`571-272-7822
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`Paper 7
`Entered: February 11, 2019
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`DR. REDDY’S LABORATORIES, INC.,
`Petitioner,
`
`v.
`
`CELGENE CORP.,
`Patent Owner.
`____________
`
`Case IPR2018-01504
`Patent 9,056,120 B2
`____________
`
`
`Before GRACE KARAFFA OBERMANN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`PAULRAJ, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314(a)
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`
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`
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`IPR2018-01504
`Patent 9,056,120 B2
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`
`I.
`
`INTRODUCTION
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`Dr. Reddy’s Laboratories, Inc. (“Petitioner”) filed a Petition (Paper 2,
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`“Pet.”), requesting institution of an inter partes review of claims 1–8, 12–34,
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`and 38–53 of U.S. Patent No. 9,056,120 B2 (Ex. 1001, “the ’120 patent”).
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`Celgene Corp. (“Patent Owner”) timely filed a Preliminary Response (Paper
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`6, “Prelim. Resp.”). We have jurisdiction under 35 U.S.C. § 314, which
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`provides that an inter partes review may not be instituted “unless . . . there is
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`a reasonable likelihood that the petitioner would prevail with respect to at
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`least 1 of the claims challenged in the petition.”
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`Upon consideration of the Petition and the Preliminary Response, and
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`for the reasons explained below, we determine that Petitioner has not
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`demonstrated sufficiently that certain press releases relied upon in its
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`patentability challenges qualify as printed publications. We thus decline to
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`institute an inter partes review of claims 1–8, 12–34, and 38–53 of the ’120
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`patent.
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`A.
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`Related Proceedings
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`“Petitioner is not aware of any reexamination certificates or pending
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`prosecution concerning the ’120 patent” and “is not aware of any prior
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`petitions for inter partes review related to the ’120 patent.” Pet. 55–56.
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`Petitioner is a defendant in the following litigation involving the ’120 patent:
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`Celgene Corp. v. Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s
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`Laboratories, Inc., Case No. 2:17-cv-05314-SDW-LDW (D.N.J.). Id.
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`Additionally, Case IPR2018-01507 (IPR507) and Case IPR2018-
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`01509 (IPR509) involve the same parties but different challenged patents.
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`Concurrently with this decision, the Board issues decisions denying
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`1
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`IPR2018-01504
`Patent 9,056,120 B2
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`institution in IPR507 and IPR509 based on substantially the same analysis
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`set forth in this decision.
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`B.
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`The ’120 Patent (Ex. 1001)
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`The ’120 patent issued on June 16, 2015, and claims priority to
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`Provisional application No. 60/418,468 filed on October 15, 2002. See Ex.
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`1001, Title Page. It names Jerome B. Zeldis as the sole inventor. Id.
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`The ’120 patent discusses methods of treating, preventing and/or
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`managing myelodysplastic syndromes (“MDS”) with a combination therapy
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`using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidin-2,6-dione
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`(lenalidomide) and azacitidine. Id., Title, Abstract. The ’120 patent
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`identifies lenalidomide, also known by its commercial name as Revimid, as
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`an immunomodulatory compound to be used in such treatment methods. Id.
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`at 1:24–30.
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`C.
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`Illustrative Claim
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`Claims 1 and 28 are the only independent claims. Claim 1 is
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`illustrative and reproduced below:
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`1. A method of treating myelodysplastic syndrome, which comprises
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`administering to a patient in need thereof about 1 mg to about 25 mg per day
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`of a compound having the formula:
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`or a pharmaceutically acceptable salt, solvate or stereoisomer thereof.
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`
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`Ex. 1001, 27:26–42.
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`2
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`IPR2018-01504
`Patent 9,056,120 B2
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`D.
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`Asserted Grounds of Unpatentability
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`Petitioner challenges the patentability of the claims of the ’120 patent
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`on the following grounds:
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`Reference(s)
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`Basis
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`Claims Challenged
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`List 2001,1 ’230 patent,2 Celgene
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`§ 103(a) 1–8, 12–34, and 38–53
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`Press Release 5/8/2001,3 and Celgene
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`Press Release 8/28/20014
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`Thomas 2000a,5 ’230 patent, Celgene
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`§ 103(a) 1–8, 12–34, and 38–53
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`Press Release 5/8/2001, and Celgene
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`Press Release 8/28/2001
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`
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`1 Richard J. Klasa, Alan F. List, and Bruce D. Cheson, Rational Approaches
`to Design of Therapeutics Targeting Molecular Markers, HEMATOLOGY 443
`(2001) (Ex. 1004).
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`2 U.S. Patent No. 6,281,230 B1 (Ex. 1006).
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`3 Press Release, Celgene Corp., Positive Interim Results Presented at the
`VIIIth International Myeloma Workshop on Celgene Corporation’s Lead
`IMiD(TM) (REVIMID(TM)) (May 8, 2001) (on file with PR Newswire) (Ex.
`1008).
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`4 Press Release, Celgene Corp., Celgene Corporation Awarded Additional
`Patent Protection For Lead IMiD(TM), REVIMID(TM): Comprehensive
`Patent Protection for REVIMID Includes Coverage of the Active Ingredient,
`Pharmaceutical Compositions, and Therapeutic Uses (Aug. 28, 2001) (on
`file with PR Newswire) (Ex. 1010).
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`5 Deborah A. Thomas, MD and Hagop M. Kantarjian, MD, Current Role of
`Thalidomide in Cancer Treatment, 12 CURRENT OP. IN ONCOLOGY 564
`(2000) (Ex. 1005).
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`3
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`IPR2018-01504
`Patent 9,056,120 B2
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`II. ANALYSIS
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`A. Claim Construction
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`We interpret claims in an unexpired patent using the “broadest
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`reasonable construction in light of the specification of the patent in which
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`[they] appear[].” 37 C.F.R. § 42.100(b) (2016)6. Under that standard, claim
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`terms are given their ordinary and customary meaning in view of the
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`specification, as understood by a person of ordinary skill in the art at the
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`time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257
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`(Fed. Cir. 2007). We resolve disputed claim terms only to the extent
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`necessary to our decision. Nidec Motor Corp. v. Zhongshan Broad Ocean
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`Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only
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`construe terms ‘that are in controversy, and only to the extent necessary to
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`resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g,
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`Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).
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`The Petition does not assert that any claim term requires express
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`construction and states that “one of ordinary skill in the art would
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`understand the claim terms to have their plain and ordinary meanings.” Pet.
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`4. Patent Owner agrees with Petitioner. Prelim. Resp. 32. We determine
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`that no explicit construction of any claim term is necessary to determine
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`whether to institute trial in this case.
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`B.
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`Public Accessibility of Prior Art Relied Upon in Petition
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`Patent Owner contends that Petitioner has failed to establish Celgene
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`6 A recent amendment to this rule does not apply here, because the Petition
`was filed before November 13, 2018. See “Changes to the Claim
`Construction Standard for Interpreting Claims in Trial Proceedings Before
`the Patent Trial and Appeal Board,” 83 Fed. Reg. 51,340 (Oct. 11, 2018) (to
`be codified at 37 C.F.R. pt. 42).
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`4
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`IPR2018-01504
`Patent 9,056,120 B2
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`Press Release 5/8/2001 and Celgene Press Release 8/28/2001 (collectively,
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`“the Celgene Press Releases”) are prior art because Petitioner has not
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`provided evidence that the documents were publicly available. Prelim.
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`Resp. 29–31.
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`“A petitioner in an inter partes review may request to cancel . . .
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`claims of a patent only on a ground that could be raised under section 102 or
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`103 and only on the basis of prior art consisting of patents or printed
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`publications.” 35 U.S.C. § 311(b) (emphasis added). Thus, before
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`considering the merits of Petitioner’s obviousness challenges, we must
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`address whether Petitioner has provided a sufficient threshold showing that
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`the Celgene Press Releases constitute prior art under section 102—a legal
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`question based on underlying factual determinations. Kyocera Wireless
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`Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed. Cir. 2008); Panduit
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`Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1568 (Fed. Cir. 1987).
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`Petitioner has the ultimate burden of persuasion to prove
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`unpatentability by a preponderance of the evidence. Dynamic Drinkware,
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`LLC v. Natl. Graphics, Inc., 800 F.3d 1375, 1378–79 (Fed. Cir. 2015).
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`Petitioner also bears the initial burden of production to establish the
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`existence of prior art that renders the claims unpatentable. Id. To satisfy the
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`initial burden of production, we have often required a petitioner to make a
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`threshold showing in the petition, as a prerequisite to trial institution, that the
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`reference relied upon was publicly accessible as a printed publication prior
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`to the effective filing date of a challenged patent. See, e.g., Frontier
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`Therapeutics, LLC v. Medac Gesellschaft Fur Klinische Spezialpraparate
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`MBH, IPR2016-00649, slip op. at 22 (PTAB Sept. 1, 2016) (Paper 10)
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`(denying trial institution upon finding that petitioner failed to make a
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`IPR2018-01504
`Patent 9,056,120 B2
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`threshold showing that an alleged “printed package insert” was a printed
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`publication); Instradent USA, Inc. v. Nobel Biocare Services AG, IPR2015-
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`01786, slip op. at 16–17 (PTAB Feb. 19, 2016) (Paper 14) (finding that
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`deposition testimony from the challenged patent’s co-inventor stating that
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`hundreds of copies of a catalog may have been printed and distributed to
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`customers was sufficient to make a threshold showing of public
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`accessibility; granting trial institution); Symantec Corp. v. Trs. of Columbia
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`Univ., IPR2015-00371, slip op. at 5–9 (PTAB June 17, 2015) (Paper 13)
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`(denying trial institution upon finding that petitioner failed to make a
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`threshold showing that a thesis was publicly accessible prior to the critical
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`date); Temporal Power, Ltd. v. Beacon Power, LLC, IPR2015-00146, slip
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`op. at 8–11 (PTAB Apr. 27, 2015) (Paper 10) (denying trial institution upon
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`finding that no threshold showing was made that a PowerPoint presentation
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`document was publicly available at a technical conference on the date
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`indicated on the face of the document); Dell, Inc. v. Selene Comm’n Techs.,
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`LLC, IPR2014-01411, slip op. at 21–23 (PTAB Feb. 26, 2015) (Paper 23)
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`(denying trial institution upon finding that no threshold showing was made
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`to establish the prior art status of three asserted references).
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`To qualify as a “printed publication” within the meaning of § 102(b),
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`a reference “must have been sufficiently accessible to the public interested in
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`the art” before the critical date. In re Cronyn, 890 F.2d 1158, 1160 (Fed.
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`Cir. 1989). Whether a reference is publicly accessible is determined on a
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`case-by-case basis based on the “facts and circumstances surrounding the
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`reference’s disclosure to members of the public.” In re Lister, 583 F.3d
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`1307, 1311 (Fed. Cir. 2009) (quoting In re Klopfenstein, 380 F.3d 1345,
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`1350 (Fed. Cir. 2004)). “A reference is considered publicly accessible if it
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`IPR2018-01504
`Patent 9,056,120 B2
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`was ‘disseminated or otherwise made available to the extent that persons
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`interested and ordinarily skilled in the subject matter or art[,] exercising
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`reasonable diligence, can locate it.’” Id. (quoting Kyocera, 545 F.3d at
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`1350).
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`Here, Petitioner asserts, without elaboration, that “Celgene Press
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`Release 8/28/2001 was published more than one year before the priority date
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`of the ’120 patent. Therefore, the Celgene Press Release 8/28/2001 is
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`§ 102(b) prior art.” Pet. 15. Similarly, Petitioner asserts that “Celgene Press
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`Release 5/8/2001 was published more than one year before the priority date
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`of the ’120 patent and is therefore, § 102(b) prior art to the ’120 patent.”
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`Pet. 20. The Petition provides no further details tending to establish the date
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`of public accessibility of the Celgene Press Releases. Petitioner’s expert,
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`Dr. Levin, likewise asserts that “Celgene Press Release 8/28/2001 was
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`published more than one year before the priority date of the ’120 patent.
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`Therefore, the Celgene Press Release 8/28/2001 is § 102(b) prior art.”
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`Declaration of Mark Levin, M.D. ¶ 117 (Ex. 1003, “Levin Decl.”). By way
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`of objective support, however, Dr. Levin explains only that “Celgene Press
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`Release 8/28/2001 also provided a hyperlink to ‘the chemical structure of
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`REVIMID’” but states that “[a]lthough the hyperlinked page is not currently
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`available, my expectation is that as of August 28, 2001 and for some time
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`thereafter, Celgene’s Press Release 8/28/2001 disclosed or provided the
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`chemical structure of Revimid. From that chemical structure, a POSA could
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`also have determined the chemical formula.” Id. ¶ 119.
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`In response, Patent Owner contends that the Celgene Press Releases
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`do not constitute prior art because Petitioner failed to provide evidence of
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`public accessibility and “has not even alleged, let alone established, that a
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`7
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`IPR2018-01504
`Patent 9,056,120 B2
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`POSA would have been aware of these documents, known where or how to
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`access them, been able to access them, or that they would have been in the
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`same form and with the same content shown in Exhibits 1008 and 1010.”
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`Prelim. Resp. 29–30. Patent Owner also responds that Petitioner has not
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`shown that the “alleged ‘hyperlink’ in the document it refers to as ‘Celgene
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`Press Release 8/28/01’ (Pet. at 15–16) was active—either on August 28,
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`2001 or otherwise—or that, even if active, it showed the chemical structure
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`of any compound, let alone the compound now known as lenalidomide.”
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`Id. In support of that assertion, Patent Owner points to Dr. Levin’s
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`declaration and contends that he “acknowledges that ‘the hyperlinked page
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`is not currently available’ and provides no evidence whatsoever of public
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`accessibility other than his unsupported ‘expectation [that] as of August 28,
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`2001 and for some time thereafter,’ this document allegedly disclosed or
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`provided the chemical structure of the compound now known as
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`lenalidomide.” Prelim. Resp. 31.
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`
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`We agree with Patent Owner that Petitioner fails to provide a
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`threshold showing that the Celgene Press Releases constitute printed
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`publications under 35 U.S.C. § 102. As noted by Patent Owner, there is no
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`persuasive objective evidence in this record of when, where, or to whom the
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`Celgene Press Releases were available, or how they were allegedly
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`accessible. Exhibit 1008 bears a date of May 8, 2001 (which does not
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`appear to be a copyright date). Exhibit 1010 bears a date of August 28,
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`2001, and a copyright date of 2001. Those indicia, standing alone, do not
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`satisfy Petitioner’s initial burden of production to make a threshold showing
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`of public availability as of those dates. See Ford Motor Co. v. Versata Dev.
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`Grp., IPR2016-01019, slip op. at 5–6 (PTAB Oct. 4, 2016) (Paper 9)
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`8
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`IPR2018-01504
`Patent 9,056,120 B2
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`(denying trial institution and noting that a “copyright date is not helpful
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`[where] there is no evidence as to whether [the documents in question] were
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`published or made sufficiently accessible to the public interested in the art
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`prior to the critical date.”). Petitioner’s conclusory assertion without
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`evidence of distribution or dissemination is insufficient to establish that a
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`document is a printed publication. See Coal. for Affordable Drugs IV v.
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`Pharmacyclics, Inc., IPR2015-01076, slip op. at 7 (PTAB Oct. 19, 2015)
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`(Paper 33). As Patent Owner points out, Dr. Levin’s “expectation” of public
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`accessibility is entitled to little weight because it is supported by no
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`objective proof of public accessibility. Prelim. Resp. 31; see 37 C.F.R.
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`§ 42.65(a) (opinion testimony that does not disclose underlying facts or data
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`“is entitled to little or no weight”); Ashland Oil, Inc. v. Delta Resins &
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`Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (finding lack of
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`objective factual support for expert opinion “may render the testimony of
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`little probative value in a validity determination”).
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`III. CONCLUSION
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`As we have determined that Petitioner has not established that the
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`Celgene Press Releases were available as prior art printed publications,
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`Petitioner has not shown a reasonable likelihood of prevailing in its
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`unpatentability challenges, which rely upon the Celgene Press Releases.
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`Accordingly, we do not institute an inter partes review of claims 1–8,
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`12–34, and 38–53 of the ’120 patent on the ground of obviousness over List
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`2001, the ’230 patent, and the Celgene Press Releases or on the ground of
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`obviousness over Thomas 2000a, the ’230 patent, and the Celgene Press
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`Releases.
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`9
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`IPR2018-01504
`Patent 9,056,120 B2
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`It is
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`IV. ORDER
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`
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`ORDERED that under 35 U.S.C. § 314(a), the petition is denied and
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`no inter partes review is instituted.
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`10
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`IPR2018-01504
`Patent 9,056,120 B2
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`PETITIONER:
`
`Brandon White
`bmwhite@perkinscoie.com
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`Crystal Canterbury
`ccanterbury@perkinscoie.com
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`PATENT OWNER:
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`Christopher Harnett
`charnett@jonesday.com
`
`Anthony Insogna
`aminsogna@jonesday.com
`
`John Elsevier
`pelsevier@celgene.com
`
`Francis Cerrito
`nickcerrito@quinnemanuel.com
`
`Elizabeth Miller
`cmiller@jonesday.com
`
`Frank Calvosa
`frankcalvosa@quinnemanuel.com
`
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`11
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