In a recent TV talk show, two discussants involved with the medicine and the pharmaceutical industry, were discussing the uncertainty of getting the Covid-19 vaccine. One of them asked why they wrre not issuing compulsory licences for the vaccine production. It appeared to this scribe that both of them thought manufacturers of the Covid-19 vaccine had obtained the necessary patents for the vaccine in Bangladesh, and they have submitted to the Department of Patents, Designs and Trademarks (DPDT or the national patents office) a list of all the information about the vaccine such as library information about the inventor of the vaccine and the patent applicant or patent holder, details of technological innovation and related developments and the scope of patent protection. Now the government can issue compulsory licences under section 22 of the Patents and Designs Act 1911 to produce the Covid-19 vaccine through government-controlled Essential Drug Company Limited or any other pharmaceutical company and supply it to hospitals or markets free of costs or with costs. Is that the case? Let us discuss.
A patent is an exclusive right of a patent owner based on which a patented product or process cannot be made, used, distributed, imported, or sold commercially without the consent of the patent owner. To obtain this right, the patent owner submits the necessary information related to the patent in the Patents Office. This obligation to disclose information about newly invented technologies balances the exclusive right granted to the patent holder of an invention. In addition, other inventors can solve new technological problems based on such published information. Again, without publications, there is no way for the public to get information about new technological developments.
The patent owner can voluntarily transfer the exclusive patent right to another through a voluntary licence agreement. The agreement will contain how much of the licencing fee the patent owner will receive from the licencee, what purposes the agreement will serve like licencing it to another due to lack of production facilities or inadequate production or concentration in a geographical market, how long the agreement will remain valid, and to what designated area the product will be delivered.
However, this exclusive right of the patent owner can sometimes be legally curtailed to prevent monopoly abuse or to give greater prominence to the public interest for maintaining the balance between the patent owner and the third party or public interest or the interest of the society. The compulsory licence is one of the grounds. This allows the government to allow someone else to produce patented products or processes without the consent of the patent owner or to plan to use the patent-protected innovation itself. Such provisions are enshrined in the Paris Convention 1883 and the TRIPS Agreement 1994, and in the light of these provisions, manufactured goods can be supplied to the country through compulsory licences. However, Article 31bis, newly added to the TRIPS, allows patented pharmaceutical products to be manufactured through compulsory licences and conditionally exported to third countries.
The TRIPS does not specifically list the factors that may be used to justify a compulsory licence. However, the Doha Declaration on Public Health 2001 ensured that countries were free to determine the basis for the issuance of compulsory licences and the conditions under which a national emergency would arise.
Generally, a person or an organisation applying for a voluntary licence must try to negotiate reasonable terms with the patent owner within a reasonable time. If this fails, a compulsory licence can be issued. There is also no need to first try for a voluntary licence in case of 'national emergency', 'other circumstances of extreme urgencies' or 'public non-commercial use' (or 'government use') or anti-competitive practices. However, even if a compulsory licence is issued, the patent owner requires to be paid royalties considering the economic condition of the issuing country.
Although Bangladesh's Patents and Designs Act 1911 does not yet comply with the TRIPS, it provides for a compulsory licence in Section 22. According to the provisions of this Act, if the demand for a patented product is not being met adequately and on reasonable conditions, any person interested in that behalf and with the prescribed fee may file a petition at the Patent Office for issuing a compulsory licence. If the matter has not been settled through negotiation between the parties, the government may then dispose of the application or may refer it to the High Court Division for the order of a compulsory licence reflecting the unfulfilled demand for the patented product adequately and on reasonable terms.
The question now is whether the Covid-19 vaccine is registered as a patent in Bangladesh and whether it can be made available through a compulsory licence. To my knowledge, no patent application has been filed in Bangladesh for any Covid-19 vaccine; and Bangladesh, as an LDC, is not obliged to give patents for medicines until it graduates to a developing country in 2026. Hence, the country will not have the formulas, processes, and descriptions of the vaccines to produce them locally unless they are patented.
Considering the above, vaccines can be made available in the country by paying royalties through voluntary licences, using formulas, bulks (API) and cheap labour in the country to produce vaccines, or by joining coalitions of about 60 countries, including South Africa and others to free the vaccine patent and enable them to economically produce vaccines.
Further, if any other country produces the Covid-19 vaccine through compulsory licence and Bangladesh can import it, then the vaccine will be easily available in Bangladesh. In addition, although it is time-consuming and raw materials are scarce, domestic pharmaceutical companies can identify the molecules of the vaccines in their laboratories and make the vaccines readily available by making generics according to the required test and error rules.
Dr Mohammad Towhidul Islam is a Professor of Law in the University of Dhaka. [email protected]