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15 Notice: Petitioner Mylan Pharmaceutical Incs First Updated Mandatory Notice

Document IPR2019-01095, No. 15 Notice - Petitioner Mylan Pharmaceutical Incs First Updated Mandatory Notice (P.T.A.B. Dec. 2, 2020)
U.S. Patent No. 9,517,219 to Warner et al. Issue Date: December 13, 2016 Title: Topical dapsone and dapsone/adapalene compositions and methods for use thereof Inter Partes Review No.: IPR2019-01095
Pursuant to 37 C.F.R. §42.8(a)(3) and §42.8(b)(1), Petitioner Mylan Pharmaceuticals, Inc. (“Mylan”) hereby updates its mandatory notices as set forth below.
No other changes to any of the previously identified information under 37 C.F.R. §42.8 are being made pursuant to this Notice.
Each Real Party in Interest (37 C.F.R. § 42.8(b)(1)) On November 16, 2020, Viatris Inc. replaced Mylan N.V. as the parent company of all entities that were previously subsidiaries of Mylan N.V.
Dated: December 2, 2020 Respectfully submitted, Katten Muchin Rosenman LLP /Jitendra Malik/ Jitendra Malik (Reg. No. 55,823) for Petitioner Mylan Lead Counsel Pharmaceuticals, Inc. 146746847v1
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11 Reply: Petitioners Reply

Document IPR2019-01095, No. 11 Reply - Petitioners Reply (P.T.A.B. Oct. 14, 2019)
In General Plastic, the Board set out seven nonexclusive factors to be weighed in deciding whether to exercise its denial discretion.
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8 Other Not for motions: Patent Owner Almirall, LLCs Motion for Pro Hac Vice Admission of Elizabeth B Hagan Pursuant to 37 CFR Section 4210c

Document IPR2019-01095, No. 8 Other Not for motions - Patent Owner Almirall, LLCs Motion for Pro Hac Vice Admission of Elizabeth B Hagan Pursuant to 37 CFR Section 4210c (P.T.A.B. Jul. 2, 2019)
Pursuant to 37 C.F.R. § 42.10(c), and as authorized in the Board’s Notice of Filing Date issued June 10, 2019 (Paper 5), Patent Owner Almirall, LLC (“Almirall”) respectfully requests the pro hac vice admission of Elizabeth B. Hagan in this proceeding.
As trial counsel for Almirall, LLC, Ms. Hagan has been actively involved in all aspects of the district court litigations, including development of validity positions regarding the patent challenged in this proceeding.
Ms. Hagan has also applied to appear pro hac vice before the Office in Eli Lilly and Co. v. Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center,
Based on the facts contained herein, as supported by Ms. Hagan’s declaration (Ex. 2001), good cause exists to admit Ms. Hagan pro hac vice in this proceeding.
Motion for Admission Pro Hac Vice Dated: July 2, 2019 Respectfully submitted, FENWICK & WEST LLP By: /James Trainor/ James Trainor (Reg. No. 52,297) Attorneys for Patent Owner Almirall, LLC
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1 Petition: Petition for Inter Partes Review of US Patent No 9,517,219 Under 35 USC 311 319 AND 37 CFR 421 80, 42100 123

Document IPR2019-01095, No. 1 Petition - Petition for Inter Partes Review of US Patent No 9,517,219 Under 35 USC 311 319 AND 37 CFR 421 80, 42100 123 (P.T.A.B. Jun. 7, 2019)
Similarly, none of Garrett’s compositions include adapalene. (MYLAN1002/1035, ¶54; MYLAN1004, Abstract, 3:33-4:15, 14:20-15:18); see also Sud-Chemie, Inc. v. Multisorb Techs., Inc., 554 F.3d 1001, 1004-05 (Fed. Cir. 2009) (finding ...
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9 Preliminary Response: Patent Owners Preliminary Response

Document IPR2019-01095, No. 9 Preliminary Response - Patent Owners Preliminary Response (P.T.A.B. Sep. 10, 2019)
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.
Amneal has filed an ANDA seeking approval to engage in commercial manufacture of a generic dapsone gel, 7.5% drug product prior to the expiration of the Orange Book-listed ʼ219 patent.
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 previously set forth by Patent Owner in its preliminary responses in the related proceedings.
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.
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.”).
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7 Power of Attorney: Patent Owner Almirall, LLCs Power of Attorney

Document IPR2019-01095, No. 7 Power of Attorney - Patent Owner Almirall, LLCs Power of Attorney (P.T.A.B. Jun. 28, 2019)

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6 Mandatory Notice: Patent Owner Almirall, LLCs Mandatory Notices Under 37 CFR...

Document IPR2019-01095, No. 6 Mandatory Notice - Patent Owner Almirall, LLCs Mandatory Notices Under 37 CFR Section 4210b (P.T.A.B. Jun. 28, 2019)

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4 Power of Attorney: POA

Document IPR2019-01095, No. 4 Power of Attorney - POA (P.T.A.B. Jun. 7, 2019)

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2 Petition: Petitioners Motion For Joinder Under 37 CFR 4222 AND 42122b

Document IPR2019-01095, No. 2 Petition - Petitioners Motion For Joinder Under 37 CFR 4222 AND 42122b (P.T.A.B. Jun. 7, 2019)

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3 Exhibit List: Exhibit List

Document IPR2019-01095, No. 3 Exhibit List - Exhibit List (P.T.A.B. Jun. 7, 2019)

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2001 Exhibit: Exhibit 2001 Declaration of Elizabeth B Hagan in Support of Patent O...

Document IPR2019-01095, No. 2001-36 Exhibit - Exhibit 2001 Declaration of Elizabeth B Hagan in Support of Patent Owner Almirall, LLCs Motion for Admission Pro Hac Vice (P.T.A.B. Jul. 2, 2019)

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2001 Exhibit: Exhibit 2001 Declaration of Elizabeth B Hagan in Support of Patent O...

Document IPR2019-01095, No. 2001 Exhibit - Exhibit 2001 Declaration of Elizabeth B Hagan in Support of Patent Owner Almirall, LLCs Motion for Admission Pro Hac Vice (P.T.A.B. Jul. 2, 2019)

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1020 Exhibit: Affidavit of Christopher Butler

Document IPR2019-01095, No. 1020-19 Exhibit - Affidavit of Christopher Butler (P.T.A.B. Jun. 7, 2019)

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1007 Exhibit: US Patent Publication No 20060204526 Lathrop

Document IPR2019-01095, No. 1007-7 Exhibit - US Patent Publication No 20060204526 Lathrop (P.T.A.B. Jun. 7, 2019)

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1016 Exhibit: US Patent No 5,863,560 Osborne II

Document IPR2019-01095, No. 1016-16 Exhibit - US Patent No 5,863,560 Osborne II (P.T.A.B. Jun. 7, 2019)

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