AZURITY PHARMACEUTICALS, INC. vs Helsinn Healthcare S.A.

Notice: Notice filing date accorded

Power of Attorney for Patent Owner Helsinn Healthcare S.A.

Patent Owner's Mandatory Notices

U.S. Patent 8,623,826 B2, issued 17 January 2014

U.S. Patent 9,186,357 B2, issued 17 November 2015

U.S. Patent 9,943,515 B2, issued 17 April 2018

U.S. Patent 10,828,297 B2, issued 10 November 2020

Prosecution history for U.S. Appl. 13/077,462, filed 31 March 2011, Pt1

Prosecution history for U.S. Appl. 13/077,462, filed 31 March 2011, Pt2

Prosecution history for U.S. Appl. 14/069,927, filed 01 November 2013

Prosecution history for U.S. Appl. 15/003,327, filed 19 May 2016, Pt1

Prosecution history for U.S. Appl. 15/003,327, filed 19 May 2016, Pt2

Prosecution history for U.S. Appl. 15/923,050, filed 16 March 2018

J. Herrstedt & P. Dombernowsky, Anti-Emetic Therapy in Cancer Chemotherapy

T. Hoffmann et al., Design and synthesis of a novel

R. Hargreaves, Imaging Substance P Receptors (NK1)

The Antiemetic Subcommittee of the Multinational Association of Supportive

M. Bös et al., 4-phenyl-pyridine derivatives, U.S. Patent 6,297,375

Eisai, Inc., ALOXI (palonosetron HCl) Capsules, package insert (Aug. 2008)

J.D. Herrington et al., Randomized, Placebo-controlled

D. Bonadeo et al., Soft Capsules Comprising Palonosetron Hydrochloride

R.J. Gralla et al., Recommendations for the use of antiemetics

K. Jordan et al., Guidelines for Antiemetic Treatment of Chemotherapy

Curriculum Vitae of Dr. Stephen J. Peroutka

G.K. Reddy et al., Novel Neurokinin-1 Antagonists as Antiemetics

M.S. Aapro et al., A phase III, double-blind, randomized trial

D. Campos et al., Prevention of cisplatin-induced emesis

A.E. Chang et al., eds., Oncology: An Evidence-Based Approach (2006)

S.P. Chawla et al., Establishing the Dose of the Oral NK1 Antagonist

S.P. Chawla et al., Establishing the Dose of the Oral NK1 Antagonist

A. De Leon, Palonosetron (Aloxi): a second-generation 5-HT3

R.A. Duffy, Potential therapeutic targets for neurokinin-1 receptor

Press Release, Eisai Co., FDA Approves ALOXIⓇ (Palonosetron HCl)

Merck & Co., EMEND, package insert (2008)

DailyMed, EMEND (aprepitant) Capsule

U.S. Food and Drug Administration, General Considerations for the Clinical

U.S. Food and Drug Administration, Q3A Impurities in New Drug Substances

D.G. Warr et al., Efficacy and tolerability of aprepitant

S.M. Grunberg et al., Effectiveness of a single-day three-drug regimen

Press Release, GSK provides update on regulatory filings for Zunrisa

P.J. Hesketh et al., The Oral Neurokinin-1 Antagonist Aprepitant

G.S. Paulekuhn et al., Trends in active pharmaceutical ingredient salt

S. Poli-Bigelli et al., Addition of the neurokinin 1 receptor antagonist

T. Qiu et al., Antiemetic regimen with aprepitant in the prevention

C. Rojas, The antiemetic 5-HT3 receptor antagonist Palonosetron inhibits

C. Ruhlmann & J. Herrstedt, Casopitant: a novel NK1-receptor antagonist

R. Saito et al., Roles of substance P and NK1 receptor in the brainstem

Ronald D. Schoenwald, Pharmacokinetics in Drug Discovery and Development

A.G. Thomas, Netupitant and palonosetron trigger NK1 receptor

K.E. Thummel, Gut instincts: CYP3A4 and intestinal drug metabolism, 117(11)

D.S. Wang, Effect of aprepitant for the prevention of chemotherapy-induced

W. Yeo et al., A randomized study of aprepitant, ondansetron

S.F. Zhou, Drugs Behave as Substrates, Inhibitors and Inducers of Human

Parenteral, Merriam-Webster

NK1 receptor antagonist by Roche, Advances in Drug Discovery

RxList, ALOXI (palonosetron HCl) Capsules

DailyMed excerpts relating to ALOXI (palonosetron HCl) Capsules

DailyMed excerpts relating to Aloxi (palonosetron HCl) Capsules

PCT Publication WO 2011/061622, filed 18 November 2010

Provisional Patent Appl. 61/382,709, filed 14 September 2010

Provisional Patent Appl. 61/262,470, filed 18 November 2009

Drugs@FDA: FDA-Approved Drugs

P. Li & L. Zhao, Developing Early Formulations: Practice and Perspective

G. Sanso, Double capsule for the administration of active principles

B. Cromie, Drug Combinations, 1(2) Current Medical Research and Opinion

Notice: Power of Attorney

Expert Declaration of Dr. Stephen J. Peroutka

Petition: as filed