‘Data exclusivity’ in pharmaceutical patent system

The Article 39 (3) of the TRIPS Agreement states that-

“Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products, which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public or unless steps are taken to ensure that the data are protected against unfair commercial use.”

In other words it is the protection of clinical test data submitted to a regulatory agency to prove safety, quality and efficacy of a new drug and preventing the generic drug manufacturers from relying on this data in their own applications.

Data exclusivity provides the originator a certain period of time after the approval of the application during which it restrains the authority to assess any other generic application. The time period is known as “period of market exclusivity”. In EU this has been granted for 10 years in totality & for 5 years in US.

The generic drug applications are always submitted for approval on their own merits based upon the requirements set-out in the respective laws of the country. Generic drug manufacturers certainly can not take data from the originator’s application. However, their efficacy of data and other testings in the generic application can be evaluated by the authority against the original
application, only after the expiry of exclusivity period.

This has been criticized mainly on the ground that it can act as a patent term extension by providing an additional restriction to producing a generic copy however the intention behind the regulation is to protect to protect the originator’s data from commercial exploitation by another player.

In India, which is a major supplier of generic drugs to the world (especially developing countries) “data exclusivity” has been an issue of enormous debate recently. It has been reported that Indian government is also considering grant of exclusivity right for non-patentable drugs.

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