Novartis Pharmaceuticals Corporation vs Shilpa Pharma, Inc.

EXPUNGED

Denying Patent Owner’s Motion to Expunge Confidential Materials from the Record 37 C.F.R. §§ 42.56

Patent Owner Shilpa Pharma, Inc.'s Notice of Appeal

Patent Owner's Reply in Support of Motion to Expunge Confidential Materials from the Record

Petitioner's Opposition to Patent Owner's Motion to Expunge

PO's Motion to Expunge Confidential Materials from the Record

Exhibit 2178

Replacement Exhibit 1066

Replacement Exhibit 2143

JUDGMENT Final Written Decision Dismissing Petitioner’s Motion to Exclude Evidence Denying Petitioner’s Motion for Sanctions Dismissing-in-Part and Denying-in-Part Patent Owner’s Motion to Exclude Evidence Determining All Challenged Claims Unpatentable 35 U.S.C. § 318(a)

Ex. 3005

EXPUNGED

PUBLIC VERSION Oral Hearing Transcript 08-02-2023

ORDER Conduct of the Proceeding 37 C.F.R. § 42.5

Other: Hearing transcript

Order: ORDER Denying Patent Owner’s Request for Authorization to File a Motion for Sanctions 37 C.F.R. §§ 42.5(a), 42.20(b) (REDACTED)

Order: ORDER Denying Patent Owner’s Request for Authorization to File a Motion for Sanctions 37 C.F.R. §§ 42.5(a), 42.20(b)

Patent Owner's Unopposed Motion to Seal Demonstrative Exhibits

Patent Owner Shilpa Demonstrative Exhibits PUBLIC

Patent Owner Shilpa Demonstrative Exhibits SEALED

Petitioner Novartis’s Unopposed Motion to Seal

[SEALED] Petitioner's Demonstratives for Oral Argument

[Redacted] Petitioner's Demonstratives for Oral Argument

Motion to Seal July 20, 2023 Hearing Transcript

July 20, 2023 Teleconference Hearing Transcript IPR2022-00886

Petitioner Novartis’s Unopposed Motion to Seal

Reply in Support of Petitioner Novartis’s Motion to Exclude

Redacted Reply in Support of Petitioner Novartis’s Motion to Exclude

Patent Owner's Unopposed Motion to Seal

Patent Owner's Reply to Petitioner's Opposition to Motion to Exclude - SEALED

(Public) Patent Owner's Reply to Petitioner's Opposition to Motion to Exclude

August 6, 2012 email from Dr. A.K. Chaturvedi Dr. Singh and Mr. Purohit (SHIL0332086-095)

Redacted version of Exhibit 2173

Declaration – L. Roman Rachuba (July 19, 2023)

Panel Change Order

Patent Owner's Opposition to Petitioner's Motion to Exclude-SEALED

Patent Owner's Opposition to Petitioner's Motion to Exclude-Public Version

Patent Owner's Unopposed Motion to Seal

Petitioner Novartis’s Unopposed Motion to Seal

Petitioner Novartis’s Opposition to Patent Owner Shilpa’s Motion to Exclude

June 9, 2023 email

June 9, 2023 email

August 26, 2022 email from Castro to Trenchard

November 11, 2022 email from Castro to Trenchard

January 9, 2023 email from Rachuba to Trenchard

March 3, 2023 email from Castro to Trenchard

Stipulated ESI Order from C.A. No. 21-558-MN

Shilpa’s Responses to Novartis’s First RFAs (Mar. 30, 2023)

Printout from Shilpa’s website

2023-06-13 Trenchard Declaration

2023-06-13 Supplemental McClurg Declaration

[Redacted] Ex. 1149 June 9, 2023 email

[Redacted] Ex. 1150 June 9, 2023 email

[Redacted] Ex. 1156 Shilpa’s Responses to Novartis’s First RFAs (Mar. 30, 2023)

[Redacted] Ex. 1158 2023-06-13 Trenchard Declaration

[Redacted] Ex. 1159 2023-06-13 Supplemental McClurg Declaration

[Redacted] Ex. 1151 August 26, 2022 email from Castro to Trenchard

[Redacted] Ex. 1152 November 11, 2022 email from Castro to Trenchard

[Redacted] Ex. 1153 January 9, 2023 email from Rachuba to Trenchard

[Redacted] Ex. 1154 March 3, 2023 email from Castro to Trenchard

[Redacted] Petitioner's Opposition to Patent Owner Shilpa's Motion to Exclude

EXPUNGED

Redacted Opposition to Motion for Sanctions

Patent Owner's Opposition to Motion for Sanctions

2014 Orange Book Listing for Gilenya

Complaint Against Actavis in 2014

Dr. Rafiuddin's Transcripts of April 6-7 2023

U.S. Pat. No. 9,732,030

Declaration - L. Roman Rachuba [July 10, 2023]

Patent Owner's Unopposed Motion to Seal [July 10, 2023]

ORDER Setting Oral Argument 37 C.F.R. sec 42.70

Petitioner’s Objections to Patent Owner’s Evidence in Patent Owner Sur-Reply

Petitioner Novartis’s Unopposed Motion to Seal

Petitioner Novartis’s Motion to Exclude

Redacted Petitioner Novartis’s Motion to Exclude

Patent Owner's Motion to Exclude Evidence

March 15, 2023 Email Correspondence Between Shilpa’s counsel Brett Sylvester to Novartis’ Counsel Christine Ranney

Email Exchanges between Shilpa and Novartis Counsel re Scheduling Depositions of Shilpa Witnesses in the District Court Proceeding

Declaration of L. Roman Rachuba - July 5, 2023

Cover pages of the deposition transcripts of Shilpa witnesses Varnasi, Bhutada, Rafiuddin, and Shrawat

Petitioner's Unopposed Motion to Seal

Petitioner Novartis’s Motion for Sanctions

April 22 email from Robert W. Trenchard to Chid S. Iyer.

Transcript of Deposition of Dr. Rafiuddin (Day 1)

Transcript of Deposition of Dr. Rafiuddin (Day 2)

Errata to Transcript of Deposition of Dr. Rafiuddin (Day 1)

Errata to Transcript of Deposition of Dr. Rafiuddin (Day 2)

March 29, 2023 email from L. Roman Rachuba II to Patent Trial and Appeal Board

Redacted April 22 email from Robert W. Trenchard to Chid S. Iyer.

Redacted Petitioner’s Motion for Sanctions

Sealed 2023.06.29 Hearing Transcript

PATENT OWNER’S UNOPPOSED MOTION TO SEAL

SEALED Patent Owner Surreply

REDACTED PUBLIC ver of PO Sur-Reply

Deposition Transcript of Dr. Richard McClurg, taken June 21, 2023

Guo, Wei, et al. Thermal Properties of Drug Polymorphs: A Case Study with Felodipine Form I and Form IV, Journal of Saudi Chemical Society (April 18, 2020)

U.S. Patent No. 10,065,957 to Casarez et al

XRDs of Fingolimod (SHIL0332162-0332178)

Experimental Details and Consumption of FM Product (SHIL0312853)

Redacted version of Exhibit 2143

Redacted version of Exhibit 2152

Redacted version of Exhibit 2153

Declaration of L. Roman Rachuba dated June 28, 2023

Patent Owner's Notice of Deposition for Richard B. McClurg, Ph.D

PETITIONER NOVARTIS’S UNOPPOSED REQUEST FOR ORAL HEARING

Patent Owner’s Request for Oral Argument

Patent Owner’s Objections to Petitioner’s Evidence in Petitioner’s Reply

PETITIONER’S UNOPPOSED MOTION TO SEAL

Petitioner Novartis’s Reply

Reply Declaration of Dr. Richard McClurg

Certificate of Analysis, Shilpa Pharma Lifesciences Ltd. (Jan. 25, 2023)

Kowa Transcript - Trial transcript of proceedings before Judge Paula A. Crotty

UN-SCAN-IT, XY data from Fig. 1 of WO 2010/055028 A2

UN-SCAN-IT - References, Reviews, and Testimonials

UN-SCAN-IT: Graph Digitizing Software, Journal of the American Chemical Society

Announcement of Un-Scan-It in Analytical Chemistry,

Analysis of Intra- and Intermolecular Interactions Relating to the Thermophysical Behavior of α-, β-, and δ-Octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazocine

Elucidation of high sensitivity of δ-HMX: New insight from first principles simulations

3.2.S – Fingolimod Hydrochloride: Module – 3 - Quality

Shilpa Medicare Limited (R & D Centre): Specifications and Test Procedure

Study Report/Journal Manuscript

Influence of Experimental Variables on Curves in Differential Scanning Calorimetry. Part I. Study Design and Results of Calibration Checks

Thermal Analysis in Practice: Collected Applications

Solid-State Chemistry of Drugs

(891) Thermal Analysis

Thermal decomposition kinetics of in situ reinforcing composite based on polypropylene and liquid crystalline polymer

Thermal Decomposition Properties and Compatibility of CL-20 with Binders HTPB, PBAN, GAP and polyNIMMO,

DSC Pattern for Fingolimod HCl Sample

SIPRA Labs Limited, Test Report

June 6, 22014 DSC request

Comparison of Fingolimod HCl XRD Data

(941) Characterization of Crystalline and Partially Crystalline Solids by X-ray Powder Diffraction (XRPD)

Introduction to X-Ray Powder Diffractometry vii–xiii, xvii–xviii, xix–xxiii

Fundamentals of Powder Diffraction and Structural Characterization of Materials

X-Ray Diffraction Techniques in Analytical Geomicrobiology: A Handbook of Instrumental Techniques

Basics of X-Ray Powder Diffraction

X-Ray Line Broadening From Filed Aluminium and Wolfram

Mechanisms of Suppressing Secondary Nucleation For Low-Power and Low-Temperature Microwave Plasma Self-bias-enhanced Growth of Diamond Films in Argon Diluted Methane

Diamond Specifications

March 23, 2013 email from Dr. V.K. Singh to Purohit

March 23, 2013 attachment

Methods, Problems and Solutions, Available Software for Powder Diffraction Indexing including a Literature Search List

A New Torsion–Rotation Fitting Program for Molecules With a Sixfold Barrier: Application to The Microwave Spectrum of Toluene

Concepts in Biophysical Chemistry

European Patent 0 627 406 B1

August 2, 2012 email from Purohit to Dr. A.K. Chaturvedi and Dr. V.K. Singh

XRPD overlay attached to August 2, 2012 email

July 10, 2014 email from N. Balakrishna to Dr. A.K. Chaturvedi

June 27 2014 email from Dr. V.K. Singh to Dr. Rafiuddin

Preparation of Fingolimod. HCl From Fingolimod (Free Base) as per published procedure

June 16, 2020 email from Purandhar to Viswaprasad

Process for the preparation of Fingolimod HCl by using Diethyl ether HCl as per Patent US5604229 (Product Patent) US5952316 (Family of US ’229 Expired) of Yoshitomi Pharmaceuticals

2014 Kiuchi Reproduction Procedure (June 10, 2014)

File History for U.S. Pat. Pub. No. 2014/0051766

File History for U.S. Pat. Pub. No. 2014/0051766

Prolonged Exposure to Sphingosine 1–Phosphate Receptor-1 Agonists Exacerbates Vascular Leak, Fibrosis, and Mortality after Lung Injury

FTY720 Promotes Local Microvascular Network Formation and Regeneration of Cranial Bone Defects

FTY720 Reduces Inflammation and Promotes Functional Recovery after Spinal Cord Injury

Select, Merriam-Webster Dictionary

February 13, 2023 email from Brett S. Sylvester to Robert W. Trenchard

February 13, 2023 letter from Brett S. Sylvester to Robert W. Trenchard

Shilpa Pharma, Inc., v. Novartis Pharmaceuticals Corporation, C.A. No. 21-558 (MN) (transcript of Mar. 9, 2023 hearing)

May 14, 2013 email from Dr. A.K. Chaturvedi

Redacted Ex. 1066

Redacted Ex. 1067

Redacted Ex. 1075

Redacted Ex. 1076

Redacted Ex. 1077

Redacted Ex. 1084

Redacted Ex. 1085

Redacted Ex. 1086

Redacted Ex. 1087

Redacted Ex. 1096

Redacted Ex. 1097

Redacted Ex. 1102

Redacted Ex. 1103

Redacted Ex. 1104

Redacted Ex. 1105

Redacted Ex. 1106

Redacted Ex. 1107

Redacted Ex. 1108

Redacted Ex. 1109

Redacted Ex. 1116

Redacted Ex. 1117

Redacted Ex. 1118

Redacted Ex. 1119

2023-05-22 Novartis Reply to Shilpa POR_Redacted

Patent Owner's Unopposed Motion to Seal

Supplement to Patent Owner's Response

Second Supplemental Declaration of Dr. William E. Mayo

Excerpts from Deposition Transcript of Dr. Mutz taken March 17, 2023

Mutz Deposition Exhibit 54 (NOVSHLP001779503 – 001779512)

Mutz Deposition Exhibit 56 (NOVSHLP001779644 – 001779669)

Mutz Deposition Exhibit 60 (NOVSHLP001766182 – 001766196)

Certified Translation of Ex. 2127 (Mutz Depo Exhibit 60)

Excerpts from Deposition Transcript of Dr. Jordine taken February 3, 2023

Jordine Deposition Exhibit 27 (NOVSHLP002011513 – 002011523)

Certified Translation of Ex. 2130 (Jordine Depo Exhibit 27)

Redacted version of Paper 32 (Supplement to Patent Owner’s Response)

Redacted version of Exhibit 2123

Redacted version of Exhibit 2124

Redacted version of Exhibit 2125

Redacted version of Exhibit 2126

Redacted version of Exhibit 2127

Redacted version of Exhibit 2128

Redacted version of Exhibit 2129

Redacted version of Exhibit 2130

Redacted version of Exhibit 2131

Declaration of L. Roman Rachuba dated May 5, 2023

Protective Order

Order: ORDER Granting Joint Motion for Entry of a Stipulated Protective Order 37 C.F.R. § 42.54

Exihibit 3004

Other : 2023-04-03 Teleconference Transcript re Rafiuddin b/f the Board

Joint Stipulation to Modify Due Dates 2 and 3

PETITIONER’S NOTICE OF DEPOSITION OF DR. RAFIUDDIN

PETITIONER’S NOTICE OF DEPOSITION OF DR. WILLIAM MAYO

PETITIONER’S NOTICE OF DEPOSITION OF DR. CRAIG ECKHARDT

Joint Motion for Entry of PO

Petitioner’s Objections to Patent Owner’s Evidence in Patent Owner Response

Patent Owner's Response

Declaration of Dr. William E. Mayo

Curriculum Vitae of Dr. William E. Mayo

Deposition Transcript of Dr. Richard McClurg, taken Jan. 10, 2023

Second Declaration of Craig J. Eckhardt, Ph.D.

Certified File History of U.S. Patent No. 9,266,816_Part1

Certified File History of U.S. Patent No. 9,266,816_Part2

Certified File History of U.S. Patent No. 9,266,816_Part3

U.S. Patent No. 9,815,772 to Kumar et al

U.S. Patent No. 9,216,943 to Katkam et al.

Solid-State Properties of Pharmaceutical Materials, S.R. Byrn, G. Zografi & X. Chen

Guidance for Industry

USP 32 NF 27

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Pecharsky (2009)

Gilmore (2004)

Lee (2020)

Kaduk (2019)

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How to Analyze Materials

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Gates-Rector (2019)

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Jenkins (1996)

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Kaduk (2007)

Brittain (2014)

Myerson (1993)

Myerson (1993)

Lee (2014)

Newman (2013)

Bauer (2001)

Declaration of Dr. Rafiuddin

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Cruz-Cabeza & Bernstein (2014)

Balog (2000)

Pereyaslavets (2022)

Maruyama (2019)

Caira (2017)

Polymorphism in Pharmaceutical Solids

Caira (1998)

Bucar (2015)

Coles (2014)

Hall (2022)

Salbego (2019)

Declaration of Jerry L. Atwood, Ph.D., Case 1:21-cv-00558-MN Document 225 Filed 12/09/22

Suryanarayana

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Rudolph

Suryanarayana

Pecharsky

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Brittain (2009)

ISO 11357-1

Baird (2019)

Hindi (2016)

Lee (2009)

E600POL Nikon

THMS600

EP2829268

Byrn (2017)

US 2013/0281739

Kaduk data

Fujita et al EP 0 627 406 A1

Board's email from Sept 6, 2022

EP2356090 Mutz

File History of US 13964817_Part1

File History of US 13964817_Part2

Espacenet EP 406 pubs

Declaration of L. Roman Rachuba

Notice of Joint Stipulation to Modify Due Dates 1, 2 and 3

ORDER Granting Petitioners Unopposed Motions for Admission pro hac vice of Robert W. Trenchard and Christine L. Ranney 37 C.F.R. sec 42.10

Notice of Joint Stipulation to Modify Due Dates 1 & 2

Patent Owner's Notice of Deposition

Order: Conduct of the Proceeding - 37 CFR 42.5

Ex. 3003

Petitioner’s Objections to Patent Owner’s Evidence

Institution Decision: DECISION Granting Institution of Inter Partes Review 35 U.S.C. § 314, 37 C.F.R. § 42.4

Exhibit 3002

Order: Scheduling Order

Patent Owner���s Sur-Reply to Petitioner���s Re-filed Reply to Patent Owner���s Preliminary Response

Petitioner Novartis���s Re-Filed Reply to Patent Owner���s Preliminary Response (as authorized by the Board in its August 23, 2022 Order (Paper No. 9) and September 6, 2022 Email Order)

Petitioner Novartis���s Reply to Patent Owner���s Preliminary Response

European Patent No. EP 0627406 B1 (Fujita)

U.S. Patent No. 8,530,522

European Patent No. EP 2356090 B1

Ex. 3001

Order Authorizing Additional Briefing

Patent Owner Preliminary Response

Shilpa Pharma, Inc. v. Novartis Pharmaceuticals Corporation, Civ. No. 21-558-MN, Stipulation and Order Regarding Amended Scheduling Order, D.I. 141 (D. Del. June 23, 2022)

Shilpa Pharma, Inc. v. Novartis Pharmaceuticals Corporation, Civ. No. 21-558-MN, Complaint, D.I. 1 (D. Del. April 21, 2021)

Shilpa Pharma, Inc. v. Novartis Pharmaceuticals Corporation, Civ. No. 21-558-MN, Novartis��� Initial Invalidity Contentions (D. Del. March 7, F2022)

Shilpa Pharma, Inc. v. Novartis Pharmaceuticals Corporation, Civ. No. 21-558-MN, Joint Claim Construction Brief, D.I. 124 (D. Del. June 3, 2022)

Information Disclosure Statement, Appln. Ser. No. 13/635,207, dated Sept. 14, 2012

Information Disclosure Statement (List of References cited by Applicant and considered by examiner), Appln. Ser. No. 13/635,207 (dated Feb. 23, 2015)

Declaration under 37 CFR �� 1.132, Appln. Ser. No. 13/635,207 (dated May 14, 2015 )

Declaration of Prof. Craig Eckhardt, Ph.D.

Curriculum Vitae of Prof. Craig Eckhardt, Ph.D.

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Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

Terence L. Threlfall, Analysis of Organic Polymorphs, A Review, Analyst, Volume 120 p. 2435 (October 1995)

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JP-2011-535130, Decision of Refusal (dated June 4, 2015) (original and machine translation)

JP-2011-535130, Notice of Withdrawal of Application (dated October 2, 2015) (original and machine translation)

JP-2011-535130 Divisional Application Information

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JP 2015-173474, Notice of Reasons for Refusal (June 21, 2016) (original and machine translation)

JP 2015-173474, Decision of Refusal (dated April 14, 2017) (original and machine translation)

JP 2015-173474, Notice of Withdrawal of Application (dated September 21, 2017) (original and machine translation)

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NOVARTISS MOTION FOR ADMISSION PRO HAC VICE OF CHRISTINE L. RANNEY

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Curriculum Vitae of Dr. Richard McClurg

Declaration of Dr. Richard McClurg (McClurg Decl.)