The biotechnology sector is grappling with patent issues pertaining to gene therapy, tissue engineering and foetal tissue research. These issues fall outside the purview of what is defined as patentable in the new Patents Act.

The Indian patent law grants a patent on anything new and having commercial utility. The definition has now included microorganisms.

India is now TRIPS-compliant as microorganisms and non-biological and microbiological processes are under mandated review at the World Trade Organization. However, by leaving out all the higher organisms and gene constructs from it, the definition of patentability remains very narrow.

Experts agreed that although issues like inadequate patent protection have not affected the research and development (R&D) potential gravely, it could hit the sector as the industry developed.

The shift to biogenerics and biopharma is creating a hybrid model of discovery in which research information is extremely valuable. However, others believe that patent protection increases the transactions cost, as the holder has to be approached for approval and thereby, impedes innovation.

Interestingly, the debate on the issue is yet to settle globally as well. In the different deliberations by the government, different departments have formed different opinions, and they are yet to come to a consensus. There are no clear guidelines on patentability.

(www.business-standard.com)