The outbreak of COVID-19 – a clinical manifestation caused by the new coronavirus SARS-CoV-2 – that has spread to more than 200 countries and the establishment of a pandemic has triggered the race for strategic solutions for treating, preventing and diagnosing the disease. At the same time, in the scope of Public Health, the growing number of infections and deaths raises several concerns related to the access to these possible solutions.
Different epidemics and pandemics around the world have been recorded since AD 165, in which bubonic plague that haunted the world between 1327 and 1351, leading to the death of approximately 200 million people, is considered to be the greatest of them1. To date, the World Health Organization (WHO) accounts more than 780,000 infections and more than 35,000 deaths by COVID-19, but that number has been increasing daily2.
WHO defines “epidemic” as the occurrence of a disease in an excessive or unusual way in a given region, while a “pandemic” is established with the worldwide spread of a disease. Before COVID-19, the last pandemic decreed by WHO was Influenza type H1N1, in 2009. However, according to Health Minister Luiz Henrique Mandetta, the biggest difference between the two pandemics is that H1N1 already had a treatment available and specific vaccines could be quickly developed, since vaccines for other types of influenza already existed. For COVID-19 no treatment or vaccines to safely and effectively combat the pandemic are available so far.
With the eminence of new technologies to combat the pandemic, some jurisdictions have already raised the concern of how and if these technologies should be protected and about the impact of this possible protection on the access by the population and, mainly, by the less developed or less privileged countries. While patent applications have been filed in some countries, experts argue that technologies to combat COVID-19 should be voluntarily made available to the public or that compulsory licenses should be granted in response to the pandemic.
In Brazil, we can point out some particularities of Brazilian legislation that may be relevant to this scenario.
As already known, Brazil accumulates an expressive backlog in patent applications examination. Although the Brazilian Patent office (BPO) – in Portuguese, Instituto Nacional de Propriedade Industrial – has been taking effective measures to reduce this backlog, the time for concluding examination and, then, issuing a decision is still substantial. As a result, priority examination can be interesting for the players.
In view of the nature of the technologies, two possibilities for priority examination can be envisaged:
Health treatment technologies:
Patent applications related to pharmaceutical products and processes and to equipment and/or materials for use in health related to the assistance policies of the Ministry of Health and considered strategic for Brazilian Health System (SUS, in Portuguese, Sistema Único de Saúde) can be prosecuted as a priority by request of the Ministry of Health, according to the provisions of article 13 of BPO’s Resolution No. 239, of June 4, 2019.
Technologies of Public Interest or National Emergency:
The priority prosecution can also be applied to patent applications whose subject-matter is covered by an act of the Executive Branch that declares a national emergency or public interest, following the provisions of article 14 of BPO’s Resolution No.239, of June 4, 2019.
Moreover, the BPO recently published BPO’s Ordinance No. 149/2020, which stablishes the priority examination of patent applications related to pharmaceutical products and processes and to equipment and/or materials for use in health for the diagnosis, prophylaxis and treatment of COVID-19. According to said Ordinance, priority examination may be requested by any interested party up to June 30, 2021.
PATENTS OF INTEREST TO NATIONAL DEFENSE
There is no specific decision on the granting of patents in Brazil for technologies of interest to national defense that come from other countries, that is, the granting of patents whose first filing is made in a foreign country. However, article 75 of Brazilian Industrial Property Law (BIPL), Law No. 9,279/1996, establishes that the patent application originated in Brazil whose object is of interest to national defense will be prosecute in a confidential manner and will not be subject to the publications foreseen in the BIPL. The foreign filing of the application is also prohibited, as well as any disclosure, exploitation and assignment of the application or patent, except expressly authorized by the competent body.
Nonetheless, there are some impasses for applying the provisions of article 75 of the BIPL, such as, the definition of what would be the object of interest to National Defense3. Some experts consider the literal definition of National Defense – the set of measures and actions of the State, with emphasis on military expression, for the defense of the territory, sovereignty and national interests against predominantly external, potential or manifest threats. On the other hand, another front defends that the object of interest to national defense is not completely dissociated from the concept of National Security, which is more comprehensive and whose main role is to allow the country to preserve its sovereignty and territorial integrity, to promote its national interests, free pressures and threats, and to guarantee to its citizens the exercise of their constitutional rights and duties, which could include, therefore, addressing a Public Health emergency4.
VOLUNTARY OR COMPULSORY LICENSING
The BIPL guarantees to the titleholder of a patent the ownership of the claimed invention and the right to prevent third parties from producing, using, offering for sale, selling or importing a product covered by a patent and a process or product obtained directly by a patented process without his consent.
In turn, the titleholder of a patent may voluntarily grant a license to third parties exploit the patent and may request the BPO to place the patent on offer for exploitation purposes (Articles 61 and 64 of the BIPL).
In some cases, the BIPL also allows compulsory licensing of the rights of a patent. Compulsory licensing occurs when the Government allows third parties to temporarily exploit the object of a patent without the consent of the patent holder. Compulsory licensing is allowed not only in Brazil, but also in other jurisdictions.
As established by the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPs), each jurisdiction has the right to adopt legal exceptions to the exclusive rights guaranteed to the patent holder, which includes provisions for the compulsory licensing of these rights.
In general, Brazilian legislation follows the conditions stipulated by TRIPs. According to article 68 of the BIPL, the holder who practice the rights granted by the patent in an abusive manner or whose exploitation results in abuse of economic power proven under the law by administrative or judicial decision, will be subject to compulsory licensing. In addition, compulsory licensing may also be required when there is no exploitation of the object of the patent within Brazilian territory or when the commercialization does not meet the needs of the market.
There is also a provision for compulsory licensing for patents that directly depend on another patent and that cannot be exploited without infringing the rights of the other patent. However, according to article 70 of the BIPL, the dependent patent must offer a technical progress related to the patent on which it depends and compulsory licensing can only be required if an agreement between the parties was not achieved.
Compulsory licensing can only be requested by a person with a legitimate interest and who has the technical and economic capacity to exploit the object of the patent. In addition, the exploitation right granted is not exclusive and is restricted to the internal market.
However, an important aspect to be considered is that contrary to what is broadcast in the media, compulsory licensing cannot be confused with the term “patent breach” commonly used. This is because, TRIPs itself stipulates specific conditions to grant a compulsory license and that the rights granted to the holder are not suspended, including the right of receiving remuneration for the exploitation of his patent, provided that such values are agreed and are not abusive.
Historically, with the support of the 2001 Doha Declaration on TRIPs and Public Health, compulsory licensing has played a prominent role in Public Health policies, mainly in ensuring access to objects of pharmaceutical patents in underdeveloped or under development countries. Doha Declaration was fundamental to reinforce that each country member has the right to apply flexibilities to compulsory licensing for pharmaceutical patents aiming at the protection of Public Health and that these flexibilities do not contradict the conditions established by TRIPs. In addition, Doha Declaration also established that each country must determine what it considers to be a national emergency or public interest.
In some cases, even though compulsory license has not been implemented, this provision was used as a tool to boost negotiations and facilitate the achievement of favorable measures, such as, price reduction. In Canada and in the United States, discussions about a possible compulsory license resulted in reduced prices for Ciprofloxacin (Bayer) in the face of bioterrorism threats involving anthrax in 20016,7. This artifice has also achieved similar results in the accessibility of antiretroviral drugs in African countries to address AIDS epidemic.
COMPULSORY LICENSING IN BRAZIL
Undoubtedly, the reflections involving the access to antiretroviral drugs (ARVs) for combating Acquired Immunodeficiency Syndrome (AIDS) were essential for the evolution of compulsory license measures and their impact on access to medicines and Brazil played a fundamental role in this process.
In Brazil, the BIPL stipulates that the compulsory license may be granted on an official basis and temporarily in cases of national emergency or public interest, declared in an act of the Federal Executive Branch, provided that the patent holder or its licensee are not able to meet the existing demand (Article 71 of the BIPL).
In 1988, with the increase in AIDS cases in Brazil, the Ministry of Health established the free supply of drugs to treat opportunistic infections, as well as AIDS and the antiretroviral Efavirenz (Merck Sharp & Dome) was introduced in the Brazilian pharmaceutical protocol in 1999. Over the years, the price of this medicine to attend programs of the Ministry of Health was negotiated with the manufacturer.
However, as of 2006, the consensus between the Government and Merck ceased to be effective and after several attempts of negotiation, the Government, by act of the President of the Republic established by Decree No. 6,108/2007, granted the non-exclusive compulsory licensing of Efavirenz for 5 years8. The Decree further defined that the licensing would be destined solely and exclusively to supply the domestic market and would not result in prejudice to the rights of the holder, who would continue to receive remuneration for exploiting the patent, however, in a defined and more reasonable amount.
With the end of the stipulated period, the license was extended for additional 5 years by means of Decree No. 7,723/2012. It is estimated that the compulsory licensing of Efavirenz patents resulted in savings of around US$ 30 million per year to public funds8. Compulsory licensing of Efavirenz in Brazil was the first compulsory licensing case in Latin America and is referred to as a model of success until today.
In addition, the possibility of compulsory licensing contributed to the voluntary reduction in prices of several other antiretroviral drugs under negotiation, such as: nelfinavir (Roche); lopinavir + ritonavir (Abbott); lamivudine, zidovudine, lamivudine + zidovudine (GlaxoSmithKline); nevirapine (Boehringer Ingelheim) and tenofovir (Gilead).
Medicines for other clinical indications also used this instrument to negotiate their prices, such as, Imatinib (Novartis), for the treatment of cancer.
It is worth mentioning that several patents related to the prevention and treatment of H1N1, the most recent pandemic case before COVID-19, have been granted worldwide or are still being examined. Although the pandemic state was decreed by WHO, in Brazil, the pandemic was not considered a national emergency, therefore, there was no request for compulsory licensing for Tamiflu (Roche/Gilead), the drug indicated for the treatment of H1N1 . In turn, since there was no protection in Brazil for the vaccine developed by Sanofi and currently produced by Instituto Butantan for preventing H1N1, the vaccine is in under public domain and can be freely explored9
Recently, two Bills related to compulsory licensing were presented in the Chamber of Deputies10. The first, Bill No. 1,320/2020, presented by deputy Alexandre Padilha (PT-SP), aims to change the BIPL in order to grant automatic compulsory licenses to patents related to technologies for emergency care, by means of the declaration of public health emergency of international value by the World Health Organization (WHO) or of national value by the competent national authority. The aforementioned project stipulates that the license will be valid as long as the emergency lasts and that the patent holder will receive a fixed payment of 1.5% on the sale price to the Government from the date the patent is granted, if the patent is granted, and must provide to the Government all the necessary and sufficient information for reproducing the object under protection. According to the Bill, the BPO would be responsible for listing patent applications for such technologies.
On the other hand, Bill No. 1,184/2020, by deputy Jandira Feghali (PCdoB-RJ), is more direct and punctual and aims to grant the compulsory license to patents related to new coronavirus during the state of emergency in health at the international level provided for in Law No. 13,979/2020, which provides for measures to deal with the public health emergency of international value related to the coronavirus that leaded to the 2019 outbreak.
Although concrete solutions to fight the pandemic have not been proposed so far, there is a great expectation for new technologies in view of the constant efforts directed to this end. Therefore, it is necessary that all sectors involved and of interest are aware of the tools made available by the Patent System so that they can then act in the best way and in order to meet, mainly, the public interest in view of the severity of the current scenario. Discussions about these tools have already been raised by other jurisdictions, which could not be different in Brazil. Although there is no clear position from the Government regarding the adoption of the national emergency, we can already see movements to mitigate the impacts of the pandemic, such as, the recent suspension of the taxes for importing pharmaceutical and medical-hospital goods for use to combat COVID-19 and the abovementioned proposals presented in the Chamber of Deputies, which leads us to believe that there is a possibility of intervention to guarantee access to new technologies to combat the pandemic.
1 LEPAN, N. A visual history of pandemics. Visual Capitalist, 2020. Available at: https://www.weforum.org/agenda/2020/03/a-visual-history-of-pandemics/
2 WHO. Coronavirus disease (COVID-19) Situation Dashboard. Access: April 1, 2020. Available at: https://experience.arcgis.com/experience/685d0ace521648f8a5beeeee1b9125cd 3 FREITAS, N. O. Aspectos Jurídico-Históricos da Patente de Interesse da Defesa Nacional. Revista Brasileira de Inteligência. Brasília: Abin, n. 6, abr. 2011.
4 BRASIL. Estratégia nacional de Defesa. Ministério da Defesa. Brasília, 2012. Available at: https://www.defesa.gov.br/arquivos/estado_e_defesa/END-PND_Optimized.pdf
5LENA, L. Os 10 anos da licença compulsória do Efavirenz: caminhos para garantir acesso aos medicamentos. ABIA. Rio de Janeiro, 2019.
6LOVE, J. P. Recent examples of the use of compulsory licenses on patents. Knowledge Ecology International, 2007.
7Congressional Research Service. Compulsory Licensing of Patented Inventions. CRS Report, 2014. Available at: https://www.everycrsreport.com/files/20140114_R43266_43c4b4d4d5617e941885ea753aacb3738cd39f0a.pdf
8 NOGUEIRA, T. S. Licenciamento compulsório e acesso ao tratamento do HIV/AIDS no Brasil. Dissertação apresentada com vistas à obtenção do título de Mestre Modalidade Profissional em Saúde Pública. Brasília, 2013.
9 ECCLESTON-TURNER, M. The right to health and access to pandemic influenza vaccines: procurement options for developing states. Thesis for the degree of Doctor of Philosophy in the Faculty of Humanities. The University of Manchester. Manchester, 2016. Available at: https://www.research.manchester.ac.uk/portal/files/84020304/FULL_TEXT.PDF
10 AGÊNCIA CÂMARA DE NOTÍCIAS. Propostas permitem a quebra de patentes durante combate à pandemia. Available at: https://www.camara.leg.br/noticias/650918-propostas-permitem-a-quebra-de-patentes-durante-combate-a-pandemia/
By Ludmila Kawakami