{"id":5764,"date":"2025-10-31T03:03:44","date_gmt":"2025-10-31T03:03:44","guid":{"rendered":"https:\/\/affa.co.id\/global\/?p=5764"},"modified":"2025-12-04T06:50:06","modified_gmt":"2025-12-04T06:50:06","slug":"a-new-wave-of-tuberculosis-rd-in-indonesia-industry-must-stay-alert-drug-patents-are-heating-up","status":"publish","type":"post","link":"https:\/\/affa.co.id\/global\/2025\/10\/31\/a-new-wave-of-tuberculosis-rd-in-indonesia-industry-must-stay-alert-drug-patents-are-heating-up\/","title":{"rendered":"A New Wave of Tuberculosis R&amp;D in Indonesia: Industry Must Stay Alert\u2014Drug Patents Are Heating Up!"},"content":{"rendered":"<p><span style=\"font-weight: 400\">At the beginning of 2025, Indonesia once again drew global attention as it joined international efforts to fight <\/span><b><i>tuberculosis (TB)<\/i><\/b><span style=\"font-weight: 400\">, an ancient infectious disease. The collaboration between the Indonesian government and the <\/span><b>Bill &amp; Melinda Gates Foundation<\/b><span style=\"font-weight: 400\"> became a major highlight following news that Indonesia was selected as one of the sites for late-phase clinical trials of a TB vaccine.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400\">This spotlight presents an intriguing paradox. Despite having one of the world\u2019s highest TB burdens, Indonesia is now emerging as a leading candidate in medical innovation. How did this happen?<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>Indonesia: From Market to Innovation Player<\/b><\/p>\n<p><span style=\"font-weight: 400\">The collaboration with the Gates Foundation opens significant opportunities for new TB-related inventions\u2014ranging from active compounds, drug or vaccine formulations, manufacturing methods, to diagnostic solutions. Patents play a key role in:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Strengthening exclusive rights<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Supporting development and production,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Facilitating commercialization.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400\">Indonesia\u2019s pharmaceutical and biotech industries, therefore, cannot remain idle. This momentum must be leveraged to actively participate in research and Patent filing, through both local and global collaboration.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>Clinical Trial Progress: What Is Happening in Indonesia?<\/b><\/p>\n<p><span style=\"font-weight: 400\">Vaccine development follows strict standardized stages:<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><span style=\"font-weight: 400\">Pre-clinical<\/span><\/td>\n<td><span style=\"font-weight: 400\">Initial testing on animals<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400\">Phase I<\/span><\/td>\n<td><span style=\"font-weight: 400\">3\u201380 healthy volunteers; determines safe dosage<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400\">Phase II<\/span><\/td>\n<td><span style=\"font-weight: 400\">20\u2013200 volunteers; tests early efficacy &amp; immune response<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400\">Phase III<\/span><\/td>\n<td><span style=\"font-weight: 400\">Hundreds\u2013thousands of participants; confirms effectiveness &amp; safety<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400\">Phase IV<\/span><\/td>\n<td><span style=\"font-weight: 400\">Post-marketing long-term monitoring<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>&nbsp;<\/p>\n<p><span style=\"font-weight: 400\">According to the Ministry of Health (May 2025), the TB vaccine candidate M72\/AS01_E has entered Phase III and involves 2,095 Indonesian participants as part of a global study.<\/span><\/p>\n<p><span style=\"font-weight: 400\">The Gates Foundation has contributed more than US$300 million to Indonesia since 2009 to support health, nutrition, sanitation, and vaccination systems\u2014including TB vaccine research.<\/span><\/p>\n<p><span style=\"font-weight: 400\">This positions Indonesia not merely as a research site, but as a part of the global innovation ecosystem.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>Open = Not New? Disclosure Risks to Novelty<\/b><\/p>\n<p><span style=\"font-weight: 400\">Participation in late-phase clinical trials carries both scientific and legal consequences. In Phases III\u2013IV, transparency is required, including:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Clinical trial registration, and<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Disclosure of research plans and results.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400\">However, transparency can be a double-edged sword. <\/span><b>Barcombe et al. (2024)<\/b><span style=\"font-weight: 400\"> notes that in Europe and the U.S., excessive disclosure can threaten novelty, a core patentability requirement.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Why? Various forms of publication, including:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Trial protocols,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Informed consent forms (ICF),<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Press releases,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Study registry entries,<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400\">can be considered prior art if they contain technical information enabling others to practice the invention.<\/span><\/p>\n<p><span style=\"font-weight: 400\">If information such as vaccine composition or dosage is revealed too early, it may even be categorized as public prior use, invalidating novelty.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>Regulatory Framework Exists \u2014 But Not Enough<\/b><\/p>\n<p><span style=\"font-weight: 400\">Clinical trials in Indonesia are governed by:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">BPOM No. 8\/2024 (Clinical Trials)<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">BPOM No. 24\/2025 (Drugs &amp; New Drug Development)<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400\">Both adopt ICH\u2013GCP and CUKB (Good Clinical Practice) principles, emphasizing:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Confidentiality of data for both parties,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Protection of sponsor &amp; subject information,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Quality control and distribution safety.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400\">The informed consent mechanism does not require sponsors to disclose detailed formulas or compositions to participants.<\/span><\/p>\n<p><span style=\"font-weight: 400\">However, regulatory protection alone does not guarantee Patent novelty. Information leaks may still occur through:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Scientific publications,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Recruitment materials,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Trial registries identifying compounds or dosage regimens,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Test subjects not bound by NDAs,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Third parties, such as CROs, laboratories, logistics vendors, or IT providers, lack strong confidentiality clauses.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400\">Even simple items like:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Open-label packaging,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Certificates of Analysis (CoA),<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Batch-to-subject records,<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400\">may reveal sensitive technical information.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Thus, non-regulatory strategies are crucial to ensure confidentiality and preserve novelty.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>TB Patent Landscape in Indonesia: Dynamic &amp; Expanding<\/b><\/p>\n<p><span style=\"font-weight: 400\">International collaboration has created a \u201cdomino effect,\u201d driving more TB-related Patent filings in Indonesia. Directorate-General IP (DJKI) data shows several emerging categories:<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400\"><b>Active Compound<\/b><span style=\"font-weight: 400\"><br \/>\n<\/span><span style=\"font-weight: 400\">Examples:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">IDP000065523: Quabodepistat compound with strong antibacterial activity against Mycobacterium tuberculosis<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">IDP000028943: Quinoline derivatives; protection expires in 2025, opening opportunities for generics and new formulations<br \/>\n<\/span>These demonstrate that Indonesia is no longer just a market, but a site for testing and adapting global molecules.<\/li>\n<\/ul>\n<\/li>\n<li style=\"font-weight: 400\"><b>Formulations &amp; Compositions<br \/>\n<\/b>Examples:<\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">IDP000058680: Live-attenuated Mycobacterium vaccine formulation<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">P00202402878: Fusion-protein &amp; nucleic-acid vaccine platform<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">P00202314496: Bone implant composition for post-TB complications<br \/>\n<\/span>Innovation extends beyond molecular discovery to optimizing therapeutic forms and platforms.<\/li>\n<\/ul>\n<\/li>\n<li><b>Manufacturing Methods &amp; Processes<\/b><span style=\"font-weight: 400\"><br \/>\n<\/span><span style=\"font-weight: 400\">Some inventions protect synthesis and production techniques that improve efficiency and stability, offering additional protection over manufacturing technologies.<\/span><span style=\"font-weight: 400\"><\/p>\n<p><\/span><\/li>\n<li style=\"font-weight: 400\"><b>Diagnostics<\/b><span style=\"font-weight: 400\"><br \/>\n<\/span><span style=\"font-weight: 400\">Example:\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">IDP000067942: Liposomal KIT to detect mycolic acid, a key biomarker of M. tuberculosis<br \/>\n<\/span>Diagnostics research is paving the way to precision therapy.<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p><b>When Should You File a Patent?<\/b><\/p>\n<p><span style=\"font-weight: 400\">Because disclosure may threaten novelty, the best time to secure a Patent is before technical information is made public.<\/span><\/p>\n<p><span style=\"font-weight: 400\">It is important to note:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Patent filing does not require BPOM marketing authorization.<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Pre-clinical data is often sufficient to support a Patent application.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400\">In other words,<\/span><b> the pre-clinical stage is the golden window<\/b><span style=\"font-weight: 400\"> to file a Patent.<\/span><\/p>\n<p><span style=\"font-weight: 400\">Delaying until research results are published increases the risk of losing novelty.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>What Industry &amp; Researchers Must Do<\/b><\/p>\n<p><span style=\"font-weight: 400\">With TB-related research and patenting on the rise, industry players and researchers must balance:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Scientific innovation,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Disclosure management,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Legal protection strategies.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400\">Without proper strategies, valuable inventions may lose their Patent value.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><b>From Experiment to Investment<\/b><\/p>\n<p><span style=\"font-weight: 400\">Indonesia now stands at a crucial crossroads. Once a country with one of the highest TB burdens, Indonesia is evolving into a center of research and innovation for TB vaccines and therapies. To maximize this opportunity, the local industry must actively protect research results through smart and structured Patent strategies.<\/span><\/p>\n<p><span style=\"font-weight: 400\">AFFA is ready to be your strategic partner to:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Map Patent pathways,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Conduct freedom-to-operate (FTO) analyses,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Preserve the novelty of inventions,<\/span><\/li>\n<li style=\"font-weight: 400\"><span style=\"font-weight: 400\">Prevent overlapping Patent rights.<\/span><\/li>\n<\/ul>\n<p><i><span style=\"font-weight: 400\">\u201cInnovation without strategy is only experimentation \u2014 but innovation with protection is an investment.\u201d<\/span><\/i><\/p>\n<p>&nbsp;<\/p>\n<p><b>For more information on Patent filing and protection in Indonesia, please contact us through the channels below:<\/b><\/p>\n<p><span style=\"font-weight: 400\">? E-Mail : <\/span><a href=\"mailto:patent@affa.co.id\"><span style=\"font-weight: 400\">patent@affa.co.id<\/span><span style=\"font-weight: 400\"><br \/>\n<\/span><\/a><span style=\"font-weight: 400\">? Book a Call : +62 21 83793812<\/span><span style=\"font-weight: 400\"><br \/>\n<\/span><span style=\"font-weight: 400\">? WhatsApp : +62 812 87000 889<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>At the beginning of 2025, Indonesia once again drew global attention as it joined international efforts to fight tuberculosis (TB), an ancient infectious disease. The collaboration between the Indonesian government and the Bill &amp; Melinda Gates Foundation became a major highlight following news that Indonesia was selected as one of the sites for late-phase clinical trials of a TB vaccine. &nbsp; This spotlight presents an intriguing paradox. Despite having one of the world\u2019s highest TB burdens, Indonesia is now emerging as a leading candidate in medical innovation. How did this happen? &nbsp; Indonesia: From Market to Innovation Player The collaboration with the Gates Foundation opens significant opportunities for new TB-related inventions\u2014ranging from active compounds, drug or vaccine formulations, manufacturing methods, to diagnostic solutions. Patents play a key role in: Strengthening exclusive rights Supporting development and production, Facilitating commercialization. Indonesia\u2019s pharmaceutical and biotech industries, therefore, cannot remain idle. This momentum must be leveraged to actively participate in research and Patent filing, through both local and global collaboration. &nbsp; Clinical Trial Progress: What Is Happening in Indonesia? Vaccine development follows strict standardized stages: Pre-clinical Initial testing on animals Phase I 3\u201380 healthy volunteers; determines safe dosage Phase II 20\u2013200 volunteers; tests early efficacy &amp; immune response Phase III Hundreds\u2013thousands of participants; confirms effectiveness &amp; safety Phase IV Post-marketing long-term monitoring &nbsp; According to the Ministry of Health (May 2025), the TB vaccine candidate M72\/AS01_E has entered Phase III and involves 2,095 Indonesian participants as part of a global study. The Gates Foundation has contributed more than US$300 million to Indonesia since 2009 to support health, nutrition, sanitation, and vaccination systems\u2014including TB vaccine research. This positions Indonesia not merely as a research site, but as a part of the global innovation ecosystem. &nbsp; Open = Not New? Disclosure Risks to Novelty Participation in late-phase clinical trials carries both scientific and legal consequences. In Phases III\u2013IV, transparency is required, including: Clinical trial registration, and Disclosure of research plans and results. However, transparency can be a double-edged sword. Barcombe et al. (2024) notes that in Europe and the U.S., excessive disclosure can threaten novelty, a core patentability requirement. Why? Various forms of publication, including: Trial protocols, Informed consent forms (ICF), Press releases, Study registry entries, can be considered prior art if they contain technical information enabling others to practice the invention. If information such as vaccine composition or dosage is revealed too early, it may even be categorized as public prior use, invalidating novelty. &nbsp; Regulatory Framework Exists \u2014 But Not Enough Clinical trials in Indonesia are governed by: BPOM No. 8\/2024 (Clinical Trials) BPOM No. 24\/2025 (Drugs &amp; New Drug Development) Both adopt ICH\u2013GCP and CUKB (Good Clinical Practice) principles, emphasizing:\u00a0 Confidentiality of data for both parties, Protection of sponsor &amp; subject information, Quality control and distribution safety. The informed consent mechanism does not require sponsors to disclose detailed formulas or compositions to participants. However, regulatory protection alone does not guarantee Patent novelty. Information leaks may still occur through: Scientific publications, Recruitment materials, Trial registries identifying compounds or dosage regimens, Test subjects not bound by NDAs, Third parties, such as CROs, laboratories, logistics vendors, or IT providers, lack strong confidentiality clauses. Even simple items like: Open-label packaging, Certificates of Analysis (CoA), Batch-to-subject records, may reveal sensitive technical information. Thus, non-regulatory strategies are crucial to ensure confidentiality and preserve novelty. &nbsp; TB Patent Landscape in Indonesia: Dynamic &amp; Expanding International collaboration has created a \u201cdomino effect,\u201d driving more TB-related Patent filings in Indonesia. Directorate-General IP (DJKI) data shows several emerging categories: Active Compound Examples: IDP000065523: Quabodepistat compound with strong antibacterial activity against Mycobacterium tuberculosis IDP000028943: Quinoline derivatives; protection expires in 2025, opening opportunities for generics and new formulations These demonstrate that Indonesia is no longer just a market, but a site for testing and adapting global molecules. Formulations &amp; Compositions Examples: IDP000058680: Live-attenuated Mycobacterium vaccine formulation P00202402878: Fusion-protein &amp; nucleic-acid vaccine platform P00202314496: Bone implant composition for post-TB complications Innovation extends beyond molecular discovery to optimizing therapeutic forms and platforms. Manufacturing Methods &amp; Processes Some inventions protect synthesis and production techniques that improve efficiency and stability, offering additional protection over manufacturing technologies. Diagnostics Example:\u00a0 IDP000067942: Liposomal KIT to detect mycolic acid, a key biomarker of M. tuberculosis Diagnostics research is paving the way to precision therapy. &nbsp; When Should You File a Patent? Because disclosure may threaten novelty, the best time to secure a Patent is before technical information is made public. It is important to note: Patent filing does not require BPOM marketing authorization. Pre-clinical data is often sufficient to support a Patent application. In other words, the pre-clinical stage is the golden window to file a Patent. Delaying until research results are published increases the risk of losing novelty. &nbsp; What Industry &amp; Researchers Must Do With TB-related research and patenting on the rise, industry players and researchers must balance: Scientific innovation, Disclosure management, Legal protection strategies. Without proper strategies, valuable inventions may lose their Patent value. &nbsp; From Experiment to Investment Indonesia now stands at a crucial crossroads. Once a country with one of the highest TB burdens, Indonesia is evolving into a center of research and innovation for TB vaccines and therapies. To maximize this opportunity, the local industry must actively protect research results through smart and structured Patent strategies. AFFA is ready to be your strategic partner to: Map Patent pathways, Conduct freedom-to-operate (FTO) analyses, Preserve the novelty of inventions, Prevent overlapping Patent rights. \u201cInnovation without strategy is only experimentation \u2014 but innovation with protection is an investment.\u201d &nbsp; For more information on Patent filing and protection in Indonesia, please contact us through the channels below: ? E-Mail : patent@affa.co.id ? Book a Call : +62 21 83793812 ? WhatsApp : +62 812 87000 889<\/p>\n","protected":false},"author":5,"featured_media":5765,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[71,81],"tags":[],"_links":{"self":[{"href":"https:\/\/affa.co.id\/global\/wp-json\/wp\/v2\/posts\/5764"}],"collection":[{"href":"https:\/\/affa.co.id\/global\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/affa.co.id\/global\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/affa.co.id\/global\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/affa.co.id\/global\/wp-json\/wp\/v2\/comments?post=5764"}],"version-history":[{"count":1,"href":"https:\/\/affa.co.id\/global\/wp-json\/wp\/v2\/posts\/5764\/revisions"}],"predecessor-version":[{"id":5766,"href":"https:\/\/affa.co.id\/global\/wp-json\/wp\/v2\/posts\/5764\/revisions\/5766"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/affa.co.id\/global\/wp-json\/wp\/v2\/media\/5765"}],"wp:attachment":[{"href":"https:\/\/affa.co.id\/global\/wp-json\/wp\/v2\/media?parent=5764"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/affa.co.id\/global\/wp-json\/wp\/v2\/categories?post=5764"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/affa.co.id\/global\/wp-json\/wp\/v2\/tags?post=5764"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}