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` Paper 17
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` Entered: February 9, 2017
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`Trials@uspto.gov
`571-272-7822
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACUTICALS 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 ZHENHU YANG,
`Administrative Patent Judges.
`
`SCHEINER, Administrative Patent Judge.
`
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`
`
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`Patent 8,853,156 B2
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`I. INTRODUCTION
`Mylan Pharmaceuticals Inc. (“Petitioner” or “Mylan”) filed a Petition
`(Paper 2, “Pet.”) 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”). Boehringer Ingelheim International GmbH (“Patent Owner” or
`“Boehringer”) filed a Preliminary Response to the Petition (Paper 11,
`“Prelim. Resp.”). We have statutory authority under 35 U.S.C. § 314, which
`provides that an inter partes review may not be instituted “unless . . . there is
`a reasonable likelihood that the petitioner would prevail with respect to at
`least 1 of the claims challenged in the petition.”
`Upon consideration of the arguments and evidence presented in the
`Petition and the Preliminary Response, we are persuaded that Petitioner has
`established a reasonable likelihood that it would prevail in its challenge to
`claims 1, 2, 4, 5, and 23 of the ’156 patent. Accordingly, we institute an
`inter partes review of claims 1, 2, 4, 5, and 23.
`
`A. Related Proceedings
`The ’156 patent has been asserted in Boehringer Ingelheim Pharm.
`
`Inc. v. Mylan Pharmaceuticals, Case No. 1:15-cv-00145-JPB (N.D.W.Va.)
`(inactive), and Boehringer Ingelheim Pharm. Inc. v. HEC Pharm Group,
`Case No. 3:15-cv-05982 (D.N.J.) (consolidated). Pet. 3; Paper 7, 3.
`
`U.S. Patent Nos. 8,673,927, 8,846,695, and 9,173,859 also have been
`asserted in the consolidated litigation, and Petitioner has filed IPR2016-
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`2
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`IPR2016-01565
`Patent 8,853,156 B2
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`01563, IPR2016-01564, and IPR2016-1566, requesting inter partes review
`of those patents, respectively. Pet. 3.
`
` B. The Asserted Grounds of Unpatentability
`Petitioner asserts that the challenged claims are unpatentable on the
`
`following grounds:
`
`References
`
`Basis
`
`Claims Challenged
`
`Mikhail1
`The Januvia Label,2
`Huettner,3 and Mikhail or the
`Knowledge of a POSA
`
`§ 102(a) 1, 2, 4, 5, and 23
`§ 103(a) 1, 2, 4–8, 10–18, and
`23–25
`
`
`
`Petitioner supports its challenges with the Declaration of Mayer B.
`Davidson, M.D, dated August 10, 2016 (Ex. 1002, “Davidson Declaration”).
`
`
`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 845–853 (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”).
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`C. The ’156 Patent (Ex. 1001)
`
`The ’156 patent, titled “Treatment for Diabetes in Patients
`Inappropriate for Metformin Therapy,” issued October 7, 2014, names
`inventors Klaus Dugi, Eva Ulrike Graefe-Mody, Ruth Harper, and Hans-
`Juergen Woerle. Ex. 1001 (54), (75).
`“One of the typical long-term complications of diabetes is diabetic
`neuropathy,” which can lead to renal impairment, and “can progress to renal
`failure in some cases.” Id. at 1:17–25. The ’156 patent teaches that
`“[m]etformin is an antihyperglycemic agent which improves glucose
`tolerance in patients with type 2 diabetes mellitus,” but “treatment with
`metformin can be associated with adverse symptoms, such as e.g.
`gastrointestinal symptoms or, occasionally, as a severe adverse effect, lactic
`acidosis (which can be fatal), for which one putative risk factor is decreased
`renal function.” Id. at 1:51–62. “Further, since metformin is largely
`eliminated unchanged by the kidneys via glomerular filtration and tubular
`secretion, it is contraindicated in patients with renal disease or kidney
`impairment.” Id. at 1:62–65. “Thus, conventional metformin therapy can be
`inappropriate for certain patients, e.g. due to intolerability or
`contraindication against metformin.” Id. at 1:65–67.
`The ’156 patent discloses another class of drugs, DPP-IV inhibitors,
`which “are considered to be promising drugs for the treatment of diabetes
`mellitus.” Ex. 1001, 4:12–13. DPP-IV inhibitors act through a different
`mechanism than metformin. Ex. 1002 ¶ 29. A highly simplified explanation
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`of the mechanism is as follows: the enzyme DPP-IV (dipeptidyl peptidase
`IV) breaks down certain bioactive peptides, including glucagon-like peptide
`(GLP-1) (Ex. 1001, 4:6–11), a naturally occurring peptide “that helps reduce
`blood glucose by stimulating the pancreas to produce insulin and by
`inhibiting the release of glucagon, a substance that causes the liver to release
`glucose” (Ex. 1002 ¶ 29), but DPP-IV inhibitors block the activity of the
`DPP-IV enzyme, thereby preventing the breakdown of GLP-1 and helping to
`lower blood glucose levels (id.).
`The ’156 patent discloses a number of DPP-IV inhibitors (Ex. 1001,
`16:35–19:28), including a particularly preferred species, 1-[(4 -methyl-
`quinazolin-2 -yl)methyl]-3-methy1-7-(2-butyn-1-y1)-8-(3-(R)-amino-
`piperidin-l-y1)-xanthine—also known as “BI 1356” or “linagliptin” (Ex.
`1001, 16:39–40; Ex. 1002 ¶ 17). According to the ’156 patent, DPP-IV
`inhibitors are “particularly suitable for treating and/or preventing (including
`preventing or slowing the progression) of metabolic diseases, particularly
`diabetes (especially type 2 diabetes mellitus) and conditions related thereto
`(e.g. diabetic complications), particularly in patients for whom metformin
`therapy is inappropriate due to intolerability or contraindication against
`metformin.” Ex. 1001, 9:33–39. Such patients include those ineligible for
`metformin therapy due to renal disease, renal impairment or renal
`dysfunction, unstable or acute congestive heart failure, acute or chronic
`metabolic acidosis, or hereditary galactose intolerance. Id. at 27:51–60.
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`D. Illustrative Claim
`Petitioner challenges claims 1, 2, 4–8, 10–18, and 23–25 of the ’156
`patent, of which claims 1 and 23–25 are independent claims. Claim 1,
`reproduced below, is illustrative.
`1. A method of treating and/or preventing metabolic diseases
`in a patient for whom metformin therapy is inappropriate
`due to at least one contraindication against metformin
`comprising orally administering to the patient a DPP-IV
`inhibitor wherein the contraindication is selected from the
`group consisting of:
`renal disease, renal impairment or renal dysfunction,
`unstable or acute congestive heart failure, acute or
`chronic metabolic acidosis, and hereditary galactose
`intolerance.
`Ex. 1001, 29:1–11.
`E. Patent Owner’s Motion to Seal & Proposed
`Protective Order
`Patent Owner filed a Motion to Seal (Paper 10), seeking authorization
`to file “confidential versions of Exhibits 2010, 2011, 2012, 2013, 2014, and
`2015 under seal, pursuant to 37 C.F.R. § 42.54” (id. at 2).
`Patent Owner asserts that Exhibits 2010–2015 are copies of internal
`Boehringer clinical development plans, management summaries, nonclinical
`and clinical study reports, and industry communications strategy documents,
`containing confidential and commercially sensitive technical and business
`information. Id. Patent Owner contends that public disclosure of this
`information would significantly harm Boehringer’s competitive position
`because it would allow competitors to access sensitive technical and
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`business information related to, among other things, Boehringer’s drug-
`development and marketing strategy. Id. “To the best of Boehringer’s
`knowledge, none of the confidential, proprietary information in Exhibits
`2010-2015 has previously been made publicly available and Boehringer has
`taken reasonable steps to prevent the public disclosure of this information.”
`Id.
`
`Patent Owner indicates that the parties have met and conferred and
`have agreed that the Board’s Default Protective Order (attached to the
`Motion to Seal as Appendix A) shall govern Exhibits 2010–2015, to the
`extent they are found to contain confidential information. Id. at 2–3.
`At this stage of the proceeding, we have not found it necessary to
`discuss explicitly Patent Owner’s confidential information, but we remind
`Patent Owner that there is an expectation that confidential information
`subject to a protective order will be made public should the need to refer to it
`arise. Although we reserve ruling on the Motion to Seal and entry of the
`Default Protective Order, Exhibits 2010–2015 will remain under seal in the
`interim.
`
`II. ANALYSIS
`
`A. Claim Construction
`In an inter partes review, claim terms in an unexpired patent are given
`their broadest reasonable interpretation in light of the specification of the
`patent in which they appear. 37 C.F.R. § 42.100(b). Under this standard, we
`presume that a claim term carries its “ordinary and customary meaning,”
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`which “is the meaning the term would have to a person of ordinary skill in
`the art in question” at the time of the invention. In re Translogic Tech., Inc.,
`504 F.3d 1249, 1257 (Fed. Cir. 2007); see also Trivascular, Inc. v. Samuels,
`812 F.3d 1056, 1062 (Fed. Cir. 2016) (“Under a broadest reasonable
`interpretation, words of the claim must be given their plain meaning, unless
`such meaning is inconsistent with the specification and prosecution
`history.”).
`Petitioner “believes that no terms or phrases require specific
`construction for purposes of this IPR.” Pet 6. Patent Owner does not
`address claim construction in its Preliminary Response. We determine that
`no claim term requires express construction for purposes of deciding
`whether to institute a review in this case. See, e.g., Wellman, Inc. v.
`Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms
`need only be construed ‘to the extent necessary to resolve the
`controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200
`F.3d 795, 803 (Fed. Cir. 1999)).
`
`B. Asserted Anticipation of Claims 1, 2, 4, 5, and 23
`by Mikhail
`Petitioner asserts that Mikhail discloses all the limitations of claims 1,
`
`2, 4, 5, and 23, and therefore, anticipates those claims. Pet. 17–19. Patent
`Owner opposes, contending that Mikhail “is not prior art to the ’156 patent.”
`Prelim. Resp. 2, 9–11.
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`1. Overview of Mikhail (Ex. 1003)
`Mikhail discusses the results of clinical trials evaluating the efficacy
`of the DPP-4 inhibitors, sitagliptin and vildagliptin, orally administered to
`patients with type 2 diabetes mellitus. Ex. 1003, 847. Mikhail concludes
`that both DPP-4 inhibitors are useful as “add-on agent[s] to ongoing
`metformin therapy,” and as monotherapy agents in patients unable to tolerate
`metformin. Id. at 845, 847. In addition, Mikhail concludes that sitagliptin,
`in particular, can be used as monotherapy in “[p]atients who cannot take
`metformin due to . . . renal insufficiency.” Id. at 850, Table 1, 851.
`
`2. Analysis
`Petitioner, relying on the testimony of Dr. Davidson, contends that
`Mikhail discloses all the limitations of independent claims 1 and 23, as well
`as the limitations of dependent claims 2, 4, and 5. Pet. 17–19. In particular,
`Petitioner contends that “Mikhail discloses the use of DPP-IV Inhibitors,
`specifically sitagliptin and vildagliptin, through a single oral dose, for the
`treatment of type II diabetes,” a metabolic disorder, and “discloses that oral
`doses of sitagliptin should be used as monotherapy for ‘patients who cannot
`take metformin due to adverse effects or renal insufficiency.’” Pet. 17–18
`(citing Ex. 1003, 845, 847, 851; Ex. 1002 ¶¶ 40, 43, 47).
`Patent Owner does not address Mikhail’s disclosure at this stage of
`the proceeding. Nevertheless, we have reviewed the disclosures of Mikhail
`relied on by Petitioner, and are satisfied that Petitioner shows sufficiently
`that Mikhail discloses all the elements of claims 1, 2, 4, 5, and 23, in the
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`manner required by the claims. In particular, Mikhail discloses that
`sitagliptin, a DPP-IV inhibitor, can be used to treat type 2 diabetes in
`“patients who cannot take metformin due to adverse effects or renal
`insufficiency.” Ex. 1003, 847, 851. This disclosure appears to meet the
`limitations of claims 1 and 2, directed to treating or preventing metabolic
`diseases by orally administering a DPP-IV inhibitor to a patient for whom
`metformin therapy is contraindicated, wherein contraindications include
`renal disease, impairment or dysfunction, congestive heart failure, etc. This
`same disclosure also appears to meet the limitations of claims 4 and 5, which
`each depend from claim 1, and respectively specify that the metabolic
`disease is type 2 diabetes mellitus, and the contraindication is renal disease,
`impairment, or dysfunction. Finally, this same disclosure also appears to
`meet the limitations of claim 23, directed to treating or preventing type 2
`diabetes mellitus by orally administering a DPP-IV inhibitor to a patient for
`whom metformin therapy is contraindicated, wherein contraindications
`include renal disease, impairment or dysfunction, congestive heart failure,
`etc.
`
`As indicated above, Patent Owner does not address Mikhail’s
`disclosure at this stage of the proceeding. However, Patent Owner contends
`that Mikhail, published in June 2008, is not prior art because “the inventions
`of the ’156 patent were conceived and reduced to practice no later than
`August 7, 2007.” Prelim. Resp. 2.
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`“In an inter partes review, the burden of persuasion is on the
`petitioner to prove ‘unpatentability by a preponderance of the evidence’”
`“and that burden never shifts to the patentee.” Dynamic Drinkware, LLC v.
`Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015). Petitioner also
`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. Id. at 1379. Once Petitioner has met that initial burden, however, the
`burden of production shifts to Patent Owner. That shifting burden “may
`entail ‘producing additional evidence and presenting persuasive argument
`based on new evidence and evidence already of record.’” Id. (quoting Tech.
`Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1327 (Fed. Cir. 2008).
`
`A threshold issue, then, is whether Petitioner has met its initial burden
`of showing that Mikhail is prior art to the ’156 patent. The parties agree that
`Mikhail has a publication date in June, 2008. Pet. 15; Prelim. Resp. 2.
`According to the face of the ’156 patent, however, the earliest possible
`effective filing date of the patent is August 6, 2008, the filing date of
`Provisional Application No. 61/086,620. Ex. 1001 (60). On this record, we
`determine that Petitioner has satisfied its initial burden of going forward
`with evidence that Mikhail is prior art to the ’156 patent, at least under 35
`U.S.C. § 102(a). Therefore, the burden of producing evidence and/or
`argument in rebuttal shifts to Patent Owner.
`As discussed above, Patent Owner contends that the subject matter of
`the challenged claims was conceived and reduced to practice by the
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`inventors of the ’156 patent prior to August 7, 2007. To remove Mikhail as
`a prior art reference, Patent Owner must produce evidence showing either
`(1) conception and reduction to practice before Mikhail’s publication date;
`or (2) conception before Mikhail’s publication date combined with
`reasonably continuous diligence up to reduction to practice after that date.
`See Taurus IP, LLC v. DaimlerChrysler Corp., 726 F.3d 1306, 1323 (Fed.
`Cir. 2013).
`“Priority of invention and its constituent issues of conception and
`reduction to practice are questions of law predicated on subsidiary factual
`findings.” Singh v. Brake, 317 F.3d 1334, 1340 (Fed. Cir. 2003).
`“[C]onception must encompass all limitations of the claimed invention . . .
`and ‘is complete only when the idea is so clearly defined in the inventor's
`mind that only ordinary skill would be necessary to reduce the invention to
`practice, without extensive research or experimentation.’” Id. at 1340
`(quoting Burroughs Wellcome Co. v. Barr Labs. Inc., 40 F.3d 1223, 1228
`(Fed. Cir. 1994)). To establish an actual reduction to practice, the inventor
`must prove that: (1) an embodiment of the invention was constructed that
`meets all the limitations of the claims at issue; and (2) the inventor
`appreciated that the invention would work for its intended purpose. Cooper
`v. Goldfarb, 154 F.3d 1321, 1327 (Fed. Cir. 1998).
`In addition, a showing of prior invention requires corroboration.
`This court has developed a rule requiring corroboration where a
`party seeks to show conception through the oral testimony of an
`inventor. Price, 988 F.2d at 1195. This requirement arose out
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`of a concern that inventors testifying in patent infringement cases
`would be tempted to remember facts favorable to their case by
`the lure of protecting their patent or defeating another’s patent.
`
`Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1577 (Fed. Cir. 1996); see also
`Brown v. Barbacid, 436 F.3d 1376, 1380 (Fed. Cir. 2006) (addressing
`conception, reduction to practice, and reasonable diligence in an interference
`case (citing Price v. Symsek, 988 F.2d 1187, 1196 (Fed. Cir. 1993)).
`“Sufficiency of corroboration is determined by using a ‘rule of reason’
`analysis, under which all pertinent evidence is examined when determining
`the credibility of an inventor’s testimony.” Medichem, S.A. v. Rolabo, S.L.,
`437 F.3d 1157, 1170 (Fed. Cir. 2006) (citation omitted). Corroboration may
`be testimony of a witness, other than the inventor, to the actual reduction to
`practice, or it may consist of evidence of surrounding facts and
`circumstances independent of information received from the inventor. Id.
`At this early stage of the proceeding, Patent Owner’s evidence in
`support of its contention consists of confidential internal documents
`detailing clinical development plans, management summaries, nonclinical
`and clinical study reports, and industry communications strategy documents.
`Prelim. Resp. 9–11 (citing Exs. 2010–2015). This evidence has neither been
`developed nor tested on this record. Merely by way of example, the
`evidence cited has not been shown persuasively to reflect the work of the
`named inventors of the ’156 patent. On this record, we conclude that Patent
`Owner’s evidence of prior invention is not sufficient to establish conception
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`and reduction to practice prior to Mikhail, nor to remove Mikhail as a prior
`art reference.
`Moreover, this avenue is unavailable to antedate a reference that
`qualifies under 35 U.S.C. § 102(b)—i.e., a reference that constitutes a
`statutory bar—thus, Patent Owner must show that the ’156 patent is entitled
`to the benefit of its Provisional Application No. 61/086,620 (filed August 6,
`2008) or Provisional Application No. 61/105,915 (filed October 16, 2008).
`Finally, as discussed above, on this record, we are satisfied that
`Petitioner has shown sufficiently that Mikhail discloses all the elements of
`claims 1, 2, 4, 5, and 23, in the manner required by the claims.
`Accordingly, we determine that Petitioner has established a
`reasonable likelihood of prevailing in its assertion that claims 1, 2, 4, 5, and
`23 are anticipated by Mikhail.
`
`C. Asserted Obviousness of claims 1, 2, 4–8, 10–18, and 23–25
`over the Januvia Label, Huettner, and Mikhail
`
`Petitioner asserts that claims 1, 2, 4–8, 10–18, and 23–25 would have
`
`been obvious over the Januvia Label and Huettner together with either
`Mikhail or the knowledge of a person of ordinary skill in the art. Pet. 19–31.
`Patent Owner opposes, contending that Petitioner “has not shown that the
`Januvia Label and Huettner are ‘printed publications’” within the meaning
`of 35 U.S.C. § 311(b). Prelim. Resp. 11.
`
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`1. The Januvia Label (Ex. 1006)
`The Januvia Label provides “Highlights of Prescribing Information”
`
`for JanuviaTM (sitagliptin phosphate) tablets. Ex. 1006, 1. According to the
`Januvia Label, sitagliptin “is indicated as an adjunct for diet and exercise to
`improve glycemic control in patients with type 2 diabetes mellitus” at a dose
`of 100 mg once daily, when used as monotherapy. Id. The Januvia label
`provides dosage adjustments (downward) for patients with moderate, severe,
`and end stage renal disease. Id. The Januvia label also states that “[t]hese
`highlights do not include all the information needed to use Januvia safely
`and effectively.” Id. The Januvia Label indicates an “Initial U.S. Approval”
`date of 2006, and also indicates it was “Revised: 10/2006.” Id.
`
`2. Huettner (Ex. 1004)
`Huettner describes BI 1356, i.e., linagliptin, as “a xanthine analogue,
`which exhibits a high potency for DPP-4 inhibition, increases the half-life of
`circulating incretin hormones, and improves glucose homeostasis in
`preclinical studies.” Ex. 1004, 1. Huettner reports the results of a
`randomized, double-blind, placebo controlled single rising dose study in
`healthy male volunteers, and concludes, among other things, that “[r]enal
`excretion was low and does not constitute the main pathway for elimination
`of BI 1356.” Id. Huettner appears to be a poster (Poster No. 0586P)
`associated with an American Diabetes Association (ADA) meeting held in
`Chicago, June 22–27, 2007.
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`3. Analysis of the Januvia Label and the Huettner Poster
`as Printed Publications
`35 U.S.C. § 311(b) states that “a petitioner in an inter partes review
`may request to cancel . . . claims of a patent only on a ground that could be
`raised under section 102 or 103 and only on the basis of prior art consisting
`of patents or printed publications.” Thus, before considering Petitioner’s
`obviousness challenge, we must address whether Petitioner has provided a
`sufficient threshold showing that the Januvia Label and Huettner constitute
`prior art under section 102—a legal question based on underlying factual
`determinations. Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1568
`(Fed. Cir. 1987); Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d
`1340, 1350 (Fed. Cir. 2008).
`Petitioner has the ultimate burden of persuasion to prove
`unpatentability by a preponderance of the evidence. Dynamic Drinkware,
`800 F.3d at 1378–79. Petitioner also bears the initial burden of production
`to establish the existence of prior art that renders the claims unpatentable.
`Id. To satisfy the initial burden of production, we have often required a
`petitioner to make a threshold showing that the reference relied upon was
`publicly accessible as a printed publication prior to the effective filing date
`of a challenged patent. See, e.g., Frontier Therapeutics, LLC v. Medac
`Gesellschaft Fur Klinische Spezialpraparate MBH, Case IPR2016-00649,
`slip op. at 22 (PTAB September 1, 2016) (Paper 10) (finding that an alleged
`“printed package insert” was not a printed publication); Symantec Corp. v.
`Trs. of Columbia Univ., Case IPR2015-00371, slip op. at 5–9 (PTAB June
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`17, 2015) (Paper 13); Temporal Power, Ltd. v. Beacon Power, LLC, Case
`IPR2015-00146, slip op. at 8–11 (PTAB Apr. 27, 2015) (Paper 10); Dell,
`Inc. v. Selene Comm’n Techs., LLC, Case IPR2014-01411, slip op. at 21–22
`(PTAB Feb. 26, 2015) (Paper 23). “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)); see also Voter Verified, Inc. v. Premier Election Solutions,
`Inc., 698 F.3d 1374, 1380 (Fed. Cir. 2012).
`A party seeking to introduce a reference “should produce sufficient
`proof of its dissemination or that it has otherwise been available and
`accessible to persons concerned with the art to which the document relates
`and thus most likely to avail themselves of its contents.” Wyer, 655 F.2d at
`227 (quoting Philips Elec. & Pharm. Indus. Corp. v. Thermal & Elecs.
`Indus., Inc., 450 F.2d 1164, 1171 (3d Cir. 1971)). As explained by the
`Federal Circuit, 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.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir.
`2004).
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`Petitioner, relying on the cover page of the Januvia Label, asserts that
`“[t]he Januvia Label published in 2006” and therefore, is “§ 102 prior art to
`the ’156 patent.” Pet. 19 (citing Ex. 1006, 1). Similarly, relying on the
`document itself, Petitioner asserts that “Huettner was published in June 2007
`and is § 102(b) prior art to the ’156 patent.” Pet. 21 (citing Ex. 1004).4
`Patent Owner contends that Petitioner has not shown that either of
`these documents was publically accessible before the priority date of the
`’156 patent. Prelim. Resp. 11.
`Specifically, Patent Owner contends that Petitioner “offers no
`evidence when (or even if) the [Januvia Label] was published and publically
`available,” but simply relies on “conclusory assertions.” Id. at 13. Patent
`Owner contends that:
`The document, on its face, is labeled “Highlights of Prescribing
`Information” but contains no source-identifying information.
`Indeed, the front page notes that “[t]hese highlights do not
`include all the information needed to use JANUVIA safely and
`effectively” and direct the reader to “[s]ee full prescribing
`information.” . . . Moreover, [the Januvia Label] contains no
`information identifying when it became publically available.
`Even assuming the document to be the label that the FDA
`approved for JANUVIA in 2006, Mylan has provided no
`evidence that it became publically available at the same time as
`approval. The only date on the document appears on the first
`
`
`4 Although not relied on in the Petition, we note that Dr. Davidson also
`states, without further elaboration, that “[t]he Januvia Label published in
`2006,” and “Huettner was published in June 2007).” Ex. 1002 ¶¶ 52, 56.
`
`
`18
`
`
`
`
`IPR2016-01565
`Patent 8,853,156 B2
`
`
`page, noting that it was “Revised: 10/2006.” . . . By its plain
`terms, the 10/2006 date only indicates when the document was
`revised, and has no bearing on whether and when it became
`publically available.
`Prelim. Resp. 14–15.
`
`In addition, Patent Owner contends that Huettner “is a poster that was
`allegedly displayed at the June 22–26 2007 American Diabetes Association
`annual meeting.” Id. at 18. Citing 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),
`Patent owner contends that:
`[Petitioner] has not presented any evidence suggesting that the
`poster was in fact displayed or, if it was indeed displayed, (i) the
`length of time the display was exhibited; (ii) the expertise of the
`target audience; (iii) the existence of reasonable expectations that
`the material displayed would not be copied; and (iv) the
`simplicity or ease with which the material displayed could have
`been copied. . . . Neither has Mylan provided allegations or
`evidence regarding if and when Huettner was published aside
`from being displayed at the ADA meeting.
`Prelim. Resp. 18.
`We agree with Patent Owner that Petitioner fails to provide a
`threshold showing that the Januvia Label and the Huettner poster constitute
`“printed publications” under 35 U.S.C. §§ 102 and 311(b). The above-
`quoted contentions constitute Petitioner’s entire argument that these
`documents qualify as prior art. Pet. 19 (citing Ex. 1006, 1), 21 (citing Ex.
`1004). The Petition does not include or cite to any information related to
`
`19
`
`
`
`
`IPR2016-01565
`Patent 8,853,156 B2
`
`whether the Januvia label was publically accessible in the relevant time
`frame, how one might have obtained a copy of it, or whether it was
`reasonably accessible through generally available means. But as the Board
`recognized in Frontier Therapeutics, a date merely printed on a reference is
`not synonymous with a publication date. IPR2016-00649, Paper 10 at 22.
`Similarly, the Petition does not include or cite to any information related to
`the display or subsequent publication of the Huettner poster.
`Without more, Petitioner’s contentions do not rise to the level of
`“threshold evidence” that the Januvia Label or the Huettner poster qualify as
`“printed publication” prior art, and we determine Petitioner has not satisfied
`its initial burden of production to show that either document is available as a
`prior art printed publication.
`Claims 1, 2, 4, 5, and 23
`In challenging claims 1, 2, 4, 5, and 23 as obvious, Petitioner relies on
`the combined teachings of the Januvia Label and Mikhail, or the Januvia
`Label and the knowledge of one of ordinary skill in the art. Petitioner,
`however, has not established that the Januvia Label is available as a prior art
`printed publication.
`Nevertheless, as discussed above in Section II.B.2, we are satisfied
`that Petitioner has shown sufficiently that Mikhail discloses all the elements
`of claims 1, 2, 4, 5, and 23, in the manner required by the claims.
` Inasmuch as “anticipation is the epitome of obviousness” (In re
`McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002)), we determine that
`
`20
`
`
`
`
`IPR2016-01565
`Patent 8,853,156 B2
`
`Petitioner has established a reasonable likelihood of prevailing in its
`assertion that claims 1, 2, 4, 5, and 23 would have been obvious over
`Mikhail alone.
`
`Claims 6–8, 10–18, 24, and 25
`Petitioner’s challenge to these claims relies heavily on the Januvia
`Label and/or the Huettner poster. Pet. 25–43. As we have determined that
`Petitioner has not established that either the Januvia Label or the Huettner
`poster is available as a prior art printed publication, Petitioner has not shown
`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.
`Accordingly, we do not institute an inter partes review of claims 6–8,
`10, 18, 24, and 25 of the ’156 patent.
`
`III. CONCLUSION
`For the foregoing reasons, on this record, we are persuaded that the
`Petition establishes a reasonable likelihood that Petitioner would prevail in
`showing that claims 1, 2, 4, 5, and 23 of the ’156 patent are unpatentable.
`We emphasize that at this stage of the proceeding, we have not made a
`final determination as to the patentability of the instituted claims. Our final
`decision will be based on the full record developed during trial.
`
`
`
`21
`
`
`
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`IPR2016-01565
`Patent 8,853,156 B2
`
`
`IV. ORDER
`
`Accordingly, it is
`ORDERED that that pursuant to 35 U.S.C. § 314 an inter partes
`review of claims 1, 2, 4, 5, and 23 of U.S. Patent No. 8,853,156 B2 is hereby
`instituted on the following grounds:
`Claims 1, 2, 4, 5, and 23 under 35 U.S.C. § 102
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