COMPULSORY LICENSING AND BAYER PROVISION: THE ROOTS OF IMPLICATION OF TRIPS
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Abstract
Patent is one of the instruments which are mostly debated for its role under pharmaceutical industry. What is patent all about? Why is it in debate nowadays?
The simple answer to all these questions is that Patent is an instrument by which grant of some privilege, property or authority is made by the government or the Sovereign of the country to one or more individuals. The debate started when India signed General agreement for trade and tariff in 1994 wherein it agreed to implement all the flexibilities of TRIPS within a given time period. India faced challenges while adopting the provisions of TRIPS as maintaining stability between the provisions of TRIPS (Trade Related Intellectual Property Rights) and Protection of Public Interest was the aim of Indian policy makers.
TRIPS brought in drastic change in the existing patent law wherein it introduced Product patent, Rights of Patentee. The provisions also extended the term of patent. Certain modifications/ flexibilities were also introduced by TRIPS agreement, which were: Compulsory licensing, Bolar exemption and Parallel imports.
Introduction of product patent led to a great loss for the generic pharmaceutical industry in India as they were no longer allowed to continue the process of “reverse engineering”. On one hand the implementation of TRIPS restricted the pharmaceutical industry in terms of producing generic drugs; on the other hand it opened up opportunities for the industry in terms of investments in Research and Development of molecules.
Compulsory Licensing was incorporated by Section 84 of Indian Patent Act, 1970. Also, there was recognition of India’s Bolar Exemption under section 107A of Indian Patent Act, 1970. No doubt every new implication has its own positive and negative effect what needs to be observed is which of the effect is more prevalent and what is the general view of pharmaceutical companies on such changes. Most of the companies viewed the change within the patent system as positive and accepted and started gearing up for the same where others found it to be an opportunity for basic Research and Development.
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