Patent evergreening designates a recognized strategic approach wherein pharmaceutical corporations secure sequential patent grants for insubstantial alterations to pharmaceutical products that have already been subject to patent protection. The objective is to extend market exclusivity beyond the initial twenty-year patent term thereby precluding the entry of generic competitors into the market. In a country like India where generic medicines account for over 80 percent of drug consumption by volume this practice carries serious public health consequences. It inflates drug prices, restricts access and disproportionately affects the weaker and poorer sections of the population. India has replied to this challenge with section 3(d) of the Patents Act 1970, An existing provision specifically tailored to exclude the patenting of trivial and therapeutically unimportant variations to known drugs. This provision was upheld and strongly interpreted by the supreme court in Novartis AG v Union of India. But patent law alone cannot address the full spectrum of anti-competitive conduct associated with evergreening. In competition law specifically sections 3 and section 4 of the Competition Act 2002, provides a complementary framework capable of addressing pay-for-delay settlements, patent thickets and abuse of dominance in pharmaceutical markets. This paper argues that a coordinated implementation of both patent law and competition law is essential to effectively curb evergreening and protect generic drug access in India.
Dakshina Tripathi (Fri,) studied this question.