UNITED STATES PATENT AND TRADEMARK OFFICE
`———————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`———————————————
`
`TEVA PHARMACEUTICALS USA, INC.
`
`&
`
`FRESENIUS KABI USA, LLC
`
`PETITIONERS
`
`v.
`ELI LILLY AND COMPANY,
`Patent Owner
`CASE NO.: IPR2016-01341
`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
`———————————————
`
`TEVA PHARMACEUTICALS USA, INC.
`
`&
`
`FRESENIUS KABI USA, LLC
`
`PETITIONERS
`
`v.
`ELI LILLY AND COMPANY,
`Patent Owner
`CASE NO.: IPR2016-01341
`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)
`
`
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 1
`
`II.
`
`STATEMENT OF MATERIAL FACTS ........................................................ 2
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED ........................ 3
`
`A.
`
`Legal Standard ....................................................................................... 3
`
`B. Teva and Fresenius’s Motion For Joinder Is Timely ............................ 4
`
`C.
`
`Joinder is Appropriate .......................................................................... 5
`
`D.
`
`
`
`The Teva/Fresenius Petition Raises No New Grounds of
`Unpatentability and Will Have No Impact on the Trial Schedule
`for the Neptune IPR ............................................................................... 6
`
`
`
`
`
`IV. CONCLUSION ................................................................................................ 9
`
`i
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`
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`
`
`
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`Teva Pharmaceuticals USA, Inc. (“Teva”) and Fresenius Kabi USA, LLC
`
`I.
`
`
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`(“Fresenius”) respectfully submit this Motion for Joinder, together with a petition
`
`for inter partes review of U.S. Patent No. 7,772,209 (“the ’209 patent”) (“the
`
`Teva/Fresenius petition”). Pursuant to 35 U.S.C. § 315(c), 37 C.F.R. § 42.22, and
`
`37 C.F.R. § 42.122(b), Teva and Fresenius request institution of an inter partes
`
`review (“the Teva/Fresenius IPR”) and joinder of this proceeding with Neptune
`
`Generics, LLC v. Eli Lilly and Company, Case IPR2016-00237 (the “Neptune IPR”
`
`or “IPR 237”) which was instituted on June 3, 2016. This Motion for Joinder is
`
`timely under 37 C.F.R. §§ 42.22 and 42.122(b), as it is submitted within one month
`
`of June 3, 2016, the date on which the Neptune IPR was instituted. See Neptune
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`IPR, Paper No. 13. It is also narrowly-tailored to the same claims, prior art, and
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`grounds of unpatentability that are the subject of the Neptune IPR.1 In addition,
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`Teva and Fresenius are willing to streamline discovery and briefing. Accordingly,
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`joinder is appropriate because it will not prejudice the parties to the Neptune IPR
`
`and will promote the efficient resolution of the question of validity of a patent in a
`
`
`1 The second sentence of each of sections VI.B.1., VI.B.2., and VI.B.3. has been
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`slightly modified from Neptune’s petition for accuracy purposes, but such
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`modifications do not substantively change any of Neptune’s arguments.
`
`
`
`1
`
`
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`single proceeding. Absent joinder, Teva and Fresenius will be prejudiced because
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`their interests may not be adequately represented in the Neptune IPR.
`
`II.
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`STATEMENT OF MATERIAL FACTS
`
`
`
`1.
`
`Eli Lilly and Company (“Lilly” or “Patent Owner”) owns U.S. Patent
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`7,772,209. There is no current district court patent litigation between Eli Lilly and
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`Teva or Fresenius with respect to the ’209 patent. Teva and Fresenius were
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`previously sued by Eli Lilly with respect to the ‘209 patent. Eli Lilly and Company
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`v. Teva Parental Medicines, Inc., et al., INSD-1:10-cv-01376 (filed Oct. 29, 2010).
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`That suit is currently on appeal at the Federal Circuit. (Eli Lilly and Company v.
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`Teva Parenteral Medicines, No. 15-2067 (Fed. Cir.) (filed Sept. 21, 2015).
`
`
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`2.
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`On November 24, 2015, Neptune filed its petition for inter partes
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`review seeking cancellation of claims 1-22 of the ’209 patent. (Neptune IPR, Paper
`
`No. 1.)
`
`
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`3.
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`The Neptune IPR petition included the following ground for
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`challenging the validity of the ’209 patent:
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`
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`Ground 1: Claims 1-22 are obvious in view of Niyikiza, U.S. 5,217,974, and
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`EP 0 595 005.
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`
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`4.
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`On March 4, 2016, Patent Owner filed a Preliminary Response.
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`(Neptune IPR, Paper No. 10.)
`
`
`
`2
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`
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`
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`5.
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`On June 3, 2016, the Board instituted review of claims 1–22 of the
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`’209 patent in the Neptune IPR. (Neptune IPR, Paper No. 13.)
`
`
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`6.
`
`On June 3, 2016, the Board entered a scheduling order in the Neptune
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`IPR setting various dates, including the oral argument set for February 7, 2017.
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`(Neptune IPR, Paper No. 14.) On June 17, 2016, the Board entered a revised
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`scheduling order in the Neptune IPR changing various dates, including moving the
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`oral argument to March 7, 2017. (Neptune IPR, Paper No. 15.)
`
`
`
`7.
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`The Teva/Fresenius petition in this proceeding proposes that claims
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`1–22 of the ’209 patent should be cancelled in view of Ground 1, as set forth in the
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`Neptune IPR petition.
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`
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`8.
`
`The Teva/Fresenius petition in this proceeding presents the identical
`
`grounds on which the Neptune IPR was instituted.
`
`
`
`9.
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`The Teva/Fresenius petition in this proceeding proposes the same
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`claim construction positions as the petition in the Neptune IPR, and relies upon the
`
`same prior art.
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`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`
`
`
`A.
`
`Legal Standard
`
`The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes
`
`review proceedings. The statutory provision governing joinder of inter partes
`
`review proceedings is 35 U.S.C. § 315(c), which reads as follows:
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`
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`3
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`
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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.
`
`Under 35 U.S.C. § 315(c), the Board has authority to join a second inter
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`
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`partes review proceeding to an instituted first inter partes review proceeding. The
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`motion for joinder must be filed within one month of institution of the first inter
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`partes review proceeding. 37 C.F.R. § 42.122(b).
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`In deciding whether to exercise its discretion, the Board considers factors
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`including: (1) the movant’s reasons why joinder is appropriate; (2) whether the
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`new petition presents any new grounds of unpatentability; (3) what impact (if any)
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`joinder would have on the trial schedule for the existing review; and (4) how
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`briefing and discovery may be simplified. See Dell, Inc. v. Network-1 Security
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`Solutions, Inc., Case IPR2013-00385, Paper No. 17 (July 29, 2013) at 3. 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 this
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`framework, joinder of the present IPR with the Neptune IPR is appropriate.
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`
`
`B.
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`Teva and Fresenius’s Motion For Joinder Is Timely
`
`The instant Petition and this Motion for Joinder are timely under 35 U.S.C. §
`
`315(c) and 37 C.F.R. § 42.122(b). While, as a general proposition, inter partes
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`
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`4
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`
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`review may not be instituted more than one year after the date on which a
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`petitioner is served with a complaint alleging infringement of the patent-at-issue
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`(35 U.S.C. § 315(b)), the one year period does not apply when a petition for inter
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`partes review is accompanied by a motion for joinder filed within one month of
`
`institution of the inter partes review for which joinder is requested. 37 C.F.R. §
`
`42.122(b). This Motion for Joinder and the accompanying Petition are timely, as
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`they are submitted within one month of the June 3, 2016 institution of the Neptune
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`IPR.
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`C.
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`Joinder is Appropriate
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`Joinder is appropriate because Teva and Fresenius will be unduly prejudiced
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`if joinder is denied. In order to permit Teva and Fresenius to protect their interests
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`related to the validity and interpretation of the ’209 patent claims, Teva and
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`Fresenius should be permitted to participate in the Neptune IPR. For example,
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`allowing a joined inter partes review would avoid prejudice to Teva and Fresenius
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`in the event that Neptune and Eli Lilly reach a resolution of their disputes during
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`the pendency of the Neptune IPR. 35 U.S.C. § 317(a) provides that an inter partes
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`review “shall be terminated with respect to any petitioner upon the joint request of
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`the petitioner and the patent owner” unless the Board has already reached its
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`decision on the merits. If no petitioner remains after settlement, “the Office may
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`terminate the review.” Id. Here, if Eli Lilly and Neptune settled, the Neptune IPR
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`5
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`
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`could terminate without proceeding to a final written decision, prejudicing Teva
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`and Fresenius. At this stage, in order to challenge Eli Lilly’s claims in an inter
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`partes review, the only option available to Teva and Fresenius is to file their
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`petition and simultaneously request joinder to Neptune’s IPR pursuant to 37 C.F.R.
`
`§ 42.122(b). Absent joinder, the Teva/Fresenius petition for inter partes review
`
`would be barred under 35 U.S.C. § 315(b). Fresenius and Teva would therefore be
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`prejudiced if the Board refuses joinder, as their interests may not be adequately
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`represented in the Neptune IPR.
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`
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`In contrast, permitting joinder will not prejudice Eli Lilly or Neptune. Teva
`
`and Fresenius raise no issues not already before the Board, so joinder will not
`
`affect the timing of the Neptune IPR or the content of Eli Lilly’s Patent Owner
`
`response. Teva and Fresenius also believe that given the procedural safeguards
`
`proposed below, any additional costs to Eli Lilly and Neptune associated with their
`
`participation in the Neptune IPR will be minimal, and not so great as to justify the
`
`potential prejudice to Teva and Fresenius if the Neptune IPR was otherwise
`
`terminated before a final written decision by the Board.
`
`D.
`
`The Teva/Fresenius Petition Raises No New Grounds of
`Unpatentability and Will Have No Impact on the Trial Schedule
`for the Neptune IPR
`The Teva/Fresenius Petition includes the identical obviousness grounds for
`
`the same claims as in the Neptune IPR, and is supported by the identical prior art
`
`
`
`6
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`
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`and prior art combinations as that relied on in the Neptune IPR and considered by
`
`the Board in instituting review in the Neptune IPR. Teva and Fresenius also intend
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`to rely on the same expert as Neptune (discussed further below). As such, Teva and
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`Fresenius raise no issues that are not already before the Board in the Neptune IPR.
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`Further, the Teva/Fresenius petition proposes the same claim construction
`
`positions as the petition in the Neptune IPR, and relies upon the same exhibits.
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`Accordingly, joinder in this case will not impact the Board’s ability to
`
`complete its review of the ’209 patent in a timely manner. 35 U.S.C. § 316(a)(11)
`
`and associated rule 37 C.F.R. § 42.100(c) provide that inter partes review
`
`proceedings should be completed and the Board’s final decision issued within one
`
`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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`Petition filed in the present Teva/Fresenius IPR is substantially identical to the
`
`Neptune IPR. Indeed, in circumstances such as these, the PTO anticipated that
`
`joinder would be granted as a matter of right. See 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).
`
`
`
`7
`
`
`
`
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`Teva and Fresenius will agree to proceed in the instant IPR based only upon
`
`the arguments and evidence advanced by Neptune and accept a back‐seat,
`
`“understudy” role in those joined proceedings, without any right to separate or
`
`additional briefing or discovery, unless authorized by the Board upon a request to
`
`address an issue that is unique to Teva and/or Fresenius. Only if Neptune drops out
`
`of the proceedings for any reason, will Teva and Fresenius cease their understudy
`
`role.
`
`Teva and Fresenius agree to assume a primary role in IPR 237 only if
`
`Neptune ceases to participate in IPR 237. In other words, Teva and Fresenius
`
`request permission to be added to the case caption as a petitioner in IPR 237,
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`without any active participation or involvement that is separate from Neptune,
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`unless authorized by the Board upon a request pertaining to an issue unique to
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`Teva and/or Fresenius.
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`
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`In order to further simplify the proceeding, Teva and Fresenius intend to rely
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`on the same expert as Neptune. If Neptune allows Teva and Fresenius to retain the
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`same expert, then Teva and Fresenius will withdraw their expert declaration of Dr.
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`Ratain and rely solely on the declaration and testimony of Neptune’s expert, Dr.
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`Bleyer.2 The Board has previously acknowledged that such concessions on the
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`2 Teva and Fresenius have submitted an expert declaration of their own expert, Dr.
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`Raitan. Dr. Ratain has reviewed and adopted the opinions set forth in Dr. Bleyer’s
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`
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`8
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`
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`part of a party seeking to join are sufficient to minimize the impact on the original
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`proceeding (see SAP America Inc. v. Clouding IP, LLC, IPR2014-00306, Paper 13,
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`page 4).
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`Even if, through no fault of their own, Teva and Fresenius were required to
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`proceed with their own expert, there would be no impact on the Board’s ability to
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`complete its review in a timely manner, in light of the identity between the
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`declarations of Teva and Fresenius’s expert and Neptune’s expert. Moreover, there
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`would be only a modest impact on the Patent Owner, given that little additional
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`preparation would be needed for the deposition of Teva and Fresenius’s expert
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`beyond that required for the deposition of Neptune’s expert.
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`IV. CONCLUSION
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`
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`For all the foregoing reasons, Teva and Fresenius respectfully request this
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`proceeding be joined with the Neptune IPR.
`
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`declaration. To the extent that Neptune does not agree to allow Teva and Fresenius
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`to retain Neptune’s expert, Teva and Fresenius would still agree to withdraw Dr.
`
`Ratain’s declaration if Neptune’s expert, Dr. Bleyer, had already been deposed
`
`based on any declarations he submits in IPR 240, and the deposition transcript(s)
`
`have been made of record, and instead rely solely on the declaration of Dr. Bleyer.
`
`
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`9
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`
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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.
`
`July 1, 2016
`
`
`
`Mark D. Schuman (Reg. No.
`31,197)
`Carlson, Caspers, Vandenburgh,
`Lindquist & Schuman
`225 South Sixth St. Suite 4200
`Minneapolis, MN 55402
`P: 612-436-9600/F: 612-436-9605
`
`Cynthia Lambert Hardman (Reg.
`No. 53,179)
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`P:212-813-8800/F: 212-355-3333
`Back-Up Counsel for Petitioner
`
`Respectfully Submitted,
`
`s/ Gary J. Speier
`Gary J. Speier (Reg. No. 45,458)
`Carlson, Caspers, Vandenburgh,
`Lindquist & Schuman
`225 South Sixth St. Suite 4200
`Minneapolis, MN 55402
`P: 612-436-9600/F: 612-436-9605
`Lead Counsel for Petitioner
`
`
`
`10
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`
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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
`
`42.122(b)” by EXPRESS MAIL on Patent Owner, counsel of record for Eli Lilly
`
`and Company and counsel of record for Petitioner in IPR2016-00237 for U.S.
`
`Patent No. 7,772,209 at its correspondence address as follows:
`
`
`ELI LILLY & COMPANY
`PATENT DIVISION
`P.O. BOX 6288
`INDIANAPOLIS IN 46206-6288
`
`Dov P. Grossman
`Williams & Connolly, LLP
`725 12th St., NW
`Washington, DC 20005
`
`Sarah Spires
`Skiermont Puckett LLP
`2200 Ross Ave., Suite 4800W
`Dallas, TX 75201
`
`
`
`Dated: July 1, 2016
`
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`Respectfully submitted,
`
`
`
`
`
`
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`
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`
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`
`
`
`
`
`
`/Gary J. Speier/
`
`Gary J. Speier, Lead Counsel
`Reg. No. 45,458
`Attorney for Petitioner
`
`
`
`
`
`11
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