Health Canada Releases Report on the Administration of the NOC Regulations and Data Protection Provisions

Recently, the Office of Patented Medicines and Liaison of Health Canada released its Statistical Report for 2007 (Report) on the administration of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations) and the data protection provisions (C.0.8.004.1) of the Food and Drug Regulations (F & D Regulations). The Report outlines statistics relating to the Patent Register, particularly, the number of patents added to the register, the number of patents rejected, and the reason for rejection. The Report also provides a summary of all the judicial review proceedings initiated in response to the Minister of Heath's refusal to add patents to the Patent Register. The Report also gives statistics relating to the number of Notices of Allegation served by second persons to address patents listed on the Patent Register, the number of resulting prohibition applications initiated, and the outcomes of those applications. Finally, the Report outlines the number of innovative drugs registered in accordance with the data protection provisions of the F & D Regulations. These provisions were introduced on October 18, 2006 to ensure that innovative drugs receive a guaranteed minimum period of data protection of eight years where the drug contains a new chemical entity. For those in the industry and industry-watchers, there may be several differing interpretations of the information in this Report and whether the administration of the NOC Regulations meets the government's pharmaceutical patent policy objective of balancing "the effective patent enforcement over new and innovative drugs with the timely entry of their lower priced generic competitors." For a copy of the Report, visit: http://tinyurl.com/5kmjtj Summary by: Nick Wong