Hatch Waxman Act and the Indian Pharmaceutical Firms: An Analysis

In the US, the Drug Price Competition and Patent Term Restoration Act of 1984, (the Hatch-Waxman Act or HWA), was designed to provide cheaper drugs to consumers while leaving intact a financial incentive for research and development for pharmaceutical firms. The HWA permits non-brand name, generics to market their molecules subsequent to patent expiry; however, recent judgments on “authorized generics” have tilted the scale toward large pharma brand name firms by decreasing the “playing space” available to the generic manufacturer. On the other hand, recent rulings in the US have the potential to help Indian pharmaceutical firms by allowing them earlier access to the molecules that brand name firms are investigating. Recent case laws have revisited the trade-off between the interests of innovator and generic companies.

Today, Indian companies need to revisit their generics focused strategy given the implications of recent case law. Although Indian companies have already adapted authorized generics route besides maintaining a steady flow of ANDA filing, Indian companies have to be careful in striking a proper balance between. generics and authorized generics, innovator and copy cat strategy. This paper evaluates the impact of recent case law on the prospects of Indian pharma firms.