Case: 18-1203
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`Document: 63
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`Page:1
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`Filed:02/05/2019
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`NOTE: This disposition is nonprecedential.
`
`flfiniteh étatefi Qtnurt of gppeals
`
`for the jfeheral (fllirwit
`
`SANOFI MATURE IP,
`Appellant
`
`V.
`
`MYLAN LABORATORIES LIMITED,
`Appellee
`
`2018-1203
`
`Appeal from the United States Patent and Trademark
`Office, Patent Trial and Appeal Board in No. IPR2016-
`00712.
`
`Decided: February 5, 2019
`
`DANIEL JOHN MINION, Venable LLP,‘ New York, NY, ar-
`gued for appellant. Also represented by WILLIAM E.
`SOLANDER, KATHERINE ADAMS, DOMINICK A. CONDE,
`WHITNEY LYNN MEIER.
`
`MATTHEW R. REED, Wilson, Sonsini, Goodrich & Rosati,
`PC, Palo Alto, CA, argued for appellee. Also represented
`by STEVEN WILLIAM PARMELEE, MICHAEL T. ROSATO, JAD
`ALLEN MILLS, Seattle, WA; WENDY L. DEVINE, San Fran-
`cisco, CA.
`
`

`

`Casez18-1203
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`Document: 63
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`Page:2
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`Filed:.02/05/2019
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`2
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`SANOFI MATURE IP V. MYLAN LABORATORIES LIMITED
`
`Before PROST, Chief Judge, O’MALLEY and STOLL, Circuit
`Judges.
`
`O’MALLEY, Circuit Judge.
`
`involves US. Patent No. 8,927,592
`This appeal
`(“the ’592 patent”), which is assigned to Sanofi Mature IP
`(“Sanofi”).1 In an inter partes review requested by Mylan
`Laboratories Limited, the US Patent Trial and Appeal
`Board (“Board”) invalidated claims 1—5 and 7—80 of the ’592
`patent. Mylan Labs. Ltd.
`v. Aventis Pharma S.A.,
`IPR2016-712, 2017 WL 4221400, at *2 (P.T.A.B. Sept. 21,
`2017) (”59? Decision”). The Board also denied Sanofi’s con-
`tingent motion to amend claims 27—30. Id. Sanofi appeals
`the Board’s denial of its motion. Because we conclude that
`
`the Board improperly placed the burden of proof on Sanofi
`to establish that its proposed claims were patentable and
`applied the wrong claim construction in its analysis, we va-
`cate its denial of the motion and remand for further pro-
`ceedings consistent with this opinion.
`
`I.
`
`BACKGROUND
`
`A. The ’592 Patent
`
`According to the ’592 patent, prostate cancer is gener-
`ally treated with hormone deprivation.
`’592 patent, col. 1,
`11. 35—43. This can include surgery, e.g. castration.
`Id.
`But if prostate cancer metastasizes,
`i.e. spreads to other
`
`This appeal was originally filed by Aventis Pharma
`1
`S.A. On January 24, 2019, Aventis filed an unopposed mo-
`tion to substitute Sanofi Mature IP, which acquired the
`’592 patent during this appeal, as the named party in this
`case. On January 28, 2019, we granted this request. Thus,
`although Aventis was the original named party, we will re-
`fer to Sanofi throughout this opinion for clarity.
`
`

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`SANOFI MATURE IP V. MYLAN LABORATORIES LIMITED
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`3
`
`parts of the body, then castration is ineffective. And while
`other forms of hormone deprivation exist, the ’592 patent
`explains that they do not “improve [] .
`.
`. survival time.” Id.
`at col 1, 11. 40—43. Chemotherapy drugs, such as docetaxel,
`are therefore used, in combination with estramustine or
`
`prednisone, to treat castration resistant, metastatic pros-
`tate cancers.
`Id. at col. 1, 11. 62—65. Even then, however,
`patients can become resistant to docetaxel treatments. Id.
`at col. 2,
`ll. 11—13. These patients are then left with
`“limit[ed] .
`.
`. possible treatment options.” Id.
`~
`
`The ’592 patent purports to provide these patients—
`“patients with castration resistant metastatic prostate can-
`cer who have been previously treated with docetaxel”—
`with a new treatment option. Id. at col. 2, 11. 18—24. This
`treatment involves administering an antitumoral agent,
`cabazitaxel, in combination with a corticoid such as pred-
`nisone or prednisolone. Id. at col. 3, 11. 1—5.
`
`B. Procedural History
`
`On March 15, 2016, Mylan petitioned for inter partes
`review of claims 1—5 and 7—30 of the ’592 patent. The
`Board instituted review on all challenged claims.
`
`1. Sanofi Proposes Substitute Claims
`
`On December 23, 2016, Sanofi filed an opposed motion
`to amend its claims by substituting proposed claims 31—34
`for claims 27—30. See, e.g., J .A. 655 (“If original Claim 27
`is found unpatentable, the Board is requested to replace it
`with proposed substitute Claim 81.”). Proposed substitute
`claim 31 recites:
`
`31. A method of increasing survival comprising ad-
`ministering" to a patient in need thereof (i) an anti-
`histamine, (ii) a corticoid, (iii) an H2 antagonist,
`and (iv) a dose of 20 to 25 mg/m2 of cabazitaxel, or
`a hydrate or solvate thereof, wherein said antihis-
`tamine, said corticoid, and said H2 antagonist are
`administered prior to said dose of 20 to 25 mg/m2 of
`
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`SANOFI MATURE IP V. MYLAN LABORATORIES LIMITED
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`cabazitaxel, or hydrate or solvate thereof, in com-
`bination with prednisone or prednisolone, wherein
`said patient has castration resistant or hormone re-
`fractory, metastatic prostate cancer that has pro-
`gressed during or after treatment with docetaxel.
`
`J.A. 681 (emphases added).
`
`Proposed claim 31, like claim 27, requires administer-
`ing cabazitaxel, in combination with prednisone or predni-
`solone, to a patient with castration resistant or hormone
`refractory metastatic prostate cancer who has progressed
`during or after treatment with docetaxel. But, as the
`Board noted, “[s]ubstitute claim 31 amends the preamble
`[of claim 27] to recite a ‘method of increasing survival’ fol-
`lowed by ‘comprising administering to a patient in need
`thereof.”
`’592 Decision, 2017 WL 4221400, at *28. Pro-
`posed claim 31 also limits claim 27 by requiring the admin-
`istration of an antihistamine, a corticoid, and an H2
`antagonist prior to administering the cabazitaxel. Id.
`
`Proposed claims 82—34 depend directly from proposed
`claim 3 1. These dependent claims do not differ from claims
`28—30 in any way that is relevant to this appeal?
`
`2. The Board’s Decision
`
`On September 21, 2017, the Board issued its final writ-
`ten decision. First, the Board invalidated claims 1—5 and
`7—30 of the ’592 patent for obviousness. ’592 Decision, 2017
`WL 4221400, at *2. Sanofi has not appealed this aspect of
`the Board’s decision. Additionally,
`the Board denied
`Sanofi’s contingent motion to amend because, according to
`
`Proposed claims 32 and 34 are substantively iden-
`2
`tical to claims 28 and 30. Proposed claim 33, however, ad-
`ditionally requires
`the
`cabazitaxel
`regimen to
`be
`administered with an antihistamine, corticoid, and H2 an-
`tagonist. J.A. 682.
`
`

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`the Board, Sanofi failed to establish that its proposed
`claims would be patentable. Id. at*28
`
`the Board concluded
`In addressing Sanofi’s motion,
`that the preamble of proposed claim 3 1 was the only phrase
`requiring explicit construction.
`Id. at *29. Sanofi argued
`that the preamble—“[a] method of increasing survival”—
`was a “statement of intentional purpose for how the
`method is to be performed,” as we described in Jansen v.
`Rexall Sundown, Inc, 342 F.3d 1329, 1333 (Fed. Cir. 2003).
`Id. The Board disagreed, distinguishing Jansen in favor of
`Bristol—Myers Squibb Co. 1:. Ben Venue Laboratories, Inc.,
`246 F.3d 1368, 1375—78 (Fed. Cir. 2001). Id. at *30 (“Bris-
`tol—Myers Squibb is relevant precedent and stands for the
`proposition that a method of treatment preamble stating
`the intended purpose of the treatment does not impose a
`result limitation on the recited method step”). The Board
`therefore concluded that the preamble of proposed claim 31 ‘
`should not be treated as limiting because it merely provides
`“additional description,” as in Bristol-Myers Squibb, rather
`than an “intentional purpose for how the treatment method
`is to be practiced,” as in Jansen.
`Id. (internal quotation
`marks omitted). And, while Sanofi invited the Board to
`treat its claim construction arguments as a disclaimer, the
`Board declined to do so. Id. (citing Ten'ipo Lighting, Inc. U.
`Tivoli, LLC, 742 F.3d 973, 978 (Fed. Cir. 2014)).
`
`On the merits, Sanofi argued “that the prior art d[id]
`not disclose or suggest that 20—25 mg/m2 of cabazitaxel in
`combination with prednisone or prednisolone would in-
`crease overall survival,” as required by the preamble to
`claim 31.
`Id. at 31. The Board rejected this argument
`based on its construction of proposed claim 31, i.e. that the
`preamble was not limiting. Id.
`
`Sanofi also argued that a skilled artisan would not
`have been motivated to use the claimed premedication reg-
`imen—administration of an antihistamine, a corticoid, and
`
`

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`SANOFI MATURE l'P V. MY LAN LABORATORIES LIMITED
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`an H2 antagonist—prior to cabazitaxel therapy.
`Board rejected this argument as well. Id.
`
`Id. The
`
`On October 4, 2017, we issued our en banc decision in
`Aqua Products, Inc. v. Matal, 872 F.3d 1290 (Fed. Cir.
`2017) (en banc). A few days later, the Board offered Sanofi
`additional time to request rehearing in View of Aqua Prod-
`ucts. J.A. 16653—54. Sanofi did not request rehearing.
`
`Sanofi timely filed a notice of appeal from the Board’s
`final written decision. This Court has jurisdiction pursu-
`ant to 28 U.S.C. § 1295(a)(4)(A) and 35 U.S.C. § 141(c).
`
`H. DISCUSSION
`
`Sanofi argues that the Board erroneously placed the
`burden of proof on Sanofi to show that its proposed claims
`would be patentable. Sanofi also appeals the Board’s con-
`struction of proposed claim 31, along with the Board’s ulti-
`mate conclusion that
`the proposed claims would be
`unpatentable. For the following reasons, we agree that the
`Board erred in requiring Sanofi to prove that its proposed
`claims would be patentable and in construing the proposed
`claims.
`
`A. Burden of Proof
`
`In an inter partes review, the petitioner bears the bur-
`den of proving that proposed amended claims are un-
`patentable. Aqua Prods, 872 F.8d at 1327—28. But in
`deciding whether Sanofi could amend its claims here, the
`Board expressly required Sanofi to prove that its proposed
`substitute claims were patentable.
`’59? Decision, 2017 WL
`4221400, at *28 (“As the moving party, [Sanofi] bears the
`burden of proving patentability of each proposed substitute
`claim .
`.
`. we conclude that [Sanofi] has not met its burden
`with respect to the proposed substitute claims”). This was
`error. See Aqua, Prods, 872 F.3d at 1327—28.
`
`Even so, Mylan maintains that the Board’s error was
`harmless because the Board “found that [Mylan] satisfied
`
`

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`7
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`the burden of showing the proposed substitute claims are
`unpatentable by a preponderance of the evidence.” Appel-
`lee Br. at 58. We disagree. While the Board at times sug-
`gested Mylan had “establish[ed]” certain facts, it also noted
`other failures of proof and gaps in Mylan’s expert testi-
`mony.
`’592 Decision, 2017 WL 4221400, at *31—32. We
`therefore decline to speculate as to how the Board would
`resolve this case under the correct legal standard. See, e.g.,
`Sirona Dental Sys. GmbH U. Institat Straumann AG, 892
`F.3d 1349, 1357 (Fed. Cir. 2018) (vacating and remanding
`for the Board to reconsider the evidence after Aqua Prod-
`ucts); Bosch Auto. Seru. Sols, LLC (1. Matal, 878 F.3d 1027,
`1040 (Fed. Cir. 2017), as amended on,
`reh.’g in part
`(lVlar. 15, 2018) (same); Silver Pea/v. Sys, Inc. 1‘. Matal, 698
`F. App’x 1036 (Fed. Cir. 2017) (same).
`
`Mylan also contends that remand is inappropriate be-
`cause Sanofi did not seek rehearing of the Board’s decision.
`But Sanofi Was not required to request rehearing. See In
`re Magnum Oil Tools Int’l, Ltd, 829 F.3d 1364, 1377 (Fed.
`Cir. 2016) (“Nowhere does the statute granting parties the
`right to appeal a final written decision in an [inter partes
`review] require that the party first file a request for rehear-
`ing before the Board .
`.
`.
`.”); see also 35 U.S.C. § 141(c).
`Sanofi therefore did not waive this issue. And, to the ex-
`tent Mylan’s argument is premised on administrative ex-
`haustion, it is similarly unpersuasive. Compare Darby v.
`Cisneros, 509 US. 137, 154 (1993) (“[W]here the [Adminis-
`trative Procedure Act] applies, an appeal
`to ‘superior
`agency authority’ is a prerequisite to judicial review only
`when expressly required by statute or when an agency rule
`requires appeal before review and the administrative ac-
`tion is made inoperative pending that review”), with
`35 U.S.C.§141(c) (imposing no such requirement). We
`therefore vacate the Board’s denial of Sanofi’s contingent
`motion to amend and remand for proceedings consistent
`with our decision in Aqua Products.
`
`

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`SAN OFI MATURE 1P V. MYLAN LABORATORIES LIMITED
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`B. Claim Construction
`
`We review the Board’s conclusions of law de nouo and
`
`its findings of fact for substantial evidence. In re Gartside,
`203 F.3d 1305, 1316 (Fed. Cir. 2000). This framework also
`applies to claim construction. PPC Broadband, Inc.
`1).
`Coming Optical Commc’ns RF, LLC, 815 F.3d 747, 751
`(Fed. Cir. 2016). We therefore conduct a ale novo review of
`the Board’s determination of the broadest reasonable inter-
`pretation of the claims, reviewing any underlying factual
`findings for substantial evidence.3 Id.
`
`A claim’s preamble may be limiting “if it recites essen-
`tial structure or steps, or if it is ‘necessary to give life,
`meaning, and Vitality’ to the claim.” Catalina Mktg. Int 7,
`Inc. v. Coolsauingsconi, Inc, 289 F.3d 801, 808 (Fed. Cir.
`2002)
`(quoting Pitney Bowes,
`Inc. U. Hewlett-Packard
`Co., 1820F.3d 1298, 1305 (Fed. Cir. 1999)). But, generally,
`“a preamble is not limiting ‘where a patentee defines a
`structurally complete invention in the claim body and uses
`the preamble only to state a purpose or intended use for
`the invention.” Id. (quoting Rome 0. Dror, 112 F.3d 473,
`478 (Fed. Cir. 1997)).
`
`Sanofi argues that the preamble of proposed claim 31
`is limiting based on our decisions in Rapoport u. Dement,
`254 F.3d 1053 (Fed. Cir. 2001) and Jansen. We agree.
`
`3
`
`The US. Patent and Trademark Office has indi-
`
`cated it intends to apply the Phillips claim construction
`standard to petitions filed on or after November 13, 2018.
`See Changes to the Claim Construction Standard for Inter~
`preting Claims in Trial Proceedings Before the Patent Trial
`and Appeal Board, 83 Fed. Reg. 51,340 (Oct. 11, 2018) (to
`be codified at 37 G.F.R. pt. 42). Because Mylan filed its
`petition before November 13, 2018, we apply the broadest
`reasonable interpretation standard here (as the Board did
`below).
`
`

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`In Rapoport, the claims recited “[a] method for treat-
`ment of sleep apneas comprising administration of a ther-
`apeutically effective regimen of a Formula I azapirone
`compound .
`.
`. to a patient in need of such treatment.”
`254 F.3d at 1056. After noting the parties’ agreement that
`the preamble should be limiting, we concurred, explaining
`that the preamble—“ [a] method for treatment of sleep ap-
`neas”—was limiting there because “without treating the
`phrase ‘treatment of sleep apneas’ as a claim limitation,
`the phrase ‘to a patient in need of such treatment’ would
`not have a proper antecedent basis.” Id. at 1059. We then
`concluded that the most natural
`interpretation of “[a]
`method for treatment of sleep apneas” in this context was
`that the method—administering ‘a certain compound——
`must be practiced to achieve the purpose stated in the pre-
`amble.
`Id. at 1058—61 (construing the preamble phrase
`“treatment of sleep apneas” and then concluding that a cer-
`tain reference did not anticipate because it was not “admin-
`istered to patients suffering from sleep apnea with the
`intent to cure the underlying condition”); see also Jansen,
`342 F.3d at 1333 (discussing Rapeport).
`
`Although it was undisputed in Rapoport that the pre-
`amble was limiting, when confronted with similar claims
`in Jansen, we reached the same result. In (arisen, the rel-
`evant claim recited:
`
`1. A method of treating or preventing macroeytic-
`megaloblastic anemia in humans which anemia is
`caused by either folic acid deficiency or by vitamin
`B12 deficiency which comprises administering a
`daily oral dosage of a vitamin preparation to a hu-
`man in need thereof comprising at least about 0.5
`mg. of Vitamin B12 and at least about 0.5 mg. of
`folic acid.
`
`Jansen, 342 F.3d at 1330 (emphases added). Based in part
`on this claim language, and Hapoport, we reasoned that the
`preamble—“[a] method
`of
`treating
`or
`preventing
`
`

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`macrocytic-megaloblastic anemia”~«was limiting because
`it articulated the “purpose for which the method must be
`performed.” Id. at 1833.
`
`Jansen and Rapoporl support a conclusion that the pre-
`amble is limiting here.’1 As in Rapoport, the phrase “pa-
`tient in need thereof” from proposed claim 31 relies on the
`preamble for antecedent basis. 254 F.3d at 1059. And, as
`in Jansen, the preamble expresses the “intentional pur-
`pose [—increasing survival~——] for which the method must be
`performed.” 342 F.3d at 1333. We therefore “interpret the
`nearly parallel language in the [’592] patent claims in the
`same way.” Id.
`
`Our conclusion is also consistent with the specification
`of the ’529 patent, which emphasizes increasing survival as
`an important aspect of the invention. Example 1 of the pa-
`tent, for instance, describes a clinical study where patients
`with castration resistant metastatic prostate cancer who
`had previously been treated with docetaxel received either
`treatment with cabazitaxel or mitoxantrone (an antitumor
`antibiotic), each combined with either prednisone or pred-
`nisolone.
`’529 patent at col. 10, 11. 30—34, 44415.
`In dis-
`cussing the results of this study, the ’529 patent highlights
`that patients in the cabazitaxel group demonstrated in-
`creased overall survival rates compared to patients treated
`with mitoxantrone and prednisone. Id. at col. 11, 11. 26—37
`(“The median survival for patients in the cabazitaxel group
`was 15.1 months in comparison to 12.7 months in the
`
`To the extent the Board disregarded Jansen simply
`4
`because it was on appeal from a district court, ’529 Deci-
`sion, 2017 WL 4221400 at *30 (“Jansen is distinguishable
`from the present case because it was an infringement
`case .
`.
`.
`.”), it erred. Claim construction standards vary be-
`tween district court litigations and inter partes reviews,
`but basic principles of construction do not. Cf. Power Inte-
`grations, Inc. v. Lee, 797 F.3d 1318, 1326 (Fed. Cir. 2015).
`
`

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`1 1
`
`mitixantrone group”); see also id. at col 1, ll. 4-0—43 (criti-
`cizing various prior art hormone deprivation therapies be-
`cause they did not “improve[] .
`.
`. survival time”).
`
`Mylan’s attempts to distinguish Jansen, and Rapoport
`are unpersuasive, and its reliance on Bristol-Myers Squibb
`is misplaced.
`In Bristol-Myers Squibb, we concluded that
`the claim language “strongly suggest[ed] the independence
`of the preamble from the body of the claim.” Bristol-Myers
`Squibb, 246 F.3d at 1375. But here, the claim language
`suggests the opposite.
`Indeed, there is a direct link be-
`tween the claim as a whole and the preamble, which pro-
`vides
`an antecedent basis
`for
`“in need
`thereof.”
`
`See Rapoport, 254 F.3dat 1059.
`
`Mylan’s reliance on the ’529 patent’s prosecution his-
`tory is also unavailing. According to Mylan, the decision to
`delete the phrases “effective amount” and “clinically proven
`effective amount” from claim 1 and claim 24 (issued as
`claim 27), respectively, reflected an “accept[ance] that the
`claimed methods did not require ‘an effect on the cancer to
`be treated.” Appellee Br. at 27. Mylan therefore argues
`that the claims do not require the administered doses to
`have any effect on the patient. .ld. But thesephrases were
`deleted to specify the clinically effective doses, not to sug-
`gest
`that
`their effects were irrelevant. J.A. 4111—16;
`J.A. 1859. And Mylan conflates concepts of curing cancer
`or sending it into remission with longer survival while the
`cancer remains intact. Regardless, the proposed claims
`would now clearly require “increasing survival.” J .A. 681.5
`
`5 Alternatively, Sanofi argues that the prosecution
`history here supports its proposed construction because its
`contingent motion to amend constitutes a clear and unmis-
`takable disclaimer of any embodiments lacking the purpose
`limitation. Mylan argues that this is not clear disclaimer.
`Regardless of whether Sanofi’s motion to amend consti-
`tutes a clear and unmistakable disclaimer, we conclude
`
`

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`SANOFI MATURE IP V. MYLAN LABORATORIES LIMITED
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`the patent owner’s proposed claim 31
`Ultimately,
`closely mirrors language from cases, such as Jansen and
`Rapoport, which we have treated as limiting. The Board
`erred by treating the preamble here as non-limiting. On
`remand, the Board-should therefore treat the preamble as
`an additional limitation of proposed claim 31.
`
`III. CONCLUSION
`
`For the reasons stated above, we vacate the Board’s de-
`
`nial of Sanofi’s contingent motion to amend and its con-
`struction of the proposed substitute claims and we remand
`for further consideration consistent with this opinion.
`
`VACATED AND REMANDED
`
`COSTS
`
`No costs.
`
`that it is at least relevant to the inquiry and favors treating
`the preamble as limiting. Cf. Bristol-Myers, 246 F.3d at
`1375 (“[T]his is not a case in which a new use of a process
`should be considered to be a limitation because that new
`
`use distinguishes the process over the prior art .
`
`.
`
`.
`
`.”).
`
`

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`6151111183 gatateg (211mm of gppeais
`
`for the jfeheral @imu’t
`
`SANOFI MATURE IP,
`
`Appellant
`
`MYLAN LABORATORIES LIMITED,
`
`Aslppelloe
`
`2018- 1203
`
`Appeal from the United States Patent and Trademark
`Office, Patent Trial and Appeal Board in No. IPR2016-
`00712
`
`JUDGMENT
`
`THIS CAUSE having been considered, it is
`
`ORDERED AND ADJUDGED:
`
`VACATED AND REMANDED
`
`ENTERED BY ORDER OF 'I‘Hr. COURT
`
`February 5, 2019
`
`Ls/“15’oter R. Marksteiner
`Peter R. Marketeiner
`
`Clerk of Court.
`
`

`

`Case: 18—1203
`
`Document: 65
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`Page: 1
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`Filed: 03/14/2019
`
`Clinitm games Qtuutt of @maeals
`
`for the jfeheral QEirtutt
`
`SANOFI MA’I‘URE IP,
`
`Appellunl
`
`MYLAN LABORATORIES LINIITED,
`
`Appallcv
`
`2018-1203
`
`Appeal from the United States Patent and Trademark
`Office, Patent Trial and Appeal Board in No. IPR2016-
`00712.
`
`MANDATE
`
`In accordance with the judgment of this Court, entered
`February 05, 2019, and pursuant to Rule 41 of the Federal
`Rules of Appellate Procedure,
`the formal mandate is
`hereby issued.
`'
`
`March 14, 2019
`
`FOR THE COURT
`
`/s/ Peter R. Marksteiner
`Peter R. Marksteiner
`Clerk of Court
`
`