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USTR Report Flags India’s Drug Patent Rules

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01.05.2026

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India has again been placed on the Priority Watch List in the 2026 Special 301 Report released on April 30 by the Office of the United States Trade Representative, reflecting continued U.S. pressure over pharmaceutical-related intellectual property protection and enforcement in India.

The Special 301 process is not legally binding; it is an administrative review used by the US as a pressure tool. It does not impose immediate penalties but can lead to negotiations, investigations, and sometimes trade action if issues escalate.

For India, the report has no direct legal impact but signals continued US push on IP issues. The USTR plans to engage more closely with Priority Watch List countries, and such listings often shape future trade demands and negotiations.

The new report reviews 25 countries based on their IP regimes. Vietnam has been named a Priority Foreign Country, which can trigger a Section 301 investigation within 30 days, while countries like India face closer bilateral engagement.

The other countries on the list alongside India are Chile, China, Indonesia, Russia and Venezuela.

India was also on the Priority Watch List in 2025 and 2024, showing this is an ongoing status, not a one-time action. In fact, it has remained on the USTRs  Priority Watch List since 1990s, reflecting long-standing differences with the U.S. over intellectual property policy, especially in pharmaceuticals.

Key issues flagged by the USTR report

The report raises several concerns about India’s IP framework, especially in pharmaceuticals.

A key issue is Section 3(d) of the patent law, which denies patents to new forms of known drugs unless they show improved therapeutic effect. This is meant to stop “evergreening” – minor changes made to extend patents without real benefit.........

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