Adequate safeguards should be taken to reduce the impact on generic manufacturers and compulsory license applicants, if the Indian Government decides to allow data exclusivity in India, warn experts.

Talking to Pharmabiz, Dr Gopakumar G Nair, a leading patent expert and CEO, GNA Patent Gurukul & Gopakumar Nair Associates, noted that these safeguards should include provisions like fixing a common priority date of first market approval any where in the world, exclusivity for only one NCE based dosage form, exemption for compulsory license holder etc.

Data exclusivity for a fixed period should be calculated from a common priority dates of first market approval any where in the world. At present, with the Internet and other database resources available, any information divulged can be treated as a global disclosure. If a drug got marketing approval in US in 2004 and in Kenya in 2006, data exclusivity should be applicable since 2004, where the first marketing approval was given.

Another provision is to consider only one NCE based dosage form for data exclusivity. New use or indication, new strengths, new packings, change in excipients or delivery system should not be considered for additional exclusivity.

Similarly, exception from data exclusivity should be given to compulsory license holder to obtain regulatory approval under a granted compulsory license. If that provision is not allowed, the compulsory license holder will have to generate entire data from the beginning, leading to a plethora of problems and delays in approval.

Another important provision that should be incorporated should be to ensure all data exclusivities also expire with the expiry of the corresponding NCE Patent. Such a situation has happened in the case of many molecules in the US, wherein the data exclusivities remain even with the expiry of the patent. This helped many patent holder companies to evergreen their products and come out with new doses with data protection.

Safeguards in the form of these four provisions could considerably reduce the negative impacts of data exclusivity on the generic manufacturers and compulsory license applicants. However, the Government should incorporate more safeguards. Decision on data exclusivity should be taken considering the interests of the domestic industry, felt Gopakumar.