Singapore legislation
Section 12A
Section 12A
Whether medicinal product subject to patent
(1)
Subject to the provisions of this Part, in dealing with an application for a product licence, the licensing authority must consider whether a patent under the Patents Act 1994 is in force in respect of any medicinal product to which the application relates and, if so —
whether the applicant is the proprietor of the patent; or
if the applicant is not the proprietor of the patent, whether —
the proprietor has given consent to or has acquiesced in the grant of the licence to the applicant; or
the patent is invalid or will not be infringed by the doing of the act for which the licence is sought.
(2)
Unless the licensing authority otherwise determines, an applicant for a product licence must, at the time of the applicant’s application and at such other time as the licensing authority may require, make and furnish to the licensing authority a declaration in the prescribed form —
stating whether a patent under the Patents Act 1994 is in force in respect of any medicinal product to which the application relates;
if the applicant states that there is such a patent, stating whether the applicant is the proprietor of the patent; and
if the applicant states that the applicant is not the proprietor of the patent, stating —
the name and other particulars of the proprietor of the patent;
whether —
the proprietor has consented to or has acquiesced in the grant of the licence to the applicant; or
in the applicant’s opinion and to the best of the applicant’s belief, the patent is invalid or will not be infringed by the doing of the act for which the licence is sought; and
any other information that may be prescribed.
(3)
The licensing authority may, if the applicant has declared that in the applicant’s opinion and to the best of the applicant’s belief the patent is invalid or will not be infringed by the doing of the act for which the licence is sought, or if the licensing authority considers it appropriate in any particular case, require the applicant to do the following within such time as the licensing authority may determine:
serve on the proprietor of the patent a notice in the prescribed form of the applicant’s application;
furnish to the licensing authority such evidence of the service as the licensing authority may require.
(4)
The licensing authority need not determine the application until the applicant has complied with subsection (2) and, where applicable, subsection (3), to the reasonable satisfaction of the licensing authority.
(5)
If the licensing authority is satisfied that a notice mentioned in subsection (3)(a) has been served on the proprietor of the patent, the licensing authority may grant the licence to the applicant if the proprietor has not, before the expiry of the period prescribed for the purposes of this subsection —
applied for the order or declaration by a court or the Registrar of Patents or a Deputy Registrar of Patents holding office under the Patents Act 1994, as specified in that notice; and
given written notice to the licensing authority stating that such application has been made.
(6)
The licensing authority may grant the licence to the applicant if —
application for the order or declaration mentioned in subsection (5)(a) has been made; and
at the expiry of the period prescribed for the purposes of this subsection, the order or declaration has not been obtained.
(7)
For the purpose of subsection (1), the licensing authority may rely upon and must not be concerned to inquire into the truth of any statement made in a declaration furnished under subsection (2).
(8)
This section applies only to an application for a product licence made on or after 1 July 2004.