Paper No. ___
`Date Filed: Nov. 16, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`___________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`___________________
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`WOCKHARDT BIO AG,
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`Petitioner
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`v.
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`JANSSEN ONCOLOGY, INC.,
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`Patent Owner.
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`___________________
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`CASE IPR2016-01582
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`Patent 8,822,438
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`___________________
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`JANSSEN ONCOLOGY INC.’S PRELIMINARY RESPONSE
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`Date Filed: Nov. 16, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`___________________
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`
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`___________________
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`WOCKHARDT BIO AG,
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`Petitioner
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`v.
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`JANSSEN ONCOLOGY, INC.,
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`Patent Owner.
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`___________________
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`CASE IPR2016-01582
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`Patent 8,822,438
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`___________________
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`JANSSEN ONCOLOGY INC.’S PRELIMINARY RESPONSE
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`TABLE OF CONTENTS
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`I.
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`INTRODUCTION ........................................................................................... 1
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`II.
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`FACTUAL BACKGROUND.......................................................................... 2
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`III. THE WOCKHARDT PETITION SHOULD BE DENIED BECAUSE IT
`FAILS TO IDENTIFY AMERIGEN AS A REAL PARTY-IN-INTEREST
`PURSUANT TO SECTION 312(A)(2) ........................................................... 7
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`A. Disclosure Of All Real Parties-in-Interest Is A Mandatory
`Requirement .......................................................................................... 8
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`B. Wockhardt Was Required To Identify Amerigen As A Real Party-in-
`Interest ................................................................................................. 10
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`C.
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`The Failure To Identify Amerigen As A Real Party-In-Interest
`Mandates Vacating The Wockhardt Petition Filing Date ................... 14
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`IV. THE WOCKHARDT PETITION SHOULD ALSO BE DENIED UNDER
`SECTION 325(D) .......................................................................................... 15
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`A.
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`B.
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`The Wockhardt Petition Uses the Same or Substantially the Same
`Prior Art and Arguments As Those Presented In Co-Pending IPRs ... 15
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`The Arguments Against Denial Based On Section 325(d) Made In The
`Wockhardt Petition Fail ...................................................................... 19
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`V.
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`CONCLUSION .............................................................................................. 22
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`
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`i
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`I.
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`INTRODUCTION
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`The Petition filed by Wockhardt Bio AG (“the Wockhardt Petition”) should
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`be rejected for each of two independent reasons.
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`First, the Wockhardt Petition does not identify a real party-in-interest
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`(“RPI”)—Amerigen Pharmaceuticals Ltd. (“Amerigen”). Amerigen filed an inter
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`partes review (“IPR”) petition challenging the same claims of the ’438 Patent on
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`December 4, 2015 (the “Amerigen IPR”) and has been coordinating closely with
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`Petitioner Wockhardt in connection with each of these proceedings. Wockhardt’s
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`own statements confirm that Wockhardt and Amerigen are in effect jointly
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`controlling these IPRs. Wockhardt has further admitted
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`The RPI disclosure requirement is intended “to assure proper application of
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`the statutory estoppel provisions… [which] seek[] to protect patent owners from
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`harassment via successive petitions by the same or related parties, to prevent
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`parties from having a ‘second bite at the apple.’” Office Patent Trial Practice
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`Guide, 77 Fed. Reg. 48756, 48759 (Aug. 14, 2012). The Wockhardt Petition seeks
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`to do precisely what the RPI provisions are designed to prevent. Wockhardt’s
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`failure to disclose Amerigen as a RPI mandates dismissal of the Petition under 35
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`U.S.C. § 312(a)(2).
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`Second, and independently, the Wockhardt Petition relies on “substantially
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`the same prior art or arguments previously presented to the Office” in the
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`Amerigen IPR. 35 U.S.C. § 325(d). Indeed, the Amerigen and Wockhardt IPR
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`petitions are effectively the same in substance. Any differences in the art relied
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`upon in the Wockhardt Petition are merely cosmetic—a fact that is underscored by
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`verbatim identical experts’ conclusions concerning what the new reference relied
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`upon does and does not teach to those of ordinary skill. The Board should
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`therefore exercise its sound discretion to dismiss the Wockhardt Petition under
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`Section 325(d).
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`II.
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`FACTUAL BACKGROUND
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`Patent Owner’s U.S. Patent No. 8,822,438 (“the ’438 patent”) claims a
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`breakthrough discovery in cancer treatment, i.e., that abiraterone acetate and
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`prednisone can be used in combination to provide a dramatically more effective
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`treatment for preventing or slowing the growth of castration resistant metastatic
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`prostate cancer. This discovery, which is commercially embodied in the FDA
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`approved uses of ZYTIGA®, has transformed doctors’ ability to combat a deadly
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`form of prostate cancer and extend patients’ lives, in sharp contrast to earlier
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`treatment options that were largely ineffective.
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`Numerous generic drug companies, each seeking to market generic versions
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`of ZYTIGA®, have challenged the validity of ’438 patent by providing the Patent
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`Owner with “Paragraph IV” certifications under the Hatch-Waxman Act. On July
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`31, 2015, Patent Owner1 sued twelve of these companies, including Petitioner
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`Wockhardt and its subsidiaries, in the U.S. District Court for the District of New
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`Jersey asserting infringement of the ’438 patent. See BTG Int’l Ltd. et al. v.
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`Actavis Labs. Fl. Inc. et al., Case No. 2:15-cv-05909-KM-JBC (D.N.J.) (the
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`“District Court Litigation”).2
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`Although Amerigen was not one of the companies that originally submitted
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`a “Paragraph IV” certification notice, and thus was not one that was originally
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`sued, on December 4, 2015, Amerigen nonetheless filed an IPR petition
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`challenging the patentability of claims of the ’438 patent. Amerigen Pharms., Ltd.
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`v. Janssen Oncology, Inc., IPR2016-00286 (the “Amerigen IPR”).
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`Later, on March 24, 2016, Amerigen did serve the Patent Owner with a
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`“Paragraph IV” certification for the ’438 patent, whereupon, on May 2, 2016,
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`1 In addition to Patent Owner, the District Court Litigation named as co-plaintiffs
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`BTG International Limited, Janssen Biotech, Inc., and Janssen Research &
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`Development, LLC (collectively, "co-plaintiffs"),
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`2 Defendants, including Wockhardt, submitted Invalidity Contentions as required
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`by the local patent rules in February 2016. Defendants’ February 2016 Invalidity
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`Contentions set forth each of the prior art references that Wockhardt relies upon as
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`grounds in this IPR.
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`Patent Owner and co-plaintiffs sued Amerigen for infringement, which suit was
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`then consolidated with the District Court Litigation for purposes of discovery. See
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`BTG Int’l Ltd. et al. v. Amerigen Pharms., Inc. et al., Case No. 2:16-cv-02449-
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`KM-JBC (D.N.J.) (the “Amerigen Lawsuit”).
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`On May 31, 2016, the Board instituted the Amerigen IPR based on the
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`record before it. Amerigen IPR, Paper 14 at 19 (PTAB May 31, 2016).3
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`3 Subsequently, two other generic drug makers, Argentum Pharmaceuticals LLC
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`(“Argentum”) and Mylan Pharmaceuticals Inc. (“Mylan”), submitted IPR petitions,
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`on June 29, 2016 and June 30, 2016, respectively, challenging the claims of the
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`’438 patent and raising grounds that were identical or nearly identical to those
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`raised in the Amerigen IPR. See Argentum Pharms. LLC v. Janssen Oncology,
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`Inc., IPR2016-01317 (“Argentum IPR”); Mylan Pharms. Inc. v. Janssen Oncology,
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`Inc., IPR2016-01332 (“Mylan IPR”). Motions for joinder to the already pending
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`Amerigen IPR were filed with each. Argentum’s motion for joinder was granted.
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`Argentum IPR, Paper 9 at 8-9 (PTAB Sept. 19, 2016); Amerigen IPR, Paper 30 at
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`8-9 (PTAB Sept. 19, 2016). Patent Owner submitted its preliminary response to
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`Mylan’s petition on October 12, 2016 and the Board’s decision on whether to
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`institute IPR will be made on or before January 4, 2017. See Mylan IPR, Paper 11
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`at 4 (PTAB Aug. 26, 2016). Mylan is also a named defendant in the District Court
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`Litigation.
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`Thereafter, a series of events transpired that demonstrate that Wockhardt and
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`Amerigen are jointly controlling these related proceedings, and other proceedings
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`relating to the ’438 patent.
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`On June 6, 2016, less than one week after the institution decision in the
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`Amerigen IPR, Wockhardt contacted Patent Owner
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` Specifically, Petitioner Wockhardt’s Vice President of Global IP, Dr.
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`Vipin Dhanorkar, contacted Patent Owner’s in-house counsel, Ms. Jennifer Reda.
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`(Ex. 2002 at 3-4). Dr. Dhanorkar
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`Id.
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`Dr. Dhanorkar’s email stated that
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`Counsel for Patent Owner responded to Dr. Dhanorkar by email on June 6,
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`2016. (Ex. 2002 at 3).
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`The next day, when Dr. Dhanorkar spoke by telephone with Patent Owner’s
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`counsel, he specifically indicated that
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` (Ex. 2003 (Reda Dec.) at ¶5).
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`Following the telephone call, counsel for Patent Owner sent an email to Dr.
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`Dhanorkar asking for additional information. (Ex. 2002 at 2). In a subsequent
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`email dated June 8, 2016, Dr. Dhanorkar
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`2002 at 1-2) (emphasis added).
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` Id.
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`On July 23, 2016, Dr. Dhanorkar sent counsel for Patent Owner another
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`email. In his email, he said “I am sure you are aware that Janssen’s request for
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`rehearing is denied.” In addition, he requested that counsel for Patent Owner “let
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`[him] know [her] availability for call next week.” (Ex. 2002 at 1).
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`On July 26, 2016, counsel for Patent Owner had a subsequent telephone
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`conversation with Dr. Dhanorkar. During that call,
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`. (Ex. 2003 (Reda Dec.) at ¶9).
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` The Wockhardt Petition was filed by Wockhardt on August 10, 2016.
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`See Paper 4.
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`III. THE WOCKHARDT PETITION SHOULD BE DENIED BECAUSE
`IT FAILS TO IDENTIFY AMERIGEN AS A REAL PARTY-IN-
`INTEREST PURSUANT TO SECTION 312(A)(2)
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`Wockhardt’s own statements confirm that Amerigen and Wockhardt are
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`jointly controlling the Amerigen IPR and Wockhardt Petition as part of a common
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`strategy that jointly attacks the validity of the ’438 patent. Each company
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`exercises effective control over the other’s IPR proceeding. For the purposes of
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`challenging the claims of the ’438 patent, Amerigen is a RPI of Wockhardt.
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`Because the Wockhardt Petition fails to identify Amerigen as a RPI, the
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`Wockhardt Petition is defective on its face and should be denied pursuant to 35
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`U.S.C. § 312(a)(2).
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`A. Disclosure Of All Real Parties-in-Interest Is A Mandatory
`Requirement
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`The America Invents Act (“AIA”) is unequivocal: a petition for IPR “may
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`be considered only if” it identifies all RPI’s. 35 U.S.C. § 312(a)(2) (emphasis
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`added). See also Reflectix, Inc. v. Promethean Insulation Tech. LLC, IPR2015-
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`00039, Paper 18 at 7 (PTAB Apr. 24, 2015).
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`The identification of all RPI’s must be made as part of a petitioner’s
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`mandatory notices, required to be filed as a part of the petition itself. 37 C.F.R.
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`§§ 42.8(a)(1); 42.8(b)(1). The only provision for updating the identification of a
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`RPI is “within 21 days of a change of the information,” i.e., a change in the status
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`of a party as RPI. 37 C.F.R. § 42.8(a)(3) (emphasis added).
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`Otherwise, correcting the identification of RPIs listed in a petition results in
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`a loss of the petition’s filing date, with a new filing date assigned as of the date the
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`RPI identification is corrected. See, e.g., Reflectix, IPR2015-00039, Paper 18 at 7-
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`8 (citing Askeladden LLC v. McGhie, IPR2015-00122, Paper 30 at 15 (PTAB Mar.
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`6, 2015)). In cases where the newly-assigned filing date falls outside the one-year
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`period for filing a petition under 35 U.S.C. § 315(b), the Board has found that the
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`failure to identify all RPIs in the original petition results in denial of that petition.
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`Reflectix, IPR2015-00039, Paper 18 at 8 (citing ZOLL Lifecor Corp. v. Philips
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`Elec. North America Corp., IPR2013-00609, Paper 15 at 16-17 (PTAB Mar. 20,
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`2014)).
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`Determining whether an unidentified party is a RPI does not lend itself to
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`per se rules because of its highly fact-dependent nature. Reflectix, IPR2015-
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`00039, Paper 18 at 9. What is clear is this: the touchstone of the RPI analysis is
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`the ability of a party to exercise control with respect to the IPR proceeding. Id. at
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`9-10. “The non-party’s participation may be overt or covert, and the evidence may
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`be direct or circumstantial, but the evidence as a whole must show that the non-
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`party possessed effective control from a practical standpoint.” ZOLL, IPR2013-
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`00609, Paper 15 at 10-11 (citing Gonzalez v. Banco Cent. Corp., 27 F.3d 751, 759
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`(1st Cir. 1994)); see also Aruze Gaming Macau, Ltd., v. MGT Gaming, Inc.,
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`IPR2014-01288, Paper 13 at 11 (PTAB Feb. 20, 2015) (“central to the Board’s
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`determination was that a party other than the named petitioner was controlling, or
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`capable of controlling, the proceeding before the Board”); Atlanta Gas Light Co. v.
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`Bennett Regulator Guards, Inc., IPR2013-00453, Paper 88 at 11-12 (PTAB Jan. 6,
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`2015).
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`9
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`B. Wockhardt Was Required To Identify Amerigen As A Real
`Party-in-Interest
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`Wockhardt was required to identify Amerigen, the petitioner in the
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`Amerigen IPR, as a RPI in this proceeding, but Wockhardt did not do so. See
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`Wockhardt Petition, Paper 4 at 66.
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`Counsel for Wockhardt has acknowledged that
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` The communications from Wockhardt to
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`counsel for Patent Owner show
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`As counsel for Wockhardt informed Patent Owner’s counsel,
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` Wockhardt has never provided
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`Patent Owner with an explanation as to why it did not seek to file its IPR petition
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`earlier; indeed, its invalidity contentions were served on Patent Owner in the
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`District Court Litigation in February 2016.
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`After the Board’s institution decision in the Amerigen IPR in June 2016,
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`however,
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` Thus, Wockhardt’s counsel contacted counsel for
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`Patent Owner just days after the institution decision in the Amerigen IPR
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` (Ex. 2002 at 1-4).
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` confirm that Wockhardt and
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`Amerigen effectively exercise a degree of control over the other’s efforts to attack
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`the ’438 patent, including this IPR proceeding.
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` (Ex. 2002 at 1-2).
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` both parties effectively had control over (or the capacity to control) the
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`disposition of the other’s actual or threatened challenges to the validity of the ’438
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`patent, whether in district court or here before the Board in an IPR proceeding.
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`In other words, Amerigen had the ability to effectively control
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`had the ability to effectively control
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` Further, Wockhardt
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`11
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`What’s more, counsel for Wockhardt’s communications to Patent Owner
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`confirm that Wockhardt and Amerigen’s coordinated activities relating to the ’438
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`patent remain ongoing. By the time counsel for Wockhardt contacted Patent
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`Owner’s counsel, both Wockhardt and Amerigen knew that the final determination
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`in the Amerigen IPR would be made in May 2017. At the same time, District
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`Court Litigation involving Wockhardt had been scheduled for trial in October
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`2017.
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`As an insurance policy against an adverse decision in the Amerigen IPR that
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`would benefit both parties, Wockhardt therefore timed the filing of its petition to
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`preserve its invalidity attacks on the ’438 patent in the District Court Litigation.
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`See 35 U.S.C. § 315(e)(2) (estoppel prevents IPR challenges resulting in final
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`written decision from being raised again in district court).
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`Dec.) at ¶9). Meanwhile, Wockhardt has admittedly
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` (Ex. 2003 (Reda
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` These joint activities and exercise of control clearly
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`demonstrate that Amerigen is a RPI. See, e.g., ZOLL, IPR2013-00609, Paper 15 at
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`12-15 (holding that the presence of an unidentified RPI’s management member at a
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`court-ordered mediation of petitioner indicated control); Atlanta Gas, IPR2013-
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`00453, Paper 88 at 7-9 (holding that an unnamed party was a RPI where the two
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`companies were so “intertwined” that it was difficult to determine precisely where
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`one company ended and the other began); Galderma S.A. & Q-MED AB v.
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`Allergan Indsturie SAS, et al., IPR2014-01422, Paper 14 at 9-12 (PTAB Mar. 5,
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`2015) (holding unnamed parties are RPIs based on pattern of “intertwined”
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`control); Aruze Gaming, IPR2014-01288, Paper 13 at 10 (website challenging the
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`validity of patents on behalf of other parties, without naming the other parties,
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`failed to identify all RPIs (citing In re Guan, Reexamination Control No.
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`95/001,045 (Aug. 25, 2008) (Decision Vacating Filing Date)).
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`The RPI disclosure requirement is meant “to assure proper application of the
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`statutory estoppel provisions… [which] seek[] to protect patent owners from
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`harassment via successive petitions by the same or related parties, to prevent
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`parties from having a ‘second bite at the apple.’” Office Patent Trial Practice
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`Guide, 77 Fed. Reg. at 48759.
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`By failing to identify Amerigen as a RPI, both Amerigen and Wockhardt
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`seek not only to harass Patent Owner with successive IPR petitions, they also seek
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`to game the IPR system in order to levy multiple attacks on the ’438 patent not
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`only here before the Board, but also in different forums. Such “gamesmanship” is
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`not only disfavored, see Toyota Motor Corp. v. Cellport Sys., Inc., IPR2015-01422,
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`Paper 8 at 19-22 (PTAB Dec. 16, 2015), it is the very conduct that the RPI
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`13
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`disclosure requirements were designed the prevent. Office Patent Trial Practice
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`Guide, 77 Fed. Reg. at 48759.5
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`C. The Failure To Identify Amerigen As A Real Party-In-Interest
`Mandates Vacating The Wockhardt Petition Filing Date
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`By failing to identify Amerigen as a RPI, the Wockhardt Petition is defective
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`and the original filing date must be vacated. See 35 U.S.C. § 312(a)(2); see also
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`supra at Section III.A. Correcting the identification of RPI results in a new filing
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`date assigned as of the date the correction is made. See Reflectix, IPR2015-00039,
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`Paper 18 at 7-8; Askeladden, IPR2015-00122, Paper 30 at 15.
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`Here, any newly-assigned filing date for the Wockhardt Petition would be
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`outside the one-year period for filing a petition defined in 35 U.S.C. § 315(b).
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`Patent Owner served Wockhardt with a complaint for patent infringement of the
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`’438 patent no later than August 13, 2015. See District Court Litigation, Case No.
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`5 Additionally, the Board has recognized, “the opportunity to read Patent Owner’s
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`Preliminary Response in [the first IPR], prior to filing the Petition here, is unjust.”
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`Toyota Motor Corp. v. Cellport Sys., Inc., IPR2015-01423, Paper 7 at 8 (PTAB
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`Oct. 28, 2015) (emphasis added); see also LG Elecs. Inc. v. Core Wireless
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`Licensing S.A.R.L., IPR2016-00986, Paper 12 at 11 (PTAB Aug. 22, 2016) (noting
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`that incremental-petitioning, where a petitioner relies on a Board decision from a
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`prior proceeding to mount a second attack, is highly disfavored).
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`14
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`2:15-cv-05909-KM-JBC, D.I. 17 (D.N.J. Aug. 13, 2015). Counsel for
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`Wockhardt’s attempt to use the Wockhardt Petition as an end run around a
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`potential estoppel effect in the District Court Litigation has actually created an
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`estoppel effect here. The Wockhardt Petition should be denied.
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`IV. THE WOCKHARDT PETITION SHOULD ALSO BE DENIED
`UNDER SECTION 325(D)
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`The Wockhardt Petition challenges the same claims of the same patent,
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`using substantially the same prior art and arguments that were (and still are) at
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`issue in not only the Amerigen IPR, but also the Argentum and Mylan IPR’s. The
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`Board has broad discretion to deny a petition that raises the same or substantially
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`the same prior art or arguments previously presented to the Office and
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`appropriately uses Section 325(d) as the basis to not institute IPR on such petitions.
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`E.g., Unilever, Inc. v. Procter & Gamble Co., IPR2014-00506, Paper 17 at 6
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`(PTAB July 7, 2014); Unified Patents, Inc. v. PersonalWeb Techs., LLC, IPR2014-
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`00702, Paper 13 at 7-8 (PTAB July 24, 2014); Medtronic, Inc. v. Nuvasive, Inc.,
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`IPR2014-00487, Paper 8 at 6-7 (PTAB Sept. 11, 2014); Medtronic, Inc. v. Robert
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`Bosch Healthcare Sys., Inc., IPR2014-00436, Paper 17 at 11-12 (PTAB June 19,
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`2014). The Board should exercise its discretion here and deny the Wockhardt
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`Petition.
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`A. The Wockhardt Petition Uses the Same or Substantially the Same
`Prior Art and Arguments As Those Presented In Co-Pending
`IPRs
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`The Wockhardt Petition seeks cancellation of claims 1-20 of the ’438 patent
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`as unpatentable under 35 U.S.C. § 103(a), relying on three publications:
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`O’Donnell,6 Gerber,7 and Sartor8. The Amerigen IPR seeks cancellation of the
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`same claims of the same patent, relying on the same principal references cited by
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`Wockhardt—O’Donnell and Gerber. The petitions in the Argentum IPR and the
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`Mylan IPR rely on the same prior art and the same or substantially the same
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`arguments raised in the Amerigen IPR.
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`O’Donnell and Gerber are the principal references relied upon in essentially
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`the same way to support the obviousness arguments challenging the claims of the
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`’438 patent before the Board in the Amerigen, Argentum, and Mylan IPRs, and in
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`6 Ex. 1005, O’Donnell, A. et al., “Hormonal impact of the 17α-hydroxylase/C17
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`20-lyase inhibitor abiraterone acetate (CB7630) in patients with prostate cancer,”
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`British Journal of Cancer, (90):2317-2325 (2004) (“O’Donnell”).
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`7 Ex. 1004, Gerber, G.S. et al., “Prostate specific antigen for assessing response to
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`ketoconazole and prednisone in patients with hormone refractory metastatic
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`cancer,” The Journal of Urology, 144(5):1177-1179 (1990) (“Gerber”).
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`8 Ex. 1006, Sartor, O. et al., “Effect of prednisone on prostate-specific antigen in
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`patients with hormone-refractory prostate cancer,” Urology, 52:252-256 (1998)
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`(“Sartor”).
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`the present Wockhardt petition.9 Patent Owner fully addresses the O’Donnell and
`
`Gerber references in the consolidated Amerigen IPR.
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`Moreover, the Wockhardt Petition rehashes nearly all of the same arguments
`
`raised in the Amerigen IPR, using the O’Donnell and Gerber references. Indeed,
`
`the Wockhardt Petition makes arguments based on each reference that are
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`substantially the same as those made in not only the Amerigen IPR, but also in the
`
`Argentum IPR and in the Mylan IPR. Id.
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`In an attempt to gain a second bite in a new IPR, Wockhardt tries to
`
`manufacture a distinction based upon the introduction of the secondary Sartor
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`reference, but Sartor adds no further support to the conclusions of Wockhardt’s
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`experts, which are verbatim the same as those advanced in the earlier IPRs. In
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`particular, Wockhardt relies on Sartor for the specific proposition that it allegedly
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`“teaches that prednisone treats prostate cancer.” Wockhardt Petition, Paper 4 at
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`22. But the purported teaching in Sartor that, at least some time before the
`
`invention of the ’438 Patent, there was disclosure of prednisone for treating
`
`prostate cancer, is cumulative to the evidence presented by Amerigen’s expert in
`
`
`9 See e.g., Amerigen IPR, IPR2016-00286, Paper 1 at 37-38 (PTAB Dec. 4, 2015);
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`Argentum IPR, IPR2016-01317, Paper 2 at 37-38 (PTAB June 29, 2016); Mylan
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`IPR, IPR2016-01332, Paper 1 at 38-40 (PTAB June 30, 2016); Wockhardt Petition,
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`Paper 4 at 24 (PTAB Aug. 10, 2016).
`
`17
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`IPR2016-01582
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`its IPR. Amerigen’s expert, Dr. Serels, stated in his Declaration, “It was also
`
`reported that prednisone might have some anti—tumor effect by feedback inhibition
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`of the hypothalamic-pituitary-adrenal axis.” Amerigen IPR, Ex. 1002, 1179.
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`But importantly, Dr. Serels then refuted the notion that one skilled in the art
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`would actually have prescribed prednisone as an anti—cancer or anti—tumor agent as
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`of the time of the ’438 invention. Using precisely the same words, Wockhardt’s
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`expert provides the same opinion:
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`W°°“““'““
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`Ex. 1002 at 116 emhasls added .
`
`filed Au ; . 10, 201 s
`filed Dec. 4, 201
`a]Ithough prednisone was known to
`“It was also reported that prednisone
`have a modest anti—cancer efi'ect on
`might have some anti-tumor
`eflect. . . [however,] in my experience, no mCRPC as explained above, in my
`treating physician would prescribe
`experience no treating physician would
`prednisone alone as an anti—cancer or
`prescribe prednisone alone as an anti-
`anti—tumor agent to a patient with |sic|
`cancer a ent to a atient with sic a
`prostate cancer.” Amerigen IPR, Ex.
`prostate cancer. . . Wockhardt Petition,
`1002 at 79 emhasis added .
`
`The “new” Sartor reference thus adds nothing of substance to the prior art and
`
`arguments already presented in the Amerigen IPR.
`
`The declaration of Wockhardt’s commercial success expert, Dr. Stoner, is
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`similarly duplicative of the declarations submitted by the other petitioners. Indeed,
`
`many of the statements found in Dr. Stoner’s declaration are similarly copied
`
`verbatim from the commercial success declaration filed in the Amerigen IPR.
`
`Compare Ex. 1077 (Stoner Dec.) at 1]1]36-45 with Amerigen IPIL Ex. 1017
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`18
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`IPR2016-01582
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`
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`(McDuff Dec.) at ¶¶18-20; and also compare Ex. 1077 (Stoner Dec.) at ¶¶54-58
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`with Amerigen IPR, Ex. 1017 (McDuff Dec.) at ¶¶27-30.
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`In the petition itself, Wockhardt does not even attempt to identify any new
`
`arguments raised by Dr. Stoner on the issue of commercial success. In fact, Dr.
`
`Stoner’s declaration expressly relies on both the “McDuff Declaration” from the
`
`Amerigen IPR and the “Hofmann Declaration” from the Mylan IPR. See Ex. 1077
`
`(Stoner Dec.) at fn. 1. Such wholesale copying of evidence and reliance on
`
`evidence from the Amerigen IPR further supports the Board’s exercise of its
`
`discretion to decline to institute IPR under Section 325(d). See Maxlinear, Inc. v.
`
`Cresta Tech. Corp., IPR2015-00591, Paper 9 at 4-5 (PTAB June 15, 2015);
`
`Initiative for Responsibility in Drug Pricing LLC v. Wyeth LLC, IPR2014-01259,
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`Paper 8 at 6-7 (PTAB Feb. 13, 2015).
`
`B.
`
`The Arguments Against Denial Based On Section 325(d) Made In
`The Wockhardt Petition Fail
`
`Wockhardt’s various attempts to avoid dismissal under Section 325(d) fail.
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`Wockhardt Petition, Paper 4 at 21-22. First, the assertion that it is not involved in
`
`the Amerigen IPR proceeding is simply false. As discussed supra at III.B,
`
`Wockhardt and Amerigen
`
`
`
` and are closely intertwined and coordinated in their activities
`
`challenging this patent.
`
`19
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`IPR2016-01582
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`
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`Second, the argument that its Petition “specifically addresses the Board’s
`
`construction of ‘therapeutically effective amount of prednisone,’” is unavailing.
`
`Claim construction findings based primarily on the intrinsic record, as was the case
`
`in the Amerigen IPR, are insufficient to justify institution of a subsequent petition.
`
`Great West Cas. Co. v. Intellectual Ventures II LLC, IPR2016-00453, Paper 12 at 7
`
`(PTAB June 9, 2016) (finding a claim construction determination alone insufficient
`
`to justify institution of the later petition, particularly when it is “based primarily on
`
`portions of the intrinsic record that were relevant to claim terms that were
`
`reasonably foreseeable as being in dispute.”).
`
`Third, Wockhardt alleges that “the 286 [Amerigen] IPR is still in the
`
`beginning stages.” Not so. Discovery is near completion in the Amerigen IPR and
`
`the oral hearing is only a few months away. 10
`
`
`10 Patent Owner has already submitted its response in the Amerigen IPR. A
`
`February 16, 2017 oral hearing date is approaching and a determination will be
`
`made on or before May 31, 2017 as to whether the claims of the ’438 patent are
`
`unpatentable as obvious over O’Donnell and Gerber, based on substantially the
`
`same flawed arguments presented in the Wockhardt Petition. Consequently,
`
`consolidation of “[this proceeding with the previously-instituted IPR] is not
`
`practical.” HTC Corp. et al. v. NFC Tech., LLC, IPR2015-00384, Paper 11 at 11-
`
`20
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`IPR2016-01582
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`
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`The bottom line is that Wockhardt could have filed its petition months ago,
`
`when Amerigen filed its IPR, or at least by the time it submitted its invalidity
`
`contentions in the District Court Litigation. Wockhardt instead chose a different
`
`path.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Indeed, the Wockhardt Petition relies upon substantially the same prior art
`
`and arguments as in the Amerigen IPR, and in the Argentum IPR and Mylan IPR,
`
`includes the same expert admissions, and copies large portions of declarations filed
`
`in the prior IPRs.
`
`
`
` Wockhardt wastes judicial resources by making
`
`consolidation with the Amerigen IPR impractical. Wockhardt should not be
`
`rewarded for such conduct.
`
`
`12 (PTAB July 6, 2015). Judicial resources will therefore be wasted if the Board
`
`were to institute IPR on the Wockhardt Petition.
`
`
`
`21
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`IPR2016-01582
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`
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`V. CONCLUSION
`
`For either of the foregoing reasons, the Board should deny institution of IPR
`
`based on the Wockhardt Petition.
`
`
`
`Dated: November 16, 2016
`
`Respectfully submitted,
`
`
`
`By: /s/ Dianne B. Elderkin
`Dianne B. Elderkin (Reg. No. 28,598)
`delderkin@akingump.com
`Barbara L. Mullin (Reg. No. 38,250)
`bmullin@akingump.com
`Ruben H. Munoz (Reg. No. 66,998)
`rmunoz@akingump.com
`AKIN GUMP STRAUSS HAUER
`& FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel: (215) 965-1200
`Fax: (215) 965-1210
`
`David T. Pritikin (pro hac vice
`forthcoming)
`Bindu Donovan (pro hac vice
`forthcoming)
`S. Isaac Olson (pro hac vice
`forthcoming)
`SIDLEY AUSTIN LLP
`787 Seventh Avenue
`New York, NY 10019
`Tel.: (212) 839-5300
`Fax: (212) 839-5599
`ZytigaIPRTeam@sidley.com
`
`Counsel for Patent Owner
`
`22
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`IPR2016-01582
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`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing JANSSEN
`
`ONCOLOGY INC.’S PRELIMINARY RESPONSE was served on counsel of
`
`record on November 16, 2016 by filing this document through the End-to-End
`
`System, as well as delivering a copy via electronic mail to counsel of record for the
`
`Petitioner at the following addresses:
`
`Dennies Varughese - dvarughe-PTAB@skgf.com
`Deborah A. Sterling - dsterlin-PTAB@skgf.com
`Christopher M. Gallo - cgallo-PTAB@skgf.com
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`By: /s/Dianne B. Elderkin/
`Dianne B. Elderkin
`Registration No. 28,598
`Counsel for Patent Owner
`
`
`
`
`
`
`
`Date: Nov. 16, 2016
`
`
`
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`
`
`
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`
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`23
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`IPR2016-01582
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`CERTIFICATE OF COMPLIANCE PURSUANT TO 37 C.F.R. §42.24
`
`This paper complies with the type-volume limitation of 37 C.F.R. § 42.24.
`
`The paper contains 4,731 words, excluding the parts of the paper exempted by
`
`§42.24(a).
`
`
`
`This paper also complies with the typeface requirements of 37 C.F.R. §
`
`42.6(a)(ii) and the type style requirements of § 42.6(a)(iii)&(iv).
`
`
`
`Dated: November 16, 2016
`
`Respectfully submitted,
`
`
`
`By: /s/ Dianne B. Elderkin
`Dianne B. Elderkin (Reg. No. 28,598)
`delderkin@akingump.com
`Barbara L. Mullin (Reg. No. 38,250)
`bmullin@akingump.com
`Ruben H. Munoz (Reg. No. 66,998)
`rmunoz@akingump.com
`AKIN GUMP STRAUSS HAUER
`& FELD LLP
`Two Commerce Square
`2001 Market Street, Suite 4100
`Philadelphia, PA 19103
`Tel: (215) 965-1200
`Fax: (215) 965-1210
`
`Counsel for Patent Owner
`
`
`
`
`24
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