Making The Case For Responsible Science For A Safe Environment

By Sunita K. Sreedharan

[Editor’s Note: the protection of regulatory data is expected to be discussed in an upcoming round of EU-India free trade agreement negotiations.]

Innovation or “jugaad” has always driven the Indian economy. However, the last decade has been witness to an emerging paradigm shift to high-quality value-added innovation.

Innovation will fuel the next generation of Indian growth as opposed to the inexpensive labour-intensive production focus of the 20th century. To sustain this evolution it is imperative that we continue to cultivate a creative and innovation-friendly environment that co-exists harmoniously with the natural ecosystem.

Intellectual property operates as a driver for innovation, but remains to be fully understood and appreciated as such. Sound intellectual property regimes not only benefit particular right holders, but also society as a whole. For example, in agriculture, they make it possible to develop innovative tools, such as crop protection products and improved plant traits, to help meet the critical challenge of feeding a growing world.

Intellectual property policy efforts have commonly focused on patents, trademarks and copyrights to spur innovation and creativity, particularly in industrialised and service-driven economies. One of the plant science industry’s most important contributions to agriculture derives from the research and development of novel agrochemical technologies. There is a specific and globally accepted intellectual property instrument to bolster ongoing research in agrochemical technologies: regulatory data protection.

It is important to understand that regulatory data and patents are two different concepts. Whereas patents are the basis for acknowledging intellectual property rights, regulatory data is the set of information required to demonstrate a product’s benefit and impact for a given market. This information typically includes data related to product efficacy as well as health and environmental impacts. This data is used by regulators to determine whether to approve a product for a given market.

As an example, India has already accepted the concept of data protection for agricultural chemical products based on the recommendations of the Satwant Reddy Report released in May 2007. While demarcating between the data protection requirements for the agricultural chemicals, from pharmaceuticals and traditional knowledge, the Report recommends strengthening legal provisions on data protection and observes that India does not meet the minimum standards of data protection required by the World Trade Organisation (under Section 39.3 of the TRIPS Agreement).

The authors of the report recognise that improving agricultural productivity depends on helping farmers get access to the tools and technologies they need to compete internationally and increase their yields over time.

In order to provide food security to a population of over one billion, India, with constantly shrinking tillable land, calls for innovative efforts in agriculture. Crop protection plays a significant role in increasing the yield per hectare. The regulatory approvals require submission of safety and efficacy tests to ensure safety to the biodiversity and the ecosystem. The incentive to invest in such innovations vests in a robust intellectual property regime as well as the certainty of data protection for studies submitted to obtain regulatory approvals.

Every type of innovation must be supported with workable systems for technology transfer, fostering an environment of less resource-intensive growth while ensuring continued safe and efficient new products.

It is therefore the need of the times to ensure that every market participant must shoulder the social and ecological responsibilities that come with investments in technologies that solve the challenges of the 21st century and keep the Indian economy growing at the historic rates it has enjoyed of late.

Sunita K. Sreedharan is the CEO of SKS Law Associates, a three year old New Delhi based law office with strong focus on prosecution, litigating and licensing of intellectual property rights. Its list of clients is available here. Prior to this, she was a Partner with Anand and Anand heading their Life Sciences and Geographical Indications Group.

Sunita obtained her LL.B. (awarded Gold Medal) from The School of Legal Studies, Cochin University of Science and Technology, and followed it with an LL.M. from The George Washington University Law School, Washington DC, USA. Prior to her study of law, she obtained her M.Sc. in Cytogenetics, an MBA and a Diploma in Computer Science.

Sunita is a prolific author having published in MIP, Business Briefing – Pharmatech and IAM among others. Her book “An Introduction to Intellectual Asset Management” published by Wolters-Kluwer is widely available. She is also a frequent speaker at various domestic and international fora, including WIPO and LESI seminars. Sunita is a member of the Bar Council of India, Bar Council of Kerala, Patent Agent, the LES and AIPPI and has been empanelled as legal counsel for the Protection of Plant Variety and Farmers’ Rights (PPV & FR) Authority, Ministry of Agriculture. Presently she is the Legal Advisor on the Central Technology Management Committee of the Indian Council for Agricultural Research.