Importance of Non-Patent Exclusivities in the Life-Cycle Management of Pharmaceuticals

Résumé :

In order to provide a fair balance between the need for new pharmaceuticals and the need to provide medicine at a reasonable price to the general public, governments have put in place different mechanisms of protection and exclusivities. While patenting is probably the oldest and most common form of protection, other forms of exclusivities exist. Some forms of protection are especially suited to research-based pharmaceutical companies’ needs, while others are more in line with the needs of generic companies. This article discusses the use of alternative, non-patent forms of protection, otherwise known as “marketing exclusivity,” “data protection” or “data exclusivity,” and “patent term extension.” This article defines and establishes the span of such protections in different jurisdictions, including the United States, Canada, Europe, and Japan, by analyzing and comparing the various existing regulations. It is critical in the life-cycle management of new drugs that pharmaceutical stakeholders be aware of, fully understand, and properly use these additional forms of protection to maximize their return on investment.