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