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The Workshop

In-depth analysis of Supplementary Protection Certificates

Thursday 18 September 2008

Dr. Duncan Curley
Director
Innovate Legal
 
About the workshop
This workshop will provide an in-depth analysis of Supplementary Protection Certificates for medicinal products.  It will discuss the latest legal decisions and examine topical issues, such as SPCs for combination drug products, six month paediatric extensions for SPCs and the importance of the basic patent and the scope of SPCs.

Workshop agenda
08:30  

Registration
09:00 Session 1

a) Overview of key concepts

  • Commercial background
  • Council Regulation (EEC) No. 1768/92
  • Introduction to the case law

b) Detailed analysis of recent decisions

  • MIT, Yissum
  • Pending references to the European Court of Justice
  • The AstraZeneca decision
10:15  

Coffee break
10:40 SESSION 2

Specific issues and case studies

  • Combination products - fromTakeda to Truvada®
  • The basic patent – olanzapine
11:20 SESSION 3

Paediatric Extensions

  • The Paediatric Regulation
  • PIPs and the Paediatric Committee
  • Six month extension of SPCs
  • Comparison with the US experience
12:00 SESSION 4

SPCs – time for reform?
Q&A and discussion
   

Workshop review and close


About the workshop leader:   About Innovate Legal:
     
Dr Duncan Curley obtained his doctorate in Medicinal Chemistry from University College, London in 1992.  He qualified as a solicitor in 1995 and in October 2000 he joined the London-based IP department of a major US law firm, where he ran a number of high profile cases, including BioProgress v Stanelco (patent entitlement) and Sportswear v Stonestyle (trade marks and antitrust), before leaving to found Innovate Legal in 2007. Duncan is the author of Extending Rewards for Innovative Drug Development (a report on SPCs for Pharmaceutical Products) and Intellectual Property Licensing and Technology Transfer, the leading textbook on the EU technology transfer block exemption   Innovate Legal (www.innovatelegal.co.uk) is a boutique London-based law firm that advises on all aspects of patents, trade marks, trade secrets and other intellectual property rights. The firm offers a full range of legal services to the life sciences industry, including pharmaceutical patent litigation, advice on trade mark (especially parallel import) disputes, infringement and freedom to operate opinions and IP/antitrust issues.