Case IPR2016-01563
`Patent 8,673,927
`Paper No. 18
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v .
`
`BOEHRINGER INGELHEIM INTERNATIONAL GMBH,
`Patent Owner.
`
`Case IPR2016-01563
`Patent 8,673,927 B2
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S MOTION FOR
`REHEARING UNDER 37 C.F.R. § 42.71
`
`
`Patent 8,673,927
`Paper No. 18
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v .
`
`BOEHRINGER INGELHEIM INTERNATIONAL GMBH,
`Patent Owner.
`
`Case IPR2016-01563
`Patent 8,673,927 B2
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S MOTION FOR
`REHEARING UNDER 37 C.F.R. § 42.71
`
`
`
`Case IPR2016-01563
`Patent 8,673,927
`
`I.
`II.
`
`TABLE OF CONTENTS
`INTRODUCTION......................................................................................... 1
`ARGUMENT................................................................................................. 4
`A.
`Legal Standards ................................................................................... 4
`B.
`The Proper Obviousness Standard was Not Applied........................... 5
`C.
`The Board Routinely Applies an Obviousness Presumption
`when a Prior Art Range Encompasses the Claimed Amount............... 8
`The Presumption of Obviousness was Not Overcome....................... 11
`The Board Overlooked Petitioner’s Evidence Establishing a
`Reasonable Expectation of Success................................................... 12
`III. CONCLUSION ........................................................................................... 14
`
`D.
`E.
`
`ii
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`
`
`TABLE OF AUTHORITIES
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`Cases
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`Case IPR2016-01563
`Patent 8,673,927
`
`Page(s)
`
`Ex Parte Berlin
`No. 2011-009313, 2013 WL 3339398, at *5 (May 31, 2013)....................... 9, 10
`
`Ex Parte Fehr
`No. 2013-006774, 2015 WL 4349960, at *3 (PTAB July 14, 2015) ................ 10
`
`Ex Parte Reinsinger,
`No. 2009-013204, 2012 WL 991653 (PTAB Mar. 22, 2012)........................... 10
`
`Ex Parte Saitou
`No. 2010-003525, 2011 WL 2174633, at *1–*2 (PTAB May 31, 2011).......... 10
`
`Galderma Labs., L.P. v. Tolmar, Inc.,
`737 F.3d 731 (Fed. Cir. 2013).................................................................... passim
`
`In re Baird,
`16 F.3d 380 (Fed. Cir. 1994)............................................................................. 11
`
`In re Geisler,
`116 F.3d 1465 (Fed. Cir. 1997)................................................................. 4, 8, 11
`
`In re Jones,
`958 F.2d 347 (Fed. Cir. 1992)........................................................................... 11
`
`In re Malagari,
`499 F.2d 1297 (CCPA 1974) .......................................................................... 4, 8
`
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2003)................................................................... 4, 5, 8
`
`In re Woodruff,
`919 F.2d 1575 (Fed. Cir. 1990)......................................................................... 11
`
`Merck Sharp & Dohme B.V. v. Warner Chilcott Co., LLC,
`No. 13-cv-2088, 2016 WL 4497054 (D. Del. Aug. 26, 2016) .......................... 11
`
`iii
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`Case IPR2016-01563
`Patent 8,673,927
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`Ormco Corp. v. Align Tech., Inc.,
`463 F.3d 1299 (Fed. Cir. 2006)............................................................... 4, 6, 7, 8
`
`OSRAM Sylvania v. Am. Induction Techs.,
`701 F.3d 698 (Fed. Cir. 2012)......................................................................... 7, 8
`
`Samsung Elecs. Co. Ltd. v. Home Semiconductor Corp.,
`No. IPR2015–00467, 2016 WL 3228146 (PTAB June 13, 2016)....................... 5
`
`Star Fruits S.N.C. v. United States,
`393 F.3d 1277 (Fed. Cir. 2005)........................................................................... 4
`
`Warner Chilcott Co., LLC v. Teva Pharm. USA, Inc.,
`89 F. Supp. 3d 641, 654, 673–74 (D.N.J. 2015) aff’d, 642 F. App’x 996
`(Fed. Cir. 2016)............................................................................................. 6, 11
`
`REGULATIONS
`
`37 C.F.R. § 42.71..................................................................................................... 4
`
`iv
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`
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`Case IPR2016-01563
`Patent 8,673,927
`Petitioner Mylan Pharmaceuticals Inc. respectfully requests rehearing of the
`
`Board’s February 3, 2017 decision denying inter partes review of claims 2–9 and
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`11–26 (collectively the “Challenged Claims”) of U.S. Patent No. 8,673,927 as
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`obvious based on Petitioner’s Ground 3.1 (Paper 16 at 22). Rehearing is warranted
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`because the Board’s decision was based on an incorrect
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`legal standard for
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`obviousness.
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`I.
`
`INTRODUCTION
`Under Federal Circuit precedent,
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`the Challenged Claims are presumed
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`obvious because the claimed linagliptin dosages and dosage ranges fall squarely
`
`within the prior art range disclosed in the ’510 Publication (Ex. 1003), and Patent
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`Owner did not meet its burden to overcome this presumption. See Galderma Labs.,
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`L.P. v. Tolmar, Inc., 737 F.3d 731, 737–38 (Fed. Cir. 2013) (Patent Owner has
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`burden of overcoming obviousness presumption “where there is a range disclosed in
`
`the prior art, and the claimed invention falls within that range”).
`
`The Challenged Claims are directed to administrating specified dosages and
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`dosage ranges of a combination of the drugs metformin and linagliptin to treat
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`patients with type II diabetes. (Paper 2, Tables 2–3). It is undisputed that, as of the
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`1 The Board instituted inter partes review on claims 1 and 10 based on Ground 3 but
`denied review of the Challenged Claims. (Paper 16 at 22–23). The Board also denied
`inter partes review of claims 18–26 as anticipated over the ’510 Publication (Ex.
`1003) (Ground 1) and of claims 1–26 as obvious based on Ground 2. (Id. at 11, 14–
`15). Petitioners do not seek rehearing of the Board’s decision on Grounds 1 or 2.
`
`1
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`Case IPR2016-01563
`Patent 8,673,927
`claimed May 4, 2006 priority date, linagliptin was a known compound and was
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`disclosed in the ’510 Publication specifically for the purpose of treating type II
`
`diabetes in a preferred oral dosage range of “1 mg to 100 mg, 1 to 4 times a day.”
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`(Paper 16 at 8). Further, as the Board found, the ’510 Publication disclosed that
`
`linagliptin could be used in combination with metformin to treat type II diabetes.
`
`(Paper 16 at 20). The Board also found that Petitioner provided sufficient evidence
`
`to show the POSA would have been motivated to substitute linagliptin—disclosed
`
`in the ’510 Publication—for the DPP-IV inhibitors disclosed in the prior art
`
`metformin combination therapies of Ahrén (Ex. 1005), Hughes (Ex. 1006), and
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`Brazg (Ex. 1007). (Id. at 19–21).
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`Based on these factual findings, along with the expert testimony of Dr.
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`Davidson, Petitioner contended that the Challenged Claims were obvious because,
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`every claimed linagliptin dosage and dosage range was encompassed within the ’510
`
`Publication’s preferred oral dosage range for linagliptin. (Paper 2 at 38–40). The
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`Board rejected Petitioner’s obviousness contention,
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`stating that
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`the ’510
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`Publication’s disclosure of an oral dosage range “that ‘encompasses’ the recited
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`linagliptin dosages, without more,
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`is not sufficient
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`to support a reasonable
`
`expectation of success in determining the linagliptin dosages recited in [the
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`Challenged Claims].” (Paper 16 at 22 (emphasis added)). But additional support is
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`not required where Petitioner established and the Board found that each claimed
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`2
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`Case IPR2016-01563
`Patent 8,673,927
`dosage or dosage range fell within the ’510 Publication’s preferred range. (Id. at 9–
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`11). Indeed, given the Board’s finding that the ’510 Publication’s preferred “dosage
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`range ‘encompasses’ the specific linagliptin dosages” (id. at 9–11), the Board should
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`have presumed that the Challenged Claims were obvious as a matter of law and
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`required it to produce sufficient evidence showing: (i) unexpected results; or (ii) that
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`the prior art taught away from the claimed invention. See Galderma, 737 F.3d at
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`737–38. Patent Owner could not have rebutted the obviousness presumption because
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`Patent Owner produced no evidence of unexpected results and its “teaching away”
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`arguments were legally insufficient and not adequately supported by expert
`
`declaration testimony. (See Paper 16 at 20–21; see generally Paper 10).
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`The Board’s decision denying institution of the Challenged Claims is thus not
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`premised on the correct legal standard for obviousness. Under the proper standard,
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`Petitioner had shown a reasonable likelihood of prevailing on its assertion that the
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`Challenged Claims are obvious over the prior art. Accordingly, the Board’s errors
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`are material, and Petitioner respectfully requests rehearing of the Board’s decision
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`not to institute inter partes review on Ground 3 with respect to the Challenged
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`Claims.
`
`3
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`Case IPR2016-01563
`Patent 8,673,927
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`II.
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`ARGUMENT
`A.
`Legal Standards
`Pursuant to 37 C.F.R. § 42.71(d), a party may request rehearing of a decision
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`by the Board whether to institute a trial. “The request must specifically identify all
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`matters the party believes the Board misapprehended or overlooked, and the place
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`where each matter was previously addressed in a motion, opposition, or reply.” Id.
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`The Board will review the previous decision for an abuse of discretion. 37 C.F.R. §
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`42.71(c). “An abuse of discretion occurs where the decision is based on an erroneous
`
`interpretation of law, if a factual finding is not supported by substantial evidence, or
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`if the decision represents an unreasonable judgment in weighing relevant factors.”
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`Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005)).
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`As a matter of law, “[w]here a claimed range overlaps with a range disclosed
`
`in the prior art, there is a presumption of obviousness.” Ormco Corp. v. Align Tech.,
`
`Inc., 463 F.3d 1299, 1311 (Fed. Cir. 2006); In re Geisler, 116 F.3d 1465, 1469 (Fed.
`
`Cir. 1997) (prima facie case of obvious established by prior art where disclosed
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`range (50–100 Angstroms) overlapped claimed range (100–600 Angstroms) at a
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`single point); In re Malagari, 499 F.2d 1297, 1303 (CCPA 1974) (claimed invention
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`is rendered prima facie obvious by the teachings of a prior art reference that discloses
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`a range that abuts the range recited in the claim). Additionally, where the “claimed
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`ranges are completely encompassed by the prior art, the conclusion [of obviousness]
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`4
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`Case IPR2016-01563
`Patent 8,673,927
`is even more compelling than in cases of mere overlap.” In re Peterson, 315 F.3d
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`1325, 1330 (Fed. Cir. 2003). “[T]he existence of overlapping or encompassing
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`ranges shifts the burden to the [Patent Owner] to show that [the] invention would
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`not have been obvious.” Id.
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`“[W]here there is a range disclosed in the prior art, and the claimed invention
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`falls within that range, the burden of production falls upon the patentee to come
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`forward with evidence” that the claimed dosages are critical (e.g., unexpected
`
`results) or that the prior art teaches away2 from the claimed invention. Galderma,
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`737 F.3d at 737–38; Peterson, 315 F.3d 1330. If the Patent Owner fails to adequately
`
`rebut this presumption, the claims must be found invalid as obvious. Id.; see also
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`Samsung Elecs. Co. Ltd. v. Home Semiconductor Corp., No. IPR2015–00467, 2016
`
`WL 3228146, at *8 (PTAB June 13, 2016) (patent owner failed to rebut presumption
`
`of obviousness where prior art range “fully encompasses” claimed range by showing
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`unexpected results or teaching away).
`
`The Proper Obviousness Standard was Not Applied.
`B.
`The Board made a factual finding that the ’510 Publication discloses a
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`preferred oral dosage range of linagliptin from 1 to 100 mg, 1 to 4 times a day, and
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`2 In order to teach away, a prior art reference must “criticize, discredit, or otherwise
`discourage investigation into the invention claimed.” Galderma, 737 F.3d at 739. “A
`reference does not teach away . . . if it merely expresses a general preference for an
`alternative invention . . . .” Id. at 738.
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`5
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`Case IPR2016-01563
`Patent 8,673,927
`that such a “relatively broad range ‘encompasses’ the specific linagliptin dosages”
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`recited in the Challenged Claims. (Paper 16 at 9–11). However, despite this factual
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`finding, the Board did not apply the correct legal standard and, as a result, did not
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`afford the Challenged Claims the presumption of obviousness. (Id. at 22). This was
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`legal error. See Ormco, 463 F.3d at 1311; Galderma, 737 F.3d 737–38 (looking only
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`to whether the claimed range was encompassed by the prior art range in applying the
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`obviousness presumption).
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`Moreover, in Section II(B) of its decision, the Board evaluated Petitioner’s
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`Ground 1, the “Asserted Anticipation of Claims 18–26” under the standard for
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`evaluating anticipation of a species claim by prior art containing a genus. (Paper 16
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`at 7 (emphasis added)). But, in Section II(D)(5)(b), when analyzing the “Asserted
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`Obviousness” of the Challenged Claims, the Board improperly scrutinized the
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`claims through the lens of anticipation by “reiterat[ing] [its] analysis and
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`conclusion with regard to the linagliptin dosages . . . from Section II.B, above”
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`(i.e., the Board’s anticipation analysis of claims 18–26). (Id. at 22 (emphasis
`
`added)). This too was legal error. See Warner Chilcott Co., LLC v. Teva Pharm.
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`USA, Inc., 89 F. Supp. 3d 641, 654, 673–74 (D.N.J. 2015) (applying presumption of
`
`obviousness where claimed dosage fell within prior art range, but applying different
`
`legal standard for anticipation analysis) aff’d, 642 F. App’x 996 (Fed. Cir. 2016).
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`6
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`Patent 8,673,927
`In relying on its anticipation analysis, the Board framed its obviousness
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`analysis as a dispute over whether there was a reasonable expectation of successfully
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`determining the specifically claimed amounts of linagliptin in the range disclosed in
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`the ’510 Publication. See id. (would a POSA “have had a reasonable expectation of
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`successfully determining those dosages from the teachings of the ’510 Publication”);
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`id. at 10 (would a POSA “immediately envisage [from the ’510 Publication’s
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`disclosure] administering linagliptin in the dosage amounts recited in claims 18 and
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`19 of the ’927 patent”). But nothing in the statute or Federal Circuit precedent
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`requires such a standard to establish obviousness when the claimed amount or range
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`overlaps with or is encompassed by a prior art range. See Ormco, 463 F.3d at 1311.
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`Likewise, in referring back to its anticipation analysis, the Board required
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`Petitioner to establish how a POSA would have “understood the dosage range of
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`DPP-IV inhibitors disclosed in the ’510 Publication, relative to the claimed
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`linagliptin dosages used in a method for treating type II diabetes.” (Paper 16 at 10).
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`This inquiry is not part of the legal standard for obviousness nor was it necessary in
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`establishing a prima facie obviousness case when dealing with a prior art range that
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`encompasses a claimed range or amount. See Galderma, 737 F.3d at 737–38.
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`Moreover, the Board’s anticipation analysis of claims 18–26 relies on a
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`different, more stringent standard from OSRAM Sylvania v. Am. Induction Techs.,
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`701 F.3d 698, 706 (Fed. Cir. 2012), which is not applicable to obviousness. (Paper
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`7
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`Case IPR2016-01563
`Patent 8,673,927
`16 at 10). OSRAM delineates a standard used for determining anticipation of a
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`claimed species by a broader genus. 701 F.3d at 706. The portion of OSRAM the
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`Board relied upon (e.g. “of ‘critical importance’ in conducting the anticipation
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`analysis . . .” (Paper 16 at 10)) related to an appeal from a summary judgment
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`anticipation finding. OSRAM, 701 F.3d at 705–706. It had nothing to do with
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`determining obviousness and runs contrary to the Federal Circuit’s obviousness
`
`presumption when a prior art reference discloses a range that encompasses a range
`
`recited in the claims. Id. The Board’s reliance on OSRAM in finding that Petitioner
`
`had not met its burden that the Challenged Claims were obvious was legal error.3
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`C.
`
`The Board Routinely Applies an Obviousness Presumption when a
`Prior Art Range Encompasses the Claimed Amount.
`The Board has routinely applied the legal standard of Ormco, Geisler,
`
`Peterson, Malagari, and Galderma in finding claimed inventions prima facie
`
`obvious, even where prior art ranges compared to claim limitations in prior decisions
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`are relatively much broader than the ’510 Publication’s range as compared to the
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`3 This same error is apparent in the Board’s statement that Petitioner failed to
`establish a “reasonable expectation of successfully determining [the claimed
`linagliptin] dosages from the teachings of the ’510 Publication.” (Paper 16 at 22).
`The too is not the proper inquiry for determining obviousness under the facts of this
`case. See Ormco, 463 F.3d at 1311; Galderma, 737 F.3d at 737–38.
`
`8
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`Case IPR2016-01563
`Patent 8,673,927
`claim limitations of the Challenged Claims here.4 For example, in Ex Parte Berlin,
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`the Board applied a legal presumption of obviousness for claims directed to
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`pharmaceutical compositions of ibuprofen and phenylephrine because the prior art
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`disclosed broader ranges of the two drugs encompassing the claimed ranges. No.
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`2011-009313, 2013 WL 3339398, at *5 (May 31, 2013) (Scheiner, J.). There, the
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`prior art taught using a combination of 50–800 mg of ibuprofen with 1–100 mg of
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`phenylephrine, while the claimed ranges were 150–250 mg of ibuprofen with less
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`than 10 mg of phenylephrine. Id. at *1–*4. In Berlin, the patent applicant argued that
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`it would not have been obvious to select the claimed dosage amount (< 10 mg) of
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`phenylephrine. Id. at *5. The Board rejected applicant’s argument, explaining that
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`the “claimed amounts fall squarely within the ranges suggested” by the prior art and
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`that it “is well settled that selecting a narrow range from a broader disclosed range
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`is prima facie obvious, absent a demonstration that the selected range is critical,
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`generally by showing that the claimed range achieves unexpected results.” Id. at *6.
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`4 Although not critical to Petitioner’s request, Petitioner disputes the Board’s
`adoption of Patent Owner’s characterization of the ’510 Publication’s disclosure “1
`to 100 mg, in each case 1 to 4 times a day” as directed to only a total range of 1 mg
`to 400 mg of linagliptin. (See Paper 16 at 9). This is not the appropriate range for the
`Board’s obviousness determination as it is contrary to the disclosure’s ordinary
`meaning. The ’510 Publication plainly reveals “1 to 100 mg” 1X, 2X, 3X or 4X a
`day and necessarily includes administering “1 to 100 mg” of linagliptin once daily
`as a preferred, standalone dosage range.
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`9
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`Because the applicant failed to establish unexpected results, the Board affirmed the
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`examiner’s rejection. Id. at *5–*6.
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`Similarly, in Ex Parte Saitou the Board held that the disclosure of a “very
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`broad” range of “1000 µm or less” was enough to establish a prima facie case of
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`obviousness for the claimed range of “10 to 90 µm.” No. 2010-003525, 2011 WL
`
`2174633, at *1–*2 (PTAB May 31, 2011). There, the Board rejected the patent
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`applicant’s argument that the prior art range was too broad to provide the motivation
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`to select the more narrow claimed range. Id. at *2. After finding the applicant’s
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`evidence of unexpected results insufficient to rebut the prima facie case, the Board
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`affirmed the examiner’s rejection. Id. at *2–*4.
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`Likewise, in Ex Parte Fehr, the Board held that a claimed molecular weight
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`range of 600 to 700 was obvious over a “somewhat broader” molecular weight range
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`of 200 to 10,000 that completely encompassed the claimed range. No. 2013-006774,
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`2015 WL 4349960, at *3 (PTAB July 14, 2015). There, the Board agreed that the
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`examiner was correct in finding the claims prima facie obvious. Id. at *4. See also
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`Ex Parte Reinsinger, No. 2009-013204, 2012 WL 991653, at *2 (PTAB Mar. 22,
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`2012) (prior art range of +/- 8000 ppm disclosed a claimed range of +/- 300 ppm,
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`and applicant failed to meet its rebuttal burden to establish that the claimed range
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`was critical).
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`10
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`Patent 8,673,927
`District courts apply the same legal principle for presuming a claimed
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`limitation is obvious. See, e.g., Merck Sharp & Dohme B.V. v. Warner Chilcott Co.,
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`LLC, No. 13-cv-2088, 2016 WL 4497054, at *13 (D. Del. Aug. 26, 2016) (claims
`
`were prima facie obvious where the claimed dosage ranges fell “within the broad
`
`ranges” of the prior art disclosures); Warner Chilcott Co., 89 F. Supp. 3d at 673–74
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`(applying presumption of obviousness where claimed 100 mg dosage fell within
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`prior art range between 20 and 175 mg); cf. In re Jones, 958 F.2d 347, 350 (Fed. Cir.
`
`1992) (claims not obvious where prior art encompassed a “potentially infinite genus”
`
`of salts); In re Baird, 16 F.3d 380, 382 (Fed. Cir. 1994) (obviousness not found
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`where prior art encompassed “more than 100 million different diphenols”).
`
`The Presumption of Obviousness was Not Overcome.
`D.
`Had the Board properly presumed the Challenged Claims were obvious, then
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`it would have been required to shift the burden to the Patent Owner to come forward
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`with sufficient evidence showing either that
`
`the claimed linagliptin amounts
`
`possessed unexpected properties relative to the prior art or that the prior art taught
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`away from using the claimed amounts. In re Woodruff, 919 F.2d 1575, 1578 (Fed.
`
`Cir. 1990); Geisler, 116 F.3d at 1469. This the Board did not do.
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`Even so, Petitioner provided evidence that there were no unexpected results
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`(Paper 2 at 40–41; Ex. 1002 at ¶¶ 87–89). Patent Owner, on the other hand, did not
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`even argue unexpected results and provided no evidence thereof. The Board’s only
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`11
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`finding regarding teaching away was that Patent Owner failed to establish through
`
`supporting expert declaration testimony that
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`the prior art
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`taught away from
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`combining metformin with linagliptin. (Paper 16 at 20–21 (rejecting Patent Owner’s
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`“additional arguments”). Patent Owner likewise provided no expert declaration
`
`testimony for its other arguments regarding teaching away from the claimed
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`linagliptin dosages. (See generally, Paper 10). Accordingly, there is insufficient
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`record evidence to adequately rebut the presumption that the Challenged Claims
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`were obvious.
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`E.
`
`The Board Overlooked Petitioner’s Evidence Establishing a
`Reasonable Expectation of Success.
`The Board denied institution of the Challenged Claims under Ground 3
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`because: (i) Petitioner failed to explain why a POSA “would have had a reasonable
`
`expectation of successfully determining [the claimed] dosages from the teachings of
`
`the ’510 Publication,” and (ii) Petitioner’s assertion that the “’510 Publication
`
`discloses an oral dosage range that ‘encompasses’ the recited linagliptin dosages,
`
`without more, is not sufficient to support a reasonable expectation of success in
`
`determining the linagliptin dosages recited in the [Challenged Claims].” (Paper 16
`
`at 22).
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`From the outset, the Board’s comments related to the issues at hand are
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`unclear. To the extent that the Board believes that Petitioner has not established a
`
`reasonable expectation of success in practicing the claimed invention, the Board’s
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`12
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`Case IPR2016-01563
`Patent 8,673,927
`decision is incorrect and this rehearing is warranted on this basis.5 Petitioner
`
`established, through Dr. Davidson’s declaration testimony, that the POSA would
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`have been motivated to combine the prior art, and in doing so, the POSA would have
`
`had a reasonable expectation of success with respect to the oral doses of linagliptin
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`across the preferred range disclosed in the ’510 Publication. Specifically,
`
`in
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`Paragraphs 84 and 85 of his Declaration (Ex. 1002), Dr. Davidson refers to Table 1,
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`claim 18 (iii) to establish that the claimed linagliptin dosages and dosage ranges are
`
`disclosed in the ’510 Publication’s preferred oral dosage range from 1 mg to 100
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`mg, 1 to 4 times a day. In those same paragraphs, Dr. Davidson also testified that the
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`Challenged Claims would have been obvious for the same reasons claims 1 and 10
`
`would have been obvious. There, Dr. Davidson was clearly referring to the preceding
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`paragraphs above, namely paragraphs 73–83, where he explains how claims 1 and
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`10 would have been obvious over the ’510 Publication’s preferred oral dosage range
`
`in view of Ahrén, Hughes, and Brazg. Id.
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`In those paragraphs, Dr. Davidson explains in detail how the POSA would
`
`have been motivated to substitute the “linagliptin oral doses disclosed in the ’510
`
`Publication” (i.e., any of the doses from 1 mg to 100 mg, 1 to 4 times a day) for the
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`DPP-IV inhibitors for use in combination with the metformin doses used in the cited
`
`5 This additional basis for rehearing is distinct from the basis stated supra in
`§§ II(B)–(D) related to the legal standard for obviousness. As it is a separate basis
`for rehearing, it is not critical to the Petitioner’s request.
`
`13
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`
`
`Case IPR2016-01563
`Patent 8,673,927
`prior art. (See id. ¶¶ 79–81). Dr. Davidson also explains how the POSA would have
`
`had a reasonable expectation of successfully treating type II diabetes in making this
`
`substitution. (Id. ¶ 82). Thus, Dr. Davidson’s declaration testimony provided that the
`
`POSA would have a reasonable expectation of success in treating a type II diabetes
`
`patient by using the prior art doses in combination with the preferred oral dosages
`
`disclosed in the ’510 Publication, which encompass the linagliptin dosages recited
`
`in the Challenged Claims.
`
`Accordingly, the Board erred in holding that Petitioner had not established
`
`that the POSA would have had a reasonable expectation of success in practicing the
`
`claimed invention.
`
`III. CONCLUSION
`
`For the foregoing reasons, Petitioner Mylan Pharmaceuticals Inc. respectfully
`
`requests that the Board institute inter partes review of claims 2–9 and 11–26 on the
`
`ground that the claims are obvious over the ’510 Publication, Ahrén, Hughes, and
`
`Brazg (Ground 3).
`
`Dated: February 17, 2017
`
`Respectfully submitted,
`
`/ Thomas J. Parker /
`Thomas J. Parker
`Reg. No. 42,062
`ALSTON & BIRD LLP
`90 Park Avenue, 15th Floor
`New York, NY 10016
`Telephone: 212.210.9400
`
`14
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`
`
`Case IPR2016-01563
`Patent 8,673,927
`
`Fax: 212.210.9444
`Thomas.parker@alston.com
`
`Counsel for Petitioner
`
`15
`
`
`
`Case IPR2016-01563
`Patent 8,673,927
`
`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. §42.6(e), the undersigned hereby certifies that, on the
`
`17th day of February, 2017 a complete copy of the foregoing “MOTION FOR
`
`REHEARING UNDER 37 C.F.R. § 42.71” was served via e-mail on counsel for
`
`Patent Owner:
`
`Leora Ben-Ami (Reg. No. 32,455)
`Email: leora.benami@kirkland.com
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, New York 10022
`Tel: (212) 446-4800
`Fax: (212) 446-4900
`
`Jeanna Wacker (Pro Hac Vice)
`Email: jeanna.wacker@kirkland.com
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, New York 10022
`Tel: (212) 446-4800
`Fax: (212) 446-4900
`
`Eugene Goryunov (Reg. No. 61,579)
`Email: eugene.goryunov@kirkland.com
`KIRKLAND & ELLIS LLP
`300 North LaSalle
`Chicago, Illinois 60654
`Tel: (312) 862-2000
`Fax: (312) 862-2200
`
`Mira Mulvaney (Reg. No. 69,850)
`Email: mira.mulvaney@kirkland.com
`KIRKLAND & ELLIS LLP
`601 Lexington Avenue
`New York, New York 10022
`Tel: (212) 446-4800
`Fax: (212) 446-4900
`
`Dated: February 17, 2017
`
`/ Thomas J. Parker /
`Thomas J. Parker
`(Reg. No. 42,062)
`
`16
`
`
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