Patent suspension on the COVID-19 vaccine in Indonesian patent law perspective

Abstract Vaccination patent is associated with exclusive rights that restrict the production, use, and sale of inventions by third parties for a specific period. This factor contributes to the high cost of vaccines, making it challenging to access vaccines in many underdeveloped nations such as Indonesia. The urgency for faster vaccine distribution during the COVID-19 pandemic further highlights this issue. However, the patent provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPs Agreement) may exacerbate the unequal distribution of vaccines worldwide. This study analyzes the implementation of the flexibility feature of the TRIPs Agreement, and Doha Declaration contained in Law Number 13 of 2016 respecting Patent to achieve a pandemic-free era. It is also necessary to examine the Indonesian patent rules and regulations, the TRIPs Agreement, the Doha Declaration, and other legal documents to examine these issues. The results showed that the patent rules and regulations have adopted flexibility under the TRIPs Agreement and the Doha Declaration. However, the effect on the country’s sluggish pharmaceutical supply chain has not been improved. A patent suspension system on a global scale is required to hasten the transition to a pandemic-free period since the feature of flexibility cannot handle the slow pace of vaccine procurement. The patent suspension system can be implemented through international agreements, such as the Patent Suspension Proposal filed by South Africa and India in October 2020. The suspension is crucial to accelerate the equitable distribution of vaccines and reduce their price.


Introduction
The outbreak of COVID-19 was first reported in Wuhan, China, in December 2019. On March 2020, the World Health Organization (WHO) declared the virus a global pandemic. It originated from selling wild animal meat in a seafood market in China (Cui et al., 2019). In January 2020, the WHO designated the outbreak as a Public Health Emergency of International Concern (World Health Organization, 2020a). The common symptoms include fever, cough, myalgia, phlegm stones, headache, hemoptysis, and diarrhea (World Health Organization, 2020a). The understanding is constantly evolving, with new information emerging. According to Google News, on 20 January 2023, there were 668,493,659 reported cases and 6,737,898 deaths globally (Corona Virus Spread in Indonesia, n.d..). Indonesia is one of the countries heavily impacted by the pandemic. It experienced a decline in its economic sector due to decreased tourism and increased layoffs of workers (Susilawati et al., 2020). The Indonesian government, with other countries, implemented various strategies and efforts, such as Large-Scale Social Restrictions and Community Activities, to curb the spread of the virus. However, these efforts did not reduce the number of cases, underscoring the importance of vaccine development.
Currently, developed countries around the world are promoting various vaccines. These include Sinovac from China, AstraZeneca from the UK, Pfizer-BioNTech from the United States and Germany, and Sputnik V from Russia (Eslahtalab et al., 2021). These vaccines are protected by Intellectual Property Rights (IPR), representing a significant investment in human knowledge, time, and resources (Maskus, 2000). Vaccines have been highlighted as patentable inventions with commercial value. However, the patent regulations on Trade-Related Aspects of Intellectual Property Rights (TRIPs) could pose challenges to the accessibility of COVID-19 vaccines and medications in developing countries (Mercurio, 2007). TRIPs was established in the Uruguay Round of 1994 and implemented in 1995. It regulates intellectual property rights among WTO members and requires developing nations to file and enforce pharmaceutical patent. This can result in increased costs, reduced availability of affordable medications, and decreased export of medicines (Sell & Prakash, 2004).
The Doha Declaration, adopted by the WTO Ministerial Conference in 2001, provides flexibility in suspending patent rights for access to essential medicines and addresses the ongoing discussions on the issue (Adigwe et al., 2022). Furthermore, the declaration outlines procedures, such as the suspension of patent and the mandatory licensing of pharmaceutical products used in emergencies to improve medication access (Chin & Chang, 2022). It ensured equitable access to medicine for developing nations, but inequality persists in the current COVID-19 outbreak. The price rise concerns developing countries such as India, South Africa, and Indonesia, which have large populations but limited funds to purchase vaccines. In response, India and South Africa proposed suspending certain TRIPs regulations. This includes vaccine patent to the WTO in October 2020, with full support from Indonesia, the fourth most populous country expected to be affected greatly over a longer period (Chaudhuri et al., 2021;Djalante et al., 2020). The suspension of vaccine patent is imperative for the following reasons: (1) It facilitates the acceleration of COVID-19 vaccine self-production, which has been proven effective in assisting developing countries (Meridith, 2021).
(2) It guarantees timely access to cost-effective medical products, including vaccines and medicines, to promote research, development, manufacture, and supply of essential products in the battle against COVID-19 (Mercurio, 2007).
(3) It eliminates the possibility of a monopoly on patent rights by pharmaceutical companies producing vaccines to avoid exorbitant prices (Nichols, 2021).
The suspension of patent rights on vaccines is the optimal solution for countries to overcome the pandemic. The cost becomes more affordable by granting access to manufactured vaccines, making it feasible to receive vaccination. The US Secretary of State, Anthony Blinken, noted that vaccine patent waivers could increase production (Nichols, 2021). Therefore, this study examines Indonesian patent law perspective regarding the difficulties associated with implementing vaccine patent flexibility at national and international legal levels.

Patent protection
The In some cases, the government may determine that a patent is necessary for national defense or security and will prioritize its proper implementation. The public interest in patent protection is backed by normative, constitutional, and philosophical justifications. On a normative level, public interest considerations are regulated through conventions, agreements, and laws in the field of patent. From a constitutional standpoint, it is aligned with the goals and objectives of the state. Philosophically, the public interest is viewed through rights, obligations, and justice principles (Sitorus, 2014)

Flexibility clauses in the TRIPs agreement and Doha declaration
The IPR provisions regulated in the TRIPs Agreement and the Doha Declaration are associated with patent protection. In terms of protection, the TRIPs Agreement provides flexibility clauses in line with the Indonesian government. Each country can carry out IPR protection under irrational needs without conflicting with the provisions of the TRIPs Agreement (C. Correa, 2000). Flexibility clauses include parallel import, compulsory license, government use of patent, and bolar provision.
Parallel import, according to Article 6 of the TRIPs Agreement, is the importation conducted without the patent holder's consent (C. Correa, 2000). The WHO defined parallel importation of a patent into another country without the consent of the holder" (World Health Organization, 2001). This process enables competitive support by permitting the importation of equivalent products to be marketed at lower prices in other countries. The implementation should comply with general importation procedures and other relevant regulations enforced in a country. Furthermore, Article 6 of the TRIPs Agreement classifies the concept as a "release" or "exhaustion" of IPR not subjected to the WTO dispute resolution process (Related Aspects of Intellectual Property Rights, 1994; art. 6). In the international context, the parallel import is based on the first sale doctrine and the right of exhaustion. According to the first sale doctrine, the IPR owner loses control of oversold goods and relinquishes intellectual rights.
A compulsory license, according to Article 31 of the TRIPs Agreement, is the authority granted by a judicial institution to a third party to use an invention patented for the public interest (Wheaton, 1986). Bass stated that this is a practical step for developing countries to provide better access to medicines (C. Correa, 2000). The use of patent by other parties without the holder's knowledge is permitted, assuming various requirements associated with the initial application process are fulfilled. This compulsory licensing issue arrangement is based on the desire to increase technological innovation and knowledge transfer.
The implementation of patent is permitted by the government as stated in Article 31 of the TRIPs Agreement. However, the requirements are not similar to compulsory licenses requiring permission from the holder or owner. A patent needs to fulfill 3 requirements to be exercised by the government. These are the existence of a national emergency, circumstances of extreme urgency, and non-commercial public use. The patent holder should be notified about the implementation of the first and second requirements. Meanwhile, for the third requirement, the government and its performance must inform the holder (Related Aspects of Intellectual Property Rights, 1994; art. 31).
Bolar or Roche-bolar provisions is stated in Article 30 of the TRIPs Agreement. This policy, known as the third-party doctrine, permits external entities to evaluate, utilize, and produce drugs to secure approval for marketing and food regulatory authority before the expiration of the patent protection (Related Aspects of Intellectual Property Rights, 1994). The flexibility clauses in patent regulations are permissible, provided it does not compromise the proper functioning of patent or undermine the holder's legitimate rights. This enables member countries to establish special public health measures to ensure equitable access to medicinal products for all individuals. Developing and developed countries may ensure that generic drugs are accessible to economically disadvantaged populations.
The flexibility clauses of the TRIPs Agreement are viewed as inadequate due to the offered advantages in developed countries (Nkomo, 2010). This resulted in the Doha Declaration, which offers provisions to provide access to medicines in the health sector to developing and underdeveloped countries. The fourth paragraph of the Doha Declaration reinforces the provisions in Articles 7 and 8 of the TRIPs Agreement. Member countries can utilize elements of patent flexibility clauses, such as compulsory licensing and parallel imports, to address related challenges (C. M. Correa, 2002). The seventh paragraph also promotes technology transfer to developing and underdeveloped countries, in line with Article 66.2 of the TRIPs Agreement.

Vaccine
A vaccine is a substance that contains antigens derived from pathogenic microorganisms, recombinant organisms, or synthetic peptides designed to stimulate the recipient's immune system to produce specific antibodies. It provides active and passive immunity against certain diseases when administered to a person (Morrow & Felcone, 2004). Generally, vaccines are biological products that grant acquired or adaptive immunity against specific diseases. They can be categorized into several types, namely (1) live attenuated bacterial vaccines, (2) subunit vaccines, (3) live attenuated viral vaccines, (4) recombinant vaccines, (5) inactivated viral vaccines, (6) conjugated polysaccharide vaccines, and (7) combination vaccines. Furthermore, it is important to consider stability issues during the development of each vaccine type (Dumpa et al., 2019).
A vaccine is a medical intervention that promotes the formation of specific immunity against certain viruses or diseases. It is one of the most effective ways of preventing and controlling infectious diseases such as COVID-19 (Chen, 2020). On 25 September 2020, the World Health Organization (WHO) released data entitled "Landscape COVID-19 Vaccine", where 40 vaccine candidates had entered clinical trials, with 9 in phase 3 and the remaining 149 in the preclinical phase. These vaccines have to be tested for efficacy in humans. Some of the most well-known COVID-19 vaccines include Pfizer, Moderna, Sinovac, and AstraZeneca.

Research methods
This normative juridical study was conducted to examine applicable laws and regulations, rules, norms, and legal principles. Furthermore, an analysis was carried out on national legal instruments in the form of Indonesian Law Number 13 of 2016 concerning Patent and international legal instruments in the form of the TRIPs Agreement. Books and international journals on law of patent, TRIPs, and vaccine of COVID-19 became the secondary sources to strengthen the legal analysis towards the legal issue.

Problematic with the implementation of the flexibility provisions in the TRIPs agreement, the Doha declaration, and the national patent law
The TRIPs Agreement, a cornerstone in the justification of IPR and patent, offers flexibility to member states by allowing for parallel imports, mandatory licensing, government-executed patent, and bolar provisions. Indonesia has adopted the agreement and integrated its provisions into domestic laws as a member state. Patent Law is constantly evolving to adapt to changing societal circumstances. Furthermore, the most recent update is Law Number 13 of 2016 concerning Patent, which amends Law 14 of 2001. This improvement was made to address economic changes, respond to the public's demand for patent laws aligned with international trends, and provide legal certainty and equitable protection for patent holders and industrial businesses. The Indonesian National Law includes various provisions related to the flexibility clauses of the TRIPs Agreement. These provisions are as follows: (1) Parallel Import and Bolar Provision The TRIPs Agreement, specifically Article 6, addresses parallel imports performed without the patent holder's consent (Related Aspects of Intellectual Property Rights, 1994). This is reflected in Indonesian law through Article 167 of Law No. 13 of 2016, which outlines the exemption from criminal and civil liability for importing pharmaceutical products. These imported products are protected for 5 years and can be marketed before the expiration of the patent protection. The study also covers parallel imports and the bolar provision, which allows for third-party testing of drugs protected by patent.
(2) Compulsory License In the TRIPs Agreement, the provisions regarding this compulsory license are contained in Article 31, which regulates the authority to utilize an invention patented for public purposes without the holder's permission (Related Aspects of Intellectual Property Rights, 1994; art. 31). Furthermore, Law 13 of 2016 includes a compulsory license clause in Articles 81 to 107 regarding regulating granting, delaying, recording, and rejecting applications until the expiration of the compulsory license.
(3) Implementation of Patent by the Government (Government Use) In the TRIPs Agreement, the implemented policies are stated in Article 31 and the provisions regarding compulsory licenses. This relates to the granting of permits for implementing matters about the public interest (Related Aspects of Intellectual Property Rights, 1994). The application of the rationale for the implementation of patent is found in Articles 109 to 120 of Legislation 13 of 2016, which is an Indonesian law. Meanwhile, the 11 discussions about the implementation of patent include the grounds for the urgency and the items used as justifications for the patent.
Patent protection can affect drug prices through monopoly ownership and royalty payments to its holders. However, it provides legal certainty to their holders in terms of monopolizing drugs. The patent holders can determine where a drug will be distributed, sold at a specific price, and stored. Ultimately, it can hinder public access to medicines due to higher prices.
The application of patent is significantly impacted, particularly in the case of vaccines. Registering a patent grants exclusive economic rights, which means any country wishing to use the vaccine must pay a substantial royalty. The European Union and the United States have expressed concerns about the potential suspension of patent protection for the COVID-19 vaccine (Crützen & Kücking, 2021). They stated that lifting patent protection could increase vaccine production and distribution to underdeveloped countries. Meanwhile, Germany, home to several major pharmaceutical companies, opposes this idea because protecting intellectual property is crucial for driving innovation and should be maintained (Crützen & Kücking, 2021). In Indonesia, the number of COVID-19 cases continues to rise daily due to its vast geographical size and socioeconomic challenges. Several factors are hindering the implementation of preventive measures, such as limited vaccine stock (UNICEF et al., 2021) and impacting the inadequate state budget for procuring vaccines (UNICEF et al., 2021).
On 23 July 2021, 43717,254 and 17,154,145 individuals received the first and second doses of a vaccine, respectively, based on data obtained from the COVID-19 Handling Committee and the National Economic Recovery (Kementerian Kesehatan Republik Indonesia, n.d..). The recent data indicated some advancements towards the national objective of administering the vaccine to 208,265,720 individuals using Sinovac, AstraZeneca, and other products. However, there is still a substantial discrepancy that needs to be addressed in order to achieve the set goal fully. To address this issue, the Indonesian government may exercise the flexibility provisions outlined in the TRIPs Agreement. These provisions, including compulsory licensing, parallel imports, and government use of patent, are enshrined in the Patent Law. Despite this legal framework, the effective implementation of these provisions has been hindered by a range of internal and external factors.
First, Indonesia has a history of using patent to address public health crises, as demonstrated by Presidential Decree No. 83 of 2004 on Anti-Retroviral Drugs. However, this option requires careful consideration of the economic situation since compensation to patent holders is required (TRIPs Agreement, 1994). Adequate funding must be secured to develop new products, which presents a challenge in the current economic climate caused by the ongoing pandemic. The government's difficulty in implementing patent is due to its bureaucratic leadership (Thompson, 1965). For instance, prior approval is needed by the President and the Minister of information or related officials regarding extraordinary conditions. This bureaucratic process can take a long time, hampering the implementation of patent by the government.
Second, regarding parallel imports, the national Patent Law does not describe the institution responsible for its implementation. The study on parallel imports does not explain the procedures, the number of royalties, and administrative or technical requirements regarding parallel imports (Tahun, 2016). Third, the compulsory license is difficult to implement because Indonesia's pharmaceutical industry is non-research-based. This tends to significantly impact the dependence on vaccine raw materials from other countries for their local production (Ministry of Investment Badan Koordinasi Penanaman Modal, n.d.) Moreover, the study provided detailed explanations of the categories or number of royalties that should be given to patent holders. According to Article 86 of the Patent Law, the number of royalties and the mechanism for implementing the compulsory license is carried out by an ad-hoc expert team formed by the Minister.
Fourth, the political will of the government does not appear to be strong in implementing the flexibility aspect contained in the national patent provisions. This is evidenced by the government's inability to produce vaccines domestically. The government buys vaccines from other countries, such as Sinovac from China. Furthermore, the application of patent on vaccines prevents monopoly in developing and developed countries (Tejomurti et al., 2020). The Patent Law adopted the aspect of flexibility, which is ineffective in developing countries such as Indonesia. Therefore, the Minister of Foreign Affairs, Retno Marsudi, agreed to abolish vaccine patent to promote equality and achieve a COVID-19 free society (Iyabu, 2021).

Patent suspension initiative for vaccines from a developing country perspective
Vaccines are important tools used to minimize the spread of a virus during a pandemic. Efforts to develop these medications have been successful with the manufacture of Sinovac, Pfizer, Moderna, and AstraZeneca. However, the application of patent for vaccines has implications for global injustice. For instance, it causes developing countries to have no bargaining power because of their dependence on vaccine producers. Developed countries regulate vaccine procurement during the H1N1 (flu) pandemic by placing Advance Purchase Agreement orders for vaccine doses before production (Eccleston-Turner & Upton, 2021).
As contained in the TRIPs Agreement, the case of a global emergency also has a dimension of leniency. However, several flexibilities exist to address public health urgencies, such as Compulsory Licensing and Parallel Imports. These flexibilities are not enough to face public health challenges, specifically during the current pandemic. Many countries do not have the manufacturing capability to support the pharmaceutical sector (Ranjan, 2021). Furthermore, the extreme need for vaccines and complicated procedures make the flexibility of the TRIPs Agreement impractical (Ranjan, 2021).
Developing countries also face difficulties applying the flexibility aspects provided in the TRIPs Agreement (World Health Organization, 2020b). This can be seen from the implementation of compulsory licensing of HIV/AIDS drugs by the South African government during the pandemic. The implementation process was carried out to ensure the availability of generic substitutes and reduce the price significantly (Lanoszka, 2003). However, in February 1998, a group of pharmaceutical companies led by the South African Pharmaceutical Manufacturers Association filed a lawsuit against the government (Lanoszka, 2003). The Brazilian government is taking the same steps by implementing compulsory licensing through the Patent Act. This is due to the high rate of people infected with HIV/AIDS, with a greater percentage unable to afford medicines. In January 2001, the United States sued the Brazilian government through the WTO's Dispute Settlement Body, arguing that the authorization of the law to grant compulsory licenses was TRIPs-inconsistent (C. M. Correa, 2015). The difficulties and concerns over the risk of litigation regarding the application of the flexibility aspect of the TRIPs Agreement have not been able to address the issue of global patent needs.
Based on these concerns, there is a need for international solidarity and consensus to ensure that intellectual property rights do not create barriers to accessing vaccines globally. The consensus needs to be a temporary suspension of vaccine patent under the intellectual property obligations of WTO member countries. This includes granting and applying patent and other related intellectual property rights to drugs, vaccines, and other treatments for COVID-19 (Ranjan, 2021). Furthermore, it removes the exclusive rights inherent to the patented invention to produce vaccines for other countries without fear of facing legal challenges in the WTO (Ranjan, 2021). This is similar to the strategies used by India and South Africa on October 2020 in their patent suspension proposal to the WTO. The proposal was submitted to ensure developed countries could access the vaccines, drugs, and other technologies needed to control the pandemic. This can temporarily waive pharmaceutical patent protection and substantially reduce the cost of manufacturing vaccines (Katz et al., 2021). Additionally, the suspension of patent can allow developing countries to produce vaccines without paying fees to pharmaceutical companies.
The authority for adopting a decision to suspend patent can be found in the Marrakesh Agreement Establishing the World Trade Organization (Marrakesh Agreement). This international convention, known as the Treaty of Marrakech, governs commerce in goods and services, intellectual property rights, and several agreements and instruments (Palmeter & Mavroidis, 1998). According to Article IX (3) of the treaty, the Ministerial Conference has the power to waive obligations imposed by the WTO or other multilateral trade agreements (Feichtner, 2009). This study also specified that suspension can occur in exceptional circumstances, such as when member states face difficulties complying with two norms (Ranjan, 2021). The justification for this action is the declaration of COVID-19 as a Public Health Emergency of International Concern by the WHO.
Furthermore, this study stipulated that the suspension must be supported by at least threequarters of the WTO members (WTO, 1994;art. IX(3)). According to letter b of WTO, "a request for a waiver concerning the Multilateral Trade Agreements in Annexes 1A, 1B or 1C and their annexes shall be submitted to the Council for Trade in Goods, Services or TRIPs during 90 days". At the end of the specified period, the relevant council must present a report to the Ministerial Conference (WTO, 1994;Article IX, Paragraph 3). The council has jurisdiction over the patent suspension proposal when a request for suspension of a multilateral trade agreement is attached to 1A, 1B, or 1C and submitted to the Council for Trade in Goods, Services, and TRIPs (Article IX (3) letter b) (Ranjan, 2021).
Article IX (4) states that any suspension granted needs to justify the decision, governing the application and the expiration date (WTO, 1994). Furthermore, the Ministerial Conference must review suspension with more than one year of analysis. The existence of exceptional circumstances and the possibility of meeting the terms and conditions should be examined.
Vaccination should be considered a global product and must be accessible to all individuals, regardless of location. Therefore, the proposal to suspend patent by India and South Africa is significant (the South Centre, 2020). The COVID-19 vaccine is caught in the dynamic of competition and monopoly, primarily driven by competition for ownership and control of intellectual property rights in the global market (Adewopo, 2021). The issue of intellectual property rights and their impact on access to medicines during the COVID-19 pandemic is addressed. The relationship between intellectual property and public health has a long history, and the current situation requires a delicate balance between securing access to essential medicines and protecting patent rights (Adewopo, 2021).
In the context of developing countries, the proposal to suspend the vaccine patent is very important because the applied international system burdens countries with low economies. This is seen from the application of patent, leading to a relatively high royalty rate. Meanwhile, developing countries face more obstacles during the pandemic than their developed counterparts. In addition to the heavy burden on the health sector, the drastic decline, including tourism, led to a major reduction in economies (Mercurio, 2021). The temporary ban has the potential to facilitate widespread and efficient initiation of production processes since the greater number of actors cannot be restricted by dependence on a limited number of patent holders. The limitations of the TRIPs Agreement hinder and prohibit many developing countries from taking advantage of the existing flexibility (Mercurio, 2021). As previously stated, compulsory licensing is complicated to implement and poses a threat to developed countries. Meanwhile, several countries, such as Indonesia, Colombia, India, Ukraine, and El Salvador, are experiencing strong pressure from the pharmaceutical industry to implement flexibility, such as compulsory licensing. The patent suspension allows developing countries to act without the risk of litigation and fear of alleged patent infringement.
Obtaining a compulsory license is also onerous, rigid, time-consuming, and uncertain (Chaudhuri et al., 2021). Therefore, a compulsory license must be granted to both the importing and exporting countries, and the TRIPs Council needs to be notified by stating the name and quantity of the product required and identifying the special labeling or marking (Chaudhuri et al., 2021). This causes developing countries not to have adequate manufacturing capacity, making it difficult to import medicines to meet their health needs.
The global suspension of patent used in the manufacture of COVID-19 vaccines also has greater benefits than the implementation of compulsory licensing, which tends to be complicated. Therefore, the national government must take advantage of this omission to eradicate the pandemic. The patent waiver proposal initiated by India and South Africa had a positive impact by increasing transparency on vaccine manufacture before the agreement was reached (Thambisetty et al., 2021). Furthermore, the proposed waiver of patent at the WTO can be justified in a health emergency, and this is associated with intellectual property rights used to create barriers to vaccines. Therefore, the waiver of patent must be seen as an important step toward ending the pandemic. There is a need for consensus and global solidarity regarding the suspension of patent provisions on vaccines for a certain period by prioritizing safety and security.

Conclusion
The stipulations relating to the flexibility characteristics contained in the TRIPs Agreement and Doha Declaration have been accommodated by Law Number 13 of 2016 respecting Patent. Section 167 of the Patent Act has been amended to include a description of parallel imports and bolar requirements, and Sections 81 to 107 contain the license. However, the patent flexibility clause has not been effectively applied. The inadequate implementation guidelines and lack of political commitment contribute to the challenges in implementing the flexible provisions of the TRIPS Agreement. One of the biggest issues in ensuring global access to COVID-19 vaccines is the political pressure exerted on developing countries, which can lead to the threat of legal action. Meanwhile, these nations often face financial difficulties during pandemics, compounded by the heavy royalty fees associated with patented vaccines. Many developing such as Indonesia countries struggle to import essential goods from countries with strong manufacturing capabilities due to mandatory licensing requirements with strict conditions. In the future, a proposed solution is to temporarily suspend vaccine patent and break down monopolies to lower the cost of vaccination. This initiative prevents further hardships from pandemics and promotes fairness in vaccine distribution worldwide.