Introduction
Patent protection for biopharmaceuticals in Vietnam is a complex and nuanced field, influenced by both international agreements and local regulations. This article delves into the key insights regarding patentability, enforceability, and the scope of claims for biopharmaceutical patents in Vietnam.
Patentability Requirements
To be granted a patent in Vietnam, a biopharmaceutical invention must meet three primary criteria:
Novelty
The invention must be new and not have been disclosed to the public before the filing date of the patent application[3][4].
Inventive Step
The invention must involve an inventive step, meaning it must be non-obvious to a person skilled in the art[3][4].
Industrial Applicability
The invention must be capable of industrial application, meaning it can be used in industry or agriculture[3][4].
Types of Claims
In Vietnam, several types of claims are relevant for biopharmaceutical patents:
Markush Claims
These claims are used to describe a group of compounds that have a common structure but differ in specific substituents[5].
Selection Inventions
These involve selecting a specific compound or group of compounds from a larger class of compounds[5].
Polymorphic Forms and Enantiomers
These claims cover different physical forms or optical isomers of a compound[5].
Salts, Ethers, and Esters
These are common derivatives of pharmaceutical compounds that can be patented if they meet the novelty and inventive step criteria[5].
Formulations and Pharmaceutical Compositions
Claims can be made for specific formulations or compositions of drugs[5].
Medical Use Claims
Medical use claims, including first and second medical use claims, have been a subject of controversy in Vietnam.
Historical Perspective
Before the IP Law 2005, medical use claims were not explicitly excluded. However, after the law came into effect, new medical use claims were refused because they did not relate to "products" or "processes"[5].
Current Practice
To overcome this, patent applicants reformatted claims into "purpose/function/utility-related product claims," similar to the European Patent Office (EPO) practice. However, these claims often face delays in the substantive examination stage[5].
Patent Registration Process
The process of registering a biopharmaceutical patent in Vietnam involves several steps:
Filing
Applicants must submit a patent application to the National Office of Intellectual Property (NOIP), including a request for grant, description of the invention, claims, abstract, drawings, and necessary forms or documents[4].
Formal Examination
The NOIP conducts a formal examination to check if the application meets the required formalities. Deficiencies must be rectified within a specified period[4].
Substantive Examination
Once the formal examination is complete, the application undergoes a substantive examination to assess the patentability of the invention, including novelty, inventive step, and industrial applicability[4].
Enforceability of Patents
Enforcing biopharmaceutical patents in Vietnam can be challenging due to several factors:
Lack of Patent Linkage System
Vietnam has not adopted a patent linkage system, which means marketing approval for generic drugs is not delayed until the original drug's patent has expired. This can lead to patent infringement issues[2].
Administrative and Civil Measures
Patentees can use administrative measures, such as raids and seizures, or civil litigation to enforce their patents. Administrative measures are cost-effective and time-efficient but do not provide a means to recover damages[2].
Role of NOIP and Enforcement Bodies
The NOIP does not have the power to rule on patent infringement but can provide expert opinions. Enforcement bodies such as courts, customs, and inspectorates of science and technology are responsible for dealing with patent infringement[2].
Compulsory Licensing
The TRIPS Agreement and its amendments provide for compulsory licensing as a flexible mechanism to balance patent protection with public health needs.
TRIPS Agreement
Member states, including Vietnam, can issue compulsory licenses to allow the manufacture of patented drugs without the consent of the patent owner under certain conditions[1][2].
Amendment to TRIPS
The amendment to TRIPS, effective January 23, 2017, allows member states to export generic drugs produced under compulsory licensing agreements, facilitating access to essential medicines[1][3].
Impact on Drug Prices and Access
Patent protection for biopharmaceuticals can have significant implications for drug prices and public access.
Price Increase
Patent protection can lead to higher drug prices, limiting public access to new inventions in the pharmaceutical field[1].
Flexibility Under TRIPS and Doha Declaration
The TRIPS Agreement and the Doha Declaration provide flexibility to member states to address public health issues, including the use of compulsory licensing to ensure access to generic drugs[1].
Future Outlook
The future of biopharmaceutical patent protection in Vietnam is likely to involve continued evolution in the interpretation and application of IP laws.
Guidance on Medical Use Claims
More guidance is needed on the scope of protection for medical use claims, particularly the difference between Swiss-type claims and EPC 2000 forms[5].
Adaptation to International Standards
Vietnam may adopt more international standards and practices, such as the EPO's approach to medical use claims, to align with global trends in biopharmaceutical patenting[5].
Key Takeaways
- Biopharmaceutical patents in Vietnam must meet criteria of novelty, inventive step, and industrial applicability.
- Medical use claims face specific challenges and require careful formatting.
- The lack of a patent linkage system complicates the enforcement of biopharmaceutical patents.
- Compulsory licensing under TRIPS can help balance patent protection with public health needs.
- Patent protection can impact drug prices and access, necessitating flexible solutions.
FAQs
Q: What are the main criteria for a biopharmaceutical invention to be patented in Vietnam?
A: The invention must be novel, involve an inventive step, and be susceptible to industrial application.
Q: Can medical use claims be patented in Vietnam?
A: Medical use claims are currently not patentable in Vietnam unless reformatted into "purpose/function/utility-related product claims."
Q: How does Vietnam enforce biopharmaceutical patents?
A: Enforcement can be through administrative measures or civil litigation, with administrative measures being more common for quick action.
Q: What is the role of compulsory licensing in Vietnam's patent regime?
A: Compulsory licensing allows the government to permit the manufacture of patented drugs without the patent owner's consent to address public health needs.
Q: How does the lack of a patent linkage system affect biopharmaceutical patents in Vietnam?
A: It means that generic drugs can be approved and marketed before the original drug's patent expires, potentially leading to patent infringement issues.
Cited Sources
- Vietthink.vn: "Patent protections of pharmaceutical composition and drug price issues."
- Tilleke & Gibbins: "The pharma maze: patent enforcement in Vietnam."
- Legalwise Seminars: "Patenting Pharmaceuticals in Southeast Asia."
- iPNOTE Blog: "Patent Registration in Vietnam: Key Considerations."
- Rouse: "Patentability of Medical Use Inventions and Future Outlook."
