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In the endeavour of protecting Intellectual Property rights, pharmaceutical companies are
closely following the evolvement of work practices in patenting, litigation and deal structuring.
   
The SMi group’s Pharmaceutical Intellectual Property Conference will examine key aspects of the industry – patent infringement disputes, legal advancements and regulatory frameworks.
     
How will this conference benefit me?
Q: How will the shift towards Biological Pharmaceuticals impact the legal practice?
A: SHIFTING TOWARDS BIOLOGICS – Reviewing practices in patenting and litigation
  
Q: What thought processes should be applied to risk management in court litigation?
A: RISK MANAGEMENT IN COURT LITIGATION – Applying a strategic thought process to
assess the prospects in litigation
   
Q: What measures should be taken to protect IP rights in a global arena?
A: MAINTAINING IP RIGHTS IN THE GLOBAL ARENA - Proactive protection in multiple markets
   
With presentations from key industry experts:
  • Jim Shehan, Vice President, General Counsel, Novo Nordisk
  • Alexandre Mencik, Senior Legal Counsel, Amgen
  • Dr Frank Burkert, European Patent Attorney, Bayer Healthcare
  • Alasdair Moodie, Assistant General Counsel, Cambridge Antibody Technology
  • Thomas F. Fleming, Partner, IP Litigation, Kaye Scholar LLP
  • Peter Bogaert, Partner, Covington & Burling LLP
  • Dr Duncan Curley, Partner, IP, McDermott, Will & Emery
  • Monika Derecque-Pois, Director General, GIRP
  • Christine Hänle, Corporate Purchasing Ethical Manager, Celesio AG

Designed to meet industry needs, the conference creates the perfect setting for prolific exchanges of ideas and networking opportunities.

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Dr Duncan Curley

Dr Duncan Curley , Director, Innovate Legal

9:10 LEGISLATIVE AND REGULATORY ASPECTS OF BIO-SIMILARS IN THE US

Jim Shehan

Jim Shehan, Vice President, General Counsel, Novo Nordisk

9:50 PROTECTING INTELLECTUAL PROPERTY IN AN ALLIANCE SETTING

Alasdair Moodie

Alasdair Moodie, Assistant General Counsel, Cambridge Antibody Technology

10:30 Morning Coffee

11:00 BIO-SIMILARITY APPROVALS – PROTECTION PAST PATENT EXPIRY

Alexandre Mencik

Alexandre Mencik, Senior Legal Counsel, Amgen

  • Reviewing recently denied application – prerequisites for demonstrating bio-similarity
  • Introduction of bio-similars into clinical practice in Europe
  • Examining the language of EU and US regulation – implications for follow-on generics
  • 11:40 THE CHANGING LANDSCAPE OF PATENT INFRINGEMENT INJUNCTIONS

    Thomas F Fleming

    Thomas F Fleming, Partner, IP Litigation, Kaye Scholer LLP

  • The ebay vs. MercExchange LLC, 126 S. Ct. 1837 (2006)  case study and following rulings in the district court
  • Assessing the balance of damages: public interest against asset protection
  • Litigating infringement disputes in light of the recent shifts
  • 12:20 Networking Lunch

    13:50 RISK MANAGEMENT IN COURT LITIGATION – VARIATION IN MARKETS

    Dr Frank  Burkert

    Dr Frank Burkert, European Patent Attorney, Bayer Healthcare

  • Reimbursement of legal expenses and its impact on the choice to litigate
  • Country of origin and its effect on court rulings
  • Attached costs of litigation: documentation and brand strength
  • Case-by-case decision making – outlining the risk management process
  • 14:30 INCREASING INTERPLAY BETWEEN IP RIGHTS AND REGULATORY DECISIONS

    Peter Bogaert

    Peter Bogaert, Partner, Covington & Burling LLP

  • Patents and market authorisation procedures
  • Bolar provisions
  • Regulatory conditions for granting SPCs
  • Specific challenges presented by the new Paediatrics Regulation
  • How to obtain SPC extension based on regulatory assessments?
  • 15:10 Afternoon Tea

    15:40 SUPPLEMENTARY PROTECTION CERTIFICATES AND GENERIC COMPETITION IN EUROPE

    Dr Duncan Curley

    Dr Duncan Curley , Director, Innovate Legal

  • Supplementary Protection Certificates – a brief overview
  • Article 82 and the abuse of a dominant position
  • Case Study: AstraZeneca
  • The Commission’s market assessment
  • 16:20 COMBATING COUNTERFEIT MEDICINES

    Martin Fitzgerald

    Martin Fitzgerald, Legal Advisor, European Association of Pharmaceutical Full Line-Wholesalers (GIRP)

  • The risks counterfeit medicines present in entering the market
  • The EU legal environment for tackling the phenomenon
  • Pharmaceutical full-line wholesaling in Europe and its role in the prevention of counterfeit medicine
  • 17:00 Chairman’s Closing Remarks and Close of Conference

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    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

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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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    Opening Hours: 9.00 - 17.30 (local time)
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