UNITED STATES PATENT AND TRADEMARK OFFICE
`———————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`———————————————
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`TEVA PHARMACEUTICALS USA, INC.
`&
`FRESENIUS KABI USA, LLC
`PETITIONERS
`
`v.
`ELI LILLY AND COMPANY,
`Patent Owner
`
`
`
`CASE NO.: IPR2016-01340
`PATENT NO. 7,772,209
`FILED: JULY 11, 2007
`ISSUED: AUGUST 10, 2010
`INVENTOR: CLET NIYIKIZA
`TITLE: ANTIFOLATE COMBINATION THERAPIES
`———————————————
`Motion for Joinder
`Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b)
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`———————————————
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`———————————————
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`TEVA PHARMACEUTICALS USA, INC.
`&
`FRESENIUS KABI USA, LLC
`PETITIONERS
`
`v.
`ELI LILLY AND COMPANY,
`Patent Owner
`
`
`
`CASE NO.: IPR2016-01340
`PATENT NO. 7,772,209
`FILED: JULY 11, 2007
`ISSUED: AUGUST 10, 2010
`INVENTOR: CLET NIYIKIZA
`TITLE: ANTIFOLATE COMBINATION THERAPIES
`———————————————
`Motion for Joinder
`Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 and 42.122(b)
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`I.
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`U.S. Patent 7,772,209
`Petition for Inter Partes Review
`Motion for Joinder
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`STATEMENT OF THE PRECISE RELIEF REQUESTED
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`Teva Pharmaceuticals USA, Inc. (“Teva”) and Fresenius Kabi USA, LLC
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`(“Fresenius”) respectfully submit this Motion for Joinder, together with a Petition
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`for Inter Partes Review (“the Teva/Fresenius Petition”) of U.S. Patent No.
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`7,772,209 (“the ’209 patent”). Pursuant to 35 U.S.C. § 315(c) and 37 C.F.R.
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`§ 42.122(b), Teva and Fresenius request institution of inter partes review (IPR)
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`and joinder with the IPR concerning the same patent in Sandoz Inc. v. Eli Lilly and
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`Company, Case IPR2016-00318 (the “Sandoz IPR” or “IPR 318”), which was
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`instituted on June 16, 2016. Joinder is appropriate because it will promote the
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`efficient and consistent resolution of the validity of a single patent, and will not
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`delay the Sandoz IPR trial schedule or prejudice the parties to that IPR. Sandoz
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`has advised that they consent to Teva’s and Fresenius’s motion for joinder.
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`Further, as detailed below, Teva, Fresenius and Sandoz have entered into a
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`cooperation agreement for briefing and discovery in the event of the joinder of this
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`IPR with the Sandoz IPR.
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`Teva’s and Fresenius’s request for joinder is timely, as it is submitted within
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`one month of the June 16, 2016 institution of the Sandoz IPR. 37 C.F.R. §§ 42.22,
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`42.122(b).
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`1
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`II.
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`STATEMENT OF MATERIAL FACTS
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`U.S. Patent 7,772,209
`Petition for Inter Partes Review
`Motion for Joinder
`
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`Eli Lilly and Company (“Eli Lilly” or “Patent Owner”) owns the ’209
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`patent. Eli Lilly sued Teva and Fresenius for infringement of the ‘209 patent in
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`2010 and prevailed in the district court. That case is currently on appeal before the
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`Federal Circuit (Case Nos. 2014-1455 and 2015-2067).
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`On June 16, 2016, the Board instituted Sandoz’s IPR on the ’209 patent on
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`the following two grounds of unpatentability:
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`(1) obviousness of claims 1-22 over Calvert in view of Niyikiza I,
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`Worzalla, EP 005 and the ‘974 Patent; and
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`(2) obviousness of claims 1-22 over Calvert in view of Niyikiza I,
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`Hammond I, EP 005 and the ‘974 Patent.
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`(Sandoz IPR, Paper No. 21.).
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`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
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`A. Legal Standard
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`The Leahy-Smith America Invents Act (AIA) permits joinder of like review
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`proceedings, e.g. an IPR may be joined with another IPR. 37 C.F.R. § 42.122(a).
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`The Board has discretion to join parties to an existing IPR. 35 U.S.C. § 315(c). In
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`deciding whether to exercise its discretion, the Board considers factors including:
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`(1) the movant’s reasons why joinder is appropriate; (2) whether the new petition
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`U.S. Patent 7,772,209
`Petition for Inter Partes Review
`Motion for Joinder
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`presents any new grounds of unpatentability; (3) what impact (if any) joinder
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`would have on the trial schedule for the existing review; and (4) how briefing and
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`discovery may be simplified. Dell Inc. v. Network-1 Security Solutions, Inc.,
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`Decision on Motion for Joinder, IPR2013-00385, Paper No. 17 at 4 (July 29,
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`2013). The Board should consider “the policy preference for joining a party that
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`does not present new issues that might complicate or delay an existing
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`proceeding.” Id. at 10. Under this framework, joinder of the present IPR with the
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`Sandoz IPR is appropriate.
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`B. Joinder is Appropriate Because the Teva/Fresenius Petition Contains
`No New Grounds of Unpatentability and Joinder Will Not Impact the
`Trial Schedule
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`Joinder will not impact the Board’s ability to complete its review of the ’209
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`patent in a timely manner, as Teva and Fresenius raise no issues or evidence that is
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`not already before the Board in the Sandoz IPR. The Teva/Fresenius Petition seeks
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`review of the same claims at issue in the Sandoz IPR (claims 1-22 of the ’209
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`patent), based on the same grounds of unpatentability and combinations of prior
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`art. Indeed, the Teva/Fresenius Petition is substantively identical to Sandoz’s
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`petition (Sandoz IPR, Paper No. 2). Further, Teva and Fresenius rely on the same
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`exhibits and same expert declaration of Dr. Schiff that Sandoz submitted in
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`IPR2016-00318. Given that Teva and Fresenius and Sandoz would be addressing
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`3
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`U.S. Patent 7,772,209
`Petition for Inter Partes Review
`Motion for Joinder
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`the same prior art and grounds of unpatentability and Teva and Fresenius would
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`rely on Sandoz’s expert, Teva and Fresenius envision few, if any, differences in the
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`petitioners’ positions.
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`In such circumstances, the PTO anticipated that joinder would be granted as
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`a matter of right. See CONG. REC. S1376 (daily ed. Mar. 8, 2011) (statement of
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`Sen. Kyl) (“The Office anticipates that joinder will be allowed as of right – if an
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`inter partes review is instituted on the basis of a petition, for example, a party that
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`files an identical petition will be joined to that proceeding, and thus allowed to file
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`its own briefs and make its own arguments.”).
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`Because joinder will not introduce any new prior art, expert declarations, or
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`grounds of unpatentability into the Sandoz IPR, joining Teva’s and Fresenius’s
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`proceeding will not complicate the substantive issues already pending in the
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`Sandoz IPR. Teva and Fresenius respectfully submit that the Patent Owner would
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`thus not be prejudiced by the joinder.
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`In contrast, Teva and Fresenius would be prejudiced if joinder is denied. In
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`order to permit Teva and Fresenius to protect their interests related to the validity
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`and interpretation of the ’209 patent claims, Teva and Fresenius should be
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`permitted to participate in the Sandoz IPR. For example, allowing a joined inter
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`partes review would avoid prejudice to Teva and Fresenius in the event that
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`4
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`U.S. Patent 7,772,209
`Petition for Inter Partes Review
`Motion for Joinder
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`Sandoz and Eli Lilly reach a resolution of their disputes during the pendency of the
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`Sandoz IPR. 35 U.S.C. § 317(a) provides that an inter partes review “shall be
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`terminated with respect to any petitioner upon the joint request of the petitioner
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`and the patent owner” unless the Board has already reached its decision on the
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`merits. If no petitioner remains after settlement, “the Office may terminate the
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`review.” Id. Here, if Eli Lilly and Sandoz settled, the Sandoz IPR could terminate
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`without proceeding to a final written decision, prejudicing Teva and Fresenius. At
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`this stage, in order to challenge Eli Lilly’s claims in an inter partes review, the
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`only option available to Teva and Fresenius is to file their petition and
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`simultaneously request joinder Sandoz’s IPR pursuant to 37 C.F.R. § 42.122(b),
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`because Teva and Fresenius are otherwise time-barred from filing an inter partes
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`review petition under 37 C.F.R. § 315(b). Fresenius and Teva would be prejudiced
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`if the Board refuses joinder, as their interests may not be adequately represented in
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`the Sandoz IPR.
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`C. The Teva/Fresenius Petition Will Have No Impact on the Trial Schedule
`for the Sandoz IPR and Teva and Fresenius Agree to Simplify
`Discovery and Briefing
`The Teva/Fresenius Petition includes the identical obviousness grounds for
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`the same claims as in the Sandoz IPR, and is supported by the identical prior art
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`and prior art combinations and relies on the same expert declaration as that relied
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`5
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`U.S. Patent 7,772,209
`Petition for Inter Partes Review
`Motion for Joinder
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`on in the Sandoz IPR and considered by the Board in instituting review in the
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`Sandoz IPR. As such, Teva and Fresenius raise no issues that are not already
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`before the Board in the Sandoz IPR. Further, the Teva/Fresenius Petition proposes
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`the same claim construction positions as the petition in the Sandoz IPR, and relies
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`upon the same exhibits.
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`Accordingly, joinder in this case will not impact the Board’s ability to
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`complete its review of the ’209 patent in a timely manner. 35 U.S.C. § 316(a)(11)
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`and associated rule 37 C.F.R. § 42.100(c) provide that inter partes review
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`proceedings should be completed and the Board’s final decision issued within one
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`year of institution of the review. In this case, joinder will not affect the Board’s
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`ability to issue the decision within this required one-year timeframe because the
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`Teva/Fresenius Petition is substantively identical to the Sandoz IPR petition and
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`Teva and Fresenius rely on the same expert declaration relied upon in the Sandoz
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`IPR.
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`Teva and Fresenius will agree to proceed in the instant IPR upon the
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`schedule already set in Sandoz IPR based only upon the arguments and evidence
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`advanced by Sandoz and accept a back‐seat, “understudy” role in those joined
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`proceedings, without any right to separate or additional briefing or discovery,
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`unless authorized by the Board upon a request to address an issue that is unique to
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`6
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`U.S. Patent 7,772,209
`Petition for Inter Partes Review
`Motion for Joinder
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`Teva and/or Fresenius. Only if Sandoz drops out of the proceedings for any reason,
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`will Teva and Fresenius cease their understudy role. The Board has previously
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`acknowledged that such concessions on the part of a party seeking to join are
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`sufficient to minimize the impact on the original proceeding (see SAP America Inc.
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`v. Clouding IP, LLC, IPR2014-00306, Paper 13, page 4).
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`IV. CONCLUSION
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`Joining the Teva and Fresenius to Sandoz’s IPR would ensure protection of
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`the parties’ interests and would not negatively impact the Sandoz IPR schedule.
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`For the foregoing reasons, Teva and Fresenius respectfully request that the
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`Board institute their Petition for Inter Partes Review of U.S. Patent 7,772,209 and
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`join this proceeding with Sandoz Inc. v. Eli Lilly and Company, Case IPR2016-
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`00318.
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`Although Petitioner believes that no fee is required for this Motion, the
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`Commissioner may charge any additional fees which may be required for this
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`Motion to Deposit Account No. 502880.
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`7
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`Dated: July 1, 2016
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`U.S. Patent 7,772,209
`Petition for Inter Partes Review
`Motion for Joinder
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`Respectfully submitted,
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`
`/Gary J. Speier/
`Gary J. Speier, Lead Counsel
`Reg. No. 45,458
`Mark D. Schuman
`Reg. No. 31,197
`Carlson, Caspers, Vandenburgh,
`Lindquist & Schuman
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`
`Cynthia Lambert Hardman, Backup
`Counsel
`Reg. No. 53,179
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, New York 10018-1405
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`8
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`U.S. Patent 7,772,209
`Petition for Inter Partes Review
`Motion for Joinder
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. §§ 42.6(e), this is to certify that on July 1, 2016, I
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`caused to be served a true and correct copy of the foregoing “MOTION FOR
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`JOINDER PURSUANT TO 35 U.S.C. § 315(c), 37 C.F.R. §§ 42.22 AND
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`42.122(b)” by EXPRESS MAIL on Patent Owner, counsel of record for Eli Lilly
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`and Company and counsel of record for Petitioner in IPR2016-00318 for U.S.
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`Patent No. 7,772,209 at its correspondence address as follows:
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`ELI LILLY & COMPANY
`PATENT DIVISION
`P.O. BOX 6288
`INDIANAPOLIS IN 46206-6288
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`Dov P. Grossman
`Williams & Connolly, LLP
`725 12th St., NW
`Washington, DC 20005
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`Ralph J. Gabric
`Brinks Gilson & Lione
`Suite 3600 NBC Tower
`455 Cityfront Plaza Drive
`Chicago IL 60611-5599
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`Respectfully submitted,
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`/Gary J. Speier/
`Gary J. Speier, Lead Counsel
`Reg. No. 45,458
`Attorney for Petitioner
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`9
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`Dated: July 1, 2016
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