Generics and Patent life Cycle Management

GENERICS & PATENT LIFE CYCLE MANAGEMENT
Strategies in the Pharmaceutical Industry 2004
30th November and 1st December 2004
Workshop - 29th November 2004
Hilton Kensington, London

++FULL AGENDA BELOW. mailto:[Only registered users see links. ] for your PDF copy of
the brochure++

Visiongain Conferences are please to announce their next conference within
the pharmaceutical sector; 'Generics & Patent Life Cycle Management 2004'.
This conference shall focus on the strategies adopted by generic and branded
pharmas to battle against each other in the effect of generic erosions, and
discuss the future of biologics facing patent expirations.

KEY THEMES

**Current Legislative Hurdles & Movements Faced by the Industry
**How to Maximise Profit by Effective Patent Life Cycle Management
**Post-Election Update - Effect of Political Interference
**“Evergreening” Strategies to Compete with Generics
**Examine Novel Methods to Protect you IPs
**Strategies to Improve your Sales & Marketing
**Advice on Becoming a Generic Innovator
**Improve your Generics portfolio management
**Analyse how to Penetrate the Biogeneric Market
**Examine Protective Strategies on Biologics

KEY SPEAKERS

**William Haddad, Chairman / CEO, Biogenerics & Founder, US Biogenerics
Association
**Steve Self, Group R&D Director, Merck
**Patrick Vink, Global Head of Biopharmaceuticals, Sandoz
**Dr. Klaus Maleck, Chief Financial Officer, BioGeneriX
**Siu Lo, General Counsel, Taro Pharma ceuticals
**Dr. Jorge Mestre-Ferrandiz, Industrial Economist, Office of Health
Economics
**Dr Steven Charles, VP Business Development, Nektar Therapeutics
**Tim Schyberg, Director, Intellectual Property Europe, Alpharma

This event will provide unrivalled opportunities to promote your brand to an
audience of senior level delegates. Decision makers from all aspects of the
pharmaceutical markets will be in attendance, what better way to elevate
your product? We are continually recognised for providing innovative and
effective means to support your marketing requirements through sponsorship
and exhibitions at our leading events. Options include:

**Full Conference Sponsorship
**Exhibition Stands & Booths
**Cocktail Reception Sponsorship
**Promotional Inserts in Delegate Folders
**Conference Bag Sponsorship

Whatever your budget, whatever your requirements we can find you a way to
place your brand at Pharmaceutical Wholesale & Distribution 2004. 100
Attendees are expected at this event with the following job-titles being
targeted:

+Head of Patent Law
+Senior President, General Counsel
+Staff Vice President, Patents
+Senior Director, Corporate Communication
+Group R&D Director
+President, Generic Pharmaceutical
+Vice President Legal Affairs
+Vice President, Governmental Affairs
+Vice President, Public Affairs
+Vice President, Proprietary Marketing
+Senior Vice President, Global Patents
+Chief Legal Officer
+General Patent Counsel
+Director Intellectual Property
+Chief Financial Officer
+Chief Executive Director, Regulatory Affairs
+Managing Director
+General Counsel
+Director, Patents
+Executive Director for Development

For further information on speaking opportunities, sponsoring the event,
booking exhibition space or delegate passes please do not hesitate to
contact:

Joe Stone
Account Manager
Visiongain Conferences
Tel: +44 (0) 20 8767 6711
Fax: +44 (0) 20 8767 5001
mailto:[Only registered users see links. ]


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DELEGATE REGISTRATION
----------------------

Places at this event are limited, please call or email me now to secure your
place

- PRICING -
Attend the:
** Conf. + pre conf. workshop GBP 1600.00 Plus VAT
** Conference only Fee: GBP 1299.00 Plus VAT
** Pre conference workshop only Fee: GBP 650.00 Plus VAT

- BOOKINGS -
Booking is easy, simply contact Joe Stone on:
Telephone: +44 (0)20 8767 6711
Fax: +44 (0)20 8767 5001
Email: mailto:[Only registered users see links. ]
Terms and conditions apply - see below.

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AGENDA
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PRE-CONFERENCE INTERACTIVE WORKSHOP
Monday 29th November 2004
Generic Marketing & Management - Improve Your Strategies

Morning Session:
Generic Marketing & Management Strategies - Improve Your Strategies
• Current rules & regulatory movements
• Pricing strategies to compete in the largest markets
• Examples of recent learning from new innovative generics
• Effective portfolio management
• Outlook of biogenerics
Workshop Leader: Graham Lewis, VP Strategic Consulting, IMS Health

Afternoon Session:
Patent Awareness - Explore Competitive Intelligence Sources & Strategies
• Advance your patent awareness
• Utilise available resources on patent rights
• Advances in patent information through the years
• Current regulatory factors
• Fact interpretation - Create strategies to enhance your
Workshop Leader: Peter Steele, Director of Current Awareness, Thomson
Scientific

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DAY ONE
Tuesday 30th November 2004
**************************

09:00 Registration and coffee

09:30 Opening remarks from the Conference Chair
Steve Self, Director, Group Research & Development, Merck

LEGISLATIVE AWARENESS

09:40 The Bolar Provision - New Breakthrough for the Generics
Industry?
• Learn about the Industry reaction -Branded pharma’s response
• How will it create a beneficial environment for generic
companies
• How fast will the Provision accelerate generic approvals?
• The Provision’s effect on the European market: How to increase
overall competiveness
• The outlook of the generics industry - Europe vs US
• Bolar Provision: Bringing generic businesses to Europe

Steve Self
Director, Group R&D
Merck

10:20 How to Protect your Intellectual Properties in Europe
• Identify hurdles in the European market- Regional differences
- Evaluate advantages in the Eastern European market
• Current rules and regulatory movements- How do they affect
your organization?
• The Bolar Provision - how will it affect your organization?
• Strategies to protect your IPs in Europe - utilise the European
patent system - patent extensions
• The industry perspective of the outlook of biogenerics

Tim Schyberg
Director, Intellectual Property, Europe
Alpharma

11:00 Morning Coffee

11:20 Examine Hurdles & Solutions in the EU Patent System
• Understanding the patent system in Europe: What can you learn?
• Cost effective prescription medicines in Europe: Pinpoint
the factors limiting growth
• Why were supplementary protection certificates introduced?
- Additional protection afforded by SPCs
• Analyse value to branded pharma & cost to generic companies
• Cross examine the Europe and US patent system

Lorna Brazell
Partner
Bird & Bird

12:00 The Hatch-Waxman Act Reform - How it Will Affect
Branded Pharma
• Impact of the “final rule” - Advantages and disadvantages
• How will it affect your organisation? - Establish a new patent-end
game plan
• Implementation of the “final rule”: legal, regulatory &
business issues to watch out for
• How to use one 30 month stay per generic challenge
• Orange book listing strategies - Controversial loopholes

Joe Manak
Patent Attorney / Shareholder
Greenberg Traurig

12:40 Lunch

14:00 How to Utilise Rules and Regulation to Your Advantage
• How successful is 2nd patent filings? Past examples
• Patent infringements: How court decisions affect it?
• Can we really depend on judges to determine patent validity?
• Play with product differentiation rule - ideas and examples
• Stalling generics: Strategies employed by branded pharma
companies using the controversial Hatch-Waxman Act
• Explore current loopholes in the European patent system

Paul Ranson
Founder
Pharmalaw

14:40 US Rules & Regulations - Current Issues
• The Hatch-Waxman Act -A success story in US legislative
history?
- Examine loopholes and past exploitation stories
• The impact of recent legislative changes and initiatives on the
generic sector- How will they affect your operation?
- Novel ideas you can implement
• Will law reform benefit the generic sector? Analyse Pros &Cons
• Generic pharma versus branded pharma- success stories
• How successful has been generic pharma’s ANDA challenges?
- What are the current trends and issues to watch out for
• The future outlook of the US market -what is needed to
improve

Dr. Robert Millonig & Dr. Robert Esmond
Directors
Sterne Kessler Goldstein & Fox

15:40 Afternoon Tea

DEVELOPING BIOGENERICS

16:00 CASE STUDY: Sandoz’s Perspective - Benefiting from the
Growing Niche Market
• How to use the infancy of biotechnology market to your
advantage
• Understanding overall market and potential hurdles
• Missing the Acts - Hatch-Waxman and Federal Food Drug &
Cosmetic Act
• Possible problems with bio-equivalence and how to solve them
• Can a commercially viable business be based on biogenerics?

Peter Vink
Global Head of Biopharmaceuticals
Sandoz

16:40 How to Succeed in the Biogeneric Sector
• Learn about the Effective strategies for success
• Why are some companies are more likely to succeed in
biogenerics?
• Acquisition & strategic partnerships: how and when
• How to develop a strategic plans for biogeneric development
• What are the main criteria a company should possess in order
to grow in biogenerics?

Dr. Klaus Maleck
Chief Financial Officer
BioGeneriX

17:20 Questions and Discussion

17:30 Summation of day one from conference chair

17:40 Close of Day One


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DAY TWO
Wednesday 1st December 2004
**************************

09:00 Registration and Coffee

09:30 Opening remarks from the Conference Chair
William Haddad, Chairman / CEO, Biogenerics
Founder of US Biogenerics Association

EFFECTIVE PATENT LIFE CYCLE MANAGEMENT

09:40 Identify Hurdles to Maximise Profit
• How to gain maximum profit by extending patent life cycle
- Recent sucessful examples
• Pitfalls accompanying 2nd generation patents
- Methods to solve them and what to watch out for
• Governmental interference - latest regulatory and legal
developments in US
• Defining points in patent listing and legal loopholes

Siu Lo
General Counsel
Taro Pharma

10:20 Novel Approaches to Extend your Product’s Life Cycle
• New therapeutic guidelines -integrate your medication systems
- Novel ideas to implement these guidelines
• Evergreening -reinvent your second generation blockbusters
• Combined therapeutic approach - Extend your valuable IP’s
life cycle - Maximise profit by combining new approach to
existing products
• Pointers on opening ways to build potential "blockbuster
treatment concept”

Dr. Troels Keldmann
Managing Director
Direct-Haler

11:00 Morning Coffee

11:20 CASE STUDY: How to Compete in the Generics Market
• How to maximise profits after patent expiry - Examples
• Branded products’ marketing tactics- what can you use?
• Maximise revenue: strategies to create distribution platforms
• How to establish protective strategies on your R&D
• Selling & marketing a branded generic - recommendations and
regional variations
• “Evergreening” - different ways to reinvent your blockbusters

Peter Ballard
Director, Sales & Marketing
Genus Pharmaceuticals

12:00 How to Effectively Guard Your Branded Blockbuster
• Mastermind patent life cycle strategy to launch "blockbusters"
• How to use Freedom to Operate effectively to manage patents
• Using new concepts and ideas to protect your new invention
• How to strengthen your existing business to maximise profit?
• The expert's experience - What we have learnt so far

Richard Onyett
Director, Business Development
KuDOS

12:40 Lunch

14:00 Strategies to Form Successful Alliances
• How to collaborate drug delivery and life cycle management
• How will drug delivery benefit branded generics?
- Overcome product differentiation rule -”Evergreening”
• Current innovative drug delivery approaches - examples
• How can combinations change the overall market? - Fast
dissolve drug delivery - Other cost effective approaches

Dr. Steven Charles
VP, Business Development
Nektar Therapeutics

METHODS TO PENETRATE THE GENERICS MARKET

14:40 Generics - From Cheap Alternative to Market Leader
• Beat competition: advice on how to dominate the market
• Understanding pricing restrictions - what changes should you
make? - how to implement these restrictions
• Pricing & reimbursement policies that are encouraging generics
- reference pricing, generic prescribing & generic substitutions
- How will they benefit your organization?

Dr. Jorge Mestre-Ferrandiz
Industrial Economist
Office of Health Economics

15:20 Afternoon Tea

15.40 Learn to Recognise Opportunities in the Generics
Market
• The position and value of generic products
• Intellectual property and patenting - supplementary protection
certificates -Increase your understanding
• Patent expiration - what losses versus gains will you face in
the coming years?
• Methods to achieve success in this money generating market

Matthew Harris
Partner
Norton Rose

16.20 How to Become a Generic Innovator
• The rise of generics - how it affects the industry
• The innovation deficit in the new drug output - current issues
• Ways to increase the sophistication of R&D
• Generic innovation - examples
• How to maintain profit? - challenges and hurdles

Dr. Faiz Kermani
Marketing Executive, Business Development
Chiltern International

17:00 Post-Election Update - The Status of Biogenerics
• After effect of US election to the progress of biogenerics
• Current legislative concerns - TRIPS, C-9 law, Europe’s new
bioequivalence regulation and biosimilar legislation
• Approaches to affordable drugs -country by country analysis
• Overview of current trends and concerns - How will India and
Eastern Europe contribute to the market?

William Haddad
Chairman / CEO
Biogenerics

17:40 Questions and Discussion

18:00 Close of Conference















Terms & Conditions
NB - Due to high demand, we do not 'reserve' or 'hold' places - a request
for an invoice to be raised will be treated as an official booking and will
be subject to the cancellation policy as outlined below.
Cancellations/substitutions and name changes: All bookings carry a 50%
liability after the booking has been made, by post fax, email or web. There
will be no refunds for cancellations received on or after one month before
the start of the conference (e.g. cancellation on or after 20th January for
a conference starting on 20th February). If you decide to cancel after this
date the full invoice remains payable. Conference notes, which are available
on the day, will be sent to you. Unfortunately we are not able to transfer
places between conferences and executive briefings. However if you are
unable to attend the event you may make a substitution/name change at any
time as long as we are informed in writing by e-mail, fax or post. Name
changes and substitutions must be from the same company and are not
transferable between companies or countries.

Indemnity: visiongain Ltd reserve the right to change the
conference/executive briefing content, timing, speakers or venue without
notice. The event may be postponed or cancelled due to acts of terrorism,
war, extreme weather conditions, industrial action, acts of God or any event
beyond the control of visiongain Ltd. If such a situation arises we will
endeavour to reschedule the event. However, visiongain Ltd cannot be held
responsible for any cost, damage or expenses, which may be incurred by the
customer as a consequence of the event being postponed or cancelled. We
therefore strongly advise all customers to take out insurance to cover the
cost of the registration, travel and expenses.



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