The detailed information for PTAB case with proceeding number IPR2018-00293 filed by KVK-Tech, Inc. et al. against Shire, LLC et al. on Dec 11, 2017. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.

Case Details

Proceeding Number
IPR2018-00293
Filing Date
Dec 11, 2017
Petitioner
KVK-Tech, Inc. et al.
Respondent
Shire, LLC et al.
Status
Final Written Decision
Respondent Application Number
14498130
Respondent Tech Center
1600
Respondent Patent Number
9173857
Institution Decision Date
Jul 6, 2018
Termination Date
Jul 3, 2019

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

Notice of Appeal

Aug 29, 2019PAPERPETITIONER

FINAL WRITTEN DECISION 35 U.S.C. sec 318(a); 37 C.F.R. sec 42.73

Jul 3, 2019PAPERBOARD

Joint Errata Sheet for Oral Hearing Transcript

Jun 11, 2019PAPERPETITIONER

ORDER Hearing Transcript Errata Requested by Parties 37 C.F.R. § 42.5(a)

Jun 6, 2019PAPERBOARD

Hearing Transcript

May 30, 2019PAPERBOARD

Petitioner's Demonstrative Exhibits

Apr 2, 2019EXHIBITPETITIONER

Patent Owner's Demonstratives for Oral Hearing

Apr 2, 2019PAPERPATENT OWNER

Patent Owner Reply to Motion to Exclude

Mar 21, 2019PAPERPATENT OWNER

Petitioner's Reply in Support of Motion to Exclude

Mar 21, 2019PAPERPETITIONER

ORDER Conduct of Proceeding

Mar 21, 2019PAPERBOARD

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

Mar 15, 2019PAPERPATENT OWNER

Petitioner's Response to Patent Owner's Sur-Reply

Mar 15, 2019PAPERPETITIONER

Petitioner's Opposition to Patent Owner's Motion to Exclude Evidence

Mar 15, 2019PAPERPETITIONER

KVK-TECH Exhibit 1058 Corrected Declaration of James McCracken, MD

Mar 15, 2019EXHIBITPETITIONER

KVK-TECH Exhibit 1060 Declaration of Steven Roth

Mar 15, 2019PAPERPETITIONER

Patent Owner's Sur-Reply

Mar 7, 2019PAPERPATENT OWNER

Order Re. Ex Parte Communication

Mar 7, 2019PAPERBOARD

2083 - McCracken Exhibit 614

Mar 7, 2019EXHIBITPATENT OWNER

2084 - McCracken Exhibit 612

Mar 7, 2019EXHIBITPATENT OWNER

2082 - McCracken, MD Deposition Transcript

Mar 7, 2019EXHIBITPATENT OWNER

2085 - McCracken Exhibit 615

Mar 7, 2019EXHIBITPATENT OWNER

Patent Owner's Motion to Exclude Exhibits 1047, 1049, 1051, & 1054-1054

Mar 7, 2019PAPERPATENT OWNER

Patent Owner's Request for Oral Argument

Mar 7, 2019PAPERPATENT OWNER

Petitioner's Motion to Exclude

Mar 7, 2019PAPERPETITIONER

Petitioner's Request for Oral Argument

Mar 7, 2019PAPERPETITIONER

Updated Power of Attorney

Feb 28, 2019PAPERPETITIONER

Updated Mandatory Notice as to Lead and Backup Counsel

Feb 28, 2019PAPERPETITIONER

Granting Parties’ Request for Authorization to File Briefing in Lieu of Observations 37 C.F.R. §§ 42.5(a), 42.24(c)(1)

Feb 25, 2019PAPERBOARD

Patent Owner's Notice of Deposition of James T. McCracken

Feb 20, 2019PAPERPATENT OWNER

Patent Owner Objections to Petitioner's Reply Evidence

Feb 14, 2019PAPERPATENT OWNER

Decision Granting Petitioner's Motion for Admission Pro Hac Vice of David J. Galluzzo

Feb 14, 2019PAPERBOARD

Granting Patent Owner's Request for Authorization to File a Sur-Reply

Feb 14, 2019PAPERBOARD

Petitioner Reply

Feb 7, 2019PAPERPETITIONER

Declaration of James McCracken

Feb 7, 2019EXHIBITPETITIONER

1046 - Polli Deposition Tr

Feb 7, 2019EXHIBITPETITIONER

1047 - Polli Deposition Exhibit 100 Adderall XR Pharmacology Review

Feb 7, 2019EXHIBITPETITIONER

1048 - Polli Deposition Exhibit 101 US Patent RE41,148

Feb 7, 2019EXHIBITPETITIONER

1049 - Adderall XR Chemistry Review

Feb 7, 2019EXHIBITPETITIONER

1050 - Mydayis Approvable Letter

Feb 7, 2019EXHIBITPETITIONER

1051 - Mydayis Summary Review

Feb 7, 2019EXHIBITPETITIONER

1052 - Pelham

Feb 7, 2019EXHIBITPETITIONER

1053 - James

Feb 7, 2019EXHIBITPETITIONER

1054 - Dexedrine Label

Feb 7, 2019EXHIBITPETITIONER

1055 - Dyanavel XR Label

Feb 7, 2019EXHIBITPETITIONER

1056 - Adzenys ER Label

Feb 7, 2019EXHIBITPETITIONER

1057 - McGough

Feb 7, 2019EXHIBITPETITIONER

Updated Mandatory Notice as to Lead and Backup Counsel

Jan 24, 2019PAPERPETITIONER

Power of Attorney

Jan 24, 2019PAPERPETITIONER

Motion for Admission Pro Hac Vice of David J. Galluzzo

Jan 24, 2019PAPERPETITIONER

Declaration of David J. Galluzzo in Support of Motion for Admission Pro Hac Vice

Jan 24, 2019EXHIBITPETITIONER

Patent Owner Updated Mandatory Notices

Jan 22, 2019PAPERPATENT OWNER

Errata of James E. Polli Declaration, Ph.D.

Jan 17, 2019EXHIBITPATENT OWNER

DECISION Granting Petitioner’s Motion to Withdraw and Substitute Counsel 37 C.F.R. § 42.10

Jan 15, 2019PAPERBOARD

PETITIONER¿¿¿S NOTICE OF DEPOSITION OF DR. JAMES E. POLLI PURSUANT TO 37 C.F.R. ¿¿ 42.53(d)(4)

Jan 7, 2019PAPERPETITIONER

PETITIONER KVK-TECH, INC.'S MOTION FOR WITHDRAWAL AND SUBSTITUTION OF COUNSEL

Dec 17, 2018PAPERPETITIONER

Petitioner's Updated Mandatory Notice Regarding Removal of Back-Up Counsel

Nov 28, 2018PAPERPETITIONER

Petitioner's Power of Attorney Appointing Additional Back-Up Counsel

Nov 16, 2018PAPERPETITIONER

Petitioner's Updated Mandatory Notice Regarding Additional Back-Up Counsel

Nov 16, 2018PAPERPETITIONER

Patent Owner Updated Mandatory Notices

Oct 24, 2018PAPERPATENT OWNER

Declaration of James E. Polli, Ph.D.

Oct 23, 2018EXHIBITPATENT OWNER

Swanson, Canadian Child Adolesc. Psych. Re. 1 4-3 (2005)

Oct 23, 2018EXHIBITPATENT OWNER

Goodman & Gilman, 9th ed (1996)

Oct 23, 2018EXHIBITPATENT OWNER

Remington, 20th ed. (2000), Pharmaceutical Care

Oct 23, 2018EXHIBITPATENT OWNER

Jusko Deposition Exhibit. 304, Levy, Case History of a Pharmaceutical Formulation Failure, Clinical Pharmacology & Therapeutics, 8(6)

Oct 23, 2018EXHIBITPATENT OWNER

BURGESS DEPOSITION TRANSCRIPT (September 24, 2018)

Oct 23, 2018EXHIBITPATENT OWNER

Burgess Deposition Exhibit 200 (Statement regarding drug doses)

Oct 23, 2018EXHIBITPATENT OWNER

Jusko Deposition Exhibit 306, Mager et al., Drug Metabolism Pharmacokinetics, 24(1): 16-24 (2009)

Oct 23, 2018EXHIBITPATENT OWNER

Jusko Deposition Exhibit 310, Jusko, W. J., Symposium on Pediatric Pharmacology, Pediatric Clinics of North America, 19(1) (1972)

Oct 23, 2018EXHIBITPATENT OWNER

Patent Owner Response

Oct 23, 2018PAPERPATENT OWNER

Ansel, Popovich & Allen 6th, Ch. 3-5 (1995)

Oct 23, 2018EXHIBITPATENT OWNER

Brauer J. Clin. Pharm. 16-1 72-76 (1996)

Oct 23, 2018EXHIBITPATENT OWNER

Handbook of Pharmaceutical Excipients, 4th ed. (2003), Preface

Oct 23, 2018EXHIBITPATENT OWNER

Brown, J. Am. Acad. Child Psych. (19) 225-239 (1980)

Oct 23, 2018EXHIBITPATENT OWNER

Jusko Deposition Exhibit 305, Findling, Journal of Psychopharmacology, 30(4):404-410 (2010)

Oct 23, 2018EXHIBITPATENT OWNER

Jusko Deposition Exhibit 307, Jusko, Foundations of Pharmacodynamic Systems Analysis, 161-175 (2016)

Oct 23, 2018EXHIBITPATENT OWNER

Jusko Deposition Exhibit 309, Guidelines for Collection and Analysis of Pharmacokinetic, 8-29 (2006)

Oct 23, 2018EXHIBITPATENT OWNER

JUSKO DEPOSITION TRANSCRIPT (September 27, 2018)

Oct 23, 2018EXHIBITPATENT OWNER

Jusko Deposition Exhibit 303, Levy et al., Journal of Pharmaceutical Sciences, 58(4) (1969)

Oct 23, 2018EXHIBITPATENT OWNER

Jusko Deposition Exhibit 308, Sharma et al., Journal of Pharmacokinetics and Biopharmaceutics, 24(6): 611-635

Oct 23, 2018EXHIBITPATENT OWNER

Mendyk et al., Dissolution Technologies, May 2015

Oct 23, 2018EXHIBITPATENT OWNER

Shen and Burgess, J. Control Release, 2015 December 10; 219, 644-51

Oct 23, 2018EXHIBITPATENT OWNER

AstraZeneca Pharms. LP v. Anchen Pharms., 2012 US Dist LEXIS 43989 (2012)

Oct 23, 2018EXHIBITPATENT OWNER

U.S. Pharmacopeia 24, pp. 1629-1631 (2000)

Oct 23, 2018EXHIBITPATENT OWNER

Dokoumetzidis, International J. Pharm., 321, 1-11 (2006)

Oct 23, 2018EXHIBITPATENT OWNER

Burgess Declaration Errata Sheet

Oct 22, 2018EXHIBITPETITIONER

Jusko Declaration Errata Sheet

Oct 22, 2018EXHIBITPETITIONER

Notice of Deposition of Diane J. Burgess

Sep 20, 2018PAPERPATENT OWNER

Notice of Deposition of William J. Jusko

Sep 20, 2018PAPERPATENT OWNER

DECISION Granting Petitioner's Motions for Admission Pro Hac Vice of Thomas Hedemann and Chad Landmon

Aug 13, 2018PAPERBOARD

Patent Owner's Notice of Stipulation Regarding Scheduling Order

Aug 3, 2018PAPERPATENT OWNER

SCHEDULING ORDER

Jul 10, 2018PAPERBOARD

Trial Instituted Document

Jul 6, 2018PAPERBOARD

Second Corrected Certificate of Service for Patent Owner Preliminary Response

Apr 13, 2018PAPERPATENT OWNER

Patent Owner's Corrected Certificate of Service

Apr 11, 2018PAPERPATENT OWNER

DECLARATION OF SARA ROSENBAUM, Ph.D. (with CV)

Apr 10, 2018EXHIBITPATENT OWNER

MYDAYIS¿¿ FDA Label (06-2017)

Apr 10, 2018EXHIBITPATENT OWNER

MYDAYIS¿¿ Website Pages

Apr 10, 2018EXHIBITPATENT OWNER

Excerpts from Merck, 11th Ed

Apr 10, 2018EXHIBITPATENT OWNER

Stempel, 7th Ed. - Dispensing of Medication (1971)

Apr 10, 2018EXHIBITPATENT OWNER

Patrick, Human Psychopharmacology, 12_527-546 (1997)

Apr 10, 2018EXHIBITPATENT OWNER

Gibaldi, Biopharmaceutics & Clinical Pharmacokinetics, Ch.1 (1991)

Apr 10, 2018EXHIBITPATENT OWNER

Patent Owner's Preliminary Response [Confidential]

Apr 10, 2018PAPERPATENT OWNER

Gibaldi, Biopharmaceutics & Clinical Pharmacokinetics, Ch.5 (1991)

Apr 10, 2018EXHIBITPATENT OWNER

Chiao, Remington, Ch. 94 - Sustained Release (1995)

Apr 10, 2018EXHIBITPATENT OWNER

Winters, Basic Clinical Pharmacokinetics (1994)

Apr 10, 2018EXHIBITPATENT OWNER

Hendeles, J. Allergy Clin. Immunol., 72_7_43-751 (1986)

Apr 10, 2018EXHIBITPATENT OWNER

Koziolek, Advanced Drug Delivery Reviews 101_75¿¿¿88 (2016)

Apr 10, 2018EXHIBITPATENT OWNER

Swanson, Clin. Pharmacol. Therap., 66_95-305 (1999)

Apr 10, 2018EXHIBITPATENT OWNER

Percel, US 2003-0157173A1

Apr 10, 2018EXHIBITPATENT OWNER

Couch, WO 2004-028509A1

Apr 10, 2018EXHIBITPATENT OWNER

DECLARATION OF BERNHARDT L. TROUT, Ph.D. (with CV)

Apr 10, 2018EXHIBITPATENT OWNER

FDA Orange Book Listing for MYDAYIS¿¿ (NDA N022063)

Apr 10, 2018EXHIBITPATENT OWNER

Amidon, U.S. Patent No. 5,229,131

Apr 10, 2018EXHIBITPATENT OWNER

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

Apr 10, 2018EXHIBITPATENT OWNER

IPR2017-00011 Decision Denying Institution (RE41, 148 (300 Patent)

Apr 10, 2018EXHIBITPATENT OWNER

Ansel, Popovich & Allen 6th, Ch. 3-5 (1995) Part 1

Apr 10, 2018EXHIBITPATENT OWNER

Ansel, Popovich & Allen 6th, Ch. 3-5 (1995) Part 2

Apr 10, 2018EXHIBITPATENT OWNER

Sonsalia, Remington Ch. 74, - CNS Stimulants (1995)

Apr 10, 2018EXHIBITPATENT OWNER

Robinson, Remington, Ch. 94 - Sustained Release (1995)

Apr 10, 2018EXHIBITPATENT OWNER

Porter, Remington, Ch. 93 - Coating (1995)

Apr 10, 2018EXHIBITPATENT OWNER

Franz, Remington Vol. II, Ch. 57 - Sympathomimetic Drugs (1995)

Apr 10, 2018EXHIBITPATENT OWNER

Malinowsi, Remington, Ch. 53 - Bioequivalence (2000)

Apr 10, 2018EXHIBITPATENT OWNER

USP 23 NF 18 - Uniformity Sec. 905 (1955)

Apr 10, 2018EXHIBITPATENT OWNER

USP 23 NF 18 1995 - Excerpts (1955) Part 1

Apr 10, 2018EXHIBITPATENT OWNER

USP 23 NF 18 1995 - Excerpts (1955) Part 2

Apr 10, 2018EXHIBITPATENT OWNER

Spencer, Arch Gen Psych, 58775-78 (2001 Aug)

Apr 10, 2018EXHIBITPATENT OWNER

Lehninger, Principles of Biochemistry, Excerpt (1993)

Apr 10, 2018EXHIBITPATENT OWNER

Benet, Toxicologic Pathology, 23_115-123 (1995)

Apr 10, 2018EXHIBITPATENT OWNER

Shargel, Applied Bio & Pharmacokinetics, Ch. 2 (1999)

Apr 10, 2018EXHIBITPATENT OWNER

Patent Owner's Preliminary Response [Public]

Apr 10, 2018PAPERPATENT OWNER

Hinsvark, J. Pharmacokin. Biopharm., 1_319-328 (1973)

Apr 10, 2018EXHIBITPATENT OWNER

Benet, Transplantation Proc., 31 (Suppl 3A), 7S-9S (1999)

Apr 10, 2018EXHIBITPATENT OWNER

Rowland, Clinical Pharmacokinetics 2d (1989)

Apr 10, 2018EXHIBITPATENT OWNER

Mircioiu, Basic & Clinical Pharmacology & Toxicology, 96_262¿¿¿264 (2005)

Apr 10, 2018EXHIBITPATENT OWNER

Booijink, Future Microbiol. 2(3), 285-295 (2007)

Apr 10, 2018EXHIBITPATENT OWNER

Fischer, Pharm. Res., 4_480-485 (1987)

Apr 10, 2018EXHIBITPATENT OWNER

Gupta and Robinson, Controlled Release Delivery (1992)

Apr 10, 2018EXHIBITPATENT OWNER

Macheras, Oral Drug Absorption, Ch. 6 - Modeling Biopharm. (2006)

Apr 10, 2018EXHIBITPATENT OWNER

Schug, European J. Pharm. Sci., 15_279-285 (2002)

Apr 10, 2018EXHIBITPATENT OWNER

FDA Use & Limitations of In Vitro Testing (Excerpts)

Apr 10, 2018EXHIBITPATENT OWNER

Guidance for Industry ER Formulations IVIVC (1997)

Apr 10, 2018EXHIBITPATENT OWNER

Amidon, Mol. Pharm., 7_1361 (2010)

Apr 10, 2018EXHIBITPATENT OWNER

Khan, International Journal of Pharmaceutics 140_131-143 (1996)

Apr 10, 2018EXHIBITPATENT OWNER

Chasseaud, Ann. Rev. Pharmacol., 14_35-46 (1974)

Apr 10, 2018EXHIBITPATENT OWNER

Greenhill, J. Am. Acad. Child Adolesc. Psychiatry, 42_1234-1241 (2003)

Apr 10, 2018EXHIBITPATENT OWNER

Spencer, Current Diagn & Treatment Psych., Ch 35 - ADHD (2008)

Apr 10, 2018EXHIBITPATENT OWNER

Decision re Institution of IPR2015-02009

Apr 10, 2018EXHIBITPATENT OWNER

Gibaldi, Biopharmaceutics & Clinical Pharmacokinetics, Ch. 7 - (1991)

Apr 10, 2018EXHIBITPATENT OWNER

Gibaldi, Biopharmaceutics & Clinical Pharmacokinetics, Appendix II Super-position (1991)

Apr 10, 2018EXHIBITPATENT OWNER

Shire, Q3 2017 MYDAYIS Results (Excerpts)

Apr 10, 2018EXHIBITPATENT OWNER

Brauer, J. Clin. Pharm. 16-1, 72-76 (1996)

Apr 10, 2018EXHIBITPATENT OWNER

Auiler, Curr. Med. Res. Opin., 18_311-316 (2002)

Apr 10, 2018EXHIBITPATENT OWNER

Protective Order

Apr 10, 2018EXHIBITPATENT OWNER

Shire, ER and IR Utilization in Adult ADHD [CONFIDENTIAL]

Apr 10, 2018EXHIBITPATENT OWNER

Shire, MYDAYIS Performance [CONFIDENTIAL]

Apr 10, 2018EXHIBITPATENT OWNER

Patent Owner's Motion to Seal

Apr 10, 2018PAPERPATENT OWNER

Corrected Petition for Inter Partes Review

Jan 11, 2018PAPERPETITIONER

Notice of Accord Filing Date

Jan 10, 2018PAPERBOARD

Motion for Pro Hac Vice Chad Landmon

Jan 9, 2018PAPERPETITIONER

1041 Declaration of Chad Landmon in support of Pro Hac Vice

Jan 9, 2018EXHIBITPETITIONER

Motion for Pro Hac Vice Thomas Hedemann

Jan 9, 2018PAPERPETITIONER

1042 Declaration of Thomas Hedemann in support of Pro Hac Vice

Jan 9, 2018EXHIBITPETITIONER

Patent Owner Mandatory Notices

Dec 29, 2017PAPERPATENT OWNER

Petition for Inter Partes Review for Patent No. 9,173,857

Dec 11, 2017PAPERPETITIONER

1003- PDR 2004 Adderall

Dec 11, 2017EXHIBITPETITIONER

1004- Declaration of Diane J. Burgess

Dec 11, 2017EXHIBITPETITIONER

1005- File History of US Patent No. 8,846,100 part 1

Dec 11, 2017EXHIBITPETITIONER

1005- File History of US Patent No. 8,846,100 part 2

Dec 11, 2017EXHIBITPETITIONER

1007- Chang 1987

Dec 11, 2017EXHIBITPETITIONER

1009- Orange Book Approved Drug Products Adderall

Dec 11, 2017EXHIBITPETITIONER

1010- Kratochvil

Dec 11, 2017EXHIBITPETITIONER

1011- Heal, Amphetamine Past and Present

Dec 11, 2017EXHIBITPETITIONER

1012- Bradley

Dec 11, 2017EXHIBITPETITIONER

1014- Tulloch- Adderall XR

Dec 11, 2017EXHIBITPETITIONER

1016- US Patent No. 5,326,570

Dec 11, 2017EXHIBITPETITIONER

Power of Attorney

Dec 11, 2017PAPERPETITIONER

1001-US 9,173,857

Dec 11, 2017EXHIBITPETITIONER

1002- US 6,605,300

Dec 11, 2017EXHIBITPETITIONER

1006- Declaration of William J. Jusko

Dec 11, 2017EXHIBITPETITIONER

1008- Adderall 1996 Approval Letter

Dec 11, 2017EXHIBITPETITIONER

1013- Drugs @ FDA Approved Drug Products Adderall XR

Dec 11, 2017EXHIBITPETITIONER

1015- US Patent No. 4,728,512

Dec 11, 2017EXHIBITPETITIONER

1023- US Patent application No. 10 353,073

Dec 11, 2017EXHIBITPETITIONER

1026- Wagner

Dec 11, 2017EXHIBITPETITIONER

1028- HPE (2d ed.) 1994

Dec 11, 2017EXHIBITPETITIONER

1032- Adderall IR Label 2005

Dec 11, 2017EXHIBITPETITIONER

1017- US Patent No. 8,313,776

Dec 11, 2017EXHIBITPETITIONER

1018- US Patent No. 6,555,136

Dec 11, 2017EXHIBITPETITIONER

1019- US Patent No. 6,322,819

Dec 11, 2017EXHIBITPETITIONER

1020- FDA Review 2002 Adderall

Dec 11, 2017EXHIBITPETITIONER

1021- Orange Book Approved Drug Products Adderall XR

Dec 11, 2017EXHIBITPETITIONER

1022- Gilman 1990

Dec 11, 2017EXHIBITPETITIONER

1024- Agyilirah 1991

Dec 11, 2017EXHIBITPETITIONER

1025- Chambliss 1983

Dec 11, 2017EXHIBITPETITIONER

1027- Limmer 2000

Dec 11, 2017EXHIBITPETITIONER

1029- HPE (3d ed.) 2000

Dec 11, 2017EXHIBITPETITIONER

1030- File History of US Patent No. 9,173,857

Dec 11, 2017EXHIBITPETITIONER

1031- Adderall Label 2004

Dec 11, 2017EXHIBITPETITIONER

1033- Clausen 2005

Dec 11, 2017EXHIBITPETITIONER

1034- WO 1999066904

Dec 11, 2017EXHIBITPETITIONER

1035- WO 1998027967

Dec 11, 2017EXHIBITPETITIONER

1036- Reply Markman brief by Shire

Dec 11, 2017EXHIBITPETITIONER

1037- McCracken

Dec 11, 2017EXHIBITPETITIONER

1038- Wilson in Oral Drug Absorption Prediction and Assessment (2000)

Dec 11, 2017EXHIBITPETITIONER

1039- Fallingborg 1999

Dec 11, 2017EXHIBITPETITIONER

1040- Fallingborg 1990

Dec 11, 2017EXHIBITPETITIONER