Trials@uspto.gov
`571.272.7822
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` Paper 7 (IPR2015-01976)
`Paper 7 (IPR2015-01980)
`
` Paper 7 (IPR2015-01981)
` Entered: November 20, 2015
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`YEDA RESEARCH AND DEVELOPMENT CO. LTD.,
`Patent Owner.
`____________
`
`Case IPR2015-01976 (US 8,232,250 B2)
`Case IPR2015-01980 (US 8,399,413 B2)
`Case IPR2015-01981 (US 8,969,302 B2)1
`____________
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`TINA E. HULSE, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`1 This order addresses issues that are common to all three cases. We,
`therefore, issue a single order that has been entered in each case. For
`convenience, paper numbers refer to those filed in IPR2015-01976. The
`parties may use this style caption when filing a single paper in multiple
`proceedings, provided that such caption includes a footnote attesting that
`“the word-for-word identical paper is filed in each proceeding identified in
`the caption.”
`
`
`
`
`571.272.7822
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`
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`
`
`
`
`
`
` Paper 7 (IPR2015-01976)
`Paper 7 (IPR2015-01980)
`
` Paper 7 (IPR2015-01981)
` Entered: November 20, 2015
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`YEDA RESEARCH AND DEVELOPMENT CO. LTD.,
`Patent Owner.
`____________
`
`Case IPR2015-01976 (US 8,232,250 B2)
`Case IPR2015-01980 (US 8,399,413 B2)
`Case IPR2015-01981 (US 8,969,302 B2)1
`____________
`
`Before SHERIDAN K. SNEDDEN, ZHENYU YANG, and
`TINA E. HULSE, Administrative Patent Judges.
`
`HULSE, Administrative Patent Judge.
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`1 This order addresses issues that are common to all three cases. We,
`therefore, issue a single order that has been entered in each case. For
`convenience, paper numbers refer to those filed in IPR2015-01976. The
`parties may use this style caption when filing a single paper in multiple
`proceedings, provided that such caption includes a footnote attesting that
`“the word-for-word identical paper is filed in each proceeding identified in
`the caption.”
`
`
`
`
`
`IPR2015-01976 (US 8,232,250 B2)
`IPR2015-01980 (US 8,399,413 B2)
`IPR2015-01981 (US 8,969,302 B2)
`
`
`A conference call was held on November 19, 2015, among counsel for
`
`Petitioner Amneal Pharmaceutials LLC (“Amneal”), counsel for Patent
`
`Owner Yeda Research and Development Co. Ltd. (“Patent Owner”), counsel
`
`for Petitioner Mylan Pharmaceuticals Inc. (“Mylan”) in IPR2015-00643,
`
`IPR2015-00644, and IPR2015-00830 (collectively, “the Mylan cases”), and
`
`Judges Snedden, Yang, and Hulse.
`
`Along with its Petitions for Inter Partes Review, Amneal filed
`
`Motions for Joinder to join the Mylan cases. Paper 3. In short, Amneal
`
`represents that its Petitions are substantively identical to the Petitions filed in
`
`the Mylan cases, that Amneal and Mylan have agreed to consolidate their
`
`filings, and that there will be no effect on the trial schedule for the Mylan
`
`cases. Id. at 5–7. The Board initiated the conference call with the parties to
`
`discuss Amneal’s motions for joinder.
`
`During the call, Amneal stated that it has discussed the joinder issue
`
`with Patent Owner and Mylan and confirmed that as long as Mylan is an
`
`active petitioner, Mylan and Amneal will speak with one voice. Amneal
`
`also stated that the parties all agree to be bound by the schedule set forth in
`
`the Mylan cases. In response, Patent Owner confirmed that it does not
`
`oppose Amneal’s joinder motion, but stated that it currently intends to file a
`
`Patent Owner Preliminary Response to Amneal’s Petitions.
`
`Both Amneal and Mylan stated that they were previously unaware that
`
`Patent Owner intended to file a Preliminary Response in these proceedings.
`
`The Petitioners expressed concerns about the possibility of Patent Owner
`
`filing new evidence with its Patent Owner Preliminary Response and the
`
`effect that may have on their ability to speak with one voice. The parties
`
`also asked for clarification as to whether Patent Owner is entitled to use in
`
`2
`
`
`
`IPR2015-01976 (US 8,232,250 B2)
`IPR2015-01980 (US 8,399,413 B2)
`IPR2015-01981 (US 8,969,302 B2)
`
`its Preliminary Response to the Amneal Petitions the cross-examination
`
`testimony from Mylan’s declarant, which was taken after the filing of the
`
`Amneal Petitions.
`
`Patent Owner’s Preliminary Responses in these proceedings are due
`
`December 29, 2015. According to the Scheduling Order in the Mylan cases,
`
`Patent Owner’s Response is due in two of the three cases on November 20,
`
`2015, with the third due on November 25, 2015. IPR2015-00643 (Paper
`
`14); IPR2015-00644 (Paper 15); IPR2015-00830 (Paper 9).2 Given the
`
`Amneal Petitions are substantively identical to the Mylan Petitions, the panel
`
`expedited the briefing schedule for the Patent Owner Preliminary Response
`
`in the Amneal proceedings. The panel ordered that the Preliminary
`
`Responses to the Amneal Petitions are now due on December 8, 2015. The
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`panel will then consider Amneal’s motions for joinder promptly after the
`
`Preliminary Responses are filed to minimize any delays in the schedule,
`
`should the panel decide to join the proceedings.
`
`Regarding the parties’ question as to whether Patent Owner may use
`
`the cross-examination testimony of Mylan’s declarant in its Preliminary
`
`Responses in these proceedings, 37 C.F.R. § 42.107(c) states that a
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`preliminary response “shall not present new testimony evidence beyond that
`
`already of record, except as authorized by the Board.” 37 C.F.R.
`
`§ 42.107(c). Prior panels have generally held that expert witness testimony
`
`on patentability prepared after the filing of the petition is considered “new
`
`testimony evidence.” See, e.g., FLIR Sys., Inc. v. Leak Surveys, Inc., Case
`
`IPR2014-00434, slip op. at 33˗34 (PTAB Sept. 5, 2014) (Paper 8); C&D
`
`2 For future reference, the Board encourages the parties to request a
`conference call as early as possible to discuss joinder issues.
`
`3
`
`
`
`IPR2015-01976 (US 8,232,250 B2)
`IPR2015-01980 (US 8,399,413 B2)
`IPR2015-01981 (US 8,969,302 B2)
`
`Zodiac, Inc. v. B/E Aerospace, Inc., Case IPR2014-00727, slip op. at 18
`
`(PTAB Oct. 29, 2014) (Paper 15); Amneal Pharms., LLC v. Endo Pharms.,
`
`Inc., Case IPR2014-01365, slip op. at 2˗3 (PTAB Nov. 14, 2014) (Paper 11);
`
`B/E Aerospace, Inc. v. MAG Aerospace Indus., LLC, Case IPR2014-01510,
`
`slip op. at 4 (PTAB Jan. 20, 2015) (Paper 13); Stellar Energy Ams., Inc. v.
`
`TAS Energy Inc., Case IPR2015-00882, slip op. at 8–10 (PTAB Sept. 21,
`
`2015) (Paper 10).
`
`While we acknowledge that at least one panel has found that “new”
`
`testimony refers to testimony that was taken specifically for the purpose of
`
`the inter partes review proceeding at issue,3 we note that that decision is not
`
`binding on this panel. Moreover, we are persuaded that the circumstances of
`
`these proceedings differ because Amneal represents that it attended and fully
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`participated in the depositions. We also understand that Patent Owner has
`
`agreed to cross-examine Petitioners’ declarant only once. Moreover,
`
`because the Petitions in the two sets of proceedings are substantively
`
`identical, it would not appear necessary in the interests of justice for Patent
`
`Owner to rely on that testimony in the Preliminary Responses to the Amneal
`
`Petitions when it can rely on that same testimony in its Patent Owner
`
`Responses to the identical arguments made in the Mylan Petitions. Office
`
`Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,764 (Aug. 14, 2012)
`
`(“New testimonial evidence may be permitted where a party demonstrates
`
`that such evidence is in the interests of justice.”).
`
`Finally, any discussion regarding the impact on the schedule of the
`
`proceedings if the cases are joined is speculative at this time. Once the panel
`
`3 See, e.g., Anova Food, LLC v. Sandau, Case IPR2013-00114, slip op. at 2–
`3 (PTAB June 25, 2013) (Paper 11).
`
`4
`
`
`
`IPR2015-01976 (US 8,232,250 B2)
`IPR2015-01980 (US 8,399,413 B2)
`IPR2015-01981 (US 8,969,302 B2)
`
`has made a determination on Amneal’s motions for joinder, we encourage
`
`the parties to confer and stipulate to any changes in the schedule up through
`
`Due Date 5 to accommodate the joinder of cases, if so ordered.
`
`
`
`Accordingly, it is
`
`ORDER
`
`ORDERED that Patent Owner’s Preliminary Responses in IPR2015-
`
`01976, IPR2015-01980, and IPR2015-01981, which are currently due on
`
`December 29, 2015, are due on December 8, 2015.
`
`
`
`
`
`PETITIONER:
`
`Vincent Capuano
`VCapuano@duanemorris.com
`
`Christopher Kroon
`cskroon@duanemorris.com
`
`
`PATENT OWNER:
`
`Elizabeth Holland
`eholland@goodwinprocter.com
`
`William James
`wjames@goodwinprocter.com
`
`Eleanor Yost
`eyost@goodwinprocter.com
`
`
`5
`
`
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