Patents can be regarded as an exchange between the authority and the patent owner. The authority grants the patent owner an exclusive right to exploit the invention by preventing others from making, using, selling, or importing the invention, in exchange for releasing the invention to the public at the end of the patent term. Generally, patents are protected for 20 years provided that maintenance fees are paid in a timely manner, although there are mechanisms for extending the patent term.
In this article, we talk about Patent Term Extension (PTE) in ASEAN (the association of Southeast Asian nations), a globally important group.
ASEAN consists of ten member states: Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam. Currently only Singapore and Brunei allow PTE. Given that Brunei’s patent law is modelled after and essentially identical to Singapore’s, we focus our discussion on Singapore below.
PTE is available for a Singapore application that has a date of filing after 1 July 2004. However, PTE is only granted under very strict grounds, as set out in Section 36A(1) of the Singapore Patents Act (SPA). The grounds for extending a patent term are:
- There was an “unreasonable delay” by the Intellectual Property Office of Singapore (IPOS) in granting the patent. An “unreasonable delay” means that the interval between the date of filing the patent application and the date of issue of the certificate of grant exceeds four years, or that the interval between the date on which the applicant filed a request for a search and/or examination report and the date of issue of the certificate of grant exceeds two years.
However, it is crucial for applicants to know that any delay attributable to the applicant is excluded from the time for calculating the period of delay by IPOS. Examples of delay attributable to the applicant are delay in payment of the grant fee, correcting deficiencies, filing a request for a search and/or examination, responding to an Office Action, and entering the national phase in Singapore (for PCT international applications). For example, once IPOS issues a Notice of Eligibility to Grant, the applicant will have two months to pay the grant fee, in order to obtain the certificate of grant for the patent. The time taken by the applicant to pay the grant fee from the date of issuance of Notice of Eligibility to Grant is considered a delay attributable to the applicant, and is disregarded when calculating said interval. Another example would be that the time between the international filing date and the actual national phase entry date is regarded as a delay attributable to the applicant.
- The Singapore patent was granted on the basis of any prescribed corresponding application. There was an “unreasonable delay” in the issue of the corresponding patent, and the foreign patent office that granted the corresponding patent has extended the term of the corresponding patent on the basis of such delay.
A prescribed corresponding application is a patent application that is linked to the Singapore application by way of a priority claim and was filed in any one of the following jurisdictions: Australia, New Zealand (examined for inventive step under the New Zealand Patents Act 2013), Canada (filed in English only), Japan, the United Kingdom, the United States of America, the European Patent Office (filed in English only), and Korea.
- The subject of the patent includes an active ingredient of a pharmaceutical product. There was an “unreasonable curtailment” of the opportunity to exploit the patent. Because the process of obtaining marketing approval for the pharmaceutical product exceeds two years, the marketing approval was obtained after issue of the certificate of grant, and the term of the patent has not previously been extended on this ground.
Similar to the first ground mentioned above, any period attributable to the applicant is excluded from the calculation of the length of process of obtaining marketing approval from the Health Sciences Authority Singapore. Such period could be the period taken by the applicant to correct deficiencies in the application, the period taken by the applicant to respond to any request by the relevant authority for clarification or information, any extension of any period to do anything at the request of the applicant, and so on.
There are no statutory provisions (or exclusions) on the eligible claim type for the third ground of PTE, and it would include pharmaceutical products, compositions containing pharmaceuticals, and any related subject matter (including methods of manufacturing the pharmaceutical products or therapeutic uses of the products) that have been granted a patent in Singapore. However, please note that method of treatment claims are not patentable in Singapore. If a granted patent contains method of treatment claims, such patent has the risk of revocation by a third party on the ground that the invention is not a patentable invention. Note also that the patent must relate to an active ingredient that is a “pharmaceutical product” and that the pharmaceutical product is the first pharmaceutical product to obtain marketing approval which uses the active ingredient. SPA defines “pharmaceutical product” as not including any traditional or homoeopathic medicine, quasi-medicinal product, raw material used as an ingredient in the preparation of any medicinal product, medicated oil or balm, food, a food additive or supplement, or substance occurring naturally in any plant, animal or mineral.
If PTE is successfully granted, IPOS will extend the term of the patent by the period beyond four years (in case of delay in grant process) or the period beyond two years (in case of delay in search and examination process) if ground 1 is satisfied, or at most five years if ground 2 or 3 is satisfied.
- While PTE is not available in other ASEAN countries, in practice, it is fairly difficult to be granted in Singapore. The actual finding of an unreasonable delay or unseasonal curtailment of the opportunity to exploit the patent is rare.
- To increase the chance of obtaining PTE in Singapore, the applicant should carefully plan the timeline of actions to file and prosecute a Singapore patent application, by minimising the delay “attributable to the applicant”. For example, if the applicant aims to apply for PTE, they may consider initiating national phase entry in Singapore early on, requesting search and/or examination on the day of filing or shortly thereafter, responding to written opinions and pay grant fees as soon as possible. Similarly, the applicant may minimise the time taken to respond to requests or correct deficiencies when applying for marketing approval with the Health Sciences Authority.
If you have any questions, please get in touch with Vivian Wei Cheng.
Vivian is a qualified Singapore patent attorney specialized in areas such as life science and biotechnology, consumer care, food and retail, chemical and healthcare.