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For the past 20 years, generic pharmaceutical products have been used by millions to treat infection, heart disease, cancer, and numerous other medical conditions. During 2003 generics growth reached a staggering 24%, compared to a brand growth of just 8% and this is set to continue into 2005 and beyond. With an estimated $82 million worth of branded drugs coming off patent by 2007, opportunities for generic companies to expand their profile are growing.

Following the huge success of last year’s event, SMi is pleased to announce the arrival of our 8th Annual Generics, Supergenerics and Patent Strategies conference. This event is set to uncover the latest developments in the Generics industry, keeping both generic and pharmaceutical companies in touch with impending patent expiration, political and legal developments effecting both the US and Europe, and an insight into the Asian market. The conference will also seek to address the impact and complications caused by European enlargement and the new Clinical Directive, modifications to the current regulatory environment and an insight into those strategies being employed by companies seeking to enter the generics market.



Gain an insight from key industry leaders in the field including:

Harpal Singh, Chairman, Fortis Healthcare, a subsidiary of Ranbaxy
Dr Salah Ahmed, Senior Vice President, Research & Development, Barr Laboratories
Dr William Haddad, Chief Executive Officer, Biogenerics
Dr Don Stewart, Director, Research, Cangene Corporation
Dr Walter Hinderer, Director, Patent Affairs, BioGeneriX
Bertrand Gellie, Director, European Patent Office

Programme highlights include:

METHODS OF DEVELOPING GENERICS: Look at the product selection criteria, follow the filling and approval process and prepare for a successful product launch
NEW & FUTURE OPPORTUNITIES IN GENERIC DRUGS: Analyse the latest patent expirations and the future opportunities for generic drugs
LEGAL FRAMEWORK: Examine the current legal issues affecting the European and US generic markets; infringement disputes, generic approval and competition law
DEVELOPING GENERICS: Understand the latest methods and strategies in developing generic biologicals, the effect on patents and what this means for the industry
REGULATION & POLITICAL ISSUES: Hear about industrial property news relating to generics and litigating Hatch-Waxman cases
DEFINING SUPERGENERICS: Learn how supergenerics fit into the generics spectrum; how it is overlooked, and how they impact a drugs market share
NETWORK WITH KEY EXPERTS: Meet leaders in the field, make valuable contacts and learn from their experience and expertise

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Murray Ducharme

Murray Ducharme, Vice President, Pharmacokinects & Pharmacodynamics, MDS Pharma Services

9:10 BARRIERS TO COMPETITION

William (Bill) Haddad

William (Bill) Haddad, Chariman & Chief Executive Officer, Biogenerics

  • TRIPS and TRIPS plus
  • Bilateral agreements
  • Perpetual patents: generic biotech
  • AIDS medicines and PEPFAR: cases in point
  • 9:50 LEGAL KEYNOTE

    Simon Cohen

    Simon Cohen, Partner, Taylor Wessing

  • Preparing for a successful launch - what steps need to be taken?
  • Current legal framework for regulating generics
  • Loopholes in the system - how they’re being exploited
  • Effect of the patent and how the pharmaceutical companies are protected
  • Revoking the patent and ‘clearing the way’
  • Key issues of concern for the generics industry in the EU and North America – health and future of the generics industry
  • Examples of a successful launch and future challenges
  • 10:30 Morning Coffee

    11:00 INFRINGEMENT DISPUTES

    Duncun Curley

    Duncun Curley, Partner, McDermot Will & Emery

  • Understanding the European patent system
  • Potential defences to an infringement claim
  • Negotiating business resolutions of infringement disputes
  • Settlement agreements and the new patent licensing laws
  • Antitrust guidance from the European Commission on settlement agreements
  • Examples of successful and unsuccessful strategies
  • 11:40 THE US GENERIC APPROVAL PROCEDURE

    Neil Greenblum

    Neil Greenblum, Senior Managing Partner , Greenblum & Berstein PLC

  • Orange book and patent listing
  • Exclusivities
  • ANDA overview
  • The notice requirement
  • Litigation timeline
  • 12:20 Networking Lunch

    14:00 DATA EXCLUSIVITY

  • Current status of data exclusivity within intellectual property rights
  • Regional differences - the extent of diversity
  • The effect of the UK provision for new chemical entities
  • Does this impact the EU?
  • Patent disputes - a case study
  • Bruno Vandermeulen

    Bruno Vandermeulen, Partner, Bird & Bird

    George Pickering

    George Pickering , Senior Associate , Bird & Bird

    14:40 ANITRUST AND COMPETITION LAW ISSUES

    Joseph  Reisman

    Joseph Reisman, Partner, Knobbe, Martens, Olson & Bear LLP

  • Tactics used by branded manufactures
  • Generics and government reactions to these tactics
  • Branded generics – regulatory implications
  • Are settlements possible and, if so what types?
  • Case studies and lessons learned
  • 15:20 PORTFOLIO AND FUTURE ASPECTS OF GENERICS

    Norbert Bangert

    Norbert Bangert, Former Manager Generics , Bayer Healthcare AG

  • Interesting aspects of generics for the research and development company
  • Research and dvelopment business aspects in the generics company
  • Different success factors of perscription and generics and cultural aspects
  • Benefits of interaction between research and devlopment and big pharma sector
  • Limitations and future growth aspects
  • Strategic considerations and recommendations
  • 16:00 Chairman’s Closing Remarks and Close of Day One

    Murray Ducharme

    Murray Ducharme, Vice President, Pharmacokinects & Pharmacodynamics, MDS Pharma Services

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Don Stewert

    Don Stewert, Director, Research , Cangene-Corporation

    9:10 GENERIC BIOLOGICAL DRUG DEVELOPMENT

    Don Stewert

    Don Stewert, Director, Research , Cangene-Corporation

  • Process strategies for biogenerics
  • Preclinical and clinical strategies for biogenerics
  • Second generation delivery methods
  • The effect on patents and implications on biogeneric processing
  • What this means for the patient
  • Case studies
  • 9:50 BIOGENERIC DRUG DEVELOPMENT

    Walter Hinderer

    Walter Hinderer, Director, Patent Affairs, BioGenerX

  • Market opportunities
  • Difference to classical generics
  • Legal situation in the EU – the risks
  • The targets – first and second wave
  • Practical aspects – the hurdles
  • 10:30 Morning Coffee

    11:00 DRUG DELIVERY

    Salah Ahmed

    Salah Ahmed, Senior Vice President, Research & Development , Barr Laboratories

  • Product selection criteria
  • Preformulation characterisation and development strategy
  • Scale-up and submission batches
  • Bio study design and issues
  • Filing and approval process
  • Technology transfer and product launch
  • 11:40 SUPERGENERICS

    Murray Ducharme

    Murray Ducharme, Vice President, Pharmacokinects & Pharmacodynamics, MDS Pharma Services

  • Defining a supergeneric
  • How it fits into the generics spectrum - is it often overlooked?
  • Expanding research and development capabilities to incorporate supergenerics
  • How they impact a drugs market share - minimising the effects of additional competition
  • Successes and limitations
  • 12:20 Networking Lunch

    14:00 INDUSTRIAL PROPERTY NEWS RELATING TO GENERICS

    Bertrand Gellie

    Bertrand Gellie, Director, European Patent Office

  • Community patent
  • - Last developments

    - What will it change for generic companies?

  • Polymorphs
  • - The practice of the European Patent Office with respect to patentability of polymorphs

  • Counterfeit generic products
  • - What can you expect from industrial property rights in your fight against counterfeit drug manufactures?

    - Last developments

    - What will it change for generic companies?

    14:40 LITIGATING HATCH-WAXMAN CASES

  • Picking a target
  • Litigation as a strategic business tool
  • Patenting your product
  • Impact of 2003 amendments to Hatch-Waxman
  • Authorised generics
  • Generic biologicals
  • Michael  Davitz

    Michael Davitz, Vice President, Intellectual Property, Taro Pharmaceuticals U.S.A. Inc

    Brian Moriarty

    Brian Moriarty, Partner, Sonnenschein Nath & Rosenthal

    15:20 EMERGING HEALTHCARE IN INDIA

    Harpal  Singh

    Harpal Singh, Chairman , Fortis Healthcare

  • Changing scene in India
  • Corporate health – case study Fortis Healthcare
  • Outsourcing of diagnostics – case study SRL Ranbaxy
  • Integrating Indian healthcare with a global healthcare market
  • 16:00 Chairman’s Closing Remarks and Close of Day One

    Don Stewert

    Don Stewert, Director, Research , Cangene-Corporation

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