The detailed information for PTAB case with proceeding number IPR2015-02009 filed by Amerigen Pharmaceuticals Limited against Shire LLC,Shire US Inc., Shire Development LLC, and Shire Plc. on Oct 1, 2015. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number
IPR2015-02009
Filing Date
Oct 1, 2015
Petitioner
Amerigen Pharmaceuticals Limited
Respondent
Shire LLC,Shire US Inc., Shire Development LLC, and Shire Plc.
Status
Final Written Decision
Respondent Application Number
11091011
Respondent Tech Center
1600
Respondent Patent Number
RE42096
Institution Decision Date
Apr 18, 2016
Termination Date
Mar 31, 2017

Proceeding Documents

The table below shows documents filed in the case, listing each document name, filing date, document type, and filing party. Tracking these filings indicates the activity of the parties involved in the case, and the types of documents filed can provide insights into the legal strategies being employed.


Document NameFiling DateCategoryFiling Party

Alert me when new update on this case

Joint Request to File Settlement Agreement as Business Confidential Information Pursuant to 35 U.S.C. 317 and 37 C.F.R. 42.74(c)

May 3, 2017PAPERPATENT OWNER

Settlement Agreement

May 3, 2017EXHIBITPATENT OWNER

Decision - 35 U.S.C. 4264(c), 42.71(a)

Mar 31, 2017PAPERBOARD

Termination Decision Document

Mar 31, 2017PAPERBOARD

Order - Cancelling Trial Hearing - 37 CFR 42.70

Jan 10, 2017PAPERBOARD

Reply in Support of Petitioner's Motion to Exclude

Dec 30, 2016PAPERPETITIONER

Patent Owner's Reply to Petitioner's Opposition to Patent Owner's Motion to Exclude Exhibits 1081 &1082

Dec 30, 2016PAPERPATENT OWNER

Decision Denying Patent Owner's Request for Rehearing

Dec 28, 2016PAPERBOARD

Decision Denying Petitioner's Request for Rehearing

Dec 28, 2016PAPERBOARD

Petitioner's Opposition To Patent Owner's Motion To Exclude Exhibits 1081 & 1082

Dec 23, 2016PAPERPETITIONER

Patent Owner's Opposition to Petitioner's Motion to Exclude Pursuant to 37 C.F.R. ¿¿ 42.64(c)

Dec 23, 2016PAPERPATENT OWNER

Petitioner's Motion for Leave to Withdraw Appearance of Erik B. Flom

Dec 21, 2016PAPERPETITIONER

Petitioner's Motion to Exclude Evidence Pursuant to 37 C.F.R. 42.64(c)

Dec 9, 2016PAPERPETITIONER

Petitioner's Request for Oral Argument

Dec 9, 2016PAPERPETITIONER

Patent Owner's Motion to Exclude Exhibits 1081 & 1082

Dec 9, 2016PAPERPATENT OWNER

Petitioner's Second Evidentiary Objections Pursuant to 37 C.F.R. ¿¿ 42.64

Nov 23, 2016PAPERPETITIONER

Petitioner's Power of Attorney for Inter partes Review of U.S. Patent No. RE42,096

Nov 22, 2016PAPERPETITIONER

Petitioner's Third Revised Mandatory Notices

Nov 22, 2016PAPERPETITIONER

Patent Owner's Reply to Petitioner's Opposition to Motion to Amend

Nov 17, 2016PAPERPATENT OWNER

Patent Owner's Updated Exhibit List

Nov 17, 2016PAPERPATENT OWNER

Email from Trials to Dustin Weeks Re Request for Authorization to File Motion, dated July 14, 2016 at 2:35 PM

Nov 17, 2016EXHIBITPATENT OWNER

PTAB E2E Filing Notice Re Patent Owner¿¿¿s Motion to Amend the Claims, dated July 18, 2016 at 4:27 PM

Nov 17, 2016EXHIBITPATENT OWNER

PTAB¿¿¿s Top PTAB E2E Tips for Users

Nov 17, 2016EXHIBITPATENT OWNER

Email from Dustin Weeks to Erik Flom, dated July 18 at 4.53 PM

Nov 17, 2016EXHIBITPATENT OWNER

Email from E2E to Dustin Weeks, dated July 28 at 4.00 PM

Nov 17, 2016EXHIBITPATENT OWNER

PTAB E2E Filing Notice 1 July 28 at 5.39 PM

Nov 17, 2016EXHIBITPATENT OWNER

Email from Dustin Weeks to E2E, dated July 29 at 8.43 AM

Nov 17, 2016EXHIBITPATENT OWNER

Email from Joseph Robinson to Erik Flom, dated July 29 at 2.09 PM

Nov 17, 2016EXHIBITPATENT OWNER

Email from Dustin Weeks to Erik Flom, dated July 28 at 3.08 PM

Nov 17, 2016EXHIBITPATENT OWNER

E2E Filing Notice 2 July 28 at 5.39 PM

Nov 17, 2016EXHIBITPATENT OWNER

Email from Erik Flom to Dustin Weeks, dated July 29 at 11.55 AM

Nov 17, 2016EXHIBITPATENT OWNER

Declaration of Dustin Weeks

Nov 17, 2016EXHIBITPATENT OWNER

Declaration of Matthew Hu

Nov 17, 2016EXHIBITPATENT OWNER

Patent Owner's Second Evidentiary Objections

Oct 24, 2016PAPERPATENT OWNER

Petitioner's Second Revised Mandatory Notices

Oct 20, 2016PAPERPETITIONER

Orange Book Entry for Focalin XR

Oct 18, 2016EXHIBITPETITIONER

Petitioner's Opposition to Motion to Amend

Oct 18, 2016PAPERPETITIONER

Petitioner's First Updated Exhibit List

Oct 18, 2016PAPERPETITIONER

July 18, 2016 Filing Courtesy Notice

Oct 18, 2016EXHIBITPETITIONER

July 18, 2016 Email from Erik B. Flom to Dustin B. Weeks

Oct 18, 2016EXHIBITPETITIONER

July 28, 2016 Email from Dustin B. Weeks to PTAB

Oct 18, 2016EXHIBITPETITIONER

July 29, 2016 Email from Dustin B. Weeks to PTAB E2E Admin

Oct 18, 2016EXHIBITPETITIONER

July 29, 2016 Email from Erik B. Flom to PTAB

Oct 18, 2016EXHIBITPETITIONER

U.S. Patent Publication No. 2006/0204575

Oct 18, 2016EXHIBITPETITIONER

July 28, 2016 Email from PTAB E2E Admin to Dustin B. Weeks

Oct 18, 2016EXHIBITPETITIONER

July 18, 2016 Email from Dustin B. Weeks to Erik B. Flom

Oct 18, 2016EXHIBITPETITIONER

Petitioner's First Revised Mandatory Notices

Aug 1, 2016PAPERPETITIONER

Patent Owner's Motion to Amend

Jul 28, 2016PAPERPATENT OWNER

Patent Owner's Motion to Amend

Jul 28, 2016PAPERPATENT OWNER

Patent Owner's Request for Reconsideration and Proposed Order

May 2, 2016PAPERPATENT OWNER

Motion Presenting Request for Rehearing Under 37 C.F.R. 42.71(d) of Decision Denying-In-Part Institution of Inter Partes Review

May 2, 2016PAPERPETITIONER

Petitioner's First Evidentiary Objections Pursuant to 37 C.F.R 42.64

May 2, 2016PAPERPETITIONER

Patent Owner's First Evidentiary Objections Pursuant to 37 C.F.R 42.64

May 2, 2016PAPERPATENT OWNER

Scheduling Order

Apr 19, 2016PAPERBOARD

Decision - Institution of Inter Partes Review

Apr 18, 2016PAPERBOARD

Patent Owner's Preliminary Response and Exhibit List

Jan 19, 2016PAPERPATENT OWNER

FDA Orange Book for Adderall XR

Jan 19, 2016EXHIBITPATENT OWNER

Adderall XR Label

Jan 19, 2016EXHIBITPATENT OWNER

Complaint, Shire. v. Impax, 03-cv-1164 (DDel)

Jan 19, 2016EXHIBITPATENT OWNER

Complaint, Shire v. Sandoz 07-cv-197 (D.Colo.)

Jan 19, 2016EXHIBITPATENT OWNER

Complaint, Shire v. Barr 03-cv-1219,6632 (SDNY)

Jan 19, 2016EXHIBITPATENT OWNER

Complaint, Shire v. Watson, 11-cv-2340 (SDNY)

Jan 19, 2016EXHIBITPATENT OWNER

Complaint, Shire v. Neos 13-cv-1452 (DTx)

Jan 19, 2016EXHIBITPATENT OWNER

Claim Construction Stipulation, Watson, DI 83,84

Jan 19, 2016EXHIBITPATENT OWNER

Claim Constructon Order, Neos, DI 69

Jan 19, 2016EXHIBITPATENT OWNER

Burnside, US RE 41148

Jan 19, 2016EXHIBITPATENT OWNER

FH of Burnside, US 6322819 (Chrono Excerpts)

Jan 19, 2016EXHIBITPATENT OWNER

FH of Burnside, RE42096 (Chrono Excerpts)

Jan 19, 2016EXHIBITPATENT OWNER

FH of Burnside, US 6605300 (Chrono Excerpts)

Jan 19, 2016EXHIBITPATENT OWNER

Barr's Para IV in FH of Burnside, RE42096 (IDS 01 Exh. 25)

Jan 19, 2016EXHIBITPATENT OWNER

Expert Report Chambliss-Impax from FH of Burnside, RE42096 (IDS 02 Excerpts)

Jan 19, 2016EXHIBITPATENT OWNER

Expert Report Klibanov-Shire from FH of Burnside, RE42096 (IDS 02 Excerpts)

Jan 19, 2016EXHIBITPATENT OWNER

Pelham (1987) 80 Pediatrics 491

Jan 19, 2016EXHIBITPATENT OWNER

Swanson 1995, ADHD 333 NEJM 944

Jan 19, 2016EXHIBITPATENT OWNER

Ambrosini (2006) LADD.CAT (Safety, Tolerability, Effectiveness)

Jan 19, 2016EXHIBITPATENT OWNER

Biederman (2002) Randomized Study (Adderall XR)

Jan 19, 2016EXHIBITPATENT OWNER

Swanson (2002) 6 J Atten Disord, New Stimulant Medications

Jan 19, 2016EXHIBITPATENT OWNER

Pelham (1995) Pemoline Effects, 34 J. Am. Acad. Child and Adol. Psych. 1504

Jan 19, 2016EXHIBITPATENT OWNER

Dulcan (1990) Using Psychostimulants, 1 J. Child and Adol. Psych. 7

Jan 19, 2016EXHIBITPATENT OWNER

Patrick and Markowitz (1997) Pharmacology of MPH, AMP, Pemoline, 12 Human Psych. 527

Jan 19, 2016EXHIBITPATENT OWNER

Weisler (2005) 6 Expert Opn. Psych 1003 (Adderall XR)

Jan 19, 2016EXHIBITPATENT OWNER

Adderall Label

Jan 19, 2016EXHIBITPATENT OWNER

Spencer, Arch Gen Psychiatry. 2001 Aug - 58(8) 775-82

Jan 19, 2016EXHIBITPATENT OWNER

McGough, J. AM. ACAD. CHILD ADOLESC. PSYCHIATRY, 426, JUNE 2003

Jan 19, 2016EXHIBITPATENT OWNER

Pliszka, Pediatric Clinics of North America, 45-5, 1085-1098 (1 October 1998)(mixed)

Jan 19, 2016EXHIBITPATENT OWNER

SUPAC-MR- Modified Release Solid Oral Dosage Forms (Sept. 1997) (1997 FDA Guidance)

Jan 19, 2016EXHIBITPATENT OWNER

Amerigen Markman Order, DI 100

Jan 19, 2016EXHIBITPATENT OWNER

Complaint, Shire v. Colony

Jan 19, 2016EXHIBITPATENT OWNER

RE '096 Patent, Figs. 3 and 4

Jan 19, 2016EXHIBITPATENT OWNER

Annotated Fig. 1 of Mehta, US 5837284

Jan 19, 2016EXHIBITPATENT OWNER

Power of Attorney

Nov 3, 2015PAPERINDICATES ARTIFACT WAS SUBMITTED ON BEHALF OF POTENTIAL_PATENT OWNER.

Related Matters

Nov 3, 2015PAPERINDICATES ARTIFACT WAS SUBMITTED ON BEHALF OF POTENTIAL_PATENT OWNER.

Notice of Filing Date Accorded

Oct 19, 2015PAPERBOARD

Petition for Inter Partes Review of USPN RE42,096 under 35 U.S.C. Secs. 311-319 and 37 C.F.R. 42.1-42.80 and 42.100-42.123

Oct 1, 2015PAPERPETITIONER

Petitioner's Power of Attorney for Inter Partes Review of U.S. Patent No. RE42,096

Oct 1, 2015PAPERPETITIONER

Power of Attorney

Oct 1, 2015PAPERPETITIONER

U.S. Patent No. RE42,096 C1

Oct 1, 2015EXHIBITPETITIONER

US Patent No 6322819 File History, Sept 9 1999 Amendment

Oct 1, 2015EXHIBITPETITIONER

U.S. Patent No. 5,837,284

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of 1997 Physicians Desk Reference 51st ed. 1997

Oct 1, 2015EXHIBITPETITIONER

Declaration of Edmund J. Elder, Jr., Ph.D., R.Ph.

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of 1995 United States Pharmacopeia and National Formulary, USP 23-NF 18 1994

Oct 1, 2015EXHIBITPETITIONER

Chiao, Robinson Sustained-Release Delivery Systems, in REMINGTON THE SCIENCE AND PRACTICE OF PHARMACY, 1660, 19th ed. 1995

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of ANSEL, POPOVICH and ALLEN, PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS, 6th ed. 1995

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of Hoffman and Lefkowitz, Catecholamines, Sympathomimetic Drugs, and Adrenergic Receptor Antagonists, in GOODMAN and GILMANS THE PHARMACOLOGICAL BASIS OF THERAPEUTICS, 199, 9th ed. 1996

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of Answering Expert Report of Robert Langer, Sc.D. Regarding United States Patent Nos. 6,322,819 and 6,605,300, Shire Labs, Inc. v. Barr Labs., Inc., Case No. 03-cv-1219PKC, -6632PKC, S.D.N.Y. April 25, 2005

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of ELIEL and WILEN, STEREOCHEMISTRY OF ORGANIC COMPOUNDS, 167, Wiley 1994

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of AMERICAN HERITAGE COLLEGE DICTIONARY, 874, 3rd ed. 1997

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of DOYLE and MUNGALL, EXPERIMENTAL OR-GANIC CHEMISTRY, 37-38, Wiley 1980

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of J. CHILD and ADOLESCENT PSYCH., Oct. 1994

Oct 1, 2015EXHIBITPETITIONER

Earl Rosen et al., Absorption and Excretion of Radioactively Tagged Dextroamphetamine Sulfate From a Sustained-Release Preparation, JAMA, Vol. 194, No. 11, 145, 1965)

Oct 1, 2015EXHIBITPETITIONER

Stuart C. Porter, Coating of Pharmaceutical Dosage Forms, in REMINGTON- THE SCIENCE AND PRACTICE OF PHARMACY, 1650,19th ed. 1995

Oct 1, 2015EXHIBITPETITIONER

U.S. Patent No. 6,322,819 - filed Oct. 21, 1998

Oct 1, 2015EXHIBITPETITIONER

CV of Edmund J. Elder, Jr., Ph.D., R.Ph.

Oct 1, 2015EXHIBITPETITIONER

Order Construing the Terms of U.S. Patent Nos. 6,322,819 and 6,605,300, Shire Labs., Inc. v. Impax Labs., Inc., Case No. 03-1164GMS, D. Del. Feb. 9, 2005)

Oct 1, 2015EXHIBITPETITIONER

Order and Memorandum of Decision, Shire LLC v. Sandoz, Inc., Case No. 07-cv-197, D. Colo. Sept. 24, 2008

Oct 1, 2015EXHIBITPETITIONER

Policy on Period of Marketing Exclusivity for Newly Approved Drug Products with Enantiomer Active Ingredients, Request for Comments, 62 Fed. Reg. 2,167, Jan. 15, 1997

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of Edward Stempel, Prolonged-Action Medication, in DISPENSING OF MEDICATION, 1002, Eric W. Martin ed., Mack 1971

Oct 1, 2015EXHIBITPETITIONER

James R. McCowan, Coating, in DISPENSING OF MEDICATION, 812, Eric W. Martin ed., 7th ed. 1971

Oct 1, 2015EXHIBITPETITIONER

US Patent 6322819 File History, Nov 9 1999 Office Action

Oct 1, 2015EXHIBITPETITIONER

STREITWEISER and HEATHCOCK, INTRODUCTION TO ORGANIC CHEMISTRY, 2d ed. MacMillan 1981

Oct 1, 2015EXHIBITPETITIONER

Shire LLC, Shire US Inc., and Shire Development LLCs Opening Claim Construction Brief, June 29, 2015, filed in Shire LLC v. Corepharma, LLC, 14 05694, D.N.J.,filed June 29, 2015

Oct 1, 2015EXHIBITPETITIONER

US Patent RE42096 File History, Nov 23 2003 IDS

Oct 1, 2015EXHIBITPETITIONER

US Patent No 6322819 File History, May 11 2001 Interview Summary

Oct 1, 2015EXHIBITPETITIONER

Methylphenidate, A Background Paper, U.S. Dept. of Justice Drug Enforcement Administration, Oct. 1995

Oct 1, 2015EXHIBITPETITIONER

US Patent No RE42096 - Mar 3 2008 Amendment Req for Reconsideration After NonFinal Rejection

Oct 1, 2015EXHIBITPETITIONER

US Appl 09176542, Aug 1 2001 Interview Summary

Oct 1, 2015EXHIBITPETITIONER

Physicians Desk Reference, 1997, Copyright Office Public Catalog Entry

Oct 1, 2015EXHIBITPETITIONER

National Criminal Justice Reference Service Abstract for Methylphenidate, A Background Paper

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of Donald N. Franz, Sympathomimetic Drugs, in REMINGTON, THE SCIENCE AND PRACTICE OF PHARMACY, Chapter 57, 981, 987, 19th ed. 1995

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of Handbook of Pharmaceutical Excipients, Hydroxypropyl Methylcellulose, 229, 2d ed. 1994

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of The Feynman Lectures on Physics, Chapter 43, 43-4, 1963

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of DICTIONARY OF PHARMACY, Julian H. Fincher, ed., 1986

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of Multiparticulate Oral Drug Delivery, Isaac - Ghebre-Sellasie ed., 1994

Oct 1, 2015EXHIBITPETITIONER

WO 1998042379 A2

Oct 1, 2015EXHIBITPETITIONER

US Patent No 6322819 File History, Oct 21 1998 New Application Transmittal, Specification, Claims, Drawings and Oath

Oct 1, 2015EXHIBITPETITIONER

US Patent No 6322819, File History, Jun 25 2001 Amendment

Oct 1, 2015EXHIBITPETITIONER

US Patent No 6322819 File History, July 20 2001 Office Action

Oct 1, 2015EXHIBITPETITIONER

W. H. Hartung and J. C. Munch, Amino Alcohols, VI. The Preparation and Pharmacodynamic Activity of Four Isomeric Phenylpropylamines, 53 J. AM. CHEM. SOC. 1875, 1931

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of 1974 PHYSICIANS DESK REFERENCE, Obetrol 1201, 28th ed. 1974

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of 1993 PHYSICIANS DESK REFERENCE, Obetrol 1907, 47th ed. 1992

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of 1995 PHYSICIANS DESK REFERENCE, Obetrol and Adderall 1959-61, 49th ed. 1994

Oct 1, 2015EXHIBITPETITIONER

US Patent No 6322819 File History, Aug 13 2001 Notice of Allowance and Issue Fee Due

Oct 1, 2015EXHIBITPETITIONER

Copyright Catalog entry for 1993 Physicians Desk Reference

Oct 1, 2015EXHIBITPETITIONER

Copyright Catalog entry for 1995 Physicians Desk Reference

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of Fink and Simonsmeier, Laws Governing Pharmacy, in REMINGTON-THE SCIENCE AND PRACTICE OF PHARMACY, 1892, 1900, 19th ed. 1995

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of Marianne Perie et al., Time Spent Teaching Core Academic Subjects in Elementary Schools-Comparisons Across Community, School, Teacher and Student Characteristics, Feb. 1997

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of Kris Holt, Bioequivalence Studies of Ketoprofen-Product Formulation, Pharmacokinetics, Deconvolution, and in vitro-in vivo Correlations, Aug. 20, 1997, Ph.D. Dissertation submitted to Oregon State University

Oct 1, 2015EXHIBITPETITIONER

US Patent RE42096, Jun 22 2007 Non-Final Rejection

Oct 1, 2015EXHIBITPETITIONER

US Patent RE42096 Sept 24 2007 Amendment

Oct 1, 2015EXHIBITPETITIONER

US Patent RE42096 Mar 6 2008 Amendment

Oct 1, 2015EXHIBITPETITIONER

US Patent RE42096 July 24 2008 Office Action

Oct 1, 2015EXHIBITPETITIONER

US Patent RE42096 Oct 24 2008 Amendment

Oct 1, 2015EXHIBITPETITIONER

Keith Marshall and Edward M. Rudnick, Tablet Dosage Forms, in MODERN PHARMACEUTICS, 361, Banker and Rhodes, eds., 2d ed. 1990

Oct 1, 2015EXHIBITPETITIONER

US Patent RE42096 Oct 3 2005 Office Action

Oct 1, 2015EXHIBITPETITIONER

David M. Jones and Phillip J. Percel, Coating of Multiparticulates-Molten Materials, in MULTIPARTICULATE ORAL DRUG DELIVERY, 113, 1994

Oct 1, 2015EXHIBITPETITIONER

Robert A. Castello, et al., Discoloration of Tablets Containing Lactose, J. PHAR. SCI., Vol. 51, No. 2, 106, 1962

Oct 1, 2015EXHIBITPETITIONER

B. Sue Brizuela and Judith A. Hesp, Drug Information, in REMINGTON-THE SCIENCE AND PRACTICE OF PHARMACY, 42, 19th ed. 1995

Oct 1, 2015EXHIBITPETITIONER

Patricia K. Sonsalia, Central Nervous System Stimulants, in REMINGTON -THE SCIENCE AND PRACTICE OF PHARMACY, 1231, 1234, 19th ed. 1995

Oct 1, 2015EXHIBITPETITIONER

Vijay Kumar and Gilbert S. Banker, Maillard Reactions and Drug Stability, in MAILLARD REACTIONS IN CHEMISTRY FOOD AND HEALTH, 20, Theodore P. Labuza, et al., eds., 1994

Oct 1, 2015EXHIBITPETITIONER

WO 1997025064 A1

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of The Merck Index, Susan Budavari, et al., eds., 11th ed. 1989

Oct 1, 2015EXHIBITPETITIONER

Copyright Catalog entry for Goodman and Gilmans

Oct 1, 2015EXHIBITPETITIONER

US Patent RE42096 Mar 24 2005 Preliminary Amendment

Oct 1, 2015EXHIBITPETITIONER

US Patent RE42096 Exhibit 6 to Sept 24 2007 Amendment, PubMed Abstract of T. Kraemer and H. Maurer, J. CHROMAT. BIOMED. SCI. APPL., 1998 Aug 21-713-1-163-87

Oct 1, 2015EXHIBITPETITIONER

US Patent RE42096 Exhibit 7 to Sept 24 2007 Amendment, PubMed Abstract of Wong et al., J. Clin. Pharmacol., 1998 Oct-38-10, 971-8

Oct 1, 2015EXHIBITPETITIONER

US Patent 6322819 Aug 1 2001 Amendment and Remarks

Oct 1, 2015EXHIBITPETITIONER

21 U.S.C. Sec. 812b2, 1994 and Jan. 6, 1997 Supp.

Oct 1, 2015EXHIBITPETITIONER

Declaration of Deborah L. Grimm

Oct 1, 2015EXHIBITPETITIONER

Thomas Kraemer and Hans H. Maurer, J. CHROMAT. BIOMED. SCI. APPL., Vol. 713, 163, 1998

Oct 1, 2015EXHIBITPETITIONER

Y. Nancy Wong, et al., Comparison of the Single-Dose Pharmacokinetics and Tolerability of Modafinil and Dextroamphetamine Administered Alone or in Combination in Healthy Male Volunteers, J. CLIN. PHARMACOL., Vol. 38, 971, 1998

Oct 1, 2015EXHIBITPETITIONER

Selected Portions of Kenneth A. Connors, et al., CHEMICAL STABILITY OF PHARMACEUTICALS, 82, 2d ed. 1986

Oct 1, 2015EXHIBITPETITIONER

US Patent RE42096 Sept 24 2007 Amendment

Oct 1, 2015EXHIBITPETITIONER

Letter from Robert Temple, Director, Office of Drug Evaluation to William A. Neurge, Chief Operating Officer, Richwood Pharma Co., Feb. 13, 1996

Oct 1, 2015EXHIBITPETITIONER

US Patent 6322819 Mar 2 2000 Response to Office Action

Oct 1, 2015EXHIBITPETITIONER

Joseph B. Schwartz, Joel R. Flamholz and Robert H. Press, Computer Optimization of Pharmacaeutical Formulations 1-General Procedure, 62 J. Pharm. Sci. 1165, 1973

Oct 1, 2015EXHIBITPETITIONER