I was invited to give a talk recently on patent term extensions in South East Asia.

The talk was presented at a webinar on 2 September 2024, hosted by the Chartered Institute of Patent Attorneys in the United Kingdom.

This blog post sets out a transcript of the talk.

Transcript of Talk on Patent Term Extensions

Introduction

Good afternoon, ladies and gentlemen. I’m Chong-Yee from Cantab IP in Singapore. I’m European Patent Attorney, a UK Patent Attorney and also a Singapore Patent Attorney.

Today, I’m going to talk to you about patent term extensions in Southeast Asia.

What We’ll Cover

First, I’ll explain what patent term extensions are in the context of this region.

I will then tell you about the different types of patent term extensions that are available and we will go through each of the countries in the region.

I will explain whether patent term extensions are available in each of these countries, and, if so, how long a PTE will be available in each of these countries.

I will end the talk with a summary of what we have learned today.

South East Asia and ASEAN

I’ll briefly show you where the countries we will talk about are located.

On the slide is a map of the region. Starting first in the northwest, we have Burma, or nowadays known as Myanmar, and it’s got a border with India and China. Then there are the three Indochinese countries of Vietnam, Laos, and Cambodia. Next, we have the archipelago of the Philippines.

Heading back to the mainland, we have Thailand, followed by Malaysia, comprising Peninsular Malaysia in the west, and East Malaysia. We move south to Singapore, where this talk is being broadcast from.

The oil-rich state of Brunei Darussalam is in the island of Borneo, and this island is shared with Malaysia and the next country, Indonesia. Indonesia is the largest country in Southeast Asia.

Finally, we have the newest and one of the smallest countries in the region, East Timor, also known as Timor-Leste.

As shown in this slide, all of these countries, with the exception of East Timor, are members of the Association of Southeast Asian Nations, also known as ASEAN.

Patent Term Extensions: What They Are

As you are aware, the normal term of a patent is 20 years from the date it was filed.

This 20-year term is more or less harmonized across the world.

However, in order to put the “patent bargain” into effect, it is recognized that in certain industries, there may be a need for the term of the patent to be extended if the patent cannot be adequately exploited within the 20-year normal term.

In some countries, such as the US, and also in Singapore and Brunei, an extension of patent term may be obtained if there was a delay in the prosecution of a patent application to grant.

What we will discuss here today, however, are extensions of a patent term to compensate a patent owner for delays in obtaining marketing approval for a pharmaceutical product covered by that patent.

In this sense, PTEs are analogous to supplementary patent protection certificates, or SPCs, in Europe.

Patent Term Extensions in Singapore: Legislative Background

We’ll start off first with the smallest country in the region, and the one I’m most familiar with, Singapore.

In 2004, the Singapore Patents Act was amended to provide for patent term extensions for both delays in prosecution as well as delays in obtaining regulatory approval.

The PTE provisions are set out in Sections 1, 36A and the schedule of the Singapore Patents Act, as well as Rule 51A of the Singapore Patents Rules.

An important point is that these patent term extensions are only available for applications filed on or after 1 July 2004.

Under the Singapore Patents Act, a PTE may be obtained for a patent directed to a substance which is an active ingredient of any pharmaceutical product.

As a consequence of this, the protection of the patent during the extended term only extends to the substance which is the active ingredient of the pharmaceutical product for which marketing approval was sought.

Patent Term Extensions in Singapore: Pharmaceutical Products

The Patents Act defines a pharmaceutical product as a medicinal product which is a substance used wholly or mainly by being administered to a human being for the purposes of treating or preventing disease.

I’ve set out on the slide a list of items the Act does not consider to be pharmaceutical products. The Act also sets out definitions of some of these terms.

Patent Term Extensions in Singapore: Conditions

In order to obtain a patent term extension, the applicant must show that there was an unreasonable curtailment of the opportunity to exploit the patent which is caused by the marketing approval process.

So what does unreasonable curtailment mean?

Here the Act tells you there are two conditions to be satisfied. One is that the marketing approval was obtained after the patent was granted.

The second is that the period for obtaining marketing approval has exceeded two years. This period excludes any delay which is caused by the applicant. The period of two years will become relevant when we go through how to calculate the PTE that is available.

One important point from this slide is that the pharmaceutical product must be the first pharmaceutical product which uses the substance as an active ingredient to obtain marketing approval.

Finally, the term of the patent must not have been previously extended under this Act.

Patent Term Extensions in Singapore: Deadlines for Application

With regard to timing, the applicant must make sure that the application for patent term extension is filed within six months from the later of the date of patent grant and the date of marketing approval.

The patent term extension may only be obtained while the patent is in force and the application cannot be made after six months from the normal 20-year expiry date.

Patent Term Extensions in Singapore: Application for Patent Term Extension

I’ll give you a brief rundown of the process for filing an application for a patent term extension in Singapore.

You’ll need to have us prepare Patent Form 54 and there is a large official fee which is payable to IPOS of $950. This is equivalent to about £550 at today’s rates.

The applicant needs to state the term of extension sought on the form and we’ll go through how to calculate this in the next few slides.

As evidence, we need to submit a certificate from the Health Sciences Authority which is the authority that grants marketing approval.

This certificate sets out important information about the marketing approval including the date of application and the date of grant of approval.

The certificate also contains details of what the HSA considers are the delays in the approval process which are caused by the applicant for marketing approval.

According to the Patents Act, IPOS has to take this at face value. It therefore does not appear possible to challenge any statement on the certificate as to any periods attributable to the delay of the applicant at least before the Patent Office.

Patent Term Extensions in Singapore: Duration of Patent Term Extension

So how long a patent term extension can we expect to obtain under the Act?

Well, the Patent Act states that the term of extension is the shortest of the period between the date of grant of the patent and the date of marketing approval, the time taken to obtain marketing approval minus a period of two years and a period of five years.

As before, any delays which are attributable to the applicant are not counted in these terms.

As a consequence of this calculation, we can see from the above that the absolute maximum period of a patent term extension in Singapore is five years.

Patent Term Extensions in Singapore: Calculation Term of Extension

This slide sets out a suggested method of working out whether a patent term extension is available in Singapore and what this term might be.

First, you need to work out two specific periods. I’ll call them period A and period B.

Period A is the time between the date of patent grant and the date of the marketing approval. Period B is the actual time taken for the marketing approval process; you must subtract from this any delays caused by the applicant and you must also subtract two years from this period.

After you’ve worked out these two periods, you determine which of the periods is the shorter period and we’ll call this period C.

So here comes the logic. If period C is more than five years, then the term of extension is five years. This fits in with our understanding from our previous slide that the maximum term of a PTE in Singapore is five years.

On the other hand, if period C is less than five years, then the term of the patent term extension is that actual period C.

In other words, the shorter of the two periods we talked about above. Finally, if period C is zero or is a negative number, then no patent term extension is available.

I’ve set out a summary of this in the table on the right-hand side.

You’ll see from this that a logical upshot of these rules is that if the time taken to get marketing approval is shorter than the two-year period, then no patent term extension is available at all.

Patent Term Extensions in Singapore: Data Exclusivity

In fact, this is what happens in the vast majority of cases in Singapore. Here, most drugs are approved under the abridged approval rule, under which the Health Sciences Authority accepts the approval obtained in another country, such as the US or Europe, instead of having the applicant make a fresh application for approval.

In such an abridged approval procedure, the applicant can typically get approval in a year or a year and a half. We’ve seen that where the delay in getting approval is less than two years, then no extension of patent term is available.

On the other hand, under the Singapore Medicines Act, there are provisions for data exclusivity and the inability to obtain a product license for a generic product, both for a period of five years from the date of application for approval.

Both of these may provide additional protection for innovative companies.

Patent Term Extensions in Brunei

I’ll turn next to Brunei, which is coincidentally the second smallest country in Southeast Asia. We see that in Brunei, patent term extensions are available.

One important point is that the Brunei Patents Order is based on the Singapore Patents Act.

This slide shows the basic considerations as to whether a patent term extension is available in Brunei. As you can see, the provisions are very, very similar to those of Singapore. There is a requirement for pharmaceutical product and unreasonable curtailment. The fact that the product is the first product to obtain marketing approval and that the term of the patent has not previously been extended.

The definition of unreasonable curtailment is also essentially identical to the corresponding provisions in Singapore. The marketing approval must have been obtained after the grant of the patent and the period of time for obtaining marketing approval must be more than two years.

Finally, with regard to the term of extension, the provisions and the calculation of the periods are essentially those as I’ve described in Singapore.

This slide sets out the formal procedures for filing an application for a patent term extension in Brunei. Again, with the exception of the form number and the currency, the provisions are essentially identical to those in the Patents Act of Singapore.

So we now understand that Brunei and Singapore have essentially similar provisions for granting patent term extensions.

Patent Term Extensions in Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Thailand, Viet Nam and East Timor

What about the remaining countries in the region?

Well, as part of the preparation for this talk, I wrote to IP firms in each of these countries and asked them this question. The answers came in, some quite early, some later.

For Myanmar, in fact, I couldn’t initially get in touch with my associate. Because of the civil war in that country, he has actually relocated his office to a neighbouring country. But I eventually got an answer this week.

The replies from each of these associates in these countries is that patent terms are not available in Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, or in Thailand.

What about Vietnam? Here, patent term extensions are also not available.

However, Vietnam has an interesting and quite a unique way of compensating the patentee for regulatory delays. Under Vietnamese patent law, during the term of the delay, the patentee does not have to pay any maintenance fees which might otherwise have been payable for keeping the patent alive. However, the term of the patent is unchanged.

Finally, we come to the newest country in the region, East Timor. East Timor only became independent in 2002, in May. The news here is that there is currently no patent system in East Timor. As a result, there is no patent term extension available.

We might expect that East Timor might inherit the law of its ex-colonising state, which is Indonesia, but even that is unclear.

I hope to have given you a flavour of the patent term extension landscape in ASEAN and in Southeast Asia.

Patent Term Extensions South East Asia: Summary

I’ve put on this slide a summary of what we’ve talked about today. For most of the countries in the region, there is no scope for obtaining an extension of a patent due to any regulatory delay.

In Singapore and Brunei, you can extend the term of a patent by applying to get a PTE and we’ve discussed the procedures and the requirements for this. However, as I’ve described, this is not usually done in practice because of the use of the abridged procedure, at least in Singapore. In East Timor, there is no patent system, and interestingly, in Vietnam, the renewals are waived during the time the marketing approval is sought.

Patent Term Extensions in South East Asia: Acknowledgements

I’d like to acknowledge the help and assistance of these firms in helping me prepare for this talk. Any omissions or errors are mine entirely.

We are grateful to our friends at:, CCW Partnership (Brunei), Abacus IP (Cambodia), Tilleke & Gibbins (Indonesia), Raja, Darryl & Loh (Malaysia), U Myint Lwin Law Firm (Myanmar), Cruz Marcelo & Tenefrancia (Philippines), Tilleke & Gibbins (Thailand), Kenfox IP (Vietnam and Laos) for their assistance in compiling the information for this talk.

I hope this talk has been interesting and helpful. I’ve included on this slide some resources which you may wish to refer to.

Thank you very much for your time and attention and listening to my talk. I’m happy to take any questions, and you can also email me at our email address, [email protected], if you have any questions on the topics discussed. Thank you for your time.

Question and Answer Session

Jo Emery: Thank you, Chong-Yee, for a very interesting talk. We’re now, as many of you know, practicing reflective practice while we take our webinars, and thinking about what we’ve just heard and our expectations.

I think one question I would have is, it sounds like there’s very little scope for patent term extensions in Singapore with how the law is set up. Is there a reason why they then even enacted this law?

Because it doesn’t seem like you can take advantage of it because it’s got such quite tight parameters on the ability to put it in practice.

Chong-Yee: Yeah, that’s a very, very good question. As you can see, there are quite a lot of constraints as to how you can obtain these. In practice, it’s not done very much anyway because of the abridged procedure.

The question as to why they enacted these laws, I’m not certain, but I suspect it had something to do with a free trade agreement that the United States was signing with Singapore at that time.

Possibly as a result of this free trade agreement, Singapore was required to enact these patent term extension procedures into its law. I suspect that that’s the reason.

Jo Emery: Okay. So more political than beneficial for the patentee.

Chong-Yee: Yes, sometimes that’s the case. I think the very interesting thing was that you may know that Singapore has got quite strict laws and one of the laws prohibits anyone from selling or importing chewing gum in Singapore.

Under this exact same FTA, we were required to amend our laws to allow an exception to this for medical purposes. Chewing gum for medical purposes like nicotine-embedded gum. That sort of thing.

Jo Emery: That’s interesting. Yeah.

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