Apotex Inc.v.Merck Sharp & Dohme Corp.

Patent Trial and Appeal Board

Oct 27, 2015

08525870 (P.T.A.B. Oct. 27, 2015)

Trials@uspto.gov Paper No. 18
571-272-7822 Entered: October 27, 2015

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

APOTEX INC.,
Petitioner,

v.

MERCK SHARP & DOHME CORP.,
Patent Owner.
____________

Case IPR2015-00419
Patent 5,691,336
____________

Before LORA M. GREEN, ZHENYU YANG, and
ROBERT A. POLLOCK, Administrative Patent Judges.

YANG, Administrative Patent Judge.

DECISION
Order Denying Petitioner’s Request for Rehearing
37 C.F.R. § 42.71

IPR2015-00419
Patent 5,691,336

INTRODUCTION
Apotex Inc. (“Petitioner”) filed a Petition for an inter partes review of
claims 1, 3–8, and 10–25 of U.S. Patent No. 5,691,336 (“the ’336 patent,”
Ex. 1001). Paper 1 (“Pet.”). The Board denied the Petition. Paper 14
(“Dec.”). Petitioner filed a Request for Rehearing. Paper 15 (“Reh’g
Req.”). Petitioner also filed a Petition under 37 C.F.R. § 41.3, suggesting
reconsideration by an expanded panel. Paper 16.
For the following reasons, we deny Petitioner’s Request for
Rehearing. The Acting Chief Administrative Judge declined to expand the
panel.

STANDARD OF REVIEW
When rehearing a decision on institution, the Board reviews the
decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of
discretion occurs when a decision was based on an erroneous conclusion of
law or clearly erroneous factual findings, or a clear error of judgment. In re
Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).
The party requesting rehearing bears the burden of showing the
decision should be modified. 37 C.F.R. § 42.71(d). Specifically, a request
for rehearing must identify all matters the party believes the Board
misapprehended or overlooked. Id.

DISCUSSION
In our Decision denying the Petition, we determined that Petitioner
has failed to sufficiently explain why, at the time of the ’336 patent
2

IPR2015-00419
Patent 5,691,336

invention, a skilled artisan would have chosen compound 96 of Dorn ’699 to
further develop its prodrug, which is the subject matter of the challenged
claims. Dec. 12. In its Request, Petitioner argues that we erred in
concluding that compound 96 is not a lead compound. Reh’g Req. 1. We
are not persuaded.
Petitioner relies on In re Dillon, 919 F.2d 688 (Fed. Cir. 1990) (en
banc). According to Petitioner, “[u]nder Dillon, structural similarity alone is
sufficient to provide motivation to a person skilled in the art (“POSA”) to
modify a prior art compound.” Id. at 7. Dillon did not hold so. Instead,
Dillon held that “structural similarity between claimed and prior art subject
matter, proved by combining references or otherwise, where the prior art
gives reason or motivation to make the claimed compositions, creates a
prima facie case of obviousness.” Dillon, 919 F.2d at 692 (emphasis added).
In other words, a patent challenger must provide “some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness,” independent of the structural similarity. See KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007). Indeed, the Federal Circuit has
repeatedly explained so. See e.g., Daiichi Sankyo Co., Ltd. v. Matrix
Laboratories, Ltd., 619 F.3d 1346, 1352 (Fed. Cir. 2010) (“Proof of
obviousness based on structural similarity requires . . . evidence that a
medicinal chemist of ordinary skill would have been motivated to select and
then to modify a prior art compound (e.g., a lead compound) to arrive at a
claimed compound . . . .”). “Absent a reason or motivation based on such
prior art evidence, mere structural similarity between a prior art compound
3

IPR2015-00419
Patent 5,691,336

and the claimed compound does not inform the lead compound selection.”
Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280, 1292 (Fed. Cir. 2012).
We recognize that the motivation to select and modify a lead
compound need not be explicit in the art. Daiichi, 619 F.3d at 1352. Here,
however, Petitioner does not offer any persuasive evidence or otherwise
explain why a skilled artisan would have selected compound 96 of Dorn
’699 for modification. As we pointed out in the Decision, Dorn ’699 lists
over 600 compounds by their chemical names but provides no activity data
for any of them. Dec. 11. Under such circumstances, Petitioner’s failure to
articulate any reason why one of ordinary skill in the art would have selected
compound 96 is fatal to its obviousness analysis.
Petitioner contends that our lead compound analysis conflicts with Ex
parte Dong, Appeal No. 2011-010047 (P.T.A.B. Jan. 28, 2013), and Ex
parte Cao, Appeal No. 2010-004081 (B.P.A.I. Sept. 19, 2011). Id. at 2–6.
According to Petitioner, we must follow Dong and Cao, in which the panels
affirmed obviousness rejections, even though the prior art taught numerous
compounds and did not provide activity data. Id. We disagree. First, the
Board did not designate either Dong or Cao as precedential. Thus, those
opinions do not bind this panel. More importantly, obviousness, while a
question of law, is based on underlying factual findings. Graham v. John
Deere Co., 383 U.S. 1, 17–18 (1966). And the facts in this case are
distinguishable from those in Dong and Cao. For example, the reference in
Dong did not only list the prior art compound among hundreds of others, it
actually made the compound. Dong, 2013 WL 5375700, *3. In contrast, in
this case, Dorn ’699 prepared over 90 specific compounds in Examples 1–85
4

IPR2015-00419
Patent 5,691,336

and 88–93. Ex. 1003, 60:58–102:1, 121:26–122:60. It also taught how to
make nearly 500 other specific compounds in Examples 86 and 87. Id. at
102:2–121:25. Dorn ’699, however, neither actually prepared compound 96,
nor taught how to make it. Because of the different facts, the approach in
Dong does not apply in this case.
In the Decision, we also denied the Petition on an independent basis.
We contrasted a body of well-studied, potent tachykinin receptor antagonists
with Dorn ’699, which reported no biological or pharmacokinetic data. Dec.
9. Petitioner argues that we erred in stating that a skilled artisan would have
pursued those more promising compounds. Reh’g Req. 12 (citing Dec. 9).
We are not persuaded. Our determination is not, as Petitioner asserts, an
“assumption,” but a conclusion based on the evidence of record. Dec. 9
(citing Prelim. Resp. 16–18, which in turn, relies on Exs. 2001–05, 2007,
2008). Indeed, as Patent Owner pointed out in its Preliminary Response, by
the time of the ’336 patent invention, very potent, selective tachykinin
receptor antagonists with desirable pharmacokinetic properties had been
discovered. Prelim. Resp. 17 (citing Ex. 2007). Specifically, Patent Owner
itself identified compound 7b, a “highly potent” tachykinin receptor
antagonist, as a lead for further optimization. Id. at 18 (citing Ex. 2005).
Petitioner contends that those studies “do not disclose the numerous,
specific human therapeutic applications disclosed in Dorn ʼ699 . . . that
would have motivated those skilled in the art to pursue development of
Dorn’s compounds.” Reh’g Req. 12. We disagree. For example, prior art
teaches that compounds modulating or blocking activity of tachykinin are
suitable for treating human diseases, such as pain, inflammation, rheumatoid
5

IPR2015-00419
Patent 5,691,336

arthritis, asthma, and bronchial hyperactivity. Ex. 2007, 315. In other
words, one of ordinary skill would have had sufficient reason to pursue those
promising compounds, instead of starting with Dorn ’699.
Petitioner further contends that Patent Owner’s Preliminary Response
is inconsistent with statements by the inventors during the prosecution.
Reh’g Req. 13–15. This argument amounts to an unauthorized, improper
reply to the Preliminary Response. Moreover, because Petitioner did not
explain why a skilled artisan would have selected compound 96, we do not
need to address whether a skilled artisan would have subsequently modified
compound 96 based on the teachings of Murdock.
In sum, in the Petition, Petitioner did not establish a reasonable
likelihood that it would prevail in showing Dorn ’699, in combination with
other asserted prior art, would have rendered the challenged claims obvious.
On rehearing, we see no error in our fact findings or conclusions of law.
Thus, we conclude that Petitioner has not demonstrated that we abused our
discretion in denying institution of the challenged claims. We deny the
Request for Rehearing. The Acting Chief Administrative Judge declined to
expand the panel.

ORDER
Accordingly, it is
ORDERED that Petitioner’s Request for Rehearing is denied.

6

IPR2015-00419
Patent 5,691,336

PETITIONER:

Kenneth J. Burchfiel
Grant S. Shackelford
SUGHRUE MION, PLLC
kburchfiel@sughrue.com
gshackelford@sughrue.com

PATENT OWNER:

Bruce M. Wexler
Preston K. Ratliff II
Gregory A. Morris
Naveen Modi
PAUL HASTINGS LLP
brucewexler@paulhastings.com
prestonratliff@paulhastings.com
gregorymorris@paulhastings.com
naveenmodi@paulhastings.com

Gerard M. Devlin
Richard C. Billups
MERCK SHARP & DOHME CORP.
gerard_devlin@merck.com
richard_billups@merck.com
7