Intellectual Property Rights, Pharmaceutical Patents and Public Health: Adopting Compulsory and Government Use Licences in COVID-19 Emergency in Nigeria

Adebambo Adewopo*

ABSTRACT

COVID-19 pandemic has continued to exact enormous pressure on public health policies and systems, and raised far-reaching political, economic, social and technological questions and uncertainties on global welfare. Prospects for solution which has remained in making vaccines, drugs and diagnostics available would most singularly shape the rapidly evolving pandemic and its impact on human life and livelihood.  At the core of the questions are intellectual property rights (IPRs) issues arising from emerging bio-medical innovations particularly in the much-needed curative vaccines that promises to finally stem the tide. The current race for vaccines presents both legal and moral obligation on proactive governments and health regulatory institutions to take preemptive measures to address the potential challenge of access to the vaccines, which would prove otherwise primarily on account of price and domestic production capacity. Access to vaccines therefore has significant implications on the ability of public health care system, supported by IP, to fulfil one of its most critical objectives of providing essential medicines accessible to the large population especially in developing and sub-Saharan countries like Nigeria with relatively underdeveloped health care and innovation ecosystems. This article addresses the legal framework within the context of intellectual property (IP) system that allows for prompt and cost-effective access to the vaccines. It revisits the persistent IPR question often raised in the overwhelming public health emergencies now presented by COVID-19 pandemic and the need to integrate IPRs policies and COVID-19 related health care as it concerns access to pharmaceutical patents. The article recommends the adoption of the important compulsory licences instrument by both Federal and State governments provided under the Patents and Designs Act (PDA) with a view to addressing the imminent challenge of access when COVID vaccines are finally developed and released into the market.

INTRODUCTION

As the season of the novel coronavirus (COVID-19) pandemic rapidly evolves, policy makers and leaders have continued to grapple with one of the world’s most recent and dynamic public health challenges. Within weeks of the outbreak in Wuhan, China, the sheer gravity in both human and material cost and in terms of the rate of transmission and attended deaths across many countries has been exponential.[1] As at the end of April 2020, the World Health Organisation (WHO) has reported over 3 million confirmed cases and over 200, 000 deaths globally, with rising numbers, including more unreported cases and defying efforts to flatten the curve.[2] By all means, the pandemic has exacted enormous pressure on public health policies and systems, raising far-reaching political, economic, social and technological questions and uncertainties on global welfare and prospects for solution.[3] WHO has indicated commencement of series of consultation and discussion on COVID-19 vaccines with manufacturers and national health regulatory authorities.[4] If COVID-19 impact has been most severe in most of the best of health care systems, one can only imagine the impact on countries which has been paying lip service to health sector. As the wide-ranging questions arise, every country must begin to innovate and rethink their political and legal institutions for post-COVID dispensation particularly within the context of ensuring access to vaccines once they are approved for the global market. Vaccines would most singularly shape the rapidly evolving COVID-19 era. At the core of those questions is the issue of intellectual property rights (IPRs) arising from emerging bio-medical and technological innovations that would attend to finding the much-needed curative vaccines that would finally stem the tide. This pandemic affirms the agelong precept that ‘invention is the mother of necessity’. Most of the world’s important breakthroughs in innovation have often been inspired by catastrophic events and impact on human life.

The global anti-COVID-19 campaign supported by corporate enterprises and brand owners through production and donation of critical items and personal protective equipment (PPE) such as hydroalcoholic gels, face masks gloves and other items for health workers, first responders and patients has helped in addressing supply shortages and facilitated containment and control measures.[5] However, without vaccine yet, the ultimate global innovative test is in the cure that only vaccines, protected by patents, would deliver on the global market. As the crucial question, that has significant implications on the ability of both the IP system and the global public health care systems to fulfil one of its most critical objectives of delivering medicines accessible to the population especially in the developing and sub-Saharan countries like Nigeria with underdeveloped health care and innovation ecosystems. How best can public expectation be achieved; expectation to safeguard public health and ensure adequate access to affordable medicines during and after emergencies? How can the demands of IPRs meet the challenging public health emergencies such as presented by COVID-19 pandemic? This short article briefly discusses the need to integrate IPRs policies in the promotion of public health particularly relating to access to pharmaceutical patents through the adoption of the important compulsory licences instrument for COVID-19 related health care. The socio-economic importance of this instrument available under patent law and practice provides the rationale for considering them at this time.     

INTEGRATING IPRs POLICIES IN COVID-19 – RELATED HEALTH CARE

Generally speaking, in supporting innovation and facilitating access to products of innovation, the role of IP system is important in broad terms and in many ways, whether from the points of production or distribution including the question of access to consumers or users as the case may be. Perhaps, more than anything else in global history, public health emergencies have confronted the integrity of patent system not just in terms of pharmaceutical or bio-medical innovation itself but also in terms of access to the innovation. Although, COVID-19 vaccine that would save the world is not yet available, IP issues, as always, are of enduring relevance to the entire spectrum of innovation process. While the present challenge posed by COVID-19 pandemic is not exactly access to vaccines,[6] with the current race for it, it is out of order for proactive State institutions within the context of its policy frameworks prepare for the potential challenge that access may pose on arrival of vaccines and in doing so leverage existing IP mechanisms that are meant to address it. We expect that IP lawyers and policy makers across jurisdictions who are familiar with the protracted narratives between pharmaceutical patents and public health in the context of access to affordable medicines in health emergencies particularly brought about by the HIV/AIDS pandemic in the 80s and 90s would revisit the lessons from that controversy.[7] In the annals of pandemics, COVID-19 realities remind the global community of the unfinished IPR-public health debate that any emergent COVID-19 related patents and technologies should resolve without delay. Medical experts would instruct that in the world of infectious disease and with all the epidemics which have confronted man, the state-of-the-art vaccines have been the dominant model. COVID-19, regardless of its origin and the conspiracy theories surrounding it, is not an exception. While the absence of vaccines does not deny its prospects, the prospect of vaccines is ever-present in the bio-medical industries and places a burden of access without political, legal or economic barriers on the global community. With the global race for the COVID-19 vaccines among the big pharmaceuticals, patent and health policies must therefore align to adequately regulate the scope of rights and obligations that would govern patent protection and beneficial use of the vaccines.

Essentially, patents afford the privilege of incentivising new innovation for the benefit of society. That goal is achieved through the grant of monopoly for a limited period in order to sustain the engine of innovation that should drive development. This underlining essence of patent is coterminous to public health objectives but involves a complex dynamic of IP as an innovation policy that is not antithetical to the promotion of public interest, including public health. Patents, including pharmaceutical patents, are granted in Nigeria under the Patents and Designs Act (PDA) provided they are new, involve an inventive activity and capable of industrial application as the basic substantive requirements under most patent law.[8] While pharmaceutical and biotech companies as the vital parts of health care ecosystem, have traditionally produced drugs for protecting human health, they are commercial entities which utilise the patent rights they hold as the incentive which allows them to make profit on their research and development (R & D) investment and to maintain the cycle of innovation.[9] The concern has been in maintaining the right balance between the imperatives of private and public interests inherent in the whole enterprise for promoting public health. This concern often comes to the fore in periods of health emergencies like the current COVID-19 experience, which is desperately awaiting the development of new or adapting existing vaccines under patents that must be paid for one way or the other by the global community.

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) which regulates global trade in IPRs engages an important legal instrument in its functional relevance to public health and facilitates access to essential and affordable medicines, namely compulsory license (CL). Federick Abbott defines CL as a legal vehicle whereby a government grant to itself or to a third party the right to manufacture or import patented product without authorization of the patent holder or the right holder.[10] While TRIPs allows patents in all fields of technology, subject to the standard patentability requirements,[11] it also makes provision for exceptions and limitations to patent’s exclusive rights. It is in the latter that CL can be contextualized and the starting point is the well-known three-step rule expressed in the enabling or overarching provision which limits the exclusive rights conferred in so far as ‘such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.’[12]

Between the Article 27.1 standard guiding patents including pharmaceuticals and the substantive exception clauses across the agreement, TRIPs arguably maintains a global patent regime or imbalances, as it were, which has always courted controversy in the different sets of circumstances or applications across both the developed and developing countries. TRIPs flexibilities construct and as patent law’s exceptions and limitations provide the organic framework to bypass patent exclusive rights in making patented products and processes available without the risk of infringement. Although, TRIPs as ‘a minimum standard’ agreement has witnessed considerable ambivalence both in its rigidities and flexibilities generally and with respect to its relationship with public health, for example, with the 80s and 90s global outcry over the HIV/AIDS pandemic that necessitated the clarification of the ‘Doha Declaration on TRIPs and Public Health’ in 2001,[13] the aforementioned instruments have remained the standard legal and policy measures adopted by most patent systems for accessing pharmaceutical patents without the voluntary permission of the patentee. This has helped to meet diverse public interests, particularly public health emergencies, among others, which is particularly useful for many developing countries with low or non-existent manufacturing capacity. The range of grounds include emergency or extreme urgency, anti-competitive practices, public non-commercial use and dependent patents to be determined by national laws.[14] With the ‘countries’ right to determine what constitutes national emergency or circumstance of extreme emergency’, application of CL and government scheme is consistent with TRIPs, taking into account necessary competition and trade considerations such as parallel import.

Evidently, Nigeria satisfies the condition of a country with low income and low manufacturing capacity generally and in the pharmaceutical industry. Consistent with TRIPs, the Nigerian patent regime makes room for the utilisation of the twin instruments or mechanisms of CL and use of patent for the service of government agencies (government uses), which are essentially non-voluntary licences for the use of patented invention for public purposes. From the standpoint of limitation to patent,[15] both types of licences are the enduring patent instruments for the overall purpose of making patented products and processes available, but for certain defined circumstances, it would ordinarily constitute infringement of patent. More specifically, they facilitate access to drugs that would be unavailable due to low manufacturing capacity and the same time expensive. They can therefore be used to engage access to COVID-19 vaccines in Nigeria, when available, to save patients’ lives. In the present circumstance, the instruments present important legal and policy options available to health policy makers and practitioners to ensure prompt and adequate supply of COVID-19-related vaccines for the welfare of millions of Nigerians over time.

Currently, there are reports of development and clinical trial of potential treatment and vaccines specifically for COVID-19 by top pharmaceutical and research corporations. Prominent are Eli Lilly, which has developed Barvicitinib by artificial intelligence (BenevolentAI) with Incyte; Remdesvir by Gilead, ‘Kaletra’ by Abbvie, interfero-beta and ritonavir/lopinavir, including the well-known chloroquine and hydrochloroquine, among others.[16] The WHO has indicated a multi-country ‘solidarity’ clinical trials of these vaccines in order to develop a global data.[17] There are also reports of countries which have adopted a combination of CL and government use and other extra-ordinary measures ahead of the release of vaccines under their respective patent laws to make the vaccines available for their citizens in the prevailing COVID-19 pandemic and possible shortages in global supply. With patents on these vaccines, although the pharmaceuticals have expressed their intention to waive their patent rights in public interest, the issue of the ability of many of the developing and less developed countries to provide access to the vaccines without government intervention remains a big question. For example, Israel, Germany, France, Chile, Australia, Canada, Ecuador, among others, have invoked their respective patent statutes to authorise appropriate CL and government use licensing regulation and are now well positioned to assure access for their COVID-19 patients and citizens ahead of time.[18] In the raging pandemic, these countries, by March 2020, have issued CL and/or government patent use instruments to permit supply COVID-19 vaccines during national health emergency.[19] Many more will certainly issue in the course of the pandemic.

CASE FOR COMPULSORY AND GOVERNMENT PATENT USE LICENSING REGULATION

As the ‘most comprehensive non-voluntary licence’ especially for developing countries[20] who have used it in the past health emergencies like India, Malaysia, Thailand, Ghana among others, it is advised that the Nigerian government, perhaps for the first time in the history of public health emergencies, considers the adoption of these statute-based non-voluntary instruments under the PDA for the supply of COVID-19 vaccines to Nigerians. As at mid-April 2020, Nigerian statistics in terms of the country level epidemic trajectories appear relatively slower compared with other countries but the curve has not flattened. The contagion across borders has awakened countries to the menace of the pandemic requiring swift and effective response by utilizing available pre-emptory and extra-ordinary legal, regulatory and administrative measures for importing or making vaccines once approved available for public use.[21] While the instruments are similar in nature, they may be different in operation and/or applications under different patent systems.[22] For example, while CL is not subject to judicial process in some patent systems, it is in some others like Nigeria. Their suitability in the present circumstance ahead of the release of vaccines in Nigeria is important. There is however a concern with respect to the use of non-voluntary (compulsory) licensing in Nigeria with low pharmaceutical manufacturing capacity. CL are more effective in countries that can manufacture drugs locally. The Protocol Amending the TRIPS Agreement addresses this problem by allowing countries like Nigeria to issue CL for drugs to be imported from overseas under a TRIPS’ CL framework. Giving effect to the TRIPS framework requires the incorporation of the TRIPS flexibilities in this regard into the Nigerian national law. With particular respect to TRIPs impact and the larger role of patent to health care policies, the power to invoke CL provision allows the production, import and/or distribution of drugs during the period of emergency, where a whole set of circumstances exist, for example, the new or existing patent cannot be worked, there was low or non-existent manufacturing capacity to produce them or it would be too expensive afford in the country without the CL authorizing third party to produce or import generic drugs without the authorization of patent holder. This therefore guarantees access to affordable medicines to address the emergency implicated by the use of the licence.

 

Within the framework of non-voluntary licence, the relevant schedule of the PDA makes provision for CL and use of patent for service of government agencies on a number of grounds outlined under separate Parts of the same schedule.[23] They are, as it were, like two sides of the same coin. Under Part 1 of the Schedule, the grounds for CL essentially involve any of the situation where the patented invention being capable of being worked in Nigeria have not been worked or the degree of working does not meet the demand for the product or the working of the patent is prevented by importation or refusal of patentee to grant license on reasonable terms demand or that the industrial or commercial activities in Nigeria is unfairly or substantially prejudiced.[24]. The requirement for an application to the court by a person to be made on expiration of 4 years after filing of patent application or 3 years after patent grant whichever expires last, though ordinarily allows for transfer of technology, suggests, in application to public health emergencies, as in the case with covid-19 pandemic, that it would have to wait for those years depending on the applicable scenario before applying to the court for supply of vaccines under the applicable compulsory patent license.

 

Under Part 2 of the same Schedule, the grounds for government use of patent for service of government agencies essentially involve the efficient prosecution of war involving Nigeria, maintenance of supplies and services essential to the life of the community; securing a sufficiency of supplies and services essential to the wellbeing of the community; promoting the productivity of industry, commerce and agriculture; fostering and directing exports and reducing imports from all or any countries and for redressing the balance of trade; and generally ensuring that the whole resources of the community are available for use and are used in a manner best calculated to serve the interest of the community. [25] In meeting the key objective of promoting access to medicines in health emergencies, clearly, government use will save more time, although the only reported judicial decision on compulsory licence for government use for supply of a pharmaceutical drug prior to the PDA, did not involve public health emergency.[26] Under this scheme, the Minister, when satisfied that it is in public interest, can authorize any person to purchase, make, exercise or vend any patented article or inventions for the service of a government agency without reference to court.[27] The period of the emergency, which is defined as any period of emergency however declared or notified by or on behalf of government. Government in the circumstance may be State or Federal or their respective agencies. This is not to say that CL, by its juridical nature, is altogether inapplicable, however time is of the essence. The fact that CL is court-granted by itself implies it may be subject to the delays and other vagaries of the judicial process. In the convergence between the Nigerian patent and public health policies and regulatory systems, CL, although government use is better suited, serves to promote and guarantee access to COVID-19 vaccines. This conclusion is arrived at when the substantive and administrative character of the scheme is considered within the context of the enabling provision of the PDA and with due regard to the defined public interest purposes.

 

From the practical standpoint of patent law, the concrete urgency in invoking the powers to issue the CL for use of government under the PDA is vital to the effort FOR promoting access to affordable COVID-19 vaccines in record time and without any delay. The adoption of government use model therefore provides the instrument which helps to guarantee the supply of needed vaccines and drugs for Nigerians, given the apparent lack of manufacturing capacity and affordability for patented medicines that will accompany the release of COVID-19 vaccines thereby safeguarding public health in the challenging time. It affords the government the opportunity to exercise the powers to fulfil one of the primary public health objectives and obligations enshrined in the National Health Act. The Act for the first time established the National Health System,[28] and due to its novel provisions, in some respect, has been reputed, as if it confers the ‘right to health.’[29]  This context underlines the functional role of patent system in the development of health system in the context of facilitating access to essential medicines. As health sector has not always enjoyed any appreciable or much less significant share of the domestic budget in most sub-Saharan African countries, heavy reliance on aids and global compassion has been the most convenient option, whether in normal times, national emergencies or pandemics such as COVID-19.

In Nigeria,[30] the persistently inadequate allocation to health well below the recommended standards or benchmarks has resulted in the poor state of health care infrastructure. This fact became evident in the wake of COVID-19 pandemic, where donations, private and public intervention funds and stimulus packages were immediately generated to cushion its socio-economic impact, provide palliatives, upgrade existing medical facilities and other make-shift COVID-19 facilities were hurriedly built across the country especially in Lagos and Abuja.[31] In the context of public health, as CL has found usefulness across the developed, developing and less developed countries for meeting pricing and production gaps in health emergencies, it has become patent law’s ready handmaiden for sustaining health care systems and the rationale for committing significant domestic funding to meeting the legal, moral and constitutional obligations of government to fulfil critical needs for health and human development. This further justifies the public interest imperatives of limiting patent’s exclusive rights through the use of CL to assist in promoting access to essential medicines and vaccines in period of emergencies.

RECOMMENDATION AND CONCLUSION

In the discharge of government’s duty to safeguard life and wellbeing of the society in health emergencies, the centrality of legal regulation to preserve public health and safety has been demonstrated through the previous issuance of COVID-19 regulations, which specifically related to lockdown measures by federal and respective state governments pursuant to the Quarantine Act.[32] With the global search for vaccines and the need for government to better prepare for urgent supply of vaccines for Nigerians during the emergency, patent law’s CL mechanism for government use serves to reinforce existing regulation to meet the pressing public health needs that Nigerians will eventually face in order to access COVID-19 vaccines when they are ready for distribution. the issuance of compulsory patent licence would ensure immediate and affordable supply of the new patents as well as generics, once they are released. If government, like every government in different countries, has found it important to develop the existing economic intervention initiatives to cushion the economic impact of COVID-19 on citizens, the issuance of CL as a regulatory measure is even more crucial in the current COVID dispensation to enable citizens access low-cost vaccines.

In the present circumstances, both the Federal government and various State governments are urged to issue appropriate legal instrument/gazette pursuant to the enabling provision of PDA for compulsory licences and use of patent for service of government agencies for the ‘maintenance’ and ‘sufficiency’ of ‘supplies and services’ ‘essential to the life and wellbeing of the community’ as it relates to approved COVID-19 related vaccines in Nigeria.[33] The concurrence of patents, as a Federal matter in the exclusive legislative list and health in the concurrent list within the legislative competence of both Federal and State government, is reinforced by the provision of PDA which expressly confers the powers to make regulation for compulsory and government use licenses for emergencies, among other purposes on both the Federal and State governments and their agencies, including voluntary agency hospitals wholly or partly maintained by government by way of grant in aid or otherwise.[34] As the world draws closer to the ‘magic’ vaccines, this regulatory action is necessary to consolidate the legal, economic and moral rationale for government’s interventions and initiatives including appropriate funding to save millions of lives that will be lost where the vaccines, whether or not under patents, are unavailable or unaffordable to the Nigerian public. With the wave of economic down-turns the pandemic has engendered, the customary flow of aids from developed countries and donor institutions, once again may offer a readily available option for COVID-19 vaccines supplies to many African and developing countries who have historically relied on them. This, however, does not detract from the credibility of CL as a commercially beneficial IPR-related licensing regime at this time for the promotion of access to vaccines in a more sustainable manner.

*Research Professor, Nigerian Institute of Advanced Legal Studies. Of Counsel, L & A Legal Consultants.

[1]  See Johns Hopkins Mortality Analyses, https://coronavirus.jhu.edu/data/mortalityin. See also NCDC Updates at https://ncdc.gov.ng/diseases/sitreps/?cat=14&name=An%20update%20of%20COVID-19%20outbreak%20in%20Nigeria

[2] See WHO Situation Report-102 dated 1 May 2020 reports 3175207 cases and 224172 deaths reported, accessed at www.who.int/docs/default-source/coronaviruse/situation/reports/20200415-sitrep-102-covid-19pdf accessed on 01 May 2020. In Nigeria, there are 1932 confirmed cases reported. See Nigeria Centre for Disease Control (NCDC) Updates; NCDC COVID-19 Situation Report, Situation Report 62, Thursday 30th April 2020 at  www.covid19.ncdc.gov.ng accessed at 30 April 2020. file:///C:/Users/tonad/Downloads/An%20update%20of%20COVID-19%20outbreak%20in%20Nigeria_300420_18%20(1).pdf copy in file.

 

[3] See the IMF Policy Tracker which summarizes the key economic responses governments are taking to limit the human and economic impact of the COVID-19 pandemic. The tracker includes 193 economies at https://www.imf.org/en/Topics/imf-and-covid19/Policy-Responses-to-COVID-19

[4] See note 2. W. H. O Situation Report 102

[5] Due to insufficient understanding of the full nature of the new coronavirus, some of the well- known measures adopted across many countries include testing, tracing, social distancing, isolation & quarantine and in many cases lockdowns. See WHO Interim Recommendation of 1 April 2020 on regular soap hand washing, sanitizing at file:///C:/Users/PC/Downloads/who-interim-recommendation-on-obligatory-hand-hygiene-against-transmission-of-covid-19.pdf. Some of the locally innovative products fabricated in varying degrees of designs and functional utility including home-based herbal therapies, targeted at COVID-19 prevention, treatment and management, could be subject of copyright, trademark and other IPRs protection but this is not the focus of this paper.

[6] See Some Considerations on Intellectual Property, Innovation, Access and COVID-19, Francis Gurry at www.wipo.int/about-wipo/en/gdo/news/2020/news_0025.html accessed on 29 April 2020.

[7] See IPRs, Public Health and Pharmaceutical Industry: Issues in the Post-2005 TRIPs Agenda in Intellectual Property Rights, Legal and Economic Challenges for Development, Edited by Mario Cimoli, Giovanni Dosi, Keith Maskus, Ruth L Okediji, Jerome H Reichman & Joseph S Stiglitz, Oxford University Press, 2014, 219-241.

[8] CAP 344, Laws of the Federation of Nigeria, 2004. See section 1(1).

[9] For discussion of the monopoly of patent rights and Pharmaceutical industry in Nigeria, see Bankole Sodipo, Piracy and Counterfeiting, GATT, TRIPS and Developing Countries, Kluwer Law International, 1997, 83-118, 199-201 

[10] See FM Abbott and R V VanPuymbroeck, Compulsory License for Public Health: A Guide and Model Documents for Implementation of Doha Declaration Para.6 Decision (World Bank Working Paper NO. 61, 2005)

[11] See Article 27, TRIPs (provides that patents are available for ‘any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial applications’)

[12] See Article 30, TRIPs

[13] See the Doha Declaration, 2001, Article 4.

[14] See Article 31, TRIPs. See also note 5. For the arguments over whether the ground is limited to emergency or not, see Cynthia M Ho, A New Approach to Compulsory Licence Conundrum, in Patent Law in Global Perspective (Ruth L Okediji & Margo A Bagley, Oxford University Press, 2014, 485-513

[15] Section 11, First Schedule, PDA

[16] For report of a potential treatment with Baricitinib by Eli Lilly and Incyte using artificial intelligence (BenevolentAI) approaching clinical test, see www.clinicaltrialsarena.com/news/eli-lilly-to-study-baricitinib-for-covid-19-treatment/ accessed 14 April 2020. (According to Daniel Skovonsky, President of Lilly Research Laboratories “Lilly is moving at top speed and using all available resources to help fight this pandemic. Developing potential therapeutic medicines for COVID-19 is part of our vital and humanitarian mission. To be successful, we must combine resources, data and expertise with government, academia and other companies. We look forward to seeing the results of Banitinib clinical trials”).

[17] See www.sciencemag/news/2020/03/WHO-launches-global-mega-trial-four-most-promising-coronavirus-treatment. Accessed 15April 2020.

[18] See www.iam-media/coronavirus/the-key-COVID19-compulsory-licensing-development-so-far accessed on 13 April 2020.

[19] Ibid. Dated 18 March 2020, Israel was reported as the first country to grant compulsory license on COVID-19. The instrument allows import of a generic version of Kaletra (HIV drug) produced by AbbVie from India for treatment of coronavirus for ‘national defence purposes’ under the Patent Statute.

[20] See J Kuanpoth, Patent Rights in Pharmaceuticals in Developing Countries: Major Challenges for the Future (Edward Edgar Publishing UK; USA 2010) 34

[21] For example, there is a report of the President of Ukraine offering $1million USD to any scientist in the country who develops a COVDI-19 vaccine. See www.tellafrica.com.ng

[22] See Adebambo Adewopo, Public Health, Access to Medicines and the Role of Patent System in Nigeria, NJIP, Maiden Edition, November 2011, 164.

[23] See First Schedule pursuant to section 11, PDA. Part 1 of the First Schedule is titled ‘Compulsory Licenses and Use of Patent for Service of Government Agencies’ and provides for Compulsory Licences while Part 2 provides for ‘Use of Patent for Service of Government Agencies’.  

[24] See para.1, First Schedule, PDA for the grounds for issuing CL, which are only granted by the court upon application by a person. The grounds are the following; that the patented invention being capable of being worked in Nigeria have not been so worked; the existing degree of working of the patented invention in Nigeria does not meet on reasonable terms the demand for the product; working of the patented invention in Nigeria or prevented by importation of the patented article; by reason of the refusal of the patentee to grant licences on reasonable terms, the establishment or development of industrial or commercial activities in Nigeria is unfairly or substantially prejudiced.

[25]  See para.20 with respect to government use. The grounds include; efficient prosecution of any war in which the Federal Republic may be engaged; maintenance of supplies and services essential to the life pf the community; securing a sufficiency of supplies and services essential to the wellbeing of the community; promoting the productivity of industry, commerce and agriculture; fostering and directing exports and reducing imports from all or any countries and for redressing the balance of trade; generally ensuring that the whole resources of the community are available for use and are used in a manner best calculated to serve the interest of the community.  

[26] See Rhone Poulenc SA & May & Baker v. Lodeka Pharmacy [1965] LLR 9 (Where the pharmaceutical preparation under the name ‘Largactil’ under the plaintiff’s patent was supplied by the defendant to the Federal Ministry of Health pursuant to use for the services of the crown. The plaintiff’s alleged infringement of its patent and took the action to enforce its right to distribute the drug to the general public. The defendant contended that plaintiff’s patent was not infringed as it applied to the drug pursuant to government use and not for use by the public and therefore was not in dimunition of plaintiffs right as the patentee with the right to import and distribute the drug to the public. The court upheld the plaintiffs claim and issued an injunction against the defendant based on the view that the provision for use of patent for the service of the crown under UK Patent Act 1949 (s.46(1)) sought to be incorporated into the Patent Act by s.6, which conferred patent rights and privileges as though the patent had been issued in the UK with an extension to Nigeria, could not apply the whole of the UK Act to Nigeria. Based on that, the provision on any use of patented invention for the use of the crown could not apply to avail the defendant.  

[27] See note 25. It is important to note that government use may be issued before or after relevant patent has been granted, or before or after the doing of the acts in respect of which the authority is given (in other words having retroactive effect); or whether or not he is authorised directly or indirectly by the patentee to make, use or exercise or vend the relevant article or invention.

[28] See section 1, National Health Act 2014. The Act provides the legal framework for the regulation, development and management of Nigeria’s health system, provides ‘for persons living in Nigeria the best possible health services within the limit of available resources’ and ‘protect, promote and fulfil the rights of the people of Nigeria to have access to health care services’, among other objectives.

[29] See section 20, National Health Act 2014 (provides under subsection 1 that ‘a health care provider, health worker or health establishment shall not refuse a person emergency medical treatment for any reason’. Subsection 2 provides that a contravention of the provision is an offence punishable by a fine of =N=100,000.00 or 6 months imprisonment or both).

[30] A holistic 5-year review of budgetary allocation to health form 2014-2018 shows 33.938b, 347.26b, 353.54b, 380.16b and 528.14b respectively regarded as a far cry from global and continental level standard. See yourbudgIT.com/wp_content/uploads/2019/02/FEDERAL-GOVERNMENT-2018-final.pdf. accessed 18 April 2020.

[31] See N500 billion COVID-19 Intervention Fund, see guardian.ng/news/fg-seeks-nass-approval-for-n500b-covid-19-intervention-fund/ reported 5th April 2020. See also N50 billion Targeted Credit Facility (TCF) Stimulus Packages for households and micro, small & medium enterprises (MSMEs) see www.ripplesnigeria.com/10-things-you-need-to-know-to-access-cbns-n50b-covid-19-intervention-fund/ reported 14 April 2020. See House of Representatives proposal for Emergency Economic Stimulus Bill 2020, inter alia, to provide tax rebates, deferment of residential mortgage payment by individual contributors to national housing scheme for 180 days, waiver of import duties on medical goods, see www.news.bloombergtax.com/daily-tax-report-international/insight-covid-19-pandemic-nigerias-fiscal-and-ecpnomic-measures reported 10 April 2020  accessed 28 April 2020

[32] See COVID-19 Regulations No 1 & 2020 respectively dated 30 March & 13 April 2020 made pursuant to the Quarantine Act, CAP Q2 LFN 2004 issued by the President M Buhari.

[33] The recommended regulation under the title: COVID-19 (Compulsory Licenses and Use of Patents for Service of Government Agencies) Regulation 2020, Patents and Designs Act, 1965) can be issued under the powers and authority of the President and respective State governors.   

[34] See section 23, First Schedule, PDA

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