Abstract
This research employs a mixed-methods approach, integrating qualitative analysis and
documentary research, to achieve three primary objectives: 1) to analyze the Department of
Intellectual Property’s (DIP) interpretation of opposed patent applications involving
amendments to claims or specifications and the inclusion of "use claims"; 2) to synthesize
third-party opinions and international academic perspectives regarding the addition of "new
matter" (added subject matter) and use claims; and 3) to formulate policy recommendations
for the DIP concerning the regulatory scope of such amendments. The study was conducted
over a 10-month period through: 1) a content analysis of 32 pharmaceutical patent
applications subject to opposition or third-party observations between 2014 and 2024; 2) a
comparative legal analysis of patent laws and examination guidelines across six
jurisdictions—Thailand, Singapore, Japan, India, Brazil, and Argentina; 3) in-depth interviews
with 15 key stakeholders, including representatives from civil society, industry, legal
academia, and the judiciary; and 4) the development of academic recommendations
regarding the determination of added subject matter and use claims.
The findings are as follows:
1. Post-publication amendments were requested for 16 applications (50.0%), all of
which received approval from patent examiners. Amendments were frequently justified by
referencing "patent families". Additionally, 16 out of 32 applications contained use claims in
various forms, including medication use, methods of treatment, compounds/compositions for
treatment, or Swiss-type claims; four of these have already been granted.
2. Comparative analysis reveals that Thailand exhibits the highest degree of flexibility
regarding claim amendments, permitting modifications at any stage prior to the grant,
provided the content was present in the initial specification. In contrast, jurisdictions such as
India and Argentina restrict amendments to narrowing the claim scope or correcting clerical
errors, while Singapore and Brazil limit such requests to the pre-examination stage.
3. Third-party stakeholders identified significant ambiguities in the definition of "
added subject matter" and the examination of medical use claims. They proposed a that
voluntary amendments be restricted to the pre-publication stage. Furthermore, it was
recommended that Section 9(4) of the Patent Act be strictly interpreted, focusing on the
underlying purpose of the claim, with Swiss-type claims permitted only when the
pharmaceutical manufacturing process is explicitly detailed in the specification.
Recommendations: The study suggests amending Ministerial Regulations to permit
independent patent application modifications exclusively prior to publication.
Alternatively, if post-publication amendments are to be allowed, they must be strictly
authorized by the Director-General or high-level executives. Additionally, precise
guidelines for evaluating substantive additions to inventions and use claims must be
defined to align with the intent of Section 9(4) of the Thai Patent Act.
