1. Intellectual Property Environment 36

2. Pharmaceutical IP Overview History of compulsory licensing up to 1980s – limited R&D activity Compared to other OECD countries Canada has limited biopharmaceutical IP protection Judiciary active in field of pharmaceutical IP – rulings often contradict existing regulations e.g. Bayer (1998), Biolyse v. BMS (2005) Utility requirement – growing number of court decisions on the basis of patent utility in relation to pharmaceutical patents. – High percentage of cases have ruled that pharmaceutical patents were invalid. – The Canadian standard of utility being established through this growing case law differs from US and EU as well as TRIPS. 37

3. Pharmaceutical ‘Patent Linkage’ Mechanism Notice of Compliance mechanism in place Requires generic applicants to comment on the patent status of the reference product Significant weaknesses: – does not provide the patent holder (“first person”) with a right of appeal – the judicial proceedings determining the merits of the disputed patent(s) is a summary not full process 38

4. PTE and RDP Canada does not offer patent term extensions for pharmaceutical products – currently under discussion in EU- Canada FTA Canada offers a 8 year regulatory data protection term with the possibility of a six-month pediatric extension RDP regulatory changes in 2006 response to Bayer case – reliance is grounds for data protection 39