`571-272-7822
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`Paper 12
`August 19, 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 IPR2019-01022
`Patent 9,526,844 B2
`_____________
`
`
`Before HYUN J. JUNG, BART A. GERSTENBLITH, and
`JAMES A. TARTAL, Administrative Patent Judges.
`
`TARTAL, Administrative Patent Judge.
`
`
`DECISION
`Instituting Inter Partes Review and Granting Motion for Joinder
`35 U.S.C. §§ 314, 315(c)
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`IPR2019-01022
`Patent 9,526,844 B2
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`
`INTRODUCTION
`I.
`Pfizer Inc. (“Petitioner”) concurrently filed a Petition (Paper 2, “Pet.”)
`requesting an inter partes review of claims 21–30 of U.S. Patent
`No. 9,526,844 B2 (Ex. 1004, “the ’844 patent”) and a Motion for Joinder
`(Paper 3) with Mylan Pharmaceuticals Inc. v. Sanofi-Aventis Deutschland
`GmbH, Case IPR2018-01680 (the “Mylan IPR”). Sanofi-Aventis
`Deutschland GmbH (“Patent Owner”) filed a Response to Petitioner’s
`Motion for Joinder (Paper 8) and a Waiver of Patent Owner’s Prelminary
`Response (Paper 9). 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. We have authority to determine whether to
`institute an inter partes review. 35 U.S.C. § 314(b); 37 C.F.R. § 42.4(a).
`An inter partes review may not be instituted “unless . . . the information
`presented in the petition . . . and any response . . . shows that there is a
`reasonable likelihood that the petitioner would prevail with respect to at
`least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a).
`Applying that standard, and upon consideration of the Petition and the
`evidence of record, we conclude that the information presented shows a
`reasonable likelihood that Petitioner would prevail in showing the
`unpatentability of at least one challenged claim. Accordingly, we authorize
`an inter partes review to be instituted as to all challenged claims of
`the ’844 patent on all grounds raised in the Petition. We also grant
`Petitioner’s Motion for Joinder and, because we join Petitioner to the Mylan
`IPR, we terminate this proceeding.
`
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`IPR2019-01022
`Patent 9,526,844 B2
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`
`BACKGROUND
`II.
`The ’844 Patent
`A.
`The ’844 patent, titled “Pen-Type Injector,” issued December 27,
`2016, from an application filed May 17, 2016. Ex. 1004, [54], [45], [22].
`The application that matured into the ’844 patent claims priority to a foreign
`application filed March 3, 2003. Id. at [30]. The ’844 patent “relates to
`pen-type injectors . . . where a user may set the dose.” Id. at 1:25–29.
`Related Proceedings
`B.
`Inter partes review of claims 21–30 of the ’844 patent was instituted
`on April 3, 2019, on petitions filed by Mylan Pharmaceuticals Inc.
`(“Mylan”) in both the Mylan IPR (i.e., IPR2019-01680) and in Mylan
`Pharmaceuticals Inc. v. Sanofi-Aventis Deutschland GmbH, Case IPR2018-
`01682. Pet. 1. Additionally, inter partes review of claims 21–30 of
`the ’844 patent was denied in Mylan Pharmaceuticals Inc. v. Sanofi-Aventis
`Deutschland GmbH, Case IPR2018-01696. Id.
`The parties indicate that patents related to the ’844 patent are
`challenged in Cases IPR2018-01670, IPR2018-01675, IPR2018-01676,
`IPR2018-01677, IPR2018-01678, IPR2018-01679, IPR2018-01684,
`IPR2019-00122, IPR2019-00977, IPR2019-00978, IPR2019-00979,
`IPR2019-00980, IPR2019-00981, IPR2019-00982, IPR2019-00987,
`IPR2019-01023. Pet. 2; Paper 6, 2–4. The parties also identify related
`patent applications and patents. Pet. 2–4; Paper 6, 4–6.
`The parties further indicate that the ’844 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, et al.
`
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`Patent 9,526,844 B2
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`v. Mylan GmbH, et al., No. 1:17-cv-00181 (N.D.W.Va.). Pet. 1; Paper 6, 3.
`The parties also indicate that patents related to the ’844 patent have been
`asserted in Sanofi-Aventis U.S. LLC v. Eli Lilly and Co., Nos. 1:14-cv-
`00113-RGA-MPT and 1:14-cv-00884 (D. Del.). Pet. 1–2, Paper 6, 3.
`Real Parties in Interest
`C.
`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.
`The Asserted Grounds of Unpatentability
`D.
`Petitioner challenges the patentability of claims 21–30 of
`the ’844 patent on the following grounds:
`Reference(s)
`Giambattista1
`Giambattista and Steenfeldt-Jensen2
`Giambattista and Klitgaard3
`
`Claim(s) Challenged
`21–29
`24–29
`30
`
`Basis
`§ 102
`§ 103
`§ 103
`
`Pet. 5. Petitioner supports its challenge with a declaration by Charles E.
`Clemens, dated May 1, 2019. Ex. 1011. According to Petitioner, “[t]he
`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).” Paper 3, 3.
`
`
`1 U.S. Patent No. 6,932,794 B2, issued August 23, 2005 (Ex. 1016,
`“Giambattista”).
`2 U.S. Patent No. 6,235,004 B1, issued May 22, 2001 (Ex. 1014, “Steenfeldt-
`Jensen”).
`3 U.S. Patent No. 6,582,404 B1, issued June 24, 2003 (Ex. 1017,
`“Klitgaard”).
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`III. ANALYSIS
`Principles of Law
`A.
`A claim is unpatentable for anticipation under 35 U.S.C. § 102 if a
`single prior art reference either expressly or inherently discloses every
`limitation of the claim. Orion IP, LLC v. Hyundai Motor Am., 605 F.3d 967,
`975 (Fed. Cir. 2010). Moreover, “[a]nticipation requires the presence in a
`single prior art disclosure of all elements of a claimed invention arranged as
`in the claim.” Crown Packaging Tech., Inc. v. Ball Metal Beverage
`Container Corp., 635 F.3d 1373, 1383 (Fed. Cir. 2011) (citations omitted);
`see also Net MoneyIN v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed.
`Cir. 2008) (holding that “it is not enough [for anticipation] that the prior art
`reference discloses part of the claimed invention, which an ordinary artisan
`might supplement to make the whole, or that it includes multiple, distinct
`teachings that the artisan might somehow combine to achieve the claimed
`invention”) (citing In re Arkley, 455 F.2d 586, 587 (CCPA 1972)).
`“A single prior art reference may anticipate without disclosing a feature of
`the claimed invention if such feature is necessarily present, or inherent, in
`that reference.” Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 958 (Fed.
`Cir. 2014) (citing Schering Corp. v. Geneva Pharm., 339 F.3d 1373, 1377
`(Fed. Cir. 2003)).
`A claim is unpatentable for obviousness under 35 U.S.C. § 103 if the
`differences between the claimed subject matter and the prior art are “such
`that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which such
`subject matter pertains.” 35 U.S.C. § 103(a). The question of obviousness
`under 35 U.S.C. § 103 is resolved on the basis of underlying factual
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`determinations, including: (1) the scope and content of the prior art; (2) any
`differences between the claimed subject matter and the prior art; (3) the level
`of skill in the art; and (4) objective evidence of nonobviousness, i.e.,
`secondary considerations. Graham v. John Deere Co., 383 U.S. 1, 17–18
`(1966).
`
`Claim Construction
`B.
`The Petition was filed on May 2, 2019. Paper 2. The claim
`construction standard applied in an inter partes review in which the petition
`was 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). Petitioner proposes the same construction of claim
`terms in the Petition as asserted by Mylan in the Mylan IPR. Compare
`Pet. 19–23 with Mylan, Case IPR2018-01680 (PTAB Sept. 10, 2018)
`(Paper 2, 18–22).
`The petition in the Mylan IPR was filed prior to November 13, 2018.
`See Mylan, Case IPR2018-01680 (PTAB Sept. 10, 2018) (Paper 2). 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). During a conference call held on July 25, 2019,
`with Petitioner, Patent Owner, and the petitioner in the Mylan IPR, each
`indicated that if the Motion for Joinder is granted in this proceeding, there
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`are no issues or objections to continuing with the broadest reasonable
`interpretation standard of claim construction in the joined proceeding.
`Paper 11, 2. For purposes of this Decision, we determine that no claim term
`requires an express construction.
`Showing of a Reasonable Liklihood of Prevailing
`C.
`The Petition is substantively identical to the petition in the Mylan IPR.
`Compare Pet. with Mylan, Case IPR2018-01680 (PTAB Sept. 10, 2018)
`(Paper 2); see also Paper 3, 3 (contending that “the same claims of
`the ’844 patent are anticipated by and 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 21–30 of the ’844 patent”). Based on the
`information presented in the Petition, and for substantially the same reasons
`discussed in the decision instituting inter partes review in the Mylan IPR,
`we find Petitioner has demonstrated a reasonable likelihood of prevailing
`with respect to at least one of the challenged claims of the ’844 patent.
`See Mylan, Case IPR2018-01680 (PTAB Apr. 3, 2019) (Paper 22).
`Accordingly, we institute inter partes review of claims 21–30 of
`the ’844 patent based on all of the asserted grounds of unpatentability set
`forth in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60
`(2018) (providing that a decision to institute under 35 U.S.C. § 314 may not
`institute on fewer than all claims challenged in the petition). This is not a
`final decision as to patentability of claims for which inter partes review is
`instituted or as to any underlying factual or legal issue. Any final decision
`will be based on the record, as fully developed during trial.
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`IV. MOTION FOR JOINDER
`Petitioner seeks to join this case with the Mylan IPR. Paper 3, 1.
`Petitioner’s Motion for Joinder is timely, because it was filed on May 2,
`2019, within one month of institution of inter partes review in the
`Mylan IPR on April 3, 2019. See 37 C.F.R. § 42.122(b) (“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.”).
`Patent Owner does not oppose joinder in light of the resolution by the
`parties of certain concerns Patent Owner previously raised. Paper 8, 5
`(Patent Owner states that “[p]ursuant to the representations noted above
`. . . [Patent Owner] does not oppose [Petitioner’s] Motion for Joinder and
`agrees that judicial economy will be served.”); Paper 11, 2 (noting that
`“Petitioner, Patent Owner, and Mylan each confirmed that agreement had
`been reached regarding joinder so that Patent Owner would not oppose
`joinder under certain conditions”).
`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
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`(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).
`
`Petitioner has persuasively shown reasons why joinder is appropriate.
`Petitioner explains that the same grounds are asserted in the Petition as in the
`Mylan IPR, that no new grounds of unpatentability are asserted, and that the
`Petition presents nearly identical arguments and relies on substantially the
`same evidence as the Mylan IPR. Paper 3, 5. Petitioner also asserts that the
`Board will be determining the same issues and that joinder would be the
`most efficient and economical manner in which to proceed. Id.
`Petitioner has also shown 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 5–6. 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 initially 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
`will rely only on the declaration and testimony of Mr. Leinsing in the joined
`proceeding, and not on the declaration of Mr. Clemens, such that an
`extension of the trial schedule will not be required. Paper 10, 1–2.
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`Petitioner also represents that the petitioner in the Mylan IPR does not
`oppose joinder if there is no change to the trial schedule. Id.
`For the foregoing reasons, we are persuaded that joinder is appropriate
`and, therefore, grant Petitioner’s Motion for Joinder.
`VI. CONCLUSION
`We institute inter partes review of claims 21–30 of the ’844 patent
`based on the asserted grounds of unpatentability set forth in the Petition. We
`grant Petitioner’s Motion for Joinder and join Petitioner to IPR2018-01680.
`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 21–30 of U.S. Patent No. 9,526,844 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 IPR2018-01680;
`FURTHER ORDERED that, in view of the joinder, this proceeding,
`IPR2019-01022, is terminated under 37 C.F.R. § 42.72, and that all further
`filings shall be made only in IPR2018-01680;
`FURTHER ORDERED that the asserted grounds of unpatentability on
`which the Board instituted inter partes review in IPR2018-01680 are
`unchanged and remain the only instituted grounds;
`FURTHER ORDERED that the claim construction standard of
`IPR2018-01680 is applied to the joined proceedings;
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`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 IPR2018-01680;
`FURTHER ORDERED that the Scheduling Order in IPR2018-01680,
`and any modifications thereto, shall govern the schedule of the joined
`proceeding;
`FURTHER ORDERED that in IPR2018-01680, 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 IPR2018-01680 shall
`be changed to reflect joinder of Petitioner in accordance with the attached
`example; and
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`FURTHER ORDERED that a copy of this Decision shall be entered
`into the record of IPR2018-01680.
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`For PETITIONER:
`Jovial Wong
`WINSTON & STRAWN LLP
`jwong@winston.com
`
`
`For PATENT OWNER:
`Elizabeth Stotland Weiswasser
`Anish Desai
`Adrian Percer
`WEIL, GOTSHAL & MANGES LLP
`elizabeth.weiswasser@weil.com
`anish.desai@weil.com
`adrian.percer@weil.com
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`Example Case Caption for Joined Proceeding
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`
`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 IPR2018-016804
`Patent 9,526,844 B2
`____________
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`4 Pfizer Inc., who filed a petition in IPR2019-01022, has been joined as
`Petitioner in this proceeding.
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