Interpretation of the Term 'Product' -- new article

The October 2008 issue of the Journal of Intellectual Property Law and Practice (JIPLP), published monthly by Oxford University Press and which I edit, contains a full-length article by SPC Blog team member Catherine Katzka entitled "Interpretation of the Term 'Product' in EU Council Regulations 1768/92 and 1610/96 on Supplementary Protection Certificates". According to the abstract:

"Legal context: In order to compensate for the reduced time to exploit pharmaceutical and agrochemical patents, patent extension schemes were introduced in the 1990s. In Europe, the extension is achieved through supplementary protection certificates (SPC) with Regulation 1768/92 and 1610/96, which provide for up to 5 years additional protection or agrochemical products.

Key points: The SPC Regulations combine aspects of the patent and regulatory systems, which themselves have different aims and approaches leading to problems in definition. This is particularly the case for the definition of ‘product’. This term is defined in Article 1b as ‘the active ingredient or combination of active ingredients of a medicinal product’. However, EU legislation on SPCs does not provide an indication to precisely what is meant by ‘active ingredient’. This has lead to interpretation problems for national patent offices during the SPC application process and during litigation, which have been and continue to be resolved at the national or European level.

Practical significance: This article discusses from a European perspective the issues of what exactly constitutes a product within the meaning of Article 1 of the Regulations and which products are actually protected by an SPC. It reviews the case law of different European jurisdictions that clarify the question of which products are covered by an SPC as well as establishes what constitutes a new product over the subject matter of a previous marketing authorization. It also addresses the implications of the definition of ‘product’ for Pharma and plant protection industries".

If you'd like to access this article, please email me here and let me know. You should have it before the end of the week.