What is data exclusivity?
Data exclusivity is a separate and additional provision to patent protection for the reference medicine. It defines a period of time during which the generics applicant is restricted from applying for market authorization referencing the data developed for the reference product. Consequently, generic medicines can generally only be evaluated and approved after the data exclusivity period has expired. In the EU generics cannot be marketed until the market exclusivity has also expired.
Data exclusivity is a separate and additional provision to patent protection for the originator medicine. It defines a period of time during which the generics applicant is restricted from applying to the medicines authorities for market authorisation. Consequently generic medicines can only be evaluated and approved by the medicines authorities after the data exclusivity period has expired unless unusual and much more expensive procedures are used, which only happens very rarely. Data exclusivity was introduced in 1987 to compensate for insufficient product patent protection in some countries at that time. Although strong product patents are now available in all EU Member States, data exclusivity was nevertheless maintained in the new EU pharmaceutical legislation which entered in force in 2005.
