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

October 30, 2023

Vietnam: After Eight Years, Novartis Patent Case Ends in Positive Result

Subscribe to Updates
Managing Intellectual Property

A Resounding Victory

The last days of October brought some excitement for one of the leading pharmaceutical companies in the world, Novartis, when its patent litigation case in Vietnam against a local generic manufacturer, which had stretched over more than eight years, finally came to an end.

The background of this case is quite simple. Novartis was the owner of a patent protecting the active ingredient vildagliptin, which was commercialized through its Galvus® product, a medicine used to treat type 2 diabetes. In 2015, the company found that a drug manufacturer in Vietnam’s Binh Duong province on the outskirts of Ho Chi Minh City was producing a medicinal product containing the vildagliptin active ingredient—an infringement of its patent. Novartis first submitted a request to the Ministry of Science and Technology (MOST) to apply administrative sanctions on this infringer.

Subsequently, the MOST Inspectorate concluded in July 2015 that the defendant had committed patent infringement and ordered them to stop producing the infringing drugs and recall them from the market. However, the defendant did not comply with the conclusion, and sought an appeal while it continued to produce the infringing medicine.

Realizing that administrative sanctions were not strict enough to deter the defendant, Novartis continued to protect its legitimate rights and interests by initiating a lawsuit at the provincial court where the defendant was headquartered, Binh Duong. Novartis claimed that the defendant had infringed the patent and requesting the defendant to compensate for damages at the highest level allowed by law, pay attorney fees, and publicly apologize to Novartis in specialized newspapers. This began a long journey full of challenges that finally ended with the second appellate judgment declared by the High People’s Court of Ho Chi Minh City on October 17, 2023. The court accepted all claims raised by the plaintiff, Novartis, that were declared by the first-instance court on April 20, 2023 by rejecting the defendant’s appeal against the first-instance judgment. Previously, at the hearing, the People’s Procuracy also requested the court to deny the defendant’s appeal.

On its winding course to this conclusion, the case had a first-instance judgment that was annulled by the High People’s Court on July 24, 2020, and transferred to the People’s Court of Binh Duong for re-trial. The results of the two trials, however, were the same, with all claims raised by the plaintiff accepted by the People’s Court of Binh Duong. The patent also expired on December 9, 2019, while the case was in progress, but the manufacturer had been infringing the patent while it was still alive.

In the long process of the trial, a series of fundamental issues were raised that the court was both responsible for settling and had the opportunity to settle. This included determining that the authority of the Drug Administration of Vietnam was not related to the patent protection. In other words, a registrant for drug marketing authorization is subject to and must comply with the laws and regulations on patents with respect to the drug for which it has applied for registration to bring to market.

The court also had an opportunity to reject all claims from the defendant that the court was required to consider and collect opinions and evidence from the patent issuance process in other countries, such as the U.S. This was because, as confirmed by the IP Office of Vietnam in an official document, a clear and obvious principle that nonetheless still needed to be reaffirmed in specific cases is that patents granted in Vietnam have an independent and territorial examination process; therefore, they are not dependent on any other IP agencies in the world in any respect.

In this case, the court also settled many matters relating to the significance, role, form of solicitation and use of assessment conclusions (expert opinions) conducted by specialized agencies. In general, assessment conclusions are still decisive evidence for cases, but they must be carried out properly to be used during the case settlement by the courts.

Good Signals Sent

While the courtroom at the High People’s Court was not crowded during the hearing, the final award of the case still managed to attract a great deal of attention. Drug traders and manufacturers in Vietnam seem to understand now that they face huge risks and losses if they are not careful about legal aspects relating to IP rights. Patent owners also see in this case a very encouraging result because although it took a long time, with limitations in terms of enforcement and qualifications of specialized agencies, both the first-instance court and the appellate court issued convincing judgments in the direction of protecting the legitimate rights and interests of patent owners.

While state management agencies such as the Drug Administration of Vietnam, health departments and hospitals were not directly involved in the case, they also have recognized that IP issues must now always be carefully considered in the process of state management, such as in bidding packages for generic drugs. Vietnam’s project to establish a specialized IP court, which is expected to be submitted to the National Assembly for adoption within the next two years, should further contribute to more effective enforcement in similar cases.

At the very least, the positive results from the Novartis case should give IP owners additional confidence that their future cases will not take eight years to reach a conclusion!

T&G Law Firm LLC (TGVN), the local associate firm of Tilleke & Gibbins, represented Novartis in this case.

This article first appeared in Managing Intellectual Property.

Related Professionals

Practices

Dispute Resolution and Litigation

Intellectual Property

Location

RELATED INSIGHTS​ 

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 23, 2026
Arbitration under Thai law rests on consent. Section 11 of the Arbitration Act B.E. 2545 (2002) requires an arbitration agreement to be in writing and signed by the parties. This may also be satisfied by communications, an unchallenged allegation in pleadings, or incorporation by reference to a document containing an arbitration clause. A non-signatory cannot, as a general rule, be compelled to arbitrate merely because it participated in the transaction, received a benefit, or belongs to the corporate group of a signatory. Thai law nevertheless permits arbitration agreements and awards to affect third parties indirectly in limited circumstances. Under section 24, an arbitration clause is separable from the main contract; the invalidity of the contract does not invalidate the clause. In Supreme Court Judgment No. 3918/2563, an apparent sales contract concealed a construction contract and was void under the Civil and Commercial Code. However, the concealed construction contract and written arbitration clause remained effective. The tribunal had jurisdiction, and its award was enforceable under the Arbitration Act. Under the Arbitration Act, when a claim or liability is validly transferred, the transferee is bound by the related arbitration agreement. This includes assignment, transfer of obligations, legal succession, and subrogation. Depending on the facts and contract and agency law, consent may arise through execution by an authorized agent, ratification, assumption of obligations, or conduct accepting the contract and its arbitration clause. Thai law respects separate corporate personality. The group-of-companies doctrine has no statutory basis under the Arbitration Act, while alter egos or sham allegations require compelling evidence and an identifiable legal basis. Supreme Court Judgment No. 9161/2568 illustrates the procedural treatment of non-signatories. A consultancy contract required LCIA arbitration seated in Dubai. When the employer sued a consultant and his spouse in Thailand concerning a housing loan, the court disposed of
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
September 14, 2026
Myanmar’s first-to-file trademark registration regime under the Trademark Law 2019—which became fully operational in April 2023—provides mark owners with enhanced legal protection compared with the country’s former system. Correspondingly, the current system imposes more rigorous statutory requirements for obtaining, maintaining, and enforcing rights in marks. In this first-to-file trademark registration system, however, evidence of use remains particularly significant, as it may establish acquired distinctiveness, support a claim that a mark is well-known, and strengthen the owner’s position in both registration and enforcement proceedings. Accordingly, it can be said that this framework is underpinned by three key concepts: distinctiveness, well-known status, and, importantly, use of the trademark. Trademark Distinctiveness Under the Trademark Law, signs that lack distinctiveness are generally ineligible for mark protection. These signs include generic terms, basic shapes, unstylized single letters or numerals, and signs that merely describe the kind, quality, quantity, intended purpose, value, geographical origin, production time, or other characteristics of the relevant goods or services. However, a mark that would otherwise be refused on distinctiveness or descriptiveness grounds may be registrable if it has acquired distinctiveness through its use prior to the filing date. To show this, the applicant must demonstrate that the mark became distinctive to relevant consumers through continuous, exclusive, and good-faith use in trade within Myanmar. The burden of proving acquired distinctiveness rests with the mark owner. Accordingly, sufficient evidence demonstrating both use of the mark and the level of consumer recognition attained should be prepared in advance. Well-Known Mark Criteria Myanmar’s Trademark Rules, which govern the substantive examination of mark registration applications, establish criteria for determining well-known marks, aligned with international standards. Where an applicant claims well-known status—whether to overcome a refusal on relative grounds or to oppose a third party’s registration—the registrar will assess the claim based on the following
Read More