Paper No. ___
`Filed: July 8, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`WOCKHARDT BIO AG
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`PETITIONER
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`V.
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`ELI LILLY & COMPANY
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`PATENT OWNER
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`CASE NO.: UNASSIGNED
`PATENT NO. 7,772,209
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`MOTION FOR JOINDER UNDER 35 U.S.C. § 315(c)
`AND 37 C.F.R. §§ 42.22 AND 42.122(b)
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Filed: July 8, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`WOCKHARDT BIO AG
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`PETITIONER
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`V.
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`ELI LILLY & COMPANY
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`PATENT OWNER
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`CASE NO.: UNASSIGNED
`PATENT NO. 7,772,209
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`MOTION FOR JOINDER UNDER 35 U.S.C. § 315(c)
`AND 37 C.F.R. §§ 42.22 AND 42.122(b)
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`TABLE OF CONTENTS
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`Page
`Statement of precise relief requested ............................................................... 1
`I.
`Governing law, rules and precedent ................................................................ 2
`II.
`Statement of material facts .............................................................................. 4
`III.
`IV. Argument ......................................................................................................... 4
`A. No new grounds of unpatentability are asserted in this Petition ........... 5
`B.
`Joinder is appropriate under the governing law, rules, and precedent .. 5
`C.
`Joinder will have at most a minimal impact on the trial schedule and
`costs for the existing IPR ...................................................................... 7
`Procedures to simplify briefing and discovery...................................... 9
`D.
`Conclusion ..................................................................................................... 10
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`V.
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`ii
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`Wockhardt Bio AG (“Wockhardt”) moves for joinder of the accompanying
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`Inter Partes Review (“IPR”) Petition filed concurrently herewith, (Wockhardt Bio
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`AG, et al. v. Eli Lilly & Company, Case No. unassigned), with Sandoz, Inc. v. Eli
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`Lilly & Company, Case No. IPR2016-00318, for at least the following reasons: (1)
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`joinder is appropriate under the governing law, rules, and precedent of this Board;
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`(2) this Motion for Joinder is timely filed; (3) the two proceedings concern the
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`same parties, same patent, and same prior art; (4) Wockhardt relies in whole on the
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`same evidence and same declaration testimony in both proceedings; (5) joinder
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`would neither complicate the issues nor unduly delay the existing schedule of
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`IPR2016-00318; (6) joinder would significantly simplify briefing and discovery in
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`the two IPRs, and will have no impact on the existing schedule; and (7) joinder
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`will not prejudice any party. Finally, joinder here will secure a just, speedy, and
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`inexpensive resolution in both proceedings, more so than in the absence of joinder,
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`by avoiding having the Board preside over two separate proceedings involving
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`identical and duplicative filings and reviews of the same issues.
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`I.
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`Statement of precise relief requested
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`Wockhardt requests joinder under 35 U.S.C. § 315(c) and 37 C.F.R. §§
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`42.22 and 42.122(b) of the concurrently-filed petition for IPR of claims 1-22 of
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`U.S. Patent No. 7,772,209 (the “’209 Patent”) with the related and instituted IPR,
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`1
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`Sandoz, Inc. v. Eli Lilly & Company, Case No. IPR2016-00318 (the “Sandoz
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`IPR”).
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`II. Governing law, rules and precedent
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`Title 35 U.S.C. § 315(c) states:
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`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.
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`Title 37 C.F.R. § 42.122(b) states:
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`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 §42.101(b) shall not apply when the petition is accompanied
`by a request for joinder.
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`The Board has repeatedly allowed joinder of IPR proceedings when a second
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`petition raises the same ground(s) of unpatentability as those instituted in a first
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`proceeding. See, e.g., Mylan Pharms. Inc. v. Novartis AG, et al., IPR2015-00268,
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`Paper 17 (PTAB Apr. 10, 2015); Apple, Inc. v. SmartFlash LLC, CBM2015-00119,
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`Paper 11 (PTAB Aug. 6, 2015); LG Elec., Inc. v. Innovative Display Techs. LLC,
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`2
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`IPR2015-00493, Paper 10 (July 15, 2015); Cisco Sys., Inc., et al. v. Straight Path
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`IP Grp., Inc., IPR2015-01006, Paper 12 (PTAB June 5, 2015).
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`Indeed, there is a “policy preference for joining a party that does not present
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`new issues that might complicate or delay an existing proceeding.” See Dell Inc. v.
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`Network-1 Sec. Solutions, Inc., IPR2013-00385, Paper 17 at 10 (PTAB July 29,
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`2013) (citing 157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) (statement of Sen.
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`Kyl) (“The Office anticipates that joinder will be allowed as of right - if an inter
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`partes review is instituted on the basis of a petition, for example, a party that files
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`an identical petition will be joined to that proceeding, and thus allowed to file its
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`own briefs and make its own arguments.”) (emphasis added)).
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`That is precisely the situation here. In accordance with the Board’s
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`governing law and rules, each of the factors supporting joinder are present in this
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`Motion for Joinder: (1) reasons why joinder is appropriate; (2) the lack of any new
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`grounds of unpatentability being raised in the subsequent petition; (3) what impact
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`(if any) there will be on the trial schedule for the existing review; and (4) how
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`briefing and/or discovery may be simplified to minimize schedule impact. Kyocera
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`Corp. v. Sofiview, LLC, IPR2013-00004, Paper 15 at 4 (PTAB April 24, 2013); see
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`also Samsung Elecs. Co. Ltd. v. Unifi Sci. Batteries, LLC, IPR2013-00236, Paper
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`22 at 3 (PTAB Oct. 17, 2013).
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`Each of these factors is addressed below.
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`3
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`III. Statement of material facts
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`● On December 14, 2015, Sandoz requested IPR of claims 1-22 of the ’209
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`Patent under two grounds of unpatentability. See IPR2016-00318, Paper
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`2;
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`● On June 16, 2016, the Board instituted the Sandoz IPR on the two
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`requested grounds that claims 1-22 of the ’209 Patent would have been
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`obvious over the prior art pursuant to 35 U.S.C. § 103. See id., Paper 14;
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`● The Wockhardt Petition that accompanies the present Motion for Joinder
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`was filed within one month of the decision noted above in the Sandoz
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`IPR, and includes the same grounds of unpatentability that were
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`instituted in the Sandoz IPR; and
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`● The Wockhardt Petition that accompanies the present Motion for Joinder
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`and accompanying evidence are identical to the instituted Sandoz IPR
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`Petition, aside from procedural sections that, for example, identify
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`Wockhardt, any real parties in interest, its standing, and updated related
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`matters, etc.
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`IV. Argument
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`This Motion for Joinder addresses the criteria identified by the Board in
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`Kyocera Corp., IPR2013-00004, Paper 15. Each factor is addressed below and all
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`compel granting the instant motion.
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`4
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`A. No new grounds of unpatentability are asserted in this Petition
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`The Wockhardt Petition does not assert any new grounds of unpatentability.
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`It challenges the same ’209 Patent claims based on the same arguments, evidence,
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`and ground of unpatentability on which the Board instituted review in the Sandoz
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`IPR.
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`B.
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`Joinder is appropriate under the governing law, rules, and
`precedent
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`The Board has authority to join a properly-filed IPR petition to an instituted
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`IPR proceeding. See 35 U.S.C. § 315(c). Wockhardt’s Petition is properly filed
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`under 35 U.S.C. § 311 and timely under 37 C.F.R. § 42.122(b), that is, within one
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`month of the Board’s June 16, 2016 decision to institute the Sandoz IPR. See
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`IPR2016-00318, Paper 14.
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`Further, joinder is appropriate according to the Board’s rationale applied in
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`previous cases. As discussed above, the Board has granted numerous requests for
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`joinder of IPR proceedings under circumstances similar to the instant proceeding.
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`For example, in LG Elec., the Board granted joinder of a second petition
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`challenging the same claims on the same Grounds as that instituted in the first
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`proceeding. See LG Elec., IPR2015-00493, Paper 10. This rationale has been
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`applied by the Board in other cases. See, e.g., ION Geophysical, et al. v.
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`WesternGeco LLC, IPR2015-00565, Paper 14 at 4-5 (PTAB Apr. 23, 2015)
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`(granting joinder when both patent owner and previous petitioner initially opposed
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`5
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`because it “facilitates scheduling of the joined actions and minimizes delay”);
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`Mylan Pharms., IPR2015-00268, Paper 17; Apple, Inc., CBM2015-00119, Paper
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`11; Cisco Sys., IPR2015-01006, Paper 12; Wockhardt Bio AG v. Jazz
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`Pharmaceuticals, Inc., IPR2015-01813, Paper 10; IPR2015-01814, Paper 10;
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`IPR2015-01815, Paper 10; IPR2015-01816, Paper 10; IPR2015-01818, Paper 10;
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`and IPR2015-01820, Paper 10.
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`The Board’s consistent reasoning is equally applicable here: Wockhardt’s
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`Petition challenges the same claims at issue in the existing trial; relies on the same
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`prior art as the existing trial; and relies on the same testimony from the same expert
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`witness(es) as in the existing trial. Thus, in accordance with the Board’s
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`previously applied rationale, joinder of these proceedings is appropriate and will
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`“secure the just, speedy, and inexpensive resolution in every proceeding.” 37
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`C.F.R. § 42.1(b).
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`Further, Lilly has asserted the ’209 Patent and related patents against
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`numerous parties in concurrent district court litigation (See, e.g., IPR2016-00318,
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`Paper 2, pp. 2-4, and Paper Nos. 6, 9, 10 and 13). Wockhardt is considering taking
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`similar actions as those taken by the numerous defendants that created the basis for
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`the related district court litigation matters, and consequently, reasonably believes
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`that it also will be named as a defendant in district court litigation with respect to at
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`least the ’209 Patent. As such, allowing Wockhardt to participate in the Sandoz
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`6
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`IPR will allow Wockhardt and Lilly to resolve any potential litigation between the
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`parties in a cost effective, expeditious manner should Sandoz seek to terminate
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`their participation in the Sandoz IPR based on settlement or other factors.
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`Moreover, any opposition by Lilly or Sandoz, to the extent they file any,
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`cannot overcome the overwhelming efficiencies that will be promoted by joinder.
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`Indeed, without joinder, it will be the Board that will be burdened by having
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`needlessly to adjudicate and preside over two proceedings involving the same
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`patent, same issues, same patent owner, same evidence, and same expert
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`declarations. Therefore, granting joinder will avoid wasteful duplicative filings and
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`reviews of the same issues across multiple proceedings.
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`C.
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`Joinder will have at most 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
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`and costs for the existing Sandoz IPR because of the substantial overlap between
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`the two petitions. Based on Wockhardt’s review of the papers Sandoz has
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`submitted to date in the related portions of the previously-filed IPR petition
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`involving the ’209 Patent, Wockhardt’s substantive interests align with Sandoz,
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`and Wockhardt foresees no substantive issues or arguments on which it would
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`depart from Sandoz’s submissions going forward.
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`Accordingly, Wockhardt is prepared to adopt any papers submitted by
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`Sandoz in the joined IPR proceeding. Thus, even though Sandoz has not yet agreed
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`7
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`to coordinate with Wockhardt on joint submissions, their agreement is not
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`necessary because any filing will be public and Wockhardt is willing to agree to
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`adopt them, including the testimony from the same expert witness(es) as in the
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`instituted trial. See ION Geophysical, IPR2015-00555, Paper 14 at 4-5.
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`To the extent that a modest adjustment might be required⎯and Wockhardt
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`foresees no such need⎯Title 35 U.S.C. § 316(a)(11) allows the Director to “adjust
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`the time periods ... in the case of joinder.” See also, 37 C.F.R. § 42.100(c).
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`Accordingly, the Board has granted extensions in other trial schedules to
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`accommodate joinder. See Ariosa Diagnostics v. Isis Innovation Ltd., IPR2013-
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`00250, Paper 24 at 5 (PTAB Sept. 3, 2013) (“while some adjustments to the
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`schedule have been necessary, there is not undue delay.”); see also Microsoft Corp.
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`v. Proxyconn, Inc., IPR2013-00109, Paper 15 at 4-5 (PTAB Feb. 25, 2013);
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`Samsung Elec. Co., Ltd. v. Virginia Innovation Sci., Inc., IPR2014-00557, Paper 10
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`at 18 (PTAB June 13, 2014).
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`Any “alleged” prejudice or burden to Lilly or Sandoz⎯if not entirely
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`nonexistent is outweighed by the public interest in obtaining a speedy and efficient
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`resolution of all the patentability issues of the ’209 Patent in a single proceeding,
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`with minimal burden on this Board.
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`8
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`D.
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`Procedures to simplify briefing and discovery
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`Briefing and discovery in the joined proceeding can be simplified to
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`minimize any impact to the schedule or the volume of materials submitted to the
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`Board. Given that Wockhardt and Sandoz will rely upon the same prior art and the
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`same bases for rejection of the same claims using the same expert(s), Wockhardt
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`envisions few, if any, differences in position.
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`In the unlikely event that there might be a procedural issue or statement by
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`Sandoz in the joined IPR with which Wockhardt disagrees⎯and to be sure
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`Wockhardt foresees none at this time⎯Wockhardt will request a conference call to
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`seek permission and explain its reasons to submit a short separate filing, if needed,
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`of no more than 3-5 pages directed to points of procedural disagreement with
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`Sandoz, at the Board’s discretion. Cf. Apple, Inc., CBM2015-00119, Paper 11 at 5-
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`6. Wockhardt accepts that it will not be permitted any separate arguments in
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`furtherance of those advanced in Sandoz’s filings. See, e.g., Motorola Mobility
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`LLC v. Softview LLC, IPR2013-00256, Paper 10 at 9 (PTAB June 20, 2013). The
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`Board also can allow the patent owner a corresponding number of pages to respond
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`to any separate filings. See Dell Inc., IPR2013-00385, Paper 17 at 8; Motorola
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`Mobility, IPR2013-00256, Paper 10 at 8-9.
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`In addition, Wockhardt will not seek to submit any new expert declarations
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`from those entered by Sandoz, except to the extent that for some unlikely reason
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`9
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`Wockhardt is precluded from relying on Sandoz’s experts’ declarations, e.g., if
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`Sandoz were to settle with Lilly and contractually bind their experts from
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`continuing in the IPR with Wockhardt. Further, Wockhardt agrees that it will not
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`seek additional time at any deposition and that Sandoz will be permitted to ask
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`questions before Wockhardt. Wockhardt further agrees that it will not seek any
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`additional time at any oral argument. Indeed, Wockhardt intends to maintain a
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`secondary role in the joined proceeding.
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`Wockhardt will assume a primary role only if Sandoz ceases to participate in
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`the IPR, or to the extent Sandoz willingly seeks more prominent participation from
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`Wockhardt’s counsel. These concessions by Wockhardt remove any alleged
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`“complication or delay” or scheduling concerns caused by joinder, while providing
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`the parties an opportunity to address all issues that may arise and avoid any undue
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`burden on Lilly, Sandoz, and the Board. See, e.g., IPR2013-00256, Paper 10 at 9.
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`V. Conclusion
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`For the foregoing reasons, Wockhardt requests that its Petition for IPR of the
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`’209 Patent be granted, and that the Board grant this Motion and join this
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`proceeding with the Sandoz IPR. Joinder will ensure a just, speedy, and
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`inexpensive resolution in both proceedings, and will promote efficiency by
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`10
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`avoiding duplicative filings and reviews of the same issues.
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`Date: July 8, 2016
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`Direct: (703) 770-7755
`Main: (703) 770-7900
`Fax: (703) 770-7901
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`By:
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`Respectfully submitted,
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`/Patrick A. Doody/
`Patrick A. Doody, Reg. No. 35,022
`Bryan P. Collins, Reg. No. 43,560
`Pillsbury Winthrop Shaw Pittman LLP
`P.O. Box 10500
`McLean, Virginia 22102
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`Attorneys for Petitioner
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`11
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`CERTIFICATION OF SERVICE
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`The undersigned hereby certifies that the above-captioned MOTION FOR
`JOINDER UNDER 35 U.S.C. § 315(c) AND 37 C.F.R. §§ 42.22 AND 42.122(b)
`was served in its entirety on July 8, 2016, upon the following parties via Express
`mail:
`
`
`Elizabeth A. McGraw
`Eli Lilly and Company
`Patent Division
`P.O. Box 6288
`Indianapolis, Indiana 46206-6288
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`Dov P. Grossman, Reg. No. 72,525
`Williams & Connolly, LLP
`725 12th Street, N.W.
`Washington, DC 20005
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`By:
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`/Patrick A. Doody/
`Patrick A. Doody, Reg. No. 35,022
`Pillsbury Winthrop Shaw Pittman LLP
`P.O. Box 10500
`McLean, Virginia 22102
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`Attorney for Petitioner
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`Date: July 8, 2016
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`Direct: (703) 770-7755
`Main: (703) 770-7900
`Fax: (703) 770-7901
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