Trials@uspto.gov
`571.272.7822
`
`
`
`
`
` Paper No. 33
`
` Entered: October 19, 2015
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COALITION FOR AFFORDABLE DRUGS IV LLC,
`Petitioner,
`
`v.
`
`PHARMACYCLICS, INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01076
`Patent 8,754,090 B2
`____________
`
`
`
`Before GRACE KARAFFA OBERMANN, SUSAN L. C. MITCHELL, and
`TINA E. HULSE, Administrative Patent Judges.
`
`
`
`HULSE, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review;
`Dismissing Pending Motions as Moot
`37 C.F.R. § 42.108; 37 C.F.R. § 42.12; 37 C.F.R. § 42.104(c)
`
`
`
`
`
`
`
`571.272.7822
`
`
`
`
`
` Paper No. 33
`
` Entered: October 19, 2015
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`COALITION FOR AFFORDABLE DRUGS IV LLC,
`Petitioner,
`
`v.
`
`PHARMACYCLICS, INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01076
`Patent 8,754,090 B2
`____________
`
`
`
`Before GRACE KARAFFA OBERMANN, SUSAN L. C. MITCHELL, and
`TINA E. HULSE, Administrative Patent Judges.
`
`
`
`HULSE, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review;
`Dismissing Pending Motions as Moot
`37 C.F.R. § 42.108; 37 C.F.R. § 42.12; 37 C.F.R. § 42.104(c)
`
`
`
`
`
`
`
`
`IPR2015-01076
`Patent 8,754,090 B2
`
`
`
`INTRODUCTION
`I.
`Coalition for Affordable Drugs IV LLC (“Petitioner”) filed a Petition
`requesting an inter partes review of claims 1 and 2 of U.S. Patent No.
`8,754,090 B2 (Ex. 1001, “the ’090 patent”). Paper 1 (“Pet.”).
`Pharmacyclics, Inc. (“Patent Owner”) filed a Preliminary Response to the
`Petition. Paper 19 (“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.” 35 U.S.C. § 314(a). Upon considering
`the Petition and Preliminary Response, we determine that Petitioner has not
`established a reasonable likelihood that it would prevail in showing the
`unpatentability of claims 1 and 2. Accordingly, we decline to institute an
`inter partes review of those claims.
`A.
`Related Proceedings
`Petitioner states that it is not aware of any matters related to this
`proceeding. Pet. 4.
`
`The ’090 Patent
`B.
`Bruton’s tyrosine kinase (“Btk”) is a signaling enzyme expressed in
`all hematopoietic cell types except T lymphocytes and natural killer cells.
`Ex. 1001, 1:28–31. Btk plays an essential role in the B-cell signaling
`pathway, linking B-cell receptor stimulation to downstream intracellular
`responses. Id. at 1:31–33. Btk is also a key regulator of B-cell
`development, activation, signaling, and survival. Id. at 1:34–35. According
`to the Specification, “[t]here is currently a need for methods of treating
`(including, diagnosing) hematological malignancies, including relapsed and
`
`2
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`
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`IPR2015-01076
`Patent 8,754,090 B2
`refractory B cell malignancies.” Id. at 10:59–61. As such, the ’090 patent
`relates to methods of treating a hematological malignancy by administering
`a Btk inhibitor to a patient. Id. at 1:53–55.
`C.
`Challenged Claims
`Petitioner challenges claims 1 and 2 of the ’090 patent. The
`claims are reproduced below:
`1. A method for treating mantle cell lymphoma in an
`individual who has already received at least one prior therapy
`for mantle cell lymphoma comprising administering to the
`individual once per day between about 420 mg to about 840 mg
`of an oral dose of an inhibitor of Bruton’s tyrosine kinase (Btk)
`having the structure:
`
`
`2. The method of claim 1, wherein the once per day oral
`dose is about 560 mg.
`
`
`
`3
`
`
`
`IPR2015-01076
`Patent 8,754,090 B2
`The Asserted Grounds of Unpatentability
`D.
`Petitioner challenges the patentability of claims 1and 2 of the ’090
`patent on the following grounds:
`Reference(s)
`NCT008496541
`
`Claims challenged
`1 and 2
`
`Basis
`§ 102(b)
`
`NCT00849654, the ’582
`publication,2 and the 2009
`Press Release3
`
`
`
`§ 103
`
`1 and 2
`
`
`ANALYSIS
`II.
` Whether NCT00849654 Is a Prior Art Printed Publication
`A.
`Petitioner argues claims 1 and 2 of the ’090 patent are unpatentable as
`anticipated or obvious, relying on NCT00849654 for both asserted grounds.
`Pet. 7–8. According to Petitioner, NCT00849654 is a published clinical trial
`document that provides the details of Patent Owner’s Phase I clinical study
`with Btk inhibitor “PCI-32675.” Id. at 19. More specifically, we note that
`NCT00849654 appears to be a copy of a webpage from the website
`www.clinicaltrials.gov.
`
`1 Copy of webpage from www.clinicaltrials.gov regarding the “Study of the
`Safety and Tolerability of PCI-32765 in Patients With Recurrent B Cell
`Lymphoma,” ClinicalTrials Identifier NCT00849654 (Ex. 1002).
`2 Honigberg, et al., US 2008/0139582 A1, published June 12, 2008
`(Ex. 1003).
`3 Petitioner asserts in its Petition that claims 1 and 2 are unpatentable as
`obvious over “Press Release, Pharmacylics, Pharmacyclics Initiates Phase I
`Clinical Trial of Novel Oral Btk Inhibitor for Refractory B-Cell Non-
`Hodgkin’s Lymphoma (April 13, 2009) (‘the 2009 Press Release’) (Ex.
`1004).” Pet. 8. As-filed Ex. 1004, however, is a different press release and
`is the subject of Petitioner’s Motion to Correct Clerical Error (Paper 25).
`
`4
`
`
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`IPR2015-01076
`Patent 8,754,090 B2
`Under 35 U.S.C. § 311(b), a petitioner in an inter partes review may
`only challenge the claims of a patent based on “prior art consisting of patents
`or printed publications.” 35 U.S.C. § 311(b). Patent Owner, therefore,
`argues that Petitioner failed to meet its burden to establish that
`NCT00849654 is a “printed publication” that qualifies as available prior art
`in an inter partes review. Prelim. Resp. 19.
`Here, Petitioner has the ultimate burden of persuasion to prove
`unpatentability by a preponderance of the evidence. Dynamic Drinkware,
`LLC v. Nat’l Graphics, Inc., No. 2015-01214, 2015 WL 5166366, at *4
`(Fed. Cir. Sept. 4, 2015). Petitioner also has the initial burden of production
`to establish that there is prior art that renders the claims unpatentable. Id.
`To satisfy this initial burden, we have often required Petitioner to come
`forward with sufficient evidence to make a threshold showing that the
`reference relied upon is available prior art. See, e.g., Symantec Corp. v. Trs.
`of Columbia Univ., IPR2015-00371, slip op. at 5–9 (PTAB June 17, 2015)
`(Paper 9); Temporal Power, Ltd. v. Beacon Power, LLC, IPR2015-00146,
`slip op. at 8–11 (PTAB Apr. 27, 2015) (Paper 10); Dell, Inc. v. Selene
`Comm’n Techs., LLC, IPR2014-01411, slip op. at 21–22 (PTAB Feb. 26,
`2015) (Paper 23).
`In Dynamic Drinkware, the Petitioner relied on a prior art patent to
`challenge the claims of the involved patent. Id. at 2. Based on the earlier
`filing date of the prior art patent, Petitioner satisfied its initial burden of
`production by arguing that the prior art patent anticipated the asserted claims
`under 35 U.S.C. § 102(e)(2). Id. at 7. In contrast, here, Petitioner does not
`rely on a filing date recorded on the face of a patent. Petitioner relies on a
`copy of a webpage to challenge the claims of the ’090 patent. Unlike the
`prior art patent asserted in Dynamic Drinkware, it is not clear from the face
`
`5
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`IPR2015-01076
`Patent 8,754,090 B2
`of the webpage whether it qualifies as prior art in an inter partes review.
`Accordingly, unlike the petitioner in Dynamic Drinkware, Petitioner cannot
`simply state that NCT00849654 is prior art to satisfy its initial burden of
`production. Rather, Petitioner must make a threshold showing that the
`reference is a prior art “printed publication[].” 35 U.S.C. § 311(b).
`Whether a reference qualifies as a “printed publication” 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). The key inquiry is whether the reference
`was made “sufficiently accessible to the public interested in the art” before
`the critical date. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989); In re
`Wyer, 655 F.2d 221, 226 (CCPA 1981). A reference is considered “publicly
`accessible” upon a satisfactory showing that the 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.” Kyocera Wireless Corp. v. ITC, 545
`F.3d 1340, 1350 (Fed. Cir. 2008) (citation and internal quotation marks
`omitted).
`After reviewing the arguments and evidence, we agree with Patent
`Owner that Petitioner has not met its initial burden of production to show
`NCT00849654 is a prior art printed publication. Petitioner asserts that
`“NCT00849654 has a publication date more than one year before the ’090
`Patent’s earliest possible effective filing date of June 3, 2010, and thus
`NCT00849654 is available as prior art under 35 U.S.C. § 102(b).” Pet. 8.
`Petitioner also asserts that Patent Owner “published a notice of clinical trial
`NCT00849654 on February 2, 2009.” Pet. 19 (citing Ex. 1002; Ex. 1021
`¶ 44). Petitioner, however, offers no probative evidence that supports its
`
`6
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`IPR2015-01076
`Patent 8,754,090 B2
`assertions, or that is sufficient to support a reasonable inference that
`NCT00849654 was publicly accessible before the critical date.
`The cited testimony from its declarant, Djordje Atanackovic, M.D., is
`nothing more than a conclusory statement that “[t]he prior art also includes
`Pharmacyclics’ Phase I clinical study with PCI-32765 recruitment
`publication.” Ex. 1021 ¶ 44. Dr. Atanackovic also testified that
`“Pharmacyclics published much of its drug development work in the area,
`including . . . clinical study recruitment documents.” Id. ¶ 38. But neither
`of these statements explains how NCT00849654 qualifies as a printed
`publication as of February 2, 2009, as Petitioner asserts. And
`Dr. Atanackovic has not attested to any personal knowledge of the public
`accessibility or dissemination of NCT00849654 in February 2009. Given
`his unsupported assertions, we give little to no weight to Dr. Atanackovic’s
`conclusory testimony that NCT00849654 constitutes prior art. See
`37 C.F.R. § 42.65(a) (stating 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)
`(stating a lack of objective support for an expert opinion “may render the
`testimony of little probative value in a validity determination”).
`We acknowledge that NCT00849654 indicates that it was “Updated:
`2009_02_23.” Ex. 1002, 1. But, as Patent Owner notes, Petitioner provides
`no explanation or evidence of what that date means. Prelim. Resp. 20–21.
`For example, Petitioner does not explain how that February 23, 2009, date
`relates to Petitioner’s assertion that NCT00849654 was published on
`February 2, 2009. Pet. 19. Nor does Petitioner offer any evidence of the
`website’s publishing practices. The website www.ClinicalTrials.gov
`appears to be a “service by the U.S. National Institutes of Health” that was
`
`7
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`IPR2015-01076
`Patent 8,754,090 B2
`“[d]eveloped by the National Library of Medicine.” See Ex. 1002, 1. But
`Petitioner does not explain how the website disseminates information to the
`public or even when the website became available to the public. Without
`such information, there is no support for a conclusion that NCT00849654
`was publicly accessible by February 2, 2009, as Petitioner asserts.
`We, therefore, determine that Petitioner has not satisfied its initial
`burden of coming forward with sufficient evidence to make a threshold
`showing that NCT00849654 is a prior art printed publication. Because
`Petitioner relies on NCT00849654 for both asserted grounds to challenge the
`patentability of the claims, we also determine that Petitioner has failed to
`establish a reasonable likelihood that it would prevail in asserting that
`claims 1 and 2 of the ’090 patent are unpatentable.
`B.
`Pending Motions
`Patent Owner filed a motion for sanctions, seeking dismissal of the
`Petition for Petitioner’s alleged abuse of process and improper use of the
`proceedings under 37 C.F.R. § 42.12. Paper 20.
`Petitioner filed a motion to correct a clerical error in which Petitioner
`filed an incorrect document as Exhibit 1004. Paper 25.
`In light of the foregoing determination that Petitioner has failed to
`establish a reasonable likelihood that it would prevail in challenging the
`asserted claims, both motions are dismissed as moot.
`
`CONCLUSION
`III.
`We conclude that Petitioner has not established a reasonable
`likelihood of prevailing on its assertions that claims 1 and 2 of the ’090
`patent are unpatentable.
`
`8
`
`
`
`IPR2015-01076
`Patent 8,754,090 B2
`
`
`ORDER
`IV.
`In consideration of the foregoing, it is hereby ordered that the Petition
`is denied.
`
`
`
`PETITIONER:
`
`Jeffrey S. Ward
`Jeffrey D. Blake
`MERCHANT & GOULD, P.C.
`jward@merchantgould.com
`jblake@merchantgould.com
`
`
`
`PATENT OWNER:
`
`Steven P. O’Connor
`M. Paul Barker
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`steven.oconnor@finnegan.com
`paul.barker@finnegan.com
`
`
`
`9
`
`
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