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

December 13, 2017

Vietnam: Registered Drugs Not Immune from Infringement Charges

Subscribe to Updates
Managing Intellectual Property

Recent patent infringement cases in Vietnam’s pharmaceutical sector have revealed the ambiguity of competent authorities’ roles in determining whether a patent has been infringed. Such vagueness has caused unexpected delays in legal proceedings.

In a recent suit between a leading international pharmaceutical group and a local generic producer, the court requested the Drug Administration of Vietnam (DAV) to clarify in writing whether the DAV had taken patent issues into account when considering approval of marketing authorization (MA) for the defendant’s pharmaceutical products. In response to the court, the DAV issued a letter confirming, for the very first time, that they have no responsibility by law to examine any IP infringement issues during drug registration.

Can Approved Drugs Still Be Infringing?

In the pharmaceutical sector, alleged patent infringers often defend themselves from the accusations by pointing to their MA registrations. They argue that any pharmaceutical products authorized to the market by the DAV must, by nature, be legitimate, and free from IP infringement issues. Therefore, holders of granted MAs should be released from any infringement liability.

Some infringers even contend that IP holders should instead place the blame on the competent authorities, such as the DAV, who approved the suspected infringing pharmaceutical products for circulation and distribution in the market. They presume that the DAV’s responsibility to carefully review drug registration dossiers prevents any potential IP infringement prior to the market entry of products. As a result, they argue, the DAV must be liable for any patent-infringing drugs on the market.

An examination of the prevailing laws, however, reveals that such arguments are unjustified. The Law on Intellectual Property explicitly requires every individual and organization to respect the intellectual property rights of IP owners. Meanwhile, the independent and separate laws on drug registration contain no provisions stipulating the DAV’s power and role to consider any IP issues with respect to drugs seeking MA registration. Furthermore, under Article 13 of Circular 44/2014/TT-BYT, the law clarifies that drug registrants or registering entities must themselves be responsible for IP-related issues both during the course of registration and after the drug has been granted a MA number.

The DAV Denies Responsibility

Regardless of the clear stipulation by law, the unjustified arguments of putative infringers have raised concerns among the courts in relation to the DAV’s role in the management of drug registration, including IP-related issues. The courts seem to be inclined to side with the defendants and thus continue to seek the DAV’s opinions on patent infringement.

In its letter to the court, the DAV strongly confirmed its independent position regarding IP-related issues during the process of drug registration, and reiterated the laws confirming that the Ministry of Health grants MA numbers for pharmaceutical products based only on the evaluation of their safety, effectiveness, and quality, with no obligation to review IP-related issues. The drug registrants, instead, are responsible for any matters relating to IP rights when the drugs are in circulation. In other words, the DAV has no responsibility by law to examine any IP infringement issues during drug registration. Therefore, drug registration does not render MA holders immune from IP infringement charges.

The DAV also acknowledges that under the law, when there is a judicial decision or final conclusion of the IP authorities on the infringement of IP rights, the DAV only needs to consider whether or not to revoke the MA or suspend the sale of a drug. Previously, such a decision or conclusion was grounds for mandatory revocation, but under the new Law on Pharmacy 2016 and Decree No. 54/2017/ND-CP, the DAV seems to be given more discretion. In a number of cases, the DAV has been reluctant to withdraw an MA even when there has been an infringement conclusion from an authority such as the Inspectorate of the Ministry of Science and Technology. Thus, there is no clear regime for an IP holder to force the DAV to withdraw and/or cancel an MA, regardless of any decisions on IP infringement from competent authorities.

If the drug registry body has no responsibility to consider IP-related issues during the MA procedures, the courts need to play a proactive role in settling patent disputes to effectively and expeditiously protect the legitimate rights of IPR holders. In the absence of coordination between drug registry authorities and IP enforcement authorities, a drug can be authorized for the market by the DAV if it meets requirements for drug registration, without IP-related issues ever being considered. However, if such drug is later found by the court to infringe others’ IP, it could be banned from circulation by an authority like the court, the MOST Inspectorate, or Customs regardless of the MA.

Download Full Article
Related Professionals

Practices

Intellectual Property

Location

RELATED INSIGHTS​ 

September 30, 2026
Packaging is a valuable commercial asset that helps consumers identify and distinguish products through their shape, colors, graphics, labels, and overall presentation. Obtaining legal protections for these assets is thus an important step. Businesses entering into or operating in the Myanmar market should assess whether trademark protection, industrial design protection, or both provide the strongest IP strategy for these features. The country’s Intellectual Property Department (IPD) under the Ministry of Commerce now administers trademark and industrial design registrations since Myanmar’s modernization of its intellectual property framework through the enactment of four key IP laws in 2019. Trademark Protection for Packaging Under the Trademark Law 2019, a “mark” is any visually perceptible sign, including words, names, letters, numerals, figurative elements, color combinations, or combinations of these signs, capable of distinguishing one undertaking’s goods or services from another’s. Trademark protection may therefore extend to certain elements of product packaging that function as source identifiers. Depending on their presentation and distinctiveness, packaging elements such as brand names, logos, labels, configurations, color combinations, and three-dimensional (3D) shapes may qualify for trademark protection. However, under the current practice of the IPD and its available examination guidelines, the packaging and  trade dress (including product get-up) are not expressly recognized as separate registrable subject matter in Myanmar. Under the Trademark Law 2019, trademark infringement—including unauthorized use of a registered mark on packaging—may give rise to civil remedies, including injunctions and damages, as well as criminal penalties. A 3D mark may protect packaging shape or configuration if it has acquired distinctiveness through use and consumers associate it with the relevant products. However, a shape dictated by a functional or technical purpose is ineligible for registration. Registration of a 3D mark may be renewed indefinitely for successive ten-year periods, subject to compliance with renewal requirements. Industrial Design Protection
Read More
September 30, 2026
Under Thailand’s Patent Act B.E. 2522 (1979), any person may raise the invalidity of a patent as a matter of defense. However, the right to initiate court proceedings to cancel a patent is reserved exclusively for an “interested person” or the public prosecutor. This distinction between merely challenging validity and initiating judicial revocation proceedings has given rise to a significant body of Supreme Court (Dika) jurisprudence interpreting who qualifies as an “interested person” under the Patent Act. Statutory Framework Section 54 of the Patent Act provides that any invention patent granted not in compliance with the patentability requirements will be invalid, and that a petition to cancel such a patent may be submitted to the court by any “interested person” or the public prosecutor. Section 64 mirrors this provision for design patents, and section 65 novies extends the same framework to petty patents. However, none of these provisions defines the term “interested person,” leaving its interpretation to the courts. Supreme Court Interpretation The Thai Supreme Court has developed a consistent body of case law establishing that an “interested person” must be someone directly affected by the existence of the patent—not simply any member of the public. In 1989, the court found (Dika No. 2670/2532) that a party whose intended use of the patented technology was still in a preparatory stage—before actual manufacturing had commenced—did not qualify as an interested person. However, in 2009 the Supreme Court further elaborated  (Dika No. 2906/2552) that an interested party is one whose rights to utilize the invention are restricted by virtue of the patent, such as a manufacturer or producer whose operations are directly impacted by the patentee’s exclusive rights. In the 2008 case of T.M. Grating Steel Co., Ltd. v. Billion Mass Industry Co., Ltd. (Dika No. 974/2551), where the plaintiff had
Read More
September 24, 2026
Vietnam is implementing and developing a broad package of regulatory reforms that could reshape how IP, data, digital platforms, and product authenticity are regulated and enforced. Several of the key measures have been led by the Ministry of Public Security in its legislative and administrative capacity, as part of a broader government effort. The core reform package consists of four key legal instruments: proposed amendments to the Criminal Code, a proposed new Data Security Law, a draft Decree on Product Identification, Authentication and Traceability, and the newly enacted Decree No. 330/2026/ND-CP. These instruments include rules on criminal enforcement, data security, electronic identification, product identification and traceability, administrative violations, and cybersecurity sanctions. Combined, these measures will affect copyright enforcement, industrial property rights, trade secrets, AI training data, product provenance, online takedowns, valuation of counterfeit goods and electronic evidence. It is worth noting that, in addition to strengthening criminal penalties for IP crimes, Vietnam’s emerging regulatory framework increasingly treats infringement, data misuse, product authentication, and platform-enabled violations as interconnected regulatory and enforcement challenges. For rights holders and foreign investors, this could mean stronger tools against counterfeiting and online infringement, but also more compliance obligations around data, traceability, AI, platform controls and government-facing reporting. Expansion of Criminal IP Enforcement Proposed amendments to Article 225 of the Criminal Code would expand criminal copyright exposure beyond reproduction and distribution to cover large-scale commercial public performance and online communication of works, phonograms and video recordings. This is important because piracy is increasingly about streaming, unauthorized communication, and platform access models rather than physical copying. Aggravated copyright infringement could be subject to up to 10 years in prison for individuals and fines of up to VND 6 billion (about USD 228,300) for commercial legal entities. The amended Article 226 would expand criminal industrial property liability beyond
Read More
September 21, 2026
Thailand’s first-to-file trademark system has a serious vulnerability: it lacks both an explicit mechanism for refusing bad-faith registrations and any means of invalidating them in court after the five-year limitation period has expired. While brand owners worldwide confront trademark squatting, Thailand’s statutory silence stands out, particularly in light of AIPPI’s 2017 Resolution Q249, which recommended that every jurisdiction provide clear tools to address bad faith at all stages of the trademark lifecycle. Nearly a decade later, Thailand has yet to act. This article proposes a concrete reform blueprint, drawing on the legislative models of China, the United Kingdom, and the European Union. The Statutory Gap Under the Thai Trademark Act B.E. 2534, no provision expressly authorizes examiners to reject an application on grounds of bad faith. Section 8(10) addresses well-known marks but offers no relief where the targeted mark lacks well-known status. Practitioners have resorted to Section 8(9)—which bars marks “contrary to public order, morality, or public policy”—as a workaround. However, this provision was designed to address the characteristics of the mark itself, not the applicant’s intent. Thai Supreme Court decisions have split on whether it can reach bad-faith conduct, creating persistent legal uncertainty. The gap extends beyond examination. Civil actions to cancel a bad-faith registration must be brought within five years—a deadline that frequently expires before foreign brand owners discover the squatted mark. Cancellation through the Board of Trademarks remains available but is slow, costly, and subject to court appeal, leaving bad-faith registrations in force during protracted proceedings. The system effectively rewards squatters and penalizes legitimate owners. Lessons from International Best Practices Several major jurisdictions have already closed this gap. China’s 2019 amendment to Article 4 of the Trademark Law introduced an absolute ground for refusal: “bad faith trademark applications without intent to use shall be rejected.” Bad
Read More