The Patents (Amendment) Act 2004 introduced patent term extensions to take into account delays in obtaining marketing approval for pharmaceutical products in Singapore. These are generally equivalent to Supplementary Protection Certificates (SPE) issued for pharmaceutical patents in Europe.
Patent term extensions are granted to patents where the subject of the patent includes “any substance which is an active ingredient of any pharmaceutical product”.
According to Section 36A(9), the protection conferred by the patent during the term of the extension only applies to the substance which is the active ingredient of the pharmaceutical product for which marketing approval was sought.
The Applicant must show that there was an “unreasonable” curtailment of the opportunity to exploit the patent caused by the marketing approval process.
The Act treats as unreasonable the fact that marketing approval was obtained after grant of the patent, and that it has taken more than 2 years to obtain the grant of marketing approval. This period excludes any period attributable to an act or omission of the applicant (a number of examples of such acts and omissions are set out in the Act).
In common with many other countries, 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 relevant patent must not previously have been extended.
The term of extension is the shortest of:
Accordingly, the maximum period of patent term extension for a Singapore patent is 5 years.
A “pharmaceutical product” is defined in the Act as 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.
The Act sets out a number of things that are not considered “pharmaceutical products” (Section 1, Schedule) for the purposes of patent term extensions:
The Schedule to the Act sets out detailed definitions of “homoeopathic medicine”, “medicated oil or balm”, “quasi-medicinal product” and “traditional medicine”.
The Act apparently does not consider a substance “which occurs naturally in any plant, animal or mineral” as a “pharmaceutical product”.
This raises questions as to whether a patent to a drug originally isolated from natural sources (whether or not now synthesised artificially) or a biologic such as an un-engineered antibody is susceptible to patent term extension. The Act does not define what “occurs naturally” means and unfortunately no case law is available on this point.
Not being able to obtain a patent term extension for such products, however, would appear to defeat the purpose of the legislation.
Further, the definition of “traditional medicine” in the Schedule is such that a substance derived from a natural source, which is administered by injection into a human body or used as a vaccine by a human being, is considered not a “traditional medicine”. According to this definition, a “pharmaceutical product” might indeed include a natural substance, provided the use requirements are fulfilled.
The Act specifies that the application for patent term extension must be the proprietor of the patent.
An application for patent term extension must be made to the Intellectual Property Office of Singapore (IPOS) on Patents Form 54 with a fee currently of S$950. Patents Form 54 requires the Applicant to state the period of the extension of the patent term it seeks.
The Applicant needs to submit a certificate from the Health Sciences Authority in Singapore (the regulatory authority). The certificate sets out the date of application and the date of grant of the marketing approval. It also sets out the periods within this considered attributable to any acts or omissions of the Applicant.
According to Section 36A of the Act, IPOS “shall rely on” the statements in the certificate provided by the Health Sciences Authority. This would imply that it might not be possible to challenge any statement on the certificate as to any periods attributable to the delay of the applicant, at least before IPOS.
An application for a patent term extension needs to be made within 6 months from the later of the date of grant of the patent and the date marketing approval was obtained. The patent must still be in force, and an application cannot be made after 6 months from the normal 20 year term of the patent.
Please do not hesitate to contact us if you require more information on patent term extensions for pharmaceutical patents in Singapore.