Use claims & Pharmaceutical Patents in Vietnam

This memorandum is prepared for foreign counsel and in-house legal teams seeking a practical understanding of how use claims and pharmaceutical patents are treated under Vietnamese IP law in practice.

1. Executive Summary

Use claims are formally recognized in many jurisdictions as a legitimate form of patent protection, particularly in the pharmaceutical sector. However, in Vietnam, the practical enforceability of use claims diverges significantly from their theoretical validity under statutory law.

Foreign companies relying on use claims without adjusting for Vietnamese examination, enforcement, and judicial practice face material legal and commercial risks.

This memo explains where those risks arise and how they should be managed.

2. Use claims under international patent practice

In EU and US practice, use claims are commonly employed to:
- protect second medical uses
- extend patent life through new indications
- support lifecycle management strategies

Courts and patent offices in these jurisdictions generally accept use claims
as long as novelty and inventive step are satisfied.

3. Statutory position in Vietnam (Law on paper)

Vietnamese IP Law does not explicitly prohibit use claims. Article 4.12 of Vietnam IP Law defines invention as a technical solution in the form of  ”product” or “process”, and therefore does not exclude “use-type claims”, which would be classified as relating to either a product or a process, from protection.
In theory, claims drafted in the form of “Composition for use” or “Method for use” may be accepted during process examination as to formality but will certainly be rejected during the examination as to substance.

Thus, statutory silence should not be interpreted as substantive acceptance.

4. Practice before the IP Office and Courts (Law in practice)

In examination practice, Vietnam IP Office tend to:
- treat use claims as disguised method claims
- require technical features beyond mere use or indication
- apply a high threshold for inventive step

In enforcement and litigation, use claims face additional barriers:
- difficulty proving infringing “use”
- reluctance of courts to rely on abstract claim scope
- preference for product- or process-based protection

As a result, successful enforcement of pure use claims in Vietnam is extremely rare.

5. Key risk areas for foreign pharma companies

(i) Illusory protection risk:
   In the future, even if any kind of use claims may be granted, such improvement will provide little to no enforceable value.

(ii) Regulatory disconnect:
   Drug registration data is not automatically linked to patent enforcement.

(iii) Evidence burden:
   Proving infringing use is practically unworkable in most scenarios.

(iv) Strategic misalignment:
   Global lifecycle strategies may not translate into Vietnam.

6. Strategic implications and Recommendations

Foreign companies should:
- avoid relying solely on use claims for Vietnam
- prioritize compound, formulation, or process claims where possible
- integrate regulatory strategy with IP strategy
- reassess enforcement expectations early

Even if in the future use claims will be acceptable in Vietnam, they should be viewed as supplementary at best, not as a core pillar of patent protection.

7. Closing observation

Vietnam is not hostile to pharmaceutical patents, but it applies a distinctly pragmatic and substance-focused approach. Understanding this distinction is essential for effective risk management.

Note: Pham & Associates provides this memo as a strategic analysis, not as legal advertising or solicitation.