Regional Trade Agreement – IPR Issues


Regional Trade Agreement which are under negotiations like RCEP, ASEAN TA etc. contain several IPD provisions which may harm Indian interest.
Data exclusivity and Patent term extension are two of the major issues.
What is “Data exclusivity”?
  • It  is a form of legal monopoly protection for a drug, over and above the patent protections.
  • It  is given expressly to compensate for the investment made during clinical trials.
  • It implied that regulators cannot approve a similar drug with similar data for the next five years, delaying the entry of generic, affordable versions.
What is “Patent Term Extensions”?
  • These are given to compensate the company for delays in processing patent applications.
  • A patent term extension will give another five-year monopoly to the innovator company, again delaying the entry of generic drugs in the market.
What would be impact of these provisions?
These provisions will impact innovation centric sectors like Pharma.



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