Filed on behalf of: Corcept Therapeutics, Inc.
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner
`
`v.
`
`CORCEPT THERAPEUTICS, INC.,
`Patent Owner
`_______________________
`
`Case PGR2019-00048
`U.S. Patent No. 10,195,214
`_______________________
`
`PATENT OWNER’S AUTHORIZED SUR-REPLY IN
`FURTHER SUPPORT OF ITS PRELIMINARY RESPONSE
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner
`
`v.
`
`CORCEPT THERAPEUTICS, INC.,
`Patent Owner
`_______________________
`
`Case PGR2019-00048
`U.S. Patent No. 10,195,214
`_______________________
`
`PATENT OWNER’S AUTHORIZED SUR-REPLY IN
`FURTHER SUPPORT OF ITS PRELIMINARY RESPONSE
`
`
`
`PGR2019-00048
`U.S. Patent No. 10,195,214
`
`Teva’s new arguments do not change the fact that institution would be an
`
`inefficient use of Board resources. The new arguments are based on: (1) the false
`
`assertion that the District Court “adopted” Corcept’s schedule, such that any trial
`
`decision “would likely come well into 2021”; and (2) the misguided premise that
`
`the lack of finality of a preliminary injunction (“PI”) decision would negate the
`
`inefficiency of institution. Reply, 1-3. Each of these arguments lacks merit.
`
`First, while Teva references dates that Corcept had proposed for the close of
`
`fact and expert discovery, it omits that the District Court did not adopt Corcept’s
`
`proposal. Ex. 1063. Teva argued to the Court that its ANDA already has tentative
`
`approval from the FDA, and thus the case should not extend “beyond the 30-month
`
`stay.” Ex. 2003. As a result, the Court is well aware of the ramifications of not
`
`issuing a trial decision prior to the August 2020 expiration of the 30-month stay.
`
`Moreover, the current lack of a trial date does not support Teva’s position. Teva
`
`has specifically stated that it “does not agree not to launch its ANDA Product at-
`
`risk pending the issuance of the district court’s decision.” Ex. 2047. Thus, before
`
`the stay expires, the Court will necessarily issue a decision, if not after trial then on
`
`a PI. Either way, that decision will come months before the November 2020 date
`
`for the Board to enter a final written decision (“FWD”) in this PGR. POPR at 6-7.
`
`Second, Teva’s arguments that a PI determination is insufficiently final to
`
`render consideration of Teva’s petition inefficient are unconvincing. Teva
`
`1
`
`
`
`PGR2019-00048
`U.S. Patent No. 10,195,214
`
`speculates that a PI decision “may not involve validity [of the ’214 patent] at all”
`
`(Reply at 3), but Teva has submitted 135 pages of invalidity contentions directed to
`
`the ’214 patent (and has not asserted any legitimate non-infringement argument
`
`with respect to the ’214 patent). Thus, any PI will necessarily involve the validity
`
`of the ’214 patent, and specifically the same obviousness defenses presented in
`
`Grounds 1 and 2 of the Petition. Ex. 2002. As such, even if Teva is correct that
`
`final resolution of the validity of the ’214 patent in the district court will not occur
`
`until after a FWD, institution would still result in three adjudications on the
`
`obviousness arguments presented in the Petition within a matter of months: (1) the
`
`district court’s PI decision before August 2020; (2) the Board’s FWD in November
`
`2020; and (3) the District Court’s decision following trial shortly thereafter. This
`
`alone would be duplicative and wasteful, let alone that both the Board’s and the
`
`District Court’s decisions would each be subject to appeal, potentially resulting in
`
`five decisions on the same defenses in a short time frame.
`
`Congress did not intend for PGR to result in such duplication. “Post grant
`
`reviews were meant to be quick and cost effective alternatives to litigation.” Ex.
`
`2001 at 9 (emphasis added). Teva’s Petition was not filed as an alternative to
`
`litigation; instead, Teva has hired the same attorneys to simultaneously make the
`
`same obviousness arguments based on the same references (POPR at 6) in both
`
`proceedings. This is contrary to Congressional intent, and should not be permitted.
`
`2
`
`
`
`PGR2019-00048
`U.S. Patent No. 10,195,214
`
`None of the cases Teva cites support its position—or contradict Corcept’s.
`
`Unlike here, the parallel district court litigation in Facebook “ha[d] been stayed.”
`
`IPR2018-01622, Paper 8 at 1. In Mylan, unlike here, the Petitioner was not taking
`
`“two bites at the apple” because the Petitioner “agree[d] to not pursue in the
`
`district court action any specific ground that the Board institute[d],” and there was
`
`no possibility of a PI. IPR2018-01682, Paper 19 at 14-15. Finally, the Intuitive
`
`Surgical and Samsung cases state that denial of institution is “based on specific
`
`circumstances and not the mere presence of district court litigation.” See IPR2018-
`
`01500, Paper 10 at 14. Here, it is not the mere presence of a co-pending district
`
`court case that counsels in favor of denial; it is the fact that Teva will force two
`
`separate tribunals (not to mention potentially the Federal Circuit) to issue multiple
`
`decisions adjudicating the same obviousness arguments based on the same
`
`combination of references—which fail to demonstrate unpatentability under any
`
`standard of review—within a short amount of time of one another. Congress did
`
`not intend for patent owners to have to defend against invalidity defenses in
`
`multiple, consecutive fora, nor did it intend for the Board to waste its time
`
`adjudicating such disputes. While the duplicative costs may not be an issue for
`
`Teva, one of the world’s largest pharmaceutical companies, they are an issue for
`
`Corcept, a small, one-product company. The Board should exercise its
`
`discretionary authority to deny institution of this Petition pursuant to § 324(a).
`
`3
`
`
`
`Date: October 3, 2019
`
`Respectfully Submitted,
`
`PGR2019-00048
`U.S. Patent No. 10,195,214
`
`F. Dominic Cerrito (Reg. No. 38,100)
`Eric C. Stops (Reg. No. 51,163)
`Daniel C. Wiesner (pro hac vice)
`Frank C. Calvosa (Reg. No. 69,064)
`John Galanek (Reg. No. 74,512)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`ericstops@quinnemanuel.com
`danielwiesner@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`johngalanek@quinnemanuel.com
`
`Counsel for Patent Owner
`
`4
`
`
`
`PGR2019-00048
`U.S. Patent No. 10,195,214
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that on the date indicated below a copy of the
`
`foregoing Patent Owner’s Authorized Sur-Reply in further support of its
`
`Preliminary Response and accompanying Exhibit thereto were served
`
`electronically by filing these documents through the PTAB E2E System, as well as
`
`by e-mailing copies to counsel of record for Petitioners at dsterling-
`
`PTAB@sternekessler.com, opartington-PTAB@sternekessler.com, jcrozendaal-
`
`PTAB@sternekessler.com, ueverett-PTAB@sternekessler.com, wmilliken-
`
`PTAB@sternekessler.com.
`
`Date: October 3, 2019
`
`Respectfully Submitted,
`
`F. Dominic Cerrito (Reg. No. 38,100)
`Eric C. Stops (Reg. No. 51,163)
`Daniel C. Wiesner (pro hac vice)
`Frank C. Calvosa (Reg. No. 69,064)
`John Galanek (Reg. No. 74,512)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`ericstops@quinnemanuel.com
`danielwiesner@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`
`
`
`PGR2019-00048
`U.S. Patent No. 10,195,214
`
`johngalanek@quinnemanuel.com
`
`Counsel for Patent Owner
`
`
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