s Motion (id. at
`4–5), Petitioner subsequently explains in reply that the parties agreed that if
`joinder is granted, Petitioner would withdraw the declaration of
`Mr. Clemens and rely on the declaration and testimony of Mr. Leinsing such
`that an extension of the trial schedule would not be required. Paper 10, 1–2.
`Petitioner also represents that the petitioner in the Mylan IPR does not
`oppose joinder if there is no change to the trial schedule. Id.
`In view of Petitioner’s representations and the parties’ agreement,
`Petitioner has persuaded us that joinder is appropriate. We, therefore, grant
`Petitioner’s Motion for Joinder.
`
`
`
`6
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`IPR2019-00977
`Patent 8,603,044 B2
`
`
`V. CLAIM INTERPRETATION
`The Petition in the Mylan IPR was filed on September 10, 2018. See
`Mylan IPR, Paper 8. In an inter partes review based on a petition filed prior
`to November 13, 2018, “[a] claim in an unexpired patent . . . shall be given
`its broadest reasonable construction in light of the specification of the patent
`in which it appears.” 37 C.F.R. § 42.100(b) (2018); Cuozzo Speed
`Techs., LLC v. Lee, 136 S. Ct. 2131, 2142 (2016) (upholding the use of the
`broadest reasonable interpretation standard). Accordingly, the broadest
`reasonable construction standard applies to the Mylan IPR.
`The Petition in this case was filed on May 2, 2019. Paper 4. The
`claim construction standard applied in an inter partes review when a petition
`is filed on or after November 13, 2018, is the federal court claim
`construction standard used in a civil action under 35 U.S.C. § 282(b). See
`Changes to the Claim Construction Standard for Interpreting Claims in Trial
`Proceedings Before the Patent Trial and Appeal Board, 83 Fed. Reg. 51,340,
`51,344 (Oct. 11, 2018). Accordingly, absent joinder, the federal court claim
`construction standard used in a civil action under 35 U.S.C. § 282(b) applies
`to this proceeding.
`During a conference on July 25, 2019, with all involved parties,
`Petitioner and Patent Owner each indicated that, if the Motion for Joinder is
`granted, there would be no issues or objections to continuing with the
`broadest reasonable interpretation standard of claim construction in the
`joined proceeding. Paper 11, 2; see also Mylan IPR, Ex. 1043, 5:19–6:14
`(asking if there were any issues with continuing with the broadest reasonable
`interpretation standard in the joined proceeding and Petitioner and Patent
`Owner each indicating no objections or issues with continuing with that
`
`
`
`7
`
`
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`IPR2019-00977
`Patent 8,603,044 B2
`
`standard). Thus, we will construe any claim term that requires construction
`according to the broadest reasonable interpretation standard. If, however,
`any party contends that a claim term should be given a different
`interpretation from the broadest reasonable interpretation under the federal
`court claim construction standard used in a civil action under 35 U.S.C.
`§ 282(b), that party may request authorization to file an additional brief in
`support of its contentions.
`
`VI. CONCLUSION
`We institute inter partes review of claims 11, 14, 15, 18, and 19 of the
`’044 patent based on the asserted ground of unpatentability set forth in the
`Petition. We grant Petitioner’s Motion for Joinder and join Petitioner to
`IPR2018-01675. In view of this joinder, we terminate the present
`proceeding in accordance with 37 C.F.R. § 42.72.
`
`VII. ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that, pursuant to 35 U.S.C. § 314(a), an inter partes
`review of claims 11, 14, 15, 18, and 19 of U.S. Patent No. 8,603,044 B2 is
`instituted with respect to the sole ground set forth in the Petition;
`FURTHER ORDERED that, pursuant to 35 U.S.C. § 315(c) and
`37 C.F.R. § 42.122(a), Petitioner’s Motion for Joinder is granted, and that
`Petitioner is joined as a petitioner in IPR2018-01675;
`FURTHER ORDERED that, in view of the joinder, this proceeding,
`IPR2019-00977, is terminated under 37 C.F.R. § 42.72, and that all further
`filings shall be made only in IPR2018-01675;
`
`
`
`8
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`IPR2019-00977
`Patent 8,603,044 B2
`
`
`FURTHER ORDERED that the asserted ground of unpatentability on
`which the Board instituted inter partes review in IPR2018-01675 is
`unchanged and remains the only instituted ground;
`FURTHER ORDERED that the claim construction standard of
`IPR2018-01675 is applied to the joined proceedings;
`FURTHER ORDERED that, as agreed to by all the parties, Petitioner
`will no longer rely upon the declaration of Mr. Clemens and will, instead,
`rely on the declaration and testimony of Mr. Leinsing in IPR2018-01676;
`FURTHER ORDERED that the Scheduling Order in IPR2018-01675,
`and any modifications thereto, shall govern the schedule of the joined
`proceeding;
`FURTHER ORDERED that in IPR2018-01675, Petitioner will file
`each paper, except for any paper that does not involve the other party, as a
`single, consolidated filing with Mylan, subject to the page limits set forth in
`37 C.F.R. § 42.24, and shall identify such filing as a consolidated filing;
`FURTHER ORDERED that for any consolidated filing, if Petitioner
`wishes to file an additional paper to address points of disagreement with
`Mylan, Petitioner must request authorization from the Board to file a motion
`for an additional paper or pages;
`FURTHER ORDERED that Petitioner shall collectively designate
`attorneys with Mylan to conduct the cross-examination of any witness
`produced by Patent Owner and the redirect of any witness produced by
`Mylan and Petitioner, within the timeframes set forth in 37 C.F.R. § 42.53(c)
`or agreed to by the parties;
`
`
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`9
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`IPR2019-00977
`Patent 8,603,044 B2
`
`
`FURTHER ORDERED that Petitioner shall collectively designate
`attorneys with Mylan to present at the oral hearing, if requested and
`scheduled, in a consolidated argument;
`FURTHER ORDERED that the case caption in IPR2018-01675 shall
`be changed to reflect joinder of Petitioner in accordance with the attached
`example; and
`FURTHER ORDERED that a copy of this Decision shall be entered
`into the record of IPR2018-01675.
`
`
`
`
`
`
`
`10
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`
`
`IPR2019-00977
`Patent 8,603,044 B2
`
`PETITIONER:
`Jovial Wong
`WINSTON & STRAWN LLP
`PfizerIPRs@winston.com
`
`
`PATENT OWNER:
`Elizabeth Stotland Weiswasser
`Anish R. Desai
`Sudip K. Kundu
`Adrian C. Percer
`Brian C. Chang
`William S. Ansley
`Matthew D. Sieger
`WEIL, GOTSHAL & MANGES LLP
`Sanofi.IPR.Service@weil.com
`elizabeth.weiswasser@weil.com
`anish.desai@weil.com
`sudip.kundu@weil.com
`adrian.percer@weil.com
`brian.chang@weil.com
`sutton.ansley@weil.com
`matthew.sieger@weil.com
`
`
`
`
`
`11
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`IPR2019-00977
`Patent 8,603,044 B2
`
`
`Example Case Caption for Joined Proceeding
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC. and PFIZER INC.,
`Petitioner,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`____________
`
`Case IPR2018-016751
`Patent 8,603,044 B2
`____________
`
`
`
`
`
`
`
`
`
`1 Pfizer Inc., who filed a petition in IPR2019-00977, has been joined as
`petitioner in this proceeding.
`
`
`
`12
`
`
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