Trials@uspto.gov
`Tel. 571-272-7822
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`
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`Paper 23
`Entered: August 1, 2017
`
`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 IPR2016-01565
`Patent 8,853,156 B2
`______________
`
`
`
`
`Before TONI R. SCHEINER, BRIAN P. MURPHY, and ZHENYU YANG,
`Administrative Patent Judges.
`
`SCHEINER, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`
`
`
`
`
`Tel. 571-272-7822
`
`
`
`
`
`Paper 23
`Entered: August 1, 2017
`
`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 IPR2016-01565
`Patent 8,853,156 B2
`______________
`
`
`
`
`Before TONI R. SCHEINER, BRIAN P. MURPHY, and ZHENYU YANG,
`Administrative Patent Judges.
`
`SCHEINER, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2016-01565
`Patent 8,853,156 B2
`
`
`I.
`INTRODUCTION
`Mylan Pharmaceuticals Inc. (“Petitioner”) filed a Petition requesting
`an inter partes review of claims 1, 2, 4–8, 10–18, and 23–25 of U.S. Patent
`No. 8,853,156 B2 (Ex. 1001, “the ’156 patent”). Paper 2 (“Pet.”).
`Specifically, Petitioner challenged claims 1, 2, 4, 5, and 23 under 35 U.S.C.
`§ 102(a) as anticipated by Mikhail,1 and claims 1, 2, 4–8, 10–18, and 23–25
`under 35 U.S.C. § 103(a) as obvious over the Januvia Label,2 Huettner,3 and
`Mikhail or the Knowledge of a POSA. Pet. 15–26. Boehringer Ingelheim
`International GmbH (“Patent Owner”) filed a Preliminary Response to the
`Petition. Paper 11 (“Prelim. Resp.”).
`In our Decision on Institution (Paper 17, “Decision” or “Dec.”), we
`determined that Petitioner had established a reasonable likelihood that it
`would prevail in its challenge to claims 1, 2, 4, 5, and 23 as anticipated by
`Mikhail, and instituted trial on that ground. Dec. 8–14. We further
`determined that Petitioner had established a reasonable likelihood that it
`would prevail in its challenge to claims 1, 2, 4, 5, and 23 as obvious over
`Mikhail and instituted trial on that ground as well (relying on the general
`principle that “anticipation is the epitome of obviousness” (In re McDaniel,
`293 F.3d 1379, 1385 (Fed. Cir. 2002))). Dec. 14–21.
`
`
`1 Nasser Mikhail, Incretin mimetics and dipeptidyl peptidase 4 inhibitors in
`clinical trials for the treatment of type 2 diabetes, 17 EXPERT. OPIN.
`INVESTIG. DRUGS 845–53 (2008) (Ex. 1003, “Mikhail”).
`2 JanuviaTM (sitagliptin phosphate tablets) Prescribing Information (2006)
`(Ex. 1006, “the Januvia Label”).
`3 Silke Huettner et al., BI 1356, a Novel and Selective Xanthine Based
`DPP-4 Inhibitor, Demonstrates Good Safety and Tolerability with a Wide
`Therapeutic Window, Poster No. 0586P, ADA (June 22–25, 2007) (Ex.
`1004, “Huettner”).
`
`
`
`2
`
`
`
`IPR2016-01565
`Patent 8,853,156 B2
`
`
`Claims 6–8, 10–18, 24, and 25, however, are narrower than claims 1,
`2, 4, 5, and 23. Pet. 27–30. Because we determined that Petitioner had not
`made a threshold showing that the Januvia Label and Huettner are printed
`publications within the meaning of 35 U.S.C. §§ 102 and 311(b), and
`because Petitioner’s challenge to claims 6–8, 10–18, 24, and 25 relied on the
`Januvia Label and/or Huettner to meet the additional limitations of those
`claims, we declined to institute trial on those claims as obvious over the
`Januvia Label, Huettner, and Mikhail or the Knowledge of a POSA. Dec.
`18–21.
`Petitioner requested rehearing of our decision not to institute trial on
`claims 6–8, 10–18, 24, and 25. Paper 19 (“Rehearing Request” or “Req.
`Reh’g”).
`After considering Petitioner’s Rehearing Request, our Decision, and
`the evidence of record, Petitioner’s request is denied.
`II. ANALYSIS
`A party requesting rehearing bears the burden of showing that the
`decision should be modified. 37 C.F.R. § 42.71(d). The party “must
`specifically identify all matters the party believes the Board misapprehended
`or overlooked, and the place where each matter was previously addressed in
`a motion, an opposition, or a reply.” Id.
`When reconsidering a decision on institution, we review the decision
`for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may
`be determined if a decision is based on an erroneous interpretation of law, if
`a factual finding is not supported by substantial evidence, or if the decision
`represents an unreasonable judgment in weighing relevant factors. Star
`Fruits S.N.C. v. U.S., 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold
`
`
`
`3
`
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`IPR2016-01565
`Patent 8,853,156 B2
`
`Partnership v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside,
`203 F.3d 1305, 1315–16 (Fed. Cir. 2000).
`
`A. The record evidence is insufficient to qualify the Januvia
`Label as a “printed publication” within the meaning of
`§§ 102 and 311(b)
`
`In the Petition, page 1 of Exhibit 1006 was cited as evidence that
`“[t]he Januvia Label published in 2006” and, therefore, is “§ 102 prior art to
`the ’156 patent.” Pet. 19 (citing Ex. 1006, 1). In its Request for Rehearing,
`Petitioner contends that “the Januvia Label is conspicuously dated ‘2006’ in
`at least two places on its face.” Reh’g Req. 2. Petitioner argues that this
`“evidence should [have been] assessed while recognizing that this
`assessment is being done without the benefit of a fully developed record”
`(id. at 1), and should have been “sufficient for institution” (id. at 2). In other
`words, Petitioner argues that we “erred by imposing a greater evidentiary
`burden than required to establish that a reference is a printed publication at
`the institution stage.” Id. at 1.
`We are not persuaded that we erred. The decision whether to institute
`a trial is based on “the information presented in the petition.” 35 U.S.C.
`§ 314(a). Under 35 U.S.C. § 311(b), in an inter partes review, a petitioner
`may only challenge the claims of a patent based on “prior art consisting of
`patents or printed publications,” and the petitioner has the initial burden of
`production to show that an asserted reference is prior art to the challenged
`claims under a relevant subsection of 35 U.S.C. § 102. Dynamic Drinkware,
`LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1379 (Fed. Cir. 2015); Dec. 16.
`As explained in our Decision, we have often required a petitioner to make a
`threshold showing that the reference relied upon was publicly accessible as a
`
`
`
`4
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`IPR2016-01565
`Patent 8,853,156 B2
`
`printed publication prior to the effective filing date of a challenged patent to
`satisfy the initial burden of production. See, e.g., Apple Inc. v. DSS Tech.
`Mgmt., Inc., Case IPR2015-00369, slip op. at 5 (PTAB Aug. 12, 2015)
`(Paper 14) (noting that petitioner has the burden to make a threshold
`showing that a reference is “printed publication” prior art under 35 U.S.C.
`§§ 102 and 311(b)); Frontier Therapeutics, LLC v. Medac Gesellschaft Für
`Klinische Spezialpräparate MBH, Case IPR2016-00649, slip op. at 22
`(PTAB September 1, 2016) (Paper 10). We further explained that “[a] given
`reference is ‘publicly accessible’ ‘upon a satisfactory showing that such
`document has been disseminated or otherwise made available to the extent
`that persons interested and ordinarily skilled in the subject matter or art
`exercising reasonable diligence, can locate it.’” Bruckelmyer v. Ground
`Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006) (citing In re Wyer, 655
`F.2d 221, 226 (CCPA 1981)); Dec. 17.
`In our Decision, we noted that Exhibit 1006 (termed the “Januvia
`Label” by Petitioner) relates to “prescribing information” for Januvia, and
`that page 1 of the exhibit bears two dates: “Initial U.S. Approval . . . 2006”
`and “Revised: 10/2006.” Dec. 15. We explained that we agreed with Patent
`Owner that that neither of these dates is “synonymous with a publication
`date” (Dec. 20; Prelim. Resp. 14), and that Petitioner had “offer[ed] no
`evidence when (or even if) the [Januvia Label] was published and publically
`available” (Prelim. Resp. 13–15; Dec. 19–20). In other words, we agreed
`that Petitioner had provided no evidence that the revised prescribing
`information for Januvia became publicly available simultaneously with FDA
`approval of the revision and, therefore, had failed to make the requisite
`threshold showing that the Januvia Label was publicly accessible at the
`
`
`
`5
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`IPR2016-01565
`Patent 8,853,156 B2
`
`relevant time. Petitioner has not pointed to anything we misapprehended or
`overlooked that would indicate that either of the dates on the face of the
`Januvia Label establishes that the document qualifies as a printed
`publication within the meaning of §§ 102 and 311(b), and we maintain our
`determination here.
`In its Request for Rehearing, Petitioner further contends that we
`overlooked other “indicia of public accessibility, namely a trademark
`(‘JanuviaTM’); product use instructions; FDA phone numbers and a website;
`safety warnings; and Merck’s U.S. and Italian contact addresses,” as well as
`“a prominently dated copyright notice.” Reh’g Req. 9, 10. Petitioner
`acknowledges that it “[did] not specifically call out all of these indicia in its
`Petition,” but contends “such indicia are nonetheless facts relevant to the
`Board’s inquiry and should have been afforded proper evidentiary weight
`given their prominence and import to the issue of public availability.” Id. at
`3.
`
` Again, we are not persuaded. Although Petitioner did not discuss any
`of these indicia in the Petition, we did not “overlook” them—we simply did
`not perceive that they had any bearing on when (or even if) Exhibit 1006
`became publicly accessible as a printed publication. Moreover, we note that
`a copyright date is associated with the creation of a document, but not
`necessarily its publication. See, e.g., 17 U.S.C. §§ 408, 409.
`Accordingly, we are not persuaded that we erred in determining that
`the information presented in the Petition was insufficient to qualify the
`Januvia Label as a “printed publication” within the meaning of §§ 102 and
`311(b).
`
`
`
`6
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`IPR2016-01565
`Patent 8,853,156 B2
`
`
`B. The record evidence is insufficient to qualify Huettner as a
`“printed publication” within the meaning of §§ 102 and 311(b)
`
`In the Petition, relying solely on the document itself, Petitioner
`asserted that “Huettner was published in June 2007 and is § 102(b) prior art
`to the ’156 patent.” Pet. 21 (citing Ex. 1004). In our Decision, we noted
`that “Huettner appears to be a poster (Poster No. 0586P) associated with an
`American Diabetes Association (ADA) meeting held in Chicago, June 22–
`27, 2007.” Dec. 15. Relying on In Re Klopfenstein, 380 F.3d 1345, 1350
`(Fed. Cir. 2004) for factors relevant to determining whether a temporarily
`displayed reference constitutes a “printed publication” under section 102(b),
`we further noted that “the Petition does not include or cite to any
`information related to the display or subsequent publication of the Huettner
`poster.” Dec. 19. Petitioner argues that “there is no requirement for
`Petitioner to establish these factors in order to make a threshold showing at
`the institution stage.” Reh’g Req. 13.
`We are not persuaded that we erred in determining that Petitioner had
`not met its burden of making a threshold showing that Huettner is a “printed
`publication” within the meaning of §§ 102 and 311(b). Again, the decision
`whether to institute a trial is based on “the information presented in the
`petition.” 35 U.S.C. § 314(a). In our Decision, we explained that a
`“determination of whether a reference is a ‘printed publication’ under
`35 U.S.C. § 102(b) involves a case-by-case inquiry into the facts and
`circumstances surrounding the reference’s disclosure to members of the
`public.” Klopfenstein, 380 F.3d at 1350. No such evidence was cited or
`discussed in the Petition.
`
`
`
`7
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`IPR2016-01565
`Patent 8,853,156 B2
`
`
`To the extent Petitioner now argues that “the declaration testimony of
`Dr. Davidson and the facial indicia on Huettner are sufficient” to make a
`threshold showing that Huettner was publically accessible as of the relevant
`date (Reh’g Req. 13), we are not persuaded. We note that Dr. Davidson
`testifies, without elaboration, that “Huettner was published in June 2007.’”
`Ex. 1002 ¶ 56. Petitioner, however, did not rely on Dr. Davidson’s
`testimony on this issue in the Petition. Moreover, even if Dr. Davidson’s
`testimony had been relied on, Petitioner does not point to any evidence—nor
`can we discern any in Dr. Davidson’s Declaration—that would reasonably
`suggest that Dr. Davidson has personal knowledge as to when and how
`Huettner was made available to the public. Accordingly, Dr. Davidson’s
`conclusory declaration of Huettner’s publication date is entitled to little or
`no weight. See Dell, Inc. v. Selene Commc’n Techs., LLC, Case IPR2014-
`01411, slip op. at 22–23 (PTAB Feb. 26, 2015) (Paper 23) (explaining that
`an expert declaration is not enough to prove a prior art reference’s
`publication date where the expert declaration merely repeats assertions made
`by the petitioner).
`For the reasons given above, we are not persuaded that we erred in
`determining that the information presented in the Petition was insufficient to
`qualify Huettner as a “printed publication” within the meaning of §§ 102 and
`311(b).
`
`III. CONCLUSION
`Having reconsidered the information presented in the Petition, our
`Decision on Institution, and Petitioner’s Request for Rehearing, we are not
`persuaded that we erred in declining to institute trial on claims 6–8, 10–18,
`24, and 25. Petitioner, having failed to meet its burden of providing a
`
`
`
`8
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`
`IPR2016-01565
`Patent 8,853,156 B2
`
`threshold showing that the Januvia Label and Huettner are printed
`publications under 35 U.S.C. §§ 102 and 311(b), did not demonstrate a
`reasonable likelihood of prevailing in its assertion that the subject matter of
`claims 6–8, 10–18, 24, and 25 of the ’156 patent would have been obvious
`over the Januvia Label, Huettner, and Mikhail or the Knowledge of one of
`ordinary skill in the art..
`
`IV. ORDER
`
`Accordingly, it is
`ORDERED that Petitioner’s Rehearing Request is denied.
`
`
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`
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`9
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`IPR2016-01565
`Patent 8,853,156 B2
`
`FOR PETITIONER:
`Thomas Parker
`Ellen Cheong
`Charles Naggar
`Chris McArdle
`ALSTON & BIRD LLP
`thomas.parker@alston.com
`ellen.cheong@alston.com
`charles.naggar@alston.com
`chris.mcardle@alston.com
`
`FOR PATENT OWNER:
`Leora Ben-Ami
`Eugene Goryunov
`Mira Mulvaney
`Jeanna Wacker
`KIRKLAND & ELLIS LLP
`leora.benami@kirkland.com
`egoryunov@kirkland.com
`mira.mulvaney@kirkland.com
`jeanna.wacker@kirkland.com
`
`
`
`10
`
`
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