The biotechnology sector is grappling with patent issues pertaining to gene therapy, tissue engineering and foetal tissue reseach. These issues fall outside the purview of what is defined as patentable in the new Patents Act. |
According to a recent ICRA report on the biotechnology sector, "Legal issues relate to discoveries in genetics, patentability, conduct of clinical trials involving gene therapy... and other issues like tissue engineering, foetal tissue research, etc." |
The Indian patent law grants a patent on anything new, not anticipated a priori and having commercial utility. The definition has now included micro organisms. |
India is now TRIPS-compliant as micro-organisms and non-biological and micro-biological processes are under mandated review at the World Trade Organisation. However, by leaving out all the higher organisms and gene constructs from it, the definition of patentability remains very narrow. |
"There is ambiguity in the existing patent laws with regard to gene patenting, which includes micro-organisms as well. The law does not allow patenting of any life form. However, patents based on microbial processes are permitted," explains Rajesh Jain, joint managing director, Panacea Biotec Ltd. |
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. |
"Patent protection secures the fruit for the one who sweats. For a sector that has long gestation periods and still faces a funding crunch, this kind of protection would provide young firms with more saleable 'assets' which would pool into their own growth," commented an industry analyst. |
"The shift to biogenerics and biopharma is creating a hybrid model of discovery in which research information is extremely valuable. After all, the core business of more entrants in genomics is information, not sale of drugs or diagnostics," explained another expert. |
However, contrarians believe that patent protection increases the transactions cost as the holder has to be approached for approval and thereby, impedes innovation. |
"By not allowing patenting of naturally occurring micro-organisms/genes or its functions helps widen the scope of research by multiple companies. Many countries including the US where micro-organisms and its function are patentable, Indian industry will find it difficult to use such micro-organism for research purposes", explained Jain. |
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 is yet to come to a consensus. There are no clear guidelines on patentability", said Jain. |