A New Wave of Tuberculosis R&D in Indonesia: Industry Must Stay Alert—Drug Patents Are Heating Up! - AFFA IPR

A New Wave of Tuberculosis R&D in Indonesia: Industry Must Stay Alert—Drug Patents Are Heating Up!

Patent, Intellectual Property

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 & 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.   This spotlight presents an intriguing paradox. Despite having one of the world’s highest TB burdens, Indonesia is now emerging as a leading candidate in medical innovation. How did this happen?   Indonesia: From Market to Innovation Player The collaboration with the Gates Foundation opens significant opportunities for new TB-related inventions—ranging 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’s 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.   Clinical Trial Progress: What Is Happening in Indonesia? Vaccine development follows strict standardized stages: Pre-clinical Initial testing on animals Phase I 3–80 healthy volunteers; determines safe dosage Phase II 20–200 volunteers; tests early efficacy & immune response Phase III Hundreds–thousands of participants; confirms effectiveness & safety Phase IV Post-marketing long-term monitoring   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—including TB vaccine research. This positions Indonesia not merely as a research site, but as a part of the global innovation ecosystem.   Open = Not New? Disclosure Risks to Novelty Participation in late-phase clinical trials carries both scientific and legal consequences. In Phases III–IV, 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.   Regulatory Framework Exists — But Not Enough Clinical trials in Indonesia are governed by: BPOM No. 8/2024 (Clinical Trials) BPOM No. 24/2025 (Drugs & New Drug Development) Both adopt ICH–GCP and CUKB (Good Clinical Practice) principles, emphasizing:  Confidentiality of data for both parties, Protection of sponsor & 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.   TB Patent Landscape in Indonesia: Dynamic & Expanding International collaboration has created a “domino effect,” 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 & Compositions Examples: IDP000058680: Live-attenuated Mycobacterium vaccine formulation P00202402878: Fusion-protein & 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 & Processes Some inventions protect synthesis and production techniques that improve efficiency and stability, offering additional protection over manufacturing technologies. Diagnostics Example:  IDP000067942: Liposomal KIT to detect mycolic acid, a key biomarker of M. tuberculosis Diagnostics research is paving the way to precision therapy.   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.   What Industry & 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.   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. “Innovation without strategy is only experimentation — but innovation with protection is an investment.”   For more information on Patent filing and protection in Indonesia, please contact us through the channels below: ? E-Mail : [email protected] ? Book a Call : +62 21 83793812 ? WhatsApp : +62 812 87000 889

Timor Leste Joins ASEAN: What It Means for Your Trademark Protection Strategy - AFFA IPR

Timor Leste Joins ASEAN: What It Means for Your Trademark Protection Strategy

Intellectual Property, Trademark

At the 47th ASEAN Summit held on 26–28 October in Kuala Lumpur, Malaysia, Timor Leste was ratified as the 11th member of ASEAN. Under the “Trade in Goods” framework, you may consider Timor Leste as your next export destination, since ASEAN membership brings more competitive tariffs, efficiency, and easier distribution within the region.   But how can you secure Trademark protection in Timor Leste? Remember: distributing and trading without Trademark protection is a high-risk move!   Trademark Regulations in Timor Leste At present, there is no dedicated government authority handling Trademark registration in Timor Leste. Therefore, Trademark protection is obtained by publishing Cautionary Notices in local newspapers to inform the public of your claim of ownership. The publication must include a statement of ownership and a warning to others not to use the Trademark without permission.   Trademarks That Can Be Recorded Because there is no formal Trademark registration system yet, there are no specific criteria for what can or cannot be registered. However, Trademarks published through Cautionary Notices should be: Unique and not imitative of other well-known Trademarks. Not in violation of local social or cultural norms. Conversely, Trademarks we do not recommend recording include: Purely descriptive or generic marks without distinctive elements. Marks that reference national or international symbols without authorization. Marks that are similar to well-known Trademarks abroad.   Required Conditions and Documents To publish Cautionary Notices in Timor Leste, you will need: Cautionary Notice Text: An official statement including the Trademark owner’s name and address, and a detailed description of the Trademark. Trademark Specimen: A clear representation of the Trademark to be published.   Procedure/Stages for Recording a Trademark via Cautionary Notices The publication procedure includes: Document Preparation: Drafting the Cautionary Notice text and preparing the Trademark specimen. Translation: Translating documents into the official language(s), if required. Publication: Submitting the Cautionary Notice to a local newspaper for publication. The duration of each stage may vary depending on process efficiency and newspaper schedules—ranging from several weeks to a few months. Additionally, because there is no formal registration system, no official certificate is issued.   What to Do After Your Trademark Is Published After publication of the Cautionary Notice, you as the Trademark owner are advised to actively use the Trademark in business to avoid the risk of claims by others. You—and your Trademark Consultant with representation in Timor Leste—should also actively monitor its use. If an unauthorized party uses the Trademark, you may take legal action based on the published notice.   Term of Protection in Timor Leste There is no specific protection period in Timor Leste due to the absence of a formal system. However, you are advised to renew the Cautionary Notice every two years to reinforce protection.   Since the system is not based on formal registration, there is no clear grace period if you are late with renewal. Nevertheless, the longer a Trademark goes without republication, the higher the risk that others may use it.   Ready to record your Trademark in Timor Leste? For more information, contact us through the channels below and get a FREE 15-minute consultation!   ? E-Mail : [email protected] ? Book a Call : +62 21 83793812 ? WhatsApp : +62 812 87000 889

When Science Meets Beauty: The Patent Strategies Behind Cosmetic Innovation in Indonesia - AFFA IPR

When Science Meets Beauty: The Patent Strategies Behind Cosmetic Innovation in Indonesia

Patent, Intellectual Property

In an era when the definition of “beauty” is no longer a matter of taste but the result of scientific research and business strategy, Patents act like invisible fences protecting the technological gardens behind every cosmetic product. During the protection period, the inventor enjoys a time-limited monopoly, while the public still gains access to the underlying technology through mandatory disclosure. This exchange — between exclusive rights and knowledge transparency — makes Patents a valuable currency that can be licensed, negotiated, or leveraged for funding. Today, competition in the cosmetics industry extends not only to retail shelves but also to the lines of Patent claims.   Aesthetics Built by Science Discussing cosmetics means examining aesthetics shaped by science. As the market grows, so does formulation complexity. In the past, innovation stopped at creams, gels, and lotions. Now, the landscape extends to clear nanoemulsions, multi-lamellar emulsions mimicking the stratum corneum, and anhydrous solids designed for extremely dry skin. The trend of “skincare from within” has even blurred the line between cosmetics and pharmaceuticals through oral formulations. Yet, across all these evolutions, Patents serve as the locking mechanism of value — covering ingredients, carriers, system designs, and process parameters that make a product cosmetically elegant without losing efficacy.   New Value from Familiar Ingredients Names like hyaluronic acid, niacinamide, and ceramide are now household terms among consumers. As Patent Originators, the core molecular Patents behind these ingredients have long expired. However, in the hands of formulators, their role continues through formulation innovation. The new wave of Patents no longer revolves around what the ingredient is, but how it works — from delivery systems that improve penetration and comfort, to crystalline structures enhancing stability, and formulations that maintain transparency and a lightweight feel. The commercial value has shifted — and it is the “how” that is now fenced by claims.   Four Key Patent Claim Pathways in Cosmetics For formulation teams, four categories of claims hold the most value: Composition – e.g., the ceramide:cholesterol:free-fatty-acid ratio and the Hydrophilic–Lipophilic Balance (HLB) system. Process – such as the shear profile, number of passes in high-pressure homogenization, or the cooling curve. Use/Application – for instance, reducing Transepidermal Water Loss (TEWL), the amount of water naturally evaporating from the skin. Crystalline Architecture – which prevents precipitation and preserves sensory elegance, the tactile and aesthetic pleasure perceived by the senses. As long as these variables are measurable and reproducible, they can form legitimate new claims.   From Laboratory to Store Shelf Behind every claim like low-oxidation foundation, non-sticky moisturizer, or 12+ hour moisture-lock serum, there are scientists meticulously determining the right range of composition and process: Too little — ineffective. Too much — irritating; Incorrect pH — destabilizes the system; Wrong mixing order — triggers precipitation. Finding that optimal balance is the essence of invention. If it meets the criteria of novelty, inventiveness, and industrial applicability, it becomes a patentable invention. Often, what’s patented isn’t the substance itself, but the precise orchestration — ratios, droplet sizes, temperature, homogenization pressure, and crystallization kinetics.   Excipients: The Unsung Heroes In modern cosmetics, excipients — inactive ingredients that maintain stability and enhance performance — play a crucial role. Because the dosage of active ingredients is often limited by regulations, formulators rely on excipient architecture: Humectants to draw moisture, Emollients for smoothness, Surfactants for dispersion stability, Polymers to control viscosity and texture. Techniques like high-pressure homogenization, ultrasonication, and cooling control are now treated as scientific variables, not just production methods. When these protocols deliver measurable benefits — increased hydration, reduced TEWL, improved barrier function — the process itself transforms into an intellectual property asset.   The Ceramide Case: Between Stability and Sensation Take ceramide — a lipid that locks in moisture within the stratum corneum. Formulating it to be stable, pleasant, and effective is no small feat. Patent WO2023076537 (by L’Oréal) enhanced ceramide load without heaviness. Patent WO2024215106 stabilized specific crystalline forms to prevent precipitation. Patent WO2024167206 created transparent nanoemulsions with a light sensory feel. Patent WO2023048329 developed solid oil-dispersed formulations for extremely dry skin. The differentiation lies not in what is used, but in how it’s engineered. National strategies differ, too: China focuses on speed, volume, and diverse combinations — fitting its dynamic mass market. Japan emphasizes material precision, crystal form, and purity — for cleaner, longer-lasting formulas. Korea excels in sensorial design and lamellar architectures — gentle on sensitive skin and clinically tested. Three approaches, one goal: stable, effective, comfortable, and claimable innovation.   Indonesia’s Opportunity: Utility Models for Cosmetic Innovation Under Indonesia’s Patent Law, Utility Models require only novelty and functional improvement, without the complex inventive step demanded by regular Patents. This opens opportunities for incremental cosmetic innovations — adjustments in component ratios, crystal forms, or carrier/dispersant designs — to gain fast and affordable protection for local formulations. However, it’s a double-edged sword. Savvy companies can build Patent Thickets — a web of overlapping Patents to secure valuable combinations — while others risk losing protection over similar innovations. That’s why an Intellectual Property strategy is crucial: deciding when to file, when to publish defensively, and how to keep innovation space open.   From Lab Bench to Legal Strength In practice, Utility Models can extend protection through solid scientific data — such as evidence of reduced TEWL, improved hydration, or chemical stability. These data not only strengthen Patent claims but also narrow competitor movement while reinforcing brand positioning. At the same time, this mechanism encourages local downstream innovation, allowing domestically developed formulations to be protected and commercialized faster.   Regulatory and IP Synergy Remember: Product Registration Approval from the Indonesian National Agency of Drug and Food Control (BPOM) and Compliance Certification with Good Manufacturing Practice for Cosmetics (CPKB) ensure that a product is safe and high-quality, but they do not grant exclusive rights. Regulatory clearance doesn’t guarantee freedom from infringement. The best approach is to comply with regulations while reinforcing Intellectual Property protection. This dual strategy ensures a company is not only legally safe but also strategically secure — with…

When Private Tech Goes Public: The Opening Chapter of SEP Litigation in Indonesia - AFFA IPR

When Private Tech Goes Public: The Opening Chapter of SEP Litigation in Indonesia

Patent, Intellectual Property

In recent years, the global conversation about Patents has shifted from who invented first to who controls the standard. Behind the arrival of 5G on our phones, Wi-Fi in every public space, and USB-C as a universal port, lies a term that increasingly dominates Intellectual Property discussions: Standard Essential Patents (SEP). This is no longer merely about exclusive rights, but about access to technology and the governance of the global digital industry. Indonesia may not yet be the main arena for SEP disputes, but several cases—such as Nokia’s Patent disputes in the Commercial Court—signal that this issue is no longer confined to Europe or the United States. When a company’s Patent has been adopted as part of a global technical standard, the question becomes more complex: how should its license be opened? Should there be a “public interest” limitation under FRAND (Fair, Reasonable, and Non-Discriminatory) terms? Unlike disputes in the pharmaceutical or life sciences sectors that often revolve around novelty, indication, or public domain, SEP issues introduce new dimensions: standardization, access, and interoperability. A Patent does not only protect technology—it can determine who may enter the market, and under what conditions.   Indonesia’s First SEP-Related Case The first SEP-related case in Indonesia emerged in 2015 between PT Polarchem, PT Garuda Tasco International, PT Star Metal Ware Industry, and PT Golden Agin against the holder of Patent IDS0001281. Patent IDS0001281 was registered as a Utility Model, describing the technical specifications of a sprayer, filed on 31 May 2012. The Utility Model closely resembled an Indonesian National Standard (SNI) established in 2018, which governed the criteria and testing methods for electric backpack sprayers. The Patent Holder objected to the enactment of SNI 8485:2018, arguing that it infringed on the Patent and refused to license the technology—an action that clearly violated the FRAND principle for inventions adopted as national standards. Initially, the Patent Holder won before the Central Jakarta Commercial Court (Decision No. 75/Pdt.Sus-Paten/2015/PN.Niaga.Jkt.Pst, 30 June 2016). However, upon judicial review, the Supreme Court (Decision No. 147 PK/Pdt.Sus-HKI/2018) determined that Patent IDS0001281 lacked technical novelty, ruling that the Utility Model was not new, and subject to cancellation.   The Nokia SEP Cases Another major development involved four cases between Nokia Technologies Oy and mobile phone assemblers or distributors in Indonesia. These cases demonstrated consistent SEP argumentation patterns. Nokia mapped its telecommunications Patent claims to specific 3GPP Technical Specifications adopted under Indonesia’s standardization framework. The first group involved 3G/UMTS Patents related to HSDPA 64QAM, covering efficient data packaging methods for faster transmission. Nokia referred to 3GPP TS 25.212, which defines UMTS multiplexing and channel coding, arguing that any 3G-compliant phone inherently implements the patented features. The second group concerned 4G Patents, referencing 3GPP TS 36.212 (v8.8.0) on multiplexing, channel coding, and mapping to physical channels in LTE. The claims covered methods for transmitting antenna configuration information using a bit mask—allowing synchronization between the user equipment (UE) and base stations (WTS), thereby improving data transmission. Since this specification forms part of global LTE standards (including in Indonesia), Nokia argued that any LTE device compliant with TS 36.212 necessarily performs the patented steps and thus requires a valid FRAND license. All groups referred to the ETSI definition of “essential”, which states that an IPR is considered essential if, on a technical (not commercial) basis, and given the state of the art during standardization, it is impossible to make, sell, or operate compliant equipment without infringing that IPR. Patent Holders must therefore submit an Intellectual Property Rights (IPR) Information Statement and irrevocable Licensing Declaration, agreeing to license under FRAND terms—preserving exclusivity, but balancing it with fair and non-discriminatory access.   Contractual and Institutional Dimensions The contractual dimension was reinforced through Nokia’s global and local licensing history, used to demonstrate its FRAND commitment and non-discriminatory practices. Disputes typically arose when existing licenses expired and renewal negotiations failed, leaving subsequent product distributions outside the licensing scope. At this stage, familiar SEP debates emerged: Was the FRAND offer economically fair and reasonable? Was there any discrimination? Who acted in good faith—the willing or unwilling licensee? And what remedies were proportionate—monetary compensation or injunctions? Expert testimony regarding the necessity of TS 36.212 for LTE devices supported the “implementation of standard = implementation of claim” reasoning typical in cross-border SEP disputes. Institutionally, 3GPP itself is a collaborative project among global standards organizations (ETSI in Europe, ATIS in the U.S., ARIB/TTC in Japan, TTA in Korea, CCSA in China, and others). Thus, 3G/4G/5G standards are collective products, not proprietary to a single developer. ETSI provides IPR policies and declaration procedures, not a license pool. Consequently, the prevailing commercialization model is bilateral FRAND licensing, though optional license pools exist in certain sectors. All four cases referred explicitly to the ETSI IPR Policy and 3GPP Working Procedures (particularly Article 55 on early IPR disclosure), emphasizing that: Technical contributions may contain essential IPR; Such IPR must be disclosed as early as possible; and Licenses must be available on FRAND terms to any willing implementer to ensure public interoperability.   Lessons and Legal Implications Together, these four cases represent Indonesia’s first publicly visible chapter in SEP litigation. The plaintiffs explicitly linked Patent claims to 3GPP Technical Specifications, affirmed ETSI declarations and FRAND commitments, and connected them to domestic device certifications as inferential proof of implementation. For industry players, the lesson is clear: When private technology “graduates” into a public standard, Patent rights remain—but they are burdened with access obligations under FRAND. Conversely, implementers gain access to standards but must negotiate in good faith for valid licenses. In the 5G/IoT horizon, similar disputes will likely intersect with competition law and cross-jurisdictional coordination (including anti-suit injunction issues). Thus, compliance playbooks—covering standard-to-claim mapping, negotiation documentation, and economic reasonableness assessments—should be prepared from the outset.   Reassessing Essentiality In evaluating such cases, it is critical to resist the assumption of “automatic essentiality.” As noted by Yi Yu et al. (2024), an effective defense begins by testing whether the disputed Patent is truly essential to the relevant standard or merely directed…