Home
Generics, Super Generics & Patent Strategies
29 March - 30 March 2004
Generics, Super Generics & Patent Strategies
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.

SAE Media Group’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, SAE Media Group’s ‘Generics, ‘Supergenerics & Patent Busting’ Conference 2003

  • Conference agenda

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Patenting biotech inventions in the US

  • Understanding the basics of patenting biotech inventions in the US
  • Recent developments in the law
  • Tips and pitfalls of patenting biotech inventions in the USPTO
  • Trends and future of US biotech patent law
  • clock

    9:45

    Patenting biotech inventions in Europe

  • The current status of the EP directive and its impact on EP biotech law
  • Recent cases in Europe
  • Legal protection of biotech inventions
  • Future steps for the directive
  • clock

    10:30

    Morning Coffee

    clock

    10:45

    Patenting biotech inventions in China

  • Standards for patentability (novelty, lack of inventive step, utility)
  • Deposit of micro-organisms
  • Written description requirements
  • Sequence listing
  • Providing copies of references
  • clock

    11:30

    Updates on international biotech patent practice

  • Differences between the US, European and Asian biotech patent laws
  • Overview of the trilateral co-operation (US, EP and JP patent offices)
  • Trilateral Co-operation’s involvement with biotech patent applications
  • Future progress of global biotech patent practice
  • clock

    12:15

    Discussion and Questions – Review of the Session

    clock

    12:30

    Close of Executive Briefing

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    Dr Howard Rosenberg

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

    clock

    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
  • clock

    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
  • clock

    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

    clock

    11:00

    Morning Coffee

    clock

    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

    clock

    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
  • clock

    12:40

    Lunch

    clock

    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
  • clock

    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
  • clock

    15:20

    Afternoon Tea

    clock

    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?
  • clock

    16:00

    Chairman’s Closing Remarks and Close of Day One

    clock

    8:30

    Re-registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    Dr Murray Ducharme

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

    clock

    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?
  • clock

    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’
  • clock

    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
  • clock

    11:00

    Morning Coffee

    clock

    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
  • clock

    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
  • clock

    12:40

    Lunch

    clock

    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
  • clock

    14:40

    THE HATCH-WAXMAN ACT

    Andrea Wayda, Partner, Morgan & Finnegan

  • 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
  • clock

    15:20

    Afternoon Tea

    clock

    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
  • clock

    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
  • clock

    17:00

    Chairman's Closing Remarks and Close of Conference

    Grange City Hotel

    Coopers Row
    London EC3N 2BD
    United Kingdom

    Grange City Hotel

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download

    Title


    Description

    Download

    Title


    Description


    Download


    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    Group Booking

    Please complete the below form and a member of SAE Media Group’s booking team will be in contact within 24 hours

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.

    Thank you for visiting our event

    If you would like to receive further information about our events, please fill out the information below.

    By ticking above you are consenting to receive information by email from SAE Media Group.
    Full details of our privacy policy can be found here https://www.smgconferences.com/privacy-legals/privacy-policy/.
    Should you wish to update your contact preferences at any time you can contact us at data.privacy@smgconferences.com.
    Should you wish to be removed from any future mailing lists please click on the following link http://www.smgconferences.com/opt-out

    Fill in your details to download the brochure

    By submitting this form you agree to our privacy policy and consent to receiving communications, you may opt out at any time.