Patent Regime in Favour of USTR: Drawbacks

Patent Regime in Favour of USTR: Drawbacks

Question - Change in the Indian patent regime in favour of USTR will harm the Indian generic pharma industry. Discuss.

Indian generic pharmaceutical industry has earned the reputation of creating cheap and reliable versions of more expensive branded drugs. If the Indian patent regime sought by USTR( US Trade Representative) is put in place, there could be incalculable harm to the generic pharma industry.

USTR’s position

• USTR has said it is keeping India under the priority watch list

• It has however, not imposed an out of cycle review of IPR laws of India

• India and China are the sources of most counterfeit medicine shipped to US


• If Indian patent laws are aligned with international USTR standards, then it will harm the stability of India’s IPR regime

• Indian patent laws are already TRIPS compliant; further compliance will be counter productive

• Pharma MNCs have been divesting their interests in India and worldwide; there is no correlation between IPR and FDI

• Increased levels of IPR in compliance with what is above international rules will not yield investment

• It will instead create exclusive rights for profit making and destroy generic competition in India

• Industry is against data exclusivity which bars Indian Food and Drug Administration from approving competitor’s product when exclusivity on data lasts even for off-patent medicines

• Data exclusivity will prevent pre-grant oppositions and compulsory licensing; it would also harm bulk procurers like Medicines Sans Frontiers and create doubts about the future of public procurement programmes

• Accepting such an IPR regime will lead to monopolies on patented and non-patented products via regulatory process

• Cheaper medicines will become harder to procure in a country which is poor; affordability of medicines will be directly impacted

Facts and Stats

• Up to 20% of drugs sold in the Indian market are counterfeit: USTR report

• Report lauds increased bilateral engagement of NDA government for this matter

• It aims to expedite substantial and measurable improvements in India IPR and patent laws

• Counterfeit drugs from India also flood foreign markets: USTR report
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