The outbreak of Corona Virus Disease 2019 or commonly called Covid-19 has experienced a very high increase in cases in various countries, especially in Indonesia. Of course, this has created a state of emergency and a very urgent need for national health interests. The impact of the emergency has resulted in a large number of sudden deaths and has a tendency towards high prices for pharmaceutical products.
In dealing with this, many countries have taken various ways to stop cases of the spread of Covid-19 by making vaccines. The vaccine should be available and easily accessible to as many people as possible. The Covid-19 vaccine is the result of a new invention that can be protected by Intellectual Property Rights in the Patent field.
A patent is an exclusive right granted by the state to an inventor for his invention in the field of technology for a certain period time in order to carry out the invention himself or give approval to other parties to implement it. The invention can be in the form of a product, process, or improvement and development of a product or process.
Registration of such patent rights can be done without compromising the public interest. The patentability of the invention for the Covid-19 Vaccine Patent has met the existence of an element of novelty, contains an inventive step, and can be applied in the industry. If the patent is not registered, then of course it becomes public property or the public domain.
It should be remembered again that exclusive rights in patents are not absolute, but can also be limited as stipulated in the provisions of Trade-Related Aspects of Intellectual Property Rights (“TRIPs”) and the Indonesian Patent Law. The restrictions on patent rights include, among others, Mandatory Licenses and/or Government Use of Patents.
Based on Trade Related Aspects of Intellectual Property Rights (TRIPs) in Article 30 – Exceptions to Rights Conferred states that “Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that 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”.
From these provisions, each country can regulate the exceptions to exclusive patent rights on a limited basis based on valid reasons, not exploitative, and still taking into account the reasonable interests of the patent holder and third parties.
In addition, Article 31 (TRIPs) – Other Use Without Authorization of the Right Holder states that “Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected”.
In this provision, the use of patents in terms of protected products does not need to wait for a permit or license from the patent holder in order to be able to access the covid-19 vaccine, especially in emergency and urgent situations in the interest of national health.
Patents for COVID-19 vaccines, drugs, and related devices temporarily cannot be subject to exclusive rights to an invention, so that the patent becomes not absolute but can be legally limited and in accordance with international legal instruments that have been agreed upon by all countries.
In connection with the fulfillment of a very urgent need for the interest of national health, the national legal instrument through Law Number 13 of 2016 concerning Patents (“Patent Law 2016”) has authorized the government to fulfill these needs through the implementation of patents by the government (government use).
Based on Article 109 Paragraph (1) of the Patent Law 2016, it has been stated that “Government can implement Patent in Indonesia based on the following considerations:”
- Relating with National defense and security; or
- Urgent need for the public interest.
Examples of inventions related to state defense and security are firearms, explosives, ammunition, encryption devices, and other state defense and security equipment. Meanwhile, inventions related to urgent needs for the benefit of the community, namely in the health sector, such as medicines that are still protected by patents in Indonesia and are needed to tackle diseases that are widespread or endemic.
In Patent Law 2016 regarding the implementation of patents by the government, if a foreign party owns a patent and registration has been submitted at the Directorate General of Intellectual Property (DJKI) and this is a state of emergency and requires the patent in the interest of national health, then without permission or license to the owner of the patent can be produced directly.
When the government uses or exercises the rights to the patent holder or the owner of the patent, the government is responsible for the implementation of the patent which can be carried out properly, effectively, and on target.
Protection of the COVID-19 vaccine patent is considered very important by the owner/patent holder, pharmaceutical company or institution because he has made discoveries, developments, and trials which of course have sacrificed energy, large investments and time.
But what about the economic rights and moral rights of the patent owners, this will of course still be carried out in accordance with the provisions of the legislation without compromising the rights of the patent owner, such as continuing to pay royalties (reasonable compensation) as compensation for the implementation of patents by the government and recognition of his inventions in the field of patents.
This is one of the functions of patents, namely to ensure the survival of the country’s economy and strive to increase the welfare of the people in the country concerned. However, in the event that the patent holder does not agree with the compensation set by the government, the holder of the right to a patent may file a lawsuit with the Commercial Court (Pengadilan Niaga).
The decision to self-execute a patent is stated in a Presidential Decree (KEPPRES). With the issuance of the Decree President of the Republic of Indonesia Number 11 of 2020 regarding the Determination of the Corona Virus Disease 2019 (Covid-19) Public Health Emergency, the government and the Indonesian people have realized that there is a public health emergency caused by the Covid-19 Pandemic.
The implementation of patents by the government can be carried out on conditions that are very urgent, limited, meet domestic needs and are non-commercial. Further provisions regarding procedures for implementation by the Government have been regulated in Presidential Regulation of the Republic of Indonesia Number 77 of 2020 concerning Procedures for Application of Patents by the Government.
The implementation of a patent can be carried out by the Government itself if the government has considered that a patent in a country is very important for the defense and security of the country and a very urgent need for the benefit of the whole community.
Based on Article 111 of the Patent Law 2016, states that the implementation of patents by the government is related to urgent needs for the benefit of the community, including:
- pharmacy and/or biotechnology products that are expensive and/or needed to overcome the diseases that can cause sudden death in large amount, cause significant disability, and parts of Public Health Emergency which Disturbing the World (KKMMD);
- Pharmacy and/or biotechnology products related to agriculture are needed for food endurance;
- Animal drugs needed to overcome pests and/or widely infectious animal diseases; and/or
- Processes and/or products to overcome the natural disasters and/or environmental disasters.
In connection with the current state of the Covid-19 pandemic, it has caused an emergency and is of great urgency for the health interests of the entire community. So that the government can implement patents related to the Covid-19 Vaccine which is very important in stopping the 2019 Corona Virus Disease outbreak.
The Indonesian state has also been faced with an urgent situation in efforts to cure disease outbreaks or overcome the HIV (Human Immunodeficiency Virus) / AIDS (Acquired Immune Deficiency Syndrome) epidemic, where the availability of “Antiretroviral” drugs are difficult to obtain by people with HIV / AIDS in Indonesia.
At that time, antiretroviral drugs were still protected by patents and efforts were needed to overcome the HIV/AIDS epidemic in Indonesia in order to provide access to these drugs, the government issued Decree of The President Republic of Indonesia Number 83 of 2004 concerning Implementation of Patents by the Government on Anti-Retroviral Medicines.
The government provides compensation to patent holders of 0.5% of the net selling value of antiretroviral drugs and the names of the patent holders for the drugs Nevirapine and Lamivudine are Boehringer Ingelheim (BI) and Biochem Pharma INC with a patent term of 7 years for BI and 8 years for Biochem Pharma INC.
The Presidential Decree was amended in Decree of The President Republic of Indonesia No. 6 of 2007 concerning Amendments to Decree of The President Republic of Indonesia No. 83 of 2004 concerning Implementation of Patents by the Government on Anti-Retroviral Medicines and Presidential Regulation No. 76 of 2012 concerning the Implementation of Patents by the Government on Antiviral and Antiretroviral Medicines.
Then there is also the obligation to notify the patent owner as regulated in Article 114 of the Patent Law 2016 which states that “In terms of government intends to implement patent that is important for national defense and security or for urgent need for public interest as referred to in Article 109 Paragraph (1) and Patents which interfere or conflict with National defense and security interest as referred to in Article 113 Paragraph (1), the government shall notify it in writing to the Patent Holder”.
If it is reviewed in the provisions of TRIPs above, if the situation is an emergency, then the obligation to notify the patent owner does not need to be carried out. However, in the Patent Law 2016 there is an obligation to notify the patent owner and it must be implemented properly.
Furthermore, the implementation of the patent by the government is recorded in the general register of patents and announced through electronic or non-electronic media. The government’s decision that a patent is exercised by the government as referred to in Article 109 Paragraph (1) is final and binding.
What is meant by final is that the government’s decision to implement a patent cannot be carried out by civil, criminal, state administration or other legal remedies. While the binding is the government’s decision regarding the implementation of patents by the government applies to the parties.
The implementation of patents by the government related to the covid-19 vaccine needs to be considered carefully. When a patent is opened to the public, not all parties can produce the patent properly if they do not master the Know-How aspect or do not know how to produce and process the vaccine, product capacity, raw materials and infrastructure. So that the government or the party-appointed in the implementation of the patent must really have the ability to produce it themselves.
However, based on Article 116 Paragraph (1) of the Patent Law 2016, it has been stated that “If the government could not carry out its own patent as referred to in Article 109 Paragraph (1), the government may appoint a third party to carry it out”.
The third party has mandatory requirements such as having facilities and being able to implement patents, not transferring the implementation of the said patent to other parties and having good production, distribution and supervision methods in accordance with the provisions of the legislation.
Thus, the basis for consideration of the implementation of the patent implementation by the government is the existence of problems with state defense and security or a very urgent need for the benefit of the community. It is only natural that in this case, the government or a third party is given permission by the government to implement a related patent as one of the functions of patents is to ensure the survival of the country’s economy and strive to improve the welfare of the people in a country.
The government cannot move alone without the involvement of the role and public awareness in dealing with the Covid-19 pandemic, so a joint role is needed to always try to prevent and break the chain of the coronavirus by always being disciplined in carrying out the Covid-19 Health and Vaccination Protocol.
All information is provided for educational purposes and is not to be considered as legal advice. Any reliance on the material contained herein is at the user’s own risk.
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Source :
- Trade-Related Aspects of Intellectual Property Rights (TRIPs)
- Decree of The President Republic of Indonesia Number 83 of 2004 concerning Implementation of Patents by the Government on Anti-Retroviral Medicines
- Law Number 13 of 2016 concerning Patents
- Decree of The President Republic of Indonesia Number 11 of 2020 concerning the Determination of Public Health Emergency Corona Virus Disease 2019 (Covid-19)
- Regulation of The President of The Republic of Indonesia Number 77 of 2020 concerning Procedures for Implementing Patents by the Government
