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Introduction to Intellectual Property & Generics
13 May 2009
Introduction to Intellectual Property & Generics

About the workshop Leader

Peter Wittner, B.Sc., is an independent consultant specialising in the commercial and legal aspects of generics with more than 30 years’ pharmaceutical experience. Before starting his own business, Peter was responsible for European generic sales at Evans Medical and later headed the European sales and marketing department of the UK generics company H.N. Norton, which subsequently became part of IVAX.

He later joined the Indian generic leader Ranbaxy as Managing Director to help set up its UK business and then returned to consultancy work (http://www.interpharm-consultancy.co.uk/). Interpharm advises new market entrants on generic strategies, helps companies that are seeking to enlarge their product portfolios, provides support in business development for generic companies based outside the EU that are trying to enter the market and acts as an agent for a CRO providing biostudies to the generic industry.

In addition, Peter is a regular conference speaker, often runs seminar on topics related to the generics industry and has written a number of reports on the generics industry including:

  • Growth Strategies in Generics
  • Generics Defense Strategies
  • US and European Prescription Generic Markets

as well as a report just published in January on Indian Generics and another in May entitled “Asia: Threat or Opportunity?”. Peter is also a regular contributor to the GenericsWeb newsletter “INNsight”.

IP and Generics

Intellectual Property, often abbreviated to IP, plays an extremely significant role in the generic world, but not everybody who ought to know about it really understands it. The topic includes important matters such as patent issues and data exclusivity and these two are often confused, even though there are significant differences between them. IP issues can affect generic development, registration and launch and making mistakes due to a lack of knowledge can work out very expensive.

This workshop is designed to follow on from the conference and look at some specific cases where IP matters have had a significant influence. It will to permit participants to consider some of the issues discussed during the previous two days and exchange experiences and views about generics and IP

Benefits of attending. The workshop will offer:-

  • An opportunity to discuss how IP affects commercial aspects of the generics business
  • An opportunity to discuss how IP also affects regulatory aspects of the generics business
  • A look at some defence tactics used by Big Pharma with examples
  • An overview of data exclusivity topics
  • A brief examination of differences between the US and European systems
  • A chance to discuss the topic with fellow professionals in your field and exchange experiences

About the Organisation

Interpharm Consultancy specialises in offering support to the generic industry, particularly companies that are new to the field or based outside Europe. Peter Wittner set up the company in 1998 after leaving Ranbaxy with the intention of sharing his experience of the generic industry at both the national and international level.

Interpharm has cooperated with a number of generic companies to help them work out their strategy for expansion, but also with branded companies concerned about the potential impact of generics on certain of their brands that are nearing the end of the patent protection period.

Apart from giving assistance with development of growth strategies, Interpharm helps companies looking to buy in new generic products to expand their portfolio and uses its connections with the major European generic groups to introduce overseas manufacturers to potential new business partners and markets.

Interpharm can also provide on-site training on strategic, legal and regulatory issues affecting the generics industry. www.interpharm-consultancy.co.uk

Interpharm Consultancy specialises in offering support to the generic industry, particularly companies that are new to the field or based outside Europe. Peter Wittner set up the company in 1998 after leaving Ranbaxy with the intention of sharing his experience of the generic industry at both the national and international level.

Interpharm has cooperated with a number of generic companies to help them work out their strategy for expansion, but also with branded companies concerned about the potential impact of generics on certain of their brands that are nearing the end of the patent protection period.

Apart from giving assistance with development of growth strategies, Interpharm helps companies looking to buy in new generic products to expand their portfolio and uses its connections with the major European generic groups to introduce overseas manufacturers to potential new business partners and markets.

Interpharm can also provide on-site training on strategic, legal and regulatory issues affecting the generics industry. www.interpharm-consultancy.co.uk

specialises in offering support to the generic industry, particularly companies that are new to the field or based outside Europe. Peter Wittner set up the company in 1998 after leaving Ranbaxy with the intention of sharing his experience of the generic industry at both the national and international level.

Interpharm has cooperated with a number of generic companies to help them work out their strategy for expansion, but also with branded companies concerned about the potential impact of generics on certain of their brands that are nearing the end of the patent protection period.

Apart from giving assistance with development of growth strategies, Interpharm helps companies looking to buy in new generic products to expand their portfolio and uses its connections with the major European generic groups to introduce overseas manufacturers to potential new business partners and markets.

Interpharm can also provide on-site training on strategic, legal and regulatory issues affecting the generics industry. www.interpharm-consultancy.co.uk

Workshop agenda

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8:30

Registration & Coffee

clock

9:00

Welcome and Introductions

clock

9:10

Session 1 – Review – How Big Pharma uses IP to defend itself

Patent walls and clusters
New formulations and “evergreening”
Some patent case histories
 Ratiopharm vs. AstraZeneca

  • Ranbaxy vs. Pfizer
  •  Winners & losers
  • Discussion – is Big Pharma getting smarter at defending its products?
    Data exclusivity in Europe

  •  Old situation – 6 years or 10 years?
  • New situation – 8+2+1
    Controversy surrounding the Indian situation
    Data exclusivity in other parts of the world
    Data exclusivity or patent exclusivity – which matters more?
    Discussion - Is Data Exclusivity a good thing or a bad thing
  • clock

    10:30

    Morning coffee

    clock

    11:00

    Session 2 – A look at how generic companies use IP

  • Blocking tactics
  • Generic vs GeneriGeneric Clopidogrel launch – will it set a trend?
  • Paragraph IV and “Authorized Generics”
  • Patent situation in other parts of the world – why are Indian companies becoming more enthusiastic
  • Discussion – will generic companies spend more time fighting each other instead of Big Pharma?
  • Changing generic model – the hybrid company
  • Future growth areas – biosimilars, supergenerics, inhalation products
    Discussion – will these areas be limited to generic companies that can fund patent challenges or will companies form coalitions to fight them?
  • clock

    12:15

    Discussion, questions and problems from the participants

    clock

    12:30

    Close of Workshop

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    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:

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    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.

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    GLOBAL CPD

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