The National Intellectual Property Rights (IPR) Policy promises to overhaul patents administration in India, but has raised concerns in the pharmaceutical industry and among those who seek a balance between IPR and free access to knowledge. Finance minister Arun Jaitley has asserted that India would retain its right to compulsory licensing in public interest to meet contingencies, and there would be no changes to Section 3(d) of the Indian Patents Act, which prevents ever-greening of drug patents. Though the policy claims that India’s patent laws are compliant with the Doha Declaration and the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement, certain provisions in the policy document have alarmed the generic drugs industry. It promises to “carry out legislative changes” whenever existing laws become inadequate to address changes in the knowledge field. 

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With India constantly pressured by developed countries to amend its patent laws, it is feared that these changes can proceed only in the direction that favours global pharma companies. Only last week, the Patents Office reversed its own decision to reject a patent application by a US company for a hepatitis C medicine. The patent office had earlier said that the drug was not significantly different from an earlier formulation by another company. Despite these fears, the mission statement of the policy says it aims to balance the imperatives of fostering creativity and innovation, and enhancing access to healthcare, food security and environmental protection. The biggest hindrance to creativity and innovation in India is the poor state of the patents administration system. In April, commerce minister Nirmala Sitharaman told Parliament that as many as 2.37 lakh patent applications were pending clearance. To compound the delay in clearing patent applications is the even poorer rate of commercialisation of successful patents. In India, it is less than three per cent of the total patents granted. 

Not surprisingly, India was placed on the “Priority Watch List” for inadequate IPR protection by the US Trade Representative’s Office, along with China and Russia. The new IPR policy was expected to give a boost to India’s quest for more foreign direct investment. But there is criticism that the document has few specifics like protection for global pharma majors to get them interested in investing in India.  Nevertheless, the offer of tax benefits and fee waivers to encourage research and development and patent creation aligns with the Make In India, Start-up India and the Digital India initiatives and could produce results in the long run. Even while the government claims to be upholding access to healthcare, it is at best a balancing act. 

The Doha Declaration was categorical in stating that the TRIPS agreement “does not and should not prevent members from taking measures to protect public health”. There is criticism that the compulsory licensing provision under Section 84 of the Indian Patent Act is not being used sufficiently. The compulsory licences can be issued after three years where the patented invention is not available at a reasonably affordable price and does not satisfy the reasonable requirements of the public. However, the government has been extremely parsimonious with granting compulsory licences. This is the case with many life-saving drugs and treatments for rare diseases. With Prime Minister Narendra Modi headed for the US, the announcement of the new policy will stave off some of the pressure that could have been brought to bear on him. Jaitley has reaffirmed the government’s commitment to price controls and preventing monopolies from cropping up. Though developed countries may insist otherwise, there is no contradiction between upholding both intellectual property rights and public interest. The Doha Declaration settled this argument and India must not retreat from this position of strength.