Trials@uspto.gov
`571-272-7822
`
`
`
`
`
` Paper 41
` 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 IPR2019-00980
`Patent 8,992,486 B2
`____________
`
`Before HYUN J. JUNG, BART A. GERSTENBLITH, and
`JAMES A. TARTAL, Administrative Patent Judges.
`
`JUNG, Administrative Patent Judge.
`
`
`
`DECISION
`Instituting Inter Partes Review
`and
`Granting Motion for Joinder
`35 U.S.C. §§ 314, 315(c)
`
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
` Paper 41
` 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 IPR2019-00980
`Patent 8,992,486 B2
`____________
`
`Before HYUN J. JUNG, BART A. GERSTENBLITH, and
`JAMES A. TARTAL, Administrative Patent Judges.
`
`JUNG, Administrative Patent Judge.
`
`
`
`DECISION
`Instituting Inter Partes Review
`and
`Granting Motion for Joinder
`35 U.S.C. §§ 314, 315(c)
`
`
`
`
`
`
`
`
`IPR2019-00980
`Patent 8,992,486 B2
`
`
`INTRODUCTION
`I.
`Pfizer Inc. (“Petitioner”) filed a Petition (Paper 2, “Pet.”) requesting
`institution of an inter partes review of claims 1–6, 12–18, 20, 23, 26–30, 32,
`33, 36, and 38–40 of U.S. Patent No. 8,992,486 B2 (Ex. 1003, “the ’486
`patent”). Concurrently with its Petition, Petitioner filed a Motion for Joinder
`seeking to join the instituted inter partes review in Mylan Pharmaceuticals
`Inc. v. Sanofi-Aventis Deutschland GmbH, Case IPR2018-01678 (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 also 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 1–6, 12–18, 20, 23, 26–30, 32, 33, 36, and 38–40 of the ’486 patent.
`We also grant Petitioner’s Motion for Joinder and join Petitioner to
`IPR2018-01678. In view of the joinder, we terminate this proceeding.
`
`
`BACKGROUND
`
`II.
`A. Related Proceedings
`The parties indicate that the ’486 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.); and Sanofi-Aventis U.S. LLC v. Eli Lilly
`
`
`
`2
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`IPR2019-00980
`Patent 8,992,486 B2
`
`and Co., No. 1:14-cv-00113-RGA-MPT (D. Del.). Pet. 1–2; Paper 3, 2–3;
`Paper 5, 2; Exs. 1029, 1030.
`The parties also indicate that the ’486 patent is challenged in Cases
`IPR2018-01677, IPR2018-01679, IPR2019-00122, IPR2019-00981, and
`IPR2019-00982. Pet. 1, 2; Paper 5, 3–4. Petitioner notes that IPR2018-
`01677 was terminated after granting an unopposed motion to dismiss.
`Pet. 1; Paper 3, 2.
`The parties additionally indicate that related patents are challenged in
`Cases IPR2018-01670, IPR2018-01675, IPR2018-01676, IPR2018-01680,
`IPR2018-01682, IPR2018-01684, IPR2018-01696, IPR2019-00977,
`IPR2019-00978, IPR2019-00979, IPR2019-00987, IPR2019-01022, and
`IPR2019-01023. Pet. 2; Paper 5, 2–4. The parties further identify related
`patent applications and patents. Pet. 2–4; Paper 5, 4–6.
`B. Evidence Relied Upon
`Petitioner identifies the following references as prior art in the
`asserted grounds of unpatentability:
`(1) U.S. Patent No. 6,235,004 B1, issued May 22, 2001 (Ex. 1014,
`“Steenfeldt-Jensen”); and
`(2) U.S. Patent Application Publication No. US 2002/0052578 A1,
`published May 2, 2002 (Ex. 1015, “Moller”).
`In support of its challenges, Petitioner provides a Declaration of
`Charles Clemens (Ex. 1011). See Paper 3, 3 (stating that the “Petition is also
`supported by the expert declaration of Charles Clemens” and that 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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`IPR2019-00980
`Patent 8,992,486 B2
`
`
`C. Asserted Grounds
`Petitioner challenges, under 35 U.S.C. § 103, claims 1–6, 12–18, 20,
`23, 26–30, 32, 33, 36, and 38–40 as unpatentable over (1) Steenfeldt-Jensen
`and (2) the combination of Moller and Steenfeldt-Jensen. Pet. 5, 23–98.
`
`
`INSTITUTION OF INTER PARTES REVIEW
`III.
`The Petition is substantively identical to the petition in the Mylan IPR.
`Compare Pet. with Mylan, Case IPR2018-01678 (PTAB Sept. 10, 2018)
`(Paper 2); see also Paper 3, 3 (stating that “the same claims of the ’486
`patent are obvious over the same grounds and for substantially the same
`reasons set forth in the Mylan IPR”), 3–4 (stating 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
`1–6, 12–18, 20, 23, 26–30, 32, 33, 36, and 38–40 of the ’486 patent”). For
`substantially the same reasons discussed in the Decision instituting inter
`partes review in the Mylan IPR, Petitioner demonstrates a reasonable
`likelihood of prevailing with respect to at least one of the challenged claims
`of the ’486 patent. Mylan, Case IPR2018-01678 (PTAB Apr. 3, 2019)
`(Paper 20).
`Accordingly, we institute inter partes review of claims 1–6, 12–18,
`20, 23, 26–30, 32, 33, 36, and 38–40 of the ’486 patent based on the asserted
`grounds of unpatentability set forth in the present 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.
`
`
`
`
`4
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`IPR2019-00980
`Patent 8,992,486 B2
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`
`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.
`“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 3, 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).
`
`
`
`5
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`IPR2019-00980
`Patent 8,992,486 B2
`
`
`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.
`Petitioner also contends that the Board will be determining the same issues
`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 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 044, 486, 008, and 844 IPRs.” Paper 8, 2–5. Although Patent
`Owner proposed an extension of the trial schedule in its Response to
`Petitioner’s Motion (Paper 8, 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
`
`
`
`6
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`IPR2019-00980
`Patent 8,992,486 B2
`
`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.
`
`
`CLAIM INTERPRETATION
`V.
`The Petition in the Mylan IPR was filed on September 10, 2018. See
`Mylan, Case IPR2018-01678 (PTAB Oct. 4, 2018) (Paper 6). 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 inter partes reviews in which
`petitions were 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.
`
`
`
`7
`
`
`
`IPR2019-00980
`Patent 8,992,486 B2
`
`
`During a conference held 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 Ex. 1043 in IPR2018-01678, 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 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 1–6, 12–18, 20, 23, 26–30,
`32, 33, 36, and 38–40 of the ’486 patent based on the asserted grounds of
`unpatentability set forth in the Petition. We grant Petitioner’s Motion for
`Joinder and join Petitioner to IPR2018-01678. In view of this joinder, we
`terminate the present proceeding in accordance with 37 C.F.R. § 42.72.
`
`
`
`
`8
`
`
`
`IPR2019-00980
`Patent 8,992,486 B2
`
`
`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 1–6, 12–18, 20, 23, 26–30, 32, 33, 36, and 38–40 of U.S.
`Patent No. 8,992,486 B2 is instituted with respect to all grounds 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 IPR2018-01678;
`FURTHER ORDERED that, in view of the joinder, this proceeding,
`IPR2019-00980, is terminated under 37 C.F.R. § 42.72, and that all further
`filings shall be made only in IPR2018-01678;
`FURTHER ORDERED that the asserted grounds of unpatentability on
`which the Board instituted inter partes review in IPR2018-01678 are
`unchanged and remain the only instituted grounds;
`FURTHER ORDERED that the claim construction standard of
`IPR2018-01678 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 IPR2018-01678;
`FURTHER ORDERED that the Scheduling Order in IPR2018-01678,
`and any modifications thereto, shall govern the schedule of the joined
`proceeding;
`
`
`
`9
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`IPR2019-00980
`Patent 8,992,486 B2
`
`
`FURTHER ORDERED that in IPR2018-01678, 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;
`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 IPR2018-01678 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 IPR2018-01678.
`
`
`
`
`
`
`
`10
`
`
`
`IPR2019-00980
`Patent 8,992,486 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
`
`
`
`
`
`11
`
`
`
`IPR2019-00980
`Patent 8,992,486 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 IPR2018-016781
`Patent 8,992,486 B2
`____________
`
`
`
`
`
`
`1 Pfizer Inc., who filed a petition in IPR2019-00980, has been joined as
`petitioner in this proceeding.
`
`
`
`12
`
`
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