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The generics industry is set to boom from 2004 onwards, owing to approximately $82 billion worth of branded blockbusters coming off patent by 2007. This provides unprecedented opportunities for generic manufacturers to expand their profile.

SMi’s 7th Annual conference Generics, Supergenerics & Patent busting will cover:

  • the latest developments within the generics industry keeping both generic and pharmaceutical companies up to date with impending patent expirations
  • Legal and political developments affecting the generics industry in the US and Europe
  • The impact and complications resulting from European Enlargement
  • Current strategies being employed to enter the generics market

    A unique opportunity to learn from leading industry experts including:
    · Bertrand Gellie, Director, European Patent Office
    · Dr Kurt Nielsen, Executive Director, Generic Research & Development, Teva
    · Charles DiLiberti, Vice President, Scientific Affairs, Barr Laboratories
    · Dr Eric Mittleberg, Vice President, Research & Development, Ivax
    · Vijay Soni, Director, Intellectual Property, Dr Reddys
    · Garth Boehm, Vice President, Product Development, Purepac Division, Alpharma
    · William Hare, Patent Counsel, Ranbaxy Pharmaceuticals
    · Dr Salah Ahmed, Senior Vice President, Research & Development, Barr Laboratories
    · Beata Stepniewska, EU Accession Manager, European Generic Medicines Association
    · Dr Andrea Wayda, Partner, Morgan & Finnegan

    BENEFITS OF ATTENDING:
    · NEW & FUTURE OPPORTUNITIES IN GENERIC DRUGS: Look at the impending patent expirations and explore the commercial issues in 2003 and beyond
    · DEVELOPING ‘SUPERGENERICS’: Learn how to invest in the development of supergenerics and hear about the methods deriving economic value
    · LEGAL ISSUES: Assess the current legal issues and challenges in developing generic drugs and hear an update of the changes confronting Europe & the US
    · A GENERIC FOCUS: Analyse the changing dynamics and examine how to overcome the obstacles the generic industry is facing
    · REGULATORY & POLITICAL ISSUES: Examine the loopholes in the Hatch-Waxman Act and learn about the impact of enlargement on regulatory practice
    · NETWORK WITH KEY EXPERTS: Discuss and exchange ideas with leaders in the field

    “This conference is always one of the best of the year”
    David Koch, Senior Advisor, Sicor
    Delegate, SMi’s ‘Generics, ‘Supergenerics & Patent Busting’ Conference 2003

  • Conference programme

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr Howard Rosenberg

    Dr Howard Rosenberg, Director, IP & API Strategy, Merck Generics

    9:10 KEYNOTE ADDRESS

    Charles DiLiberti

    Charles DiLiberti, Vice President, Scientific Affairs, Barr Laboratories

  • The diverse forces shaping the generic market
  • Historical patterns and observations
  • Recent events impacting the generic drug industry
  • A snapshot of the present: the generic market, products and stakeholders
  • Future trends and opportunities for generics
  • 9:40 STREAMLINING PRODUCT DEVELOPEMENT RESEARCH IN GENERIC INDUSTRIES

    Dr Salah Ahmed

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

  • Research and development process strategy
  • Product selection
  • Resource management
  • Technology evaluation and manufacturing consideration
  • Bio/Clinical study
  • FDA filing
  • Product launch
  • 10:20 WHAT EFFECTS WILL REGULATORY CHANGES HAVE ON GENERIC COMPANIES AND HOW LIKELY ARE THEY TO OCCUR BY 2005?

    Charles DiLiberti

    Charles DiLiberti, Vice President, Scientific Affairs, Barr Laboratories

    Dr Eric Mittleberg

    Dr Eric Mittleberg, Vice President, Research & Development, Ivax

    Dr Robert Harrison

    Dr Robert Harrison, Patent Attorney, Senior Manager, Rouse & Co International

    Dr Murray Ducharme

    Dr Murray Ducharme, Vice President, Pharmacokinetics & Pharmacodynamics, MDS Pharma Services

    Lisa Graver

    Lisa Graver, Director of Intellectual Property, Alpharma

    11:00 Morning Coffee

    11:20 INTERIM INJUNCTIONS AND KEY ISSUES TO CONSIDER PRIOR TO LAUNCH FROM ALL PERSPECTIVES

  • Steps to take to prepare for launch
  • Does one have to ‘clear the way’ in advance of launch?
  • What are the prospects of obtaining/avoiding an interim injunction?
  • Effect of cross undertaking – how much is this worth to the injuncted party?
  • Predicting the importance of interim injunctions in the next few years
  • Simon Cohen

    Simon Cohen, Partner, Taylor Wessing

    Nigel Stoate

    Nigel Stoate, Partner, Taylor Wessing

    12:00 REGULATORY DATA EXCLUSIVITY

    Bruno Vandermeulen

    Bruno Vandermeulen, Partner, Bird & Bird

  • Changes to EU legislation: increasing the periods of data exclusivity
  • Generic approvals in Europe and the US
  • Is data exclusivity necessary?
  • Case studies
  • 12:40 Lunch

    14:00 LICENSING & BUSINESS DEVELOPMENT IN THE GENERIC SECTOR

    Paul Ranson

    Paul Ranson, Partner, Pharma Law UK

  • Intellectual property considerations
  • Development and regulatory aspects
  • Financial terms
  • Supply terms
  • Liability and indemnity provisions
  • Termination and the consequences of termination
  • Dispute resolution
  • Competition issues
  • 14:40 INFRINGEMENT

    Mark Elmslie

    Mark Elmslie, Partner, Hewitsons

  • Patent infringement litigation
  • Structuring and negotiating business resolutions of patent infringement disputes
  • Counselling with respect to patent matters
  • Administrative proceedings relating to patents and patent infringement
  • Defences to infringement
  • 15:20 Afternoon Tea

    15:20 STRATEGIES FOR BIOGENERIC SUCCESS IN EUROPE

    Jim Furniss

    Jim Furniss, Director, Pricing and Reimbursement, Bridgehead Technologies

  • The technical barriers to success
  • The intellectual property barriers to success
  • The regulatory barriers to success
  • The commercial barriers to success
  • Winning strategies?
  • 16:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr Murray Ducharme

    Dr Murray Ducharme, Vice President, Pharmacokinetics & Pharmacodynamics, MDS Pharma Services

    9:10 GENERIC PROUCT DEVELOPMENT FROM 1984 TO 2004

    Dr Kurt Nielsen

    Dr Kurt Nielsen, Executive Director, Generic Research & Development, Teva Pharmaceuticals

  • Companies: who has been successful and why?
  • Technology: new vs old
  • Government: USPTO and FDA
  • How do the pieces fit together?
  • 9:40 PATENTS AND THE CHANGING DYNAMICS OF THE (US) GENERIC INDUSTRY

    Lisa Graver

    Lisa Graver, Director of Intellectual Property, Alpharma

  • Brand products and multiple patents
  • Patent challenges generic companies now engage in
  • New barriers: cost and time
  • Losses of patent challenges in generics companies
  • Preparation to ‘launch at risk’
  • 10:20 GENERIC PATENT PROTECTION IN AN EXPANDED EUROPE

    Dr Robert Harrison

    Dr Robert Harrison, Patent Attorney, Senior Manager, Rouse & Co International

  • Important into the ‘old’ EU (free trade?)
  • Pharmaceutical patent protection in the accession states
  • EU trade marks for pharmaceuticals
  • 11:00 Morning Coffee

    11:20 CURRENT CHALLENGES FOR GENERIC COMPANIES

    Dr Eric Mittleberg

    Dr Eric Mittleberg, Vice President, Research & Development, Ivax

  • Bioequivalence and regulations
  • Legal challenges and avoiding delays by brand name companies
  • Manufacturing and supply
  • Marketing strategies: ensuring success of your generic
  • 12:00 INVESTING IN THE DEVELOPMENT OF SUPERGENERICS

    Joachim Greuel

    Joachim Greuel, Partner, Bioscience Valuation

  • Predicting uncertain cash flows
    • Estimating investment returns
    • Contrasting alternative approaches to calculate NPVs
    • Choosing the right discount rate
  • Accounting for development risks
    • Decision trees
    • Discrete probability distributions
    • Estimating probabilities
  • Pricing for supergenerics
  • Analysing competitors
  • Analysing commercial risks
    • Continuous probability distributions
    • Monte Carlo simulation
  •  Maximising the value of a supergenerics
  • 12:40 Lunch

    14:00 LATEST DEVELOPMENTS OF COMMUNITY PATENTS AND INTERPRETATION OF PHARMACEUTICAL PATENT CLAIMS IN THE LIGHT OF NATIONAL COURT CASE LAW

    Bertrand Gellie

    Bertrand Gellie, Director, European Patent Office

  • Community patents
    • Present status and latest developments
    • What will be the costs?
    • What will it change?
  • Interpretation of pharmaceutical patent claims
    • Standard interpretation rules
    • European National Courts case law
    • Practical examples of (non) infringements
  • 14:40 THE HATCH-WAXMAN ACT

    Andrea Wayda

    Andrea Wayda, Partner, Morgan & Finnegan
    View Bio

  • What are the historic loopholes in the Hatch-Waxman Act?
  • How will the new legislation and rules reform the Act?
  • What is the impact for the global generics industry?
  • Recent US cases of particular interest to generics under Hatch-Waxman:
    • What is the scope of patent rights during patent term extension?
    • Recent federal circuit cases and their impact on generics
  • 15:20 Afternoon Tea

    15:40 EUROPEAN ENLARGEMENT

    Beata Stepniewska

    Beata Stepniewska, EU Accession Manager, European Generic Medicines Association

  • Current status of implementation of ‘acquis communautaire’
  • Practical consequences of accession treaty: transitional period, SPC
  • How to deal with applications at the time of the accession?
  • New elements of regulatory strategy after enlargement
  • 16:20 BRANDED GENERICS OVER THE LAST 10 YEARS

    William Hare

    William Hare, Patent Counsel, Ranbaxy Pharmaceuticals

  • How have branded generics progressed over the past 10 years?
  • What changes has the industry seen over the past decade?
  • New tactics and strategies
  • The future of branded generics
  • 17:00 Chairman's Closing Remarks and Close of Conference

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    Workshops

    Patenting Biotechnology Inventions: An International Perspective
    Workshop

    Patenting Biotechnology Inventions: An International Perspective

    Grange City Hotel
    31st March 2004
    London, United Kingdom

    Grange City Hotel

    Coopers Row
    London EC3N 2BD
    United Kingdom

    Grange City Hotel

    HOTEL BOOKING FORM

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