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.”).

Patent Owner Power of Attorney / Date: ~ · Name: Ron Menezes Title: President and General Manager, Almirall, LLC

Almirall, LLC, a limited liability company, states that, for the patent identified above, it is the assignee of the entire right, title, and interest.

From: Inventors Bhatt & Swaminathan To: Dow Phannaceutical Sciences The document was recorded in the United States Patent and Trademark Office at Reel 038398, Frame 0200.

From: Inventors Batt & Swaminathan To: Dow Pharmaceutical Sciences The document was recorded in the United States Patent and Trademark Office at Reel 038398, Frame 0001.

From: Allergan, Inc. To: Almirall, LLC The document was recorded in the United States Patent and Trademark Office at Reel 047132, Frame 0642.

Pursuant to 37 C.F.R. § 42.8, Patent Owner, Almirall, LLC (“Almirall”), hereby files its Mandatory Notices: A. Real Party-In-Interest Under 37 C.F.R. § 42.8(b)(1) The real party-in-interest is Almirall, LLC, a Pennsylvania limited liability company.

The ʼ219 Patent is also the subject of Almirall, LLC v. Amneal Pharmaceuticals LLC, Civil Action No. 19-658 (LPS) in the United States District Court for the District of Delaware, filed April 9, 2019.

37 C.F.R. § 42.8(b)(4) – Service Information Almirall may be served through its counsel, Fenwick & West LLP, at the above-indicated postal and email addresses.

Power of Attorney Filed concurrently with these Mandatory Notices is a Power of Attorney from Patent Owner Almirall to the above-designated counsel at Fenwick & West LLP to transact all business in the United States Patent and Trademark Office in connection with the above-referenced Inter Partes Review.

The Power of Attorney is accompanied by a Statement Under 37 C.F.R. § 3.73(c), executed by Almirall.

Patent Owner.

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

Mail Stop “PATENT BOARD” Patent Trial and Appeal Board U.S. Patent and Trademark Office P.O.

Thomas W. Jenkins Assistant General Counsel, Global IP Litigation

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

A. Legal Standards The Leahy-Smith America Invents Act (AIA) permits joinder of inter partes review (IPR) proceedings.

Accordingly, for the reasons stated above, joinder of Mylan to the Amneal IPR will not affect the Board’s ability to complete its review and final decision within the statutory time limits under 35 U.S.C. § 316(a)(11) and 37 C.F.R. § 42.100(c).

Moreover, joinder eliminates the need for the Patent Owner to participate in multiple, staggered inter partes review proceedings instituted upon identical grounds of unpatentability.2 Indeed, in the very inter partes review Mylan seeks to join, this very Patent Owner told the PTAB that staggered proceedings with different schedules presents a burden to it.

For the foregoing reasons, Mylan respectfully requests that its Petition for Inter Partes Review of the ’219 patent be granted and that the proceedings be joined with IPR2019-00207.

), Handbook of Pharmaceutical Excipients, 6th Ed., Pharmaceutical Press: London, UK (2009) Bonacucina, G., et al., “Characterization and Stability of Emulsion Gels Based on Acrylamide/Sodium Acryloyldimethyl Taurate Copolymer,” AAPS PharmaSciTech 10:368-375 (2009) (“Bonacucina”) U.S. Patent No. 5,863,560 (“Osborne II”) File History of U.S. Patent No. 9,517,219 Declaration of Elaine S. Gilmore, M.D., Ph.D. US_139681447v1_391026-00295

Mylan Exhibit # 1019 1020 1021 1022 1023 1024 1025 1026 1027 1028 1029 1030 1031 1032 1033 Description Curriculum Vitae for Elaine S. Gilmore, M.D., Ph.D. Affidavit of Christopher Butler Intentionally left blank Wozel, D., “Innovative Use of Dapsone” Dermatol.

28: 599– 610 (2010) (“Wozel”) Thiboutot, D., et al., “Pharmacokinetics of Dapsone Gel, 5% for the Treatment of Acne Vulgaris” Clin.

46: 697- 712 (2007) (“Thiboutot”) Nguyen, R. and Su, J., “Treatment of Acne Vulgaris” Pediatrics and Child Health 21: 119-125 (2010) (“Nguyen”) Williams, H., et al., “Acne vulgaris” Lancet 379: 361–72 (2012) (“Williams”) SepineoTM P 600 Brochure Barclay, L., “Use of Topical Corticosteroids for Dermatologic Conditions Reviewed” Medscape - Jan 21, 2009, accessed from https://www.medscape.com/viewarticle/587159_print (“Barclay”) Remington: The Science and Practice of Pharmacy, 21st Ed., Lippincott Williams & Wilkins: Baltimore, MD (2005) (“Remington”) Kim, J-Y., et al., “Rheological properties and microstructures of Carbopol gel network system,” Colloid.

Mylan Exhibit # 1034 1035 1036 1037 1038 Description Andersson, D., “Evonik-Degussa expands its cooperation with Alsiano,” Pharma & Healthcare News : 1-10 (2007) Declaration of Audra L. Stinchcomb, Ph.D. Curriculum Vitae for Audra L. Stinchcomb, Ph.D.

This declaration is made in support of Patent Owner Almirall, LLC’s Motion for Admission Pro Hac Vice of Elizabeth B. Hagan Pursuant to 37 C.F.R. § 42.10(c).

The Board granted the pro hac vice motion on May 15, 2019, authorizing me to represent Patent Owner Almirall, LLC as back-up counsel.

As trial counsel for Almirall, I have been actively involved in all aspects of the district court litigations, including development of validity and infringement positions regarding the patent challenged in this proceeding.

Hagan Declaration in Support of Motion for Admission Pro Hac Vice Amneal Pharmaceuticals of New York, LLC challenging the ʼ219 patent at issue in this proceeding.

As back-up counsel for Almirall in IPR2019-00207, I am actively involved in all aspects of the inter partes review proceeding, including development of validity positions regarding the ʼ219 patent, and am familiar with the grounds, expert testimony, and prior art on which Petitioner relies.

This declaration is made in support of Patent Owner Almirall, LLC’s Motion for Admission Pro Hac Vice of Elizabeth B. Hagan Pursuant to 37 C.F.R. § 42.10(c).

The Board granted the pro hac vice motion on May 15, 2019, authorizing me to represent Patent Owner Almirall, LLC as back-up counsel.

As trial counsel for Almirall, I have been actively involved in all aspects of the district court litigations, including development of validity and infringement positions regarding the patent challenged in this proceeding.

Hagan Declaration in Support of Motion for Admission Pro Hac Vice Amneal Pharmaceuticals of New York, LLC challenging the ʼ219 patent at issue in this proceeding.

As back-up counsel for Almirall in IPR2019-00207, I am actively involved in all aspects of the inter partes review proceeding, including development of validity positions regarding the ʼ219 patent, and am familiar with the grounds, expert testimony, and prior art on which Petitioner relies.

15000 12000 9000 6000 3000 Brookfield viscosity @ 20 rpm (mPa*s) pH 1 Based on customer request, Lubrizol certifies select lots of product against the JPE Carboxyvinyl Polymer Monograph Mylan (IPR2019-01095) MYLAN1020, p. 006

These APIs have been incorporated in a variety of dosage forms: solutions, suspensions, emulsions, lotions, creams, gels and toothpaste for peroral or topical administration (skin, mucosa - oral, ophthalmic, nasal, rectal, vaginal).

Numerous enhancements have been made to the Carbopol® polymer family over time to address regulatory requirements, meet formulation demands and improve product handling during processing.

For aesthetic reasons, it is often desirable to produce small particle size emulsions having a high degree of whiteness, opacity and creamy appearance.

The droplet size of the oil phase can be reduced by increasing the mixing time, using moderate shear agitation when the emulsion is made, or by the use of a liquid nonionic surfactant (HLB 8-12) at 0.1 - 0.4 wt.

It has been used to treat skin diseases characterized by the abnormal infiltration of neutrophils, such as Dermatitis herpetiformis, linear IgA dermatosis, pustular psoriasis, pyoderma gangrenosum, acne vulgaris, and Sweet's Syndrome.

They remove essential [0011] The oil phase component includes any pharmaceu tically acceptable organic, hydrophobic substance that soft ens and moistens the skin layers such as the epidermis and Mylan (IPR2019-01095) MYLAN1007, p. 002

[0093] The following formulation was prepared: Excipient Dapsone White petrolatum Isopropyl palmitate Emulium Delta ® 1 Purified water Carbopol 980 Ethoxydiglycol Methylparaben Propylparaben Sodium hydroxide solution, 10% o/ow/w 3.0 5.0 5.0 10.0 qs 100 0.25 15.0 0.2 0.05 0.25 1Emulium Delta® is manufactured by Gattefosse.

2.0 30.0 0.3 0.2 10.0 0.15 0.05 qs 100 0.5 Excipient Dapsone Isopropyl myristate Octyldodecanol Cetyl palmitate Pemulen TR2 Carbopol 980 Propylene glycol Ethoxydiglycol Benzyl alcohol Methylparaben Butylated hydroxytoluene Purified water Sodium hydroxide, 10% Procedure:

[0142] The following formulations were prepared: Procedure: [0128] 1) The white petrolatum, emulsifying wax, isopro pyl myristate, diisopropyl adipate, and BHT were com bined and melted at 70° C. [0129] 2) The Dapsone was added to the mixture of propylene glycol and benzyl alcohol and mixed to wet.