`Tel: 571-272-7822
`
`
`
`
`
`
`IPR2016-01209, Paper 16
`IPR2015-01340, Paper 38
`Entered: October 21, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`WOCKHARDT BIO AG
`Petitioner,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`____________
`
`Case IPR2016-01029
`Patent RE44,186 E
`____________
`
`Before MICHAEL P. TIERNEY, RAMA G. ELLURU, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`ELLURU, Administrative Patent Judge.
`
`
`
`REPLACEMENT DECISION1
`Grant of Motion for Joinder
`37 C.F.R. § 42.108
`37 C.F.R. § 42.222
`
`
`
`
`
`1 This “replacement” decision is issued to only correct typographical errors
`in the original decision (IPR2015-01340, Papers 32 and 33; IPR2016-01029,
`Paper 15), e.g., with respect to party names and case number cites.
`
`
`
`IPR2016-01029
`Patent RE44,186 E
`
`
`
`Petitioner, Wockhardt Bio AG (“Wockhardt”), 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 1, “Pet.”). Concurrently with its Petition,
`Wockhardt 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”) did not file a
`preliminary response in the present proceeding, but opposes Wockhardt’s
`Motion for Joinder. Paper 8 (“Opp.”).
`For the reasons set forth below, we conclude that Wockhardt 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 Wockhardt’s Motion
`for Joinder and exercise our discretion to join Wockhardt as a Petitioner to
`the Mylan IPR. We further terminate the present proceeding, IPR2016-
`01209.
`
`I. PETITION FOR INTER PARTES REVIEW
`Wockhardt 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. 16–17. In addition, the ’186 patent is the subject of pending
`
`2
`
`
`
`IPR2016-01029
`Patent RE44,186 E
`
`
`
`inter partes review proceedings, including IPR2016-01122, IPR2016-01104,
`and IPR2016-01117. 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.
`IPR2015–01340, Pet 17; Mot. 5–6; IPR2015-01340, Paper 16, 34–35.
`
`
`
`Pet. 17.
`Wockhardt supports its assertions with the same evidence and
`arguments proffered in the Mylan IPR. Pet. 23–57. Wockhardt notes that
`“Wockhardt’s Petition that accompanies the present Motion for Joinder and
`accompanying evidence are the same as the instituted Mylan IPR Petition
`and Petitioner’s Reply to the Patent Owner Response, aside from procedural
`sections that, for example, identify Wockhardt, any real parties in interest,
`and its standing, etc.” Mot. 6.
`
`3
`
`
`
`IPR2016-01029
`Patent RE44,186 E
`
`
`
`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 Wockhardt 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, Wockhardt seeks joinder with the inter
`
`partes review in the Mylan IPR. Mot. 1–2. Wockhardt filed the present
`Motion on May 11, 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
`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.
`
`4
`
`
`
`IPR2016-01029
`Patent RE44,186 E
`
`
`
`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
`Wockhardt 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
`Wockhardt as a Petitioner to the Mylan IPR.
`In its Motion for Joinder, Wockhardt asserts that:
`[A]llowing Wockhardt to participate in the Mylan IPR will
`allow Wockhardt and AstraZeneca to resolve the underlying
`litigation between the parties in a cost effective, expeditious
`manner should Mylan seek to terminate its participation in the
`Mylan IPR based on settlement or other factors.
`Mot. 8–9.
`Upon authorization, Wockhardt and AstraZeneca filed a joint
`stipulation explaining the agreement between Petitioners Mylan and
`Wockhardt, 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 13. Pursuant to the stipulation, Wockhardt 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,
`Wockhardt 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. Wockhardt also
`
`5
`
`
`
`IPR2016-01029
`Patent RE44,186 E
`
`
`
`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 Wockhardt 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.” Paper 13, 2. In
`addition, Wockhardt 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 Wockhardt 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 “[j]oinder will
`complicate the Mylan IPR because Wockhardt and Mylan are not working
`together.” Opp. 4. For example, AstraZeneca asserts that “Wockhardt 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.”
`
`6
`
`
`
`IPR2016-01029
`Patent RE44,186 E
`
`
`
`Opp. 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 Wockhardt and Mylan
`should joinder be granted. The level of cooperation agreed to between
`Mylan and Wockhardt addresses AstraZeneca’s concerns about Wockhardt
`proffering different arguments and evidence. AstraZeneca’s opposition
`further requests that safeguards be imposed should Wockhardt’s motion for
`joinder be granted. Opp. 8. 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 13, 3. Thus, we determine that
`AstraZeneca’s requested safeguards have been agreed to by Petitioners
`Mylan and Wockhardt.
`
`AstraZeneca further contends that joinder will not enhance
`efficiencies, because Wockhardt’s petition “has no independent right to seek
`an IPR” given its petition is time-barred pursuant to 35 U.S.C. § 315(b).
`Opp. 7–8. 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 “[t]he last sentence of § 315(b) provides an
`exception to the one-year bar only for a request for joinder, not for a petition
`for IPR.” Opp. 9. According to AstraZeneca, the one-year time bar applies
`to “all petitions, even in the joinder context,” and that § 315(c) does not
`
`7
`
`
`
`IPR2016-01029
`Patent RE44,186 E
`
`
`
`“provide a backdoor for time-barred petitions to be effectively instituted
`through joinder.” Opp. 9. In support, AstraZeneca asserts that § 315(c)
`“requires compliance with § 311, which in turn requires compliance with the
`other provisions of Title 35, Chapter 31 of the U.S. Code, including the
`timeliness provisions.” Opp. 10.
`AstraZeneca’s argument does not persuade us from granting joinder.
`The Office has implemented a regulation that implements § 315(b)’s one-
`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 Wockhardt as a Petitioner to the Mylan IPR.
`Because Wockhardt has satisfied the requirements of § 315(c), we
`grant Wockhardt’s Motion for Joinder and exercise our discretion to join
`Wockhardt as a Petitioner to the already existing Mylan IPR. We further
`terminate the present proceeding.
`As a Petitioner in the Mylan IPR, Wockhardt 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 13.
`More specifically, all filings by Wockhardt in the Mylan IPR shall be
`
`8
`
`
`
`IPR2016-01029
`Patent RE44,186 E
`
`
`
`consolidated with the filings of the other Mylan IPR Petitioner(s), unless the
`filing involves an issue unique to Wockhardt or states a point of
`disagreement related to the consolidated filing. In such circumstances,
`Wockhardt 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.
`Wockhardt 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 Wockhardt to resolve any disputes
`between them and to contact the Board only if such matters cannot be
`resolved.
`
`
`III. ORDER
`
`Accordingly, it is
`ORDERED that Wockhardt’s Motion for Joinder is granted;
`FURTHER ORDERED that Wockhardt is joined as a Petitioner in
`IPR2015-01340;
`FURTHER ORDERED that the instant proceeding, IPR2016-01209,
`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;
`
`9
`
`
`
`IPR2016-01029
`Patent RE44,186 E
`
`
`
`FURTHER ORDERED that the current Scheduling Order for
`IPR2015-01340 shall continue to govern IPR2015-01340;
`FURTHER ORDERED that Wockhardt shall adhere to the existing
`schedule in the Mylan IPR IPR2015-01340;
`FURTHER ORDERED that Wockhardt shall abide by the joint
`stipulation with respect to consolidated filings, and discovery and testimony
`(Paper 13);
`FURTHER ORDERED that all filings by Wockhardt 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 Wockhardt or
`states a point of disagreement related to the consolidated filing. In such
`circumstances, Wockhardt 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 Wockhardt 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 Wockhardt shall resolve any
`disputes between them and to contact the Board only if such matters cannot
`be resolved;
`
`10
`
`
`
`IPR2016-01029
`Patent RE44,186 E
`
`
`
`FURTHER ORDERED that the case caption in IPR2015-01340 shall
`be changed to reflect the joinder of Wockhardt 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.
`
`
`11
`
`
`
`IPR2016-01029
`Patent RE44,186 E
`
`
`
`
`FOR PETITIONER MYLAN:
`
`FOR PETITIONER WOCKHARDT:
`Patrick Gallagher
`pcgallagher@duanemorris.com
`
`Steven Parmelee
`sparmelee@wsgr.com
`Richard Torczon
`rtorczon@wsgr.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
`
`
`
`
`
`
`
`12
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC., and
`WOCKHARDT BIO AG
`Petitioner,
`
`v.
`
`ASTRAZENECA AB
`Patent Owner.
`____________
`
`Case IPR2015-013401
`Patent RE44,186 E
`____________
`
`
`
`
`
`
`
`
`
`
`1 Petitioner Wockhardt from IPR2016-01209 has been joined as a Petitioner
`to this proceeding.