Panacea Biotec Ltd.v.DAIICHI SANKYO COMPANY, LIMITED

Patent Trial and Appeal Board

Jan 7, 2016

12006546 (P.T.A.B. Jan. 7, 2016)

Trials@uspto.gov Paper No. 11
571.272.7822 Entered: January 7, 2016

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

PANACEA BIOTEC LTD.,
Petitioner,

v.

DAIICHI SANKYO COMPANY, LIMITED AND
UBE INDUSTRIES, LTD.,
Patent Owner.
____________

Case IPR2015-01492
Patent 8,569,325 B2
____________

Before ERICA A. FRANKLIN, TINA E. HULSE, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

HULSE, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

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Patent 8,569,325 B2
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INTRODUCTION I.
Petitioner Panacea Biotec Ltd. (“Panacea”) filed a Petition requesting
an inter partes review of claims 1–26 of U.S. Patent No. 8,569,325 B2
(Ex. 1001, “the ’325 patent”). Paper 2 (“Pet.”). Daiichi Sankyo Company,
Ltd. and Ube Industries, Ltd. (collectively, “Patent Owner”) filed a
Preliminary Response to the Petition. Paper 8 (“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 the Petition raises
the same prior art and arguments previously presented to the Office in
IPR2015-00865. Accordingly, we exercise our discretion and decline to
institute an inter partes review of any of the ’325 patent claims.
A. Related Proceedings
Panacea states that the ’325 patent is asserted in the consolidated
action styled Eli Lilly & Co. v. Accord Healthcare, Inc., No. 14-cv-00389-
SEB-TAB (S.D. Ind.). Pet. 7. The ’325 patent is also asserted in Eli Lilly &
Co. v. Lupin Ltd., No. 1:15-cv-00673-SEB-TAB (S.D. Ind.) and in Eli Lilly
& Co. v. HEC Pharm USA, Inc., No. 1:15-cv-00792-SEB-TAB (S.D. Ind.).
Id.
Panacea has also filed concurrently a petition for inter partes review
of related U.S. Patent No. 8,404,703 (“the ’703 patent”) in IPR2015-01496.
The ’325 patent and the ’703 patent are also, respectively, the subject of
pending cases IPR2015-00865 (“the 865 IPR”) and IPR2015-00864 (“the
864 IPR”). We instituted inter partes review in the 864 IPR and the 865 IPR
on September 15, 2015. 864 IPR, Paper 28; 865 IPR, Paper 28.
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Patent 8,569,325 B2
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Patent Owner also notes that the ’325 patent and the ’703 patent are
the subjects of pending petitions for inter partes review in IPR2015-01881
and IPR2015-01882, respectively. Paper 10, 1.
B. The ’325 Patent
The ’325 patent relates to a method for preventing diseases caused by
thrombus or embolus. Ex. 1001, Abstract. 2-acetoxy-5-(α-
cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-
c]pyridine1 (“prasugrel”) possesses inhibitory activity against platelet
aggregation. Id. at 1:33–36. Aspirin is also well known to have low
inhibiting activity against platelet aggregation. Id. at 1:36–38. The claimed
method comprises separately administering prasugrel or a pharmaceutically
acceptable salt thereof, and aspirin, in their pharmacologically effective
amounts, to a warm-blooded animal. Id., Abstract.
According to the ’325 patent, the combination of prasugrel and aspirin
“possess[es] excellent inhibitory activity against platelet aggregation and
thrombogenesis with short onset latency and low toxicity.” Id. at 2:64–3:5.
The combined use of the drugs results in more potent effectiveness than the
use of each component alone. Id. at 3:25–29. Moreover, in the case where
both agents cannot be mixed technically, “each component can be
administered separately.” Id. at 3:50–52.

1 2-acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-
tetrahydrothieno [3,2-c]pyridine is also known as “CS-747” and “prasugrel.”
See, e.g., Ex. 1044, Niitsu et al., Pharmacology of CS-747 (Prasugrel,
LY640315), a Novel, Potent Antiplatelet Agent with in Vivo p2Y12 Receptor
Antagonistic Activity, 31 SEMINARS IN THROMB. HEMOST., 184–185 (2005)
(characterizing the recited compound as “CS-747” and “prasugrel”).
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Patent 8,569,325 B2
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C. Illustrative Claim
Panacea challenges claims 1–26 of the ’325 patent. Claim 1 is
illustrative and is reproduced below:
1. A method for preventing disease caused by
thrombus or embolus, said method consisting of
separately administering to a human in need of
prevention of said disease:
(a) 2-acetoxy-5-(α-cyclopropylcarbonyl-2-
fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-
c]pyridine or a pharmaceutically acceptable salt
thereof, and one or more pharmaceutically
acceptable excipients, lubricants, binders,
disintegrators, emulsifiers, stabilizers, corrigents
and/or diluents, and
(b) aspirin, and one or more pharmaceutically
acceptable excipients, lubricants, binders,
disintegrators, emulsifiers, stabilizers, corrigents
and/or diluents,
wherein said 2-acetoxy-5-(α-cyclopropylcarbonyl-2
fluorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-
c]pyridine or the pharmaceutically acceptable salt
thereof, and aspirin are administered in
pharmacologically effective amounts to prevent
said disease caused by thrombus or embolus by
reducing thrombogenesis or by reducing platelet
aggregation in said human, after both (a) and (b)
have been administered.
D. The Asserted Grounds of Unpatentability
Panacea challenges the patentability of claims 1–26 of the ’325 patent
on the following grounds:

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References Basis Claims challenged
Coniglio2 § 103(a) 1–26
Bernat3 and Asai4 § 103(a) 1–26
Bernat and Koike5 § 103(a) 1–26
Coniglio, Bernat, Asai, and
Koike
§ 103(a) 1–26

ANALYSIS II.
A. Statutory Discretion to Institute
When a petition for inter partes review challenges the same patent
raised in a proceeding already before us, our decision as to whether or not to
institute a trial is guided by 35 U.S.C. §§ 315(d) and 325(d). Section 315(d)
states:
[D]uring the pendency of an inter partes review, if another
proceeding or matter involving the patent is before the Office,
the Director may determine the manner in which the inter partes
review or other proceeding or matter may proceed, including
providing for stay, transfer, consolidation, or termination of any
such matter or proceeding.
Id. Section 325(d) has similar language, and further explains: “In
determining whether to institute or order a proceeding under this chapter,

2 Coniglio et al., WO 99/65500, published Dec. 23, 1999 (Ex. 1003).
3 Bernat et al., US 5,989,578, issued Nov. 23, 1999 (Ex. 1006).
4 Asai et al., CS-747, a New Platelet ADP Receptor Antagonist, 51 ANNU.
REP. SANKYO. RES. LAB. 1–44 (1999) (Ex. 1010).
5 Koike et al., US 5,288,726, issued Feb. 22, 1994 (Ex. 1012).
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chapter 30, or chapter 31,6 the Director may take into account whether, and
reject the petition or request because, the same or substantially the same
prior art or arguments previously were presented to the Office.” Id.
With those statutory provisions in mind, we turn to the question of
whether the Petition in this proceeding warrants inter partes review in light
of the trial that has been instituted in the 865 IPR on the same prior art and
grounds presented in this Petition.
B. Discussion
The Petition is substantively identical to the petition in the 865 IPR.
In the Petition, Panacea admits this fact, stating that it “recognizes that the
instant Petition presents the same prior art and arguments that have been
presented to the Office in the petition in Case IPR2015-00865.” Pet. 8.
At the time Panacea filed this Petition, the petition in the 865 IPR was
pending before us. The 865 IPR petition was filed collectively by eighteen
different entities, including Panacea. 865 IPR, Paper 10, 1. In the Patent
Owner Preliminary Response in the 865 IPR, Patent Owner asserted that the
collective Petitioner failed to identify all of the real parties-in-interest, as
required by 35 U.S.C. § 312(a)(2), and argued that the petition should be
denied. 865 IPR, Paper 17, 5–22.
In this Petition, Panacea states that it disagrees with Patent Owner’s
assertion regarding the real parties-in-interest issue, but nonetheless states,
“in the event that the Office agrees with the patent owners and denies the
petition in Case IPR2015-00865 on that basis, [Panacea] respectfully
submits that the prior art and arguments presented in the instant Petition,

6 Chapter 31 of the Patent Act covers inter partes review proceedings. Thus,
although § 325(d) appears in Chapter 32, which is directed to post-grant
reviews, it is applicable to inter partes reviews.
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Patent 8,569,325 B2
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which would not have been previously considered by the Board on the
merits in Case IPR2015-00865, should be considered in this proceeding.”
Pet. 8. Thus, Panacea recognizes the duplicative nature of this Petition and
appears to condition our review on our denial of the petition in the 865 IPR.
As mentioned above, we have instituted an inter partes review of all
challenged claims in the 865 IPR. 865 IPR, Paper 28. Because the Petition
in this proceeding presents the same prior art and arguments that were
previously presented in the 865 IPR, and because Panacea is also involved in
the 865 IPR, we determine, under the current circumstances, that our limited
judicial resources are best spent elsewhere. See Heckler v. Chaney, 470 U.S.
821, 831 (1985) (stating that when deciding whether to take action in a
particular matter, an agency must determine whether its resources are best
spent on one matter or another). Thus, we find it is appropriate to exercise
our discretion under § 325(d) to deny institution on all of the challenged
claims.
CONCLUSION III.
Because the Petition challenges the same patent based upon the same
art and arguments presented in the petition for the 865 IPR, to which
Panacea is also a party, we exercise our discretion to deny institution of inter
partes review under 35 U.S.C. § 325(d).

ORDER IV.
In consideration of the foregoing, it is hereby ordered that the Petition
is denied.

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Patent 8,569,325 B2
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PETITIONER:
Samuel S. Park
spark@winston.com

Andrew R. Sommer
asommer@winston.com

PATENT OWNER:
Dov P. Grossman
dgrossman@wc.com

David M. Krinsky
dkrinsky@wc.com