Case number IPR2020-00440
Mylan Laboratories Ltd. v. Janssen Pharmaceutica NV > Documents
| Date Field | Doc. No. | Party | Description |
|---|---|---|---|
| Mar 22, 2022 | 21 | board | Notice: refund approved Download |
| Mar 17, 2022 | 20 | petitioner | PETITIONERS REQUEST FOR REFUND OF IPR FEES Download |
| Dec 2, 2020 | 19 | petitioner | Petitioner Mylan Laboratories Ltd First Updated Mandatory Notice Download |
| Oct 20, 2020 | 18 | petitioner | Petitioner's Notice of Appeal Download |
| Sep 16, 2020 | 17 | board | Decision Denying Institution of Inter Partes Review Download |
| Jul 20, 2020 | 16 | petitioner | Authorized Reply to Patent Owner's Preliminary Response Download |
| Jul 20, 2020 | 15 | board | Download |
| Jul 17, 2020 | 14 | patent_own | Patent Owners Authorized Surreply Download |
| Jul 10, 2020 | 13 | petitioner | Updated Exhibit List Download |
| Jul 10, 2020 | 12 | petitioner | AUTHORIZED REPLY TO PATENT OWNERS PRELIMINARY RESPONSE Download |
| Jul 10, 2020 | 1049 | petitioner | Exhibit 1049: Clinical Trials: Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia Download |
| Jul 9, 2020 | 2009 | patent_own | Comparison of Examples 2 and 3 of U.S. Provisional Application No. 61/014,918 with PI-75 and PI-74 (Ex. 1003) Download |
| Jul 9, 2020 | 2001 | patent_own | Complaint, Janssen Pharm., Inc. v. Mylan Labs. Ltd., No. 2:19-cv-16484 (CCC) (MF) (D.N.J. Aug. 8, 2019) (Dkt. No. 1) Download |
| Jul 9, 2020 | 11 | board | ORDER Granting Patent Owner's Request to Expunge and Replace Exhibits 2001 and 2009 Download |
| Jul 2, 2020 | 10 | board | Download |
| Jun 30, 2020 | 9 | petitioner | Petitioner's Updated Exhibit List Download |
| Jun 30, 2020 | 1048 | petitioner | Report of Proceedings Download |
| Jun 19, 2020 | 8 | patent_own | Patent Owners Preliminary Response Download |
| Jun 19, 2020 | 2012 | patent_own | Declaration of Joong Youn (Jay) Cho Download |
| Jun 19, 2020 | 2011 | patent_own | Download |
| Jun 19, 2020 | 2010 | patent_own | Search results from FDA website (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm) for FDA-approved drugs containing paliperidone palmitate Download |
| Jun 19, 2020 | 2009 | patent_own | Comparison of Examples 2 and 3 of U.S. Provisional Application No. 61/014,918 with PI-75 and PI-74 (Ex. 1003) Download |
| Jun 19, 2020 | 2008 | patent_own | Excerpts of Mylans Initial Invalidity Contentions, Janssen Pharm., Inc. v. Mylan Labs. Ltd., No. 2:19-cv-16484 (CCC) (MF) (D.N.J. Dec. 20, 2019) Download |
| Jun 19, 2020 | 2007 | patent_own | Download |
| Jun 19, 2020 | 2006 | patent_own | Stipulation and Order Regarding Infringement of Claims 1-21 of U.S. Patent No. 9,439,906, Janssen Pharm., Inc. v. Teva Pharm. USA, Inc., No. 2:18-cv-734 (CCC) (MF) (D.N.J. June. 8, 2020) (Dkt. No. 88) Download |
| Jun 19, 2020 | 2005 | patent_own | Scheduling Order, Janssen Pharm., Inc. v. Teva Pharm. USA, Inc., No. 2:18-cv-734 (CCC) (MF) (D.N.J. June. 11, 2020) (Dkt. No. 90) Download |
| Jun 19, 2020 | 2004 | patent_own | Joint Proposed Discovery Plan, Janssen Pharm., Inc. v. Mylan Labs. Ltd., No. 2:19-cv-16484 (CCC) (MF) (D.N.J. Nov. 8, 2019) (Dkt. No. 34-1) Download |
| Jun 19, 2020 | 2003 | patent_own | Order, Janssen Pharm., Inc. v. Mylan Labs. Ltd., No. 2:19-cv-16484 (CCC) (MF) (D.N.J. Dec. 13, 2019) (Dkt. No. 43) Download |
| Jun 19, 2020 | 2002 | patent_own | Excerpts of Janssens Preliminary Responses to Mylans Initial Invalidity Contentions with Respect to U.S. Patent No. 9,439,906, Janssen Pharm., Inc. v. Mylan Labs. Ltd., No. 2:19-cv-16484 (CCC) (MF) (D.N.J. Feb. 7, 2020) Download |
| Jun 19, 2020 | 2001 | patent_own | Complaint, Janssen Pharm., Inc. v. Mylan Labs. Ltd., No. 2:19-cv-16484 (CCC) (MF) (D.N.J. Aug. 8, 2019) (Dkt. No. 1) Download |
| May 11, 2020 | 7 | Order - Granting Patent Owner's Motion to Extend Deadline - 37 CFR 42.5 Download | |
| Feb 28, 2020 | 6 | Janssen Pharmaceutica NVs Mandatory Notices Download | |
| Feb 28, 2020 | 5 | Janssen Pharmaceutica NVs Power of Attorney Download | |
| Feb 21, 2020 | 4 | Notice of Accord Filing Date Download | |
| Feb 12, 2020 | 1019 | EX1019 (003)_Part2.pdf Download | |
| Feb 12, 2020 | 1019 | EX1019 (003)_Part1.pdf Download | |
| Feb 12, 2020 | 1019 | EX1019 (003)_Part3.pdf Download | |
| Feb 7, 2020 | 1035 | Download | |
| Feb 7, 2020 | 1036 | ClinicalTrials.gov, Evaluate the Efficacy in the Prevention of Recurrence of the Symptoms of Schizophrenia (April 2006) ("NCT00111189") Download | |
| Feb 7, 2020 | 1037 | Guarino, Richard A. "Clinical research protocols." New Drug Approval Process. CRC Press, 2004, pages 257-61 Download | |
| Feb 7, 2020 | 1038 | Bishara, Delia, and David Taylor. "Upcoming agents for the treatment of schizophrenia." Drugs 68.16 (2008): 2269-2292 Download | |
| Feb 7, 2020 | 1039 | Kramer, M., et al. "322-Efficacy/tolerability of paliperidone palmitate: 9-week, placebo-controlled study in schizophrenia patients." Schizophrenia Research 98 (2008): 165-166 Download | |
| Feb 7, 2020 | 1040 | '906 Patent Specification as Filed Download | |
| Feb 7, 2020 | 1 | Power of Attorney Download | |
| Feb 7, 2020 | 1042 | Declaration of Laboratory Research Analyst Alys Tryon Download | |
| Feb 7, 2020 | 1043 | Nankivell, Brian J. Creatinine clearance and the assessment of renal function. Australian Prescriber, 2001 Download | |
| Feb 7, 2020 | 1044 | Perry, Paul J., ed. Psychotropic drug handbook. Lippincott Williams & Wilkins, 2007, pages 74-77 Download | |
| Feb 7, 2020 | 1045 | Traynor, Jamie, et al. How to measure renal function in clinical practice. Bmj 333.7571 (2006): 733-737 Download | |
| Feb 7, 2020 | 1046 | Janicak, Philip G., and Elizabeth A. Winans. Paliperidone ER: a review of the clinical trial data. Neuropsychiatric disease and treatment 3.6 (2007):869 Download | |
| Feb 7, 2020 | 1047 | Physicians' Desk Reference (2002), HALDOL Decanoate Download | |
| Feb 7, 2020 | 2 | Exhibit List Download | |
| Feb 7, 2020 | 3 | IPR Petition Download | |
| Feb 7, 2020 | 1034 | ClinicalTrials.gov, A Study to Compare the Effectiveness and Safety of Flexibly Varied Doses of Paliperidone Palmitate and Risperidone in Treating Patients With Schizophrenia (July 2006) ("NCT00210717") Download | |
| Feb 7, 2020 | 1033 | ClinicalTrials.gov, Safety and Efficacy of an Anti-Psychotic Versus Placebo in Subjects With Schizophrenia (November 2005) ("NCT00101634") Download | |
| Feb 7, 2020 | 1032 | ClinicalTrials.gov, A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia (October 2006) ("NCT00210548") Download | |
| Feb 7, 2020 | 1031 | Download | |
| Feb 7, 2020 | 1030 | INVEGA SUSTENNA Label ("INVEGA LABEL") Download | |
| Feb 7, 2020 | 1029 | Janssen Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. et al., 2-18-cv-00734 (D.N.J.) ("Claim Construction Agreement") Download | |
| Feb 7, 2020 | 1028 | Janssen Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. et al., 2-18-cv-00734 (D.N.J.) ("Joint Claim Construction") Download | |
| Feb 7, 2020 | 1027 | Curriculum Vitae of Dr. Mansoor Amiji Download | |
| Feb 7, 2020 | 1026 | Excerpt of '906 Patent Prosecution History ("11-11-2015 IDS") Download | |
| Feb 7, 2020 | 1025 | Orange Book Entry for Invega Sustenna Download | |
| Feb 7, 2020 | 1024 | Ansel et al., Pharmaceutical Dosage Forms and Drug Delivery Systems 8th ed. (2005) ("Added Substances") Download | |
| Feb 7, 2020 | 1023 | U.S. Patent No. 6,818,633 ("the '633 patent") Download | |
| Feb 7, 2020 | 1022 | D. Waller & A. Renwick, Principles of Medical Pharmacology (1994) ("Principles of Medical Pharmacology") Download | |
| Feb 7, 2020 | 1021 | Goodman & Gilman's, The Pharmacological Basis of Therapeutics (2001), Chapter 1 ("Goodman & Gilman") Download | |
| Feb 7, 2020 | 1020 | L. Ereshefsky, et al., Future of Depot Neuroleptic Therapy: Pharmacokinetic and Pharmacodynamic Approaches. J. Clin. Psychiatry, 45(5):50-59 (1984) ("Ereshefsky") Download | |
| Feb 7, 2020 | 1018 | Excerpt of '906 Patent Prosecution History ("6-12-2016 Amendment and Response") Download | |
| Feb 7, 2020 | 1017 | U.S. Provisional Application No. 61/120,276 ("the '276 provisional") Download | |
| Feb 7, 2020 | 1016 | U.S. Provisional Application No. 61/014,918 ("the '918 provisional") Download | |
| Feb 7, 2020 | 1015 | R. Urso, P. Blardi, G. Giorgi. A short introduction to pharmacokinetics, Rev. Med. Pharmacol. Sci. 6: 33-44 (2002) ("Urso") Download | |
| Feb 7, 2020 | 1014 | U.S. Patent No. 7,449,184 ("the '184 patent") Download | |
| Feb 7, 2020 | 1013 | U.S. Patent No. 5,254,556 ("the '556 patent") Download | |
| Feb 7, 2020 | 1012 | Comparison of the '276 and the '918 provisional application specifications ("Specification Comparison") Download | |
| Feb 7, 2020 | 1011 | M.E. Aulton. Pharmaceutics: The Science of Dosage Form Design (2002), Chapter 19 ("Aulton") Download | |
| Feb 7, 2020 | 1010 | N. Marder, et al. Pharmacokinetics of long-acting injectable neuroleptic drugs: clinical implications. Psychopharmacology. 98:433-439 (1989) ("Marder") Download | |
| Feb 7, 2020 | 1009 | J.M. Kane, et al. Guidelines for depot antipsychotic treatment in schizophrenia. B. Eur. Neuropharmacol. 8(1):55-65 (1995) ("Kane") Download | |
| Feb 7, 2020 | 1008 | U.S. Patent No. 6,495,534 ("the '534 patent") Download | |
| Feb 7, 2020 | 1007 | N. Washington, C. Washington, C. Wilson. Physiological Pharmaceutics: Barriers to Drug Absorption. (2001), pages 26-29 ("Physiological Pharmaceutics") Download | |
| Feb 7, 2020 | 1006 | Download | |
| Feb 7, 2020 | 1005 | U.S. Patent No. 6,555,544 ("the '544 patent") Download | |
| Feb 7, 2020 | 1004 | L. Citrome, Paliperidone: quo vadis?, Int: J. Clin. Pract. 61(1):653-662 (Apr. 2007) ("Citrome") Download | |
| Feb 7, 2020 | 1003 | Abstracts of the Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics, 83 Supp. 1 Clin. Pharmacol. & Therapeutics S31, PI-74 and PI-75 (Mar. 2008) ("Cleton") Download | |
| Feb 7, 2020 | 1002 | Declaration of Dr. Mansoor M. Amiji, Ph.D. and Accompanying Exhibits Download | |
| Feb 7, 2020 | 1001 | U.S. Patent No. 9,439,906 ("the '906 patent") Download | |
| Feb 7, 2020 | 1041 | Kramer M, Litman R, Lane R, et al. "908. Efficacy and tolerability of two fixed dosages of paliperidone palmitate in the treatment of schizophrenia: results of a 9-week placebo-controlled trial." Biol Psychiatry 2008;63:1S-319S Download |
