Protecting Pharmaceutical Inventions: A Comparative Guide for ASEAN Countries

17 Dec 2024

Protecting pharmaceutical inventions presents unique challenges in intellectual property law, particularly in the ASEAN region. While patents are essential for safeguarding healthcare and pharmaceutical innovations, the legal frameworks across ASEAN countries vary significantly regarding the patentability of such inventions. Some jurisdictions explicitly exclude pharmaceutical inventions from patentability, while others provide specific pathways for securing patent rights. This article examines the diverse approaches to patenting pharmaceutical inventions in ASEAN member states, highlighting the opportunities and challenges inventors face in this dynamic and rapidly evolving region.

Different categories of subject matters for pharmaceutical inventions

Pharmaceutical inventions encompass a range of subject matters, which can generally be categorized as follows:

1. Products/substances per se
2. First medical use of:
    •  New products/substances (more common)
       Inventions where the product or substance is novel, and hence the medical use thereof is also novel.
    •  Known (non-medical) products/substances (rare) 
       These are cases where a product or substance, previously known and used for non-medical purposes, is discovered to have a            novel medical application. These claims are less common because it is rare to find known products without any prior medical              use that can be repurposed for medical applications.
3. Second and subsequent medical uses of known medical products/substances (common)
4. Method of medical treatment   
    These are claims drafted in the following format:
    •  A method of treating disease Y in a patient by administering compound X.                                                       

Method of treatment claims are patentable in the US and Australia but are generally excluded from patentability in other major jurisdictions. This exclusion aims to ensure that medical practitioners can exercise their professional skills without being hindered by patent rights. The limitation is narrow, designed only to prevent patent law from interfering directly with what a doctor does to the patient.

Patentability of pharmaceutical inventions in ASEAN countries

All ASEAN countries exclude method of treatment claims from patentability. However, there is some relief for innovators wishing to patent substances or compositions used in methods of medical treatment in many ASEAN countries. This is typically achieved by re-drafting method of treatment claims into the proper medical use claim formats.

The practices in different ASEAN member states are summarized below:

Singapore

Products/substances per se are patentable.
First medical uses are patentable and can be written in the following formats:

• Compound X for use as a medicament. (broad)

• Compound X for use in the treatment of disease Y. (EPC2000 format)

It is worth noting that, although EPC2000 claims appear narrower, they are interpreted as broad medical use claims under Singaporean practice. This means the two claims above are considered to have identical scope in Singapore (at least during prosecution). This approach differs from the practice in Europe and other ASEAN member states that also allow EPC2000 claims. 

Second and subsequent medical uses are patentable and must be written in the Swiss-type format.

Brunei

The patent practice in Brunei generally follows that of Singapore.

Malaysia

Products/substances per se are patentable.
First medical uses are patentable and can be written in the following formats:

• Compound X for use as a medicament. (broad)

Second and subsequent medical uses are patentable and can be written in either EPC2000 or Swiss-type format.

Indonesia

Products/substances per se are patentable.

According to Article 4(f) of the amended Indonesian Patent Law of 2016, a new use of a known or existing product is not patentable. Despite the restriction imposed by Article 4(f), the Indonesian Patent Examination Guidelines permitted the patentability of first and second medical use claims, creating a clear inconsistency with the law. The good news is that a recent amendment to the Indonesian Patent Law has repealed Article 4(f), thus resolving this inconsistency.

Indonesia generally does not allow broad first medical use claims. As such, even for first medical use claims, they have to be drafted in either the EPC2000 claim format or the Swiss-type format.

Second and subsequent medical uses must be written in the EPC2000 claim format.

Philippines

Products/substances per se are patentable.

According to the IP Code of the Philippines, the new use for a known substance is excluded from patentability. The Examination of Pharmaceutical Applications Involving Known Substances (QUAMA Guide) provides explanations and elaborations on how the above provision in the IP Code should be interpreted. While the situation in the Philippines regarding first and second medical uses may be more complex as compared to other ASEAN countries, in practice, it can be summarized that medical use claims which rely solely on the following features for patentability are not patentable:

• New mode, time, frequency or dosage of administration

• New patient group

• New mechanism or technical effect

• New advantage to known use

• New clinical situation

First medical uses can be written in the following formats:

• Compound X for use as a medicament. (broad)

Second medical use claims must be written in the Swiss-type claim format.  

Thailand

Products/substances per se are patentable.

It is possible to patent first and second medical use claims. Acceptable claim formats are Swiss-type claims for all medical uses. It is to be noted that the claims must not directly or indirectly feature dosage or therapeutic steps, as doing so may render the claims being classified as non-patentable “methods of treatment”.

Vietnam

Products/substances per se are patentable.

The patentability of medical use claims remains ambiguous in Vietnam due to the lack of explicit provisions. In practice, Swiss-type claims will not be accepted. EPC2000 claims may be accepted at the formality examination stage on a case-by-case basis, though eventually such claims will probably be rejected at the substantive examination stage.

Cambodia, Laos, Myanmar

These countries are designated as Least Developed Countries (LDCs) by the United Nations. Currently, they are not obligated to grant patent protection for pharmaceutical products due to waivers issued by the World Trade Organization’s (WTO) Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Conclusion

The devil is in the details. Innovators seeking to protect their medical inventions across multiple regions must carefully adapt their claims and even the patent specifications to comply with the specific requirements of each patent office. Understanding these nuances is essential for securing comprehensive protection for medical inventions in global markets.

Before filing a patent application, it is crucial to understand the local patent laws to determine whether filing an application in a particular country is worthwhile, considering the likelihood of obtaining patent protection.

During patent prosecution, patent claims should be appropriately amended to the required claim format to streamline the application process, expedite prosecution, and minimize costs.