IPR Toolkit

Data Protection

Article 39.3 of the TRIPS Agreement sates that the "Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use.  In addition, Members shall protect such data against disclosure…" In other words, data protection is the protection of efficacy and safety data for a limited period of time against unfair commercial use and disclosure. The Drugs and Cosmetics Act of 1940 regulates manufacture and marketing approval of drugs and traditional medicines, and the Insecticides Act of 1968 addresses the manufacture and marketing of agricultural chemicals (insecticides, fungicides and weedicides). However, there is no statute in place in India at this time for the protection of pharmaceutical, agrochemical and traditional medicine-related data against disclosure and reliance by third parties.

In order to comply with its international obligations under the TRIPS Agreement, the Government of India designated the Department of Chemicals and Petrochemicals, Ministry of Chemicals and Fertilizers as the responsible party to suggest measures that should be adopted in context of TRIPS Article 39.3 and to consider whether data protection can be offered under the existing legal provisions. An Inter-ministerial Committee was constituted on February 10, 2004 under Chairmanship of Secretary Reddy to act as a Consultative Group on the matter.  The Committee released the Reddy Report on May 31, 2007. The Reddy Report finds that the present Indian legal provisions on data protection are not adequate to meet the spirit of Article 39.3 of TRIPS Agreement, though it concludes that existing legislation may be amended to achieve TRIPS consistency. The report further recommends that an explicit legal mechanism in the Drugs and Cosmetics Act, 1940 and the Insecticides Act, 1968, and the Rules framed under these Acts, should be provided to ensure that undisclosed test data of the originator is not put to unfair commercial use by others. Several other key recommendations in the Reddy Report are as follows:

• The term of data protection for agricultural chemical products should be three years from the date of marketing approval in India;
• The term of data protection for traditional medicines should be five years from the date of marketing approval and
• There should be an indefinite transition period for pharmaceuticals.  After the transition period, the term of data protection would be five years from date of first marketing approval anywhere in world.

These recommendations are now being considered by the Ministry of Commerce and Industry, Ministry of Agriculture and Ministry of Health.

Though this report is a step in the right direction for India to implement a data protection law, there are certain recommendations that are of concern to the pharmaceutical and agrochemical companies that want to do business in India. For example, the recommended term of protection for agricultural chemical products is for three years and there is an indefinite transition period for pharmaceuticals. Furthermore, the report recommends that data protection be subject to a number of conditions that appear onerous. For example, data protection should only be awarded for a drug based on a new chemical entity and not for new indications or for new dosage forms, the term of data protection of a patented drug is limited by the patent term in India, there is a requirement to apply for marketing approval in India within 24 months of receiving first marketing approval anywhere in the world and the product has to be launched in India within six months of grant of marketing approval, and the term of data protection for pharmaceuticals starts with the date of first marketing approval anywhere in world.

International Treaties to which India is a signatory

Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS)

Data Protection Related Websites

http://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm
http://chemicals.nic.in/DPBooklet.pdf