Data Exclusivity and Trips

Apart from the legal rights of Intellectual property over a medicine, there exist drug regulatory systems to ensure that the medicines sold in the market are safe and effective. The safety and efficacy of a drug can be either proved through full-fledged clinical trials or by showing that the drug is chemically and biologically equivalent to an existing previously registered drug. Thus, in reality, the originator companies goes through a tedious task of clinical trials, whereas the generic companies easily surpasses the need of clinical trials, by submitting bioequivalence tests. The demand for data exclusivity begins with that, which would grant the originator company an exclusivity to utilise the data for certain duration of time, preventing others reliance on it. 

The Article 39.3 of the TRIPS is one of the confusingly interpreted provision relating to data exclusivity and the insight into the origin of the concept of data exclusivity, the changes that occurred during the round of negotiations and the drafts are required to ascertain the actual intention of the Article. The conditions mentioned in the Article and the obligations casted on it also required to be analysed carefully to understand how each country, especially a developing nation can make use of the flexibilities imbibed in it.