Notice of Deposition of Dr. Gilmore

PLEASE TAKE NOTICE that pursuant to 37 C.F.R. § 42.53, Patent Owner Almirall, LLC will take the deposition of Petitioners’ declarant, Dr. Elaine S. Gilmore, M.D., Ph.D. upon oral examination as follows.

Location: Sterne, Kessler, Goldstein & Fox P.L.L.C. 1100 New York Avenue NW Washington, DC 20005 The deposition will be recorded by stenographic and/or audio means by a court reporter licensed to administer oaths.

Respectfully submitted, FENWICK & WEST LLP By: /James Trainor/ James Trainor (Reg. No. 52,297)

Attorneys for Patent Owner Almirall, LLC

Pursuant to 37 C.F.R. § 42.10(c), and as authorized in the Board’s Notice of Filing Date issued November 14, 2018 (Paper 4), Patent Owner Almirall, LLC (“Almirall”) respectfully requests the pro hac vice admission of Elizabeth B. Hagan in this proceeding.

She represented Patent Owner Almirall, LLC in the district court litigation against Taro Pharmaceutical Industries Ltd. that terminated March 11, 2019.

As trial counsel for Almirall, LLC, Ms. Hagan was actively involved in all aspects of the district court litigation, 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, IPR2014-00752.

Motion for Admission Pro Hac Vice familiarity with the subject matter at issue in this proceeding, including the ’219 patent, the parties’ written submissions, and the cited references.

Patent Owner.

PLEASE TAKE NOTICE that pursuant to 37 C.F.R. § 42.53, Patent Owner Almirall, LLC will take the deposition of Petitioners’ declarant, Dr. Bozena B. Michniak-Kohn, upon oral examination as follows.

Location: Norris McLaughlin P.A. 400 Crossing Boulevard Bridgewater, NJ 08807 The deposition will be recorded by stenographic and/or audio means by a court reporter licensed to administer oaths.

Respectfully submitted, FENWICK & WEST LLP By: /James Trainor/ James Trainor (Reg. No. 52,297)

Attorneys for Patent Owner Almirall, LLC

This Petition presents the opportunity for the Board to clarify that AIA proceedings are not test-vehicles to be gamed or gimmicked – not least by Petitioners, as here, maintaining parallel validity challenges under the Hatch-Waxman scheme.

Two paramount questions remain unmeaningfully answered by Petitioner: (1) what explains its delay in bringing this Petition relative to the earlier-instituted, virtually identical IPR of its ’926 parent?

Where made at all, Petitioner’s unresonant responses to these questions solidify the most reasonable inference: that Petitioner purposefully staggered the two petitions– identical in Grounds, extensively verbatim in supporting argument and evidence, and targeting claims asserted as reciting “identical” compositions.

Instituting this IPR “would require the Board to conduct an entirely separate proceeding involving numerous issues that have been considered already…The result would be a significant waste of the Board’s resources.” NetApp Inc. v. Realtime Data LLC, IPR2017-01195, Paper 9, p. 13 (October 12, 2017).

As such, and where neither the spirit of the AIA nor any public policy would be served in sanctioning Petitioner’s test-and-see challenge paradigm, the Board is well within its discretion to deny institution on–but limited to–the facts of this Petition.

Patent Owner’s Updated Mandatory Notices Under 37 C.F.R. § 42.8

Pursuant to 37 C.F.R. § 42.8, Patent Owner, Almirall, LLC (“Almirall”), hereby files the following updated mandatory notices.

Dated: November 19, 2019 Respectfully submitted,

Reg. No. 52,297 Counsel for Almirall, LLC Patent Owner’s Updated Mandatory Notices Under 37 C.F.R. § 42.8

Moreover, Almirall’s arguments raise material factual disputes as to whether Amneal’s cited art overcomes Almirall’s alleged unexpected results evidence, further compelling institution of the IPR.

The Board typically exercises its discretion under § 314(a) and the General Plastic factors to deny institution of “follow-on” IPRs that are duplicative of earlier-filed petitions on the same patent, to avoid offending notions of res judicata, judicial economy, and petitioner diligence.

Almirall also ignores that in a parallel district court litigation over the ’219 patent—where Amneal was not a party—claim construction of the term “polymeric viscosity builder” was outstanding prior to this Petition.

Factors 6 and 7 also do not warrant denying institution because the Petition is not a serial attack on the same patent that imposes any inefficient and uneconomical “tax” on the Board.

At bottom, Almirall’s analysis of Becton factor (f) asks this Board to make factual findings as to whether the Petition “warrant[s] reconsideration” of alleged unexpected results.

Patent Owner’s Objections to Reply Evidence finding that Exhibit 1045 “is what [Amneal] claims it is.” See FRE 901.

Patent Owner’s Objections to Reply Evidence consequence in determining this action more or less probable than it would be without this exhibit.

Patent Owner’s Objections to Reply Evidence states on its face that “no representations… of any kind are made as to [the] accuracy” of the information contained therein.

Exhibit 1052 appears to be a printout of a portion of a spreadsheet titled “3Q2018EXCEL,” and Amneal’s expert Dr. Michniak-Kohn describes it as “the FDA DMF database that [she] downloaded” from a particular weblink.

Amneal relies on Exhibit 1075 only as a seventh source to support the sentence “a POSA would have known that Aczone 5% Gel contained undissolved dapsone before 2012.” Paper 28 at 9–10.

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 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) 1045 1046 1047 1048 1049 1050 1051 1052 1053 1054 1055 1056 1057

), 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.

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”) 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.

CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e), 42.105(a)) The undersigned hereby certifies that the above-captioned “Petitioners’ Exhibit List”, along with exhibits 1035 – 1038, were served in their entirety on October 18, 2019, via electronic mail upon the following counsel for Patent Owner:

Notice of Deposition of David W. Osborne, Ph.D.

PLEASE TAKE NOTICE that pursuant to 37 C.F.R. § 42.53, Petitioners Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals of New York, LLC, hereby provide notice to Patent Owner Almirall, LLC that the deposition of David W. Osborne, Ph.D. will be held on Friday, October 18, 2019, beginning at 9:00 AM, at the offices of Fenwick & West, LLP, located at 1191 Second Avenue, 10th Floor, Seattle, WA 98101.

The deposition will be recorded using audiotape and/or stenographic means pursuant to 37 C.F.R. § 42.53(a).

The deposition will also be transcribed by real-time reporting software.

Lead Attorney for Petitioners Registration No. 61,868 CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e)) The undersigned hereby certifies that the “Notice of Deposition of David W. Osborne, Ph.D.” was served in its entirety on September 27, 2019, via electronic mail upon the following counsel for Patent Owner: