Coalition for Affordable Drugs IV LLCv.Pharmacyclics, Inc.

Patent Trial and Appeal Board

Oct 19, 2015

13340522 (P.T.A.B. Oct. 19, 2015)

Trials@uspto.gov Paper No. 33
571.272.7822 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)

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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.
B. The ’090 Patent
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
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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.
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D. The Asserted Grounds of Unpatentability
Petitioner challenges the patentability of claims 1and 2 of the ’090
patent on the following grounds:
Reference(s) Basis Claims challenged
NCT008496541 § 102(b) 1 and 2
NCT00849654, the ’582
publication,2 and the 2009
Press Release3
§ 103 1 and 2

ANALYSIS II.
A. Whether NCT00849654 Is a Prior Art Printed Publication
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).
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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
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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
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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
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“[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.
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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