Conference Documentation: Generics, Supergenerics & Patent Strategies

議程中很多是generic drugs的重要issue

May 15, 2006 - Pub ID: SMI1316157
Day 1
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
Dr Murray Ducharme, Vice President, PK & PD, MDS Pharma Services.
9.10 REGULATORY ISSUES
The commercial implications for generics
Effectively sourcing API for generic products following amendments in the GMP auditing system
De-centralisation procedure - implications of applying this to the industry
Application of Roch-Bolar - practical challenges
Case study: generics that have survived litigation - how and why?
Stephen Bennett, Partner, Lovells.
9.50 EUROPEAN ENLARGEMENT
Increasing investment opportunities
Cost containment policies used by governments to control health care expenditure
The decline in competitiveness of the European research-based pharmaceutical industry
The effect of parallel trade in generics
Will there be a single European market for pharmaceuticals?
The challenges that face the industry with enlargement of the EU
Threats to your company: instability of the Euro-National legislative entry barriers
How to lobby around these issues to maintain market shares
Dr Brian Lovatt, Chief Executive Officer & Managing Director, Vision Healthcare Research.
10.30 Morning Coffee
11.00 THE CHALLENGE FROM THE EAST
An analysis of research and development - industry aspects
Evolving perspective - generics for the research and development company
Successful strategies of prescription generics
Cultural considerations
Benefits of interaction between research and development and big-pharma sector
Limitations affecting sustainable growth
Strategic considerations and recommendations
What lies beyond the blockbuster market?
Dr Brian Tempest, Chief Executive Officer & Managing Director, Ranbaxy Laboratories Ltd.
11.40 THE NORTH AMERICAN GENERICS MARKET
An overview of current trends
Global generics marketplace - the North American perspective
Pricing and regulatory compliance issues
Generic penetration and consolidating growth in pharmacy channels
Market presence of brands vs generics
Investigating similarities and differences with Europe
Dr David Goodman, Executive Vice President, Pharmascience.
12.20 Networking Lunch
1.50 PERFORMING INNOVATIVE GENERIC STUDIES
Understanding how to optimise a generic development programme
Study designs (size, crossover arms, sampling time points)
When and how to do a pilot study depending on the compound
Analysing and understanding results: when to reformulate, when not
Choosing the correct sample size
When to perform additional data analysis
Understanding results from studies that do not meet bioequivalence criteria
Dr Paul Zeman, Head, Pharma Exclusives, Siegfried Ltd.
2.30 LAUNCHING YOUR PRODUCT
Key considerations and legal loopholes
Prominent issues for the safe launch of generics
What steps need to be taken?
Legal framework for regulating generics
Loopholes in the system - how are they being exploited?
Patent protection - benefits to the pharmaceutical companies
Revoking the patent and ‘clearing the way’
Will the revised legislation solve all problems?
Mr Simon Cohen, Partner, Taylor Wessing (Solicitors).
Mr Nigel Stoate, Partner, Taylor Wessing (Solicitors).
3.10 Afternoon Tea
3.40 DATA EXCLUSIVITY
A comparison of EU and US regimes
Changes to EU legislation: when do increased exclusivity periods apply?
Advantages of being first to file following the exclusivity period
Orange book and patent listing: the US litigation timeline
Effect on exclusivity periods of:
Line extensions
Hybrid applications
Effect of reference product withdrawal
Challenging generic marketing authorisations
What about biosimilars?
Mr George Pickering, Senior Associate, Reed Smith .
4.20 SUPPLEMENTARY PROTECTION CERTIFICATES
Understanding pharmaceutical patent term extensions
Clarifying EU Supplementary Protection Certificates (SPC/CPC)
Coping with different interpretations of EU Directive
USA pharmaceutical Patent Term Extensions
Litigation covering pharmaceutical patent term extensions
Other counties approach to pharmaceutical patent term extensions
Comparative approaches by originators and generic producers
Mr Martin Paltnoi, CEO, MPA Business Services Ltd.
5.00 Chairman’s Closing Remarks and Close of Day One
Day 2
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
Mr William Haddad, Chariman & Chief Executive Officer, Biogenerics.
9.10 SETTLING INFRINGEMENT DISPUTES
The competition law framework
Structuring and negotiating business resolutions
Defences to infringement
The anti-trust implications of agreements to settle patent disputes in the industry
Settlement agreements and the new patent licensing laws
Recent FTC and Commission investigations
Abusing of a dominant position
Mr Edward Miller, Partner, Reed Smith .
9.50 GRANTING COMMUNITY PATENTS
Examining the breakthroughs
Community Patent and Generics:
What it could change for Generic Companies?
Expectable costs
Latest developments
Recent developments of the case law of the Boards of Appeals at the EPO
Impact on Polymorph patentability
Impact on further medical uses
International Convention on the Pharmaceutical Crime & IPRs
Latest international developments
Will generics have a place in it?
Mr Bertrand Gellie, Director, European Patent Office.
10.30 Morning Coffee
11.00 BIOGENERICS - MYTH OR REALITY?
An interprestation of the opportunities
Establishing the regulatory pathway in biogenerics
Understanding the terminology - essential similarity vs product comparability
Demonstrating equivalence - proving essential bio-similarity
Pharmaceutical equivalence
Therapeutic equivalence
Implications to the Waxman-Hatch provision
The patent hurdle - product process, formulation and indication
What are the lessons learned?
Mr Charles DiLiberti, Vice President, Scientific Affairs, Barr Laboratories.
11.40 PANEL DISCUSSION
Are biogenerics doomed?
Current practices and principles
Changes in IP and regulatory frameworks
Process strategies for biogenerics
How long can the biotech industry hold off legislation?
Implications for the patent
Mr Charles DiLiberti, Vice President, Scientific Affairs, Barr Laboratories.
Dr Murray Ducharme, Vice President, PK & PD, MDS Pharma Services.
Mr William Haddad, Chariman & Chief Executive Officer, Biogenerics.
12.20 Networking Lunch
2.00 EUROPEAN MARKET STRATEGIES
Assessing current aspects and trends
Recent movements in different European markets
European intercommunication
Impact on profitability in competing markets
A sound competitive environment
Mr Norbert Bangert, Former Manager Generics , Bayer Healthcare AG.
2.40 STRATEGIC MEASUREMENT AND MANAGEMENT OF INFRINGEMENT AND PARAGRAPH IV RISKS AND REWARDS
Defining and developing management strategies
Assessment of patent quality and its implications for defence, offence and partnering strategies
Risk management strategies including legal, financial, and insurance options
Implications of WTO and TRIPS initiatives for patent equitable conduct in global trade
Building settlement contracts that can create or preserve future financing options
The anti-trust implications of agreements to settle patent disputes in the industry
Dr David Martin, Chief Executive Officer, M-CAM.
Dr Gary Liberson, Consultant, Life Sciences, PA Consulting.
3.20 INTERNAL STRATEGIES EMPLOYED
A global insight - key factors to succeed
Cost containment
Counteracting market saturation
Identifying the key competitors brands
Competitors product range portfolio
Market position in key markets
First in - last out strategy
Broad product portfolio, including ‘difficult to make’ generics
Cost competitiveness (products, sourcing and vertical integration)
Proactive responses to a changing business environment
Mr William Haddad, Chariman & Chief Executive Officer, Biogenerics. 4.00 Chairman’s Closing Remarks followed by Afternoon Tea. Close of Conference