India remained on the ‘Priority Watch List’ of the United States Trade Representative’s (USTR) “Special 301 Report”, for using legal tools to protect generic competition and access to affordable medicines.
This report is a part of an annual review of intellectual property (IP) laws of the United States’ trading partners. India is among the 11 countries put on a ‘watch list’ for harsh IP enforcement and could result in sanctions.
The 301 report was released late Wednesday night and attacks section 3(d) of the Indian Patent Act, which has enabled the Indian government to establish stricter patentability standards for medicines — allowing access to affordable generic drugs.
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The report comes in the backdrop of increased pressure on the Department of Industrial Policy & Promotion (DIPP), the agency that administers IP laws and policy — to ensure stringent IP enforcement, fast track examination of patent claims of its companies and a moratorium on compulsory licensing (CL).
Soon after the 301 report was released, humanitarian aid organisation MSF urged the Indian Government to continue to uphold, and even to intensify efforts, to align India’s patent law and practice with access to treatment and public health needs. “These latest U.S. 301 Report placing India on its Priority Watch List underscores the influence that the U.S. pharmaceutical industry has in wielding U.S. government pressure on countries like India to rollback progressive patent law safeguards. India’s use of patent law safeguards is fully consistent with WTO trade rules, and seen as a model for many countries, including Philippines, Brazil and South Africa, where governments have reformed or are reforming their patent system to encourage generic competition in medicines.
As a treatment provider, we would like to emphasise the importance of India’s current intellectual property system in enabling us to meet the needs of our patients in India and around the world as affordably and effectively as possible,” said Leena Menghaney, South Asia head of MSF’s Access campaign.
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India, the report states, “has also not taken the opportunity to address longstanding challenges that represent significant IPR regime deficiencies compared to other markets. The pharmaceutical industry in particular faces a host of challenges related to IPR. These include irregularities in the application of Section 3(d) of India’s Patents Act; …lack of clarity on standards for Sections 85 and 92 compulsory licenses and revocation under Section 66…”
In a press statement, Mark Elliot , executive vice president of the U.S. Chamber of Commerce’s Global Intellectual Property Center (GIPC) said that, “while India has been identified by the U.S. Trade Representative as a Priority Watch List country, recent policy reversals continue to pose challenges for creators and innovators. We remain hopeful that further engagement between the United States and India will lead to a much improved IP environment and allow India to make positive contributions to the global innovation ecosystem.”