2010 Business Agenda : Patents vs Patients

2010 Business Agenda : Patents vs Patients

India’s patent system…So near and yet so far?

Dr Prabuddha Ganguli, CEO, VISION-IPR proposes that the IPR ecosystem debate has to now leapfrog from its present emotive platform to a framework that is bold and objective for sustenance of socio-economic growth

The IPR scenario in India has undergone metamorphic changes in the last fifteen years. Major amendments in the Patents Act, Trademarks Act, Designs Act and Copyright Act, introduction of new Acts on Geographical Indications, Protection of New Plant Varieties and Farmers Rights, Biodiversity, Protection of Layouts for Integrated Circuits Act and the enactment of the Competition Law, India’s portfolio of IPR related Acts now appears comprehensive.

We now need to examine whether the IPR ecosystem is ‘innovation-shy’ or ‘innovation-enabling’, ‘investments-encouraging’ or ‘investments-curbing’, ‘public-private-partnership propagating’ or ‘public-private-partnership discouraging’. Desirably we need a balanced IPR system that is supportive of investments, competition, enables fair protection of innovations, ensures enforcement of rights, encourages knowledge sharing and transfer, facilitates IPR transactions synergistically in societal interests. The debate obviously has to leapfrog from its present emotive platform to a framework that is bold and objective for sustenance of socio-economic growth.

The patent system in India has made remarkable progress in recent times. While the infrastructure is in the Indian Patent Offices have made significant improvements, a few aspects of the Indian Patents (Amendments) Act (2005) needs immediate redressing to operate on benchmarks that are truly global.

Specifically,

o Section 3(d) continues to be superfluous despite the statutory definition of inventive step in the Indian Patents Act, all that is needed is to set the guidelines for the evaluation of inventive step as per internationally acceptable benchmarks and this will minimise if not eliminate the possibilities of granting patents for frivolous inventions

o Special requirements in specification under Section 10(4)(ii)(D) requiring mandatory disclosure of source and geographical origin of ‘biological materials’ where the meaning of geographical origin remains undefined. Disclosure of the source of the biological material should be adequate for the purposes of patenting

o Section 11A(7) dealing with the enforcement of Patents for applications made under subsection(2) of Section 5 before 01-01-2005 wherein ‘Rights of a patentee in respect of applications made under sub-section 5 before the 1st day of January 2005 shall accrue from the date of grant of the patent provided also that after a patent is granted in respect of applications made under sub-section (2) of section 5, the patent holder shall only be entitled to receive reasonable royalty from such enterprises which have made significant investment and were producing and marketing the concerned product prior to 1.1.2005 and which continue to manufacture the product covered by the patent on the date of grant of the patent, and no infringement proceedings shall be instituted against such enterprises.” This clause needs to be amended such that the patentee of patents that were granted after 01-01-2005 when infringed ought have the right to enforce their rights against those who continue to infringe their patents after 01-01-2005

o Section 84 (7) dealing with compulsory licences wherein “a compulsory licence could be requested on the ground that ‘a market for export of the patented article has not been met to an adequate extent or on reasonable terms’. This section is superfluous especially as sourcing and serviceability of markets are rationalized based on multiple considerations

o Section 83 in which ‘Working of Patents’ continues to be undefined despite it being a crucial benchmark for compulsory licensing

‘A differential pricing’ enabling ecosystem needs to be evolved and some of the essential conditions include effective enforcement of data protection, streamlined regulatory approval systems and systems for speedy enforcement of patent rights. It is recommended that the Drugs and Cosmetics Act be appropriately amended and a linkage with the patent system statutorily be established so that approvals for products take into cognizance the patents status of the products under approval. The policy makers and the judiciary have major roles to play in such an initiative.

Addressing these concerns should be on the radar of the policy makers in India. Plugging of these gaps with the enhancement of the infrastructure and training of human resource will provide the much needed innovation enabling climate for sustained national economic growth.