Schedule 4

The specification of an application for a patent, or of a patent, for an invention which requires for its performance the use of a micro-organism —

which is not available to the public at the date of filing of the application; and

which cannot be described in the specification in such a manner as to enable the invention to be performed by a person skilled in the art,shall, in relation to the micro-organism itself, be treated for the purposes of the Act as disclosing the invention in such a manner only if one of the conditions set out in sub-paragraph (2), is satisfied.

The conditions referred to in sub-paragraph (1) are —

a condition that —

not later than the date of filing of the application, a culture of the micro-organism has been deposited with any international depositary authority which is able to furnish a sample of the micro-organism; and

the name of the international depositary authority, the date when the culture was deposited and the accession number of the deposit are given in the specification of the application; and

a condition, in the case of an international application for a patent (Singapore) which is treated, by virtue of section 85 as a patent under the Act, or, as the case may be, an application for a patent under the Act, that the corresponding provisions of the Implementing Regulations to the Patent Co-operation Treaty have been complied with,and where a new deposit is made under paragraph 4, a further condition that the applicant or proprietor makes a new deposit in accordance with that paragraph.

Where the condition of sub-paragraph (2)(a)(ii) is not satisfied at the time the application for a patent is filed, it shall be satisfied —

within 16 months from —

the declared priority date; or

the date of filing the application where there is no declared priority date;

where, on a request made by the applicant, the Registrar publishes the application before the end of the period prescribed for the purposes of section 27(1), before the date of the request; or

where the Registrar sends notification to the applicant that, in accordance with section 108(4), he has received a request by any person for information and inspection of documents under subsection (1) of that section, before the end of one month after his sending to the applicant notification of his receipt of the request,whichever is the earliest.

The giving of the information specified in sub-paragraph (2)(a)(ii) shall constitute the unreserved and irrecoverable consent of the applicant to the international depositary authority with which a culture (including a deposit which is to be treated as having always been available by virtue of paragraph 4(2)) is from time to time deposited making the culture available on receipt of the Registrar’s certificate authorising the release to the person who is named therein as a person to whom the culture may be made available and who makes a valid request therefor to the authority.Availability of cultures2.—

Subject to paragraph 3, a request that the Registrar certify a person as a person to whom an international depositary authority may furnish a sample of a micro-organism —

before publication of the application for a patent, to a person who has made a request under section 108(1) in the circumstances mentioned in paragraph 1(3)(c); and[S 688/2021 wef 01/10/2021](b)at any later time, to any person,shall be made on the form provided for by the Regulations under the Budapest Treaty.[S 739/2014 wef 13/11/2014](2) The Registrar shall send a copy of any form lodged with him under sub-paragraph (1) and of his certificate authorising the release of the sample —

to the applicant for, or proprietor of, the patent;

to the international depositary authority; and

to the person making the request.

A request under sub-paragraph (1) shall comprise, on the part of the person to whom the request relates, undertakings for the benefit of the applicant for, or proprietor of, the patent —

not to make the culture, or any culture derived from it, available to any other person; and

not to use the culture, or any culture derived from it, otherwise than for experimental purposes relating to the subject matter of the invention,and —

subject to sub-paragraph (iii), both undertakings shall have effect during any period before the application for a patent has been withdrawn, has been treated as having been abandoned, has been refused or is treated as having been refused (including any further period allowed under rule 100 or 108(1) or (5) but excluding, where an application is reinstated under either of those rules, the period before it is reinstated);[S 81/2014 wef 14/02/2014](ii)if a patent is granted on the application, the undertaking set out in sub-paragraph (a) shall also have effect during any period for which the patent is in force and during the period prescribed under section 36(3); and[S 399/2022 wef 26/05/2022](iii)the undertaking set out in sub-paragraph (b) shall not have effect after the date of publication in the journal of a notice that the patent has been granted,and, in this sub-paragraph, references to a culture derived from a deposited culture of a micro-organism are references to a culture so derived which exhibits those characteristics of the deposited culture essential for the performance of the invention.

For the purpose of enabling any act specified in section 57 to be done in relation to the culture for the services of the Government, the undertakings specified in sub-paragraph (3) —

shall not be required from any Government department or person authorised in writing by a Government department for the purposes of this paragraph; and

shall not have effect in relation to any such person who has already given them.

An undertaking given pursuant to sub-paragraph (3) may be varied by way of derogation by agreement between the applicant or proprietor and the person by whom it is given.

Where, in respect of a patent to which the undertaking set out in sub-paragraph (3)(a) has effect —

an entry is made in the register under section 53 to the effect that licences are to be available as of right; or

a compulsory licence is granted under section 55,that undertaking shall not have effect to the extent necessary for effect to be given to any such licence.Availability of cultures to experts3.—

Subject to sub-paragraph (3), where, before the preparations for publication under section 27 of an application for a patent have been completed, the applicant gives notice in writing to the Registrar of his intention that a sample of the micro-organism should be made available only to an expert, the provisions of this paragraph shall have effect.[S 739/2014 wef 13/11/2014](2) The Registrar —

shall, at the time of publication of the application under section 27, publish a notice in the journal that the provisions of this paragraph have effect; and

notwithstanding paragraph 2, shall not, until the patent is granted or the application has been withdrawn, has been treated as having been abandoned, has been refused or is treated as having been refused, issue any certificate authorising release of a sample otherwise than under this paragraph.

In the case of an international application for a patent (Singapore), the applicant may, for the purpose set out in sub-paragraph (1), give notice in writing to the International Bureau under rule 13 bis 3 of the Regulations under the Patent Co-operation Treaty before the technical preparations for international publication of the application are complete of his intention that a sample of the micro-organism should be made available only to an expert and he shall be treated by the Registrar for the purposes of this paragraph as having complied with the conditions in sub-paragraph (1) and sub-paragraph (2)(a) shall not apply.

Any person wishing to have a sample of the micro-organism made available (“the requester”) —

shall make a request to the Registrar on the form provided for by the Regulations under the Budapest Treaty nominating the person (“the expert”) to whom he wishes the sample to be made available; and[S 81/2014 wef 14/02/2014][S 739/2014 wef 13/11/2014][S 688/2021 wef 01/10/2021](b)shall at the same time file undertakings by the expert as set out in paragraph 2(3) in accordance with the provisions of that paragraph.[S 688/2021 wef 01/10/2021](5) The Registrar shall send a copy of the form filed under sub-paragraph (4) to the applicant for the patent and shall specify the period within which the applicant may object, in accordance with sub-paragraph (6), to a sample of the micro-organism being available to the expert.[S 81/2014 wef 14/02/2014][S 739/2014 wef 13/11/2014](6) Unless, within the period specified by the Registrar under sub-paragraph (5) (or within such longer period as the Registrar may, on application made to him within that period, allow), the applicant for the patent files a notice of objection in writing and a statement setting out fully the reasons for his objection to the release of a sample of the micro-organism to an expert, the Registrar shall send a copy of any form lodged with him under sub-paragraph (4)(a) and of his certificate authorising the release of the sample —

to the applicant for the patent;

to the international depositary authority concerned;

to the requester; and

to the expert.[S 81/2014 wef 14/02/2014][S 739/2014 wef 13/11/2014](6A) The applicant for the patent shall, at the time the notice of objection and the statement are filed, serve on the requester a copy of the notice of objection and a copy of the statement.[S 81/2014 wef 14/02/2014](7) Where, in accordance with sub-paragraph (6), the applicant for the patent sends notice to the Registrar of his objection to the issue of a certificate in favour of the expert, the Registrar —

shall decide, having regard to the knowledge, experience and technical qualifications of the expert and to any other factors he considers relevant, whether to issue his certificate in favour of the expert; and

if he decides to authorise the release of the sample to the expert, shall send to the persons referred to in sub-paragraph (6) a copy of any form lodged with him under sub-paragraph (4)(a) and of his certificate authorising the release of the sample to the expert.

Before making a decision in accordance with sub-paragraph (7), the Registrar shall afford the applicant and the requester the opportunity of being heard.

If the Registrar decides under sub-paragraph (7) not to issue his certificate in favour of the expert, the requester may, by notice in writing to the Registrar and the applicant, nominate another person as the expert for the purposes of this paragraph; and the Registrar shall give such directions as he may think fit with regard to the subsequent procedure.

Nothing in this paragraph shall affect the rights under section 56 of any Government department or of any person authorised in writing by a Government department.New deposits4.—

Where the international depositary authority with which a deposit or a new deposit of a culture has been made under this Schedule —

notifies the applicant or proprietor that it —

cannot satisfy a request made in accordance with paragraph 2(1) or 3(4); or[S 688/2021 wef 01/10/2021](ii)is not able lawfully, to satisfy such a request, for the culture to be made available;

ceases temporarily or permanently to carry out the functions of an international depositary authority; or

ceases for any reason to conduct its activities as an international depositary authority in an objective and impartial manner,subject to sub-paragraph (3), the applicant or proprietor may, unless the culture has been transferred to another international depositary authority which is able to make it available, make a new deposit of a culture of the micro-organism.

For the purposes of paragraph 1 and this paragraph, the deposit shall be treated as always having been available if, within 3 months of the receipt of such notification or of the international depositary authority ceasing to perform the functions of an international depositary authority or to conduct its activities as such an authority in an objective and impartial manner, the applicant or proprietor —

in a case where the deposit has not already been transferred, makes the new deposit;

furnishes to the international depositary authority with which the new deposit is made a declaration that the culture so deposited is of the same micro-organism as was the culture originally deposited; and

requests amendment of the specification under section 31 or 38, as the case may be, so as to indicate the accession number of the transferred or new deposit and, where applicable, the name of the international depositary authority with which the deposit has been made.

The new deposit referred to in sub-paragraph (1) —

shall, subject to sub-paragraph (b), be made with the same international depositary authority as was the original deposit; or

in the cases referred to in sub-paragraphs (1)(a)(ii), (b) and (c), shall be made with another international depositary authority which is able to satisfy the request.Definitions

carries out the functions of receiving, accepting and storing micro-organisms and the furnishing of samples thereof; and

conducts its affairs in so far as they relate to the carrying out of those functions in an objective and impartial manner;“international depositary authority” means a depositary institution which has acquired the status of international depositary authority as provided in Article 7 of the Budapest Treaty.