Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`
`IPR2016-01122, Paper 14
`IPR2015-01340, Paper 34
`Entered: September 23, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`____________
`
`Case IPR2016-01122
`Patent RE44,186
`____________
`
`Before MICHAEL P. TIERNEY, RAMA G. ELLURU, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`ELLURU, Administrative Patent Judge.
`
`
`
`DECISION
`Grant of Motion for Joinder
`37 C.F.R. § 42.208
`37 C.F.R. § 42.222
`
`
`
`
`
`Tel: 571-272-7822
`
`
`
`
`
`
`IPR2016-01122, Paper 14
`IPR2015-01340, Paper 34
`Entered: September 23, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`____________
`
`Case IPR2016-01122
`Patent RE44,186
`____________
`
`Before MICHAEL P. TIERNEY, RAMA G. ELLURU, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`ELLURU, Administrative Patent Judge.
`
`
`
`DECISION
`Grant of Motion for Joinder
`37 C.F.R. § 42.208
`37 C.F.R. § 42.222
`
`
`
`
`
`
`IPR2016-01122
`Patent RE44,186
`
`
`Petitioner, Teva Pharmaceuticals, USA, Inc. (“Teva”), filed a Petition
`requesting inter partes review of claims 1, 2, 4, 6–22, 25–30, 32–37, and
`39–42 (the “challenged claims”) of U.S. Patent No. RE44,186 (Ex. 1001,
`“the ’186 patent”) (Paper 1, “Pet.”). Concurrently with its Petition, Teva
`filed a Motion for Joinder (Paper 3, “Mot.”), seeking to consolidate this
`case, under 35 U.S.C. § 315(c), with the inter partes review in Mylan
`Pharms., Inc. v. AstraZeneca AB, LLC, Case IPR2015-01340 (“the Mylan
`IPR” and Petitioner “Mylan”), which was instituted on May 2, 2016. See
`IPR2015-01340 (Paper 16, 34–35) (rehearing decision instituting review of
`claims 1, 2, 4, 6–22, 25–30, 32–37, and 39–42 of the ’186 patent).
`Patent Owner AstraZeneca AB (“AstraZeneca”) waived filing a
`preliminary response. Paper 13. AstraZeneca initially opposed Teva’s
`Motion for Joinder (Paper 10), but subsequently withdrew its opposition to
`the Motion for Joinder (Paper 13).
`For the reasons set forth below, we conclude that Teva has shown that
`the Petition warrants institution of inter partes review of claims 1, 2, 4, 6–
`22, 25–30, 32–37, and 39–42 of the ’186 patent. This conclusion is
`consistent with our institution decision in the Mylan IPR. See IPR2015-
`01340, Paper 16, 34–35. Further, we grant Teva’s Motion for Joinder and
`exercise our discretion to join Teva as a Petitioner to the Mylan IPR. We
`further terminate the present proceeding, IPR206-01122.
`
`I. PETITION FOR INTER PARTES REVIEW
`Teva indicates that the ’186 patent is the subject of numerous district
`court cases filed in the U.S. District Court for the District of Delaware. Pet.
`18. In addition, the ’186 patent is the subject of pending inter partes review
`proceedings, including IPR2016-01029, IPR2016-01104, and IPR2016-
`
`2
`
`
`
`IPR2016-01122
`Patent RE44,186
`
`01117. The ’186 patent also was the subject of the Mylan IPR, as noted
`above.
`
`In the Mylan IPR, we instituted inter partes review of claims 1, 2, 4,
`6–22, 25–30, 32–37, and 39–42 of the ’186 patent on the same grounds of
`unpatentability asserted in the present Petition, reproduced below. Pet 19;
`see also Mot. 5–6; and IPR2015-01340, Paper 16, 34–35.
`
`
`
`Pet. 19.
`Teva supports its assertions with the same evidence and arguments
`proffered in the Mylan IPR. Pet. 24–60. Teva notes that “[i]n this case,
`joinder will not affect the Board’s ability to issue the decision within [the]
`required one-year timeframe because the Petition filed in the present Teva
`IPR is substantially identical to the Mylan IPR.” Mot. 8.
`We incorporate our analysis from our institution decision in the Mylan
`IPR. IPR2015-01340, Paper 16, 6–32, 34–35. For the same reasons, we
`determine that Teva has demonstrated a reasonable likelihood that it will
`prevail with respect to its challenge to claims 1, 2, 4, 6–22, 25–30, 32–37,
`and 39–42 of the ’161 patent on the asserted grounds.
`
`3
`
`
`
`IPR2016-01122
`Patent RE44,186
`
`
`II. MOTION FOR JOINDER
`In the Motion for Joinder, Teva seeks joinder with the inter partes
`
`review in the Mylan IPR. Mot. 1. Teva filed the present Motion on May
`June 1, 2016, within one month of our decision instituting inter partes
`review in IPR2015-01340, which issued on May 2, 2016. See IPR2015-
`01340, Paper 16; see also Mot 2. Therefore, the Motion is timely under 37
`C.F.R. § 42.122(b). See 37 C.F.R. § 42.122(b) (“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 Board, acting on behalf of the Director, has the discretion to join
`a party to a pending inter partes review where the conditions of 35 U.S.C.
`§ 315(c) are met. See 35 U.S.C. § 315(c); see also 37 C.F.R. § 42.4(a) (“The
`Board institutes the trial on behalf of the Director.”). Specifically, 35 U.S.C.
`§ 315(c) provides:
`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.
`
`As noted above, we have instituted inter partes review of claims 1, 2,
`4, 6–22, 25–30, 32–37, and 39–42 of the ’186 patent in the Mylan IPR. See
`generally IPR2015-01209, Paper 16. In addition, we determined above that
`Teva has filed a Petition that warrants institution of inter partes review of
`the same claims. Accordingly, the conditions of 35 U.S.C. § 315(c) are
`satisfied, and we must consider whether to exercise our discretion to join
`Teva as a Petitioner to the Mylan IPR.
`
`4
`
`
`
`IPR2016-01122
`Patent RE44,186
`
`
`In its Motion for Joinder, Teva asserts that:
`Joinder is also warranted in order to permit Teva to protect
`its interests related to the validity and interpretation of the ’186
`patent claims, and Teva could be prejudiced if it is not permitted
`to participate in the Mylan IPR. For example, allowing a joined
`inter partes review would avoid potential inconsistency and
`avoid prejudice to Teva in the event that Mylan and AstraZeneca
`reach a resolution.
`Mot. 11–12.
`Upon authorization, Teva and AstraZeneca filed a Joint Stipulation
`explaining the agreement between Petitioners Mylan and Teva with respect
`to the level of cooperation that will be maintained should joinder be granted.
`Paper 12. Pursuant to the stipulation, Teva agrees with Mylan “to share the
`use of Mylan's experts with Mylan, the ‘Lead Petitioner,’ and all joined
`petitioners in this IPR proceeding.” Id. at 1. Further, as long as Mylan
`remains a party in the Mylan IPR, Teva agrees to “coordinate any
`communications with Mylan’s experts through Mylan; not produce their
`own testifying witness; and not file substantive papers (except for those
`associated with Board-approved motions that do not affect Mylan or
`Mylan’s position).” Id. Teva also agrees to confer and cooperate with
`Mylan, and all joined petitioners, on the consolidated filings, and that as
`long as Mylan remains a party in the Mylan IPR, Mylan will make all Final
`decisions, will retain responsibility for oral argument (including telephone
`hearings and appeals) and Teva will not receive separate time and will not
`separately argue during oral argument, including during telephone hearings
`and appeals, except when addressing “Board-approved motions that do not
`affect Mylan or Mylan’s position.” Id. at 1, 2. In addition, Teva agrees to
`coordinate the discovery and testimony relating to witnesses with Mylan,
`
`5
`
`
`
`IPR2016-01122
`Patent RE44,186
`
`and that as long as Mylan remains a party in the Mylan IPR, Mylan will
`make all final decisions, and Teva will not separately file or serve objections
`or discovery requests, will not receive separate cross examination or redirect
`time, will not separately cross examine or redirect any witness, and
`stipulates that cross examinations will occur within the timeframe normally
`allotted to one party without a need for extensions in light of joinder. Id. at
`2. Further, if Mylan is no longer a party to the Mylan IPR, Teva agrees to
`“meet and confer with the remaining joined parties, if any, to select a new
`Lead Petitioner,” and that any such “Lead Petitioner will effectively take
`Mylan place in this proceeding and Teva will continue to be bound.” Id. at
`2–3.
`
`AstraZeneca stipulated that if joinder is granted “it will not request
`any additional level of cooperation other than that specified in the previous
`section.” Id. at 3. In addition, as noted above, AstraZeneca withdrew its
`opposition to the Motion for Joinder. Paper 13.
`Because Teva has satisfied the requirements of § 315(c), we grant
`Teva’s Motion for Joinder and exercise our discretion to join Teva as a
`Petitioner to the already existing Mylan IPR. We further terminate the
`present proceeding.
`As a Petitioner in the Mylan IPR, Teva shall adhere to the existing
`schedule in the Mylan IPR and abide by the Joint Stipulation with respect to
`consolidated filings, and discovery and testimony. Paper 12. More
`specifically, all filings by Teva in the Mylan IPR shall be consolidated with
`the filings of the other Mylan IPR Petitioner(s), unless the filing involves an
`issue unique to Teva or states a point of disagreement related to the
`consolidated filing. In such circumstances, Teva shall seek authorization
`
`6
`
`
`
`IPR2016-01122
`Patent RE44,186
`
`from the Board to file a separate paper. The page limits set forth in
`37 C.F.R. § 42.24 will apply to all consolidated filings.
`Teva is bound by any discovery agreements, including deposition
`arrangements, between AstraZeneca and Mylan, and shall not seek any
`discovery beyond that sought by Mylan. AstraZeneca shall not be required
`to provide any additional discovery or deposition time as a result of joinder.
`The Board expects Mylan and Teva to resolve any disputes between
`them and to contact the Board only if such matters cannot be resolved.
`
`
`IV. ORDER
`
`Accordingly, it is
`ORDERED that Teva’s Motion for Joinder is granted;
`FURTHER ORDERED that Teva is joined as a Petitioner in IPR2015-
`01340;
`FURTHER ORDERED that the instant proceeding, IPR2016-01122,
`is terminated under 37 C.F.R. § 42.72, and all further filings shall be made
`only in IPR2015-01340;
`FURTHER ORDERED that the asserted grounds of unpatentability on
`which a trial was instituted in IPR2015-01340 are unchanged;
`FURTHER ORDERED that the current Scheduling Order for
`IPR2015-01340 shall continue to govern IPR2015-01340;
`FURTHER ORDERED that Teva shall adhere to the existing schedule
`in the Mylan IPR, IPR2015-01340;
`FURTHER ORDERED that Teva shall abide by the Joint Stipulation
`with respect to consolidated filings, and discovery and testimony (Paper 12);
`
`7
`
`
`
`IPR2016-01122
`Patent RE44,186
`
`
`FURTHER ORDERED that all filings by Teva in the Mylan IPR shall
`be consolidated with the filings of the other Mylan IPR Petitioner(s), unless
`the filing involves an issue unique to Teva or states a point of disagreement
`related to the consolidated filing. In such circumstances, Teva shall seek
`authorization from the Board to file a separate paper;
`FURTHER ORDERED that all page limits set forth in 37 C.F.R.
`§ 42.24 will apply to all consolidated filings;
`FURTHER ORDERED that Teva shall be bound by any discovery
`agreements, including deposition arrangements, between AstraZeneca and
`Mylan, and shall not seek any discovery beyond that sought by Mylan;
`FURTHER ORDERED that AstraZeneca shall not be required to
`provide any additional discovery or deposition time as a result of joinder;
`FURTHER ORDERED that Mylan and Teva shall resolve any
`disputes between them and to contact the Board only if such matters cannot
`be resolved;
`FURTHER ORDERED that the case caption in IPR2015-01340 shall
`be changed to reflect the joinder of Teva as a Petitioner in accordance with
`the attached example; and
`FURTHER ORDERED that a copy of this Decision be entered into
`the file of IPR2015-01340.
`
`
`8
`
`
`
`IPR2016-01122
`Patent RE44,186
`
`FOR PETITIONER MYLAN:
`Steven Parmelee
`sparmelee@wsgr.com
`Richard Torczon
`rtorczon@wsgr.com
`
`FOR PETITIONER WOCKHARDT:
`Patrick Gallagher
`pcgallagher@duanemorris.com
`
`FOR PETITIONER TEVA:
`Gary Speier
`gspeier@carlsoncaspers.com
`
`Iain McIntyre
`IMcIntyre@carlsoncaspers.com
`
`FOR PATENT OWNER:
`Charles Lipsey
`Charles.lipsey@finnegan.com
`David Weingarten
`David.weingarten@finnegan.com
`Eric Grondahl
`egrondahl@mccarter.com
`John Livingstone
`Jonh.livingstone@finnegan.com
`Anthony Hartmann
`Anthony.hartmann@finnegan.com
`
`
`
`
`
`
`
`9
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG, and TEVA PHARMACEUTICALS USA, INC.,
`Petitioner,
`
`v.
`
`ASTRAZENECA AB
`Patent Owner.
`____________
`
`Case IPR2015-0134012
`Patent RE44,186 E
`____________
`
`
`
`
`
`
`
`
`
`
`1 Petitioner Wockhardt from IPR2016-01209 has been joined as a Petitioner
`to this proceeding.
`2 Petitioner Teva from IPR2016-01122 has been joined as Petitioner to this
`proceeding.
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