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`Tel. 571-272-7822
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`Paper 19
`Entered: March 17, 2017
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`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
`______________
`
`
`Before TONI R. SCHEINER, BRIAN P. MURPHY, and
`ZHENYU YANG, Administrative Patent Judges.
`
`MURPHY, Administrative Patent Judge.
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
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`

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`IPR2016-01563
`Patent 8,673,927 B2
`
`
`
`INTRODUCTION
`I.
`Mylan Pharmaceuticals Inc. (“Petitioner”) filed a Petition requesting an inter
`partes review of claims 1–26 of U.S. Patent No. 8,673,927 B2 (Ex. 1001, “the ’927
`patent”). Paper 2 (“Pet.”). Boehringer Ingelheim International GmbH (“Patent
`Owner”) filed a Preliminary Response to the Petition. Paper 10 (“Prelim. Resp.”).
`On February 3, 2017, we instituted an inter partes review. Paper 16 (“Decision” or
`“Dec.”). We determined that “there is a reasonable likelihood Petitioner would
`prevail with respect to claims 1 and 10 of the ’927 patent challenged in the
`Petition,” pursuant to 35 U.S.C. § 314(a). Id. at 1. We did not institute trial on
`claims 2–9 or 11–26. Id. Petitioner now requests rehearing of our decision not to
`institute trial on claims 2–9 and 11–26 with respect to Ground 3. Paper 18
`(“Rehearing Request” or “Req. Reh’g”).
`We will grant a request for rehearing if the requesting party demonstrates
`“an abuse of discretion” in the decision. 37 C.F.R. § 42.71(c). However, we will
`grant a request for rehearing only if the requesting party “specifically identif[ies]
`. . . the place where each matter [that we misapprehended or overlooked] was
`previously addressed.” Id. § 42.71(d). After considering Petitioner’s Rehearing
`Request, our Decision, and the evidence currently of record, Petitioner’s Rehearing
`Request is denied.
`
`
`
`
`II. ANALYSIS
`Section 314(a) provides (emphasis added):
`THRESHOLD.—The Director may not authorize an inter partes
`review to be instituted unless the Director determines that the
`information presented in the petition filed under section 311 and
`any response filed under section 313 shows that there is a
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`IPR2016-01563
`Patent 8,673,927 B2
`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).
`It is Petitioner’s burden to set forth the basis for its challenge in the Petition.
`See Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing
`35 U.S.C. § 312(a)(3), requiring inter partes review petitions to identify “with
`particularity . . . the evidence that supports the grounds for the challenge to each
`claim.”). In Harmonic, the Federal Circuit held that “it was Harmonic’s burden to
`explain to the Board how Haskell combined with Rossmere rendered the
`challenged claims unpatentable. With respect to claim 11 of the ’291 patent,
`Harmonic did not do so.” Id. Petitioner here also did not meet its burden with
`respect to claims 2–9 and 11–26 of the ’927 patent.
`The Petition failed to explain and support the position Petitioner now argues
`for the first time in its Rehearing Request, namely that claims 2–9 and 11–26 “are
`presumed 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 Owner did not meet its burden to overcome this presumption.” Req.
`Reh’g 1 (emphasis added) (citing Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d
`731, 737–38 (Fed. Cir. 2013)); see also id. at 4–5 (citing 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); In re Malagari, 499 F.2d 1297, 1303 (CCPA 1974); In re
`Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)). Petitioner’s Rehearing Request
`fails to acknowledge that the Petition does not (i) contain any argument or
`reasoned support for applying a legal presumption of obviousness based on
`overlapping linagliptin dosage ranges, or (ii) cite Galderma, Ormco, Geisler,
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`IPR2016-01563
`Patent 8,673,927 B2
`Malagari, or Peterson.1 The Board could not have misapprehended or overlooked
`an argument that was not made and case law that was not cited in the Petition, nor
`is it the Board’s function to present reasoned arguments on Petitioner’s behalf.
`We stated in our Decision regarding Petitioner’s obviousness challenge that
`“Petitioner relies solely on its claim 18 anticipation chart to support its assertion
`that the recited linagliptin dosages are disclosed in the ’510 Publication,” and
`further noted that Petitioner did “not provide any further analysis or support for its
`assertion regarding the disclosure of the linagliptin dosages recited in claims 2–9
`and 11–26.” Dec. 22. The sum and substance of Petitioner’s obviousness analysis
`regarding the particular linagliptin dosage limitations in claims 2–9 and 11–26
`(Ground 3) is as follows:
`As discussed above in each of Grounds 1 and 2, each of the
`recited doses or dosage ranges are disclosed in the ’510
`Publication as shown in Table 1, claim 18(iii) supra. Thus,
`claims 2–9 would have been obvious for the same reasons claims
`1 and 10 would have been obvious, as discussed above. (Ex.
`1002 ¶ 84). . . .
`
`As discussed above in each of Grounds 1 and 2, each of the
`recited doses are disclosed in the ’510 Publication as show in
`Table 1, Claim 18(iii) supra. (Ex. 1002 ¶ 85). Thus, claims 11–
`17 would have been obvious for the same reasons claims 1 and
`10 are obvious, as discussed above. (Id.). . . .
`
`Thus, for the reasons discussed above for claim18, see Table 1,
`18(ii)–(iii), each element of claims 18–20 and 21–26 are
`disclosed in the ’510 Publication. (Ex. 1002 ¶ 86).
`
`
`1 The additional cases cited on pages 9–11 of the Rehearing Request (Ex Parte
`Berlin, Ex Parte Saitou, Ex Parte Fehr, and Merck Sharp & Dome B.V. v. Warner
`Chilcott Co.) also were not cited in the Petition. We will not consider case law
`cited for the first time in a rehearing request. 37 C.F.R. § 42.71(d).
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`IPR2016-01563
`Patent 8,673,927 B2
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`Pet. 38–39.
`First, Petitioner’s obviousness analysis refers back to independent claims 1
`and 10 of the ’927 patent, which recite “a pharmaceutically effective oral amount
`of [linagliptin]” and “a therapeutically effective oral dose of [linagliptin],”
`respectively. Petitioner argues that “[t]he ’510 Publication discloses . . . the recited
`oral doses of a DPP-IV Inhibitor (linagliptin) in claims 1 and 10.” Pet 35. Claims
`1 and 10, however, do not recite the particular linagliptin dosages and dosage
`ranges recited in claims 2–9 and 11–26, and the Petition does not address them
`when analyzing claims 1 and 10 in an obviousness context. Pet. 34–38.
`Dr. Davidson’s Declaration testimony cited by Petitioner adds nothing to the
`block-quoted arguments in the immediately preceding paragraph, because the
`block-quoted arguments are identical to Dr. Davidson’s Declaration. Compare Pet.
`38–39 with Ex. 1002 ¶¶ 84–86.
`Second, Petitioner’s Table 1, claim 18(iii) chart contains the following
`single sentence of analysis pertaining to Petitioner’s anticipation ground based on
`the ’510 Publication’s disclosure of a preferred dosage range for linagliptin
`(“preferably 1 to 100 mg, in each case 1 to 4 times a day”):
` As seen from this passage, the most preferable oral dosage range
`for linagliptin encompasses and thus anticipates the claimed dose
`recited in claim 18. See Perricone v. Medicis Pharma. Corp.,
`432 F.3d 1368, 1376 (Fed. Cir. 2005).
`
`Pet. 18–19 (citing Ex. 1003 ¶ 3002). In our Decision, we discussed the Perricone
`case and explained why it was distinguishable from the facts of the present case
`with regard to Petitioner’s anticipation ground. Dec. 9–10. Petitioner chose not to
`
`
`
`2 Petitioner also cites Dr. Davidson’s Declaration (Ex. 1002 ¶ 35), which duplicates
`the Petition, but for the citation to Perricone.
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`add a substantive obvious analysis to the single sentence quoted above from its
`anticipation ground, when addressing the linagliptin dosages recited in claims 2–9
`and 11–26. In sum, Petitioner’s conclusory obviousness argument refers back to
`one sentence citing an anticipation case that we distinguished in our Decision. We
`did not misapprehend or overlook any argument or case law presented in the
`Petition.
`Third, we agree with Petitioner that an anticipation analysis cannot substitute
`for an obvious analysis. Reh’g Req. 6–8. It was not the Board, however, that
`“relied on” the anticipation analysis regarding claim 18 when addressing
`obviousness for the linagliptin dosages recited in claims 2–9 and 11–26 (id); that
`was Petitioner’s choice. We reject Petitioner’s attempt to assert legal error in the
`Board’s Decision, when it was Petitioner who cited to a one-sentence anticipation
`analysis for a single claim, without legal citation or analysis in the context of
`alleged obviousness regarding multiple claims reciting various linagliptin dosages.
`Fourth, Petitioner relies heavily on the Galderma case for the proposition
`that the Board “should have presumed that the Challenged Claims were obvious as
`a matter of law and required [Patent Owner] to produce sufficient evidence
`showing: (i) unexpected results; or (ii) that the prior art taught away from the
`claimed invention.” Req. Reh’g 3; see also id. at 8–9 (citing Ormco, Geisler,
`Peterson, Malagari, and Galderma). Petitioner argues that the Board has
`“routinely applied” such a presumption in support of finding a prima facie case of
`obviousness when the prior art discloses a relatively broader range of values than
`those recited in the claims. Id. at 8–9. Even if Petitioner had made such an
`argument and cited Galderma and the related cases in the Petition, the Board will
`not apply such a legal presumption in an analytical vacuum.
`In Galderma, for example, the claim recited a “topically applicable
`pharmaceutical composition comprising 0.3% by weight of [adapalene] . . .
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`effective for the treatment of acne.” Galderma, 737 F.3d at 734. The prior art
`Shroot patents disclosed topical adapalene compositions for treating acne “in a
`preferred range of 0.01%–1%,” including exemplary formulations containing
`0.001%, 0.1%, and 1%. Id. at 735–36. The court noted the Shroot patents were
`listed in the FDA’s Orange Book for “prior art Differin® 0.1% Gel as well as
`Differin® Gel, 0.3%.” Id. at 735. The court further noted that other prior art
`references disclosed the use of 0.3% adapalene lotion in an animal model for acne
`treatment and taught the use of 0.3% adapalene for other skin conditions “without
`intolerable irritability.” Id. It was in the foregoing context that the court framed
`the issue as “whether there was motivation to select the claimed 0.3% adapalene
`composition in the disclosed range.” Id. at 737–38. The Petition here simply does
`not provide the same type of context and analysis with regard to the claimed
`linagliptin dosages, sufficient for us to apply the requested presumption.3
`
`
`III. ORDER
`
`Accordingly, it is
`ORDERED that Petitioner’s Rehearing Request is denied.
`
`
`
`
`
`
`3 To the extent Petitioner argues for a presumption of obviousness that shifts the
`burden of persuasion to Patent Owner, such an argument is misplaced. (Req.
`Reh’g 1, 4–5). See In re Magnum Oil Tools Int’l Ltd., 829 F.3d 1364, 1375 (Fed.
`Cir. 2016) (“‘[A] burden-shifting framework makes sense in the prosecution
`context,’ where ‘[t]he prima facie case furnishes a procedural tool of patent
`examination, allocating the burdens of going forward as between examiner and
`applicant,’ . . . however that burden-shifting framework does not apply in the
`adjudicatory context of an IPR.” (emphasis added, citations omitted)).
`7
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`8
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`IPR2016-01563
`Patent 8,673,927 B2
`
`FOR PETITIONER:
`Thomas Parker
`Chris McArdle
`Ellen Cheong
`Charles Naggar
`Alston & Bird LLP
`
`thomas.parker@alston.com
`chris.mcardle@alston.com
`ellen.cheong@alston.com
`charles.naggar@alston.com
`
`FOR PATENT OWNER:
`Leora Ben-Ami
`Eugene Goryunov
`Mira Mulvaney
`Kirkland & Ellis LLP
`
`leora.benami@kirkland.com
`egoryunov@kirkland.com
`mira.mulvaney@kirkland.com
`
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