Patents grant inventors exclusive rights to their inventions for a certain period. In medicine, this means pharmaceutical companies that develop drugs control their production and sale. In Nigeria, patent protection is governed by the Patents and Designs Act, Cap P2 Laws of the Federation of Nigeria 2004. While patents promote innovation, they also raise concerns when public health is at risk, especially when life-saving medicines become too costly for the general population.
To address this tension, the law provides for compulsory licensing. Compulsory licensing permits the government or a third party, under certain conditions, to use a patented invention without the patent holder’s consent. Section 11 of the Nigerian Patents and Designs Act authorises compulsory licences in cases where, after four years from the date of filing or three years after a patent grant, the invention is not being worked in Nigeria on a commercial scale, or if the working is insufficient to meet demand.¹ The aim is to prevent abuse of patent rights and to make essential products more accessible.
This framework aligns with Nigeria’s obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which recognises compulsory licensing as a flexibility available to member states. Article 31 of TRIPS allows countries to grant compulsory licences in cases of national emergency, public non-commercial use, or where there is anti-competitive conduct by the patent holder.
The significance of this mechanism was emphasised during the COVID-19 pandemic, when debates around intellectual property waivers for vaccines and treatments dominated global discussions. Nigeria, like many developing nations, faced challenges in accessing vaccines and medical supplies due to international shortages and the concentration of manufacturing in developed countries. Compulsory licensing could have been a useful tool, but practical difficulties remain.
One of the main challenges is the weakness of Nigeria’s pharmaceutical manufacturing industry. Even if a compulsory licence is granted, the ability to produce patented drugs locally is restricted by inadequate infrastructure, lack of advanced technology, and reliance on imported active pharmaceutical ingredients.³ Without robust local capacity, compulsory licensing risks being a theoretical solution rather than a practical one.
Another challenge is the administrative complexity. Under Section 11 (and the First Schedule) of the Patents and Designs Act, an applicant for a compulsory licence must demonstrate to the court that he has requested a contractual licence from the patentee on reasonable terms and within a reasonable timeframe, and must provide guarantees to work the invention to address deficiencies, etc. The jurisdiction to hear legal proceedings under the Act lies with the Federal High Court under Section 26.⁴ This process is often slow, technical, and costly, which discourages its use in urgent public health emergencies.
Moreover, Nigeria has not fully utilised other TRIPS flexibilities such as parallel importation, which permits the import of more affordable versions of patented medicines from other countries.⁵ Instead, there is still a heavy dependence on the goodwill of patent holders or voluntary licensing agreements. This weakens the potential of the compulsory licensing regime as a tool for safeguarding public health.
International comparisons show that some developing countries have effectively used compulsory licensing to enhance access to medicines. For instance, Brazil and Thailand have issued compulsory licences for HIV/AIDS treatments, which significantly lowered the cost of drugs and increased access for patients.⁶ Nigeria has yet to adopt this approach, potentially due to political hesitancy, fear of trade retaliation, or absence of a coordinated policy framework.
There is also a tension between compulsory licensing and Nigeria’s desire to attract foreign investment in its pharmaceutical sector. Strong patent protection is often seen as an incentive for foreign companies to invest. Frequent use of compulsory licences could create the perception of an unfriendly business environment. This tension calls for a careful balance between protecting intellectual property rights and ensuring the right to health, as guaranteed under Section 17(3)(d) of the Nigerian Constitution, which obliges the state to provide adequate medical facilities.⁷
A reform-minded approach would require the Nigerian government to:
- Modernise and simplify the mandatory licensing process, perhaps by empowering the National Agency for Food and Drug Administration and Control (NAFDAC) or the equivalent Nigerian Copyright Commission to handle applications swiftly.
- Invest significantly in pharmaceutical research and development to enhance local capacity.
- Incorporate clear guidelines on the use of TRIPS flexibilities into national health and industrial policies.
Ultimately, the success of compulsory licensing in Nigeria relies not only on the legal framework but also on political commitment and practical capability. The COVID-19 experience has demonstrated that waiting for voluntary cooperation from multinational pharmaceutical companies is not always enough. To protect public health, Nigeria must be prepared to utilise the legal tools available under the Patents and Designs Act and TRIPS, while also strengthening its local pharmaceutical industry to ensure these tools are effective.
Footnotes
- Patents and Designs Act, Cap P2 LFN 2004, s.11.
- TRIPS Agreement, art. 31.
- Adebola, T., Compulsory Licensing and Access to Medicines in Africa (2019) Journal of Intellectual Property Law & Practice 14(9).
- Patents and Designs Act, Cap P2 LFN 2004, s.26.
- Correa, C., Integrating Public Health Concerns into Patent Legislation in Developing Countries (2000), South Centre, Geneva.
- ’t Hoen, E., The Global Politics of Pharmaceutical Monopoly Power (2009).
- Constitution of the Federal Republic of Nigeria 1999 (as amended), s.17(3)(d).