Mylan Pharmaceuticals Inc. et al. vs Bausch Health Ireland Limited et al.

Other: Fed Circuit mandate

Other: other court decision

Panel Change Order

EXPUNGED

Petitioner Mylan's Notice of Appeal

Petitioner Mylan's Notice of Appeal

Final Written Decision: original

Petitioner's Updated Exhibit List

Transcript of Telephone Conference between the Parties and the Board, held on August 17, 2023

Order Conduct of the Proceeding

Email

Other: Hearing transcript

UNREDACTED - Paper 38 Petitioner's Reply to Patent Owner's Response

UNREDACTED - Paper 54 Mylan's Motion to Exclude

UNREDACTED - Paper 56 Petitioner's Opposition to Motion to Seal

UNREDACTED - Transcript of the Deposition of Stephen G. Davies

UNREDACTED - Second Declaration of Blake Peterson, Ph.D.

UNREDACTED - Declaration of Dr. Michael Epstein

Petitioner's Demonstratives

Patent Owner's Response (Unredacted copy of Paper 27)

Patent Owner's Sur-Reply (Unredacted Copy of Paper 49)

Patent Owner's Updated Exhibit List

EX2023 - Declaration of Kunwar Shailubhai (Unredacted))

EX2024 - Declaration of Stephen G. Davies (Unredacted)

EX2025 - Declaration of Scott A. Waldman (Unredacted)

EX2027 - Study No. SP-PH-001 (Unredacted)

EX2028 - Study No. SP-PH-004 (Unredacted)

EX2071 - Patent Owner's Demonstratives

Patent Owner's Notice Pursuant to the Board's Order

Patent Owner's Updated Mandatory Notices

Patent Owner's Reply in Support of Its Motion to Exclude

Petitioner Mylan's Reply Supporting Mylan's Motion to Exclude

ORDER Conduct of the Proceeding

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

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

Patent Owner's Updated Exhibit List

EX2066 - Supplemental Declaration of Kunwar Shailubhai

Petitioner's Opposition to PO's Motion to Exclude

April 7, 2023 Exhibit List

Petitioner's Updated Exhibit List

Patent Owner's Motion to Exclude

(Under Seal) Petitioner's Motion to Exclude Evidence

Petitioner's Opposition to Motions to Seal

(Under Seal) Petitioner's Opposition to Motions to Seal

Petitioner's Notice re Material Filed Under Seal

Patent Owner's Sur-Reply

Patent Owner's Motion To Seal

Patent Owner's Sur-Reply (Public)

Patent Owner's Updated Exhibit List

Deposition Transcript of Blake R. Peterson, Ph.D., dated April 25, 2023

Deposition Transcript of Michael Samuel Epstein, M.D., dated April 11, 2023

Petitioner's May 10, 2023 Exhibit List

Public Redacted Version of Second Declaration of Blake R. Peterson, Ph.D.

Public Redacted Version of Declaration of Dr. Michael S. Epstein

Public Redacted Version of Petitioner's Reply (Paper 38) to POR

Patent Owner's Motion to Seal

ORDER Setting Oral Argument

Petitioner's Request for Oral Argument

Patent Owner's Request for Oral Hearing

Patent Owner's Objections to Petitioner's Evidence

Patent Owner's Notice of Deposition of Blake R. Peterson, Ph.D.

Patent Owner's Notice of Deposition of Michael S. Epstein, M.D.

Petitioner's Reply to Patent Owner Response

Petitioner's Non-Confidential Description of the Nature of Confidential Information

Transcript of Deposition of Stephen G. Davies

Transcript of Deposition of Stephen G. Davies

Transcript of the Deposition of Kunwar Shailubhai Ph.D.

Transcript of the Deposition of Scott Waldman M.D.

Second Declaration of Blake Peterson, Ph.D.

Declaration of Michael S. Epstein, M.D>

R. Urbanski, et al., Internalization of E. Coli ST Mediated by Guanylyl Cyclase C in T84 Human Colon Carcinoma Cells, Biochimica et Biophysica Acta 1245 (1995) 29-36.

A.M. Evans, Comparative Pharmacology of S(+)Ibuprofen and (RS)-Ibuprofen, Clin >Rheumatology (2001) (Suppl 1): S9-14.

Excerpts from File History of EP App. 02721604.3, retrieved from https://register.epo.org/regviewer (last visited March 23, 2023)

U.S. Patent No. 11,319,346 to Shailubhai et al.

(Part 1) Pharmacology Review(s), “TRULANCE (Plecanatide) Tablets”, Application No. 208745Orig1s000, Dec. 2, 2016, p. 1-322,

(Part 2) Pharmacology Review(s), “TRULANCE (Plecanatide) Tablets”, Application No. 208745Orig1s000, Dec. 2, 2016, p. 1-322,

J.W. Fara, Physiological limitations: gastric emptying and transit of dosage forms, in RATE CONTROL IN DRUG THERAPY (L.F. Prescott, W.S. Nimmo eds.), Churchill Livingstone, 1985:144-150).

Curriculum Vitae of Michael S. Epstein, M.D.

Linzess® Label (March 2017), https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202811s013lbl.pdf (last visited March 23, 2023)

Joint Stipulation to Change Due Dates

Petitioner's Updated Mandatory Notices

Notice of Deposition of Scott A. Waldman, M.D., Ph.D., FDP, FAHA, FNAL, FASPET

Notice of Deposition of Stephen G. Davies, D.Phil.

Notice of Deposition of Kunwar Shailubhai, Ph.D.

Petitioner's Objections to Patent Owner's Supplemental Evidence

EXPUNGED

Petitioner's Objections to Patent Owner's Response Evidence

Institution decision and grant of joinder, IPR2023-00016

Patent Owner's Motion to Seal and Enter Default Protective Order

Patent Owner's Response (CONFIDENTIAL)

Patent Owner's Response (PUBLIC)

Patent Owner's Updated Exhibit List

EX2023 - Declaration of Kunwar Shailubhai (CONFIDENTIAL)

EX2023 - Declaration of Kunwar Shailubhai (PUBLIC)

EX2024 - Declaration of Stephen G. Davies (CONFIDENTIAL)

EX2024 - Declaration of Stephen G. Davies (PUBLIC)

EX2025 - Declaration of Scott A. Waldman (CONFIDENTIAL)

EX2025 - Declaration of Scott A. Waldman (PUBLIC)

EX2026 - Transcript of November 1, 2022 Deposition of Blake R. Peterson

EX2027 - Study No. SP-PH-001 (CONFIDENTIAL)

EX2027 - Study No. SP-PH-001 (PUBLIC)

EX2028 - Study No. SP-PH-004 (CONFIDENTIAL)

EX2028 - Study No. SP-PH-004 (PUBLIC)

EX2029 - Curriculum Vitae of Stephen G. Davies

EX2030 - Curriculum Vitae of Scott A. Waldman

EX2031 - FDA News Release

EX2032 - Dressman 1990

EX2033 - Nugent 2001

EX2034 - Rudin 1999

EX2035 - Jonson 2001

EX2036 - Fiser 1996

EX2037 - Garcia 1993

EX2038 - Takada 2000

EX2039 - Sood 2001

EX2040 - Pennington Letter

EX2041 - Grossman 1964

EX2042 - Barrett 1998

EX2043 - Jeng 1996

EX2044 - Nguyen 2004

EX2045 - Harms 2009

EX2046 - Liu 2009

EX2048 - Borgaonkar 2000

EX2049 - Francis 1997

EX2050 - Yamada Textbook 1999

EX2051 - Thompson 1999

EX2052 - Collins 2001

EX2053 - Camilleri 2001

EX2054 - Suares 2011

EX2055 - Sandler 1990

EX2056 - Faigel 2002

EX2057 - Pharmacotherapy Update - Cisapride Withdrawal

EX2058 - Bharucha 2020

EX2059 - Chey 2021

EX2060 - Carpick 1993

EX2061 - Lucas 2000

EX2062 - Beltowski 2001

EX2064 - Trulance Label (October 2020)

EX2065 - Kita 1994

Joint Stipulation to Change Due Dates

Patent Owner's Updated Mandatory Notices

Patent Owner's Updated Mandatory Notices

Patent Owner's Notice of Deposition of Blake R. Peterson, Ph.D.

Petitioner Mylan Pharmaceuticals Inc.'s Updated Exhibit List

Petitioner Mylan's Objections to Patent Owner's Pre-Institution Evidence

Patent Owner���s Objections to Petitioner���s Pre-Institution Evidence

Institution Decision: Granting Institution of Inter Partes Review 35 U.S.C. sec. 314 Granting Petitioners Motion to Amend Real Party in Interest Statement 37 C.F.R. sec. 42.5

Order: Scheduling Order

Patent Owner's Sur-Reply Regarding Discretionary Denial Under 35 U.S.C. �� 325(d) and Patent Owner's Opposition to Motion to Amend Real Party-in-Interest

Petitioner Mylan Pharmaceuticals Inc.'s Updated Exhibit List

Transcript of PTAB Video Conference Hearing held on July 28, 2022

Petitioner's Pre-Institution Reply

Ex. 3001 Email on Motion to Exclude

Order: On Motion to Exclude

Replacement Version - Patent Owner���s Preliminary Response

Patent Owner's Updated Mandatory Notices

Petitioner Mylan Pharmaceuticals Inc.'s Updated Exhibit List

(Corrected) Expert Declaration of Blake R. Peterson, Ph.D.

(Corrected) Hamra, F. K., et al., Opossum Colonic Mucosa Contains Uroguanylin and Guanylin Peptides, AM. J. PHYSIOL. GASTROINTEST. LIVER PHYSIOL., 270, 1996, G708-G716

(Corrected) U.S. Prov. Pat. App. No. 60/348,646, Guanylate Cyclase Receptor Agonists for the Treatment of Tissue Inflammation and Carcinogenesis, filed Jan. 17, 2002 by Shailubhai, K., et al.

Petitioner Mylan Pharmaceuticals Inc.'s Mandatory Change-of-Information Notices

Patent Owner's Preliminary Response

Patent Owner's Exhibit List

Amended Scheduling Order

Mylan Action, Parties' Proposed Schedule (ECF No. 98-1)

Defendants First Request for Production to Plaintiffs Nos. 1-50

Civil Docket For Case 21-10057

Mylan Request for Production 1-132

MSN Paragraph IV Notice Letter ('786 Patent)

Mylan Paragraph IV Notice Letter

Hidaka 1998

Hidaka 2000

Marx 1998

Chino 1998

Hamra 1993

Ironwood Press Release, Feb. 11, 2013

U.S. 7,371,727

U.S. 7,704,947

U.S. 7,745,409

EXPUNGED

U.S. 8,110,553

Brancale 2017

Klodt 1997

WO 01/25266 A1

U.S. 8,080,526 (Corrected)

Patent Owner's Mandatory Notices

Patent Owner's Power of Attorney and Designation of Lead and Backup Counsel

Notice: NOTICE OF FILING DATE ACCORDED TO PETITION AND TIME FOR FILING PATENT OWNER PRELIMINARY RESPONSE

U.S. Patent No. 7,041,786, Guanylate Cyclase Receptor Agonists for the Treatment of Tissue Inflammation and Carcinogenesis, issued May 9, 2006 to Shailubhai, K., et al.

Curriculum Vitae of Dr. Blake R. Peterson, Ph.D.

Prosecution History of U.S. Patent No. 7,041,786 (Part 1)

Prosecution History of U.S. Patent No. 7,041,786 (Part 2)

U.S. Patent No. 5,489,670, Human Uroguanylin, issued Feb. 6, 1996 to Currie, M. G., et al.

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Part 3 - Nelson, D. L., et al., Chapters 4-5, 7, LEHNINGER PRINCIPLES OF BIOCHEMISTRY, 3rd ed. (eds. Ryan, M., et al., Worth Publishers) 2000

Part 4 - Nelson, D. L., et al., Chapters 4-5, 7, LEHNINGER PRINCIPLES OF BIOCHEMISTRY, 3rd ed. (eds. Ryan, M., et al., Worth Publishers) 2000

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Declaration of Dr. Blake R. Peterson, Ph.D.

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Petition for Inter Partes Review

Petitioner Mylan Pharmaceuticals Inc. Power of Attorney