Patent Registration for Pharmaceutical in Vietnam

A pharmaceutical patent is not only a scientific discovery, but also the foundation for creating competitive advantage, commercial value, and brand reputation in the market. Therefore, registering a pharmaceutical patent is a necessary procedure for businesses, research institutes, and scientists to ensure intellectual property rights, prevent copying, and open up opportunities for cooperation and technology transfer. Below, Viet An Law will advise on patent registration for pharmaceutical in Vietnam according to current regulations.

Objects of patent pharmaceutical products

A patent is a technical solution in the form of a product or process that solves a specific problem by applying natural laws. Patents are protected in the form of a Patent or a Utility patent.

Objects of pharmaceutical products that can be patented include:

• New active ingredient formula;
• Drug preparation process;
• Dosage form (tablet, solution, infusion,…);
• Application of active ingredients in the treatment of specific diseases.

Note:

• A patent is protected by the granting of a Patent for Patent if it meets the following conditions: It is new; It has an inventive step; It is capable of industrial application.
• A patent is protected by the granting of a Utility Solution Patent if it is not common knowledge and meets the following conditions: It is new; It is capable of industrial application.
• The following objects are not protected under the name of patents such as: Patents, scientific theories, mathematical methods; Diagrams, plans, rules and methods for performing mental activities, training animals; Processes for producing plants and animals that are mainly biological in nature and not microbiological processes; Methods for preventing, diagnosing and treating diseases for humans and animals;…

Benefits of patent Registration for pharmaceutical in Vietnam

When registering a pharmaceutical patent, the owner will be granted a Patent of Patent or a Utility Solution Patent. Being granted this protection certificate has many meanings, specifically:

• Business monopoly: Prevent competitors from producing and selling similar products.
• Increase business value: Patents are important intellectual property, enhancing brand value and cooperation potential.
• Attract investment: Enterprises owning patents can easily call for capital and sign technology transfer contracts.
• Affirm reputation in the market: Recognized for research and development capacity in the pharmaceutical industry.

Classification of pharmaceutical patents according to the International Patent Classification (IPC)

According to the provisions of Appendix I – Part II of Decree No. 65/2023/ND-CP, in the section “International Patent Classification” in the application, the applicant must state the classification index of the technical solution to be protected according to the IPC Classification version 2025.01 (full classification, including part, class, subclass, group (main group or subgroup)). If the applicant does not classify or classifies incorrectly, the National Office of Intellectual Property will classify, and the applicant must pay the classification fee as prescribed.

On December 26, 2024, the National Office of Intellectual Property issued Notice No. 4031/TB-SHTT on the unification of the application of the International Patent Classification (according to the Strasbourg Agreement) version 2025.01 from January 1, 2025.

In the IPC (International Patent Classification) system, pharmaceutical patents are often classified into group A61K. Specifically: Group A61K – pharmaceuticals used for treatment, dental use or cosmetic purposes (devices or methods for creating special drug forms A61J3/00 chemical aspects or using ingredients to deodorize the air, disinfect or sterilize for making bandages, bandages, absorbent pads or surgical supplies A61L; room C11D).

Pharmaceutical product patent registration process in Vietnam

Step 1: Search for a protection possibility

The search is to check and evaluate the possibility of registration of the patent to be registered. To do a preliminary search for the protection possibility of the patent, customers can conduct a free search through one of the following two electronic data portals:

• Google patent: Global patent database built by Google. Customers can access it at the following address: https://patents.google.com/
• IP Vietnam: Vietnam patent database built by the Vietnam National Office of Intellectual Property.

However, searching on the above databases is very complicated and time-consuming, and is even somewhat outdated compared to reality. Customers can send patent documents to Viet An Law Firm for in-depth searching before submitting an application for patent protection.

Step 2: Prepare patent registration dossier

Pursuant to Articles 100, 101, 102 of the Intellectual Property Law, Part III of Appendix I issued with Decree 65/2023/ND-CP and Clauses 2 and 3, Article 14 of Circular 23/2023/TT-BKHCN, the patent registration dossier includes:

• Patent registration declaration (Form No. 01) in Appendix I issued with Decree 65/2023/ND-CP;
• Patent description and patent claim (01 copy, including drawings, if any);
• Patent summary (01 copy);
• Documents proving the right to register if the applicant enjoys the right to register of another person;
• Documents proving the right to priority, if priority is claimed (copy of the first application) certified by the receiving authority, except for patent applications filed under the PCT Treaty);
• Documents explaining the origin of the genetic resources or traditional knowledge about genetic resources in the patent application, for patents directly created based on genetic resources or traditional knowledge about genetic resources;
• Power of attorney for individuals or Power of attorney for organizations (if applying for a representative);
• Copy of fee and charge payment documents (in case of paying state fees, via postal service or directly into the account of the National Office of Intellectual Property).

Step 3: Applying to the National Office of Intellectual Property

The applicant submits 01 set of patent registration documents to the National Office of Intellectual Property in one of the following ways based on Article 8 of Circular 23/2023/TT-BKHCN:

• Online via the Administrative Procedures Information System of the Ministry of Science and Technology;
• Directly or via postal service to the headquarters of the National Office of Intellectual Property in Hanoi or the 2 representative offices of the Office in Ho Chi Minh City and Da Nang;

In particular, the application for registration of confidential patents must be submitted in paper form to the National Office of Intellectual Property in Hanoi or the 2 representative offices of the Office in Ho Chi Minh City and Da Nang.

Step 4: The National Office of Intellectual Property reviews and processes the application

Form examination

• 01 month from the date of applying to case the application is valid.
• 01 month and 10 days in case the applicant proactively amends or supplements the application before the National Office of Intellectual Property issues a notice of formal examination of the application.
• 03 months and 10 days in case the application is invalid and the applicant has comments or corrects deficiencies within the prescribed time limit.
• 03 months and 20 days in case the applicant proactively amends or supplements the application before the National Office of Intellectual Property issues a notice of formal examination of the application but the application is still invalid and the applicant has comments or corrects deficiencies within the prescribed time limit.

Publication of the application

Within the 19th month from the priority date for the application enjoying priority rights or the filing date, if the application has no priority date, or within 02 months from the date the National Office of Intellectual Property receives the request for early publication or from the date of acceptance of the valid application, whichever is later.

Substantive examination

• 18 months from the date of publication of the application if the request for substantive examination is submitted before the date of publication of the application or from the date of receipt of the request for substantive examination if the request is submitted after the date of publication of the application in case the application is valid.
• 24 months from the date of publication of the application in case the applicant actively amends or supplements the application before the National Office of Intellectual Property issues a notice of substantive examination of the application.
• 21 months and 15 days from the date of publication of the application in case the application does not meet the protection conditions/is deficient and the applicant has comments or corrects the deficiencies within the prescribed time limit.
• 27 months and 15 days from the date of publication of the application in case the applicant actively amends or supplements the application before the National Office of Intellectual Property issues a notice of substantive examination of the application and the application does not meet the protection conditions/deficiencies and the applicant has comments or corrects the deficiencies within the prescribed time limit. In case the application has an objection, the time limit for the applicant to respond to the objection and the time limit for the objector to respond to the applicant’s comments are not included in the time limit for the National Office of Intellectual Property to carry out related procedures as prescribed.

Granting a patent

If the patent meets the requirements, the National Office of Intellectual Property will grant a patent to the applicant. Pursuant to Article 15 and Article 16 of Circular 23/2023/TT-BKHCN:

• Granting a protection certificate: within 15 days from the date the applicant fully and timely pays the state fees.
• Announcing the decision to grant a protection certificate (except for confidential patent protection certificates) in the Industrial Property Gazette: 60 days from the date of the decision.

Information about a Pharmaceutical Patent

Title: Pharmaceutical Delivery System and Method

Inventor: HO SEE CHEK: 80 Flora Road, #08-06 Edelweiss Park Condominium, Singapore 506999

Application Number and Filing Date: VN 1-2024-08053; 24.10.2024

Publication Number and Publication Date: VN 114602; 25.08.2025

Abstract: The present patent relates to a system and method for distributing pharmaceutical products, the method comprising establishing a remote electronic connection between a vending machine in which the pharmaceutical products are stored and a data processing device of a licensee, the remote electronic connection being configured such that a customer at the vending machine can communicate with the licensee via the vending machine interface. A remote electronic connection is established between the vending machine and the financial institution’s data processing equipment to create a payment gateway so that customers can make payments to pre-determined recipients through the interface. This method includes the step of distributing one or more pharmaceuticals to customers using the vending machine, after payment.

The above is advice on patent registration for pharmaceutical in Vietnam. If clients have related questions or need advice on patent registration procedures, please contact Viet An Law for the best advice and support!