You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

February 23, 2017

Vietnam: Improving Pharmaceutical IP Protection

Subscribe to Updates
Managing Intellectual Property

Vietnam’s IP enforcement system has seen great improvements over the last several years. In particular, the Inspectorate of the Ministry of Science and Technology (MOST) has handled many complex disputes in the pharmaceutical sector related to patent infringement, unfair competition, and trademark infringement. Rights holders have generally been quite pleased with the decisions reached by MOST, as well as the expert opinions provided in various cases by the National Office of Intellectual Property (NOIP) and the Vietnam Intellectual Property Research Institute (VIPRI), which are often a precursor to a MOST administrative enforcement action. Nevertheless, with a few tweaks when Vietnam amends its Law on Intellectual Property this year, the system can be improved even further to help better protect IP in the pharma sector. Below are a few suggestions for improvement.

Patent linkage: At present, there is no strong or efficient route to have a marketing authorization blocked or withdrawn in the event of patent infringement. Even when the Drug Administration of Vietnam is notified about a drug’s potential infringement, an MA for the drug in question may still be approved. An MA may only be ordered withdrawn after a lengthy administrative or civil suit for patent infringement. In this regard, there needs to be stronger coordination among the IP enforcement and health agencies.

Preliminary injunctions: So far, preliminary injunctions have not been granted in pharmaceutical patent infringement cases, even in a case where the rights holder submitted to the court three decisions/opinions (from MOST, the NOIP, and VIPRI) affirming infringement. The infringer is still being allowed to participate in and win drug tenders at state-owned hospitals, and the rights holder cannot stop the sale despite overwhelming proof that it faces imminent, irreparable damage and will succeed on the merits of the case. Preliminary injunctions should be made available in these situations.

Fast-tracking of invalidation actions: In some cases, such as a case involving agrochemical patents, the court has ruled on patent infringement even though an invalidation action was pending. However, in other cases, the filing of a frivolous invalidation action by the defendant has resulted in a stay being imposed on an administrative or civil action. However, such invalidation actions may take years to resolve, while damages continue to be incurred by the rights holder. Vietnam should adopt systems employed in other countries where invalidation actions heard by the patent office are fast-tracked, and/or a stay is not granted if the invalidation action is not considered to have a high chance of success on its merits.

Damage calculations: In order to effectively deter patent infringement, Vietnam should adopt a system where patent damages can be trebled in the event that the infringer knowingly infringes a patent (such as by continuing to infringe after receiving a cease-and-desist letter, or after an administrative decision finding patent infringement has been issued). Moreover, the burden of proof of damages in IP cases is higher in Vietnam than in most countries. As mentioned, there are several hurdles in patent litigation in Vietnam, and it is therefore inappropriate that damages should be low if a rights holder can successfully overcome these hurdles and has suffered damages.

Specialized IP court: Vietnam would be wise to consider adopting a specialized IP Court. When Thailand established its IP Court, a strong message was sent to investors that the country was focusing on improving IP enforcement, and also helped consolidate the best experts in IP jurisprudence under one court for consistent handling of cases.

Compulsory licensing: Vietnam is considering draft regulations on compulsory licensing. However, the draft regulations are missing several key components, such as allowing the rights holder to take part in the proceedings, and not requiring failed license negotiations as a prerequisite to a compulsory license being granted. Compulsory licensing has not been granted in Thailand since 2007, and has never been granted in Japan; thus, Vietnam should reconsider whether it is truly needed, and in any case needs to ensure that any regulations comply with international commitments.

Parallel imports: Vietnam should consider adopting stricter regulations on parallel imports in the pharmaceutical sector. Pharmaceuticals can be imported from countries with different storage conditions (for example, different climates) and other regulatory requirements, or misleading information on origin, which can result in pharmaceuticals being imported into Vietnam that do not meet quality standards, or which mislead consumers. The Market Management Bureau of Hanoi should be commended for its stance against parallel-imported pharmaceuticals when regulatory violations are involved, as demonstrated in one case in 2016 when it raided a pharmacy, seized the medicines and imposed a fine.

Special import quotas (SIQ): Many IP-infringing pharmaceuticals are imported via fast-tracked special import quotas. There is rarely any public information available on the application or decision to grant the SIQ. As a result, the rights holder cannot take action until the market has already been flooded by the infringing product, thus adding to the damages to the rights holder. Further transparency is needed.

Trademarks incorporating INNs: Vietnam’s trademark registry contains many trademarks that inappropriately incorporate INNs. The registry should adopt a trademark examination system where objections can be raised automatically in certain circumstances involving INNs, and the burden is placed on the applicant to rebut the inference of non-registrability.

Download Full Article
Related Professionals

Industries

Life Sciences

Practices

Intellectual Property

Regulatory Affairs

Location

RELATED INSIGHTS​ 

August 10, 2026
On June 17, 2026, Indonesia’s National Agency of Drug and Food Control (BPOM) issued BPOM Regulation No. 10 of 2026 on Nutritional Information on Processed Food Labels. The new regulation, which revokes three previous nutrition labeling regulations, introduces several notable changes affecting food and beverage manufacturers, importers, and distributors. These changes range from updated nutrient reference values and serving-size requirements to the introduction of the Nutri-Level front-of-pack labeling system for certain beverage products. Businesses operating in Indonesia should carefully review these developments and assess their products’ compliance with the new requirements during the transition period. Implementation of the Nutri-Level Labeling System To implement the recently issued decree on Nutri-Level labeling, BPOM Regulation No. 10 of 2026 stipulates the requirements to implement the Nutri-Level labeling system on the front-of-pack. Under the new framework, ready-to-drink beverages, powdered beverages, and liquid or solid concentrates are required to display Nutri-Level labeling on the front label of their packaging. The Nutri-Level labeling system classifies products into color-coded levels A through D based on their sugar, sodium, and total fat content. The applicable Nutri-Level is determined based on the lowest level measured in the assessment of sugar, sodium, and total fat content. For products classified as level C or D, the Nutri-Level label must be accompanied by information on the relevant sugar, sodium, and total fat content per 100 ml of the ready-to-consume product. Products classified as level A or B may either display only the Nutri-Level designation or display the Nutri-Level together with the relevant nutritional information per 100 ml. Minimum Vitamin and Mineral Content Required for Declaration BPOM Regulation No. 10 of 2026 introduces a stricter threshold for the declaration of vitamins and minerals in the nutritional value information section (ING). Vitamins or minerals may only be declared if they are present at a
Read More
August 10, 2026
The drug registration process in Vietnam will be simplified, particularly for foreign applicants, following the recent issuance by Vietnam’s Ministry of Health (MOH) of a new circular that is expected to reduce administrative hurdles. Circular No. 32/2026/TT-BYT on the registration of drugs and medicinal ingredients (Circular 32) was issued on July 29, 2026, and will take effect on October 1, 2026, replacing Circular No. 12/2025/TT-BYT. Key provisions of the new circular are discussed below. Five-Year Data Exclusivity and Five-Month Public Disclosure Framework Circular 32 updates data protection guidelines by explicitly referencing Article 128 of the amended Intellectual Property Law, which sets out that new drugs supported by clinical trial data submitted for the first time will be granted a five-year data exclusivity period from the date of the initial marketing authorization (MA) approval. Subsequent applications that rely on the originator’s protected data will not be eligible for approval from the date of submission of the originator’s registration dossier until five years after the first MA is granted. Furthermore, in accordance with the new regulations, the regulatory authority must publicly disclose information on subsequent applications five months before the granting of MA, providing originator companies with an opportunity to exercise and enforce their intellectual property rights. Simplified Requirements for Foreign Legal Documents Circular 32 expands the circumstances under which legal documents issued by foreign authorities are exempt from consular legalization and authenticity verification requirements. Specifically, such documents may be exempt if the Drug Administration of Vietnam (DAV) is able to verify their authenticity directly through official electronic means, including written confirmation or email correspondence sent directly to the MOH by the competent foreign authority, or publicly accessible English-language databases maintained by recognized foreign regulatory authorities. In addition, the new circular permits the submission of electronic notarized copies of legal documents
Read More
July 24, 2026
As food innovation continues to accelerate, manufacturers are increasingly introducing ingredients derived from new sources, produced using novel technologies, or lacking a significant history of human consumption. While these innovations create new opportunities for the food industry, they also raise important questions regarding consumer safety. For this reason, many jurisdictions, including Thailand, the European Union, Australia and New Zealand, Canada, and Singapore, require a premarket safety assessment for novel food ingredients before they can be placed on the market. The objective of this assessment is to ensure that each ingredient is safe for its intended use and level of consumption, does not present toxicological, allergenic, microbiological, or nutritional concerns, and will not mislead consumers. Scientific authorities typically evaluate the ingredient’s identity, manufacturing process, composition, specifications, anticipated dietary exposure, toxicological information, nutritional impact, and history of use before determining whether it can be marketed. Against this background, the Thai Food and Drug Administration (FDA) recently took an important step toward improving regulatory transparency by publishing, for the first time, a consolidated public list of substances that have successfully completed the Thai FDA’s safety assessment process, including substances determined to be novel foods and those determined not to fall within the novel food category. The list identifies the approved substances, the corresponding manufacturers or importers, approval dates, and the approved conditions of use. Although the publication does not change the existing legal framework governing novel food approvals, it provides businesses with greater visibility into the Thai FDA’s regulatory precedents and the types of substances that have previously been accepted through the safety assessment process. The full announcement is available on the Thai FDA’s website. As the list is now publicly available, it also provides useful insight into the types of substances that have successfully completed the Thai FDA’s safety assessment process.
Read More
July 24, 2026
For businesses in Thailand’s regulated industries, the problem of “too many licenses” is one of the most familiar hurdles to getting a product to market. Take a simple example: importing the materials necessary to sell teriyaki chicken skewers. To legally do this, a business may need approvals from several different agencies—separate permits for the chicken (Department of Livestock Development), the dipping sauce (Thai FDA), the wooden skewers (Department of Forestry), and other ingredients, each under a different authority. This kind of overlap is often cited to argue for a “regulatory guillotine”—a systematic review to cut outdated or duplicative rules that slow investment and business activity. The Facilitation of Licensing and Public Service Consideration Act B.E. 2569 (2026) (Licensing Facilitation Act 2026) is Thailand’s most significant response yet to that concern. This article looks at the Facilitation Act 2026 through a life sciences and regulatory affairs lens—what it may mean for the manufacturers, importers, and distributors of food, drugs, medical devices, cosmetics, and similar products who routinely deal with several regulators to bring a single product to market. The Super License: One Approval Standing in for Many The reform with the clearest potential for regulated-product businesses is the law’s “super license” mechanism, referred to as a “main license” in the statute. Once a business obtains the main license for a regulated activity, it is automatically deemed to hold all related sublicenses issued by other agencies for that same activity, provided the activity has been designated as eligible in the Government Gazette. The Licensing Facilitation Act 2026 also creates a central application center, allowing applicants to submit a single application and pay all relevant fees at one point of contact, with the center routing the application to each agency through a shared information system. The potential benefits of this for businesses
Read More