Info Service on Health Issues (Jul19/01)
We are pleased to share with you a new TWN Policy Brief on Patents and Pre-Grant Opposition in India.
An important component of the patent law in India is the provision for third parties to challenge patent applications through the pre-grant opposition (PGO) system. The PGO could prevent the grant of patents on applications that are not truly inventive or new; do not involve an inventive step; and that are minor modifications without significant enhanced efficacy, forms or derivatives of known compounds (secondary patents), etc. A large majority of patent applications for pharmaceutical products are for secondary patents, to extend the number of years of monopoly beyond the expiry of the original patent on the compound or molecule of the pharmaceutical product. Therefore, PGO provisions in the Patents Act in India is a public interest safeguard system that has the potential to prevent non-deserving patent applications from getting patents. However, the PGO system is not popular and not used much, due to various reasons including scarce resources, and undue delay in the disposal of applications for patent opposition. Thus it displays the under-utilisation of one of the TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights) flexibilities to ensure access to affordable medicines. The wrongful grant of patents on known pharmaceutical substances could result in monopoly and unaffordable prices. This policy brief suggests some measures to enhance the efficacy and utilisation of the PGO. India’s experience also offers valuable lessons for other developing countries that are committed to public health and access to affordable medicines.