EXPLANATORY STATEMENT
STATUTORY RULES 1989 NO. 390
Issued by the Authority of the Minister of State for Industry, Technology and Commerce
The Statutory Rules amend the Patents Regulations to make implementing regulations for the Patents Amendment Act 1989 which replaces the present procedures for extending the term of a standard patent with new provisions enabling one-off 4 year extensions of term for certain standard patents for pharmaceutical substances for human use. Details of the amendments are as follows:
Regulation 1 cites the “Principal Regulations” as the Patents Regulations.
Regulation 2 amends subregulation 29(1) by adding a reference to new item 15A of Schedule 2, which sets out annual renewal fees for a patent whose term has been extended under section 95 of the Act (see regulation 7, below).
Regulation 3 repeals existing regulations 37, 38 and 39 and substitutes new regulations 37 to 39 and 39A to 39D.
New regulation 37 requires that an application for an extension of the term of a patent relating to a pharmaceutical substance must be in accordance with new Form 22A and be accompanied by the prescribed fee.
New regulation 38 prescribes for the purposes of section 91 of the Act the period within which the marketing approval certificate and a proposed claim or claims shall be given to the Commissioner, and requires the lapsing of an application under section 91 to be advertised in the Official Journal.
New regulation 39 provides that a marketing approval certificate must be in accordance with new Form 23.
New regulation 39A prescribes for the purposes of paragraph 93(2)(c) of the Act certain documents given to the Commissioner in relation to an application for extension. Under section 93, these prescribed documents are open to public inspection.
New regulation 39B prescribes the period within which a person may oppose an application for extension of the term of a patent relating to a pharmaceutical substance.
New regulation 39C requires particulars of a granted extension of term to be entered in the Register of Patents.
New subregulation 39D(1) requires a person who files an appeal under section 96B of the Act to request, within 7 days, the Commissioner to advertise the appeal in the Official Journal. New subregulation 39D(2) requires the appellant to request, within 7 days, the Commissioner to advertise in the Official Journal a final order or judgement of the Federal Court in relation to an appeal. New subregulation 39D(3) requires the Commissioner to publish an advertisement, in accordance with a request under subregulation (1) or (2), that states the particulars of the appeal or order. New subregulation 39D(4) defines the terms ‘appeal’ and ‘Federal Court’ within the meaning of new regulation 39D.
Regulation 4 makes a consequential amendment to the heading to Division 1 of Part XIV.
Regulation 5 repeals existing Division 2 of Part XIV and substitutes a new Division 2: “Proceedings in Cases of Opposition to Extension of the Term of a Standard Patent”.
New regulation 65 provides definitions of certain terms for the purposes of new Division 2.
New subregulation 66(1) specifies requirements for notices of opposition to an application for extension of term. New subregulation 66(2) provides for the Commissioner to allow the opponent to amend a notice of opposition if the amendment is necessary, and no other person will be unduly prejudiced. New subregulation 66(3) requires that the Commissioner, before allowing the amendment, must be satisfied that the applicant has been notified of the amendment, and give the parties involved opportunity to make representations about the proposed amendment. New subregulation 66(4) requires the opponent, within 14 days of giving the notice to the Commissioner, to serve on the applicant a copy of the notice or amended notice and each declaration not previously served on the applicant. New subregulation 66(5) provides for the withdrawal of an opposition to an application for an extension of term.
New regulation 67 requires notice of an opposition to be published in the Official Journal.
New regulation 68 requires that an applicant who has received a notice under subregulation 66(4) must within 3 months serve on the opponent a copy of any declarations on which the applicant intends to rely, and within 14 days of that service give the Commissioner each of those declarations and a notice specifying when and were the copies were served.
New subregulation 69(1) allows the Commissioner, on application or on his own motion, to give directions for the conduct of proceedings to which this Division applies. New subregulation 69(2) allows the Commissioner, on the application of a party to opposition proceedings, to permit the party to serve and lodge further declarations. New subregulation 69(3) requires that the
Commissioner, before giving a direction or allowing an application under the previous subsections, must be satisfied that the other party has been notified of the application or proposed action, and must give the parties an opportunity to make representations about the application or proposed action.
New regulation 70 provides that the Commissioner may extend the time, upon request, for a party to take any step under this Division, provided that the other party has been notified of the application, and that the parties have been given an opportunity to make representations concerning the proposed extension of time.
New regulation 71 sets out procedures for holding a hearing.
New regulation 71A allows the Commissioner to receive representations under specified provisions (which relate to amendment of notices, giving directions, lodgement of further declarations, and extensions of time) from the parties by correspondence or telephone and, if satisfied that each party is aware of all the representations, to act under those provisions without holding a hearing.
New regulation 71B allows the Commissioner, when making a determination on an application for an extension of term, to inform himself or herself of a fact by reference to documents in his or her custody, provided that the parties concerned have copies of, or, access to the documents; that they are aware that the Commissioner intends to refer to the document; and that they have had an opportunity to provide evidence or make representations regarding the fact or document.
New regulation 71C requires the Commissioner to send a copy of a determination under section 95 to each party.
New regulation 71D provides for the taxing, allowance, certification and review of costs.
Regulation 6 amends and omits certain forms and inserts new Forms 22A, 23 and 29A relating to extensions of term into the First Schedule to the Principal Regulations.
Regulation 7 amends Schedule 2 to the Principal Regulations by inseting new fee items 12A, 12B and 15A and amending fee items 9 and 19.
Regulation 8 provides that amendments made by these Regulations do not apply in relation to any proceedings that were pending under Part IX of the Act on 3 June 1988.