WSMI Delegation Discusses Data Exclusivity with WIPO
November 2011

A WSMI/AESGP delegation met with the Director General of the World Intellectual Property Organization (WIPO) in Geneva on 4 November 2011 to make the case for the protection of the intellectual property in the area of self-care products. The discussion focused in particular around the protection of data obtained to prepare the switch of a medicinal product from prescription to non-prescription status. This innovation often requires substantial R&D to develop data supporting the direct use of the medicine by patients and consumers, which can cost millions and may take years. It is critical to a company undertaking the R&D that its efforts cannot be quickly capitalised on by a competitor once the switch or licence extension has been granted.
Currently worldwide there is insufficient provision for data / marketing exclusivity protection to justify investment, and the number of new non-prescription ingredients registered has fallen in recent years, even in countries such as the United States where three years of data protection can be sought.
The self-care industry further argued that once products are registered and made available to patients and consumers, its principal in-market competitive device is the development of brands, which also requires substantial and on-going investment. In this area the copying of brand trade dress (‘passing off’) by competitors is one of several important issues, and the ‘protection of investment’ would be of particular interest.
The WIPO leadership was grateful for all information received and will pursue the issues as far as possible within their remit.