Amneal Pharmaceuticals LLC et al. vs Almirall, LLC

Other: fed circuit mandate

Other: other court decision

Trial Certificate Checklist

Order Denying Request for Director Review

Patent Owner Almirall, LLC's Updated Mandatory Notices Under 37 C.F.R. Section 42.8

Patent Owner's Request for Director Review Pursuant to Arthrex

Notice of Appeal

Ex. 3002

CONDUCT OF THE PROCEEDING Expunging Unauthorized New Evidence 37 C.F.R. ¿¿ 42.7

DECISION Denying Patent Owner¿¿¿s Request for Rehearing 37 C.F.R. ¿¿ 42.71(d)

Patent Owner Almirall, LLC's Updated Mandatory Notices Under 37 C.F.R. Section 42.8

EXPUNGED

Patent Owner's Updated Exhibit List

EXPUNGED

Patent Owner's Request for Rehearing Under 37 C.F.R. 42.71(d)

Termination Decision Document

Ex 3001

Denying Authorization for Patent Owner Motion to file Supplemental Information 37 C.F.R. sec 42.5(a); sec 42.123(b)

Order - Adjusting One-Year Pendency Due to Joinder

Hearing Transcript

Petitioners Reply ISO Motion to Exclude

Patent Owner's Response to Petitioner's Supplemental Brief

Patent Owner's Reply in Support of It's Motion to Exclude Evidence Under 37 C.F.R. Section 42.64

PTAB Conference Call Transcript 2020 01 17

Patent Owner's Exhibit List

Petitioners' Exhibit List

Petitioners' Opposition to Motion to Exclude

1079 - Emails re confidential material

Redacted Warner Depo Transcript

CONFIDENTIAL Warner Depo Transcript

REDACTED Petitioners' Suppl. Brief

Combined Motion to Seal and Enter Default Protective Order

CONFIDENTIAL Petitioners' Suppl. Brief

Patent Owner's Opposition to Petitioners' Motion to Exclude Evidence

Order Conduct of the Proceeding Modifying Schedule

Patent Owner's Motion to Exclude Evidence Under 37 C.F.R. 42.64

Petitioners' Motion to Exclude Evidence

Exhibit List

Emails chain from January 10, 2020 to January 13, 2020

ORDER Oral Hearing

ORDER - Granting Patent Owner¿¿¿s Motion for Additional Discovery 37 C.F.R. ¿¿ 42.51(b)(2)

Patent Owner's Request for Oral Argument

Petitioners' Request for Oral Hearing

Exhibit 2066 (Erick H. Turner, How to access and process FDA drug approval packages for use in research, BMJ (2013) (served August 30, 2019)

Exhibit 2067 (Manual of Policies and Procedures - Center for Drug Evaluation and Research [served August 30, 2019])

Patent Owner' Sur-Reply

Exhibit 2065 (Supplemental Declaration of David W. Osborne, Ph.D. [served August 10, 2019])

Exhibit 2069 (Transcript of Deposition of Elaine S. Gilmore, M.D., Ph.D., dated December 12, 2019)

Exhibit 2068 (Transcript of Deposition of Bozena B. Michniak-Kohn, Ph.D., FAAPS, M.R.Pharm.S., dated December 6, 2019)

DECISION Granting Institution of Inter Partes Review 35 U.S.C. ¿¿ 314 Granting Motion for Joinder 35 U.S.C. ¿¿ 315(c), 37 C.F.R. ¿¿ 42.122

Notice of Stipulation to Extend Due Date 3

Patent Owner Almirall, LLC's Notice of Deposition of Dr. Elaine S. Gilmore, M.D., Ph.D. Under 37 C.F.R. Section 42.53

Patent Owner Almirall, LLC¿¿¿s Notice of Deposition of Dr. Bozena B. Michniak-Kohn Under 37 C.F.R Section 42.53

Patent Owner Almirall, LLC's Updated Mandatory Notices Under 37 C.F.R. ¿¿ 42.8

Patent Owner's Objections to Reply Evidence

Kircik Depo Transcript

Osborne Depo Transcript

Allergan Announces Agreement to Acquire Aczone¿¿ Gel

USPN 7326408

FDA inactive approved database FAQ

Kircik 2016

Lubrizol Dispersion Techniques

Tanghetti 2012

Sullivan et al 2014

FDA IIG Field Descriptions

Noveon

December 2010 IIG Database

DMF approval database

9,161,926 FH

Kircik DFD 2013

Kircik DFD 2014

Kircik DFD 2015

Aczone DFD

Andersson 2007

Harper Depo Transcript Case IPR2018-00608

Aczone Gel 7.5%

Kircik CMS 2013

Kircik CMS 2014

Kircik CMS 2015

Kircik DFD 2016

Kircik CMS 2016

Kircik DFD 2017

Kircik 2017 CMS

Kircik Dollars for Docs 2018

Kircik 2018 CMS

Klibanov Declaration (2018 11 29) IPR2018-00608

USPN 9,161,926

Second Declaration for Dr. Michniak-Kohn

Second Gilmore Declaration

Reply

Exhibit List

Patent Owner's Opposition to Petitioner's Motion for Additional Discovery Pursuant to 37 C.F.R. ¿¿ 42.51(b)(2)

Motion for Additional Discovery

Poster Abstracts for the Journal of the American Academy of Dermatology 2017 Annual Meeting - served October 4, 2019 - Part 2

Poster Abstracts for the Journal of the American Academy of Dermatology 2017 Annual Meeting - served October 4, 2019 - Part 3

Email dated October 8, 2019 from Tyler Liu to [email protected] requesting authorization to file a motion for additional discovery

Proposed Joint Pretrial Order

Exhibit List

Poster Abstracts for the Journal of the American Academy of Dermatology 2017 Annual Meeting - served on October 4, 2019

Email dated October 8, 2019 from Liz Hagan to Tyler Liu, Dennies Varughese, Adam LaRock and James Trainor re: conference call

Proposed Joint Pretrial Order - Part 1

CONDUCT OF THE PROCEEDINGS

Osborne Deposition Notice

Notice of Deposition of Leon H. Kircik, MD

Petitioners' Objections to Evidence

Exhibit 2008 (Ahluwalia - Intl Publ No WO 2011014627)

Exhibit 2009 (Anderson 2009)

Exhibit 2012 (Coutinho 2010)

Exhibit 2015 (Draelos et al 2007)

Exhibit 2022 (Kircik 2011)

Exhibit 2024 (Korting et al 2009)

Exhibit 2025 (Kraft et al 2011)

Exhibit 2026 (Makrantonaki et al 2011)

Exhibit 2028 (Piette et al 2008)

Exhibit 2036 (Thiboutot et al 2009)

Exhibit 2038 (Titus et al 2012)

Exhibit 2040 (PDR 2012 Duac)

Exhibit 2041 (Epiduo press release 2011)

Exhibit 2010 (Collier et al 2008)

Exhibit 2011 (Cordain et al 2002)

Exhibit 2013 (Del Rosso 2007)

Exhibit 2014 (Fabbrocini et al 2011)

Exhibit 2016 (Fleischer et al 2010)

Exhibit 2017 (Ghods et al 2010)

Exhibit 2018 (James 2005)

Exhibit 2019 (James 2009)

Exhibit 2020 (Kircik 2010)

Exhibit 2021 (Kircik et al 2010a)

Exhibit 2023 (Kircik 2011a)

Exhibit 2027 (Mills et al 1986)

Exhibit 2029 (Powell 2005)

Exhibit 2030 (Simonart 2012)

Exhibit 2031 (Steiner 2009)

Exhibit 2032 (Strauss 1991)

Exhibit 2033 (Strauss et al 2007)

Exhibit 2034 (Tanghetti et al 2011)

Exhibit 2035 (Thiboutot et al 2008)

Exhibit 2037 (Thielitz et al 2008)

Exhibit 2039 (PDR 2011 Benzaclin)

Exhibit 2042 (Aczone 5% Medical Review)

Exhibit 2043 (Aczone 5% Clinical Pharmacol & Biopharmaceutics Review)

Exhibit 2044 (Aczone 5 Percent Prescribing Information)

Exhibit 2046 (FDA approval letter dated 3.14.2008)

Exhibit 2047 (Puavilai Article)

Exhibit 2049 (Poulsen 1990)

Exhibit 2050 (FDA Inactive Ingredient Database September 2012)

Exhibit 2052 (EU DGME 2010)

Exhibit 2045 (FDA approval letter dated 7.7.2005)

Exhibit 2048 (WHO Alert No 117 LapDap)

Exhibit 2051 (FDA Inactive Ingredient Database December 2012)

Exhibit 2053 (Osborne 2007 - US20070122435A1)

Exhibit 2054 (ACZONE Gel 5% Package Insert)

Exhibit 2056 (Curriculum Vitae of Dr Leon Kircik 2019)

Exhibit 2063 (Michniak-Kohn Deposition Transcript 2019 07 30)

Exhibit 2064 (Chang et al 2013)

Patent Owner's Response to Petition for Inter Partes Review

Exhibit 2055 (Kircik Decl ISO Patent Owner's Response)

Exhibit 2057 (Osborne Decl ISO Patent Owner's Response)

Exhibit 2058 (Curriculum Vitae of Dr David Osborne)

Exhibit 2059 (Gamble et al 2012)

Exhibit 2060 (Heffernan et al 2007)

Exhibit 2061 (Marcinkiewicz et al 2008)

Exhibit 2062 (Gilmore Deposition Transcript 2019 07 25)

Notice of Stipulation to Extend Due Dates 1, 2, and 3

Patent Owner Almirall, LLC's Notice of Deposition of Dr. Elaine S. Gilmore Under C.F.R. Section 42.53

Patent Owner Almirall, LLC's Notice of Deposition of Dr. Bozena B. Michniak-Kohn Under C.F.R. Section 42.53

Updated Mandatory Notices

Order - Granting Patent Owner's Motion for Pro Hac Vice - Admission of Elizabeth B. Hagan - 37 CFR 42.10

Trial Instituted Document

Scheduling Order

Patent Owner Almirall, LLC's Motion for Pro Hac Vice Admission of Elizabeth B. Hagan Pursuant to 37 C.F.R. 42.10(c)

Declaration of Elizabeth B. Hagan in Support of Patent Owner Almirall, LLC's Motion for Admission Pro Hac Vice

Patent Owner Almirall, LLC's Sur-Reply Pursuant to Order [Paper 9]

Exhibit 2006 (Petitioner's Notice of Paragraph IV Certification to PO (February 22, 2019) (truncated))

Petitioners' Reply to Patent Owner's Preliminary Response

Authorizing Reply to Preliminary Response to Petitioners and Sur-reply to Patent Owner 37 C.F.R. § 42.108(c)

Patent Owner Almirall, LLC's Updated Mandatory Notices Under 37 C.F.R. Section 42.8

Exhibit 2005 (Redline Comparison of Declaration)

Patent Owner's Preliminary Response

Exhibit 2001 (WO 2009/108147)

Exhibit 2002 (WO 2010/105052)

Exhibit 2003 (Redline Comparison of Petitions)

Exhibit 2004 (Redline Comparison of Declaration)

Power of Attorney from Patent Owner Almirall, LLC

Patent Owner Almirall, LLC's Mandatory Notices Under 37 C.F.R Section 42.8

NOTICE OF FILING DATE ACCORDED TO PETITION AND TIME FOR FILING PATENT OWNER PRELIMINARY RESPONSE

U.S. Patent No. 9,517,219

WO 09/061298

WO 10/072958

U.S. Patent Publ. No. 2006/0204526

PDR - Aczone Gel 5%

U.S. Patent No. 7,820,186

Michniak-Kohn CV

Certification for Translation of WO 10/072958

U.S. Patent Publ. No. 2010/0029781

Osborne 2011

Bonacucina 2009

'219 File History

Gilmore CV

Nguyen 2010

Sepineo P 600 Brochure

Barclay 2009

Remington 2005

Kim 2003

Spain's Almirall bets on dermatology

Epiduo Product Label

U.S. Patent Publ. No. 2007/0190019

Handbook of Pharmaceutical Excipients

U.S. Patent No. 5,863,560

Affidavit of Christopher Butler

Wozel 2010

Thiboutot 2007

Williams 2012

Piskin 2007

Andersson 2007

Michniak-Kohn Declaration

Power of Attorney

'219 Exhibit List

Gilmore Declaration

Petition