Paper No. __
`Filed July 1, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_____________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_____________________
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`APOTEX INC. and APOTEX CORP.
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`Petitioners
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`V.
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`ELI LILLY & COMPANY
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`Patent Owner
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`_____________________
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`U.S. Patent No. 7,772,209
`Filed: July 11, 2007
`Issued: August 10, 2010
`Inventor: Clet Niyikiza
`
`TITLE: ANTIFOLATE COMBINATION THERAPIES
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`_____________________
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`Inter Partes Review No.: IPR2016-01190
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`————————————————
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`PETITIONERS’ MOTION FOR JOINDER
`PURSUANT TO 35 U.S.C. § 315(c) AND 37 C.F.R. §§ 42.22 AND 42.122(b)
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`TABLE OF AUTHORITIES .................................................................................... ii
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`TABLE OF AUTHORITIES .................................................................................. .. ii
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`TABLE OF CONTENTS
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`TABLE OF CONTENTS
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`I.
`I.
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`II.
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`II.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 1
`STATEMENT OF THE PRECISE RELIEF REQUESTED ........................ ..1
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`STATEMENT OF MATERIAL FACTS ........................................................ 2
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`STATEMENT OF MATERIAL FACTS ...................................................... ..2
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`III.
`III.
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`STATEMENT OF REASONS FOR RELIEF REQUESTED ........................ 3
`STATEMENT OF REASONS FOR RELIEF REQUESTED ...................... ..3
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`A.
`A.
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`Reasons Why Joinder Is Appropriate .................................................... 4
`Reasons Why Joinder Is Appropriate .................................................. ..4
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`1.
`1.
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`2.
`2.
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`Substantively Identical Petitions ................................................. 5
`Substantively Identical Petitions ............................................... ..5
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`Consolidated Filings and Discovery ........................................... 6
`Consolidated Filings and Discovery ......................................... ..6
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`No New Grounds of Unpatentability .................................................... 8
`No New Grounds of Unpatentability .................................................. ..8
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`No Impact on IPR Trial Schedule ......................................................... 8
`No Impact on IPR Trial Schedule ....................................................... ..8
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`Briefing and Discovery Will Be Simplified .......................................... 8
`Briefing and Discovery Will Be Simplified ........................................ ..8
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`Joinder Will Not Prejudice Lilly or Neptune ........................................ 9
`Joinder Will Not Prejudice Lilly or Neptune ...................................... ..9
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`B.
`B.
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`C.
`C.
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`D.
`D.
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`E.
`E.
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`IV. PROPOSED ORDER .................................................................................... 10
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`PROPOSED ORDER .................................................................................. .. 10
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`IV.
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`V.
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`V.
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`CONCLUSION .............................................................................................. 10
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`CONCLUSION ............................................................................................ ..1O
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`i
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`TABLE OF AUTHORITIES
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`Federal Cases
`Amneal Pharma., Inc. v. Yeda Res. and Dev. Co., Ltd.,
`IPR2015-01976 ....................................................................................................... 2
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`Dell, Inc. v. Network-1 Security Solutions, Inc.,
`IPR2013-00385 ....................................................................................................... 4
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`Kyocera Corp. et al. v. Softview LLC,
`IPR2013-00004 ....................................................................................................... 1
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`Motorola Mobility LLC v. Softview LLC,
`IPR2013-00256 ....................................................................................................... 1
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`Sanofi-Aventis U.S. LLC and Regeneron Pharmaceuticals, Inc. v. Genentech
`and City of Hope,
`IPR2015-01624 .................................................................................................1, 10
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`Sony Corp. v. Memory Integrity, LLC,
`IPR2015-01376 ....................................................................................................... 2
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`Federal Statutes
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`35 U.S.C. § 315(c) ..................................................................................................1, 3
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`35 U.S.C. § 316(b) ..................................................................................................... 4
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`Federal Regulations
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`37 C.F.R. § 42.1(b) .................................................................................................... 4
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`37 C.F.R. § 42.122(b) ......................................................................................... 1, 2, 3
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`37 C.F.R. § 42.22 ............................................................................................... 1, 2, 3
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`157 CONG. REC. S1376 (daily ed. Mar. 8, 2011) .................................................... 5
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`Other Authorities
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`ii
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`I.
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`STATEMENT OF THE PRECISE RELIEF REQUESTED
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`Petitioners Apotex Inc. and Apotex Corp. (“Apotex”) filed the present petition
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`for inter partes review (“the Apotex IPR”) and respectfully submit this Motion for
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`Joinder. Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22, and 42.122(b), Apotex
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`requests institution of an inter partes review concerning U.S. Patent No. 7,772,209
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`(“the ‘209 patent”) and joinder with the inter partes review concerning the same
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`patent in Neptune Generics, LLC v. Eli Lilly & Co., assigned Case No. IPR2016-
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`00237, (the “Neptune 237 IPR”), which was instituted on June 3, 2016.
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`In accordance with the Board’s Representative Order identifying matters to be
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`addressed in a motion for joinder (Kyocera Corp. et al. v. Softview LLC, Paper No. 15,
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`IPR2013-00004, Apr. 24, 2013), Apotex submits that: (1) joinder is appropriate
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`because it will promote efficient determination of the validity of the ‘209 patent
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`without prejudice to the prior petitioners, Neptune Generics, LLC (“Neptune”), or to
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`the owners of the ‘209 patent, Eli Lilly & Company (“Lilly”); (2) Apotex’s Petition
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`raises the same ground of unpatentability over the same prior art as those instituted by
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`the Board in the Neptune 237 IPR; (3) joinder would not affect the pending schedule
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`in the Neptune 237 IPR nor increase the complexity of that proceeding, thereby
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`minimizing costs; and (4) Apotex is willing to agree to consolidated filings with
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`Neptune to minimize the burden and the impact on the schedule. See, e.g., Motorola
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`Mobility LLC v. Softview LLC, Paper No. 10, IPR2013-00256 (June 20, 2013) and
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`1
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`Amneal Pharm., LLC v. Yeda Res. & Dev. Co., Ltd., Paper No. 9, IPR2015-01976
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`(Dec. 28, 2015) (granting motions for joinder under similar circumstances). As
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`explained below, Apotex proposes to take an “understudy” role in any joined IPR so
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`long as Neptune does not settle and dismiss the Neptune 237 IPR. See, e.g., Sony
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`Corp. v. Memory Integrity, LLC, IPR2015-01376, Paper No. 12, Slip. Op. at 17-18
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`(Sept. 29, 2015) (“In light of [Petitioner’s] . . . understudy role . . ., we conclude
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`they have demonstrated that joinder would not unduly complicate or delay [the
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`earlier IPR].”).
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`This Motion for Joinder is timely under 37 C.F.R. §§ 42.22 and 42.122(b), as it
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`is submitted within one month of June 3, 2016, the date on which the Neptune 237
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`IPR was instituted.
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`II.
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`STATEMENT OF MATERIAL FACTS
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`1.
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`Lilly served Apotex with a complaint asserting infringement of the
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`‘209 patent on or about April 18, 2012. Eli Lilly & Co. v. Apotex Inc., Civ. A. No.
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`12-cv-499 (S.D. Ind., filed April 17, 2012), ECF 12, 13.
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`2.
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`On June 3, 2016, the Board instituted trial on claims 1-22 of the ‘209
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`patent in the Neptune 237 IPR based on one ground of unpatentability raised by
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`Neptune.
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`3.
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`Apotex filed the instant Petition and Motion for Joinder within one
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`month of the June 3, 2016, institution date of the Neptune 237 IPR.
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`2
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`4.
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`The instant petition for IPR filed by Apotex challenges the same
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`patent claims, contains the same instituted ground of unpatentability, and the
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`ground is the same in all substantive aspects as the Neptune 237 IPR. Both
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`petitions contain the same analysis and exhibits, and rely upon the same expert
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`declaration.
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`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`Apotex respectfully requests that the Board exercise its discretion and grant
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`joinder of the Apotex IPR and the Neptune 237 IPR proceedings pursuant to 35
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`U.S.C. § 315(c), 37 C.F.R. § 42.22, and 37 C.F.R. § 42.122(b). In support of this
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`motion, Apotex proposes
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`consolidated
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`filings
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`and other procedural
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`accommodations designed to streamline the proceedings.
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`The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes
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`review proceedings. The statutory provision governing joinder of inter partes
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`review proceedings is 35 U.S.C. § 315(c), which reads as follows:
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`(c) JOINDER.—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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`3
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`In exercising its discretion to grant joinder, the Board considers the impact
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`of substantive and procedural issues on the proceedings, as well as other
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`considerations, while being “mindful that patent trial regulations, including the
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`rules for joinder, must be construed to secure the just, speedy, and inexpensive
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`resolution of every proceeding.” See Dell, Inc. v. Network-1 Security Solutions,
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`Inc., IPR2013-00385, Paper No. 17, Slip Op. at 3 (July 29, 2013). The Board
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`should consider “the policy preference for joining a party that does not present new
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`issues that might complicate or delay an existing proceeding.” Id. at 10. Under
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`this framework, joinder of the present Apotex IPR with the Neptune 237 IPR is
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`appropriate.
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`“A motion for joinder should: (1) set forth the reasons why joinder is
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`appropriate; (2) identify any new grounds of unpatentability asserted in the
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`petition; (3) explain what impact (if any) joinder would have on the trial schedule
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`for the existing review; and (4) address specifically how briefing and discovery
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`may be simplified.” Id. at 4. Each of these is addressed fully below.
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`A. Reasons Why Joinder Is Appropriate
`Joinder is appropriate in this case because it is the most expedient way to
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`secure the just, speedy, and inexpensive resolution of the two related proceedings.
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`See 35 U.S.C. § 316(b); 37 C.F.R. § 42.1(b). Intentionally, the Apotex IPR is
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`substantively identical with respect to the ground instituted in the Neptune 237 IPR
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`4
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`in an effort to avoid multiplication of issues before the Board. Given the
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`duplicative nature of these petitions, joinder of the related proceedings is
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`appropriate and conserves Board resources. Further, Apotex will agree to
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`consolidated filings and discovery, and procedural concessions, so that in this
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`matter Apotex will be bound by the schedule set forth in the Neptune 237 IPR.
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`Substantively Identical Petitions
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`1.
`The instant petition for IPR filed by Apotex challenges the same patent
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`
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`claims, contains the same instituted ground of unpatentability, and is the same in
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`all substantive aspects as the Neptune 237 IPR. Both petitions contain the same
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`analysis and exhibits, and Apotex intends to rely upon the same expert declaration.
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`Because the Board has already instituted trial in the Neptune 237 IPR (Paper No.
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`13), the substantively identical Apotex IPR will not require additional Board
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`resources to determine that institution on the same ground as in the Neptune 237
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`IPR institution decision is appropriate here. See 157 CONG. REC. S1376 (daily ed.
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`Mar. 8, 2011) (statement of Sen. Kyl) (“The Office anticipates that joinder will be
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`allowed as of right—if an inter partes review is instituted on the basis of a petition,
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`for example, a party that files an identical petition will be joined to that
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`proceeding, and thus allowed to file its own briefs and make its own arguments.”)
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`Consolidated Filings and Discovery
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`2.
`Because the ground of unpatentability and the prior art relied on in the
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`Apotex IPR and the Neptune 237 IPR are the same, the case is amenable to
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`consolidated filings. Apotex will agree to consolidated filings for all substantive
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`papers in the proceeding (e.g., Reply to the Lilly’s Response, Opposition to Motion
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`to Amend, Motion for Observation on Cross Examination Testimony of a Reply
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`Witness, Motion to Exclude Evidence, Opposition to Motion to Exclude Evidence
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`and Reply). Specifically, so long as Neptune does not settle and dismiss the
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`Neptune 237 IPR, Apotex agrees to adopt Neptune’s substantive filings in the
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`Neptune 237 IPR, as its own. Thus, the joined parties’ filings will be consolidated
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`with no increase in the ordinary one-party limit on length.
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`Apotex agrees not to be permitted any arguments separate from those
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`advanced by Neptune in the consolidated filings. These limitations avoid lengthy
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`and duplicative briefing.
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`Consolidated discovery is also appropriate given that Apotex and Neptune
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`will rely on the same expert declaration in the two proceedings. So long as
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`Neptune does not settle and dismiss the Neptune 237 IPR, Apotex agrees to adopt
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`all discovery taken by Neptune. Thus, Neptune will designate an attorney to
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`conduct the cross-examination of any given witness produced by Lilly, and the
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`redirect of any given witness produced by Apotex and Neptune within the
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`6
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`timeframe normally allotted by the rules for one party. Apotex will not receive any
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`separate cross-examination or redirect time from that of Neptune.
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`Should joinder be granted, Apotex is prepared to rely solely on the testimony
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`of Neptune’s expert, Dr. Bleyer, unless the Neptune 237 IPR is settled prior to the
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`completion of expert discovery. Only in the event the Neptune 237 IPR is settled
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`prior to the completion of expert discovery would Apotex elect to rely on its own
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`expert, Dr. Kelley, who has reviewed and adopted the opinions set forth in the
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`Bleyer Declaration relating to the instituted ground of unpatentability. To be clear,
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`as long as the Neptune 237 IPR remains pending following joinder, no additional
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`discovery would be needed, and Apotex will not rely on Dr. Kelley.
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`Even if, through no fault of its own, Apotex were required to proceed with
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`its own expert, there would be no impact on the Board’s ability to complete its
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`review in a timely manner. Dr. Kelley has adopted Dr. Bleyer’s opinions and his
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`participation would inject no new issues into the Neptune 237 IPR. Moreover,
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`there would be only a modest impact on Lilly, given that little additional
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`preparation would be needed for the deposition of Apotex’s contingent expert
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`beyond that required for the deposition of Neptune’s expert as both have the same
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`opinions.
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`B. No New Grounds of Unpatentability
`The Apotex IPR contains the same ground of unpatentability instituted in the
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`Neptune 237 IPR. In fact, the ground of unpatentability is identical in all
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`substantive respects. As a result, the Apotex IPR raises no new grounds of
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`unpatentability from those of the Neptune 237 IPR.
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`C. No Impact on IPR Trial Schedule
`The difference between the filing date of the Apotex IPR and the Neptune
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`237 IPR is without consequence should the proceedings be joined. The trial
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`schedule for the Neptune 237 IPR would not need to be delayed to effect joinder
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`based on Lilly’s preliminary response and later-filed Apotex IPR. Indeed, given
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`that the Apotex IPR asserts substantively identical ground of unpatentability as
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`those instituted in the Neptune 237 IPR, there should be no need for Lilly to submit
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`a preliminary response. Moreover, so long as Neptune does not settle and dismiss
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`the Neptune 237 IPR, Apotex agrees to be bound by the schedule in the Neptune
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`237 IPR, as modified by Neptune, Lilly, and/or the Board. The joint proceeding
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`would allow the Board and parties to focus on the merits in one consolidated
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`proceeding without unnecessary duplication of effort, and in a timely manner.
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`D. Briefing and Discovery Will Be Simplified
`As discussed above, Apotex agrees to consolidated filings and discovery,
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`which will simplify the briefing and discovery process.
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`8
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`Joinder Will Not Prejudice Lilly or Neptune
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`E.
`Permitting joinder will not prejudice Lilly or Neptune. Apotex raises no
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`issues not already before the Board, so joinder will not affect the timing of the
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`Neptune 237 IPR. Moreover, because the Apotex and Neptune petitions and
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`evidence are substantively identical, the content of Lilly’s filings to-date (and
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`going forward) in the Neptune 237 IPR apply equally to the Apotex IPR.
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`Therefore no additional expense or delay will be incurred if joinder is granted.
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`On the contrary, denial of Apotex’s petition may prejudice Apotex and the
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`public’s interest. In the event that Neptune and Lilly settle their dispute 35 U.S.C.
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`§ 317(a) provides that an inter partes review “shall be terminated with respect to
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`any petitioner upon the joint request of the petitioner and the patent owner” unless
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`the Board has already reached its decision on the merits. If no petitioner remains
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`after settlement, “the Office may terminate the review.” Id. Joining Apotex serves
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`the public interest by ensuring the validity of the ‘209 patent continues to be tested
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`in the event of a settlement and—if found wanting—will allow Apotex to get
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`generic pemetrexed into the hands of patients. In re Barr Labs., Inc., 930 F.2d 72,
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`76 (D.C. Cir. 1991) (Congress enacted Hatch-Waxman precisely “to get generic
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`drugs into the hands of patients at reasonable prices—fast.”).
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`9
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`IV. PROPOSED ORDER
`Petitioner proposes a joinder order for consideration by the Board as
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`follows:
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`• The Apotex IPR will be instituted and joined with the Neptune 237
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`IPR on the same ground as those for which review was instituted in
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`the Neptune 237 IPR.
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`• The scheduling order for the Neptune 237 IPR will apply to the joined
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`proceeding.
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`• Apotex is bound by the procedural concessions set forth in its Motion
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`for Joinder to the Neptune 237 IPR, or as otherwise agreed between
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`the Parties to the joined proceedings and the Board.
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`V. CONCLUSION
`For the foregoing reasons, Apotex respectfully requests that its Petition for
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`inter partes review of U.S. Patent No. 7,772,209 be instituted and that the
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`proceeding be joined with Neptune Generics, LLC v. Eli Lilly & Co., IPR2016-
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`00237. Although no additional fee is believed to be required for this Motion, the
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`Commissioner is hereby authorized to charge any additional fees which may be
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`required for this Motion to Deposit Acct. No. 503626.
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`10
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`July 1, 2016
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`11
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`Respectfully submitted,
`
`/John D. Polivick/
`John D. Polivick (Reg. No. 57,926)
`jpolivick@rmmslegal.com
`Rakoczy Molino Mazzochi Siwik LLP
`6 West Hubbard Street, Suite 500,
`Chicago, Illinois 60654
`Tel. 312-222-5127
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`CERTIFICATE OF SERVICE
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`I hereby certify that on July 1, 2016, a copy of this Petitioner’s Motion for
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`Joinder Pursuant to 35 U.S.C. § 315(c) and 37 C.F.R. §§ 42.22 and 42.122(b) was
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`served via U.S.P.S. Priority Mail Express, on Eli Lilly & Company at the
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`correspondence address of record for the ‘209 patent as evidenced in Public PAIR
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`on July 1, 2016, namely
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`Elizabeth A. McGraw
`Eli Lilly and Company
`Patent Division
`P.O. Box 6288
`Indianapolis, Indiana 46206-6288
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`Sarah E. Spires
`Skiermont Derby LLP
`sarah.spires@skiermontpuckett.com
`Lead Counsel for Neptune Generics, LLC in the Neptune 240 IPR
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`Dov P. Grossman
`Williams & Connolly LLP
`dgrossman@wc.com
`Lead Counsel for Eli Lilly & Company in the Neptune 240 IPR
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`And electronically on:
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`Dated: July 1, 2016
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`/John D. Polivick/
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`Telephone: (312) 222-6305
`Facsimile: (312) 222-6325
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`12