The Law on Intellectual Property of Vietnam (the “IP Law”), which took effect on 1 July 2006, has introduced a new regulation on inventions. According to Circular No. 01/2007/TT-BKHCN guiding the IP Law, a subject matter is considered unsuitable for patent protection if it is not a technical solution, specifically not a product or process/method. A subject matter in the application is not considered a technical solution if: (i) it is only an idea, only raises but does not solve a problem, cannot answer the question “how”/”by which means”; (ii) the problem posed for resolution is not a technical problem and cannot be solved in a technical manner; (iii) natural products, which are not creations by human being.
What’s the Difference?
Under the above regulation, the difference of the IP Law from the previous legal provisions on intellectual property can be seen. Previously, the subject matters that are likely to be protected as inventions include products, processes/methods and use or new indications (claims referring to “use” are also known as Swiss-style claims) – and the previous regulations allowed applicants to have their new discoveries protected with respect to the new use of a known substance, active substance, compound etc. However, the IP Law has limited the scope of the subject matters protected as inventions, whereby a patentable subject matter can only be a product or a process. Thus, it can be understood that the subject matter “use” has been removed from the list of the patentable subject matters.
“Use” from Swiss Style Claims
Method-of-treatment claims are not acceptable. However, in Japan, EPO and even Vietnam formerly, a second medical use claim can be claimed in a variety of claim formats as shown below:
(1) A pharmaceutical composition for the treatment of Disease X, comprising Compound Y;
(2) An anti-disease X agent comprising Compound Y;
(3) Use of Compound Y to treat Disease X;
(4) Use of Compound Y in the manufacture of a medicament for the treatment of Disease X (Swiss type claim).
As said above, Swiss-type claims are permissible in Japan. However, Swiss type claims actually are not necessary in Japan since the other claim formats, such as composition claims, can sufficiently cover the second medical use invention. Meanwhile, EPO generally accepts second medical use claims in the format ‘Compound X for use in the treatment of disease Y’. The so-called “Swiss-stype” claims of the format ‘Use of compound X for the manufacture of a medicament for therapeutic application Z’, which were previously accepted by EPO, are no longer acceptable.
Pros and Cons
It can be understood that the removal of the “use” subject matter from the list of patentable subject matters is to protect the interests of people, avoid any monopoly, and allow people to use new advances and findings to serve their benefits.
However, since the effective date of the IP Law, the new regulation on “use” claims has revealed its disadvantages.
As you may know, the protection of inventions is intended to create a driving force for research and exploration activities, encouraging foreign investors to transfer technology from modern countries to less developed countries, stimulating economic, technological development and competition promotion through the impact on the financial dynamics of creative activities. The removal of the “use” subject matter from the list of patentable ones has somewhat made the society lose the opportunity to know the new uses of a certain product or active ingredient to reduce research activities on the new effect of a known active ingredient, compound or product. Scientific experiments show that to find a new use or else a new designation of a product or a substance, it requires research, exploration, and also consumes mind, physical resources and investment costs in the same efforts as to invent a “product” or a “process/method”.
Moreover, this new regulation on “use” claims also affects inventors. Patent protection is intended to give the inventor enough time to recoup profits to compensate for his intellectual and physical investments. In addition, it is to balance the interests of inventors and society. The discovery of a new use of a certain product or active ingredient also requires inventors to invest time, effort and money. Therefore, when the “use” subject matter is removed, it can cause the loss of this balance, so in the long term it may affect scientific development, limit access to new knowledge and possibly affect national economic development.
Provisional Solutions
Since the “use” claims are no longer acceptable, applicants tend to “transform” the “use” subject matter into another subject matter, such as a product or process/method, which is, in fact, implicitly refers to the “use” subject matter. Such transformation may sometimes embarrass examiners in that examiners cannot rely entirely on the substantive examination of similar/counterpart applications filed abroad to accept Vietnamese applications. Therefore, examiners tend to request applicants to remove the transformed claims, or reject such amendments, based on the reasoning that those claims contain only the features of function/use of the claimed subject matters, and these features are not basic technical features.