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

Transcription

1 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD FRESENIUS KABI USA, LLC, Petitioner, v. HOSPIRA, INC., Patent Owner Case No.: IPR Patent No. 8,338, MOTION FOR JOINDER UNDER 35 U.S.C. 315(c) AND 37 C.F.R AND (b) Mail Stop PATENT BOARD Patent Trial and Appeal Board U.S. Patent and Trademark Office P.O. Box 1450 Alexandria, VA

2 TABLE OF CONTENTS I. Introduction... 2 II. Statement of the Precise Relief Requested... 3 III. Governing Law, Rules, and Precedent... 3 IV. Statement of Material Facts... 5 V. Argument... 6 A. No New Grounds of Unpatentability Are Asserted in this Petition B. Joinder Is Appropriate Under the Governing Law, Rules, and Precedent C. Joinder Will Have a Minimal Impact on the Trial Schedule and Costs for the Existing IPR... 9 D. Procedures to Simplifying Briefing and Discovery VI. Conclusion... 12

3 I. INTRODUCTION Motion for Joinder Fresenius Kabi USA, LLC ( Fresenius Kabi ) moves for joinder of the accompanying Inter Partes Review ( IPR ) Petition, filed March 8, 2017, Fresenius Kabi USA, LLC v. Hospira, Inc., Case No. IPR , with Amneal Pharmaceuticals LLC v. Hospira, Inc., Case No. IPR , for at least the following reasons: (1) joinder is appropriate under the governing law, rules, and precedent of this Board; (2) this Motion for Joinder is timely filed; (3) the two proceedings concern the same parties, same patent, and same prior art; (4) Fresenius Kabi relies in whole on the same evidence and same declaration testimony in both proceedings; (5) joinder would neither complicate the issues nor unduly delay the existing schedule of IPR ; (6) joinder would significantly simplify briefing and discovery in the two IPRs, and will have no impact on the existing schedule; and (7) joinder will not prejudice any party. Finally, joinder here will secure a just, speedy, and inexpensive resolution in both proceedings, more so than in the absence of joinder, by avoiding having the Board preside over two separate proceedings involving identical and duplicative filings and reviews of the same issues. 2

4 II. Motion for Joinder STATEMENT OF THE PRECISE RELIEF REQUESTED Fresenius Kabi requests joinder under 35 U.S.C. 315(c) and 37 C.F.R and (b) of the concurrently-filed petition for IPR of claims 1-7 of U.S. Patent No. 8,338,470 ( the 470 patent ) with the related and instituted IPR, Amneal Pharmaceuticals LLC v. Hospira, Inc., Case No. IPR ( the Amneal IPR ). Fresenius Kabi notified counsel for Petitioner Amneal Pharmaceuticals LLC ( Amneal ) and Patent Owner Hospira, Inc. ( Hospira ) in the Amneal IPR of this Motion, requesting their consent for Joinder. Amneal has provided its consent, but Hospira has not to date. III. GOVERNING LAW, RULES, AND PRECEDENT Title 35 U.S.C. 315(c) states: If the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311 that the Director, after receiving a preliminary response under section 313 or the expiration of the time for filing such a response, determines warrants the institution of an inter partes review under section 314. Title 37 C.F.R (b) states: Joinder may be requested by a patent owner or petitioner. Any request for joinder must be filed, as a motion under 42.22, no later than one month after the institution date of any inter partes review for which joinder is requested. The time period set forth in (b) shall not apply when the petition is accompanied by a request for joinder. 3

5 The Board has repeatedly allowed joinder of IPR proceedings when a second petition raises the same ground(s) of unpatentability as those instituted in a first proceeding. See, e.g., Wockhardt Bio AG v. Jazz Pharms., Inc., IPR , Paper 10 (PTAB Oct. 30, 2015); Mylan Pharms. Inc. v. Novartis AG, et al., IPR , Paper 17 (PTAB Apr. 10, 2015); Apple, Inc. v. Smartflash LLC, CBM , Paper 11 (PTAB Aug. 6, 2015); LG Elec., Inc. v. Innovative Display Techs. LLC, IPR , Paper 10 (July 15, 2015); Cisco Sys., Inc., et al. v. Straight Path IP Grp., Inc., IPR , Paper 12 (PTAB June 5, 2015). Indeed, there is a policy preference for joining a party that does not present new issues that might complicate or delay an existing proceeding. See Dell Inc. v. Network-1 Sec. Solutions, Inc., IPR , Paper 17 at 10 (PTAB July 29, 2013) (citing 157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) (statement of Sen. Kyl) ( The Office anticipates that joinder will be allowed as of right if an inter partes review is instituted on the basis of a petition, for example, a party that files an identical petition will be joined to that proceeding, and thus allowed to file its own briefs and make its own arguments. ) (emphasis added)). That is precisely the situation here. Fresenius Kabi s concurrently-filed Petition is essentially identical to the petition filed in the instituted Amneal IPR. In accordance with the Board s governing law and rules, each of the factors supporting joinder are present in this Motion for Joinder: (1) reasons why joinder is 4

6 appropriate; (2) the lack of any new grounds of unpatentability being raised in the subsequent petition; (3) what impact (if any) there will be on the trial schedule for the existing review; and (4) how briefing and/or discovery may be simplified to minimize schedule impact. Kyocera Corp. v. Softview, LLC, IPR , Paper 15 at 4 (PTAB April 24, 2013); see also Samsung Elecs. Co. Ltd. v. Unifi Sci. Batteries, LLC, IPR , Paper 22 at 3 (PTAB Oct. 17, 2013). Each of these factors is addressed below. IV. STATEMENT OF MATERIAL FACTS On January 15, 2016, Hospira sued Fresenius Kabi for infringement of the 470 patent in the United States District Court for the Northern District of Illinios 1 ; On August 10, 2016, Amneal requested IPR of claims 1-7 of the 470 patent under three grounds of unpatentability. See IPR , Paper 2; 1 Fresenius Kabi is not barred from filing its Petition, even though it was served with a complaint asserting infringement of the 470 patent more than one year before filing the Petition, because Fresenius Kabi concurrently seeks joinder with IPR See 35 U.S.C. 315(b)-(c); e.g., Aurobindo Pharma U.S.A., Inc. v. AstraZeneca AB, IPR , Paper 12 at 7-9 (PTAB Oct. 21, 2016). 5

7 On November 10, 2016, Hospira filed its Patent Owner Preliminary Response. See id., Paper 9; On February 9, 2017, the Board instituted the Amneal IPR on one ground asserting that claims 1-7 of the 470 patent would have been obvious over the prior art pursuant to 35 U.S.C See id., Papers 11, 12. This ground is: 2010 Precedex Label in view of De Giorgi, Eichhorn, Palmgren, and Lavoisier. Id., Paper 11 at 15; Fresenius Kabi s Petition that accompanies the present Motion for Joinder was filed within one month of the February 9, 2017 decision to institute the Amneal IPR, and includes only the same grounds of unpatentability that were included in the Amneal IPR Petition; and Fresenius Kabi s Petition that accompanies the present Motion for Joinder and accompanying evidence are the same as the instituted Amneal IPR Petition, aside from procedural sections that, for example, identify Fresenius Kabi, any real parties in interest, and its standing. V. ARGUMENT This Motion for Joinder addresses the criteria identified by the Board in Kyocera Corp., IPR , Paper 15. Each factor is addressed below and all compel granting the instant motion. 6

8 A. No New Grounds of Unpatentability Are Asserted in this Petition. Fresenius Kabi s Petition does not assert any grounds of unpatentability additional to those asserted in the Amneal IPR. Fresenius Kabi challenges the same 470 patent claims based on the same arguments, evidence, and ground of unpatentability on which the Board instituted review in the Amneal IPR. For efficiency, Fresenius Kabi does not include additional prior art or combinations in its Petition, which it will continue to assert separately in its ongoing civil litigation with Hospira. See Shaw Indus. Grp., Inc. v. Automated Creel Sys., Inc., 817 F.3d 1293, 1300 (Fed. Cir. 2016). B. Joinder Is Appropriate Under the Governing Law, Rules, and Precedent. The Board has authority to join a properly-filed IPR petition to an instituted IPR proceeding. See 35 U.S.C. 315(c). Fresenius Kabi s Petition is properly filed under 35 U.S.C. 311 and timely under 37 C.F.R (b), that is, within one month of the Board s February 9, 2017 decision to institute the Amneal IPR. See Amneal IPR, IPR , Paper 11. Further, joinder is appropriate according to the Board s rationale applied in previous cases. As discussed above, the Board has granted numerous requests for joinder of IPR proceedings under circumstances similar to the instant proceeding. For example, in LG Electronics, the Board granted joinder of a second petition challenging the same claims on the same Grounds as that instituted in the first 7

9 proceeding. See LG Elec., IPR , Paper 10. This rationale has been applied by the Board in other cases. See, e.g., ION Geophysical, et al. v. WesternGeco LLC, IPR , Paper 14 at 4-5 (PTAB Apr. 23, 2015) (granting joinder when both patent owner and previous petitioner opposed because it facilitates scheduling of the joined actions and minimizes delay ); Wockhardt Bio AG, IPR , Paper 10; Mylan Pharms., IPR , Paper 17; Apple, Inc., CBM , Paper 11; Cisco Sys., IPR , Paper 12. And the Board s consistent reasoning is equally applicable here: Fresenius Kabi s Petition challenges the same claims at issue in the existing trial; relies on the same prior art as the existing trial; and relies on the same testimony from the same expert witness as in the existing trial. Thus, in accordance with the Board s previously applied rationale, joinder of these proceedings is appropriate and will secure the just, speedy, and inexpensive resolution in every proceeding. 37 C.F.R. 42.1(b). Further, Hospira has asserted the 470 patent against Fresenius Kabi in concurrent district court litigation. See Hospira, Inc. v. Fresenius Kabi USA, LLC, 16-cv-0651 (N.D. Ill.). Fresenius Kabi and Amneal have coordinated fact discovery in their separate suits by jointly taking depositions of Hospira s fact witnesses. As such, allowing Fresenius Kabi to participate in the Amneal IPR will allow Fresenius Kabi and Hospira to resolve the underlying litigation between the 8

10 parties in a cost effective, expeditious manner should Amneal seek to terminate its participation in the Amneal IPR based on settlement or other factors. Moreover, any opposition by Hospira, to the extent it files any, cannot dispute the overwhelming efficiencies that will be promoted by joinder. In fact, these parties have not to date articulated any reason why joinder is not appropriate or would otherwise present any undue burden. Indeed, without joinder, it will be the Board that will be burdened by having needlessly to adjudicate and preside over two proceedings involving the same patent, same issues, same patent owner, same evidence, and same expert declarations. Therefore, granting joinder will avoid wasteful duplicative filings and reviews of the same issues across multiple proceedings. See, e.g., Wockhardt Bio AG, IPR , Paper 10 at 4. C. Joinder Will Have a Minimal Impact on the Trial Schedule and Costs for the Existing IPR Joinder will have minimal indeed, likely no impact on the trial schedule and costs for the existing Amneal IPR because of the substantial overlap between the two petitions. Based on Fresenius Kabi s review of the papers Amneal has submitted to date in the instant IPR, Fresenius Kabi s substantive interests completely align with Amneal s, and Fresenius Kabi foresees no substantive issues or arguments on which it would depart from Amneal s submissions going forward. Accordingly, Fresenius Kabi is prepared to adopt any papers submitted by Amneal the joined IPR proceeding. Thus, even though Amneal has not yet agreed 9

11 to coordinate with Fresenius Kabi on joint submissions, their agreement is not necessary because any filing will be public and Fresenius Kabi is willing to agree to adopt Amneal s filings, including the testimony from the same expert witness(es) as in the instituted trial. See ION Geophysical, IPR , Paper 14 at 4-5; See Wockhardt Bio AG, IPR , Paper 10 at 3. To the extent that a modest adjustment might be required and Fresenius Kabi foresees no such need Title 35 U.S.C. 316(a)(11) allows the Director to adjust the time periods in the case of joinder. See also, 37 C.F.R (c). Accordingly, the Board has granted extensions in other trial schedules to accommodate joinder. See Ariosa Diagnostics v. Isis Innovation Ltd., IPR , Paper 24 at 5 (PTAB Sept. 3, 2013) ( while some adjustments to the schedule have been necessary, there is not undue delay. ); see also Microsoft Corp. v. Proxyconn, Inc., IPR , Paper 15 at 4-5 (PTAB Feb. 25, 2013); Samsung Elec. Co., Ltd. v. Virginia Innovation Sci., Inc., IPR , Paper 10 at 18 (PTAB June 13, 2014). And any alleged prejudice or burden to Hospira if not entirely nonexistent is outweighed by the public interest in obtaining a speedy and efficient resolution of all the patentability issues of the 470 patent in a single proceeding, with minimal burden on this Board. 10

12 D. Procedures to Simplifying Briefing and Discovery Briefing and discovery in the joined proceeding can be simplified to minimize any impact to the schedule or the volume of materials submitted to the Board. Given that Fresenius Kabi and Amneal will rely upon the same prior art and the same bases for rejection of the same claims using the same expert(s), Fresenius Kabi envisions few, if any, differences in position. In the unlikely event that there might be a procedural issue or statement by Amneal in the joined IPR with which Fresenius Kabi disagrees and to be sure Fresenius Kabi foresees none at this time Fresenius Kabi will request a conference call to seek permission and explain its reasons to submit a short separate filing, if needed, of no more than 3-5 pages directed to points of procedural disagreement with the other petitioners, at the Board s discretion. Cf. Apple, Inc., CBM , Paper 11 at 5-6. And Fresenius Kabi accepts that it will not be permitted any separate arguments in furtherance of those advanced in Amneal s filings. See, e.g., Motorola Mobility LLC v. Softview LLC, IPR , Paper 10 at 9 (PTAB June 20, 2013). The Board can also allow the patent owner a corresponding number of pages to respond to any separate filings. See Dell Inc., IPR , Paper 17 at 8; Motorola Mobility, IPR , Paper 10 at

13 Additionally, Fresenius Kabi will not seek to submit any new expert declarations from those entered by Amneal, except to the extent that for some unlikely reason Fresenius Kabi is precluded from relying on Amneal s experts declarations, e.g., if Amneal settles with Hospira and contractually bind their experts from continuing in the IPR with Fresenius Kabi. Further, Fresenius Kabi agrees that it will not seek additional time at any deposition and that Amneal will be permitted to ask questions before Fresenius Kabi. And Fresenius Kabi agrees that it will not seek any additional time at any oral argument. Indeed, Fresenius Kabi intends to maintain a secondary role in the joined proceeding. Fresenius Kabi will assume a primary role only if Amneal ceases to participate in the IPR, or to the extent Amneal willingly seeks more prominent participation from Fresenius Kabi s counsel. These concessions by Fresenius Kabi remove any alleged complication or delay caused by joinder, while providing the parties an opportunity to address all issues that may arise and avoiding any undue burden on Hospira, Amneal, and the Board. See, e.g., Motorola Mobility, IPR , Paper 10 at 9. VI. CONCLUSION For the foregoing reasons, Fresenius Kabi requests that its Petition for IPR of the 470 patent be granted, and that the Board grant this Motion and join this proceeding with the Amneal IPR. Joinder will ensure a just, speedy, and 12

14 inexpensive resolution in both proceedings, and it will promote efficiency by avoiding duplicative filings and reviews of the same issues. Date: March 8, 2017 Imron T. Aly USPTO Reg. No. 48,706 Respectfully submitted, /Imron T. Aly/ Imron T. Aly USPTO Reg. No. 48,706 Jason Harp USPTO Reg. No. 42,634 Schiff Hardin LLP 233 South Wacker Drive Chicago, Illinoi Phone: (312) Fax: (312) Attorneys for Petitioner, Fresenius Kabi USA, LLC 13

15 CERTIFICATE OF SERVICE In accordance with 37 C.F.R , I hereby certify that on March 8, 2017, a true copy of the accompanying MOTION FOR JOINDER UNDER 35 U.S.C. 315(c) AND 37 C.F.R AND (b) was served via electronic mail ( ) to Sandra Lee, Eliot Williams, and Stephen Hash at sandra.lee@bakerbotts.com, eliot.williams@bakerbotts.com, and stephen.hash@bakerbotts.com under 37 C.F.R. 42.6(e)(1) and (b), as agreed upon by the parties. Date: March 8, 2017 Imron T. Aly ialy@schiffhardin.com USPTO Reg. No. 48,706 Respectfully submitted, /Imron T. Aly/ Imron T. Aly ialy@schiffhardin.com USPTO Reg. No. 48,706 Jason Harp jharp@schiffhardin.com USPTO Reg. No. 42,634 Schiff Hardin LLP 233 South Wacker Drive Chicago, Illinoi Phone: (312) Fax: (312) Attorneys for Petitioner, Fresenius Kabi USA, LLC