Indonesia’s new patent examination guidelines for medical use claims
The Patent Office of Indonesia recently published its new patent examination guidelines which provide needed clarification regarding medical use claims.
According to Article 4(f) of the amended Indonesian Patent Law of 2016, a new use of a known or existing product and/or a new form of a known product that does not offer a significant increase in efficiency of that product is not patentable.
On the other hand, the new patent examination guidelines allow the patentability of a second medical use as long as the claim is written in Swiss-type format, using the purpose limited product claim (EPC2000) format or in the form “Use of compound X for treating disease Y”.
According to the new guidelines, a particular disease is also required to be identified for the new medical use. New use claims involving a compound’s mechanism will be considered too broad a description, which is the opposite of naming a specific disease.
Additionally, the description must also provide support for the new use/increased efficiency, e.g. the claim of new use should include clinical experimental data, animal experimental data either in vivo or in vitro, data intimating decreased side effects, and other relevant information supporting the new use and/or increased efficiency claim.
Expert opinions
“The current patent examination guidelines identify Swiss-type claims as an example of claims that are not allowed. According to the guidelines, a second medical use claim is patentable if the feature of use, activity, or function serves as a distinguishing or limiting feature. An example of an allowed claim would be a purpose-limited product claim or EPC2000-type claim, in the format of ‘compound X for use in the treatment of disease Y.’ This is not defined in the Patent Law of 2016, under which a new use of an existing or known product is not considered an invention,” said Wongrat Ratanaprayul, director at Tilleke & Gibbins in Jakarta. “It seems that the examination guidelines are introducing an exception to this exclusion by providing a wider scope of patentable subject matter than the Patent Law of 2016. For increased clarity, this exception should be incorporated into the Patent Law.”
“Overall, the new guidelines appear to be more favorable to pharmaceutical patentees and the guidelines’ example of a patentable claim should put examiners more at ease when examining pharmaceutical patent applications,” said Ratapranayul.
“Based on briefings to practitioners, the Directorate General of Intellectual Property (DGIP) is trying to take a pragmatic approach – still allowing medical use of a known substance to be patented where there is no earlier medical use for that substance. The DGIP is considering the importance of protecting investment in discovering and proving new medical use demonstrated in the current pandemic conditions. We hope that the bar against patenting second medical use will be removed,” said Kin Wah Chow, a registered foreign lawyer with Suryomurcito & Co. in Jakarta.
*** Other Articles***
– You could visit here to see 05 Legal Notes About Trademark In Indonesia – Indonesia Trademark Law
– You could visit here to check the Trademark Registration in Indonesia.
– You could check the Procedure of Trademark in Indonesia here.
– You can also check the Required documents of filing trademark in Indonesia
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