Case number IPR2022-00517
Mylan Pharmaceuticals Inc. et al. v. Bayer Pharma AG et al. > Documents
| Date Field | Doc. No. | Party | Description |
|---|---|---|---|
| Feb 2, 2022 | 1 | petitioner | Petition for Inter Partes Review of U.S. Patent No. 10,828,310 Download |
| Feb 2, 2022 | 1001 | petitioner | U.S. Patent 10,828,310, Reducing the Risk of Cardiovascular Events (issued Nov. 10, 2020) Download |
| Feb 2, 2022 | 1002 | petitioner | Expert Declaration of Dr. Randall M. Zusman, M.D. Download |
| Feb 2, 2022 | 1003 | petitioner | Curriculum vitae of Dr. Randall M. Zusman, M.D. Download |
| Feb 2, 2022 | 1004 | petitioner | File History of U.S. Patent Application No. 16/264,032 (Part 1) Download |
| Feb 2, 2022 | 1004 | petitioner | File History of U.S. Patent Application No. 16/264,032 (Part 2) Download |
| Feb 2, 2022 | 1004 | petitioner | File History of U.S. Patent Application No. 16/264,032 (Part 3) Download |
| Feb 2, 2022 | 1005 | petitioner | 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 Download |
| Feb 2, 2022 | 1006 | petitioner | Foley, T. R., et al., Antithrombotic therapy in peripheral artery disease, VASCULAR MED., 21(2), 2016, 156-69 Download |
| Feb 2, 2022 | 1007 | petitioner | Plosker, G. L., Rivaroxaban: A Review of Its Use in Acute Coronary Syndromes, DRUGS, 74, 2014, 451-64 Download |
| Feb 2, 2022 | 1008 | petitioner | 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 Download |
| Feb 2, 2022 | 1009 | petitioner | Download |
| Feb 2, 2022 | 1010 | petitioner | U.S. Patent Publication No. 2004/0242660, Substituted Oxazolidinones for Combinatorial Therapy, published Dec. 2, 2004 to Straub et al. Download |
| Feb 2, 2022 | 1011 | petitioner | Barstow, C., et al., Acute Coronary Syndrome: Diagnostic Evaluation, AM. FAM. PHYS., 95(3), 2017, 170-77 Download |
| Feb 2, 2022 | 1012 | petitioner | Download |
| Feb 2, 2022 | 1013 | petitioner | Dressman, J. B., et al., Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Acetylsalicylic Acid, J. PHARM. SCI., 101(8), 2012, 2653-67 Download |
| Feb 2, 2022 | 1014 | petitioner | 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 Download |
| Feb 2, 2022 | 1015 | petitioner | Mega, J. L., et al., Rivaroxaban in Patients with a Recent Acute Coronary Syndrome, N. ENG. J. MED., 366(1), 2012, 9-19 Download |
| Feb 2, 2022 | 1016 | petitioner | Download |
| Feb 2, 2022 | 1017 | petitioner | Deichmann, R. E., et al., Considerations for Stopping a Clinical Trial Early, OCHSNER J. 16(3), 2016, 197-98 Download |
| Feb 2, 2022 | 1018 | petitioner | Siegal, D. M., et al., Adexanet Alfa for the Reversal of Factor Xa Inhibitor Activity, N. ENG. J. MED., 373(25), 2015, 2413-24 Download |
| Feb 2, 2022 | 1019 | petitioner | European Medicines Agency, Xarelto, https://www.ema.europa.eu/en/medicines/human/EPAR/Xarelto (last accessed February 2, 2022) Download |
| Feb 2, 2022 | 1020 | petitioner | Sivolella, S., et al., Managing dentoalveolar surgical procedures in patients taking new oral anticoagulants, ODONTOL., 103(3), 2015, 258-63 Download |
| Feb 2, 2022 | 2 | petitioner | Petitioner Mylan Pharmaceuticals Inc. Power of Attorney Download |
| Feb 11, 2022 | 3 | board | Notice of Filing Date Accorded to Petition Download |
| Feb 18, 2022 | 4 | patent_own | Patent Owner's Power of Attorney Download |
| Feb 18, 2022 | 5 | patent_own | Patent Owner's Mandatory Notices Download |
| Mar 4, 2022 | 1021 | petitioner | Declaration of Elham F. Steiner Download |
| Mar 4, 2022 | 1022 | petitioner | Biography of Ellie F. Steiner Download |
| Mar 4, 2022 | 6 | petitioner | Mylan Pharmaceuticals Inc. Unopposed Motion for Pro Hac Vice Recognition Download |
| Apr 6, 2022 | 7 | board | ORDER Conditionally Granting Petitioners Motion for Admission Pro Hac Vice of Elham F. Steiner 37 C.F.R. sec 42.10 c Download |
| Apr 7, 2022 | 1021 | petitioner | (Corrected) Declaration of Elham F. Steiner Download |
| Apr 7, 2022 | 8 | petitioner | Mylan's Mandatory Change-of-Information Notices Download |
| Apr 7, 2022 | 9 | petitioner | Petitioner Mylan's Updated Exhibit List Download |
| May 5, 2022 | 10 | patent_own | Patent Owner's First Updated Mandatory Notices Download |
| May 11, 2022 | 11 | patent_own | Patent Owner Preliminary Response Download |
| May 11, 2022 | 2001 | patent_own | EX2001 - Produced Supplemental Examination Download |
| May 11, 2022 | 2002 | patent_own | EX2002 - Production Cover Letter Download |
| May 11, 2022 | 2003 | patent_own | EX2003 - Joint Initial Invalidity Contentions (Excerpt) Download |
| May 11, 2022 | 2004 | patent_own | EX2004 - Xarelto Oct 2017 Label Download |
| May 11, 2022 | 2005 | patent_own | EX2005 - Eikelboom et al. NEJM (2017) Download |
| May 11, 2022 | 2006 | patent_own | EX2006 - MDL Transfer Order Download |
| May 11, 2022 | 2007 | patent_own | EX2007 - Micro Labs Scheduling Order Download |
| May 11, 2022 | 2008 | patent_own | EX2008 - Lupin (MDL) Scheduling Order Download |
| May 11, 2022 | 2009 | patent_own | EX2009 - 2021.07.22 [01] COMPLAINT against Mylan Download |
| May 11, 2022 | 2010 | patent_own | EX2010 - Mylan's Brief Regarding Proposed Trial Date Download |
| May 11, 2022 | 2011 | patent_own | EX2011 - Bayer's Brief Regarding Proposed Trial Date Download |
| May 11, 2022 | 2012 | patent_own | EX2012 - Mylan NDWV Docket Download |
| May 11, 2022 | 2013 | patent_own | EX2013 - NOS of Initial Infringement Charts Download |
| May 11, 2022 | 2014 | patent_own | EX2014 - Order Adopting Lupin Schedule in MDL Download |
| May 11, 2022 | 2015 | patent_own | EX2015 - Mylan's Non-Opposition to Motion to Transfer. Download |
| May 11, 2022 | 2016 | patent_own | EX2016 - NOS of Defs.' Joint ROGs and RFPs Download |
| May 11, 2022 | 2017 | patent_own | EX2017 - NOS of Plfs.' ROGs and RFPs (Joint) Download |
| May 24, 2022 | 12 | petitioner | Petitioner Mylan Updated Mandatory Notices Download |
| May 31, 2022 | 13 | petitioner | Mylan's Reply to Bayer's Preliminary Response Download |
| Jun 7, 2022 | 14 | patent_own | Patent Owner's Authorized Sur-Reply Download |
| Jun 7, 2022 | 2018 | patent_own | EX2018- 2022.01.21 [66] Mylan Letter to WV Clerk Download |
| Jun 7, 2022 | 2019 | patent_own | EX2019 - 2022.05.24 [72] STIPULATION and [Proposed] Order regarding claim construction Download |
| Jun 7, 2022 | 2020 | patent_own | EX2020 - 21-cv-00314 Docket Download |
| Jun 7, 2022 | 2021 | patent_own | EX2021 - 21-md-3017 Docket Download |
| Jun 7, 2022 | 2022 | patent_own | EX2022 - In Re_ Xarelto (Rivaroxaban) (21-3017) - DRL's Responses to Interrogatories Download |
| Aug 9, 2022 | 15 | board | Download |
| Aug 9, 2022 | 16 | board | Order: SCHEDULING ORDER Download |
| Aug 23, 2022 | 17 | patent_own | Patent Owner's Objections to Evidence Download |
| Aug 23, 2022 | 18 | petitioner | Mylan Objections to Preliminary-Proceeding Exhibits Download |
| Aug 26, 2022 | 19 | patent_own | Notice of Joint Stipulation to Modify the Scheduling Order Download |
| Aug 26, 2022 | 20 | patent_own | Joint Statement Regarding Preferences for the Location of Oral Argument Download |
| Sep 1, 2022 | 21 | petitioner | Petitioner Mylan Updated Mandatory Notices Download |
| Sep 7, 2022 | 2023 | patent_own | Declaration of Alexander S. Zolan Download |
| Sep 7, 2022 | 2024 | patent_own | Declaration of Kathryn S. Kayali Download |
| Sep 7, 2022 | 22 | petitioner | Petitioner Mylan's Updated Exhibit List Download |
| Sep 7, 2022 | 23 | patent_own | Patent Owner's Motion for Pro Hac Vice Admission of Alexander S. Zolan Download |
| Sep 7, 2022 | 24 | patent_own | Patent Owner's Motion for Pro Hac Vice Admission of Kathryn S. Kayali Download |
| Sep 7, 2022 | 25 | patent_own | Patent Owner's Second Updated Mandatory Notices Download |
| Sep 20, 2022 | 26 | board | Granting Patent Owners Motions for Pro Hac Vice Admission of Alexander S. Zolan and Kathryn S. Kayali 37 C.F.R. sec 42.10 Download |
| Sep 22, 2022 | 27 | patent_own | Patent Owner's Third Updated Mandatory Notices Download |
| Sep 23, 2022 | 28 | petitioner | Petitioner Mylan Updated Mandatory Notices Download |
| Sep 26, 2022 | 1024 | petitioner | Transcript of Board Telephone Conference on September 21, 2022 Download |
| Sep 26, 2022 | 29 | petitioner | Petitioner Mylan Updated Exhibit List Download |
| Oct 6, 2022 | 30 | patent_own | Joint Notice of Stipulation Concerning Joinder Download |
| Oct 19, 2022 | 31 | patent_own | Patent Owner's Notice of Deposition of Dr. Randall M. Zusman, M.D. Download |
| Oct 19, 2022 | 32 | board | Institution decision and grant of joinder, IPR2022-01515 Download |
| Oct 19, 2022 | 33 | board | Institution decision and grant of joinder, IPR2022-01513 Download |
| Oct 31, 2022 | 34 | patent_own | Patent Owner's Objections to Evidence of Joinder Petitioner Teva Pharmaceuticals USA, Inc. Download |
| Oct 31, 2022 | 35 | patent_own | Patent Owner's Objections to Evidence of Joinder Petitioner InvaGen Pharmaceuticals, Inc. Download |
| Nov 15, 2022 | 2025 | patent_own | NCT01776424, ClinicalTrials.gov Download |
| Nov 15, 2022 | 2026 | patent_own | Trial Transcript, C.A. 1:14-264-RGA (D. Del.) (June 6, 2016) Download |
| Nov 15, 2022 | 2028 | patent_own | Curriculum Vitae of Dr. Jeffrey Weitz, M.D. Download |
| Nov 15, 2022 | 2029 | patent_own | Randall M. Zusman, M.D. Deposition Transcript, IPR2022-00517 (PTAB) (November 3, 2022) Download |
| Nov 15, 2022 | 2030 | patent_own | Weitz, Anticoagulation therapy in 2015: where we are and where we are going, J. Thromb. Thrombolysis 39:264-272 (2015) Download |
| Nov 15, 2022 | 2031 | patent_own | Jacomella et al., Novel anticoagulants in the therapy of peripheral arterial and coronary artery disease, Current Opinion in Pharmacology 13:294-300 (2013) Download |
| Nov 15, 2022 | 2032 | patent_own | Yeh et al., Overview of the New Oral Anticoagulants Opportunities and Challenges, Arterioscler Thromb. Vasc. Biol. 35:1056-1065 (2015) Download |
| Nov 15, 2022 | 2033 | patent_own | 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease, Circulation 135:e726-e779 (2017) Download |
| Nov 15, 2022 | 2034 | patent_own | Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary of Peripheral Artery Disease (COMPASS), NCT01776124, ClinicalTrials.gov (2013) JOINT_LDRIV0000368-71 Download |
| Nov 15, 2022 | 2035 | patent_own | 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) Download |
| Nov 15, 2022 | 2037 | patent_own | Download |
| Nov 15, 2022 | 2038 | patent_own | Reddy et al., The Role of Rivaroxaban in Atrial Fibrillation and Acute Coronary Syndromes, J. od Cardiovascular Pharm. & Ther. 19(6):526-532 (2014) Download |
| Nov 15, 2022 | 2039 | patent_own | Download |
| Nov 15, 2022 | 2040 | patent_own | Download |
| Nov 15, 2022 | 2041 | patent_own | Download |
| Nov 15, 2022 | 2043 | patent_own | Fredenburgh et al., Emerging Anticoagulant Strategies, Blood 129(2):145-154 (2017) Download |
| Nov 15, 2022 | 2044 | patent_own | Chan et al., Evolving Treatment for Arterial and Venous Thrombosis Role of the Direct Oral Anticoagulants, Circulation Research 1409-1423 (2016) Download |
| Nov 15, 2022 | 2045 | patent_own | Weitz et al., Trends in Prescribing Oral Anticoagulants in Canada, 2008-2014, Clinical Ther. 34(11):2506-2514e4 (2015) Download |
| Nov 15, 2022 | 2046 | patent_own | Caterina et al., Oral Anticoagulants in Coronary Heart Disease (Section IV), Thrombosis & Haemostasis 115:685-711 (2016) Download |
| Nov 15, 2022 | 2047 | patent_own | Weitz, Insights into the Role of Thrombin in the Pathogenesis of Recurrent Ischaemia After Acute Coronary Syndrome, Thrombosis & Haemostasis 112:924-931 (2014) Download |
| Nov 15, 2022 | 2048 | patent_own | 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) Download |
| Nov 15, 2022 | 2049 | patent_own | Download |
| Nov 15, 2022 | 2050 | patent_own | Download |
| Nov 15, 2022 | 2051 | patent_own | FDA Letter re Meeting Preliminary Comments (December 12, 2018) (XARELTO310_00053946) Download |
| Nov 15, 2022 | 2052 | patent_own | FDA Letter re Meeting Minutes (December 18, 2018) (XARELTO310_00053947) Download |
| Nov 15, 2022 | 2053 | patent_own | Download |
| Nov 15, 2022 | 2054 | patent_own | FDA Letter re Information Request (March 22, 2019) (XARELTO310_00054231) Download |
| Nov 15, 2022 | 2055 | patent_own | FDA Letter re General Advice (May 3, 2019) (XARELTO310_00053952) Download |
| Nov 15, 2022 | 2056 | patent_own | Download |
| Nov 15, 2022 | 2057 | patent_own | Barnes, AHA/ACC Guidelines on the Management of Lower Extremity Peripheral Artery Disease, Amer. College of Cardiology (2016) Download |
| Nov 15, 2022 | 2060 | patent_own | Expert Declaration of Dr. Jeffrey Weitz, M.D. Download |
| Nov 15, 2022 | 36 | patent_own | Patent Owner's Response Download |
| Nov 22, 2022 | 37 | petitioner | Petitioner Mylan Objections to Response Exhibits Download |
| Dec 14, 2022 | 1025 | petitioner | Declaration of Susannah M.L. Gagnon Download |
| Dec 14, 2022 | 1026 | petitioner | Attorney Bio of Susannah Gagnon Download |
| Dec 14, 2022 | 38 | petitioner | Mylan Pharmaceuticals Inc. Unopposed Motion for Pro Hac Vice Recognation Download |
| Dec 14, 2022 | 39 | petitioner | Mylan Updated Power of Attorney Download |
| Dec 14, 2022 | 40 | petitioner | Mylan Updated Mandatory Notices Download |
| Dec 22, 2022 | 41 | board | ORDER Granting Petitioners Motion for Pro Hac Vice Admission of Susannah M. L. Gagnon 37 C.F.R. sec 42.10 Download |
| Dec 30, 2022 | 42 | petitioner | Petitioner's Notice of Deposition of Jeffrey Weitz Download |
| Feb 1, 2023 | 43 | petitioner | Second Joint Stipulation to Modify Schedule Download |
| Feb 17, 2023 | 1027 | petitioner | Connolly [COMPASS Patient Info] Download |
| Feb 17, 2023 | 1028 | petitioner | Ruff [Comparison of Efficacy & Safety of NOACs with Warfarin Download |
| Feb 17, 2023 | 1029 | petitioner | Weitz Publication [NOACs, Which One Should My Patient Use] Download |
| Feb 17, 2023 | 1030 | petitioner | Weitz Deposition 1-25-23 Download |
| Feb 17, 2023 | 1031 | petitioner | Janssen Research and Development Briefing Document Download |
| Feb 17, 2023 | 1032 | petitioner | WeitzJI Braunwald Heart Disease Download |
| Feb 17, 2023 | 1033 | petitioner | Zannand 2012 Download |
| Feb 17, 2023 | 1034 | petitioner | Taylor 2004 Download |
| Feb 17, 2023 | 1035 | petitioner | McMurray 2014 Download |
| Feb 17, 2023 | 1036 | petitioner | Aggrenox Download |
| Feb 17, 2023 | 1037 | petitioner | Zusman Expert Declaration ISO Reply Download |
| Feb 17, 2023 | 1038 | petitioner | Data Supplement to the 2016 AHA ACC Guideline Download |
| Feb 17, 2023 | 44 | petitioner | Mylan Reply Download |
| Feb 17, 2023 | 45 | petitioner | Mylan's Updated Exhibit List Download |
| Feb 17, 2023 | 46 | petitioner | Mylan's Updated Exhibit List Download |
| Feb 27, 2023 | 47 | patent_own | Patent Owner's Objections to Evidence Download |
| Feb 27, 2023 | 48 | patent_own | Patent Owner's Fourth Updated Mandatory Notices Download |
| Feb 27, 2023 | 49 | patent_own | Patent Owner's Notice of Deposition of Dr. Randall M. Zusman, M.D. Download |
| Mar 6, 2023 | 50 | patent_own | Third Joint Stipulation to Modify Schedule Download |
| Mar 8, 2023 | 3001 | board | Ex. 3001 Download |
| Mar 8, 2023 | 51 | board | Order: Conduct of the Proceeding Download |
| Mar 9, 2023 | 1030 | petitioner | EX1030 - Weitz Deposition Jan. 25, 2023 Download |
| Mar 9, 2023 | 1037 | petitioner | Corrected Declaration of Randall M. Zusman, M.D. ISO Mylan Reply Download |
| Mar 9, 2023 | 1040 | petitioner | Transcript of Conference Call with PTAB Mar. 7, 2023 Download |
| Mar 9, 2023 | 52 | petitioner | Mylan Reply - CORRECTED Download |
| Mar 9, 2023 | 53 | petitioner | Petitioner's Updated Exhibit List Download |
| Mar 28, 2023 | 54 | patent_own | Patent Owner's Request for Oral Argument Download |
| Mar 28, 2023 | 55 | petitioner | Petitioner's Request for Oral Argument Download |
| Apr 4, 2023 | 2065 | patent_own | Randall M. Zusman, M.D. Deposition Transcript, IPR2022-00517 (PTAB) (March 17, 2023) Download |
| Apr 4, 2023 | 56 | patent_own | Patent Owner Surreply Download |
| Apr 5, 2023 | 57 | board | ORDER Setting Oral Argument Download |
| Apr 14, 2023 | 58 | patent_own | Patent Owner's Fifth Updated Mandatory Notices Download |
| Apr 18, 2023 | 1041 | petitioner | EX1041-Resnik Download |
| Apr 18, 2023 | 59 | petitioner | Download |
| Apr 18, 2023 | 60 | petitioner | Petitioner's Updated Exhibit List Download |
| Apr 25, 2023 | 61 | patent_own | Patent Owner's Opposition to Mylan's Motion to Exclude Download |
| Apr 25, 2023 | 0 | patent_own | Patent Owner's Opposition to Mylan's Motion to Exclude Download |
| May 2, 2023 | 62 | petitioner | Mylan Reply for Motion to Exclude Download |
| May 4, 2023 | 64 | board | LEAP Practitioner Request and Verification Form (Petitioner) Download |
| May 5, 2023 | 65 | petitioner | Petitioner's Demonstratives Download |
| May 5, 2023 | 66 | patent_own | Patent Owner's Demonstrative Exhibits Download |
| May 31, 2023 | 67 | board | Other: Hearing transcript Download |
| Jun 9, 2023 | 68 | patent_own | Patent Owner's Sixth Updated Mandatory Notices Download |
| Jun 26, 2023 | 69 | patent_own | Patent Owner's Seventh Updated Mandatory Notices Download |
| Jul 28, 2023 | 70 | board | Download |
| Sep 22, 2023 | 71 | patent_own | Patent Owner's Notice of Appeal Download |
