UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD

Transcription

1 Paper 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 IPR 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

2 I. INTRODUCTION 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 Accordingly, we institute an inter partes review of those claims. 2

3 A. Related Proceedings 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 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-( -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: 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-( -cyclopropylcarbonyl-2-fluorobenzyl)-4,5,6,7- tetrahydrothieno[3,2-c]pyridine activity is potent, and aspirin activity is low. Id. at 1: acetoxy-5-( -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 p2y 12 Receptor Antagonistic Activity, 31 SEMINARS IN THROMB. HEMOST., (2005) (characterizing the recited compound as CS-747 and prasugrel ). 3

4 C. Illustrative Claim 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-( -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. D. The Prior Art Petitioner relies upon the following prior art references: Coniglio WO 99/65500, published Dec. 23, Ex Bernat US Patent No. 5,989,578, issued Nov. 23, Ex Asai Asai et al., CS-747, A New Platelet ADP Receptor Antagonist, 51 ANNU. REP. SANKYO RES. LAB (1999). Ex Koike US Patent No. 5,288,726, issued Feb. 22, Ex 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

5 Claims Challenged Basis Reference (a) Coniglio (a) Bernat in view of Asai (a) Bernat in view of Koike (a) Coniglio in view of Bernat, Asai, and Koike II. 35 U.S.C. 312(a)(2) 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

6 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-ininterest. 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 ; (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

7 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 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 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 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 GJH, filed on March 30, 2015 (Document 26: Disclosure of Corporate Interest regarding Apotex Corporation, ApoSherm Inc., and Apotex Holdings Inc.). 7

8 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 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, IPR , Paper 12 at (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., IPR , Paper 13 at 10 (PTAB Mar. 10, 2014). See Aruze Gaming Macau, Ltd. v. MGT Gaming, Inc., IPR , Paper 13, 18 (PTAB 8

9 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 ; 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 ; (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 In particular, Mr. Zive explains that Winston & Strawn 9

10 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 III. PATENTABILITY ANALYSIS 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 (b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, (Fed. 8 Patent Owner requests, alternatively, authorization to file a motion for additional discovery under 37 C.F.R (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

11 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 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 Patent Owner does not address substantively the patentability of any challenged claim. Prelim. Resp 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, 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 (d)(2)(i). To avoid confusion, we encourage the parties do the same in future filings. 11

12 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 Bernat Bernat is directed to a combination of active ingredients having antiplatelet 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: Clopidogrel and ticlopidine are thenopyridine derivatives that provide their antithrombotic effects through the same mechanism of action. Id. at 2: Additionally, Bernat describes the clopidogrel-aspirin combination to provide synergistic activity. Id. at 2: 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 ADPreceptor antagonist. Ex. 1010, Title. CS-747 (2-acetoxy-5-( 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 4. Koike 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: Specific examples of the most preferred compounds of the invention include 2-acetoxy-5-( -cyclopropylcarbonyl-2-fluorobenzyl)-4, 5, 6, 7-tetrahydrothienol[3,2-c]pyridine. Id. at 21: 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 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 antiplatelet drug was prasugrel. Pet (citing Ex. 1002, Decl. of Dr. 13

14 Hirsch, ). Specifically, Asai teaches that prasugrel blocks ADPmediated 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: 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: Bernat preferred clopidogrel in the combination, explaining that, among other things, it provided a more effective anti-platelet aggregation than ticlopidine. Id. at 2: 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

15 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 (a). IV. CONCLUSION 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

16 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

17 PATENT OWNER: Dov P. Grossman David M. Krinsky 17