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SMi is proud to present Arnold& Porter Kaye Scholer's Understanding IP, regulatory and competition law issues in pharmaceutical parallel which takes place in London July 4th 2017.

As the patents for several innovator biologics expire, biopharmaceutical companies are taking the opportunity to develop more affordable forms. By the year 2018 more than 30 innovator biologics with sales of $79 billion will have lost their patents* making biosimilars one of the fastest growing markets. This year's event will bring together industry leaders to discuss the latest cases and complexities in the commercialisation and design of biosimilars. We will explore regulatory guidelines and the ways in which interchangeability is likely to shape the market. We will identify challenges to manufacturing, deepen our understanding of clinical trial design, and discuss the topic of pricing.

 


 

Through interactive discussions and case reviews, this workshop will help you to address all the above challenges relating to parallel trade.
 

Directors, VPs, Heads, Principals, Chiefs and Managers of:

  • Parallel Trade/ Distribution/ Import/ Export
  • Market Access
  • Pricing
  • Business Planning and Development
  • Commercial Distribution
  • Finance
  • Legal/ General Counsel
  • Regulatory Affairs


 

Masterclass programme

8:30 Registration & Coffee

9:00 Master class leader introductions

9:10 Case study 1: Competition law and management strategies

  • Legal principles - Articles 101/102 TFEU and case law
  • Quota systems and potential risks
  • Agency (direct to pharmacy/hospital) systems and potential risks
  • Other competition risks and red flags
  • Christopher Stothers

    Christopher Stothers, Partner, Arnold and Porter Kaye Scholer LLP
    View Bio

    Tim Frazer

    Tim Frazer, Managing Partner, Arnold and Porter Kaye Scholer LLP
    View Bio

    Jackie Mulryne

    Jackie Mulryne, Counsel, Arnold and Porter Kaye Scholer LLP
    View Bio

    10:30 Morning Coffee

    11:00 Case study 1 continues

    Christopher Stothers

    Christopher Stothers, Partner, Arnold and Porter Kaye Scholer LLP
    View Bio

    Tim Frazer

    Tim Frazer, Managing Partner, Arnold and Porter Kaye Scholer LLP
    View Bio

    Jackie Mulryne

    Jackie Mulryne, Counsel, Arnold and Porter Kaye Scholer LLP
    View Bio

    12:30 Lunch

    13:50 Case study 2: Trade mark exhaustion and repackaging

  • Legal principles - trade mark exhaustion
  • BMS conditions - when and how can goods be repackaged?
  • Consent to sale of goods in the EEA - what about related and group companies?
  • Christopher Stothers

    Christopher Stothers, Partner, Arnold and Porter Kaye Scholer LLP
    View Bio

    Tim Frazer

    Tim Frazer, Managing Partner, Arnold and Porter Kaye Scholer LLP
    View Bio

    Jackie Mulryne

    Jackie Mulryne, Counsel, Arnold and Porter Kaye Scholer LLP
    View Bio

    15:00 Afternoon Tea

    15:30 Case study 3: Regulatory and patent notifications

  • The Specific Mechanism - patent protection and parallel trade
  • Monitoring notifications for risk
  • Christopher Stothers

    Christopher Stothers, Partner, Arnold and Porter Kaye Scholer LLP
    View Bio

    Tim Frazer

    Tim Frazer, Managing Partner, Arnold and Porter Kaye Scholer LLP
    View Bio

    Jackie Mulryne

    Jackie Mulryne, Counsel, Arnold and Porter Kaye Scholer LLP
    View Bio

    16:45 Closing remarks and end of masterclass

    +

    FEATURED SPEAKERS

    Christopher Stothers

    Christopher Stothers

    Partner, Arnold and Porter Kaye Scholer LLP
    Jackie Mulryne

    Jackie Mulryne

    Counsel, Arnold and Porter Kaye Scholer LLP
    Tim Frazer

    Tim Frazer

    Managing Partner, Arnold and Porter Kaye Scholer LLP

    Christopher Stothers

    Partner, Arnold and Porter Kaye Scholer LLP
    Christopher Stothers

    Christopher is a recognized expert in parallel trade, with a particular focus on the pharmaceutical sector - his 2007 textbook, “Parallel Trade in Europe: Intellectual Property, Competition and Regulatory Law,” has been cited by the UK Supreme Court. Christopher is also an experienced litigator on cross-border patent disputes, other types of intellectual property, antitrust, pharmaceutical regulation, EU law and commercial disputes. He has taken cases before the First Tier Tribunal, the Upper Tribunal, the Patents County Court, the High Court, the Court of Appeal, the House of Lords, the Supreme Court, the European Patent Office, and the European Court of Justice.

    Jackie Mulryne

    Counsel, Arnold and Porter Kaye Scholer LLP
    Jackie Mulryne

    Jackie Mulryne advises clients in the life sciences, medical devices, cosmetics and foods sectors, and has a broad practice providing regulatory compliance and public policy advice. She advises on UK and EU law, and has experience with a range of regulatory issues that arise throughout the product life cycle.

    Tim Frazer

    Managing Partner, Arnold and Porter Kaye Scholer LLP
    Tim Frazer

    Tim’s practice focuses on pharmaceuticals and other IP-rich sectors. He advises pharmaceutical and medical device companies on pricing, parallel trade and supply chain design and represented a pharmaceutical client involved in one of the Competition and Markets Authority’s first dawn raids, defending it in an abuse of dominance investigation. He also advises on conduct and merger cases in the EU and UK, on compliance and audit processes, merger clearance and challenging public procurement tenders. He is the author of several books on competition law and was previously a Professor and Dean of Law at Newcastle University.

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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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