Mylan Pharmaceuticals Inc., et al. vs Sanofi Aventis Deutschland GmbH et al.

Petitioner's Mandatory Change-of-Information Notices

Patent Owner Sanofi-Aventis Deutschland GmbH¿¿¿s Notice of Extension of Time to File Petition for Writ of Certiorari

Patent Owner Sanofi-Aventis Deutschland GmbH¿¿¿s Notice of Filing Petition for Writ of Certiorari Within the Time Allowed

ORDER Granting Patent Owner¿¿¿s Motions to Withdraw Counsel 37 C.F.R. ¿¿ 42.10(e)

Patent Owner's Motion for Withdrawal of Counsel

EXPUNGED

Order Granting Patent Owner's Motion to Seal

Patent Owner Sanofi-Aventis Deutschland GmbH's Notice of Appeal Under 37 C.F.R. 90.2(a)

Patent Owner's Motion to Seal

Patent Owner's Updated Exhibit List - Public

Patent Owner's Updated Exhibit List - Confidential

Petitioner's Reply (Redacted Public Version Submitted by Patent Owner)

Expert Declaration of Professor Robert S. Langer in Support of Petition for IPR of Patent Nos. 7,476,652 and 7,713,930 - Public

Termination Decision Document

REDACTED - Paper 86 - Mylan Pharmaceutical Inc.'s Sur-Surreply

Petitioner's Motion to Seal

Mylan Pharmaceutical Inc.'s Sur-Surreply

Mylan Pharmaceuticals' Objections

Petitioner's Mandatory Change-of-Information Notices

Patent Owner's Motion to Seal

Patent Owner's Surreply - Public

Supplemental Declaration of Dr. Bernhardt Trout

Patent Owner's Surreply

Supplemental Declaration of Dr. Bernhardt Trout - Public

Declaration of Dr. Thomas Eichinger

Lantus EPAR June 2000

Internal Memorandum re FDA Contact And/Or Trip Report for Lantus (Insulin Glargine) on September 8, 1999

March 30, 2000 Aventis Pharma memorandum regarding Minutes of 29th TSV Team Meeting on HOE901 Drug Product

April 20, 2000 Response Letter to FDA re Lantus Application to Market a New Drug

Draft Aventis RMC Strategy & Risk Assessment (RCMS SRA) For Development Activities for Lantus Reformulation

Patent Owner's Updated Exhibit List

Patent Owner's Updated Exhibit List

Hoeschst Marion Roussel presentation on HOE 901 ¿¿¿ Insulin Glargine

Patent Owner's Updated Exhibit List

Hearing Transcript

Authorizing Sur-reply and Sur-sur-reply

Mylan Pharmaceutical Inc.'s Updated Exhibit List

Exhibit 1186A - Final Transcript of Telephonic Conference held September 24, 2018 in IPR-2017-01526 and IPR2017-01528

Mylan Pharmaceutical Inc.'s Updated Exhibit List

RoughtTranscript of Telephone Conference held 09-24-2018

Order Adjusting Oral Hearing Time

Trial Hearing 37 C.F.R § 42.70

Mylan Pharmaceutical Inc.'s Reply In Support of Its Motion to Exclude

Patent Owner's Reply to Motion to Exclude

Corrected Paper 57- Mylan_Pharmaceutical's_Request_For_Oral_Argument

EXPUNGED

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

Mylan's Updated Exhibit List

August 17, 2018, email serving Mylan's Response to Sanofi's Observations & Mylan¿¿¿s Opposition to Sanofi¿¿¿s Motion to Exclude[

Copy of August 17, 2018, email notifying Board of service of Mylan's Response to Sanofi's Observations & Mylan¿¿¿s Opposition to Sanofi¿¿¿s Motion to Exclude

EXPUNGED

Mylan Pharmaceutical Inc.'s Opposition to Sanofi's Motion to Exclude

Mylan Pharmaceutical Inc.'s Response to Sanofi's Observations on Cross Examination

Mylan Pharmaceutical's Motion to Exclude

Mylan Pharmaceutical's Request For Oral Argument

S. Simpson & E. Toth, ¿¿¿Expanding the Options in Insulin Therapy: A Review of Insulin Analogues,¿¿¿ 26(3) Canadian Journal of Diabetes, 195-205 (2002)

Patent Owner's Request for Oral Argument

Patent Owner's Observations on the Cross Examination of Petitioner's Reply Declarants

Annex 1, Summary of Product Characteristics

July 31, 2018, Deposition Transcript of Dr. Samuel H. Yalkowsky, Volume II

July 30, 2018, Deposition Transcript of Dr. William C. Biggs

August 2, 2018, Deposition Transcript of Dr. Robert D. McDuff

August 7, 2018, Deposition Transcript of Dr. Robert S. Langer

Patent Owner's Motion to Exclude

Patent Owner's Updated Exhibit List

Mylan Pharmaceutical Inc.'s Updated Exhibit

Mylan Pharmaceuticals' Objections

Patent Owner's Notice of Deposition of Dr. Robert S. Langer

Patent Owner's Notice of Deposition of Dr. William C. Biggs

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

Mylan Pharmaceuticals Updated Exhibit List

Transcript of Telephone Conference held on July 26th, 2018, in IPR2017-01526 and IPR2017-01528

Patent Owner's Notice of Deposition of Dr. Samuel H. Yalkowsky

Patent Owner's Notice of Deposition of DeForest McDuff, Ph.D.

Transcript of 7/17/2018 Telephonic Conference (IPR2017-01526, IPR2017-01528)

Patent Owner's Updated Exhibit List

Patent Owner Surreply

Judge Andrews' Order, Dkt. 287 (Sanofi v. Merck, 16-812-RGA)

Trial Transcript Excerpts (Sanofi v. Merck, 16-812-RGA)

Patent Owner's Motion to Strike

Petitioner's Reply - Public, Redacted

Petitioner's Reply - Under Seal

PATENT OWNER¿¿¿S OBJECTIONS TO ADMISSIBILITY OF EVIDENCE SERVED BY PETITIONER MYLAN PHARMACEUTICAL INC. IN INTER PARTES REVIEW

Patent Owner's Supplemental Motion to Seal

Petitioner's Motion To Seal And For Entry Of Proposed Protective Order

EP Pub. 0368187 A2

Deposition of Dr. Laurence Baker, Ph.D. (June 22, 2018)

Campbell, Kevin; ¿¿¿Insulin Costs Are Skyrocketing. This is Why.¿¿¿, U.S. News and World Report, June 29, 2018, pp.1-3

Sanofi Press Release, ¿¿¿LANTUS¿¿ Add-on to Oral Monotherapy Therapy Showed Improved Glycemic Control in Type 2 Diabetes Patients Compared to oral Actos Add-on to Oral Therapy¿¿¿ (June 13, 2005)

Amgen, Inc. profile of ¿¿¿NEUPOGEN¿¿¿ (Filgrastim), Apr. 2, 1998, pp. 1-27pp. 1-27

Center for Drug Evaluation and Research, Approval for ¿¿¿NUTROPIN AQ¿¿¿ (App. 20-522/S-10), Apr. 10, 2000

Deposition of Dr. Berhard Trout (June 21, 2018)

MEDWATCH, FDA Medical Products Reporting Program, Report on LANTUS¿¿, Case ID 376724, Apr. 05, 2002

Affidavit of Marlene S. Bobka (July 3, 2018)

Aventis Pharmaceuticals, Inc., Individual Safety Report for ¿¿¿LANTUS¿¿¿¿¿, Case 4054424-5-00-01, Feb. 06, 2003

Affidavit of Marlene S. Bobka (July 3, 2018)

Sanofi Press Release, ¿¿¿Prospective Study Published in Diabetes Care Confirms Basal Therapy with LANTUS¿¿ Improves Glycemic Control In Patients with Type 2 Diabetes Poorly Controlled on Prior Insulin Regimens¿¿¿ (June 8, 2005)

Sanofi Press Release, ¿¿¿Data Presented at ADA Showed That Basal Insulin Therapy with LANTUS¿¿ Achieved Target Glycemic Control In Poorly Controlled Type 2 Diabetes¿¿¿ (June 13, 2005)

U.S. SEC Form 20-F for Sanofi-Aventis FY 2004 - Part 1

Mestre-Ferrandiz, et al., ¿¿¿The R&D Cost of a New Medicine¿¿¿, Office of Health Economics, pp. 1-100 (Dec. 2012)

LANTUS¿¿ - Explore Diabetes Treatment Options (Current)

U.S. SEC Form 20-F for Sanofi-Aventis FY 2006

U.S. SEC Form 20-F for Sanofi-Aventis FY 2005 - part 1

U.S. SEC Form 20-F for Sanofi-Aventis FY 2005 - Part 2

U.S. SEC Form 20-F for Sanofi-Aventis FY 2004 - Part 2

Q4 2005 Sanofi-Aventis Earnings Conference Call

Q3 2005 Sanofi-Aventis Earnings Conference Call

Q2 2005 Sanofi-Aventis Earnings Conference Call

Q1 2005 Sanofi-Aventis Earnings Conference Call

LANTUS¿¿ (NDA 21-081 S-024) ¿¿¿ Labeling-Container Carton Labels, Labeling-Package Insert, Rev. Mar. 2007

NDA 21-081 S-005 ¿¿¿ Efficacy-New Dosing Regimen ¿¿¿ Label, Apr. 30, 2003

LANTUS¿¿ Why Lantus Page ¿¿¿ Ask Your Healthcare Provider About Switching to LANTUS¿¿¿¿¿ (October 16, 2006)

LANTUS¿¿ Using Lantus ¿¿¿How to Use the Lantus¿¿ SoloSTAR¿¿ Pen¿¿¿ (Current)

LANTUS¿¿ Savings Card (Current)

LANTUS¿¿ Resources (Current)

LANTUS¿¿ New to Lantus Page (October 2006)

LANTUS¿¿ Support ¿¿¿LANTUS¿¿ Tips and Support¿¿¿ (October 2006)

LANTUS¿¿ Home Page (Current)

LANTUS¿¿ Home Page (October 2006)

LANTUS¿¿ About (Current)

LANTUS¿¿ - Your Diabetes Treatment Routine (Current)

LANTUS¿¿ - How to Inject Lantus With a Vial and Syringe

LANTUS¿¿ - Home Page (Current)

PROTECTIVE ORDER MATERIAL - IQVIA ¿¿¿ Diabetes Data

FDA Approval Letter ¿¿¿ LANTUS¿¿ Reformulation March 2005

FDA ¿¿¿ 27th Orange Book (2007)

FDA ¿¿¿ 25th Orange Book (2005)

DiMasietal, et al. ¿¿¿Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs¿¿¿, J. of Health Eco., 37 (2016) pp. 20-33

David et al., ¿¿¿Commercial Success Economic Principles Applied to Patent Litigation¿¿¿, Economics of Pat. Damages, Chap. 9, pp. 159-160

Cowen and Company, ¿¿¿Therapeutic Categories Outlook¿¿¿, Comprehensive Study (Oct. 2006)

CDC, ¿¿¿About Diabetes¿¿¿, June 1, 2017, (http://www.cdc.gov/biabetes/data)

U.S. SEC Form 20-F for Sanofi-Aventis FY 2003

CDC, ¿¿¿Long-Term Trends in Diabetes¿¿¿, April 2017, (http://www.cdc.gov/biabetes/data)

SG Cowen ¿¿¿ Pharmaceutical Therapeutic Categories Outlook, Comprehensive Study (March 2006)

SG Cowen ¿¿¿ Pharmaceutical Therapeutic Categories Outlook, Comprehensive Study (Oct. 2005)

SG Cowen ¿¿¿Pharmaceutical Therapeutic Categories Outlook, Comprehensive Study (March 2005)

SG Cowen ¿¿¿ Perspectives, Pharmaceutical Therapeutic Categories Outlook , pp. 134-148 (Oct. 2001)

U.S. SEC Form 20-F for Sanofi-Aventis FY 2002

ABN AMRO ¿¿¿ Pharmaceutical Market Share Report (Oct. 2001)

WebMD ¿¿¿ ¿¿¿Types of Insulin for Diabetes Treatment¿¿¿ (accessed May 3, 2018)

UBS Equities ¿¿¿ Sanofi-Aventis Q405, Jan. 24, 2006

UBS Equities ¿¿¿ Sanofi-Aventis Q305, Nov. 3, 2005

UBS Equities ¿¿¿ Sanofi-Aventis Q205, Sep. 1, 2005

UBS Equities ¿¿¿ Sanofi-Aventis Q105, May 13, 2005

St. Louis Federal Reserve Economic Data, Consumer Price Index for All Urban Consumers¿¿¿ CPI Monthly (accessed May 24, 2018)

SG Cowen ¿¿¿ Perspectives, Pharmaceutical Therapeutic Categories Outlook, pp. 136-156 (March 2002)

Sanofi Press Releases 2006

Sanofi Press Releases 2005

1111A - Curriculum Vitae of Professor Robert Langer

Baynes et al., ¿¿¿Role of Arginine in the Stabilization of Proteins Against Aggregation¿¿¿, Biochemistry, Vol. 44, No. 12, pp. 4919-4925 (2005)

Baynes et al., ¿¿¿Rational Design of Solution Additives for the Prevention of Protein Aggregation¿¿¿, Biophysical J., Vol. 87, pp.1631-1639 (Sept. 2004)

Neuprogen¿¿ (Filgratim), Amgen Inc. Product label, April 2, 1998

Nielsen, et al., ¿¿¿Effect of Environmental Factors On the Kinetics of Insulin Fibril Formation: Elucidation of the Molecular Mechanism¿¿¿, Biochemistry 2001, 40, pp. 6036-6046 (2001)

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WO 83/00288 A1 (¿¿¿¿¿¿288 application¿¿¿)

CA Patent No. 1,258,427 (¿¿¿CA ¿¿¿427¿¿¿)

Shao, et al. ¿¿¿ ¿¿¿Differential Effects of Anionic, Cationic, Nonionic, and Physiologic Surfactants on the Dissociation, ¿¿-Chymotryptic Degradation, and Enteral Absorption if Insulin

Hawley¿¿¿s Condensed Chemical Dictionary, 12th Ed. ¿¿¿ Strong acid reference¿¿¿, pp. 890-891 (1993)

AU 200072263 A1 (¿¿¿AU ¿¿¿263 application¿¿¿)

U.S. Patent No. 6,335,316 (¿¿¿Hughes¿¿¿)

Part 1 - A. Martin, et al., ¿¿¿Physical Principles In the Pharmaceutical Sciences¿¿¿ Phys. Pharmacy, Drug Dynamics Inst., Col. Of Pharma., Univ. of Texas, 1983

2001 PDR Entry for ¿¿¿Etoposide¿¿¿, p. 825

2001 PDR Entry for ¿¿¿Limbitrol¿¿¿¿¿, p. 1538

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WO 00/23098 (¿¿¿¿¿¿098 application¿¿¿)

B. Farhadieh, ¿¿¿Determination of CMC and Partial Specific Volume of Polysorbates 20, 60 and 80 from Densities of Their Aqueous Solutions¿¿¿, J. of Pharma. Sciences, Vol. 62, No. 10, pp.1685-1688 (Oct. 1973)

EP 1019022 B1 (¿¿¿EP ¿¿¿022¿¿¿)

U.S. Patent No. 6,211,144 (¿¿¿Havelund¿¿¿)

Safety Alerts Internet Archive ¿¿¿Walgreen Co. Recalls Lantus Insulin Glargine (rDNA origin) Injection¿¿¿ (Nov. 15, 2001)

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U.S. Patent No. 6,737,401 (¿¿¿Kim¿¿¿)

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AU 200072263 A1 (¿¿¿AU ¿¿¿263 application¿¿¿)

Part 2 - A. Martin, et al., ¿¿¿Physical Principles In the Pharmaceutical Sciences¿¿¿ Phys. Pharmacy, Drug Dynamics Inst., Col. Of Pharma., Univ. of Texas, 1983

Expert Declaration of Mark Lanterman In Support of Petitioner¿¿¿s Reply For Inter Partes Review of U.S. Pat. No. 7,476,652 and 7,713,930

1997 PDR Entry for ¿¿¿Humalog¿¿¿¿¿, pp. 1488-1490

1997 PDR Entry for ¿¿¿Humulin¿¿R¿¿¿, pp. 1497-1498

LANGER, Robert S. et al. U.S. Publication No. 2015/0025005A1, Jan. 22, 2015

LANGER, Robert S. et al. U.S. Publication No. 2015/0320837, Nov. 12, 2015

LANGER, Robert S. et al. U.S. Patent No. 9,994,615 B2, Jun. 12, 2018

2001 PDR Entry fro ¿¿¿Norditropin¿¿¿¿¿, p. 2236

LANGER, Robert S. et al. WO2013123492 A1, Aug. 22, 2013

2001 PDR Entry for ¿¿¿Novoline¿¿¿¿¿, pp. 2238-2242

PROTECTIVE ORDER MATERIAL - Aventis, NDA 21-081 Formulation Optimization, Lantus (Insulin Glargine Injection), ¿¿¿ Description and Composition of the Drug Product¿¿¿, Nov. 1, 2004, SANOFI_00003665

PROTECTIVE ORDER MATERIAL - Aventis, ¿¿¿LANTUS (HOE 901 D) Formulation Improvement¿¿¿ Summit Meeting, Bridgewater, June 18, 2002, SANOFI_00321284

PROTECTIVE ORDER MATERIAL - Aventis, Formulation Development Report, Insulin Glargine, Lantus Reformulation (HOE 901 (30) R), June 4, 2004, SANOFI_00410543

PROTECTIVE ORDER MATERIAL - Aventis ¿¿¿Lantus Multi Dose Vial (10 ml) Complaint Situation¿¿¿, Oct. 27, 2001, SANOFI_00413048

PROTECTIVE ORDER MATERIAL - Aventis, Minutes of the 1st Team Meeting on Pro-Active Measurements Dealing with Lantus 10 ml Vials, Complaints Concerning Turbidity¿¿¿, July 19, 2001, SANOFI_00413346

PROTECTIVE ORDER MATERIAL - SANOFI, ¿¿¿Insulin Glargine ¿¿¿ Solution for Injection, Container Closure System, Injection Vial, 5 and 10 mL¿¿¿, May 2013, SANOFI_00430764

PROTECTIVE ORDER MATERIAL - Aventis, Response to Agency Request ¿¿¿Insulin Glargine Solution for Injection, 100 IU/ml¿¿¿, Jan. 13, 2005, SANOFI_01593692

PROTECTIVE ORDER MATERIAL - Aventis, Development Status Report, HOE 901, ¿¿¿In-use Stability of HOE 901 Solution for Injection¿¿¿, May 2001, SANOFI_01594032

PROTECTIVE ORDER MATERIAL - Aventis, Summary Report ¿¿¿Lantus¿¿ mL Vials ¿¿¿ Complaints Turbidity Description and Measurements¿¿¿, Aug. 19, 2002, SANOFI_01594042

PROTECTIVE ORDER MATERIAL - Aventis, LANTUS (HOE 901D) ¿¿¿Formulation Improvement Strategy¿¿¿ GPT/MAX Team Meeting, June 14, 2003, SANOFI_01628810

PROTECTIVE ORDER MATERIAL - Aventis, ¿¿¿Formulation Optimization Decision to Submit for 10-ml Vials¿¿¿, PPRC, June 17, 2004, SANOFI_01665660

PROTECTIVE ORDER MATERIAL - Aventis, ¿¿¿Comparative in Use of Stability of Lantus and Other Insulins¿¿¿, SANOFI_01666332

PROTECTIVE ORDER MATERIAL - Aventis, Minutes of the 1st Team Meeting on Pro-Active Measurements Dealing with Lantus 10 ml. Vials, Complaints Concerning Turbidity, July 24, 2001, SANOFI_01667979

PROTECTIVE ORDER MATERIAL - Aventis Reformulation LANTUS¿¿ IO QO View, Nov. 7, 2014, SANOFI_01747290

PROTECTIVE ORDER MATERIAL - E-mail Contact Report from FDA to M. Lutz, Regulatory Affairs, for proposed FDA Revision, April 28, 2003, SANOFI_01815531

PROTECTIVE ORDER MATERIAL - Aventis Pharma , Lantus Injectable, 10 ml. Vial (Insulin Glargine) NDA 21-081, Field Alert, July 12, 2001, SANOFI_70006138

PROTECTIVE ORDER MATERIAL - Aventis, ¿¿¿Formulation Optimization Decision to Submit¿¿¿, PROC, June 2, 2004, SANOFI_01664827

PROTECTIVE ORDER MATERIAL - Aventis Pharma, Formulation Development Report ¿¿¿Insulin Glargine, Lantus Formulation (HOE 901 (30) R), SANOFI3_90297269

Gerhard Wenske, Dictionary of Chemistry German/English (1st ed. 1994)

Ex. 1169D - Insulin Product Sales

U.S. Patent No. 4,783,441 (¿¿¿Thurow 1998¿¿¿)

U.S. Patent No. 4,849,227 (¿¿¿Cho¿¿¿)

U.S. Patent No. 5,518,998 (¿¿¿Backstrom¿¿¿)

U.S. Patent No. 6,306,440 (¿¿¿Backstrom 2001¿¿¿)

U.S. Patent No. 6,656,499 (¿¿¿Foldvari¿¿¿)

Z. Strickley, ¿¿¿Stability of Human Insulin Effect of Water Content and Added Excipients on the Degradation of Lyophilized Insulin at Acidic pH¿¿¿, Thesis, Dept. of Pharm. and Pharmaceutical Chem. , U. of Utah, Dec. 1995

Declaration of DeForest McDuff

Ex. 1169A - Curriculum Vitae of DeForest McDuff

Ex. 1169B - Revenues by Product

Ex. 1169C - Diabetes Patient Population

Ex. 1169E - Lantus Prescriptions

Ex. 1169F - Lantus Market Shares

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U.S. Patent No. 6,100,376 (¿¿¿the ¿¿¿376 patent¿¿¿)

U.S. Patent No. 5,656,722 (¿¿¿the ¿¿¿722 patent¿¿¿)

Susan Budavari et al., The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals (12th ed. 1996)

Declaration of William Curtis Biggs

1174A- Curriculum Vitae of William Curtis Biggs

Diabetes Complications and Control Trial (DCCT) (1993)

March 2, 2003 Usenet forum post by William Biggs, Preloading Lantus in syringes, misc.health.diabetes, https://groups.google.com/forum/#!msg/misc.health.diabetes/ZNfvSjSwISI/vlNR48z2ME4J

Phys. Desk Ref., ¿¿¿Iletin¿¿¿¿¿, 1997, pp. 1503-1504

Phys. Desk Ref., ¿¿¿Iletin¿¿ II¿¿¿, 1997, pp. 1507-1509

Velosulin¿¿ BR Buffered Regular Human Insulin Injection (rDNA origin), Physicians¿¿¿ Desk Reference 56 ed. 2002, pg. 2435

Novolin¿¿ R Regular, Human Insulin Injection (recombinant DNA origin), Physicians¿¿¿ Desk Reference 56 ed. 2002, pg. 2423

Vanofor¿¿ Physicians¿¿¿ Desk Reference 56 ed. 2002, pg. 580-581

PROTECTIVE ORDER MATERIAL - Declaration of Professor Robert Langer

References Considered by Professor Robert Langer

Ex. 1111B - References Considered by Professor Robert Langer

Declaration of Professor Samuel H. Yalkowsky

Mylan Pharmaceutical Inc.'s Updated Exhibit List

Petitioner's Reply (Protective Order Material)

Mylan Pharmaceutical Inc.'s Updated Exhibit List

Transcript of Telephone Conference Held July 5, 2018 in IPR2017-01526 and IPR2017-01528

Mylan Pharmaceuticals Inc. Revised Power of Attorney

Mylan Pharmaceuticals Inc. Updated Mandatory Notices

Granting Petitioner's Unopposed Motions for Pro Hac Vice Recognition

Joint Stipulation to Modify the Scheduling Order

Notice Of Deposition of Dr. Bernhardt Trout

Notice of Deposition of Dr. Laurence baker

Mylan Pharmaceutical's Unopposed Motion for Pro Hac Vice Recognition

Declaration of ElhamSteiner

Biography of Elham Firouzi Steiner

Supplemental Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GmbH

Patent Owner's Updated Mandatory Notices Pursuant to 37 C.F.R. 42.8

Order Granting Patent Owner's Pro Hac Vice Motions to Admit Robert Vlasis

Motion for Pro Hac Vice Admission Under 37 C.F.R. 42.10

Declaration of Robert Vlasis

Biography of Robert Vlasis

Mylan Pharmaceutical's Objections

Canadian Patent No. 1,258,427

Curriculum Vitae of Dr. Bernhardt Trout

March 12, 2018, Deposition Transcript of Dr. Samuel H. Yalkowsky

Sluzky et al., Kinetics of Insulin Aggregation, Proc. Natl. Acad. Sci. (1991)

Patent Owner's Response to Petition for Inter Partes Review of U.S. Patent No. 7,476,652

Declaration of Dr. Bernhardt Trout

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FDA¿¿¿s Office of Clinical Pharmacology and Biopharmaceutics Review 2005

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Curriculum Vitae of Dr. Laurence C. Baker

U.S. Dollar Sales of Long-Acting Insulin Products

U.S. Share of Lantus Vial Among Long-Acting Injectable Insulin Products

U.S. Formulary Placement of Long-Acting Insulin Products

U.S. Total Marketing Expenditures of Long-Acting Insulin Products

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Summary of Claim Constructions from Related Cases

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Dr. Laurence C. Baker¿¿¿s Prior Testimony

Dr. Laurence C. Baker¿¿¿s Documents Relied On

U.S. Total Prescriptions of Long-Acting Insulin Products

U.S. Price per Insulin Unit of Long-Acting Insulin Products

Patent Owner's Notice of Deposition of Dr. Samuel H. Yalkowsky

Patent Owner's Objections to Admissibility of Supplemental Evidence Served by Petitioner Mylan Pharmaceutical Inc. in Inter Partes Review

Order Conduct of the Proceeding Extending Due Date 1 and Due Date 2 of the Scheduling Order

Order Granting-in-part and Denying-in-part Petitioner's Motion for Supplemental Information

Affidavit of Christopher Butler (April 4, 2017)

Aventispharma-us.com, Lantus Prescribing Information (Jan. 10, 2001)

Mylan Pharmaceuticals's Updated Exhibit List

Patent Owner's Opposition to Petitioner's Motion for Supplemental Information

Mylan Pharmaceuticals Motion For Supplemental Information

Mylan Pharmaceutical's Updated Exhibit List

Exhibit 1047

Exhibit 1046 - Board Email

Mylan Pharmaceutical's Updated Exhibit List

Exhibit 1045 - Call Transcript

Patent Owner's Objections to Admissibility of Evidence Served with Petitioner Mylan Pharmaceutical Inc.'s Petition for Inter Partes Review

Mylan's Objecjections

SCHEDULING ORDER 37 C.F.R. ¿¿ 42.5(a)

PETITIONER MYLAN PHARMACEUTICALS INC.'S MANDATORY CHANGE-OF-INFORMATION NOTICES

Trial Instituted Document

PETITIONER MYLAN PHARMACEUTICALS INC.'S MANDATORY CHANGE-OF-INFORMATION NOTICES

Mylan Pharmaceuticals Inc.'s Updated Exhibit List

Declaration of Clark Lin

Corrected Exhibit 1004

Conduct of the Proceeding 37 C.F.R ¿¿ 42.5

Preliminary Response to Petition for Inter Partes Review of U.S. Patent No. 7,476,652

2001 Physicians Desk Reference (PDR)

Formulation-Related Problems Associated with Intravenous Drug Delivery

Physical Biochemistry of Protein Drugs, in Protein and Peptide Delivery

U.S. Patent No. 5,656,722

Patent Owner's Updated Mandatory Notices

Patent Owner's Power of Attorney

Patent Owner's Mandatory Notice

Notice of Accord Filing Date

1001A Part I - FH US 7476652

1001A Part II - FH US 7476652

1001A Part III - FH US 7476652

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1001A Part VI - FH US 7476652

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1002A - FH US 7713930

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