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

September 15, 2020

Vietnam: Who Is Responsible When Imported Drugs Infringe Patents?

Managing Intellectual Property

Are importers and distributors responsible for patent infringement related to the products they import and distribute? This seemingly simple question has still only been partially answered in Vietnam, when the Superior People’s Court of Ho Chi Minh City rendered a judgment on 28 July 2020 sending a case back to the first-instance court for a retrial.

The plaintiff in the case is a multinational pharmaceutical company, the owner of a valid Vietnamese patent protecting a compound used for the treatment of diabetes. The plaintiff had discovered a medicinal product circulating in the Vietnamese market, under a valid marketing authorization granted by the Drug Administration of Vietnam, that contained the active ingredient protected under the patent. This product was manufactured in Pakistan and exclusively imported and distributed by a local Vietnamese company.

The plaintiff decided to initiate a patent infringement lawsuit, but chose to sue only the importer/distributor of the infringing product, not the manufacturer. The strategic decision not to sue the manufacturer was based on factors that could lead to a delay in the resolution of the case, including the manufacturer’s lack of a strong commercial presence in Vietnam, the manufacturing process being carried out in Pakistan, and the procedural complications associated with filing a lawsuit against a foreign entity.

At the first-instance level, the Vietnamese importer/distributor acknowledged that the medicinal product might be patent-infringing and, as soon as the lawsuit started, ceased its import and distribution activities for the product. However, the defendant also held that it was not responsible for the patent infringement because: (i) there was a provision in the import and distribution contract between the defendant and the manufacturer under which the manufacturer took full responsibility for all IP issues; and (ii) as merely an importer and distributor, the defendant should not be responsible for a product it did not itself manufacture.

These arguments were rejected by the plaintiff because, as a general rule, any act of use of a patented invention without the permission of the patent owner is considered an infringement. Further, “use of a patented invention” is clearly defined under Article 124.1 of Vietnam’s IP Law, and includes the acts of import and distribution of patented products. In addition, the manufacturer’s contractual commitment to be responsible for IP issues was only binding on the manufacturer and the defendant, and was meaningless and irrelevant to any third party.

However, the first-instance judgment issued by the People’s Court of Ho Chi Minh City in July 2019 ruled that the defendant did not commit patent infringement because the plaintiff had not previously sued the manufacturer, and there was no judgment declaring that the drug was manufactured in violation of the invention patent. In other words, the court ruled that it was necessary to first determine that the manufacturer had committed an act of patent infringement before determining whether there was any patent infringement by the distributor/importer. This was a controversial ruling, as it appeared to be a denial of the general principles, understanding, and application of patent law in Vietnam.

The plaintiff immediately appealed to the appellate court, the Superior People’s Court of Ho Chi Minh City. At the appellate level, the controversy revolved around the questions of whether an importer/distributor is required to bear responsibility for patent infringement, and whether terms agreed to in a distribution contract are applicable to outside parties. The appellate court, with the desire to clarify the manufacturer’s role, invited a representative of the manufacturer to participate in the case as a person with related rights and obligations. The manufacturer’s representative insisted that the case was not related to them, and refuted their distributor’s arguments.

The appellate court ruled that the case should be sent back to the first-instance court for retrial, pointing out that the court had made serious mistakes in the application of the law. Specifically, the plaintiff has the right to sue whomever it chooses, and the court’s right to adjudicate is limited by the scope of the plaintiff’s petition—the court cannot tell the plaintiff who it should have sued. Additionally, the defendant, as the importer and distributor of the products, must bear independent responsibility for its own business activities. Finally, the court also ruled that the distribution contract between the two parties affected only the two parties themselves, without being binding on any other third parties.

The case now awaits the retrial of the first-instance court. It will be interesting to see how closely the guidance of the appellate court is followed. In principle, the first-instance court is not constrained in any way in how it handles the retrial. Thus, the judgment of the first-instance court will be a test to see whether the courts are unified in their jurisprudence.

RELATED INSIGHTS​ 

March 16, 2026
Indonesia’s Ministry of Law has introduced a new framework for patent applications that tightens filing requirements and introduces formal mechanisms for accelerated examination. Minister of Law Regulation No. 6 of 2026 on Patent Applications, which was issued on January 13, 2026, and took effect on February 23, 2026, serves as the implementing regulation for Law No. 65 of 2024 on Patents. It replaces the previous patent application framework (under Minister of Law and Human Rights Regulation No. 38 of 2018, as amended by Regulation No. 13 of 2021), which was considered no longer aligned with current legal, institutional, and technological developments. The regulation also reflects the institutional restructuring of the Ministry of Law and Human Rights into the Ministry of Law. Patent applications filed on or after February 23, 2026, must fully comply with the new regulation. Applications that were filed before this date will continue to be examined and processed under the previous regulation, pursuant to transitional provisions. Substantive Changes Definition of Invention The definition of “Invention” now explicitly includes systems, methods, and uses, in addition to products and processes. This expansion creates broader protection opportunities, particularly for software-enabled, digital, and method-based technologies, although it may also result in closer scrutiny during substantive examination. Excess Claims Fee Excess claims fees must now be paid at the time of filing. Failure to pay excess claims fees at filing results in the application being deemed withdrawn. There is no longer an option to defer payment to the substantive examination stage. This amendment forces applicants to face higher upfront costs. Patent claim strategy must be finalized prior to filing, reducing flexibility at later stages. Procedural and System Changes Fully Electronic Filing Patent applications must be filed electronically via the Directorate General of Intellectual Property (DGIP) online filing system. Assisted filings to
March 13, 2026
For decades, intellectual property rights holders seeking to eliminate counterfeit goods from the Thai market have relied primarily on criminal raid actions to seize infringing products and hold infringers accountable. The deterrent value of this approach is typically threefold: imposing criminal liability on infringers, removing counterfeit goods from circulation, and subjecting violators to imprisonment and fines. However, these outcomes often fall short of fulfilling brand owners’ broader objectives. In many cases, those prosecuted are merely staff or intermediaries rather than the principals orchestrating the infringing operations. Moreover, any fines imposed are remitted to the Thai government—not to the rights holders who have suffered commercial harm and invested substantial resources in investigation and coordination with law enforcement authorities. As in other jurisdictions worldwide, rights holders seeking monetary compensation for IP infringement in Thailand have traditionally pursued separate civil litigation. Before initiating such proceedings, a brand owner must gather sufficient evidence to establish both the infringement and the resulting damages. Notably, Thai law does not recognize punitive damages; courts award only actual damages proven by the claimant. In the absence of seized infringing goods, the damages awarded in such cases are typically minimal. This all leaves rights holders with limited recourse despite possibly having suffered significant commercial injury. In 2005, Thailand amended its Criminal Procedure Code to introduce Section 44/1, which enables rights holders to claim damages within criminal proceedings at the Intellectual Property and International Trade Court prior to the evidentiary hearing. In practice, this mechanism allows an injured party to submit a petition for civil damages directly within the criminal case initiated by the public prosecutor. Historically, rights holders in Thailand have been reluctant to use Section 44/1 because the compensation awarded by courts was often insufficient to justify the effort. However, recent years have seen a notable shift
March 13, 2026
Vietnam’s Law on Intellectual Property (IP Law) has undergone continuous amendment in recent years, with the latest amendment issued at the end of 2025. Among the amended and supplemented provisions, the regulation that has perhaps attracted the most attention is a provision relating to the use of protected IP objects by artificial intelligence (AI) systems. Specifically, Article 7 of the 2025 IP Law introduces a completely new Clause 5, which reads in full as follows: “Organizations and individuals are permitted to use texts and data relating to intellectual property objects that have been lawfully published, and which the public is allowed to access, for the purposes of scientific research, experimentation, and training of artificial intelligence systems, provided that such use will not unreasonably affect the legitimate rights and interests of the authors and intellectual property rights holders in accordance with this Law. With respect to texts and data that are objects protected by copyright and related rights, the use of the texts and data as set forth herein must also be in accordance with the regulations of the Government.” Analyzing this newly added provision in the context of how it was conceived, as well as the challenges that still lie ahead, can provide some interesting insights. From Aspirations to Flight in Science and Technology From the end of 2024 and throughout 2025—the 50th anniversary of the country’s reunification—Vietnam witnessed numerous sweeping changes in many areas, including legislative development. It could be said that no sessions of the National Assembly have ever adopted as many laws, resolutions, and major policies as this one. The aspirations of the highest-level leadership have been concretized into major law and policy projects, which were drafted, developed, and passed at record speed. All of this was aimed at building a foundation for Vietnam to achieve
March 10, 2026
Indonesia’s trademark prosecution process has been significantly streamlined with Ministry of Law Regulation No. 5 of 2026 (MOLR 5/2026) coming into effect on February 23, 2026. In straightforward cases without opposition, applicants may now see their trademarks proceed to registration within three months from filing—a substantial improvement over previous practice. The regulation also introduces detailed procedures for recording changes of name and address and for transferring rights over pending applications. It enhances the role of the Ministry of Law’s regional offices in assisting local individuals and SMEs, adds provisions governing force majeure situations, implements new requirements for collective trademarks, and formalizes several practices already in place. Substantive Examination Acceleration The most significant change under MOLR 5/2026 concerns substantive examination. The regulation now explicitly requires that applications be published within 15 days of filing, followed by a two-month publication period. Oppositions must be filed only within this window; late submissions will not be processed, even if the system accepts payment. The new regulation requires the Trademark Office (TMO) to forward copies of any opposition to applicants within 14 days of receipt. If no opposition is filed, substantive examination begins immediately after the publication period ends and will be completed within 30 days. If an opposition is filed, the examination is to be finalized within 90 days of the counterstatement filing date. These timelines enable unopposed applications to move from close of publication to final decision in roughly one month. If an application is provisionally refused during ex officio examination, the applicant has 30 working days from the date of notification to file a response. However, the regulation does not specify the timeline for subsequent reexamination after the response is filed. In recent practice, the TMO has been completing reexamination within approximately two to three months. Ownership Recordals May Pause Substantive