Understanding The Politics Of Patents: The government must immediately invoke Section 92 and 100 of the Patents Act. Its apprehensions about international commitments are misplaced.
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Shortages of vaccines and medicines to cope with Covid-19 are the most perturbing features of the second wave of the pandemic. As if in anticipation of these shortages, India and South Africa tabled a proposal at the World Trade Organization (WTO) in October 2020, for temporarily waiving enforcement of four forms of intellectual property rights (IPRs), copyrights, patents, industrial designs, and trade secrets, in respect of medical products, including vaccines and medicines, for the prevention, containment or treatment of Covid-19.
The two countries argued that products necessary for dealing with Covid-19 must be freed from the encumbrances of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for ensuring “unimpeded and timely access to affordable medical products”.
The waiver proposal was co-sponsored by 62 WTO members and supported by almost two-thirds of the members. But, an influential set of countries, including Australia, Brazil, the European Union (EU), Japan, Switzerland, the United Kingdom (UK), and the United States (US) opposed it. Recently, the US extended support to the proposal, agreeing to waive IPRs only on Covid-19 vaccines.
However, even after the truncated support of the US, text-based negotiations on the waiver proposal may not commence soon, for this requires a consensus among WTO members. This implies that shortages of vaccines and medicines will continue until WTO members take a decision on waiving IPRs, allowing the production of these products to increase.
India, which is facing shortages of vaccines and medicines, can do better if the government decides to invoke two provisions of the country’s Patents Act, which Parliament included to address public health emergencies. While amending India’s Patents Act after the country joined WTO, lawmakers had included important instruments such as special compulsory licences (Section 92) and government use of inventions (Section 100). These amendments were introduced by the National Democratic Alliance (NDA) government in 2001, after the Patent Amendment Bill was deliberated on by a joint committee of the two Houses of the Parliament.
Almost coinciding with the discussions in the Indian Parliament, WTO members agreed in the Doha Ministerial Conference that compulsory licences can be used in “national emergency or other circumstances of extreme urgency”.
Section 92 allows the Centre to issue compulsory licences any time after the grant of a patent “in circumstances of national emergency or in circumstances of extreme urgency”. The Controller of Patents is authorised to grant a licence to any person interested in producing the patented product and on such terms and conditions as the Controller deems fit. The provision of Section 92 can be applied in case of “public health crises…or other epidemics”. No one, including India’s lawmakers, could anticipate a pandemic such as Covid-19; the worst case scenario for invoking this Section, according to them, was, therefore, “epidemics”.
Section 100 enables the Centre, or any person authorised by it, to use the invention “at any time after an application for a patent has been filed at the patent office or a patent has been granted”. In other words, if a vaccine or medicine has been granted a patent in India, or an application for the grant of a patent in India has been made, the government can authorise anyone to produce such a product in the country. While introducing the Patent Amendment Bill in the Parliament, the then commerce and industry minister, Murasoli Maran, had explained that the government can use this provision “only in the interest of public health system. They can procure [patented medicines] and sell [them] to hospitals or they can give it to third parties” for producing in the country.
Recently, the Supreme Court (SC) of India “outlined the legal framework within which the Central Government can possibly consider compulsory licensing and government acquisition of patents (Sections 92 and 100), and observed that the government was free to choose any other course of action it deemed fit to tackle the issue of vaccine requirements in an equitable and expedient manner, which may involve negotiations with domestic and foreign producers of vaccines”.
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However, in its subsequent affidavit before SC, the government had expressed its reluctance to “exercise of statutory powers either under the Patents Act 1970 read with TRIPS Agreement and Doha Declaration … can only prove to be counter-productive at this stage” since the “central government is very actively engaging itself with global organisations at a diplomatic level to find out a solution in the best possible interest of India”.
The government’s apprehension may be ill-founded as the US has recently stated in its annual review of IPR policies that it “respects its trading partners’ rights to grant compulsory licenses in a manner consistent with the provisions of the TRIPS Agreement and the Doha Declaration”.
We would, therefore, argue that the government must invoke the public health provisions of the Patents Act immediately. By doing so, vaccine production in the country can be ramped up significantly more than offering licences to scale up production of Covaxin to select public sector units, as was done last week. If the Patent Act provisions are not invoked during the Covid-19-pandemic, when will they be invoked?