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Generics & Supergenerics

Employing Defence & Growth Strategies: Brand Protection or Patent Busting

11th to 12th May 2009, Crowne Plaza Hotel - St James, London, United Kingdom.

Introduction to Intellectual Property & Generics

Patentability

13th May 2009, Crowne Plaza Hotel - St James, London.

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

timetable:
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8.30 Registration & Coffee
9.00 Welcome and Introductions
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
10.30 Morning coffee
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?
12.15 Discussion, questions and problems from the participants
12.30 Close of Workshop
costs and discounts

Executive Briefing Registration

Executive Briefing - INTRODUCTION TO INTELLECTUAL PROPERTY AND GENERICS                £499.00    Add to Basket
Executive Briefing - ADVANCED INTELLECTUAL PROPERTY & GENERICS                £499.00    Add to Basket

Conference Registration

Conference Registration - Event Registration                £1,299.00    Add to Basket
Conference Registration - Attend Day 1 Only                £999.00    Add to Basket
Conference Registration - Attend Day 2 Only                £999.00    Add to Basket
Conference Registration - Promotional Literature Distribution                £999.00    Add to Basket
Advanced Patent Busting

How to Develop a Patent Invalidity Case

13th May 2009, Crowne Plaza Hotel - St James, London.

Workshop Leader: Dr Duncan Curley, Director, Innovate Legal

Dr Duncan Curley is a UK solicitor and the founder of Innovate Legal. He obtained his PhD in Medicinal Chemistry at University College, London in 1992. Duncan trained and qualified in the Intellectual Property department of a magic circle law firm in London, before becoming a partner in 2003 at a US law firm, where he specialised in pharmaceutical patent litigation. He formed the boutique law practice Innovate Legal in June 2007. Duncan has acted for a number of companies in a series of high profile patent clearance disputes over the years. He now principally advises on patent issues for companies operating in the generic pharmaceuticals sector. Duncan is the author of a special report on Supplementary Protection Certificates, published by the Intellectual Property Institute in December 2007. He is a frequent contributor to journals such as Patent World and European Intellectual Property Review and he comments regularly on patent cases for INNsight, the GenericsWeb newsletter.

Workshop Objectives & Benefits of Attending

This workshop will offer:

  • Practical tips on what weaknesses to look for in innovator patent specifications
  • Suggestions on how to develop a patent invalidity case
  • An opportunity to develop a deeper understanding of the requirements for patentability (novelty, inventive step, sufficiency of disclosure)
  • An opportunity to understand legal strategies that have worked successfully for removing patent obstacles
  • A chance to discuss strategic options with the Workshop Leader

About the Organisation:

Innovate Legal is a London-based law firm specialising in patents and intellectual property.

Expertise

Innovate Legal undertakes patent clearance and freedom to operate opinions and provides consultancy services to companies wishing to develop a patent strategy.

Client testimony

Innovate Legal is noted by its clients for providing clear, realistic and cost-effective advice.

Litigation clearance work

Innovate Legal’s lawyers are highly experienced litigation and dispute resolution specialists, operating from offices close to the Law Courts in London. If your company wishes to use litigation procedures to clear a patent obstacle, Innovate Legal will formulate a strategy that is aligned with your company’s business goals. This strategy will then be monitored and reviewed throughout the process, so that business objectives remain paramount and the case does not take on a life of its own. Rather than operating according to rigid hourly rate billing arrangements, Innovate Legal can offer fixed fee deals and "success based" billing structures for client projects. www.innovatelegal.co.uk

The firm’s website contains further information on intellectual property issues, including webpages on "Patent Strategy", "How to Knock out a Patent" and "Patent Infringement", as well as free downloads of articles and other briefings.

timetable:
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1.30 Welcome and introduction
1.40
Introduction to the basics:
    Novelty and inventive step
    Sufficiency
    Added subject matter
2.00
Examining novelty in detail
  • Anticipatory disclosure - documents
  • Prior use - perindopril
  • General vs. specific disclosure – olanzapine
2.50 Coffee
3.20
Exploring obviousness in detail
  • Preparing an obviousness case
  • Choosing the prior art
  • Use of experts
  • Technical advantage, commercial success and other issues
4.20
Other grounds of invalidity
  • Insufficiency - oxaliplatin
  • Added matter – clarithromycin
4.45 Discussion and Questions
5.00 Close of workshop
costs and discounts

Executive Briefing Registration

Executive Briefing - INTRODUCTION TO INTELLECTUAL PROPERTY AND GENERICS                £499.00    Add to Basket
Executive Briefing - ADVANCED INTELLECTUAL PROPERTY & GENERICS                £499.00    Add to Basket

Conference Registration

Conference Registration - Event Registration                £1,299.00    Add to Basket
Conference Registration - Attend Day 1 Only                £999.00    Add to Basket
Conference Registration - Attend Day 2 Only                £999.00    Add to Basket
Conference Registration - Promotional Literature Distribution                £999.00    Add to Basket
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