Takeaway: Petition was not dismissed where Patent Owner was able to show some blurring of the corporate separation between parent and subsidiaries, because Petitioner was able to declare that the parent company was not paying or making any decisions related to the proceeding and that the outside counsel handling the proceeding was corresponding to and being paid by only Petitioner.

In its Decision, the Board granted institution of the challenged claims (1-27) of the ’703 Patent. 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, or a pharmaceutically acceptable salt thereof, and aspirin to warm-blooded animals, particularly humans.”

The Board began by analyzing the perquisite issue that the petition identifies all real parties in interest (RPI). In the Petition, Petitioner identified many entities including Apotex Corp. and Apotex Inc., but did not identify Apotex Holdings Inc. (Apotex Holdings) as an RPI. Patent Owner asserted that Apotex Holdings is an RPI, and that because it was not listed as such, the filing date should be vacated and the proceeding terminated, as the statutory deadline for filing a corrected petition had expired for nearly all of the parties making up Petitioner.

The Board noted that determination of whether a party is an RPI is fact-dependent and multiple factors are relevant. A significant consideration is whether the party “exercised or could have exercised control over” a petitioner’s participation in an inter partesproceeding.

Patent Owner proffered the following evidence to support its assertion that Apotex Holdings is an RPI: (1) a brief filed by Apotex Holdins in an arbitration explained that Apotex Holdings “indirectly owns and controls” Apotex Corp.; (2) Corporate Disclosure Statements submitted by Apotex Corp. and Apotex Inc. in a district court case referred to Apotex Holdings as its “parent” company; (3) Disclosures of Corporate Interest submitted in a district court case referring to Apotex Holdings as the ultimate “parent” of Apotex Corp. and Apotex Inc. Patent Owner asserted that these 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.’” Patent Owner also noted that two Apotex Holdings board members serve also as two of three members constituting the board of Apotex Inc., that Dr. Sherman serves as Chairman of each of Apotex Holdings, Apotex Inc., and Apotex Corp., and that Dr. Sherman testified in a district court case that he “directs all litigation for Apotex.” Accordingly, Patent Owner asserted that Dr. Sherman “has the ultimate control of and responsibility for Apotex’s litigation.”

The Board noted that the mere existence of a parent-subsidiary relationship is insufficient to justify a parent’s status as a RPI. The Board did not believe the evidence provided by Patent Owner was sufficient “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.”

Also, Petitioner submitted testimony from Mr. Zive declaring 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.” Additionally, Mr. Zive declared that Apotex Holdings was not involved in the decision to file the Petition or preparation thereof, is not paying any portion of the fees associated with the Petition, and the outside counsel handling the Petition corresponds and sends all of its bills directly and only to Apotex Inc. The Board found Mr. Zive’s unchallenged testimony persuasive and sufficient to overcome Patent Owner’s allegations, and thus the Board declined to dismiss the Petition for allegedly failing to provide Apotex Holdings as a RPI.
The Board then proceeded to analyze one of the obviousness grounds asserted by Petitioner. Upon review and in light of there being no substantive argument against the rationale used in the Petition for the obviousness ground in the Patent Owner Preliminary Response, the Board was persuaded 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.

The Petition included three other obviousness grounds alleging claims 1-27 are obvious: one based on Coniglio alone, one based on Bernat and Asai, and one based on Bernat and Koike. The Board exercised its discretion to decline proceeding one these three grounds, because they challenge the same claims and involve one or more of the same references.

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 Ld., Glenmark Pharmaceuticals Ltd., Panace Biotec Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, Inc., Zydus Pharmaceuticals USA, Inc., and Cadila Healthcare Ltd. v. Daiichi Sankyo Company, Ltd. and UBE Industries, Ltd., IPR2015-00864

Dated: September 15, 2015

Paper 28: Decision Granting Institution of Inter Partes Review

Patent 8,404,703 B2

Before: Erica A. Franklin, Tina E. Hulse, and Christopher G. Paulraj

Written by: Franklin

Related Proceedings: Eli Lilly and Co., et al. v. Accord Healthcare, Inc. et al., No. 1:14-cv-00389-SEB-TAB (S.D. Ind. March 12, 2014)