PATENTS REGULATIONS (AMENDMENT) 1987 NO. 78 PATENTS REGULATIONS (AMENDMENT) 1987 NO. 78 - TABLE OF PROVISIONS 1. Interpretation 3. Documents other than specifications 4. Part IVB 5. Review of certain decisions by the Administrative Appeals Tribunal 6. First Schedule 1987 No. 78 PATENTS REGULATIONS (AMENDMENT) - REG 1 Interpretation 1. These Regulations shall come into operation on 7 July 1987. 2. Regulation 4 of the Patents Regulations is amended by inserting in subregulation (1) after the definition of "basic documents" the following definition: " 'Budapest Treaty Regulations' means the Regulations referred to in the definition of 'Budapest Treaty' in section 6 of the Act as affected by any amendments referred to in that definition;". 1987 No. 78 PATENTS REGULATIONS (AMENDMENT) - REG 3 Documents other than specifications 3. Regulation 6 of the Patents Regulations is amended by omitting from subregulation (2) "Documents" and substituting "Subject to subregulation 19ZB (2), documents". 1987 No. 78 PATENTS REGULATIONS (AMENDMENT) - REG 4 Part IVB 4. After Part IVA of the Patents Regulations the following Part is inserted: "PART IVB-APPLICATIONS INVOLVING MICRO-ORGANISMS Interpretation of Part IVB "19ZA. For the purposes of this Part, a reference, in relation to a micro-organism deposited with a prescribed depositary institution, being an international depositary authority whether in or outside Australia, to an undertaking is a reference to an undertaking given in accordance with paragraph (d) of Form 37 in respect of that micro-organism. Prescribed documents: subsection 35 (5) of the Act "19ZB. (1) The following documents are prescribed, for the purposes of subsection 35 (5) of the Act, for lodgment where a micro-organism is deposited with a prescribed depositary institution, being an international despositary authority whether in or outside Australia, for the purposes of section 40 of the Act in relation to a patent application or patent: (a) where that deposit of that micro-organism is an original deposit within the meaning of Rule 7.3 of the Budapest Treaty Regulations or a new deposit within the meaning of Rule 7.4 of those Regulations-a copy of the receipt, referred to in Rule 7.1 of those Regulations, issued by that authority; (b) where samples of that micro-organism were transferred to that authority under Rule 5.1 (a) (i) of those Regulations-a copy of the receipt, referred to in Rule 7.5 of those Regulations, issued by that authority; (c) a declaration by the applicant or patentee in accordance with Form 36 in respect of that deposit; and (d) where a document referred to in paragraph (a) or (b) is not in the English language-another document setting out a translation verified by declaration or otherwise to the satisfaction of the Commissioner. "(2) Subregulation 6 (2) does not apply in respect of a document referred to in paragraph (1) (a), (b), (c) or (d). Lodgment of prescribed documents "19ZC. For the purposes of subsection 35 (5) of the Act, where a micro-organism is deposited with a prescribed depositary institution, being an international depositary authority whether in or outside Australia, for the purposes of section 40 of the Act in relation to a patent application or patent: (a) a document referred to in paragraph 19ZB (1) (a), a translation, if required under paragraph 19ZB (1) (d), and a declaration referred to in paragraph 19ZB (1) (c) in respect of that deposit shall be lodged at the Patent Office by or on behalf of the applicant or patentee: (i) where that deposit of that micro-organism is an original deposit within the meaning of Rule 7.3 of the Budapest Treaty Regulations-within 3 months after the date of lodgment of the specification in respect of that patent application or patent; or (ii) where that deposit of that micro-organism is a new deposit within the meaning of Rule 7.4 of those Regulations-within 3 months after the date of lodgment of the specification in respect of that patent application or patent or the date on which that new deposit was effected, whichever is the later date; and (b) a document referred to in paragraph 19ZB (1) (b) relating to the transfer of a sample of that micro-organism under Rule 5.1 (a) (i) of the Budapest Treaty Regulations to that authority, a translation, if required under paragraph 19ZB (1) (d), and a declaration referred to in paragraph 19ZB (1) (c) in respect of that transfer shall be lodged at the Patent Office by or on behalf of the applicant or patentee within 3 months after that transfer was effected. Prescribed period: paragraph 40 (5) (c) of the Act "19ZD. (1) For the purposes of paragraph 40 (5) (c) of the Act, where a micro-organism is deposited with a prescribed depositary institution, being an international depositary authority whether in or outside Australia, for the purposes of section 40 of the Act in relation to a patent application or patent, the prescribed period is the period that ends at the expiration of: (a) 3 months after the specification is lodged in respect of that patent application or patent; or (b) subject to subregulation (2), such longer period as the Commissioner allows on an application made in accordance with Form 11 lodged at the Patent Office before or after the expiration of the 3 months referred to in paragraph (a). "(2) Subject to section 160 of the Act, the period referred to in paragraph (1) (b) shall not extend beyond 15 months after: (a) where the patent application was for, or the patent was, a standard patent: (i) if the complete specification lodged in respect of that patent application or patent contains only one claim-the priority date of that claim; (ii) if that complete specification contains more than one claim and those claims have the same priority date-that priority date; or (iii) if that complete specification contains more than one claim and those claims have more than one priority date-the earlier or earliest, as the case may be, of those priority dates; or (b) where the patent application was for, or the patent was, a petty patent-the priority date of the claim of the petty patent specification lodged in respect of that patent application or patent. Commissioner may request samples and viability statement "19ZE. (1) Where a micro-organism is deposited with a prescribed depositary institution, being an international depositary authority whether in or outside Australia, for the purposes of section 40 of the Act in relation to a patent application or patent, the Commissioner: (a) shall, on the order of a court in Australia; or (b) may, of his or her own motion or on application in writing by another person; for the purposes of proceedings before the Commissioner or any other legal proceedings in Australia: (c) make to that authority a request referred to in Rule 11.1 of the Budapest Treaty Regulations for a sample of that micro-organism; and (d) make in relation to that micro-organism the declaration referred to in that Rule. "(2) Unless a request under subregulation (1) is made on the order of a court, the Commissioner shall, before making the request, give the applicant or patentee concerned, and any other person who apparently has an interest in the request, an opportunity to be heard. "(3) Subject to subregulation 92 (2), where the Commissioner decides to make, or to refuse to make, a request under subregulation (1), the Commissioner shall inform the applicant or patentee concerned, and any other person who apparently has an interest in the request, of the decision, and of the reasons for the decision, by notice in writing given as soon as practicable after the date of the decision. "(4) Where a sample of a micro-organism has been furnished to the Commissioner in accordance with a request under subregulation (1), the Commissioner may make a request referred to in Rule 10.2 (a) (iii) of the Budapest Treaty Regulations for a statement concerning the viability of the micro-organism. Request for Commissioner's certificate authorising release of a sample of a micro-organism "19ZF. (1) Where a micro-organism is deposited with a prescribed depositary institution, being an international depositary authority whether in or outside Australia, for the purposes of section 40 of the Act in relation to a patent application or patent, a person may, in accordance with Form 37, request the Commissioner to grant, in respect of that deposit, the certification referred to in Rule 11.3 (a) of the Budapest Treaty Regulations. "(2) As soon as practicable after receiving a request by a person under subregulation (1), the Commissioner shall decide whether to: (a) comply with the request; (b) comply with the request subject to that person complying with such conditions as are reasonable including, without limiting that generality, a condition that that person give security for damages for any breach of the undertaking given by that person; or (c) refuse the request. "(3) The Commissioner shall, in accordance with paragraph (2) (a) or (b), comply with a request in respect of a patent application or patent: (a) if a declaration referred to in paragraph 19ZB (1) (c) in accordance with Form 36 has been lodged at the Patent Office in respect of that patent application or patent; (b) if the specification lodged in respect of that patent application or patent is open to public inspection; (c) unless the Commissioner is satisfied that a declaration set out in the request is false or misleading; (d) unless the Commissioner is satisfied that the undertaking is not given in good faith; (e) where the request is in respect of a patent and the person making the request is a person to whom the patentee has granted a licence under section 108 of the Act-if the Commissioner is satisfied that that licence provides that the person making the request has under that licence a right to obtain a sample of that micro-organism; and (f) where the request is in respect of a patent and the person making the request is a person who may make, use, exercise or vend the invention under subsection 125 (1) of the Act-if the Commissioner is satisfied that the terms for the making, use, exercise or vending of the invention provide that the person making the request has a right to obtain a sample of that micro-organism. "(4) Before making a decision under subregulation (2), the Commissioner shall give the person making the request, the applicant or patentee concerned, and any other person who apparently has an interest in the request, an opportunity to be heard. "(5) Subject to subregulation 92 (2), where the Commissioner makes a decision under subregulation (2), the Commissioner shall inform the person making the request, the applicant or patentee concerned, and any other person who apparently has an interest in the request, of the decision, and of the reasons for the decision, by notice in writing given as soon as practicable after the date of the decision. Breach of undertaking given in respect of a micro-organism "19ZG. (1) Where a micro-organism is deposited with a prescribed depositary institution, being an international depository authority whether in or outside Australia, for the purposes of section 40 of the Act in relation to a patent application or patent, an action or proceeding for breach of an undertaking may be instituted in a prescribed court by any person who is for the time being: (a) where a patent has not been granted on that patent application-an applicant in respect of that patent application; or (b) where a patent has been granted on that patent application or where the deposit is effected in relation to a patent-a patentee of, or an exclusive licensee under, that patent. "(2) In an action or proceeding referred to in subregulation (1) by an exclusive licensee in relation to a patent application or patent, the patentee shall, unless joined as a plaintiff, be joined as a defendant. "(3) A patentee joined as a defendant in an action or proceeding referred to in subregulation (1) by an exclusive licensee is not liable for costs unless the patentee enters an appearance and takes part in the proceedings. "(4) It is a defence to an action or proceeding for breach of an undertaking given in respect of a micro-organism to which a specification lodged in respect of a patent application or patent relates that the specification did not, when the matters complained of took place, comply with a requirement of paragraph 40 (5) (c) or (e) of the Act. "(5) A defendant may not plead a defence referred to in subregulation (4) in an action or proceeding for breach of an undertaking given in respect of a micro-organism to which a specification lodged in respect of a patent application or patent relates unless: (a) the defendant has, before becoming a defendant in that action or proceeding, lodged at the Patent Office under subregulation 19ZK (1) a notification in accordance with Form 38 of the requirement of paragraph 40 (5) (c) or (e) of the Act that has ceased to be satisfied; and (b) the applicant for the patent or the patentee, as the case requires, fails to take the steps referred to in paragraph 40 (7) (b) of the Act within the appropriate prescribed period prescribed by regulation 19ZO for the purposes of that last-mentioned paragraph. Procedure in action for breach of an undertaking "19ZH. In an action or proceeding referred to in subregulation 19ZG (1) in a prescribed court for breach of an undertaking: (a) the plaintiff shall deliver with the statement of claim or declaration, or, by order of the court or a Judge of that court, at a subsequent time, particulars of the breaches complained of; and (b) the defendant shall deliver with the statement of defence or plea, or, by order of the court or a Judge of that court, at a subsequent time, particulars of any objections on which the defendant relies. Relief in action for breach of an undertaking "19ZJ. (1) In an action or proceeding referred to in subregulation 19ZG (1) in a prescribed court, the court, or a Judge of that court, may, on the application of a party to the action or proceeding, make such order for inspection, and impose such terms and give such directions with respect to the inspection, as the court or Judge thinks fit. "(2) In an action or proceeding referred to in subregulation 19ZG (1) in a prescribed court for breach of an undertaking given in respect of a micro-organism, the court may grant such relief as the court thinks fit including, without limiting that generality: (a) an injunction on such terms as the court thinks fit; (b) an order for damages; (c) an order for an account of profits; (d) an order with respect to any security given pursuant to paragraph 19ZF (2) (b); or (e) an order on such terms as the court thinks fit to deliver to such persons as the court thinks fit the micro-organism or any things derived directly or indirectly from that micro-organism as a consequence of that breach including, without limiting that generality: (i) any products made by using that micro-organism; (ii) any other micro-organisms derived from that micro-organism; and (iii) any products made by using those other micro-organisms. Notification that a requirement of paragraph 40 (5) (c) or (e) of the Act has ceased to be satisfied "19ZK. (1) Where a requirement of paragraph 40 (5) (c) or (e) of the Act ceases to be satisfied in relation to a micro-organism to which a specification lodged in respect of a patent application or patent relates, a person other than the applicant or patentee may, after the specification has become open to public inspection, lodge at the Patent Office a notification in accordance with Form 38 of the requirement that has ceased to be satisfied. "(2) As soon as practicable after receiving a notification under subregulation (1) in relation to a micro-organism to which a specification lodged in respect of a patent application or patent relates, the Commissioner shall cause a copy of the notification to be given to the applicant or patentee. "(3) Where the Commissioner learns, otherwise than by a notification referred to in subregulation (1), of facts that may establish that a requirement of paragraph 40 (5) (c) or (e) of the Act has ceased to be satisfied in relation to a micro-organism to which a specification lodged in respect of a patent application or patent relates, the Commissioner shall cause a notification setting out those facts to be given to the applicant or patentee. "(4) As soon as practicable after the Commissioner receives a notification under subregulation (1) or gives a notification under subregulation (3), a notice of the receipt or giving of that notification shall be published in the Official Journal. "(5) The terms of a notification under subregulation (1) or (3) need not be published in the notice referred to in subregulation (4), but the notification shall be open to public inspection. "(6) In answer to a notification under subregulation (1) or (3) that a requirement of paragraph 40 (5) (c) or (e) of the Act has ceased to be satisfied in relation to a micro-organism to which a specification lodged in respect of a patent application or patent relates, the applicant or patentee may lodge at the Patent Office a written reply setting out the facts relied upon to establish that that requirement is satisfied. "(7) Where a reply lodged under subregulation (6) is in answer to a notification under subregulation (1) by a person, the Commissioner shall, as soon as practicable after receiving the reply, serve a copy of the reply on that person. "(8) As soon as practicable after a reply is lodged under subregulation (6), a notice of the lodgment of the reply shall be published in the Official Journal. "(9) The terms of a reply lodged under subregulation (6) need not be published in the notice referred to in subregulation (8), but the reply shall be open to public inspection. Amendment of specification to include a matter referred to in paragraph 40 (5) (c) of the Act "19ZL. (1) An applicant in respect of a patent application or a patentee of a patent may, by a request in writing lodged at the Patent Office, seek the leave of the Commissioner to amend the specification lodged in respect of that patent application, or that patent, as the case may be, for the purpose of including in the specification a matter referred to in paragraph 40 (5) (c) of the Act. "(2) A request under subregulation (1) shall be in accordance with Form 22 and shall specify the nature of, and the reasons for, the proposed amendment. "(3) Where a person is registered as a mortgagee or the exclusive licensee under a patent, a request under subregulation (1) for an amendment of the specification lodged in respect of the patent shall not be complied with unless the mortgagee or licensee has consented, in writing, to the request. "(4) If a mortgagee or licensee of a patent refuses to consent to a request under subregulation (1) for an amendment of the specification lodged in respect of the patent, the Commissioner may, on the application of the patentee, if the Commissioner is of the opinion that that consent has been unreasonably refused, direct that that consent shall not be necessary. "(5) Subregulations 34 (2), (3), (4) and (5) apply in respect of a request under subregulation (1). "(6) Where in relation to a micro-organism to which a specification lodged in respect of a patent application or patent relates: (a) a person has, under subregulation 19ZF (1), requested the Commissioner to grant the certification referred to in that subregulation; (b) the Commissioner has not granted that certification; and (c) the applicant or patentee has lodged under subregulation (1) a request seeking the leave of the Commissioner to amend that specification; the Commissioner shall, as soon as practicable after lodgment of the request referred to in paragraph (c), serve a copy of that last-mentioned request on the person referred to in paragraph (a). "(7) Where a request under subregulation (1) is for amendment of a specification that is open to public inspection, the Commissioner shall, as soon as practicable after the request has been lodged at the Patent Office, advertise particulars of the request in the Official Journal. "(8) Where a request under subregulation (1) for amendment of a specification that is open to public inspection is for the purpose of including in the specification a matter in respect of which a notification has been lodged at the Patent Office by a person under subregulation 19ZK (1), the Commissioner shall, as soon as practicable after the request has been lodged at the Patent Office, serve a copy of the request on that person. "(9) Where a request under subregulation (1) is for amendment of the specification lodged in respect of a patent application or patent and the specification is open to public inspection, the Commissioner shall, before making a decision under subregulation (11), give the following persons an opportunity to be heard: (a) any person to whom paragraph (6) (a) or subregulation (8) applies in respect of that request; (b) any person who has notified the Commissioner within the period referred to in subregulation (12) that the person has an interest in the request; and (c) where there is a person referred to in paragraph (a) or (b) or where there is no such person but the Commissioner proposes not to comply with the request-the applicant or patentee, as the case requires. "(10) The Commissioner shall not comply with a request under subregulation (1) to amend a specification unless it would, after amendment in accordance with the request, include a matter referred to in paragraph 40 (5) (c) of the Act. "(11) Subject to subregulation (12) and regulation 19ZM, as soon as practicable after receiving a request under subregulation (1) and, if required to do so, complying with subregulation (6), (7), (8) or (9), the Commissioner shall decide whether to comply with or refuse the request. "(12) Where a request under subregulation (1) is for amendment of a specification that is open to public inspection, a decision under subregulation (11) shall not be made until after a period of 3 months after the date on which particulars of the request are advertised in the Official Journal under subregulation (7). "(13) Upon a decision under subregulation (11) to comply with a request for an amendment of a specification, the amendment shall be deemed to have been made. "(14) Where a decision under subregulation (11) to comply with a request for amendment of a specification is made after the specification has become open to public inspection, the Commissioner shall advertise particulars of the amendment in the Official Journal. "(15) Where the Commissioner decides to comply with, or to refuse, a request under subregulation (1), the Commissioner shall inform the applicant or patentee concerned, and the persons referred to in subregulation (9), of the decision, and of the reasons for the decision, by notice in writing given as soon as practicable after the date of decision. No amendment under regulation 19ZL where certain actions or proceedings are pending "19ZM. Subregulation 19ZL (11) does not apply in respect of a specification lodged in respect of a patent while there is pending: (a) an action for an infringement of the patent; (b) a proceeding for revocation of the patent; or (c) a proceeding in which: (i) in the case of a standard patent-the validity of the patent or of a claim of the complete specification is disputed; or (ii) in the case of a petty patent-the validity of the petty patent or of the claim of the petty patent specification is disputed; whether commenced before or after the lodging under subregulation 19ZL (1) of a request for leave to amend the specification. Court may direct amendment "19ZN. (1) In: (a) an action in a court for an infringement of a patent; (b) a proceeding in a court for revocation of a patent; or (c) a proceeding in a court: (i) in which the validity of a standard patent, or of a claim of the complete specification of a standard patent, is disputed; or (ii) in which the validity of a petty patent or of the claim of the specification of a petty patent is disputed; the court or a Judge of that court may, at any time, for the purpose of including a matter referred to in paragraph 40 (5) (c) of the Act, by order made on the application of the patentee, subject to any terms as to costs, advertisements or otherwise that the court or Judge imposes, direct the amendment of the specification in the manner specified in the order. "(2) The patentee shall give notice of an application for an order under subregulation (1) to the Commissioner who shall be entitled to appear and be heard and shall appear if the court or Judge referred to in that subregulation so directs. "(3) A copy of an order made under subregulation (1) shall be lodged by the patentee at the Patent Office within 14 days after the sealing of the order and upon lodgment the specification shall be deemed to have been amended in the manner specified in the order. Appropriate prescribed period: paragraph 40 (7) (b) of the Act "19ZO. For the purposes of paragraph 40 (7) (b) of the Act, where a micro-organism is deposited with a prescribed depositary institution, being an international depositary authority whether in or outside Australia, for the purposes of section 40 of the Act in relation to a patent application or patent and a requirement of paragraph 40 (5) (c) or (e) of the Act ceases to be satisfied in relation to the micro-organism, the appropriate prescribed period is: (a) where the step referred to in paragraph 40 (7) (b) of the Act is the making of a new deposit of a sample of that micro-organism: (i) where the Commissioner has given under subregulation 19ZK (2) the applicant or patentee a copy of a notification of that requirement-the period that ends 3 months after that copy was so given; (ii) where the Commissioner has given under subregulation 19ZK (3) to the applicant or patentee a notification of that requirement-the period that ends 3 months after that notification was so given; (iii) where under Article 4 (1) of the Budapest Treaty the international depositary authority has notified the depositor of its inability to furnish samples of that micro-organism and the Commissioner has not, before that notification by that authority, given under subregulation 19ZK (2) or (3) to the applicant or patentee a copy of a notification or a notification, as the case may be, of that requirement-the period of 3 months referred to in Article 4 (1) (d) of that Treaty; or (iv) in any other case-the period that ends when that new deposit is so made; or (b) where the step referred to in paragraph 40 (7) (b) of the Act is an amendment of the specification lodged in respect of that patent application or patent: (i) where the Commissioner has given under subregulation 19ZK (2) to the applicant or patentee a copy of a notification of that requirement-the period that ends when the Commissioner decides under subregulation 19ZL (11) to comply with a request under subregulation 19ZL (1) for the amendment, being a request lodged under that subregulation within 3 months after that copy was so given; (ii) where the Commissioner has given under subregulation 19ZK (3) to the applicant or patentee a notification of that requirement-the period that ends when the Commissioner decides under subregulation 19ZL (11) to comply with a request under subregulation 19ZL (1) for that amendment, being a request lodged under that subregulation within 3 months after that notification was so given; or (iii) in any other case-the period that ends when the Commissioner decides under subregulation 19ZL (11) to comply with a request under subregulation 19ZL (1) for that amendment of that specification. Protection or compensation of certain persons: subsection 40 (7) of the Act "19ZP. (1) For the purposes of subsection 40 (7) of the Act, a person who availed himself or herself, or took definite steps by contract or otherwise to avail himself or herself, of: (a) an invention to the extent that the invention is a micro-organism; or (b) an invention that involves the use, modification or cultivation of a micro-organism; being an invention that is the subject-matter of patent application or patent, during a period between the times referred to in paragraphs 40 (7) (a) and (b) of the Act when a requirement of paragraph 40 (5) (c) or (e) of the Act was not satisfied in respect of that application or patent, may, during the period that commences on the date of publication in the Official Journal of the notice referred to in subregulation 19ZK (4) that that requirement ceased to be satisfied and ends at the time referred to in paragraph 40 (7) (b) of the Act, apply to the Commissioner in accordance with Form 27 for a licence to make, use, exercise or vend that subject-matter to the extent that the person so availed himself or herself, or took definite steps by contract to avail himself or herself, of that subject-matter during that first-mentioned period. "(2) A person who applies under subregulation (1) for a licence to make, use, exercise or vend the subject-matter of a patent application or patent shall serve a copy of the application for the licence on the applicant in respect of that patent application or the patentee of that patent, as the case requires, and on such other persons as the Commissioner directs. "(3) A person on whom a copy of an application for a licence has been served under subregulation (2) may, within a period of one month after that service or within such further time as the Commissioner allows on an application made in accordance with Form 11 within that period, give in accordance with Form 12 notice of opposition to the application for that licence. "(4) A person who gives under subregulation (3) a notice of opposition to an application for a licence to make, use, exercise or vend the subject-matter of a patent application or patent shall serve a copy of that notice on the applicant for the licence and on such other person as the Commissioner directs. "(5) The Commissioner shall hear an application under subregulation (1) for a licence and if satisfied that it is proper to do so may: (a) grant the licence on such terms as are reasonable; or (b) dismiss the application. Applications under subsection 154A (1) of the Act "19ZQ. (1) An application under subsection 154A (1) of the Act for a declaration that the specification lodged in respect of a patent application or patent, being a complete specification or a petty patent specification, does not comply with the requirements of section 40 of the Act unless the requirements of subsection 40 (5) of the Act are satisfied in relation to a micro-organism, shall: (a) be made in writing to a prescribed court or to the Commissioner; (b) be lodged at that court or the Patent Office, as the case requires; (c) state the name and business, or residential, address of the applicant for the declaration: (d) state an address for service on the applicant for the declaration of documents relating to the application for the declaration; (e) identify the patent application or patent, as the case requires; (f) state that the invention that is the subject-matter of that patent application or patent, as the case requires, involves the use, modification or cultivation of a micro-organism other than a micro-organism referred to in subsection 40 (4) of the Act; (g) state that that micro-organism was, at the date of lodgment of that specification, reasonably available to a person skilled in the art; (h) state that, but for the fact referred to in paragraph (g), subsection 40 (3) of the Act would have applied in relation to the invention referred to in paragraph (f); (i) state that that micro-organism has since ceased to be reasonably available to a person skilled in the art; and (j) set out details of any facts relied upon to justify any of the statements referred to in paragraph (f), (g), (h) or (i). "(2) A person who applies under subregulation (1) to a prescribed court or the Commissioner for a declaration concerning a specification lodged in respect of a patent application or patent shall serve a copy of the application for the declaration on the applicant or patentee, as the case requires, and on such other person as the court or Commissioner directs. "(3) Where the Commissioner of his or her own motion proposes to declare under subsection 154A (1) of the Act that the specification lodged in respect of a patent application or patent does not comply with the requirements of section 40 of the Act unless the requirements of subsection 40 (5) of the Act are satisfied in relation to a micro-organism, the Commissioner shall cause to be served on the applicant or patentee, as the case requires, a statement of the facts relied upon to justify the making of that declaration. "(4) A person on whom a copy of an application under subregulation (1) has been served, or on whom a statement under subregulation (3) has been served, may, within 3 months after that service, give to the prescribed court to which the application is made or to the Commissioner, as the case requires, a reply to that application or statement. "(5) A person who gives under subregulation (4) to a prescribed court or the Commissioner a reply to an application under subregulation (1) for a declaration concerning the specification lodged in respect of a patent application or patent shall serve a copy of that notice on the applicant or patentee, as the case requires, and on such other persons as the court or Commissioner directs. "(6) As soon as practicable after a copy of a declaration by a court under subsection 154A (1) of the Act is served on the Commissioner under subsection 154A (5), a notice of the making of that declaration shall be published in the Official Journal. "(7) As soon as practicable after the making of a decision of the Commissioner under subsection 154A (1) of the Act, a notice of the making of the decision shall be published in the Official Journal. "(8) The terms of a declaration referred to in subregulation (6) or of a decision referred to in subregulation (7) need not be published in the Official Journal, but the declaration or decision shall be open to public inspection at the Patent Office.". 1987 No. 78 PATENTS REGULATIONS (AMENDMENT) - REG 5 Review of certain decisions by the Administrative Appeals Tribunal 5. Regulation 92 of the Patents Regulations is amended: (a) by omitting "sub-regulation 7B (8) or (12) or" and substituting "subregulation 7B (8) or (12),"; (b) by inserting ", paragraph 19ZE (1) (b), subregulation 19ZF (2), 19ZL (4), 19ZL (11) or 19ZP (5)," after "regulation 7B)"; and (c) by adding at the end the following subregulations: "(2) A notice of a decision referred to in subregulation (1) that the Commissioner is required by the Act or these Regulations to give to a person whose interests are affected by that decision shall include a statement to the effect that, subject to the Administrative Appeals Tribunal Act 1975, application may be made to the Administrative Appeals Tribunal for review of the decision to which the notice relates by or on behalf of a person whose interests are affected by the decision. "(3) Failure to comply with the requirements of subregulation (2) in relation to a decision shall not be taken to affect the validity of the decision. "(4) A notice referred to in subregulation (2) may be sent by pre-paid ordinary post to the person concerned at the person's address last known to the Commissioner.". 1987 No. 78 PATENTS REGULATIONS (AMENDMENT) - REG 6 First Schedule 6. The First Schedule to the Patents Regulations is amended: (a) by omitting from Form 22 "Regulation 34" and substituting "Subregulation 19ZL (2) and regulation 34"; (b) by omitting Form 27 and substituting the following form: "FORM 27 Sub-regulations 16F (2), 19ZP (1), 50 (2) and 81A (1) COMMONWEALTH OF AUSTRALIA APPLICATION FOR LICENCE I, (insert full name of applicant), of (insert business or residential address of applicant, not being a post box address), hereby apply under section 159C of the Patents Act 1952 (or) under subregulation 16F (2) (or) 19ZP (2) (or) 50 (2) of the Patents Regulations (omit whichever are not applicable) for the grant of a licence to make, use, exercise or vend (vary these words if necessary in accordance with the kind of licence applied for) the invention that is the subject of Application No. (or) Patent No. (omit whichever is not applicable) The grounds upon which this application is made are as follows: My address for service is: Dated this day of 19 . (Signature) To: The Commissioner of Patents"; and (c) by adding at the end the following forms: "FORM 36 Paragraphs 19ZB (1) (c) and 19ZF (3) (a) COMMONWEALTH OF AUSTRALIA DECLARATION CONCERNING THE DEPOSIT, IN RELATION TO A PATENT APPLICATION OR PATENT, OF A MICRO-ORGANISM WITH AN INTERNATIONAL DEPOSITARY AUTHORITY (A declaration should relate to only one deposit) * In the matter of the application made by (insert name of applicant for patent) for a patent. * In the matter of the patent held by (insert name of patentee) for an invention entitled (insert title of patent). * I, (insert full name of declarant), of (insert address of place of business or residence of declarant), declare as follows: * 1. I am the *applicant for the patent for (or) *patentee of the invention referred to above. (or, in the case of an application by a body corporate) * 1. I am authorised by (insert full name of the applicant for the patent), the *applicant for the patent for (or) *patentee of the invention referred to above, to make this declaration on its behalf. 2. A micro-organism was deposited with (insert name of international depositary authority) on (insert date on which the deposit was made) and accorded (state whether that authority gave the deposit a file, accession or registration number and state that number). 3. The deposit referred to in paragraph 2 was: *(a) an original deposit within the meaning of Rule 7.3 of the Budapest Treaty Regulations. *(b) a new deposit within the meaning of Rule 7.4 of the Budapest Treaty Regulations. *(c) a sample that was transferred to that international depositary authority under Rule 5.1 (a) (i) of the Budapest Treaty Regulations. 4. Samples of that micro-organism are obtainable from that international depositary authority as provided by: (a) such provisions of the Budapest Treaty on the Intenational Recognition of the Deposit of Micro Organisms for the purposes of Patent Procedure, and the Regulations annexed to that Treaty as affected by any amendments made under Article 12 of that Treaty, as are applicable; and (b) such provisions of the Patents Regulations as are applicable. *5. * I am (or) * The applicant for the patent for the invention referred to above is (or) * The patentee of the invention referred to above is the depositor, within the meaning of Article 2 of the Budapest Treaty, of the deposit referred to in paragraph 2. *5. The depositor, within the meaning of Article 2 of the Budapest Treaty, of the deposit referred to in paragraph 2 is (insert full name and address of place of business or residence of depositor). 6. * I rely (or) * I have the consent of the depositor referred to above to rely (or) * The applicant for the patent for the invention referred to above relies (or) * The applicant for the patent for the invention referred to above has the consent of the depositor referred to above to rely (or) * The patentee of the invention referred to above has the consent of the depositor referred to above to rely on that deposit for the purposes of section 40 of the Patents Act 1952 in relation to * the application for the patent (or) * the patent for the invention referred to above. *(Omit whichever is inapplicable) Declared at this day of 19 . (Signature of declarant) ------------ To: The Commissioner of Patents Lodged by: (insert the name and address of the person who lodges this declaration and the name of any person on whose behalf it is lodged) "FORM 37 Regulation 19ZA and subregulation 19ZF (1) COMMONWEALTH OF AUSTRALIA REQUEST FOR COMMISSIONER'S CERTIFICATION AUTHORISING RELEASE OF A SAMPLE OF A MICRO-ORGANISM I, (insert full name of person making request) of (insert business or residential address of person, not being a post box address), hereby: (a) declare that a micro-organism was deposited with (insert name and address of the international depositary authority) under file, accession or registration No. (insert number of the deposit given by that authority) on (insert date on which that micro-organism was deposited) and that samples of that micro-organism are obtainable from that authority as provided by the rules relating to micro-organisms; (b) declare that that micro-organism and the name of that international depositary authority are referred to in the specification for patent application (if patent has been granted, omit 'application') No. (insert number of patent application or patent, as the case requires); (c) declare that the invention to which that patent application (if patent has been granted, omit 'application') applies is that micro-organism or involves the use, modification or cultivation of that micro-organism; (d) give an undertaking, if a sample of that micro-organism is furnished in accordance with this request: (i) not to make that micro-organism, or any culture derived from that micro-organism, available to any other person; and (ii) to use that micro-organism only for experimental purposes; during any period when that patent application, or any patent granted in accordance with that application, is in force (if patent has been granted, omit 'application, or any patent granted in accordance with that application,') and: (iii) if that patent application lapses under subsection 47D (1) of the Patents Act 1952-the period of 9 months after that application so lapses; or (omit this subparagraph if the patent application is not an international application or if patent has been granted) (iv) if that patent application lapses under subsection 47D (1) of the Patents Act 1952-the period of 6 months after that application so lapses; or (omit this subparagraph if the patent application is an international application or if patent has been granted) (v) if the patent granted in accordance with that patent application ceases under subsection 68 (2) of the Patents Act 1952-the period of 6 months after that cessation (if patent has been granted, omit 'the patent granted in accordance with that patent application' and substitute 'that patent'); and (if that patent application or patent, as the case may be, is not in force and if the period referred to in subparagraph (d) (iii), (iv) or (v), as the case may be, has expired, omit paragraph (d) and insert the following paragraph:) (e) declare that that patent application (if patent has been granted, omit 'application') is not in force because of the following circumstances: (set out those circumstances); and (if patent has been granted and the person making the request is a person to whom the patentee has granted a licence under section 108 of the Act, omit paragraph (d) and insert the following paragraph:) (f) declare that the patentee of that patent has granted under section 108 of the Patents Act 1952 the following licence to the person making the request: (set out details of the compulsory licence that was granted) upon terms a copy of which is set out in an annexure to this request; and (if the person making the request makes, uses, exercises or vends the invention to which that patent application or that patent refers under subsection 125 (1) of the Patents Act 1952, omit paragraph (d) and insert the following paragraph:) (g) declare that the person making the request makes, uses, exercises or vends the invention to which that patent application (if patent has been granted, omit 'application') refers under subsection 125 (1) of the Act upon terms a copy of which is set out in an annexure to this request; and (h) request the Commissioner under subregulation 19ZF (1) of the Patents Regulations to furnish to me the certification referred to in paragraph (a) of Rule 11.3 of the Budapest Treaty Regulations. My address for service is: (insert an address in Australia which may be a post box address). ...................................... (Insert signature of person making the request) ...................................... (Insert name and address of that person's patent attorney, if any) ------------ "FORM 38 Paragraph 19ZG (5) (a) and subregulation 19ZK (1) COMMONWEALTH OF AUSTRALIA NOTIFICATION THAT A REQUIREMENT OF PARAGRAPH 40 (5) (c) or (e) OF THE PATENTS ACT 1952 HAS CEASED TO BE SATISFIED IN RELATION TO A MICRO-ORGANISM I, (insert full name of person giving the notification), of (insert business or residential address of person, not being a post box address), in accordance with subregulation 19ZK (1) of the Patents Regulations hereby: (a) declare that a micro-organism was deposited with (insert name and address of the international depositary authority) under file, accession or registration No. (insert number of deposit given by that authority) on (insert date on which the micro-organism was deposited); (b) declare that that micro-organism is referred to in the specification in respect of patent application (if patent has been granted, omit 'application') No. (insert number of patent application or patent, as the case requires); (c) declare that the following *requirement *requirements of paragraph 40 (5) (c) or (e) of the Act *has *have ceased to be satisfied in relation to that patent application (if patent has been granted, omit 'application'): (set out that requirement or those requirements); and (d) declare that the following facts are relied upon to establish that *that requirement is (or) *those requirements are not satisfied: (set out a statement of those facts). My address for service is: (insert an address in Australia which may be a post box address). *(Omit whichever is inapplicable) ...................................... (Insert signature of person giving the notification) ...................................... (Insert name and address of that person's patent attorney, if any)". - NOTES 1987 No. 78*1* PATENTS REGULATIONS*2* (AMENDMENT) *1* Notified in the Commonwealth of Australia Gazette on 20 May 1987. *2* Statutory Rules 1962 No. 2 as amended by 1963 No. 52; 1965 No. 102; 1969 No. 151 (as amended by 1969 No. 212); 1974 Nos. 38 and 262; 1975 No. 201; 1976 No. 236; 1977 No. 177; 1979 No. 93; 1980 Nos. 68 and 320; 1981 Nos. 1, 202, 203, 243 and 372; 1982 Nos. 232 and 350; 1983 Nos. 48, 206 and 325; 1984 Nos. 254 and 435; 1985 No. 316; 1986 No. 259.