Abstract

REGULATORY EXCLUSIVITY STRATEGIES: FURTHER PROTECTION FOR PHARMACEUTICALS IN US, EUROPE AND JAPAN

Ravi H Mistry and Dr. Dilip G. Maheshwari*

ABSTRACT

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. Though patenting is probably the oldest and most common form of protection, other forms of exclusivities exist. Regulatory exclusivities in the form of protection are especially suited to research-based pharmaceutical company’s needs, while others are more in line with the needs of generic companies. Regulatory exclusivity is important in life-cycle management of different pharmaceuticals. This article discusses the use of alternative, non-patent forms of protection, otherwise known as marketing exclusivity and data protection or data exclusivity. This article defines and establishes the span of such protections in different jurisdictions, including the US, Europe and Japan, by analyzing the various existing regulations. Through regulatory exclusivity strategies, pharmaceutical stakeholders be aware of, fully understand, and properly use these additional forms of protection to maximize their return on investment.

Keywords: Exclusivity, Hatch-Waxman Act, Data Exclusivity, Market Exclusivity, Re-examination System.