What does DE stand for?

The worrying terms of the FTAs include the extension of patents beyond 20 years; data exclusivity, which delays the entry of a generic medicine in a market by 10- 15 years even after the expiry of a patent; and the patent- registration linkage, which prevents the registration of a generic manufacturer before the expiry of patent.

Data Exclusivity is a transitional concept of protection of exclusive test data in the form of publicly undisclosed information which is in between the protection of the data in the form of trade secrets based on the principles of equity and good faith and the domain of patent protection which requires invention to be new, having an inventive step and capable of industrial application.

EXPORTING CLINICAL TRIAL DATA EXCLUSIVITY REGIMES FROM DEVELOPED TO DEVELOPING COUNTRIES A.

Also important are "effective data exclusivity systems that will serve as a means of stopping the marketing approval of unauthorized APIs.

In essence, data exclusivity refers to a period during which no third party applicant can rely on data filed by the original applicant for a marketing authorization.

Under data exclusivity, a controversial rule first imposed in 1987, for a period of about eight years after approval of a new drug, a country cannot accept an application for a generic bioequivalent to a brand-name drug even if the patent is expired or is otherwise not a problem, because that is called "unfair" use of the knowledge that the brand-name drug worked in the first place.

If a compulsory license is granted for a drug for which registration data exclusivities remain in force, the data exclusivity can block the generic from gaining marketing approval.

Faulding expects to launch paclitaxel in Europe after expiration of data exclusivity protection in 2003.