throbber
Trials@uspto.gov
`571-272-7822
`
`
`
`
`
`Paper 28
`
`
` Entered: September 15, 2015
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ACCORD HEALTHCARE INC., USA, ACCORD HEALTHCARE, INC.,
`INTAS PHARMACEUTICALS LTD., AMNEAL PHARMACEUTICALS
`LLC, AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
`AMNEAL PHARMACEUTICALS CO. INDIA PVT. LTD., APOTEX
`CORP., APOTEX INC., DR. REDDY’S LABORATORIES, LTD., DR.
`REDDY’S LABORATORIES, INC., GLENMARK GENERICS INC.,
`USA, GLENMARK GENERICS LTD., GLENMARK
`PHARMACEUTICALS LTD., PANACEA BIOTEC LTD., SUN PHARMA
`GLOBAL FZE, TEVA PHARMACEUTICALS USA, INC., ZYDUS
`PHARMACEUTICALS USA, INC., and CADILA HEALTHCARE LTD,
`Petitioner,
`
`v.
`
`DAIICHI SANKYO COMPANY, LTD. AND UBE INDUSTRIES, LTD.,
`Patent Owner.
`____________
`
`Case IPR2015-00864
`Patent 8,404,703 B2
`____________
`
`Before ERICA A. FRANKLIN, TINA E. HULSE, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`FRANKLIN, Administrative Patent Judge.
`
`DECISION
`Institution of Inter Partes Review
`37 C.F.R. § 42.108
`
`

`

`IPR2015-00864
`Patent 8,404,703 B2
`
`
`
`INTRODUCTION
`I.
`Accord Healthcare Inc., USA, Accord Healthcare, Inc., Intas
`Pharmaceuticals Ltd., Amneal Pharmaceuticals LLC, Amneal
`Pharmaceuticals of New York, LLC, Amneal Pharmaceuticals Co. India Pvt.
`Ltd., Apotex Corp., Apotex Inc., Dr. Reddy’s Laboratories, Ltd., Dr.
`Reddy’s Laboratories, Inc., Glenmark Generics Inc., USA, Glenmark
`Generics Ltd., Glenmark Pharmaceuticals Ltd., Panacea Biotec Ltd., Sun
`Pharma Global FZE, Teva Pharmaceuticals USA, Inc., Zydus
`Pharmaceuticals USA, Inc., and Cadila Healthcare Ltd. (collectively,
`“Petitioner”) filed a Petition requesting an inter partes review of claims 1–
`27 of U.S. Patent No. 8,404,703 B2 (Ex. 1001, “the ’703 patent”). Paper 10
`(“Petition” or “Pet.”). Daiichi Sankyo Company, Ltd. and Ube Industries
`Ltd. (collectively, “Patent Owner”) filed a Preliminary Response to the
`Petition. Paper 17 (“Prelim. Resp.”). We authorized Petitioner to file a
`Reply to the Preliminary Response to address an asserted real party in
`interest issue. Paper 20 (“Reply”). Thereafter, we authorized Patent Owner
`to file a Surreply. Paper 23 (“Surreply”).
`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
`shown a reasonable likelihood that it would prevail in showing the
`unpatentability of claims 1–27. Accordingly, we institute an inter partes
`review of those claims.
`
`
`
`
`
`
`2
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`

`IPR2015-00864
`Patent 8,404,703 B2
`
`
`Related Proceedings
`A.
`Petitioner and Patent Owner identify, as a related proceeding
`involving the ’703 patent, litigation consolidated as Eli Lilly and Co., et al.
`v. Accord Healthcare, Inc., et al., No. 1:14-cv-00389-SEB-TAB, filed on
`March 12, 2014, and pending in the U.S. District Court for the Southern
`District of Indiana. Pet. 8; Paper 14, 3–4.
`Additionally, Petitioners have filed a Petition requesting an inter
`partes review of claims of U.S. Patent 8,569,325, which patent claims
`priority to the same applications as the ’703 patent. Pet. 8; Paper 14, 4.
`B.
`The ’703 Patent (Ex. 1001)
`The ’703 patent relates to methods for preventing or treating diseases
`caused by thrombus or embolus by administering an effective amount of 2-
`acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-tetrahydrothieno
`[3,2-c]pyridine,1 or a pharmaceutically acceptable salt thereof, and aspirin to
`warm-blooded animals, particularly humans. Ex. 1001, 1:24–30. The
`Specification explains that, prior to the invention, both active ingredients
`were well known to possess inhibitory activity against platelet aggregation,
`wherein 2-acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-
`tetrahydrothieno[3,2-c]pyridine activity is potent, and aspirin activity is low.
`Id. at 1:31–37.
`
`
`
` 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”).
`
`3
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`

`IPR2015-00864
`Patent 8,404,703 B2
`
`
`Illustrative Claim
`C.
`Claim 1 of the ’703 patent is illustrative and reproduced below:
`1. A method for treatment of a disease caused by thrombus
`or embolus, said method consisting of: administering (i) 2-
`acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7-
`tetrahydrothieno[3,2-c]pyridine
`or
`a
`pharmaceutically
`acceptable salt thereof, (ii) aspirin, and (iii) one or more
`pharmaceutically acceptable excipients, lubricants, binders,
`disintegrators, emulsifiers,
`stabilizers, corrigents and/or
`diluents, wherein
`(i)
`and
`(ii)
`are
`administered
`in
`pharmacologically effective amounts, to a human in need of
`reduction of
`thrombogenesis or
`reduction of platelet
`aggregation.
`
`The Prior Art
`D.
`Petitioner relies upon the following prior art references:
`
`Coniglio
`
`WO 99/65500, published Dec. 23, 1999.
`
`US Patent No. 5,989,578, issued Nov. 23,
`1999.
`
`Ex. 1003
`
`Ex. 1006
`
`
`Ex. 1010
`
`Ex. 1012
`
`Bernat
`
`Asai
`
`
`Koike
`
`
`
`Asai et al., CS-747, A New Platelet ADP
`Receptor Antagonist, 51 ANNU. REP.
`SANKYO RES. LAB. 1–44 (1999).
`
`US Patent No. 5,288,726, issued Feb. 22,
`1994.
`
`
`Petitioner also relies upon the Declarations of Jack Hirsch, M.D. (Ex.
`1002) and Paul A. Gurbel, M.D. (Ex. 1025).
`E.
`The Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 1–27 of the ’703
`patent on the following grounds (Pet. 12):
`
`
`
`
`
`
`4
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`IPR2015-00864
`Patent 8,404,703 B2
`
`
`Claims Challenged
`1–27
`
`1–27
`
`1–27
`
`1–27
`
`
`
`
`Basis
`§ 103(a)
`
`§ 103(a)
`
`§ 103(a)
`
`§ 103(a)
`
`Reference
`Coniglio
`
`Bernat in view of Asai
`
`Bernat in view of Koike
`
`Coniglio in view of Bernat,
`Asai, and Koike
`
`
`35 U.S.C. 312(a)(2)
`II.
`A prerequisite for an inter partes review of a petition is that the
`petition identifies all real parties in interest. 35 U.S.C. 312(a)(2). Generally,
`a “real party-in-interest” (“RPI”) is a party that desires review of the patent,
`whether or not the party is the Petitioner. Office Patent Trial Practice
`Guide, 77 Fed. Reg. 48,756, 48,759 (Aug. 14, 2012) (“Trial Practice
`Guide”).
`In the Petition, Petitioner identifies a number of entities, including
`Apotex Corp. and Apotex Inc., as the real parties-in-interest.2 Pet. 7.
`Petitioner, however, does not identify Apotex Holdings Inc. (“Apotex
`Holdings”) as an RPI. Id.
` Patent Owner asserts that Petitioner failed to satisfy 35 U.S.C.
`§ 312(a)(2) by not identifying Apotex Holdings Inc. as an RPI. Prelim.
`Resp. 1. Moreover, Patent Owner asserts that because naming all RPIs is a
`requirement for receiving a filing date for the Petition, the assessed filing
`date should be vacated and the proceeding should be terminated, as the
`
`
` 2
`
` Apotex Corp. and Apotex Inc. are included also among entities identified
`as the collective Petitioner. Pet. 1.
`
`
`
`5
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`IPR2015-00864
`Patent 8,404,703 B2
`
`statutory deadline for filing a corrected petition has expired for nearly all of
`the parties making up the collective Petitioner. Id. at 5, 21.
`A determination whether a party other than a petitioner constitutes an
`RPI with respect to a filed petition is a highly fact-dependent question that
`we consider on a case-by-case basis. 77 Fed. Reg. at 48,759. Multiple
`factors are relevant to that determination. A significant consideration is
`whether the party “exercised or could have exercised control over” a
`petitioner’s participation in an inter partes proceeding. Id. As exemplified
`in the Trial Practice Guide, “a party that funds and directs and controls an
`[inter partes review] petition or proceeding constitutes a ‘real party-in-
`interest.’” Id. at 48,760. Whether evidence establishing a less definitive
`situation also justifies recognizing a party as an RPI requires consideration
`of relevant factors, including, but not limited to: the party’s relationship
`with the Petitioner; the party’s relationship to the petition, including the
`nature and/or degree of involvement in the filing; and the nature of the entity
`filing the petition. Id.
`Patent Owner asserts that Apotex Holdings is an RPI and proffers
`evidence to support that contention. In particular, Patent Owner refers to:
`(a) a brief filed by Apotex Holdings in an arbitration explaining that Apotex
`Holdings “indirectly owns and controls” Apotex Corp., Ex. 20013 ¶ 24; (b)
`Corporate Disclosure Statements submitted by Apotex Corp. and Apotex
`Inc. in a district court case disclosing Apotex Holdings as the “parent” of
`
`
`
` 3
`
` Apotex Holdings Inc., et al. and the Government of the United States of
`America, ICSID Case No. ARB(AF)/12/1, filed on July 30, 2012 (Memorial
`of Claimants Apotex Holdings Inc. and Apotex Inc.).
`
`6
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`IPR2015-00864
`Patent 8,404,703 B2
`
`Apotex Corp. and Apotex Inc., Ex. 2002,4 1, Ex. 2012,5 1; and (c)
`Disclosures of Corporate Interest submitted in a district court case disclosing
`Apotex Holdings as the ultimate “parent” of Apotex Corp. and Apotex Inc.,
`Ex. 2013,6 1, Ex. 2014,7 1. Prelim Resp. 7–9. According to Patent Owner,
`those exhibits establish that Apotex Holdings has an interest in the Petition
`“through its investment in and control of its subsidiaries, Apotex Corp. and
`Apotex Inc.” such that “Apotex Holdings possesse[d] the requisite degree of
`control over the proceeding to be a real party in interest.” Id. at 11–12.
`Further, Patent Owner asserts that Apotex Holdings’ control over
`Apotex Corp. and Apotex Inc. is evident by the composition of the boards of
`directors for each of the companies. Id. at 13. According to Patent Owner,
`two Apotex Holdings board members, Dr. Bernard C. Sherman and Mr. Jack
`Kay, serve also as two of three members constituting the board of Apotex
`Inc. Id. at 13 (citing Ex. 2005, 2006, and 2007). Patent Owner asserts also
`that Dr. Sherman serves as the Chairman for each of Apotex Holdings,
`
`
` 4
`
` Eli Lilly and Co., et al. v. Apotex Corp. et al., No. 1:14-cv-586-SEB-TAB,
`filed on May 7, 2014 (Document 14: Corporate Disclosure Statement of
`Apotex Corp.).
`5 Eli Lilly and Co., et al. v. Apotex Inc. et al., No. 1:14-cv-586-SEB-TAB,
`filed on May 7, 2014 (Document 15: Corporate Disclosure Statement of
`Apotex Inc.).
`6 Otsuka Pharmaceutical Co., Ltd., et al. v. Sylvia Matthews Burwell, et al.,
`No. 8:15-cv-00852-GJH, filed on March 30, 2015 (Document 25: Disclosure
`of Corporate Interest regarding Apotex Pharmaceutical Holdings Inc. and
`Apotex Holdings Inc.).
`7 Otsuka Pharmaceutical Co., Ltd., et al. v. Sylvia Matthews Burwell, et al.,
`No. 8:15-cv-00852-GJH, filed on March 30, 2015 (Document 26: Disclosure
`of Corporate Interest regarding Apotex Corporation, ApoSherm Inc., and
`Apotex Holdings Inc.).
`
`
`
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`IPR2015-00864
`Patent 8,404,703 B2
`
`Apotex Inc., and Apotex Corp. Id. Patent Owner refers also to testimony
`relating to a district court case involving Apotex, Inc. wherein Dr. Sherman
`states that he “directs all litigation for Apotex.” Id. at 14 (citing Apotex, Inc.
`v. UCB, Inc., 970 F. Supp. 2d 1297, 1305 (S.D. Fla. 2013)). According to
`Patent Owner, Dr. Sherman’s executive positions with Apotex Holdings,
`Apotex Inc., and Apotex Corp., along with his testimony regarding his role
`with at least Apotex Inc. indicates that he “has the ultimate control of and
`responsibility for Apotex’s litigation.” Id. at 15.
`Additionally, Patent Owner lists a number of other petitions for inter
`partes review in which either Apotex Inc. and/or Apotex Corp. appeared as
`petitioners and identified non-party Apotex Holdings as an RPI. Id. at 16–
`18.
`
`Generally, the existence of a parent-subsidiary relationship is
`insufficient to justify a parent’s status as a RPI. Compass Bank v.
`Intellectual Ventures II LLC, IPR2014-00724, Paper 12 at 10–11 (PTAB
`Nov. 6, 2014)(Paper 12)). At first glance, Patent Owner’s assertions
`regarding Dr. Sherman’s executive positions with Apotex Holdings, Apotex
`Inc., and Apotex Corp., along with his testimony in an unrelated district
`court case regarding his role with at least Apotex Inc. may suggest that the
`parent is in a position to control the subsidiaries. However, the record
`before us is insufficient to establish that the lines of corporate separation
`between the parent and subsidiaries are so “blurred” such that the parent
`could have controlled the filing and activities related to this particular
`Petition, as was the case in Zoll Lifecor Corp. v. Philips Elec. N. Am. Corp.,
`IPR2013-00606, Paper 13 at 10 (PTAB Mar. 10, 2014). See Aruze Gaming
`Macau, Ltd. v. MGT Gaming, Inc., IPR2014-01288, Paper 13, 18 (PTAB
`
`
`
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`IPR2015-00864
`Patent 8,404,703 B2
`
`Feb. 20, 2015).
`Whether Apotex Holdings had the opportunity to control Apotex Inc.
`and Apotex Corp. in this proceeding requires further consideration in view
`of the testimony of Petitioner’s declarant, Mr. Kevin Zive. Mr. Zive
`declares, among other things, that: (a) he is a senior patent counsel in the
`Global Intellectual Property department of Apotex Inc., Ex. 1048 ¶ 1; he
`manages cases in which Apotex Inc. and Apotex Corp. are co-defendants, id.
`¶ 5; (b) he is not employed or paid by Apotex Holdings, id.; (c) he does not
`manage any litigation or perform any work for Apotex Holdings, id.; (d)
`Apotex Holdings was not involved in the decision of Apotex Inc. and
`Apotex Corp. to pursue a generic prasugrel product in the United States, id.
`¶ 6; (e) Apotex Holdings was not involved in Apotex Inc.’s decision to file
`an Abbreviated New Drug Application (“ANDA”) or Paragraph IV
`certification, id. ¶ 7; (f) Apotex Holdings does not pay or fund any part of
`Winston & Strawn’s work on behalf of Apotex Inc. or Apotex Corp. in the
`related district court litigation, id. ¶¶ 11–13; (g) he corresponds with
`Winston & Strawn and directs and approves actions of their counsel on
`behalf of Apotex Inc. or Apotex Corp. in the litigation, id. ¶ 14; and (h)
`Apotex Holdings is not involved in, and has no control over, the litigation,
`id.
`
`Significantly, with respect to the Petition for inter partes review of the
`’703 patent, Mr. Zive declares that Apotex Holdings was not involved in
`either the decision to file the Petition or in the preparation of the Petition,
`and that Apotex Holdings has not paid, and will not pay, any portion of the
`legal fees, filing fees, or any other fees or costs associated with the Petition.
`Id. ¶¶ 15–16. In particular, Mr. Zive explains that Winston & Strawn
`
`
`
`
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`IPR2015-00864
`Patent 8,404,703 B2
`
`represents Apotex Inc. and Apotex Corp. in the proceeding and sends bills
`only to Apotex Inc., and that he corresponds with Winston & Strawn and
`directs and approves actions of their counsel on behalf of Apotex Inc. and
`Apotex Corp. in the proceeding Id. ¶ 16. According to Mr. Zive, Apotex
`Holdings “does not control, and does not have the ability to control, any of
`the actions of Apotex Inc. or Apotex Corp. in this proceeding.” Id. at 18.
`Based on the record at this stage of the proceeding, we consider Mr.
`Zive’s unchallenged testimony persuasive and sufficient to overcome Patent
`Owner’s allegations that Apotex Holdings relationship to its subsidiaries
`Apotex Inc. and Apotex Corp. involved any potential control of this
`proceeding. Thus, without more compelling evidence to the contrary, we are
`not persuaded that Apotex Holdings is a RPI. Accordingly, we decline
`Patent Owner’s request to dismiss the Petition.8
`
`PATENTABILITY ANALYSIS
`III.
`A.
`Claim Construction
`In an inter partes review, the Board interprets claim terms in an
`unexpired patent according to the broadest reasonable construction in light
`of the specification of the patent in which they appear. 37 C.F.R.
`§ 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278–79 (Fed.
`
`
` 8
`
` Patent Owner requests, alternatively, authorization to file a motion for
`additional discovery under 37 C.F.R. § 42.51(b)(2) concerning whether
`Apotex Holdings is an RPI. Prelim Resp. 22. Prior to considering that
`request, we instruct the parties to confer within two weeks of this Decision
`and make a good faith effort to agree to discovery amongst themselves. See
`Trial Practice Guide, 77 Fed. Reg. at 48,761 (Section F. (2) Additional
`Discovery: “the parties may agree to discovery amongst themselves”). If no
`agreement is reached, Patent Owner may request a teleconference at that
`time to renew its request for authorization to file the motion.
`
`10
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`

`IPR2015-00864
`Patent 8,404,703 B2
`
`Cir. 2015). Under that standard, and absent any special definitions, we give
`claim terms their ordinary and customary meaning, as would be understood
`by one 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). Any special
`definitions for claim terms must be set forth with reasonable clarity,
`deliberateness, and precision. In re Paulsen, 30 F.3d 1475, 1480 (Fed.
`Cir. 1994).
`Neither Petitioner nor Patent Owner proposes a specific construction
`for any claim term. Pet. 10; PO Resp. 1–22. In view of our analysis, we
`determine that the construction of any claim term is not necessary for
`purposes of this Decision.
`B. Obviousness over the Combination of Coniglio, Bernat, Asai, and Koike
`Petitioner asserts that claims 1–27 of the ’703 patent would have been
`obvious over the combination of Coniglio, Bernat, Asai, and Koike. Pet.
`29–37. Patent Owner does not address substantively the patentability of any
`challenged claim. Prelim. Resp. 1–22.
`1.
`Coniglio
` Coniglio is directed to a method for preventing cerebral infarction,
`
`also known as thrombotic stroke, by administering to a patient a
`combination of an ADP-receptor blocking anti-platelet drug, an
`antihypertensive agent, and, optionally, aspirin. Ex. 1003, 5, 11.9 Coniglio
`explains that ADP-receptor blocking anti-platelet drugs that may be used in
`
`
` 9
`
` With the exception of U.S. patents, we cite to the unique page numbers
`provided by the parties for submitted exhibits according to 37 C.F.R.
`§ 42.63(d)(2)(i). To avoid confusion, we encourage the parties do the same
`in future filings.
`
`
`
`11
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`

`IPR2015-00864
`Patent 8,404,703 B2
`
`the combination and method “include clopidogrel, ticlopidine and the like.”
`Id. at 5. The combination provides a unique manner of treating diseases
`involved with platelet aggregation, thrombus formation, and ischemic
`events. Id. The combination may be formulated with physiologically
`acceptable excipients. Id. at 13.
`Bernat
`2.
`Bernat is directed to a combination of active ingredients having anti-
`
`platelet aggregation activity, consisting of clopidogrel and aspirin. Ex.
`1006, 1:5–8. Bernat describes clopidogrel as exhibiting about 10 to 50 times
`more effective anti-platelet aggregation than ticlopidine. Id. at 2:34–36.
`Clopidogrel and ticlopidine are thenopyridine derivatives that provide their
`antithrombotic effects through the same mechanism of action. Id. at 2:16–
`19. Additionally, Bernat describes the clopidogrel-aspirin combination to
`provide synergistic activity. Id. at 2:48–50. The combination may be
`formulated with a pharmaceutical excipient. Id. at 6:1–2 (claim 2).
`3.
`Asai
`Asai is a journal review article describing CS-747, a platelet ADP-
`
`receptor antagonist. Ex. 1010, Title. CS-747 (2-acetoxy-5-(α-
`cyclopropylcarbonyl-2-fluorobenzyl)-4, 5, 6, 7-tetrahydrothieno[3, 2-c]
`pyridine) is identified as an “effective platelet aggregation inhibitor with
`high potency, fast onset and long duration of action.” Id. at 3. It blocks
`ADP-mediated platelet aggregation and exhibits more potent antithrombotic
`effects than clopidogrel and ticlopidine. Id. at 13, 42. CS-747 revealed
`minimal activity in general pharmacological and toxicological studies and
`caused no serious adverse events when administered to Caucasian male
`volunteers. Id. at 4, 13.
`
`
`
`
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`IPR2015-00864
`Patent 8,404,703 B2
`
`
`Koike
`4.
`Koike is directed to tetrahydrothieno[3, 2-c]pyridine derivatives and
`
`methods of using them in compositions for inhibiting blood platelet
`aggregation to treat or prevent thrombosis or embolisms. Ex. 1012, 1:9–14,
`39:30–34. Specific examples of the most preferred compounds of the
`invention include 2-acetoxy-5-(α-cyclopropylcarbonyl-2-fluorobenzyl)-4, 5,
`6, 7-tetrahydrothienol[3,2-c]pyridine. Id. at 21:52–54.
`
`5. Analysis
`Petitioner asserts that it would have been obvious to a person of
`
`ordinary skill in the art to combine prasugrel with aspirin to treat
`cardiovascular diseases by inhibiting or reducing thrombogenesis and
`platelet aggregation based on the teachings of Coniglio, Bernat, Asai and
`Koike. Pet. 29–37. Patent Owner does not address this assertion
`substantively in the Preliminary Response.
`
`Based on the information presented at this stage of the proceeding,
`Petitioner has shown sufficiently that there is a reasonable likelihood of
`prevailing in establishing that claims 1–27 are unpatentable over the
`combination of Coniglio, Bernat, Asai, and Koike. In particular, Coniglio
`teaches a method for preventing the onset of a thrombotic stroke by
`administering to a patient a combination comprising an ADP-receptor
`blocking anti-platelet drug, aspirin, and a pharmaceutically acceptable
`excipient. Ex. 1003, 5, 11, 13. Coniglio explains that the ADP-receptor
`blocking anti-platelet drug may be clopidogrel, ticlopidine, or the like. Id. at
`5. According to Petitioner and its declarant, a skilled artisan would have
`understood from Asai and Koike that a “like” ADP-receptor blocking anti-
`platelet drug was prasugrel. Pet. 30–32 (citing Ex. 1002, Decl. of Dr.
`
`
`
`
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`IPR2015-00864
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`Hirsch, ¶¶ 93–106). Specifically, Asai teaches that prasugrel blocks ADP-
`mediated platelet aggregation and exhibits more potent antithrombotic
`effects than clopidogrel and ticlopidine, with no serious adverse effects. Ex.
`1010, 13, 42. Similarly, Koike identifies prasugrel as one of its “most
`preferred” tetrahydrothieno[3, 2-c]pyridine derivatives for use in
`compositions for inhibiting blood platelet aggregation to treat or prevent
`thrombosis or embolisms. Ex. 1012, 1:9–14, 21:52–54, 39:30–34. Thus,
`Petitioner contends that a skilled artisan would have had a reason to select
`prasugrel as the ADP-receptor blocking anti-platelet drug in Coniglio’s
`combination because Asai and Koike together taught that prasugrel functions
`by that same mechanism of action. Pet. 30.
`
`Moreover, Petitioner relies upon the teaching in Bernat of treating
`thromboembolic disorders by administering a combination of aspirin with
`either clopidogrel or ticlopidine, both of which exert antithrombotic effects
`through the same mechanism of action. Pet. 48; Ex. 1006, 1:45–49; 2:16–
`50. Bernat preferred clopidogrel in the combination, explaining that, among
`other things, it provided a more effective anti-platelet aggregation than
`ticlopidine. Id. at 2:34–36. Thus, Petitioner contends that a skilled artisan
`would have had a reason to substitute clopidogrel in Bernat’s combination
`with another agent exerting an even greater anti-platelet aggregation by the
`same mechanism, i.e., prasugrel, as taught by Asai and Koike.
`
`At this stage of the proceeding, we are persuaded that Petitioner has
`shown a reasonable likelihood that it would prevail in showing that claim 1
`is unpatentable as obvious over the combination of Coniglio, Bernat, Asai,
`and Koike. We have considered Petitioner’s arguments and evidence with
`respect to the remaining claims, and we determine that Petitioner has made a
`
`
`
`
`14
`
`

`

`IPR2015-00864
`Patent 8,404,703 B2
`
`sufficient showing as to those claims, as well. Accordingly, we institute an
`inter partes review of claims 1–27 of the ’703 patent based on the
`combination of Coniglio, Bernat, Asai, and Koike.
`C. Remaining Grounds
`The remaining grounds challenge the same claims and involve one or
`more of the same references as those involved in the ground discussed.
`Accordingly, we exercise our discretion by declining to proceed on the
`remaining obviousness grounds of unpatentability. See 37 C.F.R.
`§ 42.108(a).
`
`
`CONCLUSION
`IV.
`For the foregoing reasons, we determine that the information
`presented in the Petition establishes that there is a reasonable likelihood that
`Petitioner would prevail in showing that claims 1–27 of the ’703 patent are
`unpatentable.
`At this stage of the proceeding, the Board has not made a final
`determination as to the construction of any term or the patentability of any
`challenged claim.
`
`
`ORDER
`In consideration of the foregoing, it is hereby:
`ORDERED that pursuant to 35 U.S.C. §314 (a), an inter partes
`review is instituted as to claims 1–27 of the ’703 patent on the following
`ground of unpatentability:
`Claims 1–27 under 35 U.S.C. § 103 as obvious over Coniglio, Bernat,
`Asai, and Koike;
`FURTHER ORDERED that no other proposed grounds of
`
`
`
`
`15
`
`

`

`IPR2015-00864
`Patent 8,404,703 B2
`
`unpatentability are authorized.
`FURTHER ORDERED that pursuant to 35 U.S.C. § 314(c) and
`37 C.F.R. § 42.4, notice is hereby given of the institution of a trial
`commencing on the entry date of this decision.
`
`
`PETITIONER:
`
`Samuel S. Park
`spark@winston.com
`
`Azadeh S. Kokabi
`akokabi@sughrue.com
`
`Patrick C. Gallagher
`pcgallagher@duanemorris.com
`
`William L. Mentlik
`wmentlik@ldlkm.com
`
`Steven J. Moore
`steven.moore@withersworldwide.com
`
`John Winterle
`john.winterle@withersworldwide.com
`
`Hans-Peter Hoffman
`peter.hoffman@withersworldwide.com
`
`Alan Gardner
`alan.gardner@withersworldwide.com
`
`
`
`
`
`
`
`
`
`16
`
`

`

`IPR2015-00864
`Patent 8,404,703 B2
`
`PATENT OWNER:
`
`Dov P. Grossman
`dgrossman@wc.com
`
`David M. Krinsky
`dkrinsky@wc.com
`
`
`
`
`
`17
`
`

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