Indian Pharmaceutical Alliance (IPA), an association of 24 leading Indian pharmaceutical companies, has asked the Office of United States Trade Representative (USTR) to keep India out of its ‘priority watch list’ due to various steps taken by the Indian government, judiciary and other stakeholders to strengthen and modernise India’s intellectual property rights (IPR) ecosystem in the recent years.

USTR’s annual Special 301 Report lists out the countries that are perceived to have serious deficiencies in their national IPR systems. In 2022, USTR had reviewed more than 100 trading partners for the Special 301 Report and placed 27 of them, including India, on the Priority Watch List.

In a submission made to USTR last month, IPA cited the decision taken by the Indian Patent Office (IPO) in January 2023 to expeditiously dispose of pre-grant oppositions as well as post-grant oppositions, as one of the most recent examples of the government’s pro-active approach.

"No party shall be given more than two adjournments of hearings, and each adjournment shall be for not more than 30 days, the inner limit for adjournments has been fixed at 10 days. Another public notification published on the same day, i.e., 16 January 2023, states that no adjournment can be sought by any party without mentioning "reasonable cause" for the same, and that adjournments filed without reasonable cause will not be entertained," IPA submission had highlighted.

The association also cited a number of court judgements that upheld intellectual property rights. It highlighted the creation of the intellectual property division (IPD) by the Delhi High Court to solely deal with IPR matters and brought to USTR’s notice the decision of the IPD state that to reject a patent application the Patent Controller was required to give a detailed reasoning to explain how a person skilled in the art would arrive at the teachings of the patent application. It also highlighted another instance where IPD held that the amendment of claims of a patent specification before the grant of a patent ought to be construed liberally and not narrowly.

IPA pointed out that the Indian government is working on a new legislation - New Drugs and Cosmetics and Medical Devices Bill, 2022 - to broaden the already existing definition of "spurious drugs", in order to enforce higher quality standards on drugs that are manufactured and imported into the country.

On USTR’s criticism against high customs duties on IP intensive products in the Special 301 Report, 2022, IPA reiterated that the rates of customs duties have remained the same for these goods since 2017.

IPA members account for more than 80% of the exports of drugs from India and have over 60% of domestic market share in the country.

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