By Thieu Hai Yen --
For applicants and patent practitioners seeking protection for medical use inventions in Vietnam, recent developments in Vietnamese patent practice would likely be of great interest. This article is intended to provide readers with information concerning these developments.
When the Vietnamese patent system was first established, medical use claims were not permitted. With the advent of the Civil Code 1995, a general ground for excluding medical use inventions from patent protection was provided. The prohibition against medical use inventions was in fact based on the political will of the local government to provide the comparatively poor national population with access to medical treatment and inexpensive drugs. This is why patent protection for medical use inventions, even if for only a limited period of time, was initially not permitted under Vietnamese patent law.
Consequently, claims to inventions relating to methods of treating, preventing, or diagnosing diseases in animals or human beings were rejected in Vietnam. This constituted a significant obstacle for applicants in this field, most of which are large pharmaceutical corporations.
As the Vietnamese patent system developed, medical inventions patent practitioners and applicants began to search for other claim formats with which to secure a certain scope for these inventions. Following much debate on this controversial topic, the Vietnamese National Office of Intellectual Property (NOIP) decided to follow the practice of the European Patent Office (EPO) in allowing second medical use claims, also known as "Swiss-style" claims (i.e., "Use of a compound in the manufacture of medicaments for treating certain diseases").
Strictly speaking, neither use claims nor second medical use claims constituted a statutory class of invention under Vietnamese patent law at the time, and therefore, in contrast with EPO case law, there was no ground for allowing such claims under Vietnamese patent law. Instead, 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 Vietnamese National Office of Industrial Property (which was subsequently replaced by the NOIP). These provisions, though mainly addressing the issues of unity, allowed for a possible grouping of inventions in one patent application, wherein compounds, processes, and uses of known compounds for a different purpose were named.
Over the years, the controversy over medical use inventions continued, 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). In this way, numerous patents containing such claims were granted under the Civil Code 1995.
However, within one year of implementation of the new Intellectual Property Code of Vietnam ("the IP Code"), which was promulgated by the Vietnamese National Assembly in 2005, and which went into effect on July 1, 2006, the Vietnamese NOIP once again started to reject claims directed to use inventions, including second medical use inventions. The grounds for these new rejections can be found in the IP Code's definition of an invention, 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, containing detailed guidance for implementation of the IP Code, provides 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 in the patent prosecution process as the stage of examination as to form.
Certainly, the way the Vietnamese NOIP is treating use inventions has triggered a bitter debate regarding the meaning of a "technical solution," as well as to the pros-and-cons of rejecting such claims. In this regard, it has been observed that the above quoted provisions of the new patent law in Vietnam, which are now applied for the rejection of use claims and medical use claims, have been construed by the NOIP in a manner that is too strict, thereby unduly hurting the interests of many patent applicants. Furthermore, such a hasty and rigid construction of these legal provisions could well lead to undue implementation of the law as well as an incorrect application of the Vietnamese National Assembly's intent. This is especially true considering that Vietnam has just joined the World Trade Organization (WTO), and that the legal system should facilitate, not thwart, investment into Vietnam. Moreover, despite the fact that the Vietnamese law belongs to the civil system, the totality of the precedents in rejecting and allowing medical use claims should not be ignored.
Thieu Hai Yen is a patent attorney with the intellectual property law firm TRUNG THUC JSC. in Hanoi, Vietnam.
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