Mylan Laboratories Ltd. et al. vs Janssen Pharmaceutica NV et al.

Notice: refund approved

PETITIONERS REQUEST FOR REFUND OF IPR FEES

Petitioner Mylan Laboratories Ltd First Updated Mandatory Notice

Petitioner's Notice of Appeal

Decision Denying Institution of Inter Partes Review

Granting Petitioner's Request Submit a Revised Reply Brief and Patent Owner's Request to Change Submission Date of Sur-Reply Brief 37 C.F.R. § 42.5

Authorized Reply to Patent Owner's Preliminary Response

Patent Owners Authorized Surreply

Updated Exhibit List

Exhibit 1049: Clinical Trials: Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia

EXPUNGED

ORDER Granting Patent Owner's Request to Expunge and Replace Exhibits 2001 and 2009

Complaint, Janssen Pharm., Inc. v. Mylan Labs. Ltd., No. 2:19-cv-16484 (CCC) (MF) (D.N.J. Aug. 8, 2019) (Dkt. No. 1)

Comparison of Examples 2 and 3 of U.S. Provisional Application No. 61/014,918 with PI-75 and PI-74 (Ex. 1003)

Granting Petitioner's and Patent Owner's Requests for Authorization for Additional Briefing 37 C.F.R. § 42.5

Report of Proceedings

Petitioner's Updated Exhibit List

Patent Owners Preliminary Response

Complaint, Janssen Pharm., Inc. v. Mylan Labs. Ltd., No. 2:19-cv-16484 (CCC) (MF) (D.N.J. Aug. 8, 2019) (Dkt. No. 1)

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)

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)

Order, Janssen Pharm., Inc. v. Mylan Labs. Ltd., No. 2:19-cv-16484 (CCC) (MF) (D.N.J. Dec. 13, 2019) (Dkt. No. 43)

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)

Comparison of Examples 2 and 3 of U.S. Provisional Application No. 61/014,918 with PI-75 and PI-74 (Ex. 1003)

Search results from FDA website (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm) for FDA-approved drugs containing paliperidone palmitate

Declaration of Joong Youn (Jay) Cho

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)

Excerpts of Teva¿¿¿s Preliminary Invalidity Contentions with Respect to 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. 25, 2018)

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)

FDA Summary Review for Invega Trinza¿¿ (available at https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207946Orig1s000SumR.pdf)

Order - Granting Patent Owner's Motion to Extend Deadline - 37 CFR 42.5

Janssen Pharmaceutica NVs Power of Attorney

Janssen Pharmaceutica NVs Mandatory Notices

Notice of Accord Filing Date

EX1019 (003)_Part2.pdf

EX1019 (003)_Part1.pdf

EX1019 (003)_Part3.pdf

Power of Attorney

Exhibit List

Declaration of Dr. Mansoor M. Amiji, Ph.D. and Accompanying Exhibits

Formulary Drug Reviews - Paliperidone, ¿¿¿Hospital pharmacy 42(7):637-647 July 2007 ("Paliperidone Formulary")

N. Washington, C. Washington, C. Wilson. Physiological Pharmaceutics: Barriers to Drug Absorption. (2001), pages 26-29 ("Physiological Pharmaceutics")

U.S. Patent No. 6,495,534 ("the '534 patent")

M.E. Aulton. Pharmaceutics: The Science of Dosage Form Design (2002), Chapter 19 ("Aulton")

U.S. Patent No. 5,254,556 ("the '556 patent")

U.S. Patent No. 9,439,906 ("the '906 patent")

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")

L. Citrome, Paliperidone: quo vadis?, Int: J. Clin. Pract. 61(1):653-662 (Apr. 2007) ("Citrome")

U.S. Patent No. 6,555,544 ("the '544 patent")

J.M. Kane, et al. Guidelines for depot antipsychotic treatment in schizophrenia. B. Eur. Neuropharmacol. 8(1):55-65 (1995) ("Kane")

N. Marder, et al. Pharmacokinetics of long-acting injectable neuroleptic drugs: clinical implications. Psychopharmacology. 98:433-439 (1989) ("Marder")

Comparison of the '276 and the '918 provisional application specifications ("Specification Comparison")

U.S. Patent No. 7,449,184 ("the '184 patent")

Excerpt of '906 Patent Prosecution History ("6-12-2016 Amendment and Response")

L. Ereshefsky, et al., Future of Depot Neuroleptic Therapy: Pharmacokinetic and Pharmacodynamic Approaches. J. Clin. Psychiatry, 45(5):50-59 (1984) ("Ereshefsky")

D. Waller & A. Renwick, Principles of Medical Pharmacology (1994) ("Principles of Medical Pharmacology")

R. Urso, P. Blardi, G. Giorgi. A short introduction to pharmacokinetics, Rev. Med. Pharmacol. Sci. 6: 33-44 (2002) ("Urso")

U.S. Provisional Application No. 61/014,918 ("the '918 provisional")

U.S. Provisional Application No. 61/120,276 ("the '276 provisional")

Goodman & Gilman's, The Pharmacological Basis of Therapeutics (2001), Chapter 1 ("Goodman & Gilman")

U.S. Patent No. 6,818,633 ("the '633 patent")

Orange Book Entry for Invega Sustenna

Curriculum Vitae of Dr. Mansoor Amiji

Janssen Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. et al., 2-18-cv-00734 (D.N.J.) ("Joint Claim Construction")

Excerpt of '906 Patent Prosecution History ("11-11-2015 IDS")

Janssen Pharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. et al., 2-18-cv-00734 (D.N.J.) ("Claim Construction Agreement")

INVEGA SUSTENNA Label ("INVEGA LABEL")

ClinicalTrials.gov, A Safety and Tolerability Study of Paliperidone Palmitate Injected in the Shoulder or the Buttock Muscle in Patients With Schizophrenia (July 2006) ("NCT00119756¿¿¿)

ClinicalTrials.gov, A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia (October 2006) ("NCT00210548")

ClinicalTrials.gov, Intramuscular Injections of Paliperidone Palmitate in the Arm or Buttock of Subjects With Schizophrenia (June 2005) ("NCT00073320¿¿¿")

Kramer, M., et al. "322-Efficacy/tolerability of paliperidone palmitate: 9-week, placebo-controlled study in schizophrenia patients." Schizophrenia Research 98 (2008): 165-166

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")

ClinicalTrials.gov, Evaluate the Efficacy in the Prevention of Recurrence of the Symptoms of Schizophrenia (April 2006) ("NCT00111189")

Guarino, Richard A. "Clinical research protocols." New Drug Approval Process. CRC Press, 2004, pages 257-61

Bishara, Delia, and David Taylor. "Upcoming agents for the treatment of schizophrenia." Drugs 68.16 (2008): 2269-2292

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

'906 Patent Specification as Filed

Ansel et al., Pharmaceutical Dosage Forms and Drug Delivery Systems 8th ed. (2005) ("Added Substances")

ClinicalTrials.gov, Safety and Efficacy of an Anti-Psychotic Versus Placebo in Subjects With Schizophrenia (November 2005) ("NCT00101634")

Declaration of Laboratory Research Analyst Alys Tryon

Nankivell, Brian J. Creatinine clearance and the assessment of renal function. Australian Prescriber, 2001

Perry, Paul J., ed. Psychotropic drug handbook. Lippincott Williams & Wilkins, 2007, pages 74-77

Janicak, Philip G., and Elizabeth A. Winans. Paliperidone ER: a review of the clinical trial data. Neuropsychiatric disease and treatment 3.6 (2007):869

Traynor, Jamie, et al. How to measure renal function in clinical practice. Bmj 333.7571 (2006): 733-737

IPR Petition

Physicians' Desk Reference (2002), HALDOL Decanoate