Pharmaceutical Patents in Vietnam: Conditions and Exceptions

Pharmaceuticals are among the most strongly protected patent subject matter — a new active ingredient can enjoy 20 years of exclusivity. Yet paradoxically, pharmaceuticals are also the field where the law carves out the most exceptions to patent exclusivity: research exemptions for generic manufacturers, parallel imports, data exclusivity limits, and compulsory licensing for public health. This article explains the protection conditions and the exception system for pharmaceutical patents under current Vietnamese law.

Protection conditions for pharmaceutical patents (Article 58)

Vietnamese law has no separate exclusion regime for “pharmaceutical products” — pharmaceuticals are protected like any other invention. Under Article 58.1 of the Law on Intellectual Property (consolidated text 67/VBHN-VPQH dated 23 March 2026), a pharmaceutical patent is granted when three conditions are met simultaneously:

Novelty: not publicly disclosed in any form before the filing date (or priority date), except for statutory grace-period cases;
Inventive step: a creative advance that could not easily be created by a person of average skill in the field;
Industrial applicability: capable of being manufactured or used in industry, handicrafts, agriculture, or other fields.

Protectable subject matter in pharmaceuticals is broad: products (new compounds, formulations, new salt/crystal forms meeting the conditions) or processes (synthesis or manufacturing processes). The protection term is 20 years from the filing date (Article 93.2).

The critical boundary: methods of treatment are not patentable (Article 59.7)

Article 59.7 provides that “methods of prevention, diagnosis and treatment of diseases for humans and animals” may not be protected as inventions. A clear distinction is required:

NOT protectable: treatment regimens, dosages, methods of using a drug on the human body — these are “methods of treatment”;
Protectable as normal: the drug itself (product) and the process of manufacturing it.

In examination practice, the boundary between a “method of treatment” and a “drug manufacturing process” is assessed case by case by the examiner — businesses should seek advice before drafting claims rather than stretching the statutory text.

Four exceptions to pharmaceutical patent exclusivity (from “soft” to “hard”)

1. The Bolar exception — research to prepare marketing authorization dossiers (Article 125.2(a))

A patent owner may not prohibit others from using the invention for “evaluation, analysis, research, teaching, testing, trial production, or information gathering to carry out procedures for obtaining permission to manufacture, import, or circulate products”. This is the legal basis for generic companies to prepare marketing authorization dossiers before patent expiry, so generics can enter the market immediately after exclusivity ends.

2. Exhaustion of rights — the basis for parallel imports (Article 125.2(b))

The owner may not prohibit the circulation, importation, or exploitation of products put on the market by the owner — or by a licensed transferee (including a compulsory licensee) — including foreign markets. This underpins parallel imports: purchasing genuine drugs in lower-priced foreign markets for import into Vietnam.

3. Pharmaceutical test data exclusivity (Article 128)

Article 128.2: for 05 years from the date the applicant is granted marketing authorization, the licensing authority may not grant authorization to a subsequent applicant whose dossier relies on confidential data without the first applicant’s consent. The sole exception is point d, clause 3, Article 125 — disclosure or use of trade secrets created independently. Precision matters: the original text does not say “except for compulsory licensing” — the exception must not be stretched beyond the statute.

Article 128.3 (domestic patent linkage): when permitting a later application to rely on an already-authorized pharmaceutical, the licensing authority must publish information on the later application on its web portal 05 months before granting authorization (except for early grants under other laws).

4. Compulsory licensing for public interest (Articles 145, 146, 147)

This is the “hardest” exception. Article 145.1 lists five grounds for compulsory licensing of patent use rights:

For public or non-commercial purposes, national defense, security, disease prevention and treatment, public nutrition, or other urgent social needs;
The owner fails to fulfill the obligation to exploit the invention after 04 years from the filing date and 03 years from the grant date;
A prospective user negotiated with the owner for a reasonable period but failed to reach agreement;
The owner restricts competition in a manner prohibited by law;
To meet the pharmaceutical needs of another country under an international treaty to which Vietnam is a party.

Licensing conditions (Article 146.1): the license is non-exclusive; limited in scope and duration; non-transferable (except together with the business establishment); requires adequate compensation to the owner (except pharmaceutical imports under a treaty already paid for in the exporting country); and must mainly serve the domestic market (except grounds 4 and 5).

Decision-making authority (Article 147.1): ministries or ministerial-level agencies for grounds (1) and (5); provincial People’s Committees for grounds (2), (3), and (4). Decisions to grant or refuse a compulsory license may be complained about or sued over (Article 147.4).

New from 1 April 2026: fee exemption when marketing authorization is delayed (Article 131a)

Law 131/2025/QH15 (effective 1 April 2026) adds Article 131a: pharmaceutical patent owners are exempted from paying “protection title use fees” for the period during which first-time marketing authorization procedures are delayed — “delayed” meaning more than 02 years from the date of receipt of a complete dossier without a first written response, excluding delays caused by the applicant’s fault.

The nature of this mechanism must be understood correctly: it is a fee exemption, NOT an extension of the patent term. The consolidated text 67/VBHN-VPQH contains no provision extending patent protection terms for marketing authorization delays — so one should not assert whether Vietnam “has” or “does not have” patent term extension, nor infer commitments from treaties without consulting the original treaty texts.

Key procedural milestones

Novelty grace period: 12 months (Article 60.3) — an invention disclosed within 12 months before filing is still considered novel in grace-period cases;
Substantive examination request: within 36 months from the filing or priority date (Article 113.1);
Substantive examination: 12 months from the application publication date (Article 119.2(a), under Law 131/2025/QH15).

Transitional note: under Article 220.2, applications filed before a new law takes effect are processed under the law in force at filing — businesses with pending applications should verify which effective-date regime applies to their dossiers.

Practical checklist for pharmaceutical businesses

Originator companies: audit patent portfolios — distinguish “product” patents (strong) from “use” type claims (potentially caught by Article 59.7); track the 05-year data exclusivity periods; factor in the Article 131a fee exemption when authorization procedures stall;
Generic companies: use the Bolar exception to prepare marketing authorization dossiers early; monitor the 05-month publications on the licensing authority’s portal (Article 128.3); assess parallel import possibilities under the exhaustion principle;
Both sides: do not stretch exceptions beyond the statute — in particular, the data exclusivity exception is limited to independently created secrets (point d, clause 3, Article 125) and does not cover compulsory licensing.

Frequently asked questions

Can a new therapeutic use of a known substance be patented?

Vietnamese law does not expressly regulate “second medical use”. Neither grant nor refusal can be asserted absolutely — assessment depends on claim drafting and case-by-case examination practice. Specific advice should be sought before filing such applications.

Can generics be sold immediately after patent expiry?

In principle, yes, if the company used the Bolar exception (Article 125.2(a)) to prepare its marketing authorization dossier in advance. However, check whether the 05-year data exclusivity (Article 128.2) is still running, and the 05-month pre-grant publication procedure for later applications (Article 128.3).

Can the State force a pharmaceutical patent owner to let others manufacture the drug?

Yes, through compulsory licensing (Articles 145–147) — notably the ground of “disease prevention and treatment, public nutrition, or urgent social needs”. Such licenses are non-exclusive, limited in scope and duration, and the owner receives adequate compensation.

Cited legal instruments

Law on Intellectual Property — consolidated text 67/VBHN-VPQH dated 23 March 2026 (Articles 58, 59, 60, 93, 113, 119, 125, 128, 131a, 145, 146, 147, 220);
Law 131/2025/QH15 amending the Law on Intellectual Property — effective 1 April 2026 (adds Article 131a);
Law 93/2025/QH15 — effective 1 October 2025 (on filing rights for state-funded science and technology results).

The provisions above were checked against the original texts as of 14 October 2026. Readers should verify the laws and implementing regulations in force at the time of application.