Conference Documentation: Pharmaceutical Intellectual Property : Market Research Report

Conference Documentation: Pharmaceutical Intellectual Property

Published: Jun. 28, 2007

Day One
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks: Dr Duncan Curley , Director, Innovate Legal .
9.10 LEGISLATIVE AND REGULATORY ASPECTS OF BIO-SIMILARS IN THE US: Jim Shehan, Vice President, General Counsel, Novo Nordisk .
9.50 PROTECTING INTELLECTUAL PROPERTY IN AN ALLIANCE SETTING: Collaborative IP management - methods in partnering; Alasdair Moodie, Assistant General Counsel, Cambridge Antibody Technology.
10.30 Morning Coffee
11.00 BIO-SIMILARITY APPROVALS - PROTECTION PAST PATENT EXPIRY: From growth hormones to complex compounds; Reviewing recently denied application - prerequisites for demonstrating bio-similarity; Introduction of bio-similars into clinical practice in Europe; Examining the language of EU and US regulation - implications for follow-on generics; Alexandre Mencik, Senior Legal Counsel, Amgen .
11.40 THE CHANGING LANDSCAPE OF PATENT INFRINGEMENT INJUNCTIONS: Licensing by compulsion; The ebay vs. MercExchange LLC, 126 S. Ct. 1837 (2006) case study and following rulings in the district court; Assessing the balance of damages: public interest against asset protection; Litigating infringement disputes in light of the recent shifts; Thomas F Fleming, Partner, IP Litigation, Kaye Scholer LLP.
12.20 Networking Lunch
1.50 RISK MANAGEMENT IN COURT LITIGATION - VARIATION IN MARKETS: Applying a strategic thought process to assess the prospects in litigation; Reimbursement of legal expenses and its impact on the choice to litigate; Country of origin and its effect on court rulings; Attached costs of litigation: documentation and brand strength; Case-by-case decision making - outlining the risk management process; Dr Frank Burkert, European Patent Attorney, Bayer Healthcare.
2.30 INCREASING INTERPLAY BETWEEN IP RIGHTS AND REGULATORY DECISIONS: Are the regulatory procedures adequate to produce decisions that determine IP rights?; Patents and market authorisation procedures; Bolar provisions; Regulatory conditions for granting SPCs; Specific challenges presented by the new Paediatrics Regulation; How to obtain SPC extension based on regulatory assessments?; Peter Bogaert, Partner, Covington & Burling LLP.
3.10 Afternoon Tea
3.40 SUPPLEMENTARY PROTECTION CERTIFICATES AND GENERIC COMPETITION IN EUROPE: Looking at the patent / anti-trust interface; Supplementary Protection Certificates - a brief overview; Article 82 and the abuse of a dominant position; Case Study: AstraZeneca; The Commission’s market assessment; Dr Duncan Curley , Director, Innovate Legal .
4.20 COMBATING COUNTERFEIT MEDICINES: Pharmaceutical Full-line Wholesalers’ Actions in addressing the problem; The risks counterfeit medicines present in entering the market; The EU legal environment for tackling the phenomenon; Pharmaceutical full-line wholesaling in Europe and its role in the prevention of counterfeit medicine; Martin Fitzgerald, Legal Advisor, European Association of Pharmaceutical Full Line-Wholesalers (GIRP).
5.00 Chairman’s Closing Remarks and Close of Conference

Abstract

In the endeavour of protecting Intellectual Property rights, pharmaceutical companies are closely following the evolvement of work practices in patenting, litigation and deal structuring.

The SMi group’s Pharmaceutical Intellectual Property Conference will examine key aspects of the industry - patent infringement disputes, legal advancements and regulatory frameworks.

How will this conference benefit me?

Q: How will the shift towards Biological Pharmaceuticals impact the legal practice?
A: SHIFTING TOWARDS BIOLOGICS - Reviewing practices in patenting and litigation

Q: What thought processes should be applied to risk management in court litigation?
A: RISK MANAGEMENT IN COURT LITIGATION - Applying a strategic thought process to assess the prospects in litigation

Q: What measures should be taken to protect IP rights in a global arena?
A: MAINTAINING IP RIGHTS IN THE GLOBAL ARENA - Proactive protection in multiple markets

With presentations from key industry experts:

Jim Shehan, Vice President, General Counsel, Novo Nordisk
Alexandre Mencik, Senior Legal Counsel, Amgen
Dr Frank Burkert, European Patent Attorney, Bayer Healthcare
Alasdair Moodie, Assistant General Counsel, Cambridge Antibody Technology
Thomas F. Fleming, Partner, IP Litigation, Kaye Scholar LLP
Peter Bogaert, Partner, Covington & Burling LLP
Dr Duncan Curley, Partner, IP, McDermott, Will & Emery
Monika Derecque-Pois, Director General, GIRP
Christine Hänle, Corporate Purchasing Ethical Manager, Celesio AG

Designed to meet industry needs, the conference creates the perfect setting for prolific exchanges of ideas and networking opportunities.

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Conference Documentation: Pharmaceutical Intellectual Property

Table of Contents

Abstract