The following forms the salient legal basis governing the concept of "second medical use patents" in Vietnam: 

  • Article 27 of the Agreement on Trade-Related Aspects of Intellectual Property Rights ("TRIPS");
  • Point 25 of Circular No. 01/2007/TT-BKHCN of February 14, 2007, amended by Circular No. 16/2016/TT-BKHCN of June 30, 2016;
  • Article 18.37.2 of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership; and
  • Resolution on Question Q238 regarding second medical use and other second indication claims (Toronto Resolution) of the International Association for the Protection of Industrial Property (AIPPI) (September 17, 2014).

Second Medical Use Patents are not patented in Vietnam

Claims in the form of "new/known compound X or pharmaceutical composition containing the compound X is used for treating disease A" are currently not accepted by the Vietnam IP Office. The Vietnam IP Office's basis for such refusal is found in Paragraphs 23.6.d and 25.5.d.(i) of Circular 01/2007/TT-BKHCN. 

According to Paragraph 23.6.d, a claim must include essential technical features that are necessary and sufficient to identify the claimed subject matter, to achieve the set objective, and to distinguish the claimed subject matter from known subject matters. Whereas, Paragraph 25.5.d.(i) (as amended by Point 23.g of Circular 16/2016/TT-BKHCN) provides that essential technical features (essential features of a technical solution) can be the object structure or substance composition, and that the function or utility of a subject applied for protection is, by itself, not an essential feature, but may rather be the purpose or the obtained result of that subject matter. Therefore, the technical feature “used for treating disease A” is not one of the essential technical features of the compound/composition.

This reasoning was applied in the case of International Application PCT/JP2006/318675 for the invention “Pharmaceutical compositions comprising probucol and derivatives useful in suppressing superoxide” (Vietnamese Patent Application No. 1-2008-00901). The Vietnam IP Office, on 26 March 2014, ruled that the claims did not meet the novelty and inventiveness criteria and eventually refused the patent application. Following such a refusal, the applicant, which is a Japanese pharmaceutical company, filed an appeal against the decision on 23 June 2014 which was then dismissed by the IP Office in its Decision No. 5698/QD-SHTT dated November 21, 2019. 

While the Toronto Resolution of the International Association for the Protection of Industrial Property (AIPPI) affirmed that “as a matter of principle clearly reflected in the TRIPS Agreement, patents should be granted without discrimination for any inventions in all fields of technology, including inventions relating to second medical uses.”, Article 27 of the TRIPS Agreement on patentable subject-matters doesn't have any specific provision on this issue. 

Patents available for new uses of a known product are also prescribed in Article 18.37.2 of the CPTPP of which Vietnam is a country member:

“[E]ach Party confirms that patents are available for inventions claimed as at least one of the following: new uses of a known product, new methods of using a known product, or new processes of using a known product. A Party may limit those new processes to those that do not claim the use of the product as such.”

However, as noted in Annex II of the agreement, this provision has been suspended[4]. Thus, Vietnam has not acted in contravention of its treaty obligations. 

It is also worth noting that the new draft IP law under discussion at the National Assembly doesn't modify the provisions concerning second-use patents.

(Prepared with the contribution of Nguyen Lan Nghia and Le Viet Hung)