Article
When A Territorial Licence Crosses Borders: Product Dossiers, Copyright And Confidential Know-How In Jubilant Generics Ltd. v. Jamp India Pharmaceuticals Pvt. Ltd.
In the pharmaceutical industry, a Product Dossier may be as commercially valuable as the product itself. A pharmaceutical Product Dossier comprises of technical, scientific and regulatory information used to develop, register and commercialise a medicinal product. It may include material on composition, manufacturing, quality, stability, safety, efficacy and regulatory approvals. Its commercial value lies not only in the information itself but also in the expertise, time and investment required to compile and develop it for regulatory and commercial use.
Dhir & Dhir Associates