Patents Regulations (Amendment) (Cth)

Statutory Rules 1989 No. 3901

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Patents Regulations2 (Amendment)

I, THE GOVERNOR-GENERAL of the Commonwealth of Australia, acting with the advice of the Federal Executive Council and under section 4 of the Acts Interpretation Act 1901,hereby make the following Regulations under the Patents Act 1952.

Dated 14 December 1989.

BILL HAYDEN

Governor-General

By His Excellency’s Command,

JOHN N. BUTTON

Minister of State for Industry, Technology

and Commerce

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Interpretation

1. In these Regulations, “Principal Regulations” means the Patents Regulations.

Renewal fees

2. Regulation 29 of the Principal Regulations is amended by inserting “or 15A” after “15”.

3. Regulations 37, 38 and 39 of the Principal Regulations are repealed and the following regulations substituted:

Application for extension of the term of a standard patent relating to a pharmaceutical substance

“37. An application under section 90 of the Act for an extension of the term of a patent mentioned in that section must:

(a) be made in accordance with Form 22A; and

(b) be accompanied by the prescribed fee.

Application for extension to lapse in certain circumstances

“38. (1) For the purposes of section 91 of the Act, the prescribed period is the period of 1 month, or any greater period that the Commissioner allows, from the date of:

(a) the sending to the patentee of the certificate mentioned in paragraph (a) of that section; or

(b) the making of the application mentioned in that section;

whichever is later.

“(2) Where an application has lapsed by virtue of that section, the Commissioner must, on becoming aware of the lapsing, publish in the Official Journal a notice to that effect.

Issue of marketing approval certificate

“39. For the purposes of section 92 of the Act, a marketing approval certificate must be in accordance with Form 23.

Public inspection—prescribed documents

“39a. For the purposes of paragraph 93 (2) (c) of the Act, documents given to the Commissioner under paragraph 66 (1) (b) or 68 (a) are prescribed.

Opposition to extension—prescribed period

“39B. For the purposes of section 94 of the Act, the period prescribed for a person mentioned in that subsection to oppose the grant of an extension of the term of a patent is the period of 3 months from the publication in the Official Journal of a notice under subsection 93 (1) of the Act in respect of the application for the extension.

Grant of extension to be entered in Register

“39c. Where the Commissioner grants under section 95 of the Act an extension of the term of a patent, the Commissioner must cause particulars of the extension to be entered in the Register of Patents.

Appeals

“39D. (1) A person who files an appeal must, within 7 days, request the Commissioner to advertise the appeal in the Official Journal.

“(2) Where the Federal Court makes a final order or judgment in relation to an appeal, the appellant must, within 7 days, request the Commissioner to advertise the order in the Official Journal.

“(3) The Commissioner must publish an advertisement, in accordance with a request under subregulation (1) or (2), that states the particulars of the appeal or order, as the case may be.

“(4) In this regulation, unless the contrary intention appears:

‘appeal’ means an appeal filed under section 96b of the Act;

 

‘Federal Court’ includes a judge or registrar of the Court and, in relation to a matter that is the subject of appeal from the Court to the High Court, is to be taken to include the High Court.”.

Division 1 of Part XIV—amendment of heading

4. The heading to Division 1 of Part XIV of the Principal Regulations is amended by omitting “95” and substituting “94”.

5. Division 2 of Part XIV of the Principal Regulations is repealed and the following division substituted:

“Division 2―Proceedings in Cases of Opposition to Extension of the Term of a Standard Patent

Interpretation

“65. In this Division, unless the contrary intention appears:

‘applicant’ means the person making an application;

‘application’ means an application under subsection 90(1) of the Act

for the extension of the term of a patent;

‘opponent’ means a person giving notice of opposition to an application;

‘party’ means an applicant or opponent.

Notices of opposition

“66. (1) A notice of opposition to an application must:

(a) be in accordance with Form 29A; and

(b) be accompanied by:

(i) a copy of each declaration, if any, on which the opponent intends to rely; and

(ii) the fee prescribed in relation to the notice.

“(2) Subject to subregulation (3), the Commissioner may, if satisfied:

(a) that amendment of the notice is reasonably necessary for the proper presentation of the ground of opposition; and

(b) that no other person (including the applicant) will be unduly prejudiced by the amendment;

allow an opponent to amend the notice, or to give to the Commissioner an amended notice, on such terms (if any) as the Commissioner may specify.

“(3) Before allowing an amendment under subregulation (2), the Commissioner must:

(a) be satisfied that the applicant has been notified of the proposed amendment; and

(b) give the parties an opportunity to make representations concerning the proposed amendment.

 

“(4) An opponent must, within 14 days after giving the notice to the Commissioner, serve on the applicant a copy of the notice or amended notice, together with a copy of each declaration not previously served on the applicant.

“(5) An opponent may, at any stage, withdraw the opposition by:

(a) giving notice of withdrawal to the Commissioner; and

(b) serving a copy on the applicant.

Commissioner to publish notification of opposition

“67. Where the Commissioner receives:

(a) a notice in accordance with subregulation 66 (1); and

(b) the prescribed fee in relation to the notice;

the Commissioner must forthwith publish in the Official Journal a notice stating that the opposition to the application has been made.

Applicant to serve certain documents

“68. Where an applicant receives a notice under subregulation 66 (4) the applicant must:

(a) within 3 months of receiving the notice, serve on the opponent a copy of any declaration on which the applicant intends to rely; and

(b) within 14 days of that service, give the Commissioner each of those declarations, together with a notice specifying the date on which and the place where the copies were so served.

Directions

“69. (1) The Commissioner may, on the application of a party or on the Commissioner’s own motion, give directions, not inconsistent with the Act or these Regulations, for the conduct of proceedings to which this Division applies.

“(2) The Commissioner may, on the application of a party, permit the party to serve and lodge further declarations.

“(3) Before giving a direction under subregulation (1) or allowing an application under subregulation (2), the Commissioner must:

(a) where the Commissioner proposes to act on an application by a party—be satisfied that the other party has been notified of the application; and

(b) where the Commissioner proposes to act on the Commissioner’s own motion—ensure that the parties are notified of the proposed action; and

(c) in any case—give the parties an opportunity to make representations concerning the application or proposed action.

 

Extension of time

“70. (1) The Commissioner may, on the application of a party in accordance with Form 11, extend the time within which the party is permitted to take any step under this Division.

“(2) Before extending time under subregulation (1), the Commissioner must:

(a) be satisfied that the other party has been notified of the application;

and

(b) give the parties an opportunity to make representations concerning the proposed extension of time.

Commissioner to hold a hearing in certain cases

“71. (1) Where the Commissioner receives:

(a) a notice in accordance with subregulation 66 (1); and

(b) the prescribed fee in relation to the notice; and

(c) a request by a party to hold a hearing;

the Commissioner must, unless the notice is withdrawn, hold a hearing into the opposition of the application.

“(2) A hearing under subregulation (1) must be held as soon as practicable.

“(3) The Commissioner must give the parties not less than 10 days’ notice in writing of the date, time and place fixed for the hearing.

“(4) The Commissioner may, on reasonable notice to the parties, adjourn the hearing from time to time and from place to place.

Representations by correspondence or telephone

“71 A. The Commissioner may receive representations under paragraph 66 (3) (b), 69 (3) (c) or 70 (2) (b) from the parties by correspondence or by telephone and, if the Commissioner is satisfied that each party is aware of all the representations, the Commissioner may act under subregulation 66 (2), 69 (1) or (2) or 70 (1) without holding a hearing.

Commissioner may refer to document for the purposes of paragraph 95 (2) (a) or (b) of the Act

“71B. (1) Subject to subregulation (2), the Commissioner may satisfy himself or herself of any fact that relates to a matter mentioned in paragraph 95 (2) (a) or (b) of the Act by reference to a document in the Commissioner’s custody or possession.

“(2) Subregulation (1) applies only where the Commissioner has ensured that the parties:

(a) have copies of, or access to, the document; and

(b) are aware that the Commissioner proposes to inform himself or herself of the fact by reference to the document; and

 

(c) have had an opportunity to provide evidence and make representations with respect to the fact or document.

Notification of decision

“71c. The Commissioner must send a copy of a determination under section 95 of the Act to each party.

Costs

“71D. (1) Where:

(a) the Commissioner awards costs (other than costs of a specified amount) in proceedings to which this Division applies; and

(b) the parties do not agree on the amount of the costs;

the costs must be taxed, allowed and certified to by an officer of the Patent Office appointed by the Commissioner for the purpose.

“(2) A party affected by a taxation of costs may request the Commissioner to review the taxation, or specified items in it, and the Commissioner must review the taxation or items accordingly.”.

First Schedule

6. The First Schedule to the Principal Regulations is amended:

(a) by omitting from Form 11 “66, 67, 68” and substituting “70”;

(b) by omitting Form 23;

(c) by omitting from Form 29 “Regulations 61, 70” and substituting “Regulation 61”;

(d) by inserting in their appropriate numerical positions the forms set out in the Schedule to these Regulations.

Schedule 2
7. Schedule 2 to the Principal Regulations is amended:
(a)	by omitting “95,” from item 9;
(b)	by inserting “66,” after “51,” in item 9;
(c)	by inserting after item 12 the following items:
	“12a On lodging an application under section 90 of the Act for the extension of the term of a patent relating to a pharmaceutical substance		300
	“12b For granting an extension of the term of a patent relating to a pharmaceutical substance”;		300
(d)	by inserting after item 15 the following item:
	“15a Renewal fee where an extension of the term of a standard patent has been granted under subsection 95 (2) or (4) of the Act:
	(a)	1st year of extension	550
	(b)	2nd year of extension	600
	(c)	3rd year of extension	650
	(d)	4th year of extension	700”;

 

(e) by omitting “or 95” from item 19 (c).

Transitional

8. The 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.

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SCHEDULEParagraph 6 (d)

FORM 22A Regulation 37

COMMONWEALTH OF AUSTRALIA

Patents Act 1952

APPLICATION TO COMMISSIONER UNDER SECTION 90 FOR EXTENSION OF TERM OF A STANDARD PATENT RELATING TO A PHARMACEUTICAL

SUBSTANCE

1. I, (name of applicant), of (address) apply for an extension of Patent No. (insert Patent No.) in respect of the following pharmaceutical substances: (state, as may be appropriate, the structural chemical formulae of the substances; the full chemical names or other definition of the substances; any proprietary name or names of the substances and, where relevant, details of the active ingredients and other features of the mixture or compound of the substances)1.

2. The pharmaceutical substances are in substance disclosed in the complete specification of that patent and in substance fall within the scope of the claim or claims of that complete specification.

3. I attach a marketing approval certificate in respect of those substances or I have requested the issue of a marketing approval certificate in respect of those substances.2

5. The address in Australia for service in respect of this application is (insert address, or write ‘as above’, as appropriate).

Dated

______________________________

(Signature)

______________________________

(Insert name and address of applicant’s patent attorney or solicitor, if any)

1 these particulars must be stated sufficiently to identify the substances

2 delete as appropriate

 

FORM 23 Regulation 39

COMMONWEALTH OF AUSTRALIA

Patents Act 1952

MARKETING APPROVAL CERTIFICATE

I, the Secretary to the Department of Community Services and Health* or a delegate of the Secretary to the Department of Community Services and Health*, give a marketing approval certificate under section 92 of the Patents Act 1952 to:

(name of patentee)

in respect of an application for a marketing approval certificate made on (date of application) in respect of the following pharmaceutical substance (state, as may be appropriate, the structural chemical formulae of the substance; the full chemical names or other definition of the substance; any proprietary name or names of the substance and, where relevant, details of the active ingredients and other features of the mixture or compound of the substance):, and I certify:

(a) that the substance is a pharmaceutical substance as defined in section 6 of the Act; and

(b) that I* or (name of delegate)* or the Secretary*, on (date of approval) approved the marketing of the substance* or of a product containing the substance* in Australia.

Dated

_________________

(Signature)

(Name of signatory)

* delete as appropriate

 

FORM 29A Subregulation 66 (1)

COMMONWEALTH OF AUSTRALIA

Patents Act 1952

NOTICE OF OPPOSITION TO THE EXTENSION OF A STANDARD PATENT

To the Commissioner of Patents:

1. I, (name) of (address) give notice under section 94 of the Patents Act 1952 that I oppose the application dated (date of application) for the extension of Patent No. (number of patent).

2. The ground or grounds of my opposition are:

(set out the ground or grounds relied on, in accordance with section 94 of the Act).

3. My interest in the matter arises from the following facts:

(set out the facts in consecutively lettered paragraphs).

4. The address in Australia for service in respect of this notice is (insert address, or write 4as above’, as appropriate).

Dated

_____________________

(Signature)

_____________________

(Insert name and address of opponent’s solicitor or patent attorney, if any)

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NOTES

1. Notified in the Commonwealth of Australia Gazette on 21 December 1989.

2. Statutory Rules 1962 No. 2 as amended to date. For previous amendments see Note 2 to Statutory Rules 1989 No. 93 and see also