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Trials@uspto.gov
`Tel: 571-272-7822
`
`
`
`
`
`
`IPR2016-01104, Paper 18
`IPR2015-01340, Paper 53
`Entered: November 22, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`SUN PHARMACEUTICAL INDUSTRIES, LTD., SUN PHARMA
`GLOBAL FZE and AMNEAL PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`____________
`
`Case IPR2016-01104
`Patent RE44,186 E
`____________
`
`Before MICHAEL P. TIERNEY, RAMA G. ELLURU, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`ELLURU, Administrative Patent Judge.
`
`
`
`DECISION
`Instituting Inter Partes Review
`37 C.F.R. § 42.108
`Grant of Motion for Joinder
`37 C.F.R. § 42.122(b)
`
`
`
`
`

`
`IPR2016-01104
`Patent RE44,186 E
`
`
`
`Petitioner, Sun Pharmaceutical Industries, Ltd., Sun Pharma Global
`FZE and Amneal Pharmaceuticals LLC (collectively “Sun/Amneal”), 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 E (Ex.
`1001, “the ’186 patent”) (Paper 3, “Pet.”). Concurrently with its Petition,
`Sun/Amneal filed a Motion for Joinder (Paper 4, “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”) filed a Preliminary
`Response in the present proceeding (Paper 17), and an opposition to Sun’s
`Motion for Joinder (Paper 12 (“Opp.”)).
`For the reasons set forth below, we conclude that Sun/Amneal 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 Sun/Amneal’s Motion
`for Joinder and exercise our discretion to join Sun as a Petitioner to the
`Mylan IPR. We further terminate the present proceeding, IPR2016-01104.
`I. PETITION FOR INTER PARTES REVIEW
`Sun/Amneal 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; Paper 11, 1. In addition, the ’186 patent is the subject of
`
`2
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`

`
`IPR2016-01104
`Patent RE44,186 E
`
`
`
`pending inter partes review proceedings, including IPR2016-01029,
`IPR2016-01117, and IPR2016-01122. Pet. 18; Paper 11, 1–2. 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. Pet 19–20; Mot. 6;
`IPR2015-01340, Paper 16, 34–35.
`Sun/Amneal supports its assertions with the same evidence and
`arguments proffered in the Mylan IPR. Pet. 25–63. Sun/Amneal notes that
`“[t]he Petition that accompanies the present Motion for Joinder is
`substantially identical to the instituted Mylan IPR Petition, and the
`accompanying evidence is the same as that relied upon in the Mylan IPR
`Petition and Petitioner’s Reply to the Patent Owner Response.” Mot. 7.
`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 Sun/Amneal 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.
`
`II. MOTION FOR JOINDER
`In the Motion for Joinder, Sun/Amneal seeks joinder with the inter
`
`partes review in the Mylan IPR. Mot. 1–2. Sun/Amneal filed the present
`Motion on 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; Mot. 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
`
`3
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`IPR2016-01104
`Patent RE44,186 E
`
`
`
`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 IPR2015-01340, Paper 16. In addition, we determined above that
`Sun/Amneal 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 Sun/Amneal as a Petitioner to the Mylan IPR.
`In its Motion for Joinder, Sun/Amneal asserts that:
`AstraZeneca has asserted the ’186 patent against Petitioner in
`concurrent district court litigation, and Petitioner is in the same
`consolidated suit as Mylan (AstraZeneca AB v. Aurobinda
`Pharma, Ltd. et al., 1:14-cv-00664 (D. Del.)). As such, allowing
`Petitioner to participate in the Mylan IPR may allow Petitioner
`and AstraZeneca to resolve the underlying litigation between the
`parties in a cost-effective, expeditious manner even if Mylan
`
`4
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`

`
`IPR2016-01104
`Patent RE44,186 E
`
`
`
`seeks to terminate its participation in the Mylan IPR based on
`settlement or other factors.
`
`Mot. 9. As such, allowing Sun/Amneal to participate in the Mylan IPR may
`allow Sun/Amneal and AstraZeneca to resolve the underlying litigation
`between the parties in a cost-effective, expeditious manner even if Mylan
`seeks to terminate its participation in the Mylan IPR based on settlement or
`other factors.
`Upon authorization, the parties filed a joint stipulation explaining the
`agreement between Petitioners Mylan and Sun/Amneal, and other petitioners
`which have moved to join the Mylan IPR, with respect to the level of
`cooperation that will be maintained should joinder be granted. Paper 16.
`Pursuant to the stipulation, Sun/Amneal agrees with Mylan “to share the use
`and, after joinder, the pro rata costs of Mylan’s experts in this IPR
`proceeding in exchange for continuing access to the experts in the event that
`Mylan no longer participates in the review.” Id. at 1–2. Further, as long as
`Mylan remains a party in the Mylan IPR, Sun/Amneal 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. at 2. Sun/Amneal also agrees to confer and
`cooperate with Mylan 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 Sun/Amneal 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
`
`5
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`

`
`IPR2016-01104
`Patent RE44,186 E
`
`
`
`affect Mylan or Mylan’s position.” Id. at 2. In addition, Sun/Amneal agrees
`to coordinate the discovery and testimony relating to witnesses with Mylan,
`and that as long as Mylan remains a party in the Mylan IPR, Mylan will
`make all final decisions, and Sun/Amneal 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 2–3. AstraZeneca advised the petitioners that it maintains
`that joinder is not proper for the reasons provided in its opposition to the
`motion for joinder. Id. at 3. However, if joinder is granted, AstraZeneca
`does not request any additional level of cooperation other than that specified
`in the joint stipulation. Id.
`
`AstraZeneca opposes joinder, contending that “joinder will complicate
`the Mylan IPR.” Opp. 4. For example, AstraZeneca asserts that “Sun,
`Amneal, and Mylan are direct competitors with independent agendas that are
`advancing different substantive positions in the district court litigation with
`different lead compound theories, different prior art, and different expert
`witnesses.” Id. at 5. This argument does not persuade us from granting
`joinder because the joint stipulation filed subsequent to AstraZeneca’s
`opposition explains the level of cooperation that will exist between
`Sun/Amneal and Mylan should joinder be granted. The level of cooperation
`agreed to between Mylan and Sun/Amneal addresses AstraZeneca’s
`concerns about Sun/Amneal proffering different arguments and evidence.
`AstraZeneca’s opposition further requests that safeguards be imposed should
`
`6
`
`

`
`IPR2016-01104
`Patent RE44,186 E
`
`
`
`Sun/Ammeal’s motion for joinder be granted. Id. at 11. Pursuant to the
`subsequent joint stipulation, however, AstraZeneca asserts that “[i]f joinder
`is granted, AstraZeneca advises that it does not request any additional level
`of cooperation other than that specified in the previous section.” Paper 16,
`3. Thus, we determine that AstraZeneca’s requested safeguards have been
`agreed to by Petitioners Mylan and Sun/Amneal.
`
`AstraZeneca further contends that joinder will not enhance
`efficiencies, because Sun/Amneal’s petition “ha[s] no independent right to
`seek an IPR” given its petition is time-barred pursuant to 35 U.S.C. § 315(b).
`Opp. 7. Section 315(b) states:
`An inter partes review may not be instituted if the petition
`requesting the proceeding is filed more than 1 year after the date
`on which the petitioner, real party in interest, or privy of the
`petitioner is served with a complaint alleging infringement of the
`patent. The time limitation set forth in the preceding sentence
`shall not apply to a request for joinder under subsection (c).
`
`AstraZeneca argues that “the last sentence of Section 315(b) provides an
`exception to the one-year bar only for filing a request for joinder, not for
`filing a petition for IPR.” Opp. 8–9. According to AstraZeneca, the one-
`year time bar applies to “all petitions, even in the joinder context,” and that
`§ 315(c) does not “provide a backdoor for time-barred petitions to be
`effectively instituted through joinder.” Id. at 9. In support, AstraZeneca
`asserts that § 315(c) “requires compliance with 35 U.S.C. § 311, which in
`turn requires compliance with the other provisions of Title 35, Chapter 31 of
`the U.S. Code, including the timeliness provisions.” Id. at 10.
`AstraZeneca’s argument does not persuade us from granting joinder.
`The Office has implemented a regulation that implements § 315(b)’s one-
`
`7
`
`

`
`IPR2016-01104
`Patent RE44,186 E
`
`
`
`year deadline. See 37 C.F.R. § 42.101(b). Our regulations also address the
`exception created by the second sentence of § 315(b); they provide that the
`one-year time limit “shall not apply when the petition is accompanied by a
`request for joinder.” 37 C.F.R. § 42.122(b). See Achates Reference Publ’g,
`Inc. v. Apple Inc., 803 F.3d 652, 657 (Fed. Cir. 2015) (the second sentence
`of § 315(b) “means that an otherwise time-barred party may nonetheless
`participate in an inter partes review proceeding if another party files a
`proper petition.”) (citing 35 U.S.C. § 315(c) (emphasis added)). Thus, we
`determine that the second sentence of § 315(b) does not preclude us from
`joining Sun/Amneal as a Petitioner to the Mylan IPR.
`Because Sun/Amneal has satisfied the requirements of § 315(c), we
`grant Sun/Amneal’s Motion for Joinder and exercise our discretion to join
`Sun/Amneal as a Petitioner to the already existing Mylan IPR. We further
`terminate the present proceeding.
`As a Petitioner in the Mylan IPR, Sun/Amneal 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 16.
`More specifically, all filings by Sun/Amneal 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 Sun/Amneal or states a point of
`disagreement related to the consolidated filing. In such circumstances,
`Sun/Amneal shall seek authorization 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.
`
`8
`
`

`
`IPR2016-01104
`Patent RE44,186 E
`
`
`
`Sun/Amneal 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 Sun/Amneal 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 Sun/Amneal’s Motion for Joinder is granted;
`FURTHER ORDERED that Sun/Amneal is joined as a Petitioner in
`IPR2015-01340;
`FURTHER ORDERED that the instant proceeding, IPR2016-01104,
`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 Sun/Amneal shall adhere to the existing
`schedule in the Mylan IPR IPR2015-01340;
`
`9
`
`

`
`IPR2016-01104
`Patent RE44,186 E
`
`
`
`FURTHER ORDERED that Sun/Amneal shall abide by the joint
`stipulation with respect to consolidated filings, and discovery and testimony
`(Paper 16);
`FURTHER ORDERED that all filings by Sun/Amneal 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 Sun/Amneal or
`states a point of disagreement related to the consolidated filing. In such
`circumstances, Sun/Amneal 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 Sun/Amneal 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 Sun/Amneal 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 Sun/Amneal 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.
`
`
`10
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`

`
`IPR2016-01104
`Patent RE44,186 E
`
`
`
`
`FOR PETITIONER MYLAN:
`Steven Parmelee
`sparmelee@wsgr.com
`Richard Torczon
`rtorczon@wsgr.com
`
`FOR PETITIONER AUROBINDO:
`Sailesh K. Patel
`SPatel@schiffhardin.com
`George Yu
`gyu@schiffhardin.com
`
`FOR PETITIONER SUN/AMNEAL:
`Samuel Park
`spark@winston.com
`Andrew Sommer
`asommer@winston.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
`
`11
`
`

`
`12
`
`IPR2016-01104
`Patent RE44,186 E
`
`jonh.livingstone@finnegan.com
`Anthony Hartmann
`anthony.hartmann@finnegan.com
`
`
`
`
`
`

`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`MYLAN PHARMACEUTICALS INC., WOCKHARDT BIO AG, TEVA
`PHARMACEUTICALS USA, INC., AUROBINDO PHARMA U.S.A.,
`INC, and SUN PHARMACEUTICAL INDUSTRIES, LTD., SUN
`PHARMA GLOBAL FZE and AMNEAL PHARMACEUTICALS LLC
`Petitioner,
`
`v.
`
`ASTRAZENECA AB
`Patent Owner.
`____________
`
`Case IPR2015-013401
`Patent RE44,186 E
`____________
`
`
`
`
`
`
`
`
`
`
`1 Petitioner Wockhardt from IPR2016-01209, Petitioner Teva from
`IPR2016-01122, Petitioner Aurobindo from IPR2016-01117, and Petitioner
`Sun/Amneal from IPR2016-01104 has each been joined as a Petitioner to
`this proceeding.

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