Trials@uspto.gov
`571.272.7822
`
`
`
`
`
`
`
` Paper 35
`
` Entered: November 27, 2019
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`____________
`
`IPR2019-01095
`Patent 9,517,219 B2
`____________
`
`
`Before SUSAN L. C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`Granting Motion for Joinder
`35 U.S.C. § 315(c), 37 C.F.R. § 42.122
`
`
`
`
`
`571.272.7822
`
`
`
`
`
`
`
` Paper 35
`
` Entered: November 27, 2019
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`____________
`
`IPR2019-01095
`Patent 9,517,219 B2
`____________
`
`
`Before SUSAN L. C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`DECISION
`Granting Institution of Inter Partes Review
`35 U.S.C. § 314
`Granting Motion for Joinder
`35 U.S.C. § 315(c), 37 C.F.R. § 42.122
`
`
`
`
`
`
`IPR2019-01095
`Patent 9,517,219 B2
`
`
`I.
`
`INTRODUCTION
`Almirall, LLC (“Patent Owner” or “Almirall”) is the owner of U.S.
`Patent No. 9,517,219 B2 (Ex. 1001, “the ’219 patent”). Mylan
`Pharmaceuticals Inc. (“Petitioner” or “Mylan”) filed a Petition requesting
`inter partes review of claims 1–8 of the ’219 patent. Paper 1 (“Pet.”). With
`the Petition, Mylan also filed a Motion for Joinder under 37 C.F.R. §§ 42.22
`and 42.122(b), requesting that this case be joined with Amneal
`Pharmaceuticals LLC v. Almirall, LLC, IPR2019-00207. Paper 2 (“Mot.”).
`Patent Owner, in turn, filed a Preliminary Response. Paper 10 (“Prelim.
`Resp.”). Patent Owner did not file an opposition to Petitioner’s Motion for
`Joinder. Further, pursuant to our authorization (Paper 10), Mylan filed a
`Reply to Patent Owner’s Preliminary Response. Paper 11 (Pet. Reply).
`Although similarly authorized to file a Sur-Reply, Patent Owner made no
`such filing.
`The Petition here is styled as a “me-too” petition and it substantially
`reproduces the arguments, based on the same or substantially same evidence,
`upon which IPR2019-00207 was instituted. See IPR2019-00207, Paper 13
`(May 10, 2019); see also Pet. Reply 1. As discussed further below, we
`hereby institute trial on the same grounds upon which we instituted trial in
`IPR2019-00207, and further grant Mylan’s Motion for Joinder with that IPR.
`II. DISCUSSION
`In IPR2019-00207, Amneal Pharmaceuticals LLC and Amneal
`Pharmaceuticals of New York, LLC (collectively, “Amneal”) asserted two
`grounds for unpatentability of claims 1–8 of the ’219 patent, each under
`35 U.S.C. § 103(a) for obviousness, as follows:
`
`2
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`IPR2019-01095
`Patent 9,517,219 B2
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`
`
`
`
`35 U.S.C. §
`
`References
`
`Ground 1
`
`103
`
`Garrett ’298,1 Nadau-Fourcade2
`
`Claims
`Challenged
`1–8
`
`103
`
`Garrett ’298, Bonacucina3
`
`1–8
`
`Ground 2
`
`See IPR2019-00207, Paper 3 at 3–5, 20–62. After considering the Petition
`and the Preliminary Response in the matter, we instituted trial in IPR2019-
`00207 on each of these grounds. See id., Paper 13. Here, Mylan asserts the
`same two grounds for unpatentability against the same claims of the ’219
`patent, making identical arguments, supported by substantially the same
`evidence. Pet. 3–6, 22–66.
`THRESHOLD FOR INSTITUTION
`A.
`For the reasons stated in our Decision on Institution in IPR2019-
`000207, we institute trial on the same grounds set forth in Mylan’s Petition.
`See IPR2019-00207, Paper 13.
`BOARD’S DISCRETION UNDER 35 U.S.C. § 314(a)
`B.
`Almirall’s Preliminary Response here, as was the case in IPR2019-
`00207 (see IPR2019-00207, Paper 8 at 3–18), argues that institution should
`be denied per our discretion under 35 U.S.C. § 314(a). Prelim. Resp. 1–11.
`
`
`1 WO 2009/061298 Al (published May 14, 2009) (Ex. 1004, “Garrett ’298”).
`2 WO 2010/072958 A2 (published July 1, 2010), English translation
`(Ex. 1005, “Nadau-Fourcade”).
`3 Giulia Bonacucina et al., Characterization and Stability of Emulsion Gels
`Based on Acrylamide/Sodium Acryloyldimethyl Taurate Copolymer, 10(2)
`AAPS PHARMSCITECH 368–75 (2009) (Ex. 1015, “Bonacucina”).
`
`3
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`IPR2019-01095
`Patent 9,517,219 B2
`
`
`
`“The Director may not authorize an inter partes review to be instituted
`unless the Director determines . . . that there is a reasonable likelihood that
`the petitioner would prevail with respect to at least 1 of the claims
`challenged in the petition.” 35 U.S.C. § 314(a). This section grants the
`Director discretion to deny institution of a later-filed petition. General
`Plastic Indus. Co. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 at
`15 (PTAB Sept. 6, 2017) (precedential). General Plastic sets forth the
`following seven non-exhaustive factors that inform our analysis:
`1. whether the same petitioner previously filed a petition
`directed to the same claims of the same patent;
`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;
`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;
`4. the length of time that elapsed between the time the petitioner
`learned of the prior art asserted in the second petition and the
`filing of the second petition;
`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;
`6. the finite resources of the Board; and
`7. the requirement under 35 U.S.C. § 316(a)(11) to issue a final
`determination not later than 1 year after the date on which the
`Director notices institution of review.
`Id. at 16 (footnote omitted). No one factor is dispositive and, as the Board
`has explained on the occasion of denying institution, “not all the factors need
`to weigh against institution for us to exercise our discretion under § 314(a).”
`
`4
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`IPR2019-01095
`Patent 9,517,219 B2
`
`
`Abiomed, Inc. v. Maquet Cardiovascular, LLC, IPR2017-02150, Paper 11 at
`7 (PTAB Mar. 12, 2018).
`As explained in General Plastic: “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, Paper 19 at 16 (citing H.R. Rep. No. 112-98,
`pt. 1, at 40 (2011)). 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.” Apple Inc. v. Immersion Corp., IPR2017-01371,
`Paper 7 at 10–11 (PTAB Nov. 21, 2017) (citing General Plastic, Paper 19 at
`15–19).
`The General Plastic decision was principally directed to preventing
`the use of multiple patent office procedures to harass patent owners. See
`Wirtgen Am., Inc. v. Caterpillar Paving Prods. Inc., IPR2018-01201, Paper
`13 at 11 (PTAB Jan. 8, 2019) (IPR instituted, distinguishing follow-on
`petitions from other, non-duplicative petitions). In this case, Petitioner’s
`request for joinder obviates any concerns about harassment resulting from
`multiple proceedings. We are unaware of any prior case in which the
`General Plastic factors were found to be applicable to a petition filed with a
`timely request for joinder under 35 U.S.C. § 315(c). For the sake of
`
`5
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`IPR2019-01095
`Patent 9,517,219 B2
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`completeness, however, we nonetheless address each of the General Plastic
`factors as applied to the circumstances presented in this case.
`Here, regarding factor 1, Patent Owner argues there is a “relationship
`between Petitioner Mylan and Amneal (petitioner in IPR2019-00207).”
`Prelim. Resp. 5. Patent Owner explains that this “relationship” is based on
`the fact that these parties “are similarly situated in that both are frequent
`ANDA filers and manufacturers of generic pharmaceutical product.” Id. at
`6. If this can be considered a “relationship,” we are not persuaded that this
`constitutes any type of relationship that would weigh against institution. See
`Pet. Reply 5 (“Mylan and Amneal do not have any relationship with each
`other”). Factor 1 weighs in favor of not exercising our discretion to deny
`institution.
`Regarding factor 2, Patent Owner argues that the references asserted
`here are the same as those asserted by Amneal in IPR2018-00608 and
`IPR2019-00207. Prelim. Resp. 7. First, IPR2018-00608 involves a different
`patent than the ’219 patent challenged in this proceeding and in IPR2019-
`00207. Second, it is expected that the prior art and grounds for
`unpatentability presented here are identical to IPR2019-00207 because
`Mylan is seeking “me-too” joinder with that earlier IPR. See Pet. Reply 6–7.
`This factor weights in favor of not exercising our discretion to deny
`institution.
`Regarding factor 3, Patent Owner argues that the Preliminary
`Response and institution decision from IPR2019-00207 were available to
`Mylan prior to its filing of the Petition in this case, as well as all substantive
`briefing from IPR2018-00608. Prelim. Resp. 8. This factor is largely
`
`6
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`IPR2019-01095
`Patent 9,517,219 B2
`
`
`irrelevant here. Given that the current Petition challenges a different patent,
`we do not agree that Mylan has tailored its arguments here based on any
`hypothetical roadmap laid out in IPR2018-00608. Moreover, although
`Mylan appears to have intentionally copied the petition from IPR2019-
`00207, we do not find that to be improper in light of the request for Joinder.
`This factor does not weigh in favor of exercising our discretion to deny
`institution.
`Regarding factors 4 and 5, Patent Owner argues Mylan waited months
`to file the Petition here after the similar filing in IPR2018-00608 and has not
`explained why it waited those seven months. Prelim. Resp. 9–10. Mylan
`has complied with the filing requirements for seeking joinder with IPR2019-
`00207; that is, this Petition was filed within a month of the institution in
`IPR2019-00207. 37 C.F.R. § 42.122(b). Mylan has not sought joinder with
`IPR2018-00608; therefore, any delay from the commencement of that IPR,
`which is directed to a different patent, is not determinative and need not be
`explained for purposes of these factors. These factors do not weigh in favor
`of exercising our discretion to deny institution.
`Regarding factors 6 and 7, Patent Owner argues institution here would
`result in inefficiencies and a waste of Board’s and parties’ resources.
`Prelim. Resp. 10–11. Mylan indicates that it seeks to participate as a “silent
`understudy” in IPR2019-00207, relying on Amneal’s evidence, arguments,
`and experts unless it becomes necessary to do otherwise. Mot. 9, 3. Mylan
`does not present different arguments or evidence here. Id. at 5–7. Mylan
`seeks to follow the schedule already set in IPR2019-00207. Id. at 3–4, 8.
`Mylan agrees to be bound by agreements on discovery between Amneal and
`
`7
`
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`IPR2019-01095
`Patent 9,517,219 B2
`
`
`Patent Owner in IPR2019-00207. Id. at 9–10. We do not agree that Mylan’s
`participation, or perhaps better put, presence here will cause any undue
`waste of time or resources. These factors do not weigh in favor of
`exercising our discretion to deny institution here.
`None of the General Plastic factors weigh in favor of exercising our
`discretion to deny institution here. Therefore, we decline to exercise our
`discretion under 35 U.S.C. § 314(a) to deny institution in this case.
`C. MOTION FOR JOINDER
`Having determined that institution is appropriate, we turn to Mylan’s
`Motion for Joinder. Based on authority delegated to us by the Director, we
`have discretion to join an inter partes review to a previously instituted inter
`partes review. 35 U.S.C. § 315(c). Section 315(c) provides, in relevant
`part, that “[i]f 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.” Id. When
`determining whether to grant a motion for joinder we consider factors such
`as timing and impact of joinder on the trial schedule, cost, discovery, and
`potential simplification of briefing. Kyocera Corp. v. SoftView, LLC,
`IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013).
`Under the circumstances of this case, we determine that joinder is
`appropriate. As Mylan notes, the Petition in IPR2019-00207 is substantially
`the same as the Mylan Petition here, presenting the same arguments and
`relying on the same expert testimony and evidence––it is a “me-too”
`Petition. Mot. 5–6.
`
`8
`
`
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`IPR2019-01095
`Patent 9,517,219 B2
`
`
`
`Mylan has also agreed to assume a “silent understudy” role in the
`joined proceedings. Id. at 9. As long as Amneal remains a party, Mylan
`agrees to consolidated filings for all substantive papers in the respective
`proceedings, except for filings that do not involve Amneal. Id. Mylan also
`agrees that cross-examination will not be extended in light of the joinder. Id.
`Mylan further contends that there will be no impact on the trial schedule of
`IPR2019-00207, and that joinder will simplify the proceedings without
`prejudice to the parties. Id. at 8.
`Mylan has satisfied the requirements for joinder here. As noted
`above, Patent Owner has not opposed such joinder.
`III. CONCLUSION
`On the record before us at this stage in the proceeding, Petitioner has
`demonstrated a reasonable likelihood of prevailing on Grounds 1 and 2 in
`showing that claims 1–8 of the ’219 patent would have been obvious over
`the cited prior art combinations. In accordance with the Court’s decision in
`SAS Institute Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018) and Office
`guidance,4 we institute an inter partes review of all challenged claims of the
`’219 patent on all grounds alleged by Petitioner. Nevertheless, this decision
`does not reflect a final determination on the patentability of any claim. We
`further note that the burden remains on Petitioner to prove unpatentability of
`
`
`4 Guidance on the Impact of SAS on AIA trial proceedings (Apr. 26, 2018),
`accessible at https://www.uspto.gov/patents-application-process/patent-trial-
`and-appeal-board/trials/guidance-impact-sas-aia-trial (last accessed Oct. 2,
`2018) (“At this time, if the PTAB institutes a trial, the PTAB will institute
`on all challenges raised in the petition,” and “for pending trials . . . , the
`panel may issue an order supplementing the institution decision to institute
`on all challenges raised in the petition.”).
`
`9
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`IPR2019-01095
`Patent 9,517,219 B2
`
`
`each challenged claim. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375, 1378 (Fed. Cir. 2015). Furthermore, Petitioner has shown
`that joinder with IPR2019-00207 is appropriate and will not impact the
`timing, cost, or presentation of that trial. As joinder is appropriate, it is
`granted.
`
`ORDER
`
`Accordingly, it is hereby:
`ORDERED that, pursuant to 35 U.S.C. § 314, an inter partes review
`of claims 1–8 of the ’219 patent, in accordance with each ground on which
`the challenge to each claim is based in the Petition, is hereby instituted; and
`FURTHER ORDERED that Petitioner’s Motion for Joinder with
`IPR2019-00207 is granted; and
`FURTHER ORDERED that the Scheduling Order in place for
`IPR2019-00207 (Paper 14 in that case), including any changes thereto as
`agreed to by the parties to that case, shall govern the joined proceedings; and
`FURTHER ORDERED that all future filings in the joined proceeding
`are to be made only in IPR2019-00207; and
`FURTHER ORDERED that the case caption in IPR2019-00207 for all
`further submissions shall be changed to add Mylan as a named Petitioner,
`and to indicate by footnote the joinder of IPR2019-01095 to that proceeding,
`as indicated in the attached sample case caption; and
`FURTHER ORDERED that a copy of this Decision shall be entered
`into the record in IPR2019-00207.
`
`
`10
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`IPR2019-01095
`Patent 9,517,219 B2
`
`
`FOR PETITIONERS:
`
`Representing Mylan Pharmaceuticals Inc.
`
`Jitendra Malik, Ph.D.
`Alissa M. Pacchioli
`Lance Soderstrom
`Heike S. Radeke
`KATTEN MUCHIN ROSENMAN LLP
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`lance.soderstrom@kattenlaw.com
`heike.radeke@kattenlaw.com
`
`Representing Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of
`New York, LLC
`
`Dennies Varughese
`Adam C. LaRock
`Tyler C. Liu
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`dvarughe-PTAB@skgf.com
`alarock-PTAB@skgf.com
`PTAB@skgf.com.
`tliu-PTAB@sternekessler.com
`
`
`FOR PATENT OWNER:
`
`James Trainor
`Jennifer R. Bush
`FENWICK & WEST LLP
`jtrainor@fenwick.com
`jbush@fenwick.com
`
`11
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`Trials@uspto.gov
`571.272.7822
`
`
`
`
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` Paper No. __
`
` Date: ____ __, 20__
`
`
`
`[sample case caption]
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC, AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC, and MYLAN
`PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`____________
`
`IPR2019-002071
`Patent 9,517,219 B2
`____________
`
`
`
`
`
`
`
`
`
`1 Cases IPR2019-00207 and IPR2019-01095 have been joined in this
`proceeding.
`
`
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