Medical Use Claims in Asia Pacific Region: the Key Differences you need to know

Asia Pacific region, especially South East Asia (SEA), is a significant emerging patent market for pharmaceutical companies. Method of Treatment (MOT) claims are not patentable in most countries in this region, with a rationale to ensure that medical and veterinary doctors are not hindered from properly exercising their professional skills on their patients by patent rights. For applicants wishing to patent compounds or compositions used in methods of medical treatment, the MOT claims may be amended to medical use format to overcome the unpatentable subject matter issue.

There are two types of medical use claims:

(1) Europe-style "Purpose-limited Product claim" which has three formats:

• A more general format of "Substance X for use in therapy", or

• "Substance X for use as a medicament"; and

• In the form of a specific medical use claim "Substance X for use in treating / in the treatment of Disease Y".

(2) "Swiss-style" claim in the format of "Use of Substance X in the manufacture of a medicament for treating Disease Y".

However, the above medical use claims may be construed differently in different countries in the region due to differences in laws, which are explained below:

Singapore, Malaysia, and Thailand

Method of treatment claims are not patentable. Both medical use claims (1) and (2) are allowable.

Europe-style: Unlike the European Patent Office (EPO) which treats claims in the format "Substance X for use in treating Disease Y" as second medical use claims, European style is construed as first medical use claim in Singapore, Malaysia and Thailand, i.e. the first medical use of a new or known substance may broadly claim any therapeutic use. It is worth noting that the limitation "for use in treating Disease Y" does not read into the first medical use claim. Therefore, if the Substance X had been used in the prior art to treat any medical condition, the claim would not be novel. In other words, it provides no back up if later (e.g. after grant), a prior art arises, which discloses that Substance X had been used for any medical purpose, e.g. in any method of treatments.

Swiss-style: A Swiss-style claim is construed as a second medical use claim in these countries. Second or subsequent medical uses of a substance may only be claimed in the form of "Swiss-type" claims. However, "Swiss-type" claims are not restricted to second or subsequent medical uses of a substance and can be used even when the first medical use of the same is not previously known. Unlike Europe-style claims, the limitation "for treating Disease Y" reads into the "Swiss-type" second medical use claim, therefore providing back up if a prior art, as mentioned above, arises. Further, Swiss-style claims need to recite specific diseases to be treated in order to avoid a lack of clarity objection. Finally, in Thailand, any Swiss-style claims reciting amounts to be administered, dosage regimes, or routes of administration are not allowable and these subject matters may need to be deleted during prosecution.

Philippines

Method of treatment claims are not patentable. Both medical use claims (1) and (2) are allowable.

According to the Philippines IP Code, (a) the mere discovery of a new form or new property of a known substance, which does not result in the enhancement of the known efficacy of that substance, or (b) the mere discovery of any new property or new use for a known substance, or (c) the mere use of a known process, unless such known process results in a new product that employs at least one new reactant, is excluded from patentability.

There are further guidelines from the Philippines "Manual for Substantive Examination Procedure" and "QUAMA Guide" 2018, which appear to be somewhat inconsistent with the IP code. These guidelines clarify that MOT claims may be amended to first medical use claim (Europe-style) if a substance is known, but its pharmacological properties are not disclosed in the art. Method of treatment claims can also be amended into second medical use claim (Swiss-style) if the substance has a new therapeutic application that treats a different pathology. A second medical use claim must not rely solely on a new mode, time, frequency or dosage of administration, new patient group, new mechanism or technical effect, new advantage to known use, or new clinical situation for patentability.

Indonesia

Article 4(f) of the amended Indonesian Patent Law of 2016 stipulates that: a) a new use of a known product or b) a new form of a known product that does not offer significant increase in efficiency of that product is not patentable. However, the recently issued new Patent Examination Guidelines appear to introduce a wider scope of patentable subject matter than the Patent Law of 2016 by allowing medical use claims.

According to the new Guidelines, first medical use claims (medical use claims directed to novel product, i.e. both the product and the use are new) should be written in Swiss-type format, or in the format of "Substance X used as medicament for Disease Y", or "Use of Substance X for treating Disease Y".

Second medical use claims (medical use claims directed to known product, i.e. the product is known but the use is new) should be written in the purpose limited product claim (Europe-style) format of "Substance X for use in treating Disease Y". Based on the new Guidelines, such claims are construed as directed to Substance X per se, with the new use (feature of "Disease Y") as a limiting or distinguishing feature, which is subjected to novelty assessment. For example, such claim is patentable if Disease Y is a completely new use (Substance X was not used to treat disease before), or if Disease Y is a different unrelated disease (Substance X was used to treat Disease Z before). Specific diseases need to be recited in the second medical use claims. Second medical use claims that mention mechanism of action only (e.g. histamine receptor inhibitor, or cardiovascular dilator) are not patentable for being too broad and unclear. In addition, to provide support for second medical use claims, the description must have data such as clinical experiment result data, in vivo or in vitro animal experimentation data, data showing improved efficiency, decreased side effects, and so on. Such data if not contained in the description as filed may be submitted when requested by the Examiner.

Therefore, there is presently a discrepancy between the Patent Law of 2016 and the new Examination Guidelines. So far, very few applications filed under the Patent Law of 2016 have started examination. It is also not clear how the courts in Indonesia would act if Applicants would try to enforce patents having claims granted on the basis of this discrepancy.

Vietnam

Method of treatment claims are not patentable. The Vietnam Patent Office does not currently accept any use-related claims, regardless of the claim wordings and of which technical fields. As such, "Swiss-style" medical use claims are not patentable either.

While the MOT or "Swiss-style" medical use claims can be converted into Europe-style "Product X for use in treating Disease Y", such claims would be construed as a product per se claim with the phrase "for use in treating Disease Y" construed as referring to the "intended use" of the product only. In addition, the dependent claims should contain essential technical features for further defining the product and any dependent claims that merely define the intended use of the product would be considered as "use" claims, which would be rejected. Further, such claims would be rejected for lacking novelty if Product X is known. So, if the invention solely lies in a new medical use of a known product, it would not be possible to obtain patent protection in Vietnam as there is no suitable claim format that can be used there to claim this.

India

Medical claims, such as method of treatment claims, method of diagnosis claims, first medical use claims and second medical use claims (in any of the above mentioned formats) are considered to be unpatentable subject matter in India based on Section 3 of the Indians Patent Act.

New Zealand

New Zealand allows method of treatment performed on animals but not on humans. Swiss-style claims may be used to protect both first and second medical uses on humans. Europe-style claims are not an allowable means of protecting a second medical use, as "for use in treating Disease Y" is not considered limiting.

Australia

Method of treatment claims are allowable in Australia, as are first and second medical use claims. Similar to New Zealand, Europe-style claims are not effective in Australia since "for use in treating Disease Y" is considered non-limiting. Swiss-style claims can be used to protect first and second medical uses.

Key takeaways

Despite some nuances in the patenting systems in the Asia Pacific region, it is always effective to include product claims with first and/or second medical use type claims where method of treatment is not allowed. Carefully drafting the claims to the allowable format in each jurisdiction in the region is necessary to achieve effective prosecution.

Source: GOWLING WLG-Vivian Wei Cheng

Editor: IPR Daily-Ann