Patentability of new medical uses in Vietnam
14 November 2018
By LE Hoai Duong, B.Sc., LL.B, MIP (Franklin Pierce)
The Law on Intellectual Property of Vietnam (LIP) includes provisions against patenting of medical methods carried out on the human or animal body (Art.59.7 LIP). Therefore, a claim in the format "use of substance or composition X for the treatment of disease Y" which is considered as relating to a method for treatment is not acceptable under Art.59.7 LIP.
Like the European Patent Convention (EPC), the LIP provides that product claims can only be accepted for absolute novel products. However, unlike the EPC, the LIP does not provide for exceptions to the absolute novelty concept. Therefore, product claims, having, for example, the formats "substance/composition X for use as a medicament" (X has only been used before in non-medical methods), or "substance/composition X for use in treating disease Y" (X has been used previously in medicine) will be excluded from patentability because they do not meet the novelty requirement under Art.60.1 LIP.
Art.4.12 LIP establishes the two (02) categories of patentable subject matter, that is, product and process. However, it leaves open the question of, and therefore caused a debate about, whether "process" covers "use" – specifically, whether a process patent is available for a new use of substance/composition for a particular purpose. In practice, the Intellectual Property Office of Vietnam (IP Vietnam) refused a number of new medical use claims – notably Swiss-type claim – under Art.4.12 LIP, arguing that they related neither to "product" nor "process". This opinion of the IP Vietnam sharpened the debate.
Additionally, though a "method for the treatment of human or animals" is not patentable in Vietnam, there was another long issue of whether new medical uses of substances/compositions in particular claim formats were patentable.
To address these issues, Rule 25.5.d (i) of the Circular 01/2007/TT-BKHCN has recently been issued to include a new provision of essential features of a patent claim. Under this provision, essential features of a claim, which define "the essence of the matter for which protection is sought", are not "function, intended use of the matter". Accordingly, a claim on the new medical use of a product, even drafted in the purpose–related product format, for example, "product according to claim 1 for use in the treatment of disease Y" (regardless of whether or not the product claimed in claim 1 is new), will be refused unquestionably.
Briefly, patentability of a new medical use, regardless of its claim format, can be refused by the IP Vietnam based on various grounds, including exclusion of claim formats from the statutory categories of patentable subject matter, or exclusion of methods for treatment from patentability, or lack of the novelty, or lack of essential technical features required for defining the essence of the claimed subject-matter.
Given Vietnam patent law remains ambiguous and the IP Vietnam’s practice is fragile, we recommend that you ask us for advice before preparing claims to a medical invention for filing at the IP Vietnam.
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