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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner
`
`Case IPR2019-01095
`Patent 9,517,219
`
`PATENT OWNER’S PRELIMINARY RESPONSE
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`
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`IPR2019-01095
`Patent Owner’s Preliminary Response
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`TABLE OF CONTENTS
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`Page
`PATENT OWNER’S EXHIBIT LIST .......................................................................iii
`
`I.
`II.
`
`INTRODUCTION .............................................................................................. 1
`THE GENERAL PLASTIC FACTORS DEMONSTRATE THAT
`THE BOARD SHOULD EXERCISE ITS DISCRETION TO
`DENY INSTITUTION UNDER 35 U.S.C. § 314(A) ....................................... 3
`A.
`Factor 1: Whether the Same Petitioner Previously Filed
`a Petition Directed to the Same Claims of the Same Patent .................... 5
`Factor 2: Whether at the Time of Filing of the First Petition
`the Petitioner Knew of the Prior Art Asserted in the Second
`Petition or Should Have Known of It ...................................................... 7
`Factor 3: Whether at the Time of Filing of the Second Petition
`the Petitioner Already Received the Patent Owner’s Preliminary
`Response to the First Petition or Received the Board’s Decision
`on Whether to Institute Review in the First Petition ............................... 8
`Factor 4: Elapsed Time ........................................................................... 9
`Factor 5: Whether the Petitioner Provides Adequate Explanation
`for the Time Elapsed Between the Filings of Multiple Petitions
`Directed to the Same Claims of the Same Patent. ................................. 10
`Factors 6 & 7: The Finite Resources of the Board and the One-Year
`Final Decision Requirement .................................................................. 10
`G. Weighing the Factors ............................................................................. 11
`III. CONCLUSION ................................................................................................ 11
`
`B.
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`C.
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`D.
`E.
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`F.
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`i
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`IPR2019-01095
`Patent Owner’s Preliminary Response
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`TABLE OF AUTHORITIES
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`Page(s)
`
`CASES
`Abiomed, Inc. v. Maquet Cardiovascular, LLC,
`IPR2017-02134, Paper 7 (PTAB April 16, 2018) ....................................... passim
`Abiomed, Inc. v. Maquet Cardiovascular, LLC,
`IPR2017-02150, Paper 11 (PTAB March 12, 2018) ............................................ 4
`Almirall, LLC v. Amneal Pharmaceuticals Inc.,
`No. 19-658-LPS, Dkt. No. 8 (D. Del. May 1, 2019) ............................................ 6
`Apple Inc. v. Immersion Corp.,
`IPR2017-01371, Paper 7 (PTAB Nov. 21, 2017) ................................................ 5
`Arris Grp, Inc. v. Cirrex Sys. LLC,
`IPR2015-00530, Paper 12 (PTAB Jul. 27, 2015) .............................................. 10
`Edwards Lifesciences Corp. v. Boston Scientific Scimed, Inc.,
`IPR2017-01301, Paper 7 (PTAB Oct. 13, 2017) ............................................... 11
`General Plastic Indus. Co. v. Canon Kabushiki Kaisha,
`IPR2016–01357, Paper 19 (PTAB Sept. 6, 2017) ...................................... passim
`
`Novartis Pharms. Corp. v. Amneal Pharmaceuticals, LLC, Amneal-
`Agila, LLC, Mylan, Inc., and Mylan Institutional Inc.,
`No. 2:14-cv-07557-SDW-SCM, Dkt. No. 7 (D.N.J. Jun. 9, 2015) ...................... 6
`Samsung Elecs. Co., Ltd. v. Rembrandt Wireless Techs., LP,
`IPR2015-00555, Paper 20 (PTAB June 19, 2015) ............................................. 11
`Valve Corp. v. Electronic Scripting Prods., Inc.,
`IPR2019-00062, -00063, -00084, Paper 11 (Apr. 2, 2019) ........................ passim
`
`
`STATUTES
`35 U.S.C. §314(a) ............................................................................................. passim
`35 U.S.C. § 316(a)(11) .............................................................................................. 4
`ii
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`IPR2019-01095
`Patent Owner’s Preliminary Response
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`PATENT OWNER’S EXHIBIT LIST
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`Exhibit No.
`2001
`
`Description
`Declaration of Elizabeth B. Hagan in Support of Patent Owner
`Almirall, LLC’s Motion for Admission Pro Hac Vice
`
`
`
`
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`
`iii
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`IPR2019-01095
`Patent Owner’s Preliminary Response
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`Pursuant to 37 C.F.R. § 42.107(a), Patent Owner Almirall, LLC (“Almirall”)
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`submits the following Preliminary Response to the Petition for Inter Partes Review
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`of U.S. Patent No. 9,517,219 (“the ’219 Patent”) submitted by Petitioner Mylan
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`Pharmaceuticals Inc. (“Mylan”). The Board should deny the Petition and decline to
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`institute trial.
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`I.
`
`INTRODUCTION
`Patent Owner respectfully requests that the Board employ its discretion under
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`35 U.S.C. § 314(a) to deny institution.
`
`The Board should exercise its discretion under 35 U.S.C. §314(a) to refuse to
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`institute this follow-on petition, which presents the precise potential for abuse
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`warned against in General Plastic Industries Co. v. Canon Kabushiki Kaisha, Case
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`IPR2016–01357, Paper 19 (PTAB Sept. 6, 2017), which arises when information
`
`from a prior Board proceeding is available for a subsequent proceeding. The factors
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`set forth in General Plastic weigh heavily in support of denial. The Petitioner
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`challenges the same claims of the same patent previously challenged by Amneal
`
`Pharmaceuticals LLC and Amneal Pharmaceuticals of New York, LLC (collectively,
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`“Amneal”) in IPR2019-00207, asserting the same prior art references. Indeed,
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`Petitioner admits that its “Petition is the same as the Amneal IPR: it involves the
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`same patent, same claims, same grounds of unpatentability, and the same evidence
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`(including the same prior art combinations) as the Amneal IPR” and “identical
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`1
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`Patent Owner’s Preliminary Response
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`expert testimony.” Paper 2 at 3 (emphasis added). Petitioner transparently used the
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`publicly filed information of Amneal in the ongoing IPR2019-00207, for which the
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`oral hearing date is now five months away.
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`Amneal first asserted its prior art references, combinations, and expert
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`testimony in a proceeding challenging a related patent, U.S. Patent No. 9,161,926
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`(“the ʼ926 patent”), filed February 12, 2018. IPR2018-00608, Paper 1. It asserted
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`the same obviousness grounds and essentially the same expert testimony to challenge
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`the ʼ219 patent in IPR2019-00207 on November 6, 2018. See IPR2019-00207 Paper
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`3 (Petition); IPR2019-00207 Paper 8 (Patent Owner’s Preliminary Response). All of
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`these Amneal filings were publicly available to Petitioner, yet Petitioner waited more
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`than a year after the IPR2018-00608 petition and seven months after IPR2019-00207
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`petition to issue its copied challenge. By all reasonable appearances, Petitioner
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`waited until the IPR2019-00207 proceeding had been instituted, and then levied that
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`decision to file a follow-on, identical petition. Petitioner provided no other
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`explanation for why it delayed seven months between the filing of Amneal’s petition
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`in the prior IPR2019-00207 and the present Petition. Patent owner has already filed
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`its response in IPR2019-00207, and Amneal’s response is due in just over a month.
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`IPR2019-00207 Paper 14 at 9. The Petition should be denied accordingly, under 35
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`U.S.C. §314(a).
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`2
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`IPR2019-01095
`Patent Owner’s Preliminary Response
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`II. THE GENERAL PLASTIC FACTORS DEMONSTRATE THAT THE
`BOARD SHOULD EXERCISE ITS DISCRETION TO DENY
`INSTITUTION UNDER 35 U.S.C. § 314(a)
`Section 35 U.S.C. § 314(a) grants the Director discretion to deny institution of
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`a later-filed petition. See also General Plastic Indus. Co. v. Canon Kabushiki
`
`Kaisha, IPR2016–01357, Paper 19, p. 15 (PTAB Sept. 6, 2017) (precedential).
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`General Plastic sets forth seven non-exhaustive factors that inform the
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`analysis:
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`1. whether the same petitioner previously filed a petition directed to the
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`same claims of the same patent;
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`2. whether at the time of filing of the first petition the petitioner knew of
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`the prior art asserted in the second petition or should have known of it;
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`3. whether at the time of filing of the second petition the petitioner already
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`received the patent owner’s preliminary response to the first petition or
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`received the Board’s decision on whether to institute review in the first
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`petition;
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`4.
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`the length of time that elapsed between the time the petitioner learned of
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`the prior art asserted in the second petition and the filing of the second
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`petition;
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`3
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`5. whether the petitioner provides adequate explanation for the time
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`elapsed between the filings of multiple petitions directed to the same
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`6.
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`7.
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`claims of the same patent;
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`the finite resources of the Board; and
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`the requirement under 35 U.S.C. § 316(a)(11) to issue a final
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`determination not later than 1 year after the date on which the Director
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`notices institution of review.
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`See id. at 16.
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`The Board has found, in applying this analysis, that “[n]o one factor is
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`dispositive” and “not all the factors need to weigh against institution for us to
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`exercise our discretion under § 314(a).”
`
` See Abiomed, Inc. v. Maquet
`
`Cardiovascular, LLC, IPR2017-02134, Paper 7, p. 7 (April 16, 2018) (“Abiomed 2”
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`herein); see also Abiomed, Inc. v. Maquet Cardiovascular, LLC, IPR2017-02150,
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`Paper 11, p. 7 (Mar. 12, 2018).
`
`As further explained in the Decision Denying Institution in Abiomed 2:
`
`In exercising discretion under 35 U.S.C. § 314(a) and
`37 C.F.R. § 42.108(a), we are mindful of the goals of the
`[America Invents Act (“AIA”)]—namely, to improve patent
`quality and make the patent system more efficient by the use
`of post-grant review procedures.” General Plastic, slip op. at
`16 (citing H.R. Rep. No. 112-98, pt. 1, at 40 (2011)).
`
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`4
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`Additionally, although “an objective of the AIA is to provide
`an effective and efficient alternative to district court
`litigation, . . . [there is a] potential for abuse of the review
`process by repeated attacks on patents.” Id. at 16–17. “A
`central issue addressed by the General Plastic factors is
`balancing the equities between a petitioner and a patent
`owner when information is available from prior Board
`proceedings for a subsequent proceeding.
`Abiomed 2, IPR2017-02134, Paper 7, pp. 7-8 (emphasis added) (quoting Apple Inc.
`
`v. Immersion Corp., Case IPR2017-01371, Paper 7 at 10–11 (Nov. 21, 2017).
`
`A.
`
`Factor 1: Whether the Same Petitioner Previously Filed a Petition
`Directed to the Same Claims of the Same Patent
`It is undisputed that the Petition is directed to the same claims of the same
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`patent challenged in IPR2019-00207. The relationship between Petitioner Mylan
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`and Amneal (petitioner in IPR2019-00207) weighs in favor of denying institution.
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`As the Board has explained:
`
`[O]ur application of the General Plastic factors is not
`limited solely to instances when multiple petitions are filed
`by the same petitioner. Rather, when different petitioners
`challenge the same patent, we consider any relationship
`between those petitioners when weighing the General
`Plastic factors.
`Valve Corp. v. Electronic Scripting Prods., Inc., Cases IPR2019-00062, -00063, -
`
`00084, Paper 11 at 9 (Apr. 2, 2019). In Valve Corp., the Board denied institution of
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`5
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`follow-on petitions by Valve Corp. challenging the same claims of the same patent
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`previously challenged by HTC, and were co-defendants in a district court case. Id. at
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`16. The patent owner in that case had accused both of infringing the patent at issue.
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`Id. at 9–10. Here, although Mylan and Amneal are not co-defendants in a district
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`court case regarding the ʼ219 patent, they are similarly situated in that both are
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`frequent ANDA filers and manufacturers of generic pharmaceutical products. See,
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`e.g., Novartis Pharms. Corp. v. Amneal Pharmaceuticals, LLC, Amneal-Agila, LLC,
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`Mylan, Inc., and Mylan Institutional Inc., C.A. No. 2:14-cv-07557-SDW-SCM, Dkt.
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`No. 7 at 2 (D.N.J. Jun. 9, 2015) (stipulating that Amneal and Mylan sell and/or
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`distribute an ANDA product). Amneal has filed an ANDA seeking approval to
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`engage in commercial manufacture of a generic dapsone gel, 7.5% drug product
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`prior to the expiration of the Orange Book-listed ʼ219 patent. See Almirall, LLC v.
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`Amneal Pharmaceuticals Inc., C.A. No. 19-658-LPS, Dkt. No. 8 (Answer) at ¶1 (D.
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`Del. May 1, 2019). Although Mylan has not yet notified Almirall that it has filed an
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`ANDA, Mylan is in the business of doing so, and its interest in filing an IPR
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`challenging the claims of the ʼ219 patent is the same as Amneal’s—i.e., invalidating
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`the Orange Book-listed ʼ219 patent. Accordingly, Mylan is similarly situated to
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`Amneal.
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`6
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`Patent Owner’s Preliminary Response
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`B.
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`Factor 2: Whether at the Time of Filing of the First Petition the
`Petitioner Knew of the Prior Art Asserted in the Second Petition or
`Should Have Known of It
`Every reference asserted by Petitioner in the present petition was also asserted
`
`by Amneal in both the petitions for IPR2018-00608 and IPR2019-00207.
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`As shown below, the grounds, basis, and art asserted in the present Petition are
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`identical to those in IPR2018-00608 and IPR2019-00207:
`
`’219 Patent
`(present petition and IPR2019-
`00207)
`
` ’926 Patent
`(IPR2018-00206)
`
`Ground 1
`
`Claims
`1-8
`
` Ground 1
`
`103: Garrett
`in view of
`Nadau-
`Fourcade
`
`Ground 2
`
`Claims
`1-8
`
`103: Garrett
`in view of
`Bonacucina
`
` Ground 2
`
`Claims
`1-6
`
`Claims
`1-6
`
`103:
`Garrett in
`view of
`Nadau-
`Fourcade
`
`103:
`Garrett in
`view of
`Bonacucina
`
`
`
`This information was publicly available, and Petitioner should have known of
`
`these references as early as the filing date of the prior IPR2018-00206 petition
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`(February 12, 2018), and at least as early as the filing date of the IPR2019-00207
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`petition (November 6, 2018).
`
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`7
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`C.
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`Factor 3: Whether at the Time of Filing of the Second Petition the
`Petitioner Already Received the Patent Owner’s Preliminary
`Response to the First Petition or Received the Board’s Decision on
`Whether to Institute Review in the First Petition
`At the time of filing this petition, Petitioner had available to it both Almirall’s
`
`preliminary response in IPR2019-00207 and the Board’s decision to institute.
`
`IPR2019-00207 Papers 8, 13. Indeed, Petitioner waited until a month after IPR2019-
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`00207 was instituted to file its identical petition. In addition, Petitioner had available
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`to it all of the substantive briefing in IPR2018-00608, as well. IPR2018-00608
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`Papers 9 (Patent Owner’s Preliminary Response), 10 (Institution Decision), 23
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`(Patent Owner’s Response), 29 (Petitioner’s Reply), and 33 (Patent Owner’s Sur-
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`Reply).
`
`Petitioner thus had the benefit of the Board’s Institution Decisions in both
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`cases, and had the opportunity to evaluate and consider Almirall’s responsive
`
`arguments.
`
`In Abiomed 2, the Board found that “[t]his factor weighs heavily in our
`
`analysis because Petitioner tailored its arguments here in light of the positions
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`previously set forth by Patent Owner in its preliminary responses in the related
`
`proceedings. . . . As noted above, many of the other petitions filed by Petitioner
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`relied upon one or more of the same references asserted here and, thus, Patent
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`Owner’s preliminary responses in those proceedings were available to Petitioner for
`
`use in framing the arguments set forth in the present proceeding. Accordingly, we
`8
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`Patent Owner’s Preliminary Response
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`find that this factor weighs heavily against institution.” Abiomed 2, IPR2017-02134,
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`Paper 7, p. 11 (emphasis added).
`
`As the Petitioner in this case likewise relies upon not just similar, but identical
`
`references and used the prior filings as guidance, Factor 3 also weighs heavily in
`
`favor of denying institution in this proceeding.
`
`D.
`Factor 4: Elapsed Time
`As outlined in connection with Factor 2, Petitioner knew or should have
`
`known of the prior art asserted in this Petition at the time of filing the petition in the
`
`IPR2018-00608—in February 2018—and at the very least by the time of filing the
`
`petition in IPR2019-00207—in November 2018. It follows that Petitioner had
`
`knowledge of these prior art references for at least seven months—and likely more
`
`than a year—before deciding to file this Petition. In Abiomed 2, the Board found
`
`that an even shorter delay between petitions – six months – was sufficient to find this
`
`factor weighed against institution. Abiomed 2, IPR2017-02134, Paper 7, p. 11. And
`
`in Valve Corp., Valve’s delay of five months after HTC filed its petition was
`
`sufficient to favor denying institution. Valve Corp., IPR2019-00062 et al., Paper 11,
`
`p. 14. Thus, Factor 4 weighs even more heavily in favor of denying institution under
`
`the facts present in this proceeding than in Abiomed 2 or Valve Corp.
`
`
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`9
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`E.
`
`Factor 5: Whether the Petitioner Provides Adequate Explanation
`for the Time Elapsed Between the Filings of Multiple Petitions
`Directed to the Same Claims of the Same Patent.
`Mylan’s petition, copying Amneal’s petition word-for-word, incorrectly states
`
`that it “is the first time the ʼ219 patent has been challenged in the Office since the
`
`patent issued.” Petition at 66. Petitioner provides no reason why it delayed seven
`
`months to file its identical petition. In its motion for joinder, it asserts that its
`
`petition would not affect the schedule of IPR2019-00207. But it waited until almost
`
`the last day possible to file both its petition and motion for joinder, and provides no
`
`reason for doing so. See Papers 1,2 (Petition and Motion for Joinder, filed June 7,
`
`2019); IPR2019-00207 Paper 13 (Institution Decision, dated May 10, 2019). As
`
`such, Petitioner’s strategic decision to delay the filing of the Petition in this case
`
`weighs strongly in favor of denying the Petition as unjustifiably belated. See e.g.,
`
`Arris Grp, Inc. v. Cirrex Sys. LLC, IPR2015-00530, Paper 12, p. 10 (Jul. 27, 2015)
`
`(“Petitioner could have informed the Board of its desire to challenge the additional
`
`claims along with the [original IPR] well before [the joinder deadline], yet it chose to
`
`file its Second Petition on the very last day permitted under the rules.”).
`
`F.
`
`Factors 6 & 7: The Finite Resources of the Board and the One-
`Year Final Decision Requirement
`“[M]ultiple, staggered petition filings” are, in general, “an inefficient use of
`
`the inter partes review process and the Board’s resources.” See General Plastic,
`
`IPR2016–01357, Paper 19, p. 21. Such is the case under the present facts, when
`10
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`IPR2019-01095
`Patent Owner’s Preliminary Response
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`multiple challenges of the same claims and references are presented on a very
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`different schedule. “In general, having multiple petitions challenging the same
`
`patent, especially when not filed at or around the same time as in this case, is
`
`inefficient and tends to waste resources. Valve Corp., IPR2019-00062 et al.,
`
`Paper 11, p. 14 (referring to five-month delay between petition filings); see also,
`
`e.g., Edwards Lifesciences Corp. v. Boston Scientific Scimed, Inc., IPR2017-01301,
`
`Paper 7, p. 10 (Oct. 13, 2017) (“Proceeding with multiple challenges . . . to the same
`
`patent on different schedules presents a burden on both Patent Owner and the
`
`Board, particularly in the absence of any reasoning from Petitioner for the
`
`substantial delay between filing the petitions.” (emphasis added)); Samsung Elecs.
`
`Co., Ltd. v. Rembrandt Wireless Techs., LP, IPR2015-00555, Paper 20, p. 8 (June
`
`19, 2015). Factors 6 and 7 therefore weigh in favor of denying institution as well.
`
`G. Weighing the Factors
`Taken together, the above factors weigh in favor of the Board exercising its
`
`discretion and denying institution under § 314(a).
`
`III. CONCLUSION
`For at least the foregoing reasons, the Board should not institute inter partes
`
`review of the ’219 patent on any of the grounds proposed by Petitioner.
`
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`11
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`Dated: September 10, 2019
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`
`Respectfully submitted,
`
`
`
`
`
`
`
`FENWICK & WEST LLP
`
`By: /James Trainor/
`James Trainor (Reg. No. 52,297)
`
`
`
`Attorneys for Patent Owner
`Almirall, LLC
`
`
`
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`12
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`IPR2019-01095
`Patent Owner’s Preliminary Response
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing PATENT
`
`OWNER’S PRELIMINARY RESPONSE was served on September 10, 2019,
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`by filing this document through the Patent Trial and Appeal Board End to End
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`system as well as delivering a copy via electronic mail upon the following
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`attorneys of record for the Petitioner:
`
`
`
`Jitendra Malik, Ph.D., Reg. No. 55,823
`jitty.malik@kattenlaw.com
`Alissa M. Pacchioli, Reg. No. 74,252
`alissa.pacchioli@kattenlaw.com
`Heike S. Radeke, Reg. No. 75,394
`heike.radeke@kattenlaw.com
`KATTEN MUCHIN ROSEMAN LLP
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`
`Lance Soderstrom, Reg. No. 65,405
`lance.soderstrom@kattenlaw.com
`KATTEN MUCHIN ROSEMAN LLP
`575 Madison Avenue
`New York, NY 10022-2585
`
`Respectfully submitted,
`
`FENWICK & WEST LLP
`
`By: /James Trainor/
`James Trainor (Reg. No. 52,297)
`
`
`
`Attorneys for Patent Owner
`Almirall, LLC
`
`13
`
`
`Dated: September 10, 2019
`
`
`
`
`
`
`
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