Array BioPharma Inc. vs TAKEDA PHARMACEUTICAL COMPANY LIMITED

ORDER Granting Petitioner's Unopposed Motion to Expunge

PETITIONER'S UNOPPOSED MOTION TO EXPUNGE

ORDER Granting Petitioner's Unopposed Motion to Preserve Record Pending Appeal and to Extend Deadline for Filing a Motion to Expunge

Petitioner's Unopposed Motion to Preserve The Record Pending Appeal

DECISION ON REMAND 35 U.S.C. sec. 144 and 37 C.F.R. sec. 42.5(a)

Order Granting Joint Motion to Limit the Petition

Joint Motion to Limit Petition Pursuant to 37 C.F.R. 42.71

ORDER Conduct of Proceeding 37 C.F.R. sec. 42.5

Patent Owner's Reply to Petitioner's Response to Brief on Contingent Motion to Amend Following Remand

Petitioner's Response to Patent Owner's Brief on Remand

Patent Owner's Brief on Contingent Motion to Amend Following Remand

Order Conduct of Proceeding

Order Granting Patent Owner's Motion to Withdraw Counsel

Notice of Filing Transcript of February 22, 2018 Conference Call

Patent Owner's Updated Exhibit List

Exhibit 2065 - Feb. 22, 2018 Conference Call Transcript

Patent Owner's Motion to Withdraw Counsel

Patent Owner Updated Mandatory Notices

Patent Owner Updated Power of Attorney

Order - Granting Petitioner's Motion to Preserve Record Pending Appeal

Unopposed Motion to Preserve the Record Pending Appeal

Termination Decision Document

Decision - Motion to Seal and Protective Order

Record of Oral Hearing

Patent Owner's Opposition to Petitioner's Revised Motion to Seal and Motion for Protective Order

Patent Owner's Exhibits List

E-mail correspondence between Counsel for Patent Owner and Counsel for Petitioner

Motion for Default Protective Order

Petitioner's Revised Motion to Seal

Petitioner's Exhibit List

Redacted Array Registration Record for AR00453645

Redacted Electronic Notebook Entries of Timothy Kercher documenting the synthesis of compounds including AR00453645

Redacted Electronic Notebook Entries of Timothy Kercher documenting the structural confirmation of synthesized compounds including AR00453645

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 1 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 2 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 3 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 4 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 5

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 6 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 7 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 8 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 9 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 10 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 11 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 12 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 13 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 14 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 15 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 16 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 17 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 18 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 19 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 20 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 21 of 22

Redacted Electronic Notebook Entries of Array chemists documenting the synthesis and structural confirmation of compounds, Part 22 of 22

Redacted Summary chart of compounds synthesized and tested

Redacted Deposition Transcript of Steven Andrews, Part 1of 2

Redacted Deposition Transcript of Steven Andrews, Part 2 of 2

Redacted Declaration of John Moore, Esq.

Revised Redacted Declaration of Steven Andrews

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Redacted Deposition Transcript of Peter Bernstein

Order Trial Hearing

Patent Owner's Notice of Demonstrative Exhibits for Oral Argument

Petitioner's Demonstrative Exhibits for Oral Hearing

Patent Owner Demonstrative Exhibit 2056 (Excerpts of Exhibit 1001)

Patent Owner's Demonstrative Exhibit 2057 (Excerpts of Exhibit 1010)

Patent Owner's Demonstrative Exhibit 2058 (Excerpts of Exhibit 1011)

Patent Owner's Demonstrative Exhibit 2059 (Excerpts of Exhibit 2033)

Patent Owner's Demonstrative Exhibit 2060 (Excerpts of Exhibit 2047)

Patent Owner's Demonstrative Exhibit 2061 (Excerpts of Exhibit 2048)

Patent Owner's Demonstrative Exhibit 2062 (Excerpts of Exhibit 2052)

Patent Owner's Demonstrative Exhibit 2063 (Excerpts of Exhibit 2053)

Decision Denying Petitioner's Motion to Seal and Denying Entry of Petitioner's Proposed Protective Order

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

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

Petitioner's Response to Patent Owner's Motion for Observations on Cross-Examination

Patent Owner's Motion for Observation on Cross-Examination of Michael Crimmins

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Patent Owner's Motion to Exclude (redacted)

Patent Owner's Exhibit List

Patent Owner's Request for Oral Argument

Petitioner's Reply in Support of the Combined Motion to Seal and Motion for Protective Order

Petitioner's Request for Oral Argument

Eleftherios K Pefkianakis et al.

Grzegorz Szczepaniak et al.

Transcript of the Second Deposition of Dr. Michael Crimmins

Objection to Evidence 37 C.F.R. 42.64(b)

Board' E-mail dated February 2, 2016 in response to PO's E-mail dated February 1, 2016

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

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Expunged

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Patent Owner's Opposition to Petitioner's Combined Motion to Seal and Motion for Protective Order

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Notice of Deposition - Michael Crimmins, Ph.D.

Notice of Deposition of Steven Andrews, Ph.D.

Notice of Deposition of Peter Bernstein, Ph.D.

Notice of Stipulation to New Due Dates

Petitioner's Reply to Patent Owner's Response

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Redacted Opposition to Motion to Amend

Motion to Seal and for a Protective Order

Petitioner's Exhibit List

Certified Transcript of the December 21, 2015 Deposition of David Hunt, Ph.D.

Declaration of Michael Crimmins, Ph.D. in Support of Petitioner's Reply

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Ikeura, 41 J. Med. Chem. 4232 (1998)

Cappelli, 47 J. Med. Chem. 1315 (2004)

Harrison, 4 Bioorganic and Medicinal Chemistry Letters 2545 (1994)

Swain, 38 J. Med. Chem. 4793 (1995)

Redacted Declaration of Timothy Kercher, Ph.D.

Redacted Declaration of Steven Andrews, Ph.D.

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Array Provisional Application No. 61/485,858

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Protective Order

Proposed Protective Order (Redlined)

Redacted Declaration of Peter Bernstein, Ph.D. in Support of the Opposition to the Motion to Amend

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Petitioner's Notice of Deposition of David Hunt, PH.D.

Petitioner's Objections to Patent Owner's Exhibits Under 37 CFR 42.64

Expunged

Motion to Amend

Patent Owner's Response

Patent Owner'sExhibits List

WO 03/057668

Chemical Structure of Compound 3 of EP721

WO 03/101964

Petitioner's Expert's Synthesis of Compound 3

WO 05/068427

WO 06/030975

WO 06/115286

Proposed Substitute Claim

WO 2014/078378

WO 2012/158413

EP 721 without Compound 3

Specification of U.S. Application No. 13/119,743

Transcript of Deposition of Michael Crimmins on October 15, 2015

Declaration of David Hunt, Ph.D.

WO 07/015588

WO 07/089031

WO 09/072643

WO 00/018403

WO 06/005741

WO 02/088101

ICH Guideline for Elemental Impurities Q3D_Current Step 2b version_26 July 2013

WO 04/111000

Order Granting Petitioner's Motion to Submit Corrected Exhibits

Corrected Crimmins Declaration

Corrected Certified Translation of KR 838,645 B1

Patent Owner's Opposition to Petitioner's Motion to Submit Corrected Exhibits Under 37 CFR 42.104(c)

Notice of Deposition

Ex. 1007 Crimmins Declaration in Support Under 37 CFR 42.104(c)

Ex. 1008 Yoon Declaration in Support of Motion Under 37 CFR 42.104(c)

Ex. 1009 Johnson Declaration in support of Motion Under 37 CFR 42.104(c)

Stipulation to New Due Dates

Motion to Submit Corrected Exhibits Under 37 CFR 42.104(c)

Order - re Conference Call (10/6/2015)

Petitioners Proposed Motion List

Amended Mandatory Notices

Petitioner's Objections to Patent Owner's Exhibits Under 37 CFR 42.64

Institution Decision

Scheduling Order

Patent Owner's Preliminary Response

Original Claims 1-22 of U.S. Application No. 13/119,743

Amendment filed December 3, 2012

Final Office Action mailed January 22, 2013

FORM PTO/SB/08 filed December 3, 2012

Otsuka et al., Neurotransmitter Functions of Mammalian Tachykinins, Physiological Reviews, Vol. 73, No. 2, April 1993, pp. 229-308

Maggi et al., Tachykinin receptors and tachykinin receptor antagonists, Journal of Autonomic Pharmacology, Vol. 13, Issue 1, Feb. 1993, pp. 23-93

Lecci et al., Peripheral Tachykinin Receptors as Potential Therapeutic Targets in Visceral Diseases, Expert Opinion Ther. Targets, 7(3), 2003, pp. 343-362

Salomé et al., Selective Blockade of NK2 or NK3 Receptors Produces Anxiolytic- and Antidepressant-like Effects in Gerbils, Pharmacology, Biochemistry and Behavior, 83, 2006, pp. 533-539

Spooren et al., NK3 Receptor Antagonists the Next Generation of Antipsychotics, Nature Reviews, Drug Discovery, Vol. 4, December 2005, pp. 967-975

De Giorgio et al., Novel Therapeutic Targets for Enteric Nervous System Disorders, TRENDS in Pharmacological Sciences, Vol. 28, No. 9, 2007, pp. 473-481

Andrews et al., Abdominal Vagal Afferent Neurones an Important Target for the Treatment of Gastrointestinal Dysfunction, Current Opinion in Pharmacology, 2(6), 2002, pp. 650-656

Stanghellini et al., New Developments in the Treatment of Functional Dyspepsia, Drugs, 63 (9), 2003, pp. 869-892

Kris et al., American Society of Clinical Oncology Guideline for Antiemetics in Oncology Update 2006, Journal of Clinical Oncolony, Vol. 24, No. 18, June 20, 2006, pp. 2932-2947

Talley, Nicholas J., New and Emerging Treatments for Irritable Bowel Syndrome and Functional Dyspepsia, Expert Opinion Emerging Drugs, 7(1), 2002, pp. 91-98

Improta et al., Central Effects of Selective NK1 and NK3 Tachykinin Receptor Agonists on Two Models of Experimentally-Induced Colitis in Rats, Peptides, 24, 2003, pp. 903-911

OConnor et al., The Role of Substance P in Inflammatory Disease, Journal of Cellular Physiology, 201, 2004, pp. 167-180

Amendment After Final Rejection filed June 20, 2013

Notice of Allowance and Notice of Allowability mailed July 19, 2013

Pages 35-38 of European Patent Application 1,623,721 A1

Related Matters

Power of Attorney

Notice of Accepting Corrected Petition

Corrected Petition

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Notice of Filing Date Accorded to Petition and Defective Petition

Array BioPharma Inc. Petition for IPR of Pat. No. 8,594,454

Power of Attorney

Patent No. 8,594,454

Crimmins Declaration

European App. EP1623721 A1

KR 838,645 B1

Certified Translation of KR 838,645 B1

August 1, 2012 Non-Final Office Action