This article first appeared on Law360. To view the original, visit www.law360.com/ip.
Southeast Asia is home to approximately 600 million people and covers a diverse group of countries (Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar (Burma), Philippines, Singapore, Thailand and Vietnam), most of whom are part of the Association of Southeast Asian Nations (ASEAN). In 2013, total pharmaceutical sales in Southeast Asia were around US$20 billion, and this number is expected to double by 2020.
The ability to adjust patent terms, which may be useful for any patentable subject matter, and the provisions to extend the protection available to pharmaceutical products across the region vary from country to country.
Patent Term Adjustment
Uniquely in Southeast Asia, Singapore enables patent owners to (theoretically at least) extend the life of a patent directed to any kind of subject matter, not just pharmaceuticals. This extension is similar to the patent term adjustment (PTA) available in the US in many ways, but there are differences.
A major difference is that one must apply for the PTA within six months of grant of the Singapore patent, unlike the US where the PTA is automatically provided. Further, the applicant needs to provide evidence that there was an unreasonable delay in the grant of the patent due to:
(a) the Singapore patent office (no maximum term on the PTA); or
(b) the patent office that granted a “corresponding” patent that was used to seek grant in Singapore. The term of the “corresponding” patent must also have been extended on the basis of a delay, and the maximum PTA for the extension will be five years, subject to the Registrar’s discretion.
To the best of our knowledge, no one has attempted to apply for a PTA in Singapore on the basis of (a) or (b) to date. However, we believe that an application under point (b) has more chance of success for the reasons discussed below.
(a) Delays by the Singapore Patent Office
Under point (a) above, a PTA can be obtained only if the time period exceeds:
- four years, from the date of filing of the application to the date of grant of the patent (for a PCT application entering the national phase, this is based upon the date of entry into Singapore); or
- two years, from the date that examination or combined search and examination was requested for the application to the date of grant of the patent.
While this appears to be a simple and straightforward calculation, it should be noted that significant periods of time “attributable to an act or omission of the applicant” are excluded. This makes calculating the actual delay quite complicated. Examples of the excluded periods include:
- the time taken to fulfil any filing and formality requirements;
- the period between being informed that the formal requirements have been met and proceeding with search and examination or placing reliance on a “corresponding” application (e.g. one that does not provide PTA extensions);
- the period between issuance of an Office Action and filing the response. This excluded period includes the period to file a response within the deadline set by the Office;
- any time taken to fulfil the formal requirements for grant, such as submitting a consolidated specification with all amendments made to the specification; and
- any extension or alteration of any period of time applied for by the proprietor.
As you can see, the length of a PTA based upon delays by the Singapore Patent Office is likely to be in the order of days or weeks, rather than months or years (if any PTA is available at all).
(b) Delay by a “Corresponding” Patent Office
You can seek grant of a patent in Singapore based upon the allowance/grant of a patent in the US, Canada, the UK, Australia, Korea, New Zealand (for recent applications), Japan or Europe (by the EPO). In general, the claims presented for grant in Singapore should either be related to (pre 14 February 2014) or essentially identical to (from 14 February 2014) the claims of the allowed application/patent being relied on. Unfortunately, it is not possible to reformat method of treatment claims into an acceptable first or second medical use format when seeking grant based upon a corresponding case, which may limit the usefulness of this provision for pharmaceutical patents.
However, a PTA under point (b) above will only be available if the territory relied on also provides PTAs. This narrows the available options to the US and Korea (a Korean PTA appears to be similar to point (a) above, and requires one to apply within three months of the patent grant). Given this, we believe that reliance on the US will provide the best chance of obtaining a decent period of extension.
The Act and Rules in Singapore require you to satisfy the Registrar that the extension should be granted by providing details of the PTA obtained in the case you are relying on to seek grant. This suggests that the notice of PTA provided by the USPTO (or KIPO) should be sufficient to obtain the same period of extension in Singapore (or at least up to five years). If this is indeed the case, then such an extension may be relatively easy to obtain in Singapore and would be particularly useful for pharmaceutical cases covering the product per se, though not for methods of treatment for the reasons mentioned above.
Pharmaceutical Patent Term Extension
Only Singapore and Brunei currently allow pharmaceutical patent term extensions. Given that Brunei’s law is essentially identical to Singapore’s, we only discuss Singapore below.
Since the introduction of pharmaceutical patent term extensions to Singapore in 2004, a patent term extension of up to five years for a “pharmaceutical product” can be obtained. “Pharmaceutical product” is defined as being “a medicinal product which is a substance used wholly or mainly by being administered to a human being for the purpose of treating or preventing disease…”. However, there are a number of exceptions, which include:
- any substance which occurs naturally in any plant, animal or mineral;
- substances solely used for diagnosis or testing;
- substances used solely as a device (or equivalent); and
- traditional or homeopathic medicines, quasi-medicinal products, medicated oils or balms, foods, food additives, food supplements.
An application for PTE must be made by the later of six months from the grant of the patent or six months from obtaining the marketing authorisation in Singapore. To obtain a PTE, the patent must have been granted before regulatory approval is obtained and the period between the date of application for Marketing Approval (MA) and obtaining it exceeds two years. This excludes any time spent by the applicant responding to queries issued by the Health Services Authority (HSA) of Singapore.
In practice, MA is normally based upon approval in the US or Europe, so will almost always be obtained within two years, meaning that it is unlikely that a PTE will be granted in most cases. In fact, we understand that only one patent has been successfully extended under the PTE provisions in Singapore, and this required the innovator to seek its first marketing authorisation through Singapore’s Health Sciences Authority. For more usual cases, where approval in Singapore is sought based upon approval elsewhere, we are not aware of any extension to the life of the patent being awarded. Therefore, while the provision to extend pharmaceutical patents does exist in Singapore, its utility is severely limited.
Admittedly, the provisions appear to make it as difficult as possible to obtain a pharmaceutical patent term extension. Singapore was required to introduce such extensions as part of a free trade agreement between Singapore and the US in 2003, but Singapore’s government appears to have taken a policy decision to limit the applicability as much as possible to ensure that generics can enter the market shortly after the normal expiry of any relevant patents. This may also give a hint of what other countries in Southeast Asia may enact if the Trans-Pacific Partnership agreement requires that they provide for an extension of patents covering pharmaceutical products.
Data exclusivity refers to a period of data protection of clinical test data that is provided by an innovator company to a regulatory agency to prove the safety and efficacy of a new drug. This period of data protection prevents a competitor from relying on the innovator’s clinical data when seeking approval of a generic version of the same drug in front of the same regulatory agency.
Singapore, Malaysia and Vietnam have data exclusivity provisions covering pharmaceutical products. Cambodia, Brunei, Indonesia, Laos, Myanmar, Philippines and Thailand do not provide explicit data exclusivity protection, though some of these territories argue (e.g. Thailand) that similar protection is afforded through their trade secret laws.
Malaysia provides up to five years’ data exclusivity for a drug based on new chemical entity (which cannot be a salt, or prodrug of a known compound) and up to five years for a second medical indication of a known drug. While the language used in the relevant Act appears to be aimed at small molecules, it is arguable that the same language also covers biologics too. We understand that this has yet to be tested, and there remains a chance that Malaysia will interpret the data exclusivity provision narrowly, so as to exclude protection for biological therapies.
The period of protection is calculated based upon:
- the first marketing authorisation obtained anywhere in the world; or
- a later marketing authorisation obtained in any other country that is deemed appropriate by the Director of Pharmaceutical Services in Malaysia.
The marketing authorisation you choose to rely upon will affect the period of protection and also the date that you need to apply for protection. An application for data exclusivity for a new chemical entity (NCE) must be made within 18 months of the first marketing authorisation obtained for the product anywhere in the world, or within 18 months of a later marketing authorisation obtained in any other country that is deemed appropriate by the Director. For second medical indications, the period to apply for data exclusivity is 12 months of the marketing authorisation relied on (again reliance on a later authorisation is at the discretion of the Director). Given that the latter option appears to rely upon the Director’s discretion, basing an application on a later marketing authorisation may not be accepted, so caution is advised.
In Singapore, the data exclusivity period runs for five years from the date that a product licence is granted by Singapore’s Health Services Authority. It is worthwhile noting that the Act governing data exclusivity appears to define medicinal product more broadly than the Singapore Patents Act, as discussed below in the section on pharmaceutical patent term extensions. Therefore, products that are statutorily excluded from pharmaceutical patent term extension in Singapore may still be eligible for data exclusivity protection.
In Vietnam, the data exclusivity period runs for five years from the date that a product licence is granted by Vietnam’s regulatory authority.
For pharmaceutical products, the most general form of extended protection available in Southeast Asia is currently data exclusivity. Whether this will change following the conclusion of the Trans-Pacific Partnership agreement remains to be seen.
In Singapore, a potentially useful period of extension for almost all subject matter (excluding methods of treatment) might be obtained by seeking grant based upon a US patent/allowed application and providing details of the awarded patent term adjustment. To the best of our knowledge, this has not yet been attempted, but may provide a reasonably easy way of obtaining a meaningful extension of term.