Patent Linkage in India: Current Scenario and Need for Deliberation
Patent linkage data exclusivity drug approval
The system of
‘patent linkage’ refers to the practice of linking drug marketing approval to
the status of the patent of the originator’s product. It directly affects the
entry of generic drugs into the market. The article analyses patent linkage in
different jurisdictions and finds out whether such a system can be read into
existing Indian laws. It also discusses various judicial pronouncements and
pertinent legislations to trace the history and scope of patent linkage in India. The
Delhi High Court judgment, in Bayer Corporation and Others v
Cipla, Union of India (UOI) and Others1, which held
that patent linkage cannot be read into existing Indian provisions, has been
discussed in detail. This article tries to highlight the reasons as to why such
a system should, or should not, be introduced in India.
Disclaimer: NISCAIR assumes no responsibility for the statements and opinions advanced by contributors. The editorial staff in its work of examining papers received for publication is helped, in an honorary capacity, by many distinguished engineers and scientists.