LOCAL CHAPTER LEGAL WRITINGS
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Nurzaskia Ernita Puspa Dewi Legal Essay Patent Rights : Public Health Emergency From Indonesia’s Perspective
Patents is included as one of the Intellectual Property. According to Article 1 (1) Indonesian Law Number 13 Year 2016, patents is defined as an exclusive right that is given from the state to the inventor for its invention in technological field for a certain amount of time. However, not everything could be patented, because a patent should be related to a process or a product whose value is recognized, which means that discoveries, ideas, laws of nature, physical phenomena shouldn’t be counted as a patent. It is clear as stated in The United States Patent Office (USPTO) that the three main criteria an invention could be granted patent should be novel, nonobvious and useful. Patents work differently in different industries, such as in the electronic industry, patents are shared among competitors through pooling or cross licensing, meanwhile for pharmaceutical, chemical and biotechnology industries, patent itself usually equals to a product. According to Lex Machina, the number of legal battles of pharmaceutical patents have increased by 30 percent. 1 It is highly important to patent pharmaceutical products as the manufacturing process of a product could easily be copied, aside from that, patents is an essential tool to support the innovation process because for innovation of new drugs, enormous costs are needed and patents contribute to roughly 80% of the overall revenue of pharmaceutical companies. 2 Not only that, patents is also needed in order to value the researcher of innovators as a lot of time and a great amount of money is spent on
Keown, Alex. “Report Says: Legal Challenges to Pharmaceutical Patents Saw 30% Increase in 2017.” BioSpace, BioSpace, 4 May 2018, www.biospace.com/article/reportsays-legal-challenges-to-pharmaceutical-patents-saw-30-percent-increase-in-2017/. accessed 5 July 2020 1
“Why Are Drug Patents Important: Everything You Need to Know.” UpCounsel, www.upcounsel.com/why-are-drug-patents-important. accessed 5 July 2020 2
marketing and research of the drugs. It is argued that without patent protection companies would have no incentive to invest in innovation. 3 Nevertheless, there have been some cases happening around the world which is that prices of drugs are surging because of it being patented. Pharmaceutical products patents are monopolized by developed country producers so that access for developing country people to drugs becomes so much harder. It’s a fact that more than 85% of the world’s population live in developing countries, and the vast majority of them have no or limited access to drugs that have saved and extended the lives of people in richer, developed countries.4 Amidst the findings of vaccines and drugs to stop the spread of Corona Virus or known as COVID 19, there have been a few dilemma and pros and cons regarding to the registration of COVID drug patents as it is considered prioritizing the economical field rather than the health field, as if it doesn’t really care about healing the people in Indonesia, or around the world. Many believes that the medicine to prevent and cure the virus itself has to be available and accessible to all kinds of patient, no matter who they are, both rich or poor, so the exclusivity as the result of it being patented shouldn’t occur. Because as we all know, access to health and essential medicines is also a human right. On the other hand, as stated above, patents for COVID 19 medicine is also needed as the researchers and inventors have invested so much time and energy in doing the research. Former Indonesia Business Competition Supervisory Commission (KPPU) Syarkawi Rauf stated that “a businessman who does monopoly on his patent is not a problem, because it is his intellectual right. However, the Commission can open an investigation if there’s an excessive increase of price in implementing its patent that might lead to marketing limitations that would lead to violations of business competition.” In 1994 the World Trade Organization (WTO) established the Agreement on Trade and Related Aspects of Intellectual Property Rights (TRIPS) to standardize
CIPR (2002), pp. 29–30; International Federation of Pharmaceutical Manufacturers and Associations (2012), p. 50. 3
Richard Elliot and Marie-Héléne Bonin , ‘Patents, International Trade Law And Access To Essential Medicines’ (2002) <http://umich.edu/~spp638/Coursepack/iprmsf.pdf> accessed 5 July 2020 4
worldwide intellectual property laws, including patent laws.5 All countries that belong to the WTO are bound by the TRIPS Agreement. In order for an invention to be patented, it is stated by the Patent Laws of Indonesia on Article (3) Paragraph (1) jo. Article (2) a that in order for an invention to be patented it has to be novel, non-obvious and useful.6 Novel means that it has to be substantially different from what exists which the public knows, or often known as the public knowledge. Non-obvious means that it is a surprise to those in the field, so those in the professional field shouldn’t easily perceive the invention. Third, useful means that it has to solve a problem, and is also applicable to its problem. Based on the three criterias, a product that fulfills all three should be patented, although it is needed for the public health to cure this pandemic. It is in no doubt that access to essential medicines becomes the highest attainable standard of a country, and the 1946 Constitution of the World Health Organization and the 1948 Universal Declaration of Human Rights (UDHR) both expressly recognize the right to health. The WHO, numerous national court cases and resolutions of the Human Rights Council, and the Doha Declaration on TRIPS and Public Health reaffirm access to essential medicines as a human right that must be available “for all.” 7 A human rightsbased approach shall be done so people could see through the human rights perspective which might improve access to medicines at the policy level. The right to health offers a framework from which national health policies and laws can be shaped for universal and equitable access. A way to make the drugs available and accessible in this pandemic situation, that also benefits the researcher is that still using the patent system through a mechanism named mandatory license/ or patents for government use. It is stated in Article 31 of TRIPS that in situations of national emergency, it is possible to patent for government Millum, J. “Are Pharmaceutical Patents Protected by Human Rights?” Journal of Medical Ethics, U.S. National Library of Medicine, Nov. 2008, www.ncbi.nlm.nih.gov/pmc/articles/PMC4704437/. accessed 5 July 2020 5
6
Patent Laws of Indonesia (UU No 13 Tahun 2016) on Article (3) Paragraph (1) jo. Article (2) 7
“Access to Medicines and Human Rights.” Health and Human Rights, 12 June 2017, www.hhrguide.org/2017/06/09/access-to-medicines-and-human-rights/. accessed 5 July 2020
use without the authorization of the right holder itself. Referring to patent laws in Indonesia itself, stated in Article 109 (1b) that the government could do its own patent based on an urgency for the public needs. It has to be non-commercial as well. Sadly, the problems we’re facing in Indonesia isn’t only the increasing prices because of the patents, but what that makes drugs not accessible for public health is also inadequate health care systems, limited resources and last but not least, corruption. In some cases, the money given to fund the research and developments are misused or corrupted, which is one of the root problems in our country. In our case in Indonesia, this law could really be implemented as the situation of COVID 19 could be classified as a public health emergency. But still, pharmaceutical patency that’s related to the pandemic should still follow the flow of the registration of a patency. Every patent registration shall fulfill both the requirements and process which is the checking, announcement, and another substantive checks that has to be followed. But the inventors have their patent rights already ever since the filling date although the patents should be given after the process. This government use mechanism could really be used so the benefited party isn’t only the government and public but the inventor could still get their economical rights and their invention’s protected. To conclude the essay written above, patency is believed as something important because we have to appreciate the researches that gives their time, maybe funds and so much energy in inventing something new to solve any kinds of problem occurring in the world. Responding to the situation currently happening around the world which is the worldwide pandemic, besides benefiting the inventors, we should also take our full attention on the public health, as it is also one of the Sustainable Development Goals or known as SDGs, written in goal 3 – which commits to “Ensure healthy lives and promote well-being for all at all ages”. It is concluded from the legal perspective that in Indonesia, we can use the ‘government use’ policy in helping to tackle this pandemic, without only benefiting one party. It means that the inventors should still go through the process, such as checking, announcement, and another substantive checks that has to be followed but also fasten the process of having their patent rights. Vaccines, tests and treatments should be distributed equally and everyone in this world has the rights to have access to it. Also, the distribution of the vaccines, test and treatments shall be clear and fair to those in need for it. The EU
itself has recommended collection of patents and voluntary cross-licensing of vaccines in their draft resolution for the World Health Organization so that the production and import of the vaccine, test and treatments shall be given in a smaller cost. As it is being said, we as the world has to conquer this pandemic.
References
Undang Undang No 13 Tahun 2016 tentang Paten
Trade and Related Aspects of Intellectual Property Rights (TRIPS) Agreement 1995 Pikiran Rakyat Depok. “Organisasi Internasional Desak Pemangku Kebijakan Bebaskan Hak Paten Vaksin Corona Berbiaya Murah.” Pikiran Rakyat Depok, 15 May 2020, depok.pikiran-rakyat.com/internasional/pr-09383254/semarangku?page=2. Suhendra, and Aditya Widya Putri. “Mengendalikan Perangkap Monopoli Obat Paten.” Tirto.id, Tirto.id, 17 Apr. 2017, tirto.id/mengendalikan-perangkap-monopoli-obatpaten-cmyJ. “Patents and the Pharmaceutical Industry.” California Management Review, cmr.berkeley.edu/2017/05/patents-and-pharmaceuticals/. “Why Are Drug Patents Important: Everything You Need to Know.” UpCounsel, www.upcounsel.com/why-are-drug-patents-important. Importance of Patents in Pharmaceutical Industry, www.pharmabiz.com/ArticleDetails.aspx?aid=92383&sid=21. “Access to Medicines and Human Rights.” Health and Human Rights, 12 June 2017, www.hhrguide.org/2017/06/09/access-to-medicines-and-human-rights/. “WORLD TRADE ORGANIZATION.” WTO, www.wto.org/english/docs_e/legal_e/27-trips_04c_e.htm. Risa Amrikasari S.S., S.H. “Ulasan Lengkap : Syarat Agar Suatu Invensi Dapat Dilindungi Paten.” Hukumonline.com/Klinik, 28 Aug. 2017, www.hukumonline.com/klinik/detail/ulasan/lt593848fec69ff/syarat-agar-suatuinvensi-dapat-dilindungi-paten/. Patenting Criteria: Novel, Non-Obvious, and Useful, www.thoughtstopaper.com/knowledge/patenting-criteria-novel-non-obvioususeful.php#:~:text=The%20United%20States%20Patent%20Office,novel%2C%2 0nonobvious%2C%20and%20useful.&text=To%20be%20non%2Dobvious%2C %20the,in%20that%20invention's%20particular%20field. “Tidak Sepenuhnya Monopoli Soal Paten Dikecualikan: Kabar24.” Bisnis.com, 20 July 2017, kabar24.bisnis.com/read/20170720/16/673472/tidak-sepenuhnya-monopolisoal-paten-dikecualikan. DJKI, Humas. Pendaftaran Paten Obat Covid-19 Bisa Dilakukan Tanpa Mengorbankan Kepentingan Umum - Direktorat Jenderal Kekayaan Intelektual,
dgip.go.id/pendaftaran-paten-obat-covid-19-bisa-dilakukan-tanpa-mengorbankankepentingan-umum. “Why Patents Are Necessary for the Pharmaceutical Industry.” Servier, 13 June 2017, servier.com/en/news/why-patents-are-necessary-for-the-pharmaceutical-industry/. Robert Pearl, M.D. “Why Patent Protection In The Drug Industry Is Out Of Control.” Forbes, Forbes Magazine, 19 Jan. 2017, www.forbes.com/sites/robertpearl/2017/01/19/why-patent-protection-in-the-drugindustry-is-out-of-control/#26c031da78ca. “Keuntungan Memiliki Hak Paten Bagi Startup.” Smart Legal ID, 15 June 2020, smartlegal.id/hki/pendaftaran-paten/2020/03/10/keuntungan-memiliki-hak-patenbagistartup/#:~:text=Menurut%20Pasal%203%20UU%20Paten,harus%20dapat%20dit erapkan%20dalam%20industri. Indonesia, Redaksi CNBC. “Karena Paten, Obat-Obatan Mahal Di Negara Berkembang.” News, 18 Sept. 2019, www.cnbcindonesia.com/news/20190918164651-4-100461/karena-paten-obatobatan-mahal-di-negara-berkembang. Turner, Sally. “Drug Patents Pharmaceutical Technology.” Pharmaceutical Technology, 12 Nov. 2018, www.pharmaceutical-technology.com/features/problem-drugpatents-can-new-global-approach-help/. Atkinson & Jones, “Intellectual Property and its role in the pharmaceutical Industry” (2009) 1(9) future-science <https://www.futurescience.com/doi/pdfplus/10.4155/fmc.09.138> accessed 5 July 2020 Richard Elliot and Marie-Héléne Bonin , ‘Patents, International Trade Law And Access To Essential Medicines’ (2002) UMICH <http://umich.edu/~spp638/Coursepack/iprmsf.pdf> accessed 5 July 2020
“Author: Daniele Dionisio.” PEAH Policies for Equitable Access to Health, 9 Jan. 2020, www.peah.it/author/peah/page/7/. “Importance of Patents in Pharmaceutical Domain.” Importance of Patents in Pharmaceutical Domain | Global Patent Filing, www.globalpatentfiling.com/blog/importance-patents-pharmaceutical-domain. “Our Services.” MPA Business Services, mpasearch.co.uk/pharmaceutical-patents. Manoj Poonia and Surbhi Bhardwaj, ‘Importants of Patents in Pharmaceutical Industry’ (Pharmabiz, 17 December 2015) < http://www.pharmabiz.com/ArticleDetails.aspx?aid=92383&sid=21#:~:text=They%20p lay%20an%20integral%20role,in%20developing%20and%20developed%20countries.&
text=Strong%20patent%20protection%20is%20required%20to%20meet%20the%20nee d%20for%20pharmaceutical%20innovation.> accessed 5 July 2020
Government Patent Use, and How it Implies to Patent Medicine, and Covid-19 Pandemic. Nisrina Olivia Jasmine – ALSA Local Chapter Brawijaya University
I.
Introduction 1.1 Background Patent is an exclusive right that is given by the country to the investor for their invention or giving
rights to the other party to supervise it.1 Patent is the part of Intellectual Property Rights (IPR). The invention that can be given the patent is only new invention that is not published,2 so there must be some research to make the invention, one example of the invention that can be given the patent is medicine, as we usually called it Patent Medicine/drug. The difference between patent medicine and generic medicine is that patent medicine can only be made and distributed by the patent holder (inventor) usually under a brand name, while generic medicine marketed under a non-proprietary name and can be marketed by a few company.3 The price of patent medicine is higher than generic medicine because of the long research that are needed, the cost of patent, advertising. If the medicine get patented, there will no other party that can sell and use their medicine. Patent medicine are important because it can secure against infringement cases, as competitors can easily duplicate the manufacturing of a drug, for safeguard the innovative approaches used by pharma companies, and help raising revenue that can improves overall economic growth of companies to operate this industry.4 It does not mean that generic medicine are not good but in this pandemic we need some certainity on what kind of medicine that can cure Covid-19 and there will be no more medicine that are faked in the market. As we know that Covid-19 is very easy to disperse so that many people are infected, having some illness, and the worst case is death.5 In Indonesia, Government can use the patent to produce something patented for good and it was written in Law No. 13 of 2016 on Patent Article 109 – 120. With the patent of medicine can be held by the government, it will make the patent medicine more accessable and it can
1
Law No. 13 of 2016 on Patent Article 1 No. 1. Ibid, Article 5 No.1. 3 Richard Elliot & Marie Helene Bonin, ‘Patents, International Trade Law, and Access to Essential Medicines’, (Universit of Michigan, 2002), <www.umich.edu> accesed 7 July 2020. 4 Upcounsel, ‘Why Are Drug Patents Important’, (Upcounsel, -), <www.upcounsel.com> accessed 7 July 2020. 5 World Health Organization, ‘Coronavirus’, (World Health Organization, 2020) www.who.int> accessed 5 Juli 2020. 2
be controlled on what ingredients contained in the product so it will be fit with the national standard. With this urgency, Government Patent Use is needed at this time. 1.2 Legal issue regarding the topic 1. What is the procedure for Government Patent Use? 2. What about the implementation in Indonesia, other country, and by the International Law? 3. Recommendation for the Government to using the authority of Government Patent Use. 1.3 Basic regulation of the topic 1. Law No. 13 of 2016 on Patent. 2. Law of Minister of Finance No.199/PMK.010/2019 on Regulation of Customs and Tax for Imported Goods. 3. Presidential Regulation No. 76 of 2012 on Government Patent Use for Antiviral and Artiretroviral Medicine. 4. Trade-Related Aspects Of Intelectual Property Rights. 5. Presidental Regulation No. 54 of 2020 on Restructuration of State Budget on 2020.
II.
Analysis 2.1 The Procedure of Goverent Patent Use The procedure is written in Law No. 13 on 2016 on Patent Article 109 â&#x20AC;&#x201C; 120 can be used
for something that is related to security protection of the county or some urgent needs for many people like pharmacy, biotechnology, chemical, animalâ&#x20AC;&#x2122;s medicine, and a to help the damage that are caused by natural disaster.6 If the patent is for security protection then the inventor would not have their exclusive rights and if the patent is for urgent needs (medicine, chemical, etc) then the inventor still can have their exclusive rights,7 but they have to pay for the annual fees until the patent can be operated while the other one for security protection, the inventor does not have to pay for the annual fees.8 It is also not for commercial but for many people needs and have some period of time but can be renewed by recommendation from Minister that are related to the 6
Law No. 13 of 2016 on Patent, Article 111. Ibid, Article 112. 8 Ibid, Article 118. 7
problem.9 The government should inform the inventor by the letter and the approval from Minister and after that it is settled Presidential Regulation. After that, it will be noted in Official Country Report and it is final and binding.10 The government should paid a decent amount of money for the inventor,11 and if the inventor does not agree with the amount they can file a lawsuit to Commercial Court, but the lawsuit cannot stopped the government to producing the patent product.12 Total cost of patent will be charged to state budget.13 2.2 The implementation of Government Patent Use in Indonesia, Other Country, and a view from International Law. In Indonesia, the Government Patent Use has been done once in 2012 and settled by Presidential Regulation No. 76 of 2012 on The Operation of Patent by the Government for Antiviral and Artiretroviral Medicine. It is for urgent needs for Human Immunodeficiency VirusAcquired Immuno Deficiency Syndrome (HIV/AIDS) and Hepatitis B.14 While the implementation in USA has some similarities with Indonesian law. Sovaldi is one of the expensive medicine used to treat Hepatitis c. Actually, Sovaldi is produced by generic manufacturers in India under license from Gilead (American biopharmaceutical company) for around $1,000 for a course of treatment.15 Because patents permit companies to charge profit-maximizing prices, they reduce the uptake of patented medicines and generating the social cost. However there is law that was codified at 28 U.S.C. section 1498, could allow the federal government to substantially lower prices for high-cost drugs.16 This law gives the government the right to use patented inventions without permission, while paying the inventor the compensation. The “government use” in this case is a form of governmental immunity from patent claims, so the inventors can demand royalties but cannot stop the government from
9
Ibid, Article 109. Ibid, Patent Article 114. 11 Ibid, Article 115. 12 Ibid, Article 117. 13 Ibid, Article 119. 14 Presidential Regulation No. 76 of 2012 on Government Patent Use for Antiviral and Artiretroviral Medicine, Article 1. 15 Amy Kapczynski and Aaron S. Kesselheim, ‘Government Patent Use’: A Legal Approach To Reducing Drug Spending’, 2016 VII Health Affairs [1] 16 Ibid, page 2. 10
producing the medicine or allowing others (in this case, generic manufacturers) to produce or import the medicine.17 Well, it can be beneficial but at some point it can be used to steal the patent from the inventor because it is written that the inventor cannot stop the government from producing the medicine. Same as the law in Indonesia, it cannot stop the government to producing patent product.18 Well, it has been regulated in Agreement On Trade-Related Aspects Of Intelectual Property Rights (TRIPs Agreement) and Indonesia has ratified the agreement by Presidential Decree No. 24 of 1979. It was written that without the authorization from the inventor, there are other subject (government or third parties with the authorization from the government) that can use the patent. It can be done if considered on its individual merits. for national emergency or other circumstances of extreme urgency. But, the duration also limited, must be non assignable, except with the part of the company or goodwill which enjoys the use, authorization for such use shall be liable subject to adequate protection of the legitimate interests of the persons, the government should paid adequate amount of remuneration, and the deal with the authorization can be taken to judicial review,etc.19 Therefore, it was not meant to steal the patent but to make the medicine cheaper, accesable, but still protected by the intellectual property and for the importance of many people. 2.3 Recommendation for Government to use the authority of Government Patent Use. Now, we are on a pandemic Covid-19. In Indonesia, there is no patent medicine at all while the number of the cases is always increasing everyday. Patent medicine for extremely danger condition is very needed because it implies the research and the right of intellectual property therefore people who has infected by Covid-19 would have more certainity to the patent medicine on the effectiveness, ingredients, effects, etc. While in Indonesia is already have the regulation for govermental patent use, the proccess of patent making will be more efficient and can be done with the state budget. As we know that our government already made some regulation and they do their best to stop the pandemic, but it is better to utilize that regulation furthermore. The regulation
17
Ibid, page 2.
18
Law No. 13 of 2016 on Patent, Article 117. Trade-Related Aspects Of Intelectual Property Rights, Article 31.
19
about the state budget in President Regulation No. 54 of 2020 on Restructuration of State Budget on 2020 is written that estimated amount of State Budget itself is Rp2.613.819.877.869.000,including the additional budget for handling Covid-19 Pandemic is Rp255.110.000.000.000,-.20 If it is not enough to make Government using their authority, then we could make a better plan to collaborate with the other national party such as National Agency of Drug and Food Control to make sure of the safety of its medicine and Ministry of Forreign Affairs to help with diplomacy with other countries therefore we could share about the knowledge of ingredients, research, and other things to patented the medicine for curing covid-19. When patent medicine is available in Indonesia, then it will be more accessable to many people that are infected and gradually the number of infected people will be decreasing.
III.
Conclusion
1. The explanation about Government Patent Use is written in Law No. 13 of 2016 on Patent, Article 109 â&#x20AC;&#x201C; 120. It is also explained about what is and not allowed on Government Patent Use. 2. There are some similarities about the regulation in Indonesia and USA, it is also regulated in Trade-Related Aspects Of Intelectual Property Rights (TRIPs), Article 31. That action is legally allowed as long as the government obey the rule to fulfill the rights to inventor. 3. Patent medicine for extremely danger condition is very needed. As we know that our government already made some regulation and they do their best to stop this pandemic, but it is better to utilize that regulation furthermore with the state budget that is already restructured for handling pandemic, and to cooperate with other national parties. When patent medicine is available in Indonesia, then it will be more accessable to many people that are infected and gradually the number of infected people will be decreasing.
20
President Regulation No. 54 of 2020 on Restructuration of State Budget on 2020.
IV.
Bibliography
Regulation 1. Law No. 13 of 2016 on Patent. (State Gazette of Republic Indonesia No. 5922) 2. Law of Minister of Finance No.199/PMK.010/2019 on Regulation of Customs and Tax for Imported Goods, Article 20. 3. Presidential Regulation No. 76 of 2012 on Government Patent Use for Antiviral and Artiretroviral Medicine. 4. President Regulation No. 54 of 2020 on Restructuration of State Budget on 2020. 5. Trade-Related Aspects Of Intelectual Property Rights. Journal 6. Amy Kapczynski and Aaron S. Kesselheim, ‘Government Patent Use’: A Legal Approach To Reducing Drug Spending’, 2016 VII Health Affairs. Article 7. World Health Organization, ‘Coronavirus’, (World Health Organization, 2020) 8. Upcounsel, ‘Why Are Drug Patents Important’, (Upcounsel, -). 9. Richard Elliot & Marie Helene Bonin, ‘Patents, International Trade Law, and Access to Essential Medicines’, (Universit of Michigan, 2002).