Data Exclusivity and Orphan Drug Protection

Regulatory Data Exclusivity is a right which prevents reliance by generic companies on original toxicological, pharmacological and clinical data generated to comply with the various regulatory requirements. The protection is weakened by publication of the data which is then freely useable by the generic competition. What the protection does not prevent, as with copyright, is independent development of the same data. This form of protection can often extend post patent expiry. The period of exclusivity in Europe is between six and ten years from the date of first marketing authorisation for products approved under most procedures depending on how the member state has chosen to enact the legislation.

Orphan Drug Protection is intended to provide exclusive marketing rights for a product and to ensure that no generic approval for a drug, regardless of patent status, is granted within a period following first marketing approval, where the disease to be treated by the drug affects a small population. The grant of rights is usually limited to the specific indications for which the treatment has been approved, and should preclude 'similar products', even if developed independently, from achieving registration.