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Manufacturers of generic drugs are currently experiencing unprecedented opportunities as large numbers of brand name products lose their patent protection. To take full advantage of this they need strong patent busting strategies. This is to enable them to overcome tactics used by brand name manufacturers to extend the period of patent protection.

US and EU Health Authorities are becoming increasingly concerned about the escalating cost of drugs, and both have recently made proposals to tighten up legislation. This should prevent the exploitation of loopholes by brand name companies and favour the generics producer.

The market research company, Datamonitor, estimates that by 2005, existing Pharma companies will lose 75% of their 1999 revenues to generic competition. To survive they will need even better-developed strategies.

In addition, generic companies are posing a new threat with value-added ‘supergeneric’ drugs. These have a ‘high barrier to entry’ enabling them to enter the lucrative branded market.

The manufacture of biogenerics is more complicated owing to the difficulty of demonstrating biological equivalence. However, these companies are gaining a foothold in Asia and their next targets will be Europe and finally America.

This event will include talks on new directions in legislation from leaders in the public sector. It will also include talks from experts on intellectual property concerns and there will be case studies from generic and pharmaceutical companies with first-hand experience in this field.

A unique opportunity to learn from leading industry experts including:
Bertrand Gellie, Director, European Patent Office
Dr Jeremy Desai, Senior Vice President, Research & Development, Apotex
Bill Haddad, Chairman & Chief Executive Officer, Biogenerics & United States Research & Development Corporation
Martin Zeiger, Senior Vice President, Strategic Business Development, Barr Laboratories
Dr John Langstaff, President & Chief Executive Officer, Cangene
Dr Robert Harrison, Intellectual Property Attorney, Huber & Schuessler
Dr Andrea Wayda, Partner, Pharma Intellectual Propety, Morgan & Finnegan
Vickie O’Neill, Vice President, Business Development, Upsher-Smith Laboratories

“SMi conferences are routinely the best and most interesting.”
Dr Andrea Wayda, Partner, Pharma Intellectual Property, Morgan & Finnegan

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Martin Paltnoi

Martin Paltnoi, Senior Consultant, Martin Paltnoi Associates

9:10 KEYNOTE ADDRESS

Martin Paltnoi

Martin Paltnoi, Senior Consultant, Martin Paltnoi Associates

  • What are generics and supergenerics?
  • The role of intellectual property and patenting
  • Current issues in patenting
  • Patent expiries: the effect on big pharma and biotech
  • Public policy on branded generics
  • 9:40 PATENTS AND EXCLUSIVITY

    Dr Paul Tunnah

    Dr Paul Tunnah, Oncology Analyst, Datamonitor

  • Patents and the drug lifecycle
  • Drugs facing imminent patent loss
  • Opportunities for generic companies
  • Potential losses for major pharmaceuticals
  • Into the future: defensive strategies
  • 10:20 INTERIM INJUNCTIONS

  • Gearing patent obstacles before launch
  • Applying for interim injunctions and how to avoid them
  • Consequences of interim injunctions and value of cross undertaking as to damages
  • Lessons learnt from recent interim injunctions applications, including the Paroxetine cases: SKB v Generics UK, Alapharma & Apotex
  • Likelihood of interim injunctions in the future
  • Nigel Stoate

    Nigel Stoate, Partner, Taylor Wessing

    Simon Cohen

    Simon Cohen, Partner, Taylor Wessing

    11:00 Morning Coffee

    11:20 HEALTHCARE AND PATENT LAW

    Amanda Burton

    Amanda Burton, Researcher, University of Sheffield

  • Patents on the human genome
  • Diagnostic tests
  • Impacts on healthcare
  • The consequences of not implementing the directive properly
  • Moral issues
  • 12:00 EU PATENT LAW

    Bertrand Gellie

    Bertrand Gellie, Director, European Patent Office

  • Understanding European patent law
  • Problems, challenges and solutions
  • New directions and developments
  • Introduction to different types of invention in pharmacy
  • 12:40 Networking Lunch

    13:40 CHALLENGES FACED BY GENERIC MANUFACTURERS

    Dr David Goodman

    Dr David Goodman, Executive Vice President, Pharmascience

  • Patent expiries and opportunities
  • Introducing off patent medicines
  • Successful approaches to selling generic dossiers in Europe and the United States
  • Future of generic drug development
  • 14:20 PATENT PROTECTION PRACTISE

    Brett Rowland

    Brett Rowland, Partner, Lovells

  • What can be patented?
  • Creating innovative strategies
  • Gaining maximum effective life from patents
  • Defending patent rights
  • Interim injunctions
  • 15:00 REGULATORY DATA EXCLUSIVITY

    Jane Mutimear

    Jane Mutimear, Partner, Bird & Bird

  • Generic approvals across Europe
  • Problems with what is ‘essentially similar’
  • Regulatory protection and enlargement
  • Law reform
  • 15:40 Afternoon Tea

    16:00 IN SILICO INVENTIONS

    Dr Robert Harrison

    Dr Robert Harrison, Intellectual Property Attorney, Huber & Schuessler

  • Current law and practice on software protection
  • Protecting results from homology studies
  • Strategies to maximum protection
  • Optimising revenue
  • What needs to change?
  • 16:40 BIOTECHNOLOGY AND PATENT LAW

    Dr Penny Gilbert

    Dr Penny Gilbert, Partner, Bristows

  • The biotech directive: legal protection of biotechnological inventions
  • The consequences of not implementing the directive
  • Scope of protection for gene sequences
  • ‘Reach through’ infringement
  • Defences to infringement
  • 17:20 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Dr Murray Ducharme

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

    9:10 CURRENT ISSUES IN GENERICS

    Dr John Langstaff

    Dr John Langstaff, President & Chief Executive Officer, Cangene

  • Hatch-Waxman Act
  • Brand name companies and exploitation of legal loopholes
  • Delaying tactics to stall generics
  • Governmental influence
  • Reviewing investment options
  • 9:40 US AND EUROPEAN GENERIC LEGISLATION

    Dr Jeremy Desai

    Dr Jeremy Desai, Senior Vice President, Research & Development, Apotex

  • The similarities and differences between US and European generics legislation
  • What needs to change to ensure that the generics industry thrives?
  • Patent disputes in the US and Europe
  • How legislation affects the industry world-wide
  • 10:20 SUCCESSFULLY NAVIGATING THE CHANGING WATERS FOR GENERICS AND SUPERGENERICS IN THE US

    Dr Andrea Wayda

    Dr Andrea Wayda, Partner, Pharma Intellectual Property, Morgan & Finnegan

  • The US political climate and how it impacts generics
  • The history and status of the Greater Access to Affordable Pharmaceuticals Act
  • Generic biologics
  • Generics and supergenerics: noteworthy developments in the US patent office and US courts
  • 11:00 Morning Coffee

    11:20 CURRENT CHALLENGES IN THE ANALYSIS AND DESIGN OF BIOEQUIVALENCE STUDIES

    Dr Murray Ducharme

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

  • Scientific background supporting bioequivalence studies
  • Regulatory guidance’s governing bioequivalence studies in Europe, Canada and in the United States
  • Challenges in the analysis and design of bioequivalence studies: case studies
  • 12:00 PATENTS AND LITIGATION

    Tim Powell

    Tim Powell, Partner, Bristows

  • Patent litigation procedures: similarities, differences and parallels in Europe
  • Preparing for patent litigation
  • Patent infringement
  • Strategies and case studies
  • 12:40 Networking Lunch

    13:40 BARRIERS TO COMPETITION

    Bill Haddad

    Bill Haddad, Chairman & Chief Executive Officer, Biogenerics & United States Research & Development Corporation

  • The rise and fall of the drug price competition and patent restoration act
  • Politics not science
  • AIDS crisis: patent rights or human rights
  • WTO and TRIPS
  • Generic biotech: déjà vu all over again
  • 14:20 AN IRRESISTIBLE FORCE MEETS AN IMMOVABLE OBJECT

    Martin Zeiger

    Martin Zeiger, Senior Vice President, Strategic Business Development, Barr Laboratories

  • The need for innovative companies to have incentives to persue discovery
  • The need to control spiralling upward pharmaceutical costs
  • When do resources for discovery become pure corporate greed?
  • Should copycats have any rights? Aren’t they just parasites?
  • The battle lines are drawn
  • Challenges in the US
  • 15:00 BRANDED GENERICS

    Vickie O’Neill

    Vickie O’Neill, Vice President, Business Development, Upsher-Smith Laboratories

  • What is a branded generic?
  • Where does a branded generic fit?
  • Why sell a branded generic?
  • How do you sell a branded generic?
  • 15:00 PATENT AWARENESS

    Peter Steele

    Peter Steele, Managing Director, Current Patents

  • Awareness of patents
  • Regulatory factors
  • Relevance to monopoly rights
  • Creating successful strategies
  • 15:40 Afternoon Tea

    16:40 BRANDED GENERICS

    Dr John Siebert

    Dr John Siebert, President & Chief Executive Officer, CIMA Labs

  • Generic companies make more tablets, but less money
  • Drug delivery and life cycle management – a positive combination
  • Drug delivery and branded generics – a new trend
  • Fast dissolve drug delivery – a cost effective approach to branded generics
  • A growing market
  • What can we do together?
  • 17:20 Chairman's Closing Remarks and Close of Conference

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