Duration of Exclusivity varies from country to country, normally 5 to 10 years. During this exclusivity time no generic players dossier will be accepted by agency for approval. This exclusivity protects innovator companies' interest on investment made for clinical studies for particular drug/drug product regardless of patent protection. This protection is granted by regulatory agencies.
As of now, India does not provide any data exclusivity to innovator companies. Being a member country in WTO, this is the obligation for India to introduce such protection to protect interest of large/innovator companies as a part of TRIPS agreement.
Recently as per news articles on Economics time and business standard, WTO and Health ministry conducting questionnaire to introduce data exclusivity in Indian system of drug approval.
Indian pharmaceutical alliance (IPA) is a group of indian pharmaceutical companies, has raised objection on this issue.
To note, India has introduced product patent protection to chemical/pharmaceutical patents as a part of TRIPS agreement on 2005.
News Update:
ipkat post on data exclusivity in EU [Link]
3 comments:
Thanks for the information. I think it is a very positive thing for innovative companies to protect their patented products from generic versions.
Yes it benefits innovators,but this affects indian domestic generic business. If this is introduced in india, Indian companies can't even file their dossier for review to DCGI.
Patent protection is like you could challenge and market your product and/or you could settle out-of-court.
but data exclusivity is not like that, no dossier filing at regulatory agency
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