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

The PTAB recently rejected this very argument explaining that “there is no abuse of process where ... a different petitioner files a ‘me-too’ or ‘copycat’” petition in conjunction with a timely motion to join an inter partes review based upon the (essentially) copied petition filed by 141770677v2 Petitioner’s Reply to Patent Owner’s Preliminary Response different petitioner.” Sawai USA, Inc. v. Biogen MA, Inc., IPR2019-00789, Paper 17 at 10 (P.T.A.B. Sept. 12, 2019).

As the PTAB explained in the context of joinder, the concerns raised by General Plastic Factors 2-5 are abated: By its very nature, such a “me-too” or “copycat” petition necessarily relies on substantially the same prior art and arguments previously considered by the Office, and is timely, even though such a petition is filed after our institution decision in the earlier proceeding.

For its part, Patent Owner cites to Abiomed, Inc. v. Maquet Cardiovascular, LLC where the Board denied institution based on the abuse created by serially filed petitions.

[and] [w]e declined to institute inter 141770677v2 Petitioner’s Reply to Patent Owner’s Preliminary Response partes review in each of the previous nineteen cases.”) (emphasis added).

Given Mylan will adhere to all applicable deadlines set in the Scheduling Order for the Amneal IPR and has asked to participate as a silent understudy, there is “little, if any, waste of Board resources in allowing Petitioner to join an ongoing inter partes review proceeding.” Sawai USA, Inc., IPR2019-00789, Paper 17 at 11.

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

Petition for Inter Partes Review of U.S. Patent No. 9,517,219 “[i]n recent years, there has been great interest in the use of novel polymers with complex functions as emulsifiers and thickeners because the gelling capacity of these compounds allows the formulation of stable emulsions and creams by decreasing surface and interfacial tension and at the same time increasing the viscosity of the aqueous phase.” (MYLAN1015, 1).

A method for treating a dermatological condition selected from the group consisting of acne vulgaris and rosacea comprising administering to a subject having the dermatological condition selected from the group consisting of acne vulgaris and rosacea a topical pharmaceutical composition comprising: [a] about 7.5% w/w dapsone; [b] about 30% w/w to about 40% w/w diethylene glycol monoethyl ether; [c] about 2% w/w to about 6% w/w of a polymeric viscosity builder consisting of acrylamide/sodium acryloyldimethyl taurate copolymer; [d] and water; Petition for Inter Partes Review of U.S. Patent No. 9,517,219 Garrett: “In one preferred embodiment, the composition includes about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water; about 10% to 30% ethoxydiglycol; about 0.2% methylparaben; about 5% to 10% dapsone in a microparticulate and dissolved state; and about 0.1% to 2% sodium hydroxide solution.” (MYLAN1004, 4:2-5) Garrett: “In one preferred embodiment, the composition includes about 0.5% to 4.0% carbomer; about 53.8% to 84.2% water; about 10% to 30% ethoxydiglycol; about 0.2% methylparaben; about 5% to 10% dapsone in a microparticulate and dissolved state; and about 0.1% to 2% sodium hydroxide solution.” (MYLAN1004, 4:2-5) Garrett: “Thickening agents include polymer thickeners.

Polymer thickeners that may be used include those known to one skilled in the art, such as hydrophilic and hydroalcoholic gelling agents frequently used in the cosmetic and pharmaceutical industries.” (MYLAN1004, 13:3-5) Bonacucina: “Preferably, the gelling agent comprises between about 0.2% to about 4% by weight of the composition.” (MYLAN1004, 13:10-11) “Sepineo® P 600, based on the concept of droplet hydroswelling, is a concentrated droplet dispersion of acrylamide/sodium acryloyldimethyl taurate (a viscous liquid at room temperature) in isohexadecane as the oily Petition for Inter Partes Review of U.S. Patent No. 9,517,219 dispersing phase.” (MYLAN1015, 2; MYLAN1002/1035, ¶70) “Both techniques revealed that Sepineo® P 600 thickens and gels well, a property that depends strongly on polymer concentration.

Petition for Inter Partes Review of U.S. Patent No. 9,517,219 A POSA would understand that small variations in the preparation of the composition can affect the properties (e.g., particle size, polymorph) of a resulting recrystallized precipitate.

The examiner previously considered Garrett as a secondary reference in the context of two dependent claims for the limited proposition that topical dapsone formulations had been shown to be effective in the treatment of acne vulgaris.

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.”).