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The Hatch-Waxman Act and Indian pharmaceutical firms: an analysis

Arvind Sahay and Gordhan K. Saini

Abstract:

In the USA, 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 towards large pharma brand-name firms by decreasing the ‘playing space’ available to the generic manufacturer. On the other hand, recent rulings in the USA have the potential to help Indian pharmaceutical firms ...

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