The Indonesian Patent Office recently issued new patent examination guidelines which provide long awaited clarification regarding medical use claims.
Article 4(f) of amended Indonesian Patent Law (Indonesian Patent Law No. 14/2016) excludes from patentability A) a new use of a known product and/or B) a new form of a known product that does not offer significant increase in efficiency of that product. While Article 4(f) appears to only disallow medical use claims of known compounds, medical use claims directed to novel compounds were often also rejected. Further, there was inconsistency between examiners with respect to the format for medical use claims.
The new examination guidelines state that medical use claims directed to novel compounds (first medical use) should be written in Swiss-type format, purpose limited product claim (EPC2000) format or in the form “Use of compound X for treating disease Y”.
Further, in contradiction with Article 4(f), the guidelines clearly indicate that medical use claims directed to known compounds (second/subsequent medical use) are allowable provided they are written in purpose limited product claim (EPC2000) format. Based on the guidelines, such claims are deemed to be directed to the product per se where the new use (disease to be treated) is a limiting or differentiating feature on which the novelty assessment will be based.
Importantly, the guidelines require that the new use must be directed toward a specific disease. Claims directed to a new use in the form of a mechanism of action of a compound will be deemed too broad and unclear. The description must also provide support for the new use/increased efficiency. Such support may be in the form of clinical experimental data, in vivo or in vitro animal experimentation data, data showing improved bioavailability, stability, reduction in side effects etc. If such support is not available in the description, the applicant should ideally be able to provide the experimental data if requested by the Examiner.
The new examination guidelines provide long-awaited clarity on medical use claims in Indonesia. However, as the Indonesian Patent Law was recently amended in 2016 and the new guidelines have only recently been published, few applications filed under the new law have recently started examination and/or have been granted. As such, it is unclear how the courts in Indonesia would consider medical use claims that have been granted based on the guidelines.
- First medical use claims must be written in Swiss-type format, purpose limited product claim (EPC2000) format or in the form “Use of compound X for treating disease Y”.
- Second medical use claims must be written in purpose limited product claim (EPC2000) format.
- The new guidelines appear to contradict Article 4(f) of Indonesian Patent Law No. 14/2016 with respect to the allowability of second medical use claims. As such, while an Indonesian patent may be granted with second medical use claims, it is unclear how courts in Indonesia would consider such claims during infringement proceedings.