The Intellectual Property Office of Vietnam (IP Office), with support from the Japan International Cooperation Agency (JICA), is drafting additional annexes to its Guidelines for Patent Examination, focusing on the examination of patent applications in the pharmaceutical and biotechnology sectors. The new annexes are expected to be officially issued in early 2026 as Annexes III and IV, following the successful issuance in 2023 of Annexes I and II addressing computer program-related inventions.

The IP Office recently organized a seminar to gather feedback on the draft annexes from intellectual property representatives, academic institutions, research institutes, and other interested parties, emphasizing its intention to receive further constructive opinions to refine the guidelines for pharmaceuticals and biotechnology.

Why These Guidelines Matter

Patent examination in Vietnam has traditionally relied on the Guidelines for Patent Examination issued under Decision No. 487/QD-SHTT (2010), recently supplemented by Annexes I and II. While these documents provide a solid foundation, they do not fully address practical challenges in examining pharmaceutical and biotech inventions, particularly issues related to clarity, sufficiency of disclosure, enablement, features of function and utility, combination therapies, and inventions involving artificial intelligence (AI) applications in these fields.

Annexes III and IV aim to close these gaps by introducing structured principles and illustrative examples.

Guidance on Patent Specification Requirements

Annex III provides detailed guidance on the requirements for patent specifications in pharmaceuticals and biotechnology, covering two main parts:

• Part A addresses sufficiency of disclosure, clarity of specifications, and consistency between claims and descriptions.
• Part B covers inventions related to Markush-type compounds, claims containing exclusion statements (disclaimers), and additional experimental data submitted during examination.

The Guidelines outline specific disclosure requirements for subject matters such as compounds, formulations, pharmaceutical compositions, genes, polypeptides, proteins, vectors, transgenic organisms, modified organisms, and hybrid cells.

Annex III emphasizes that disclaimers are not accepted if they introduce new technical features, alter the nature of the subject matter, or extend beyond the original disclosure.

Regarding supplementary experimental data, the specification must still meet the requirements of sufficiency of disclosure, clarity, and enablement. Such data should only serve to clarify or demonstrate the technical effects already described in the original specification, particularly when proving an inventive step against prior art.

The inclusion of disclaimers and supplementary data in Annex III—previously absent from general guidelines—will facilitate both applicants and examiners in drafting and processing applications. Numerous examples are also provided to illustrate assessment in specific scenarios.

Novelty and Inventive Step

Annex IV addresses two critical aspects of patentability:

• Novelty: Principles for assessing inventions with functional, utility, or purpose-related features, combination inventions, and biotech inventions regarding proteins, antibodies, and genetically modified organisms.
• Inventive step: Principles for selection inventions, combination inventions, biotech inventions, genetically modified organism inventions, and inventions involving AI applications in biotech, medicine and pharmacy fields.

Overall, the principles for evaluating novelty and inventive step in Annex IV remain consistent with the general standards of patent examination and, for the most part, have already been reflected in the current Guidelines. Annex IV also provides numerous examples illustrating the principles.

Some notable points mentioned in Annex IV are as follows:

• Functional, utility, or purpose-related features are disregarded in the examination of novelty unless they imply changes to the structure of the claimed subject matter.
• When assessing novelty, the disclosure of inherent properties of a combination or its components is also considered, even if these properties are not explicitly stated in the prior art at the time of publication.
• Applying AI technologies or AI-based systems to methods in biotechnology, medicine, and pharmaceuticals for data analysis or management, without changing the nature of the methods, does not produce an effect beyond what would be expected based on the state of the art at the filing date.
• The assessment of an inventive step for a product or process involving steps performed by AI requires analyzing the correlation between input and output data of the claimed subject matter compared to the prior art. The evaluation of products created or predicted with AI assistance is carried out in the same way as for conventional products created by humans.

Conclusion

Annexes III and IV mark a major step toward a more transparent and predictable patent examination framework in Vietnam. Their primary objectives are to strengthen and improve management methods in examination activities, establish clear guidance for assessing inventions in pharmaceuticals and biotechnology, and enhance both the quality and consistency of patent examination in these fields. By addressing disclosure standards and clarifying novelty and inventive-step assessments, these annexes aim to ensure rigorous and uniform practices.

Nevertheless, stakeholders should note that certain issues remain unresolved, such as double patenting and multi-subject matters. These points are likely to be supplemented in subsequent versions of the Guidelines, ensuring that the framework remains practical, comprehensive, and adaptable to future needs.