Mylan Pharmaceuticals Inc. et al. v. Bayer Pharma AG et al. - IPR2022-00517

JUDGMENT Granting Petitioners Joint and Unopposed Motion to Withdraw and Request for Adverse Judgment After Institution of Trial and on Remand 37 C.F.R. § 42.73(b)

ORDER Conduct of the Proceeding Authorizing Petitioners’ Motion to Withdraw 37 C.F.R. § 42.5

Motion to Withdraw

Ex. 3003

Ex. 3002

Patent Owner's Eighth Updated Mandatory Notices

Petitioner's Updated Mandatory Notices

Other: Fed Circuit mandate

Other: other court decision

EXPUNGED

Panel Change Order

Patent Owner's Notice of Appeal

Determining All Challenged Claims Unpatentable 35 U.S.C. § 318(a)

Patent Owner's Seventh Updated Mandatory Notices

Patent Owner's Sixth Updated Mandatory Notices

Other: Hearing transcript

Petitioner's Demonstratives

Patent Owner's Demonstrative Exhibits

EXPUNGED

LEAP Practitioner Request and Verification Form (Petitioner)

Mylan Reply for Motion to Exclude

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

Mylan Motion to Exclude 37 C.F.R. §42.64(c)

Petitioner's Updated Exhibit List

EX1041-Resnik

Patent Owner's Fifth Updated Mandatory Notices

ORDER Setting Oral Argument

Patent Owner Surreply

Randall M. Zusman, M.D. Deposition Transcript, IPR2022-00517 (PTAB) (March 17, 2023)

Patent Owner's Request for Oral Argument

Petitioner's Request for Oral Argument

Mylan Reply - CORRECTED

Petitioner's Updated Exhibit List

EX1030 - Weitz Deposition Jan. 25, 2023

Corrected Declaration of Randall M. Zusman, M.D. ISO Mylan Reply

Transcript of Conference Call with PTAB Mar. 7, 2023

Ex. 3001

Order: Conduct of the Proceeding

Third Joint Stipulation to Modify Schedule

Patent Owner's Objections to Evidence

Patent Owner's Fourth Updated Mandatory Notices

Patent Owner's Notice of Deposition of Dr. Randall M. Zusman, M.D.

Mylan Reply

Mylan's Updated Exhibit List

Connolly [COMPASS Patient Info]

Ruff [Comparison of Efficacy & Safety of NOACs with Warfarin

Weitz Publication [NOACs, Which One Should My Patient Use]

EXPUNGED

WeitzJI Braunwald Heart Disease

Zannand 2012

Taylor 2004

McMurray 2014

Aggrenox

Zusman Expert Declaration ISO Reply

Mylan's Updated Exhibit List

Data Supplement to the 2016 AHA ACC Guideline

EXPUNGED

Second Joint Stipulation to Modify Schedule

Petitioner's Notice of Deposition of Jeffrey Weitz

ORDER Granting Petitioners Motion for Pro Hac Vice Admission of Susannah M. L. Gagnon 37 C.F.R. sec 42.10

Mylan Pharmaceuticals Inc. Unopposed Motion for Pro Hac Vice Recognation

Mylan Updated Power of Attorney

Mylan Updated Mandatory Notices

Declaration of Susannah M.L. Gagnon

Attorney Bio of Susannah Gagnon

Petitioner Mylan Objections to Response Exhibits

NCT01776424, ClinicalTrials.gov

Trial Transcript, C.A. 1:14-264-RGA (D. Del.) (June 6, 2016)

Curriculum Vitae of Dr. Jeffrey Weitz, M.D.

Randall M. Zusman, M.D. Deposition Transcript, IPR2022-00517 (PTAB) (November 3, 2022)

Weitz, Anticoagulation therapy in 2015: where we are and where we are going, J. Thromb. Thrombolysis 39:264-272 (2015)

Jacomella et al., Novel anticoagulants in the therapy of peripheral arterial and coronary artery disease, Current Opinion in Pharmacology 13:294-300 (2013)

Yeh et al., Overview of the New Oral Anticoagulants Opportunities and Challenges, Arterioscler Thromb. Vasc. Biol. 35:1056-1065 (2015)

2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease, Circulation 135:e726-e779 (2017)

Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary of Peripheral Artery Disease (COMPASS), NCT01776124, ClinicalTrials.gov (2013) JOINT_LDRIV0000368-71

Anand et al., Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomized, double-blind, placebo-controlled trial, Lancet 391:219-229 (2018)

Email from Defendants’ Serving Joint Invalidity Production, JOINT_LDRIV0000001 – JOINT_LDRIV0000645 (February 28, 2022)

Reddy et al., The Role of Rivaroxaban in Atrial Fibrillation and Acute Coronary Syndromes, J. od Cardiovascular Pharm. & Ther. 19(6):526-532 (2014)

Morrow, D. A. & Boden, W. E., Stable Ischemic Heart Disease, in Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine 1182-1244 (Elsevier Saunders, 10th ed. 2015)

Craeger, M. A. & Libby, P., Peripheral Artery Disease, in Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine 1312-1335 (Elsevier Saunders, 10th ed. 2015)

Weitz, J., Hemostasis, Thrombosis, Fibrinolysis, and Cardiovascular Disease, in Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine 1809-1833 (Elsevier Saunders, 10th ed. 2015)

Fredenburgh et al., Emerging Anticoagulant Strategies, Blood 129(2):145-154 (2017)

Chan et al., Evolving Treatment for Arterial and Venous Thrombosis Role of the Direct Oral Anticoagulants, Circulation Research 1409-1423 (2016)

Weitz et al., Trends in Prescribing Oral Anticoagulants in Canada, 2008-2014, Clinical Ther. 34(11):2506-2514e4 (2015)

Caterina et al., Oral Anticoagulants in Coronary Heart Disease (Section IV), Thrombosis & Haemostasis 115:685-711 (2016)

Weitz, Insights into the Role of Thrombin in the Pathogenesis of Recurrent Ischaemia After Acute Coronary Syndrome, Thrombosis & Haemostasis 112:924-931 (2014)

Gradoli et al., Anticoagulation in Patients with Ischaemic Heart Disease and Peripheral Arterial Disease: Clinical Implications of COMPASS Study, Eut. Card. Review 13(2):115-118 (2018)

Janssen Research & Development – Meeting Request – Type B Meeting to Discuss: The Deficiency Outlined in FDA Complete Response Letter 3 Regarding Supplemental New Drug Application 202439/S-002 for the Use of Rivaroxaban in Patients with Acute Coronary Syndromes (XARELTO310_00055604)

Janssen Research & Development – Briefing Document – Type B Meeting to Discuss: The Deficiency Outlined in FDA Complete Response Letter 3 Regarding Supplemental New Drug Application 202439/S-002 for the Use of Rivaroxaban in Patients with Acute Coronary Syndromes (XARELTO310_00055605)

FDA Letter re Meeting Preliminary Comments (December 12, 2018) (XARELTO310_00053946)

FDA Letter re Meeting Minutes (December 18, 2018) (XARELTO310_00053947)

Janssen Research & Development – Health Authority Response – Response to Information Requests from the 18 December 2018 Type B Post-Action Meeting Regarding the Completes Response Letter for Supplemental New Drug Application 202439/S-002 for the Use of Rivaroxaban in Patients with Acute Coronary Syndromes (XARELTO310_00055703)

FDA Letter re Information Request (March 22, 2019) (XARELTO310_00054231)

FDA Letter re General Advice (May 3, 2019) (XARELTO310_00053952)

Janssen Research & Development – Health Authority Response – Response to Information Requests from 22 March 2019 and 17 April 2019 Regarding the Use of Rivaroxaban in Patients with Acute Coronary Syndromes (XARELTO310_00055720)

Barnes, AHA/ACC Guidelines on the Management of Lower Extremity Peripheral Artery Disease, Amer. College of Cardiology (2016)

Expert Declaration of Dr. Jeffrey Weitz, M.D.

Patent Owner's Response

Patent Owner's Objections to Evidence of Joinder Petitioner Teva Pharmaceuticals USA, Inc.

Patent Owner's Objections to Evidence of Joinder Petitioner InvaGen Pharmaceuticals, Inc.

Patent Owner's Notice of Deposition of Dr. Randall M. Zusman, M.D.

Institution decision and grant of joinder, IPR2022-01515

Institution decision and grant of joinder, IPR2022-01513

Joint Notice of Stipulation Concerning Joinder

Petitioner Mylan Updated Exhibit List

Transcript of Board Telephone Conference on September 21, 2022

Petitioner Mylan Updated Mandatory Notices

Patent Owner's Third Updated Mandatory Notices

Granting Patent Owners Motions for Pro Hac Vice Admission of Alexander S. Zolan and Kathryn S. Kayali 37 C.F.R. sec 42.10

Petitioner Mylan's Updated Exhibit List

Patent Owner's Motion for Pro Hac Vice Admission of Alexander S. Zolan

Declaration of Alexander S. Zolan

Patent Owner's Motion for Pro Hac Vice Admission of Kathryn S. Kayali

Declaration of Kathryn S. Kayali

Patent Owner's Second Updated Mandatory Notices

Petitioner Mylan Updated Mandatory Notices

Notice of Joint Stipulation to Modify the Scheduling Order

Joint Statement Regarding Preferences for the Location of Oral Argument

Patent Owner's Objections to Evidence

Mylan Objections to Preliminary-Proceeding Exhibits

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

Order: SCHEDULING ORDER

EX2018- 2022.01.21 [66] Mylan Letter to WV Clerk

EX2019 - 2022.05.24 [72] STIPULATION and [Proposed] Order regarding claim construction

EX2020 - 21-cv-00314 Docket

EX2021 - 21-md-3017 Docket

EX2022 - In Re_ Xarelto (Rivaroxaban) (21-3017) - DRL's Responses to Interrogatories

Patent Owner's Authorized Sur-Reply

Mylan's Reply to Bayer's Preliminary Response

Petitioner Mylan Updated Mandatory Notices

EX2001 - Produced Supplemental Examination

EX2002 - Production Cover Letter

EX2003 - Joint Initial Invalidity Contentions (Excerpt)

EX2004 - Xarelto Oct 2017 Label

EX2005 - Eikelboom et al. NEJM (2017)

EX2006 - MDL Transfer Order

EX2007 - Micro Labs Scheduling Order

EX2008 - Lupin (MDL) Scheduling Order

EX2009 - 2021.07.22 [01] COMPLAINT against Mylan

EX2010 - Mylan's Brief Regarding Proposed Trial Date

EX2011 - Bayer's Brief Regarding Proposed Trial Date

EX2012 - Mylan NDWV Docket

EX2013 - NOS of Initial Infringement Charts

EX2014 - Order Adopting Lupin Schedule in MDL

EX2015 - Mylan's Non-Opposition to Motion to Transfer.

EX2016 - NOS of Defs.' Joint ROGs and RFPs

EX2017 - NOS of Plfs.' ROGs and RFPs (Joint)

Patent Owner Preliminary Response

Patent Owner's First Updated Mandatory Notices

Mylan's Mandatory Change-of-Information Notices

Petitioner Mylan's Updated Exhibit List

(Corrected) Declaration of Elham F. Steiner

ORDER Conditionally Granting Petitioners Motion for Admission Pro Hac Vice of Elham F. Steiner 37 C.F.R. sec 42.10 c

Mylan Pharmaceuticals Inc. Unopposed Motion for Pro Hac Vice Recognition

Declaration of Elham F. Steiner

Biography of Ellie F. Steiner

Patent Owner's Power of Attorney

Patent Owner's Mandatory Notices

Notice of Filing Date Accorded to Petition

U.S. Patent 10,828,310, Reducing the Risk of Cardiovascular Events (issued Nov. 10, 2020)

File History of U.S. Patent Application No. 16/264,032 (Part 1)

File History of U.S. Patent Application No. 16/264,032 (Part 2)

File History of U.S. Patent Application No. 16/264,032 (Part 3)

Committee for Medicinal Products for Human Use, European Medicines Agency, Assessment Report, Xarelto, EMA/CHMP/794349/2012, Procedure No. EMEA/H/C/000944/X/00017, March 21, 2013

Foley, T. R., et al., Antithrombotic therapy in peripheral artery disease, VASCULAR MED., 21(2), 2016, 156-69

Plosker, G. L., Rivaroxaban: A Review of Its Use in Acute Coronary Syndromes, DRUGS, 74, 2014, 451-64

Amsterdam, E. A., et al., 2014 AHA/ACC Guideline for the Management of Patients with Non-ST-Elevation Acute Coronary Syndromes, J. AM. COL. CARDIOL., 64(24), 2014, e139-228

Kubitza, D., et al., Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Rivaroxaban¿¿¿an Oral Direct Factor Xa Inhibitor¿¿¿Are Not Affected by Aspirin, J. CLIN. PHARMACOL., 46 (2006), 981-90

U.S. Patent Publication No. 2004/0242660, Substituted Oxazolidinones for Combinatorial Therapy, published Dec. 2, 2004 to Straub et al.

Barstow, C., et al., Acute Coronary Syndrome: Diagnostic Evaluation, AM. FAM. PHYS., 95(3), 2017, 170-77

Braunwald, E. & Mann, D., Braunwald¿¿¿s Heart Disease: A Textbook of Cardiovascular Medicine (10th ed.) 2015, Elsevier Saunders.

Dressman, J. B., et al., Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Acetylsalicylic Acid, J. PHARM. SCI., 101(8), 2012, 2653-67

Mega, J. L., et al., Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial, LANCET, 374, 2009, 29-38

Mega, J. L., et al., Rivaroxaban in Patients with a Recent Acute Coronary Syndrome, N. ENG. J. MED., 366(1), 2012, 9-19

Deichmann, R. E., et al., Considerations for Stopping a Clinical Trial Early, OCHSNER J. 16(3), 2016, 197-98

Siegal, D. M., et al., Adexanet Alfa for the Reversal of Factor Xa Inhibitor Activity, N. ENG. J. MED., 373(25), 2015, 2413-24

Sivolella, S., et al., Managing dentoalveolar surgical procedures in patients taking new oral anticoagulants, ODONTOL., 103(3), 2015, 258-63

Curriculum vitae of Dr. Randall M. Zusman, M.D.

Expert Declaration of Dr. Randall M. Zusman, M.D.

European Medicines Agency, Xarelto, https://www.ema.europa.eu/en/medicines/human/EPAR/Xarelto (last accessed February 2, 2022)

U.S. FDA Approves XARELTO¿¿ (rivaroxaban) to Reduce the Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD), October 11, 2018, (last accessed February 2, 2022)

Petition for Inter Partes Review of U.S. Patent No. 10,828,310

Petitioner Mylan Pharmaceuticals Inc. Power of Attorney