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 27, 2014

Enforcement of Patent Rights for Pharmaceuticals in Vietnam

Subscribe to Updates
Informed Counsel

Patents are engines of growth and are critical to the vitality of the pharmaceutical industry. They create the incentive for pharmaceutical companies to maintain their investments to find new and better cures for global health issues, and to improve the health of people around the world. From an economic perspective, patents also give their holders an upper hand over other competitors. For this reason, many generic pharmaceutical companies try to illegally use others’ patented inventions in their own products, in order to gain an unfair advantage and compete with the patentees’ drugs. In this article, we will address the process of enforcing patent rights in the pharmaceutical sector in Vietnam.

Enforcement Options

The overall goal of all pharmaceutical patent holders when carrying out enforcement measures is to force the infringers to cease the infringement, to get the market authorization of the infringing drug withdrawn or revoked, and to ultimately claim compensation for any damages incurred. These objectives can be achieved only if the patentee can select the most appropriate measures and strategies, while understanding that patent enforcement in the pharmaceutical sector in Vietnam is relatively new.

The available enforcement actions against patent infringers include administrative measures, border control measures, and civil litigation. Administrative measures, which are carried out by administrative bodies, not judicial bodies, are the most common, as they are both cost-effective and time-saving. However, only the Inspectorate of the Ministry of Science and Technology and customs are entitled to handle patent infringement through the administrative route. Border control measures, which, to some extent, are considered to be administrative in nature, are applied by customs at the borders of Vietnam. Civil litigation is also an option, although it takes a high degree of commitment to pursue this route due to the local courts’ lack of IP expertise.

The Role of the Expert Witness

In Vietnam, the role of the expert witness in patent enforcement, especially in the realm of pharmaceuticals, is of great importance. Agencies offering such services, through their expert opinions and conclusions on infringement, provide guidelines for the competent authorities to resolve the case. Despite the opinions of expert witnesses being non-binding, they are almost always followed by enforcement agencies, which often lack experience in such matters. They also help to expedite enforcement actions.

Despite the importance of expert opinions, rights holders do not have many options available to them in terms of requesting assistance from examination agencies or agencies that provide expert advice, as the Vietnam Intellectual Property Research Institute (VIPRI) is, for the moment, the only functional agency authorized to provide expert opinions. Though the National Office of Intellectual Property now and then issues expert opinions upon the request of the enforcement bodies, in practice, its main role is to facilitate the procedures for establishing IP rights in Vietnam.

In most cases, to assess the possibility of patent infringement, VIPRI requests a prior physical testing of the putative infringing drugs. In some cases, however, VIPRI can judge the infringement based on the ingredients on the packaging and/or the inserts alone.

Complementary and Preventive Measures

Though some jurisdictions ensure “patent linkage” whereby marketing approval for generic drugs is not granted until the original drug’s patent has expired, there is no such regime in Vietnam. Therefore, parallel to or even before conducting any enforcement measures, patent rights holders in the pharmaceutical sector are advised to undertake certain measures at the Drug Administration of Vietnam (DAV). Specifically, according to Article 15 of Circular No. 22/2009/TT-BYT, patentees are encouraged to notify the DAV of their patents. Once notified, the DAV will then send a notice to its drug examiners for them to consider the patents in the process of deciding on the marketing authorization of drugs belonging to other applicants.

After the dossiers of drug-related patents have been filed, if there are potential conflicts or potential patent infringements found in any drug registration dossiers, the DAV will require the applicants to clarify the legal status and/or contact the patent owners in order to resolve these conflicts. This process, however, is not mandatory for management agencies and the DAV may nonetheless grant drug market authorization. This is because, in practice, the overriding spirit of Circular No. 22/2009/TT-BYT is that issues that arise in relation to patents are the responsibilities of the parties involved, and the DAV does not play a role in review, arbitration, or adjudication of these disputes. The DAV is bound only to withdraw the market authorization of a medicinal product (if the authorization has been granted) or refuse to issue a market authorization (if the application is in the review process) once a decision confirming the infringement has been issued by the competent patent enforcement authorities, such as the Inspectorate of the Ministry of Science and Technology, customs authorities, or the court.

At present, Vietnam is actively participating in the Trans-Pacific Partnership (TPP) negotiations, and one of the agenda items relating to the TPP that has been put on the table is whether or not a pre-review mechanism should be created with respect to patents for medicinal products for which applications for circulation licenses have been filed. The majority opinion in Vietnam, however, is in opposition, due to worries about negative impacts on the time taken for people to get access to a supply of cheap drugs, as well as intellectual property barriers that the Vietnamese government wishes to avoid. Therefore, it is uncertain whether the TPP can live up to the expectations of pharmaceutical companies that are advocating a more effective enforcement mechanism in Vietnam. In any case, pharmaceutical companies should fend for themselves and employ a comprehensive and long-term enforcement strategy to protect their patent rights effectively in Vietnam’s still-emerging patent enforcement regime.

Download Full Article
Related Professionals

Practices

Intellectual Property

Location

RELATED INSIGHTS​ 

August 13, 2026
Modern agricultural machinery is no longer purely mechanical but instead technology dependent. Modern tractors, harvesters, and other farm equipment increasingly incorporate embedded software, electronic control units, sensors, and digital diagnostic systems. While such technologies enhance efficiency, productivity, and precision farming, they also affect the manner of equipment repair and maintenance. As a result, farmers and independent repair providers may have little practical choice but to rely on authorized dealers, even for routine maintenance and repairs. Section 36 of Thailand’s Patent Act reflects the principle that the authorized sale of a patented invention usually exhausts the exclusive right of the patent owner over the specific product. This means that upon legal sale of the patented product, it can typically be used or resold without further authorization from the patent holder. This principle is relatively straightforward when applied to traditional mechanical equipment. Ownership of a machine ordinarily carries with it the practical ability to diagnose faults, replace worn parts, and restore the equipment to working order. Modern agricultural machinery, however, increasingly depends on embedded software, proprietary diagnostic systems, firmware updates, and other digital resources that may remain under the control of the manufacturer or patent holder. This tension lies within the “right to repair” debate. In the United States, on July 8, 2026, the Federal Trade Commission and five states announced a settlement with Deere & Company resolving allegations that Deere had unlawfully restricted farmers’ and independent repair providers’ ability to repair their equipment. Under the terms of the settlement, for the next ten years, Deere must provide repair resources, including software capabilities, on terms equivalent to those provided to authorized dealers. The Deere settlement highlights that the nature of ownership is changing, but legal concepts have not kept pace. Traditional patent-law concepts, including patent exhaustion, were developed with physical products
Read More
August 10, 2026
Thailand has finalized its social media KYC (“know your customer”) rules under Notification of the Electronic Transactions Commission on Measures to Prevent Technological Crimes for Social Media Service Providers (No. 2), which was published in the Government Gazette on May 5, 2026, and will take effect on November 1, 2026. While an early draft of the notification proposed requiring social media platforms to arrange identification of every user account, the final notification is significantly more targeted, focusing on paid online advertising and advertiser identity verification. Though the regulatory initiative primarily aims to combat online fraud and technology-related crimes, it also has important consequences for intellectual property enforcement, because the verified platform records that will be generated under the new requirements can help IP rights holders to identify anonymous online infringers. Key Regulatory Mandates The notification requires social media service providers to verify the identity of advertisers before their paid advertisements are published and disseminated in Thailand through social media, regardless of whether the advertising fees come from the advertisers or third parties. Verification of an advertiser is valid for one year, after which verification would have to be performed again before the platform could publish additional paid advertisements from the advertiser. Permitted verification methods are specified under the notification. A platform may verify an advertiser by checking identity evidence and confirming the connection between the advertiser and that identity evidence, with the notification giving facial comparison against certain government-issued identity documents as an example. Alternatively, platforms may verify advertisers through a digital identity verification and authentication system with an identity-proofing assurance level not lower than the level prescribed by Thailand’s Electronic Transactions Commission. The notification further requires platforms to retain only the advertiser’s information necessary to identify the advertiser, beginning from the start of the advertising activity and for
Read More
August 6, 2026
Introduction: A Trademark Paradox in Sustainable Packaging Walk into any Thai supermarket, and the label-free water bottle is no longer a novelty. Thailand’s packaging market, valued at approximately USD 15.68 billion in 2025, is shifting toward minimalist, plastic-light designs as ESG pressures reshape how brands present their products. The country generated roughly 5.68 million tons of plastic waste in 2021, with a recycling rate of only 19 percent, and regulators are now considering rules that would allow label-free bottled water relying on embossing, laser printing, or QR codes instead of wrap-around labels. As packaging itself becomes the brand identifier, a paradox emerges: designs built to say the least often struggle hardest for protection under Thai intellectual property law. The Trademark Barrier: When Shape Is Not Enough Section 7, paragraph 2(10) of the Thai Trademark Act deems a shape distinctive only if it is not the natural form of the goods, is not necessary to achieve a technical result, and does not add value to the goods. The Department of Intellectual Property’s 2022 examination guidelines apply this test conservatively, as the following examples illustrate. A plain water bottle relying on subtle contours to signal its brand is typically read as just another bottle, not a source identifier. Acquired distinctiveness offers a theoretical escape route, but it demands extensive evidence of sales, advertising, and consumer recognition—an especially heavy burden for new entrants whose minimalist packaging has not yet achieved market prominence. The result is a structural bias against precisely the design innovation that sustainability goals are meant to encourage. Design Patents: A Partial, Imperfect Substitute Design patent protection, covering a product’s shape, configuration, or ornamentation, appears to offer an alternative route. In practice, it is constrained by the same forces driving the minimalist trend. Because many brands converge on similar solutions—clear
Read More
August 4, 2026
Intellectual property (IP) protection sometimes hinges on fame and recognition. However, this alone will not always be sufficient to overcome an IP dispute when it involves contractual obligations or registered rights. Below are five cases from around the world that tackle some of the basic issues in IP registration, ownership, commercialization, and enforcement. 1. USA: Taylor Swift Trademark Application Refused Taylor Swift recently filed a trademark application to register “The Life of a Showgirl,” which is the title of her 12th studio album. When examining a trademark application, the examiner considers various factors before deciding whether it should be registered. One of these factors is whether there is a likelihood of confusion (i.e., would a regular consumer mistake the origin of the trademark). In Taylor Swift’s case, the US Patent and Trademark Office (USPTO) decided that that there would be a risk of confusion. This decision was based on the existing registered trademark, “Confessions of a Showgirl,” owned by Maren Wade, which was registered in 2015. The USPTO refused Taylor Swift’s application based on the shared key distinctive element “of a showgirl,” the lack of sufficient distinguishing terms, the marks being used in overlapping markets (entertainment and performances), and because consumers may assume a common commercial source. Maren Wade then filed a lawsuit in California against Taylor Swift and her affiliated companies, arguing that Taylor Swfit’s branding is confusingly similar in structure, wording, and overall commercial impression to her registered mark. She is also drawing on the USPTO’s refusal of Taylor Swift’s application to support her argument of a likelihood of confusion. A judgment has not yet been reached in this case, but it serves as an important reminder of the importance of satisfying the essential elements required for IP registration. 2. Australia: Katy Perry v. Katie Perry In
Read More