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​ 

July 6, 2026
Indonesia’s regulation on reporting online intellectual property (IP) infringement provides comprehensive procedural guidance for IP rights holders and their licensees in reporting online infringement complaints. Issued in December 2025 by the Ministry of Law as Regulation No. 47 of 2025 regarding Handling of Intellectual Property Infringement Reports in Electronic Systems, this regulation covers all types of IP rights. It also specifies documentation when reporting infringement, and lays out the procedures for examination, verification, and enforcement actions. Submission of Complaints Complainants may submit reports through the online system of the Directorate General of Intellectual Property (DGIP) or in person at the DGIP office. Complaints may also be filed through an authorized proxy. Under the regulation, complainants are required to provide the following information and documents: Personal details of the complainant; Brief description of the protected work or subject matter (i.e., type of IP and name or address of the infringing website, portal, account, or application, or a link to the location of the infringing content); Complete description of the alleged infringement; Certificate of registration or recordal of the relevant IP; Recordal of IP license agreement, if any; and Other supporting evidence. Verification and Examination Process Upon receiving a complaint, the responsible formality officer may request clarification or additional supporting documents. In the latter case, the complainant must then submit the necessary administrative documents within 14 days of the notification date. Once the documentation is deemed complete and sufficient, the case will be formally registered. Subsequently, the DGIP will establish a verification team to handle online IP violations, which will include the Civil Servant Investigator (PPNS), the Ministry of Communication and Digital Affairs, experts with relevant expertise in IP, and representatives from related associations such as AVISI (Indonesian Video Streaming Association). After examining the report, the team will prepare the Minutes
June 30, 2026
Customs recordation is an enforcement mechanism in Myanmar that enables intellectual property (IP) rights holders to seek prevention of the cross-border movement of infringing goods. The enactment of Myanmar’s IP laws in 2019 has enabled customs recordation for registered marks and copyrights under the Trademark Law 2019 and the Copyright Law 2019. By contrast, the Patent Law 2019 and the Industrial Design Law 2019 do not provide a practical framework for customs recordation, and accordingly such rights are not subject to the customs recordation regime. Under the Trademark Law 2019, rights holders may apply for customs recordation and may also ask the Customs Department to suspend the release of goods suspected of bearing counterfeit marks. Likewise, the Copyright Law 2019 allows for customs intervention in relation to pirated works. These provisions reflect Myanmar’s gradual alignment with international standards on border measures, although the implementation framework remains at a relatively early stage of development. Customs Recordation Pursuant to the Trademark Law 2019 and the Copyright Law 2019, the relevant authorities have issued customs rules concerning the protection of registered marks and copyrights. In practice, the process generally begins with the submission of an application to the Customs Department together with supporting documentation. This typically includes proof of registration in Myanmar; details of the rights holder, applicant, and any authorized representative; and a comprehensive description of the genuine goods. Product identification materials—such as photographs, packaging samples, and distinguishing features—are particularly important in helping customs officers identify suspected infringing goods. A recordation remains valid for two years from the date of approval. It may be renewed for additional two-year terms, provided that the renewal application is filed within the thirty days prior to expiry for marks and up to thirty days in advance of the expiry date for copyrights, in accordance with
June 29, 2026
Thailand’s cabinet has approved the draft Act on Liability for Defective Goods, commonly called Thailand’s “Lemon Law.” The Draft Act is currently pending consideration by Parliament. The draft law aims to strengthen buyers’ position in pursuing cases against sellers. While the Civil and Commercial Code offers provisions governing liability for defective goods, it is difficult in practice for buyers to successfully make a claim against sellers, particularly where defects are latent and not discoverable at the time of sale or delivery. By introducing product-specific rules and clearer remedies, the new law is intended to modernize Thailand’s consumer protection framework and align it more closely with international standards, and to help relieve the buyer’s burden of proof against the seller in product liability cases. If enacted, the draft act will take effect 180 days after publication in the Government Gazette, giving businesses a transition period to assess their compliance obligations. This article provides an overview of the key provisions of the draft act and highlights some practical considerations for businesses operating in Thailand. Scope and Key Definitions The draft act applies to sellers—defined as persons who sell goods in the ordinary course of business—and protects buyers, a term defined broadly to include not just the original purchaser but also transferees and successors in title. This expands the class of people who can bring claims. The law does not apply to used goods, live animals, or goods exempted by future ministerial regulation. It also leaves intact any separate warranties, promises, advertisements, or other guarantees a seller has given; those remain enforceable alongside the new statutory rights. General Liability for Defective Goods Sellers are liable for defects that exist at the time of delivery, regardless of whether the seller knew about them. Liability arises where a defect reduces: The benefit intended under
June 24, 2026
Patent enablement requirements are provided under Article 102 of Vietnam’s Law on Intellectual Property (IP Law). In particular, a patent specification must “fully and clearly disclose the nature of the invention to such an extent that, based on the specification, a person having ordinary skill in the relevant art can implement the invention.” In pharmaceutical and biotechnology patents, this requirement is more complicated and subject to more rigorous assessment. The Patent Examination Guidelines (Guidelines) of the Intellectual Property Office of Vietnam (IP Office) were amended in March 2026 to introduce Annexes III and IV for the pharmaceutical and biotechnology sectors, in which Annex III provides detailed guidelines on the assessment of specification requirements. These amendments were made under a project for strengthening capacity in industrial property examination between the Japan International Cooperation Agency (JICA) and the IP Office. Annex III provides detailed instructions on how examiners assess enablement in a pharmaceutical or biotechnology application, and offers examples of acceptable and unacceptable descriptions with regard to the enablement aspect. Enablement Requirements in Pharma and Biotech Patents Article 12.7 of Circular 10/2026/TT-BKHCN (Circular 10) adds to the requirements of Article 102 of the IP Law that the description must demonstrate the novelty, inventive step, and industrial applicability of the technical solution. For pharmaceutical composition subject matters, Article 12.9 of Circular 10 sets out that the description must present the results of clinical trials and/or the pharmacological effects of the claimed pharmaceutical composition, and must include at least the following information: Substance/mixture used. Testing method (system) employed. Information on the test results. Correlation between the pharmacological effects obtained from the tests and the application of the pharmaceutical product in the prevention, diagnosis, and treatment of diseases. The Guidelines note that pharmacological study results should be presented in a quantified manner, and pharmacological