Compulsory license is a flexibility in the field of patent protection that enables a government to allow a third party to produce a patented product without seeking the consent of the patent holder.
“Covid-19 is a public health emergency and the government is obligated to issue an order of government authorisation under Section 100 or a compulsory licence for non-commercial public use under Section 92(1) of the Patents Act to respond and ensure continued access to the vaccines,” it said in the petition in which the government is the respondent.
- Petition in SC for compulsory license for Covid vax, drugs
- Jan Swasthya Abhiyan petition on Remdesivir, Tocilizumab, Favipiravir
- Compulsory license allows 3rd parties to produce patented drugs
- Govt can issue compulsory license during pandemic
- Limited capacity of SII, Bharat Biotech
- India has issued only one CL till now, in 2012
Section 100 of the Patents Act enables the Centre to use patented inventions for government purposes while Section 92 of the Act is a special provision enabling it to issue compulsory licenses for the manufacture of patented drug.
India issued its first compulsory licence in 2012 when Hyderabad-based drug producer -Natco was allowed to produce German pharma major Bayer’s life-saving kidney cancer drug Nexavar, with a royalty payment to the latter.
There is a shortage of Remdesivir, antiviral Favipiravir and immunosuppressant Tocilizumab in India which reported a record 3.86 lakh Covid-19 cases in the last 24 hours.
Attributing the shortage of vaccines to the limited number of manufacturers, the organisation said: “There are also issues of procurement and the pricing of the vaccine as in view of the approach taken by the Union of India, the manufacturers have applied their own pricing to the vaccine. On the other hand, some states are vaccinating the public free of cost”.
As per the petition, the combined production capacity of Serum Institute of India that is producing Covishield is 60 million a month while that of Covaxin-manufacturer Bharat Biotech is 5 million per month.
Although the Centre has roped in three public sector units to produce Covaxin “there is no clarity when the products from these facilities will be available in the market and the projected number of doses”, it said, noting that has taken 63 days for the cases to rise from 8,000 on February 2, 2021 to 1,03,558 as of April 5, 2021.
“In order to respond to the demand of these vaccines, across the country, there is a need to rapidly upscale production, which can only happen when there are more companies manufacturing the drugs,” it said, adding that this is possible by issuing authorization for Government use or orders for compulsory license for public non- commercial use in respect the patents covering the vaccines.
The petition comes at a time when India along with South Africa has called for a waiver for all World Trade Organization members of certain provisions of copyrights, industrial designs, patents and protection of undisclosed information in the Trade Related Intellectual Property Rights (TRIPS) agreement for prevention, containment or treatment of Covid-19.
Made in October last year, the proposal has the support of almost a hundred countries now.