9. The Patents Act is amended by inserting, immediately after section 36, the following section:“Extension of term of patent |
36A.—(1) The proprietor of a patent may apply to the Registrar to extend the term of the patent on any of the following grounds:(a) | that there was an unreasonable delay by the Registrar in granting the patent; | (b) | where the patent was granted on the basis of prescribed information relating to a corresponding application referred to in section 29(2)(c)(ii), that —(i) | there was an unreasonable delay in the issue of the corresponding patent; and | (ii) | the patent office that granted the corresponding patent has extended the term of the corresponding patent on the basis of such delay; |
| (c) | where the subject of the patent includes any substance which is an active ingredient of any pharmaceutical product, that —(i) | there was an unreasonable curtailment of the opportunity to exploit the patent caused by the process of obtaining marketing approval for a pharmaceutical product, being the first pharmaceutical product to obtain marketing approval which uses the substance as an active ingredient; and | (ii) | the term of the patent has not previously been extended on this ground. |
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(2) A delay by the Registrar in granting a patent shall not be treated as an unreasonable delay under subsection (1)(a) unless —(a) | the interval between the date of filing of the application for the patent and the date of issue of the certificate of grant, excluding any period attributable to an act or omission of the applicant, exceeds 4 years; or | (b) | the interval between the date on which the applicant —(i) | filed a request for a search and examination report in accordance with section 29(2)(b); or | (ii) | filed a request for an examination report in accordance with section 29(2)(c)(i), (d)(i) or (e)(i) or (4), |
and the date of issue of the certificate of grant, excluding any period attributable to an act or omission of the applicant, exceeds 2 years. |
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(3) Where the proprietor of a patent has made an application under subsection (1)(a) and has satisfied the Registrar that there was in fact an unreasonable delay under subsection (1)(a), the Registrar shall extend the term of the patent —(a) | in a case to which subsection (2)(a) applies, by the period by which the interval referred to in subsection (2)(a) exceeds 4 years; | (b) | in a case to which subsection (2)(b) applies, by the period by which the interval referred to in subsection (2)(b) exceeds 2 years; or | (c) | in a case to which both paragraphs (a) and (b) of subsection (2) apply, by the period by which —(i) | the interval referred to in subsection (2)(a) exceeds 4 years; or | (ii) | the interval referred to in subsection (2)(b) exceeds 2 years, |
whichever is the longer period. |
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(4) Where the proprietor of a patent has made an application under subsection (1)(b) and has satisfied the Registrar of the matters referred to in sub-paragraphs (i) and (ii) of subsection (1)(b), the Registrar may, if the Registrar thinks fit, extend the term of the patent by such period, not exceeding 5 years, as the Registrar may determine. |
(5) A curtailment of the opportunity to exploit a patent, the subject of which includes a substance which is an active ingredient of any pharmaceutical product, caused by the process of obtaining marketing approval for a pharmaceutical product, being the first pharmaceutical product to obtain marketing approval which uses the substance as an active ingredient, shall not be treated as an unreasonable curtailment under subsection (1)(c) unless —(a) | the marketing approval was obtained after the date of issue of the certificate of grant; and | (b) | the interval between the date the application for marketing approval was filed and the date marketing approval was obtained, excluding any period attributable to an act or omission of the applicant for marketing approval, exceeds 2 years. |
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(6) Subject to subsections (7), (8) and (9), where the proprietor of a patent has made an application under subsection (1)(c) and has satisfied the Registrar that there was in fact an unreasonable curtailment of the opportunity to exploit the patent under subsection (1)(c), the Registrar shall extend the term of the patent by —(a) | a period equivalent to the interval between the date of issue of the certificate of grant and the date marketing approval was obtained; | (b) | the period by which the interval referred to in subsection (5)(b) exceeds 2 years; or | (c) | a period of 5 years, |
whichever is the shortest period. |
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(7) The Registrar shall not extend the term of the patent under subsection (6) unless the applicant has procured and submitted to the Registrar a certificate from the relevant authority stating —(a) | the date the application for marketing approval was filed; | (b) | the date marketing approval was obtained; and | (c) | for each period attributable to an act or omission of the applicant for marketing approval, the dates on which the period started and ended. |
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(8) In determining the period by which to extend the term of the patent under subsection (6), the Registrar shall rely on, and shall not be concerned to inquire into the truth of, the statements contained in the certificate from the relevant authority under subsection (7). |
(9) Where the term of a patent has been extended under subsection (6), the protection conferred by the patent during the term of the extension shall apply only to the substance referred to in subsection (1)(c). |
(10) Every application to extend the term of a patent shall be —(a) | made by the proprietor of the patent in the prescribed form within the prescribed period; | (b) | filed in the prescribed manner; and | (c) | accompanied by the prescribed fee and any prescribed documents, |
and the Registrar may reject any application that fails to comply with any requirement under this subsection. |
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(11) As soon as practicable after the Registrar has extended the term of a patent, he shall —(a) | send to the proprietor of the patent a certificate of extension of patent term in the prescribed form specifying —(i) | the period of the extension; and | (ii) | any limitation on the protection conferred by the patent during the term of the extension; and |
| (b) | publish in the journal a notice of the extension. |
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(12) The proprietor of a patent who has made an application under subsection (1) may withdraw the application by informing the Registrar in writing of the withdrawal of the application, and any such withdrawal shall not be revocable. |
(13) In subsection (2), “period attributable to an act or omission of the applicant” includes (without prejudice to the generality of the expression) any of the following periods which is applicable:(a) | the period taken by the applicant to pay the filing fee under section 25(1)(b), calculated from the date of filing of the application for the patent to the date on which the filing fee is paid; | (b) | the period taken by the applicant to correct deficiencies in his application under section 26(3), calculated from the date of the Registrar’s notification to the applicant of the deficiencies to the date on which the applicant corrects the deficiencies; | (c) | the period taken by the applicant to file one or more claims for the purposes of the application under section 26(8), calculated from the date of filing of the application for the patent to the date on which the applicant files the claim or claims; | (d) | the period taken by the applicant to amend his application under section 28(2) to comply with the formal requirements, calculated from the date of the Registrar’s notification to the applicant that not all formal requirements have been complied with to the earliest date on which the application, as amended by the applicant, complies with the formal requirements; | (e) | the period taken by the applicant to —(i) | file a request and pay the prescribed fee for a search report under section 29(2)(a); or | (ii) | file a request and pay the prescribed fee for a search and examination report under section 29(2)(b), |
calculated from the date of the Registrar’s notification under section 29(1) to the date on which the applicant files the request and pays the fee; |
| (f) | the period taken by the applicant to file the documents referred to in section 29(2)(c)(i), (d)(i) or (e)(i) and pay the prescribed fee for an examination report, calculated from the date of the Registrar’s notification under section 29(1) to the date on which the applicant files the documents and pays the fee; | (g) | the period taken by the applicant to file the documents referred to in section 29(2)(c)(ii) or (d)(ii), calculated from the date of the Registrar’s notification under section 29(1) to the date on which the applicant files the documents; | (h) | the period taken by the applicant to file a notice under section 29(2)(e)(ii), calculated from the date of the Registrar’s notification under section 29(1) to the date on which the applicant files the notice; | (i) | the period taken by the applicant to file a request for an examination report under section 29(4), calculated from the date of the Registrar’s notification under section 29(3)(b) to the date on which the applicant files the request; | (j) | the period taken by the applicant to file the prescribed documents under section 30(2)(c) and pay the prescribed fee under section 30(2)(d) for the grant of the patent, calculated from —(i) | in a case to which section 30(2)(b)(i), (iii) or (v) applies, the date of the Registrar’s notification under section 29(5); | (ii) | in a case to which section 30(2)(b)(ii) applies, the date of the Registrar’s notification under section 29(6); | (iii) | in a case to which section 30(2)(b)(iv) applies, the date on which the applicant files the documents referred to therein; or | (iv) | in a case to which section 30(2)(b)(vi) applies, the date on which the applicant files the notice under section 29(2)(e)(ii), |
to the date on which the prescribed documents under section 30(2)(c) are filed and the prescribed fee under section 30(2)(d) is paid; |
| (k) | the period taken by the applicant to rectify any failure to satisfy any condition under section 30(3), calculated from the date of the Registrar’s notification under section 30(6)(a) to the date on which every condition in section 30(3) is satisfied; | (l) | the period taken by the applicant to respond to a written opinion under section 31(1A)(a), calculated from the date of the Registrar’s notification under section 31(1) to the date on which the applicant responds to the written opinion; | (m) | the period taken by the applicant to amend the specification of his application under section 31(1A)(b), calculated from the date of the written opinion given under section 31(1) to the date on which the applicant amends the specification of his application; | (n) | where the application is an international application for a patent (Singapore) that has entered the national phase in Singapore under section 86(3), the period taken by the applicant to cause the application to enter the national phase in Singapore, calculated from the date of the filing of the application in accordance with the Patent Co-operation Treaty to the date on which the national phase of the application begins under section 86(3); | (o) | the period taken by the applicant to rectify any failure to comply with any requirement under this Act or the rules, such period —(i) | to be calculated from the date by which the applicant is required to comply with the requirement to the date on which the applicant rectifies the failure to comply with the requirement; and | (ii) | to include any period taken by the Registrar or the Registry to detect or to notify the applicant of the applicant’s failure to comply with the requirement; |
| (p) | the period taken by the applicant to respond to any request by the Registrar for any document, information or evidence, calculated from the date of the Registrar’s notification to the applicant of the request to the date on which the applicant responds to the request; | (q) | any extension or alteration of any period to do any thing that is granted by the Registrar or the court at the request or on the application of the applicant. |
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(14) In subsections (5) and (7), “period attributable to an act or omission of the applicant for marketing approval” includes (without prejudice to the generality of the expression) —(a) | the period taken by the applicant for marketing approval to correct deficiencies in his application for marketing approval, calculated from the date of the relevant authority’s notification to the applicant for marketing approval of the deficiencies to the date on which the applicant for marketing approval corrects the deficiencies; | (b) | the period taken by the applicant for marketing approval to respond to any request by the relevant authority for clarification or information, calculated from the date of the relevant authority’s request to the date on which the relevant authority receives the response of the applicant for marketing approval; and | (c) | any extension of any period to do any thing that is granted by the relevant authority at the request or on the application of the applicant for marketing approval.”. |
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