Not only does this mean that Almirall did not satisfy its threshold obligation, but failing to timely Case IPR2019-00207 Patent 9,517,219 B2 object deprived Amneal an opportunity to cure any issue.

Because Almirall failed to diligently review the declarations of Dr. Michniak-Kohn and Dr. Gilmore and file any objections within five business days, Almirall’s motion to exclude should be denied on this basis alone.

Case IPR2019-00207 Patent 9,517,219 B2 Almirall’s sole complaint is that Dr. Michniak-Kohn and Dr. Gilmore relied on factual information supplied by counsel concerning the deposition statements and admissions by Almirall’s declarants.

Moreover, the information supplied by counsel is nothing more than confirmatory evidence that supports the already-stated opinions of Dr. Michniak-Kohn and Dr. Gilmore based on those expert’s view of the published literature and prior art, their own experience, and their own understanding of the technical field.

In fact, Almirall spent much time at both depositions examining the witness on the published literature and prior art, their own experience, and their own understanding of the technical field.

Pursuant to 35 U.S.C. §§ 141(c), 142, and 319 and 37 C.F.R.§§ 90.2(a) and 90.3(b)(1), Patent Owner Almirall, LLC (“Almirall”) hereby provides notice that it appeals to the United States Court of Appeals for the Federal Circuit from the Final Written Decision entered on May 29, 2020 (Paper 58, attached hereto as Appendix A) in IPR2019-00207 before the Patent Trial and Appeal Board regarding the inter partes review of U.S. Patent No. 9,517,219 (“the ’219 patent”), and from all underlying findings, determinations, orders, decisions, rulings, and opinions, including Almirall’s Request for Rehearing (Paper 61), which was denied on July 23, 2020 (Paper 62).

In accordance with 37 C.F.R. § 90.2(a)(3)(ii), Almirall states that the issues on appeal include, but are not limited to: 1.

Whether the Board erred in finding that claims 1–8 of the ’219 patent are unpatentable under 35 U.S.C. § 103(a) over the combination of two references: (1) Garrett; and (2) 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.

Whether the Board erred in any finding relating to the aforementioned claims and grounds, including the scope and content of the prior art; and 4.

Whether the Board erred in any other issues decided adversely to Almirall in any order, decision, ruling or opinion.

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.

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”) Sepineo™ 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.

Amneal Exhibit # Description 1045 1046 1047 1048 1049 1050 1051 1052 1053 1054 1055 1056 1057 Inactive Ingredient Search for Approved Drug Products: Frequently Asked Questions, Retrieved from https://www.fda.gov/drugs/drug- approvals-and-databases/inactive-ingredient-search-approved-drug- products-frequently-asked-questions#inactive%20as%20active?, last accessed on October 25, 2019 Lubrizol Technical Data Sheet, Dispersion Techniques for Carbopol® Polymers Kircik, L.H., “Use of Dapsone 5% Gel as Maintenance Treatment of Acne Vulgaris Following Completion of Oral Doxycycline and Dapsone 5% Gel Combination Treatment,” Journal of Drugs in Dermatology 15(2):191-195 (2016) Tanghetti, E., et al., “The Efficacy and Tolerability of Dapsone 5% Gel in Female vs.

Male Patients With Facial Acne Vulgaris: Gender as a Clinically Relevant Outcome Variable,” Journal of Drugs in Dermatology 11:1417-1421 (2012) Intentionally left blank Neutralizing Carbopol® and Pemulen® Polymers in Aqueous and Hydroalcoholic Systems, published January 2002 (“Noveon Technical Data Sheet”) 2010 Inactive Ingredient Database, available at: http://wayback.archive-it.org/7993/20170112022245/http:/www.fda.

Sullivan, D., et al., “A review of the nonclinical safety of Transcutol®, a highly purified form of diethylene glycol monoethyl ether (DEGEE) used as a pharmaceutical excipient,” Food and Chemical Toxicology 72: 4-50 (2014) FDA Inactive Ingredient Database Field Descriptions Andersson, D., “Evonik-Degussa expands its cooperation with Alsiano,” Pharma & Healthcare News 7:1-10 (2007) File History of U.S. Patent No. 9,161,926 Deposition Transcript for Julie C. Harper, M.D., Case IPR2018- 00608 (March 11, 2019)