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Intellectual Property is a core issue in the drug industry. At a time when more biotech companies are bringing products to the market, when mergers and collaborations are commonplace and with the near completion of cloning the human gene, it is crucial for companies to effectively manage their Intellectual Property Rights. On top of this, the rising costs of research and the need for increased returns on investment in order to satisfy shareholders has brought Intellectual Property Rights to the fore in the drug industry.

This conference brings together intellectual property experts from around the globe to explore and discuss the latest issues in pharmaceutical IP rights. It will provide you with up to date knowledge of developments in patent law, protecting and maximising your IP and issues involved with genes and patents and much more.

As a senior industry executive, you will be aware of the importance and potential of this field so I would therefore like to invite you to register for this conference and workshop and stay ahead of your competitors.

Intellectual Property Rights: a Global Perspective for the Drug Industry is organised and produced by SMi: we specialise in providing senior executives with timely, strategic and focused up to date information. SMi conferences are leading-edge business events offering delegates the opportunity to meet senior industry figures and seek their advice and opinions.

Please register now to guarantee your place at this excellent event.

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Dr Edward R Gimmi

Dr Edward R Gimmi, Assistant Patent Counsel, SmithKline Beecham

9:10 INTELLECTUAL PROPERTY RIGHTS: WHY ALL THE FUSS?

Warren Roiter

Warren Roiter, Senior Partner, Roiter & Zucker

  • What does IP encompass?
  • Defining intellectual property rights
  • IP creation
  • Why IP protection?
  • Effective IP protection
  • Functional IP systems
  • 9:40 PATENTS AND PATENT LIFE

    Christopher Craig

    Christopher Craig, Chartered Patent Attorney, Bridgehead Technologies

  • Knowing when best to patent for maximum advantage
  • Patents and the product life cycle
  • Prolonging the exclusivity period
  • Developing new indications and extending the life of the monopoly
  • Maximising the economic potential of the drug
  • The role of drug delivery in extending patent life
  • 10:20 LEVERAGING INTELLECTUAL PROPERTY TO MAKE NEW DRUG DEVELOPMENT PROFITABLE

    James Macfarlane

    James Macfarlane, Global Business Development & Strategy Director, Sopheon

  • Addressing content and knowledge collaborations across individuals, projects and communities
  • Reducing time to market in the eR&D economy
  • Creating directed serendipity
  • Creating sustainable IP from knowledge based products
  • Leveraging IP in a rapidly changing market
  • 11:00 Morning Coffee

    11:20 PROTECTION STRATEGIES FOR IP RIGHTS

    Dr Miles Gaythwaite

    Dr Miles Gaythwaite, Biotech Intellectual Property, Patent Attorney, Bird & Bird

  • The need for protection strategies in an IP intensive industry
  • Current legal spending by the pharma industry
  • Reducing the risk of litigation
  • Increasing the chances of extracting value from IP through a good protection strategy
  • Developing and implementing an appropriate protection strategy
  • The importance of improving IP protection
  • 12:00 EVOLVING TECHNOLOGY AND IP

    Timothy J Lithgow M.D

    Timothy J Lithgow M.D, Patent Attorney, Director, Intellectual Property, Epimmune

  • Overview of Epimmune’s technology
  • The importance of a forward looking patent strategy in a rapidly revolving technical area
  • Dealing with inherency issues
  • Development of diverse claim concepts e.g. protection of protein-based and nucleic acid-based embodiments
  • Bioinformatics; The value of petitions to make special in US practice
  • Restriction requirements and species election practice before the USPTO
  • 12:40 Networking Lunch

    13:40 IP STRATEGIES AND REALITIES WHEN CONFRONTING CORPORATE MERGERS: HERE TODAY, GONE TOMORROW

    Susan Knoll

    Susan Knoll, Partner, Patent Litigation, Biotech, Howrey Simon Arnold & White

  • Examples of real issues and problems resulting from mergers in biotechnology
  • Collaboration and research agreements - the pros and cons
  • Patent prosecution pitfalls
  • Litigation positions - beware!
  • Suggestions and recommendations when confronting corporate mergers
  • 14:20 SEQUENCING THE GENOME

    George Xixis

    George Xixis, Intellectual Property Counsel, CuraGen

  • Patents and genes: the current situation
  • Types of patents applicable to genes
  • Protecting the investment through gene patenting
  • Patenting beyond the gene per se
  • The commercial vs academic debate
  • 15:00 PATENT PROTECTION FOR INVENTIONS ARISING OUT OF GENOMICS RESEARCH

    Dr John Mendlein

    Dr John Mendlein, General Counsel & Chief Knowledge Officer, Aurora Biosciences

  • Patent protection for genes and tools; Changing patentability standards
  • Enforcing patent rights to prevent exploitation of important technology
  • Patenting related to genes where there is no apparent function
  • Identifying ‘usefulness’ and ‘utility’ for patentability
  • Implications of the evolving patent laws on the patent system and patent strategy
  • Future outlook: value migration, licensing and workarounds
  • 15:40 Afternoon Tea

    16:00 PATENTING THE HUMAN GENOME PART I

    Dr Penny Gilbert

    Dr Penny Gilbert, Partner, Biosciences & Pharma, Bristows

  • Current patenting laws in Europe
  • Developments in patent law for human genes
  • Essential differences in IP legislation between EU countries
  • ‘Reach through’ and claim scope
  • Infringement
  • Ethical and legal issues surrounding the patenting of the human genome in Europe
  • 16:30 PATENTING THE HUMAN GENOME PART II

    Dimitrios Drivas

    Dimitrios Drivas, Partner, Intellectual Property & Patents, Pharma/Biotech, White & Case

  • Current patenting laws in the USA
  • How patent laws are evolving differently either side of the ‘pond’
  • Impact on a pharmacogenomic company’s patent strategy
  • Patentability of the human genome: ethics and arguments
  • Basics of infringement litigation concerning the human genome patents
  • Current issues in genetic patents in the USA
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    17:10 Networking Drinks Reception for Speakers & Delegates

    8:30 Re-registration & Coffee

    9:00 Chairman's Opening Remarks

    Dr Konrad Becker

    Dr Konrad Becker, Head of Patents and Trademarks, Novartis

    9:10 THE EFFECT OF IMPLEMENTATION OF THE EUROPEAN BIOTECHNOLOGY DIRECTIVE WITHIN THE EUROPEAN INDUSTRY

    Catriona Hammer

    Catriona Hammer, Head of UK Intellectual Property, Amersham Pharmacia Biotech

  • What is the biotechnology directive?
  • When does it take effect?
  • Does it make any difference?
  • Key points of interest
  • 9:40 FUNDAMENTALS OF PHARMACEUTICAL LICENSING

    Georgina Wertman

    Georgina Wertman, Staff Vice President, Licensing, Schering-Plough

  • Types of licenses: patents, trademarks, know-how and trade secret licenses
  • Scope of rights granted: exclusive and co-exclusive licenses
  • Components of a license agreement: important definitions, the grant, sublicense, fees, milestones, equity investment, diligence, term of license, termination rights, representations and warranties, assignment, change of control, confidentiality, indemnification.
  • Antitrust Issues
  • Pitfalls to Avoid in License Agreements
  • 10:20 COST & TIME EFFECTIVE PATENT LITIGATION

    Dr Peter Cozens

    Dr Peter Cozens, Principal, Propharma Partners

  • Question 1: should you litigate at all? Cost/benefit analysis
  • Developing an international strategy: when should you begin?
  • Choosing jurisdiction and venue
  • Who should you fight?
  • 11:00 Morning Coffee

    11:20 THE WEB - SPIDER OR FLY?

    Tom Crowley & Howard Cottrell

    Tom Crowley & Howard Cottrell, Managing Director, & Executive Director, Intellectual Property, ArmorGroup CDR International

  • Virtual pharmacy implications
  • How safe are your products, reputation and intellectual property rights on the internet?
  • What is being said about your company and the competition on the internet?
  • Cloning corporate internet sites for fraudulent international gain
  • What is your competition doing on the internet?
  • Is it possible to police the internet?
  • 12:00 PATENTING ISSUES FOR HIGH-THROUGHPUT COMPOUND SYNTHESIS

    Michael Rivard

    Michael Rivard, Vice President, Legal & General Counsel, ArQule

  • Patent strategies for combinatorial libraries
  • Effect of new utility guidelines in USPTO
  • Strategy implementation at ArQule
  • 12:40 Networking Lunch

    14:00 LEGAL COUNSELLING FOR HIGH-TECH START-UPS

    Dr Bertram Rowland

    Dr Bertram Rowland, Vice President, General Counsel, Aclara Biosciences

  • Defining company technology; Identifying the technological landscape
  • Evaluating available commercial opportunities
  • Determining IP need and organising support
  • Monitoring IP activities in light of company activities
  • Assessing complementary external IP
  • Integrating all of the activities
  • 14:40 PHARMACEUTICAL PATENT PROSECUTION & ENFORCEMENT

    John A Tessensohn

    John A Tessensohn, Intellectual Property Attorney, Shusaku Yamamoto

  • Understanding the essentials of pharmaceutical patent prosecution
  • Expedited pharmaceutical patent prosecution strategy
  • Pitfalls in pharmaceutical patent prosecution: Japan’s strict standards and requirements
  • Opposition practice pitfalls and strategies to overcome opposition pitfalls
  • New litigation improvements
  • Invalidity defence in litigation
  • 15:20 Afternoon Tea

    15:40 WORKING WITH PATENT PROTECTION

    Dr Andrea Wayda

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

  • Patents and the product life cycle
  • Tensions between generic and branded pharmaceutical companies and the patent and business issues specific to each
  • Prolonging the exclusivity period of branded pharmaceuticals
  • Legal issues related to Big Pharma-Generic post-patent marketing agreements
  • Current legal developments in US biotech and pharma patent law
  • 16:20 THE FUTURE FOR PHARMACEUTICAL PATENT LITIGATION IN EUROPE

    Kevin Mooney

    Kevin Mooney, Partner, Head of Pharma & Medical Intellectual Property, Simmons & Simmons

  • The Brussels Convention: latest developments
  • The Hague Convention
  • The Optional Protocol: latest developments
  • The regulation for a community patent: a bold initiative or a dead duck?
  • 17:00 Chairman's Closing Remarks and Close of Conference

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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:

    ‘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, SMI 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@smi-online.co.uk

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