New developments in patent protection for medical uses in Vietnam
It would be of high interest for worldwide patent practitioners and patent right owners that medical uses have recently been subject to rejection for patent protection in Vietnam. This writing is intended to provide readers with brief information concerning this development.

At the very begining of the establishment of the patent system in Vietnam, medical uses were not allowed. The advent of the Civil Code 1995 provided a general ground for the exclusion of medical inventions from patent protection. In fact, this was based on a political will of the local goverment to not prevent the comparatively poor national population from access to medical treatment and cheap drugs. That was why patent protection, which was regularly considered as a kind of monopoly, for medical inventions was not allowed even for a limited period of time.


Consequently, inventions relating to medical methods for treatment, prevention and/or diagnosis of diseases in animal and/or human beings were all rejected. This constituted a significant obstacle for patent right owners in this field, who were mostly large pharmaceutical corporations.


With the development of the Vietnamese patent system, the medical inventions continued to be excluded from protection while patent practitioners and patent right owners were struggling to search for other formats to secure a certain scope for these inventions. As a result of many debates on this controversial topic, the Vietnamese NOIP decided to follow the practice of the EPO in allowing second medical use inventions, which were also termed “Swiss-style claims”. Strictly speaking, use claims did not constitute a statutory class of claims under the then Vietnamese patent law nor the very ground supporting second medical use inventions (Use of [known] compound in manufacture of medicaments for treating certain diseases) was found in the then prevailing law like those under EPO case law. Rather, the ground for such protection was based on a provision under the PCT Guideline for Examination and a provision under Ordinance 308/DK issued by the then Vietnamese National Office of Industrial Property (now the Vietnamese National Office of Intellectual Property). These very provisions, though mainly addressing the issues of unity, provided for a list of possible grouping of inventions in one patent application, wherein compounds, processes, and uses of known compounds/processes for a different purpose were named.


Over the years, the issue remained controversial, but the established practice of pharmaceutical patent prosecution in Vietnam was to amend patent claims relating to medical methods into second medical use format (Swiss-style claims), and in this way a certain number of patents with such claims were granted under the Civil Code 1995.


However, after one year of implementing the new intellectual property law, namely the Intellectual Property Code of Vietnam (hereafter the IP Code), which was promulgated by the Vietnamese National Assembly in 2005 and came into effect on July 1, 2006, the Vietnamese NOIP has just started once again to reject all kinds of use inventions, among which are second medical use inventions. The ground for such rejection was found in the definition for an invention under the IP Code which states that an “Invention is a technical solution, in the form of a product or a process, to resolve a specific problem by utilizing the laws of nature” (Article 4.12). Also, the new Circular 01-2007/TT-BKHCN of the Ministry of Science and Technology, providing detailed guidance for implementation of the IP Code, provided that “a subject-matter of a patent application should be regarded as incompatible with the title of protection applied for [invention] if this subject-matter is not a technical solution, in particular failing to be either a product or a process” (Article 25.3). Consequently, all patent applications with claims relating to medical uses in particular or to uses in general are now subject to rejection as early as during the stage of examination as to form.


In a recent seminar on protection of pharmaceutical related inventions, held by the Vietnamese NOIP and Swiss-Vietnam Intellectual Property Project in Hanoi, some opinions of representative legal advisor authorities had been gartherred. Much to the disappointment of many patent practitioners, the authorities regarded the substance of the second use inventions is method of treament of dieases in animal/human beings, and granting patent protection for such kind of these inventions could undue prolong patent protection of the related compound, and hence deprives the national population from the access to the necessary drugs. Thus, the policy of the authority is to outrightly reject patent protection for medical uses in particular and uses in general. As disclosed above, the NOIP has been implementing such a policy by relying on the definition of the patentable inventions under the IP Code, and hence rejecting medical uses in particular and/or uses in general for their failure to be either product or process.


Certainly, the way the Vietnamese NOIP is treating the use inventions has triggered a bitter debate on the exhaustive meaning of a “technical solution” as well as on the reasoning pros-and-cons. In this relation, it has been observered that the above quoted provisions of the new patent law in Vietnam, which are now applied for rejecting use claims in general and medical use claims in particular, have been construed by the authority in manner that is too strict and would unduly hurt the interest of the patent applicants. Furthermore, such a hasty and rigid construing of legal provisions could well lead to undue implementations of the law as well as incorrect interpretations of the policy of legislators, especially considering Vietnam has just joined the WTO and the legal system is intended to facilitate investment into the country. Moreover, despite the fact that the Vietnamese law belongs to the civil system, the entirety of so hard precedences in rejecting and allowing medical use claims should not be ignored.


Further developments concerning this interesting matter will be promptly reported.

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