Following on from our previous article on new/further medical use invention (http://iphouse.vn/best-practice-guide-for-filing-a-patent-application-in-vietnam-part-i-new-medical-use-inventions-2/), this piece serves to specifically address the issue of “use” claim format, one of the most common, typical formats of claims in PCT applications.
On 15 January 2018, the long-awaited Circular No. 16/2016/TT-BKHCN, revising Circular No. 01/2017/TT-BKHCN, one of the key regulations in the Vietnam IP system, took effect with extensive changes, including supplementation with respect to essential features of technical solution, to which it has alleged that function or purpose of a claimed subject matter is not regarded as essential technical feature. That is to say, the supplementation implies “use” claim are NOT patent-eligible in Vietnam, basically on the ground that it was not patentable subject-matter as such. This is an unfavourable point for applicants, especially for the ones owning inventions in the pharmaceutical field.
1. Format of “use” claims
Typical “use” claims are in format such as:
“1. Use of subtance X […].”
1. Use of a 2,3-dihydroimidazol[1,2,c]quinazoline compound of general formula (I) for the preparation of a medicament for the treatment or prophylaxis of breast cancer:
(claims of PCT application number: PCT/EP2012/005595).
In accordance with the PCT International Search and Preliminary Examination Guidelines (PCT/GL/ISPE/10), in some International Searching and Preliminary Examining Authorities, for purposes of international search and examination, a “use” claim of the above-mentioned form such as “Use of substance X as an insecticide” should be regarded as equivalent to a (misguided) “process” claim of the form “a process of killing insects using substance X.”
However, it should be noted that in certain designated/elected States of the PCT treaty, US for instance, “use” claims are considered by the United States Patent and Trademark Office (USPTO) to be improper process claims which lack clarity and constitute excluded subject matter on the ground that the claim above provides for the use of substance X, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass (i.e, attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112, second paragraph).
2. Legal basis in Vietnam
- Law No. 50/2005/QH11 of November 29, 2005, on Intellectual Property
- Circular No. 01/2007/TT-BKHCN of February 14, 2007 guiding the implementation of The Governments Decree No. 103/2006/ ND-CP of September 22, 2006, revised by Circular No. 16/2016/TT-BKHCN of 15 January 2018 (Circular)
3. Practice in Vietnam
3.1. “Use” claims as such used to be patentable subject-matter until the 2006 amendment of Law. At present, “use” claims as such are NOT permitted.
“Use” claim is NOT allowed based on the following:
- “Invention is a technical solution, in form of a product or a process, to resolve a specific problem by utilizing laws of nature.” (Article 4, Item 12, the Law on Intellectual Property)
- “The object stated in an invention registration application shall be considered incompatible with the type of invention protection title applied for by the applicant (invention patent/utility solution patent) if it is not a technical solution, particularlynot a product or a process […]” (Article 25.3a, the Circular)
3.2. In the light of the above, the claim format “Use of […]” as such shall not pass formality check and be rejected by the IP VIETNAM (on the ground of “Use of […]”as such is not a technical solution, in particular failing to be either a product or a process which is patent-eligible.
An amendment is thus required.
To overcome the refusal, “Use of a compound” for example can be normally amended/rephrased to “A compound for use” to just pass the formality check. Such invention will however be refused by IPVIETNAM on the ground of lack of patentability in principle.
3.3. Interpretation of the claim format
In practice, as indicated above, a claim of the form “Use of a compound“ as such shall not pass formality check and be rejected by the IP VIETNAM. One of the common proposed amendments is to rephrase “Use of a compound“ to “A compound for use” in an attempt to over come the formality rejection.
The claim format of “A compound for use“ shall normally be interpreted as directed to the compound per sei which is in fact suitable for the stated use (Article 25.5d(ii) of the Circular*, Article 184.108.40.206(2) of the Examination Guidelines for Patent and Utility Model in Vietnam, and point 5.21 of PCT/GL/ISPE/10). Furthermore, a known compound same as defined in the claim, though it has never been described for that use, would deprive the claim of novelty.
In the view of foregoing, IP VIETNAM alleges in the Office Action that novelty of a substance relates to structural and/or compositional features (e.g., the structure of the compound and/or the composition of the compound) but not functional features (new/futher use (the stated use) of the compound). Furthermore, the stated use of the compound does not imply any changes to the structure and/or composition of the claimed compound. Accordingly, the stated use, which is considered to be a functional feature, would not render the substance as novel. In orther words, the novelty of a substance requires structural and/or compositional features in principle under the current practice in Vietnam.
(*) While the legislation might be previously considered to be not really clear in this regard, the Circular No. 16/2016/TT-BKHCN, revising the Circular No. 01/2017/TT-BKHCN, has however supplemented the regulations and the definition with respect to “essential technical features” in details: “essential technical features are structural features (parts, linkage etc.) or substance structure (composition, presence, element states, etc.) with other essential features to constitute a necessary and sufficient set to determine the claimed the subject-matter”.
In short, “use” claims as such is currently regarded NOT patent-eligible in Vietnam.
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