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Open Letter to Indonesia Government : Serious Concerns Regarding the Proposed Amendments to Indonesian Patent Act, 2016 

September 26, 2024
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Open Letter to Indonesia Government 

Subject: Serious Concerns Regarding the Proposed Amendments to Indonesian Patent Act, 2016 

H.E. Joko Widodo 

President of the Republic of Indonesia 

H.E. Puan Maharani MP 

Chair of the House of Representative of the Republic of Indonesia 

H.E. Supratman Andi Agtas 

Minister of Law and Human Rights 

H.E. Budi Gunadi Sadikin 

Minister of Health 

H.E. Retno Lestari Priansari Marsudi 

Minister of Foreign Affairs 

H.E. Wihadi Wiyanto MP 

Member of the House of Representative of the Republic of Indonesia 

Dear Sir/Madam, 

We, the undersigned international civil society organizations (CSOs) are writing to express our deep  concerns regarding the recent amendments proposed to the Indonesian Patent Act of 2016. These  changes pose serious risks by extending patent monopolies on medicines, which could significantly  undermine local production and restrict access to affordable medicines in Indonesia. 

One of the proposed amendments seeks to remove Articles 4(f)(1) and (2) of the current Patents Act.  These articles prohibit patents on new uses and forms of known compounds, commonly referred to as  secondary patents. The newly proposed definition of “invention” is also overly broad and vague,  seemingly encouraging secondary patents. This enables pharmaceutical companies to exploit the patent  system by claiming exclusive rights over new uses or slight variations of well-known compounds,  effectively extending their patent monopolies. Such practices stifle competition and keep medicine 

prices artificially high, limiting access to affordable treatments. 

A study1 reviewed claims of 1304 patents on all new molecular entities approved in the U.S. between  1988 and 2005 and found that secondary patent claims are common in the pharmaceutical industry. It  further found that formulation patents extend patent monopoly by an average of 6.5 years, method  of use patents add 7.4 years of monopoly, while patents on polymorphs, isomers, prodrug, ester,  and/or salt claims add 6.3 years. This situation hinders the early entry of generic competition.  Another study in the U.S. found that extended patent monopolies from secondary patents cost patients,  insurance companies, and others an estimated $52.6 billion2 by delaying the introduction of affordable  generic alternatives. 

1 Kapczynski A, Park C, Sampat B (2012) Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of ‘‘Secondary’’  Pharmaceutical Patents. PLoS ONE 7(12): e49470. 

2 See https://anderson-review.ucla.edu/52-6-billion-extra-cost-to-consumers-of-add-on-drug-patents/

Indonesia is grappling with a dual burden of infectious and chronic diseases and has endured severe  waves of COVID-19. For instance, per August 2024, around 503,261 people in the country are living  with HIV.3 The government’s HIV/AIDS program currently covers the expense of providing access to  first- and second-line antiretrovirals. However, newer and more effective treatments—such as long 

acting formulations like intramuscular cabotegravir and rilpivirine and lenacapavir, as well as actual  and potential HIV pre-exposure prophylaxis (PrEP) medicines like cabotegravir and lenacapavir—are  protected by multiple patents in Indonesia, making them prohibitively expensive for the national  program. 

In addition, non-communicable diseases (NCDs) such as cancer, diabetes, heart disease, and chronic  lung conditions are now the leading cause of death and disability in the country. Treatments for these  conditions are often prohibitively expensive, well beyond the reach of most Indonesians, whose average  annual income is around $2,314 

The proposed amendments to the Patent Act, will extend patent monopolies, and further restrict access  to affordable medicines, including newer, life-saving treatments, potentially exacerbating the public  health challenges Indonesia already faces. 

Alarmingly, even under the current law, the Indonesian Patent Office has been granting secondary  patents on pharmaceutical products, extending market exclusivity well beyond what is necessary to  incentivize genuine innovation. Flawed examination practices have delayed the introduction of more  affordable generic medicines, driving up costs for both the government and the public. For instance,  patents granted on dolutegravir salts, their crystals & process (IDP00201403774), compositions  comprising crystalline sofosbuvir (IDP00201403478), and bedaquiline fumarate salt and solid  compositions (IDW00200901493) are examples of patents that should not have been approved. 

Indonesia faces an exceptionally high burden of tuberculosis (TB), yet multiple secondary patents have  been granted on bedaquiline, a crucial TB treatment. In contrast, countries such as India, Brazil, and  China have rejected patents for the fumarate salt of bedaquiline, with India also refusing a patent for its  dispersible tablet form. These decisions highlight the critical importance of provisions like Article 4(f)  in the current Patent Act and the need for more rigorous patent examination processes. Such safeguards  are essential to prevent the granting of undeserved patents that could hinder access to life-saving  medicines for those who need them most. 

The effect of patent evergreening of the proposed changes will also have a detrimental effect on  Indonesia’s generic industry, as secondary patents will limit the “freedom to operate” and produce  generic versions for domestic use and permissible export. Importantly the suggested amendments are  inconsistent with the objectives of Article 28H of the Indonesian Constitution, which guarantees the  right to medical care, and undermines Indonesia’s international commitments to uphold the right to  health.  

Major developing countries, such as India and Argentina have incorporated TRIPS-compliant  flexibilities into their national patent laws, regulations and practices to prevent the grant of secondary  patents and to expand freedom to manufacture and import generic medicines. In this context, it is deeply  concerning to see progressive elements in Indonesian patent law—key public health safeguards—being  

3 HIV & STIs Working Team, Directorate General of Disease Prevention and Control, Indonesian Ministry of Health. (2024). [PowerPoint  Slides].

dismantled. Such changes undermine efforts to ensure equitable access to life-saving treatments and  weaken the country’s ability to protect public health. 

We urge you to carefully consider the broader public health implications of the proposed amendments,  particularly their potential impact on Indonesia’s efforts to ensure affordable access to essential  medicines for all its citizens. We also believe numerous other important reforms could be made to the  Patent Act to improve the country’s health outcomes such as the introduction of administrative pre 

grant opposition. Indonesia is a net importer of intellectual property (IP)4 (it pays more to foreign  companies in royalties than it receives in royalties from abroad) and appears likely to continue being a  net IP importer for the foreseeable future, see graph below. Therefore, even leaving aside the health  consequences above, the economic benefits of Indonesia implementing any TRIPS+ intellectual  property protection (such as allowing patents on new uses of old medicines) largely benefit foreign  companies. 

We respectfully request that the government reconsider the proposed changes and engage in a  transparent, inclusive consultation process with all relevant stakeholders—especially affected  communities, civil society organizations, relevant ministries, and public health experts. 

We firmly believe that Indonesia can establish a balanced patent system that rewards genuine innovation  without compromising local production and access to affordable medicines. We remain committed to  supporting the government in achieving this balance and look forward to constructive dialogue on this  critical issue. 

Thank you for considering our concerns. We hope for your thoughtful reconsideration of the proposed  Patent Amendment Bill to safeguard the right to health and access to medicines for all Indonesians. 

Signatories 

1. Fundación GEP Argentina 

4 https://data.worldbank.org/indicator/BX.GSR.ROYL.CD and https://data.worldbank.org/indicator/BM.GSR.ROYL.CD/

2. Peoples Health Movement Australia Australia  3. Independent Australia  4. Samprity Aid Foundation Bangladesh 5. Bangladesh NGOs Network for Radio and Communication Bangladesh 6. People PLUS Belarus  7. Viva Salud Belgium 8. Working Group on Intellectual Property (GTPI) Brazil 9. ASSOCIATION BUKIINABE d ACTION COMMUNAUTAIRE  

ABAC /.ONG BURKINA Faso west Africa 10. social action for community and development Cambodia 11. PHM Cameroon Cameroon 12. Fundación Ifarma Colombia  13. Asociación Afecto contra el Maltrato Infantil Colombia  14. ICHANGE Côte d’Ivoire  15. Network TBpeople Georgia 16. ITPC GLOBAL Global 17. People’s Health Movement Global 18. Delhi Network of Positive People (DNP+) India 19. 1)Initiative for Health & Equity in Society 2) All India Drug  

Action Network India 

20. ITPC Global International 21. STOPAIDS International 22. Medical impact International 23. Health Global Access Project International 24. PEAH – Policies for Equitable Access to Health International 25. Global Surgery Umbrella International 26. Society for International Development International 27. Rettet den Regenwald (Rainforest Rescue) International 28. Asian Health Institute, AHI Japan 

29. Association “Answer-Kazakhstan” Kazakhstan  30. PF AGEP’C Kazakhstan. Almaty 31. KELIN(Kenya Legal and Ethical Issues Network on HIV  

and AIDS) Kenya 

32. Health Equity Initiatives Malaysia 33. Positive Malaysian Treatment Access & Advocacy Group  

(MTAAG+) Malaysia 34. Malaysian Women’s Action for Tobacco Control and  

Health (MyWATCH) Malaysia 35. Together Against Cancer Association Malaysia Malaysia 36. JEJAKA Malaysia

37. Terabai Kenyalang Heritage Association of Sarawak  

(TKHAS) Malaysia  38. PODER México 39. Initiativa Pozitivă Moldova  40. Wemos Netherlands 41. Pharmaceutical Accountability Foundation Netherlands 42. Asia Pacific Network of People living with HIV (APN+) Regional 43. International Treatment Preparedness Coalition in Eastern  

Europe and Central Asia Regional 44. Eurasian Community for Access to Treatment Regional 45. Heallh Action International Asia Pacific Regional 46. Yayasan Dedikasi Tjipta Indonesia South Sulawesi 

47. Ongd AFRICANDO Spain 48. SAVISTHRI Sri Lanka 49. Public Eye Switzerland 50. Thai Network of People Living with HIV/AIDS (TNP+) Thailand 51. Health and Development Foundation Thailand 52. Drug System Monitoring and Development Center Thailand 53. FTA WATCH, THAILAND Thailand  54. Wemos The Netherlands, EU and  international 

55. Human Rights Research Documentation Centre (HURIC 

Uganda) Uganda 

56. People’s Health Movement Uganda Chapter Uganda 57. Human Rights Research Documentation Center (HURIC 

Uganda) Uganda 

58. Just Treatment UK  

59. CO «100% Life» (former All Ukrainian Network of People living with HIV) Ukraine/Regional 60. Foundation for Integrative AIDS Research (FIAR) Untied States 61. Salud y Farmacos USA 62. REDETICA Colombia 

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