EXPLANATORY STATEMENT
STATUTORY RULES 1987 NO. 78
Issued by the Authority of the Minister for Science.
These amendments to the Patents Regulations include new regulations providing for a number of matters in relation to the provisions of the Patents Act 1952 (“the Act”) as amended by the Patents Amendment Act 1984 and certain provisions of the Statute Law (Miscellaneous Provisions) Act (No. 2) 1985.
Broadly, those provisions require or enable the making, in certain circumstances defined in the Act, of a deposit with a prescribed depositary institution of a micro-organism the use of which is involved in an invention, such that samples of the micro-organism will be obtainable by third parties in accordance with the provisions of the Budapest Treaty and regulations made under paragraph 177(1)(ae) of the Act. The deposit, in effect, supplements the requirement of the Act that a patent specification fully describe the invention, since a description of a micro-organism without a sample of it would generally be insufficient for a person skilled in the art to perform the invention.
The amendments to the Regulations relate to:
• documents, prescribed for the purposes of subsection 35(5) of the Act, which must be lodged in connection with a patent application in relation to which a micro-organism is deposited for the purposes of section 40 of the Act, and the manner and timing of lodgment of those documents;
• the period within which the matters referred to in paragraph 40(5)(c) of the Act must be included in a patent specification;
• the making of a request by the Commissioner to an international depositary authority for a sample of a deposited micro-organism for the purposes of proceedings before the Commissioner or other legal proceedings in Australia;
• the making of a request by a person to the Commissioner for the certification referred to in Rule 11.3(a) of the Budapest Treaty Regulations (which certification would entitle the person to be furnished with a sample of a deposited micro-organism by an international depositary authority), and the procedure for considering and deciding upon such requests;
• the giving of an undertaking, in certain circumstances, by a person requesting such a certification of the Commissioner, if a sample is furnished, not to make the micro-organism available to any other person and to use the micro-organism only for experimental purposes during any period when the patent application or patent concerned is in force and for certain periods after lapsing or ceasing of the application or patent;
• the taking, by an applicant, patentee or exclusive licensee, of an action or proceeding for breach of such an undertaking, and providing for defences, procedures and relief available in such an action or proceeding;
• the notification, by a person other than the applicant or patentee or by the Commissioner, of a requirement of paragraph 40(5)(c) or (e) of the Act which has ceased to be satisfied in relation to a micro-organism to which a patent specification relates;
• the amendment of a patent specification for the purpose of including in the specification a matter referred to in paragraph 40(5)(c) of the Act;
• time limits for remedying under subsection 40(7) of the Act, ceased compliance with paragraph 40(5)(c) or (e) of the Act;
• the protection or compensation of a person who avails himself or herself of an invention during a period when a patent specification had ceased to satisfy a requirement of paragraph 40(5)(c) or (e) of the Act;
• the making of an application under subsection 154A(1) of the Act for a declaration that a 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; and
• review by the Administrative Appeals Tribunal of certain decisions made by the Commissioner in the above matters.
The amendment also adds a requirement that the Commissioner, when required to notify affected parties of a decision, draw attention to the possible availability of review by the Administrative Appeals Tribunal.
The Institute of Patent Attorneys of Australia, the Australian Manufacturers’ Patents, Industrial Designs, Copyright and Trade Mark Association and the Law Council of Australia were consulted in the course of preparation of the regulations.
Subsection 4(1) of the Acts Interpretation Act 1901 provides, among other things, that where an Act (“the Act concerned”) which has not yet come into operation is expressed to confer power to make regulations, then, unless the contrary intention appears, the power may be exercised before the Act concerned comes into operation. Subsection 4(2) of that Act provides that the provisions contained in regulations made by virtue of subsection 4(1) of that Act take effect on the day on which the regulations would have taken effect if the Act concerned had been in operation when the regulations were made, whichever is the later. These amendments come into operation on 7 July 1987, the date on which the Budapest Treaty enters into force for Australia. This is the same day as the Patents Amendment Act 1984 comes into operation.
Details of the regulations are attached.
DETAILS OF THE REGULATIONS
Regulation 1 provides that the amending regulations shall come into operation on 7 July 1987.
Regulation 2 includes a definition of “Budapest Treaty Regulations” in existing regulation 4.
Regulation 3 amends existing regulation 6 with the effect that certain documents specified in proposed subregulation 19ZB(2) relating to patent applications involving micro-organisms are exempt from certain formality requirements in the Patents Regulations.
Regulation 4 inserts into the Patents Regulations a new Part IVB relating to patent applications and patents where the inventions concerned involve the use of micro-organisms. Part IVB contains new regulations 19ZA to 19ZT.
Regulation 19ZA provides that a reference, for the purposes of Part IVB, to an undertaking means an undertaking given in accordance with paragraph (d) of Form 37 (subregulation 19ZF(D).
Subregulation 19ZB(1) prescribes certain documents which are to be lodged for the purposes of sub-section 35(5) of the Act where a micro-organism is deposited with an international depositary authority for the purposes of section 40 of the Act. Those documents include:
• the receipt issued by the authority for an original, new or transferred deposit of the micro-organism;
• a declaration in accordance with Form 36, which includes a statement identifying the deposit and a statement that samples of the micro-organisms are available in accordance with the Budapest Treaty and the Patents Regulations, and declares the applicant or patentee’s consent to the application or patent’s reliance on the deposit for the purposes of section 40 of the Act; and
• a translation of the receipt (if not in English).
Subregulation 19ZB(2) has the effect of exempting documents lodged pursuant to subregulation 19ZB(1) from certain formalities requirements in existing regulation 6.
Regulation 19ZC provides a time limit, of 3 months from the original, new or transferred deposit date, within which documents referred to in regulation 19ZB must be lodged.
Regulation 19ZD prescribes a time limit, within which the matters required by paragraph 40(5)(c) of the Act must be included in a patent specification, of 3 months after the specification is lodged, or such longer period as the Commissioner allows, but not extending beyond 15 months after the earliest priority date (sections 45 and 45A of the Act) of the claim or claims in the specification.
Subregulation 19ZE(1) provides for the Commissioner to take the necessary actions to request a sample of a micro-organism from
an international depositary authority for the purposes of proceedings before the Commissioner or any other legal proceedings in Australia. Subregulations 19ZE(2) and (3) require the Commissioner to give the applicant or patentee and any other apparently interested person an opportunity to be heard before the Commissioner makes such a request (unless the request is made on the order of a court), and to give those persons notice in writing of a decision to make or refuse to make such a request and of the reasons for the decision. Subregulation 19ZE(4) empowers the Commissioner to request a viability statement from the authority after he has been furnished with a sample pursuant to such a request.
Subregulation 19ZF(1) provides that a person may request the Commissioner to grant a certification in accordance with Rule 11.3(a) of the Budapest Treaty Regulations. Such a certification would have the effect that the requestor would be entitled to be furnished with a sample of a deposited micro-organism by the international depositary authority concerned. The request must be made in accordance with new Form 37 (added by proposed regulation 6), paragraph (d) of which includes an undertaking not to make the micro-organism, or any culture derived from it, available to any other person, and to use the micro-organism only for experimental purposes, during any period when the patent application or patent concerned is in force (and for certain periods after the application or patent has lapsed or ceased). Subregulation 19ZF(2) provides for the Commissioner to decide whether to comply with or refuse the request or to comply with the request subject to the requestor’s compliance with reasonable conditions, which may include the giving of security for damages for any breach of the undertaking. Subregulation 19ZF(3) provides that the Commissioner shall comply with such a request:
• if a Form 36 declaration has been lodged (subregulation 19ZB(D);
• if the patent specification concerned is open to public inspection;
• unless the Commissioner is satisfied that a declaration set out in the request is false or misleading;
• unless the Commissioner is satisfied that the undertaking is not given in good faith; and
• where the requestor has a compulsory licence under section 108 of the Act or is acting under the Crown use provisions of section 125 of the Act - if the terms of the licence or the Crown use give the right to obtain a sample of the micro-organism.
Subregulations 19ZF(4) and (5) require the Commissioner to give the requestor, the applicant or patentee, and any other apparently interested person an opportunity to be heard before the Commissioner makes a decision on the request, and to give those persons notice in writing of the decision and the reasons for the decision.
Subregulation 19ZG(1) provides for an applicant, patentee or exclusive licensee to take an action or proceeding for breach of an undertaking (Form 37 and subregulation 19ZF(D).
Subrequlations 19ZG(2) and (3) relate to joinder of a patentee not being a plaintiff. Subregulation 19ZG(4) provides that it
is a defence, in such an action or proceeding, that the specification concerned did not, when the matters complained of took place, comply with a requirement of paragraph 40(5)(c) or (e) of the Act. Subregulation 19ZG(5) denies that ground of defence to the defendant unless the defendant had previously lodged a notification under regulation 19ZK of the requirement that had ceased to be satisfied, and the applicant or patentee had failed to take the appropriate steps to rectify non-compliance with that requirement (regulation 19ZO).
Regulation 19ZH provides for lodgment of particulars of breaches and objections by the plaintiff and defendant, respectively, in an action or proceeding for breach of an undertaking.
Regulation 19ZJ provides for various orders and relief which may be made or granted in an action or proceeding for breach of an undertaking, including an order for inspection, an injunction, an order for damages or an account of profits, an order with respect to any security given pursuant to paragraph 19ZF(2)(b), and an order for delivery up of the micro-organism or of derivatives and products obtained from it.
Regulation 19ZK provides for a notification of a requirement of paragraph 40(5)(c) or (e) of the Act which has ceased to be satisfied in relation to a micro-organism to which a patent specification relates. The procedures involved include:
• lodgment of the notification by a person (not being the applicant or patentee);
• a copy of the notification to be given to the applicant or patentee;
• notification of the applicant or patentee by the Commissioner of his own initiative;
• reply by the applicant or patentee;
• service of a copy of the reply on the person giving the notification; and
• notice of the notification and reply in the Official Journal (which is published by the Commissioner pursuant to subsection 175(1) of the Act).
Subregulation 19ZL(1) provides that an applicant or patentee may request amendment of his or her patent specification for the purpose of including in the specification a matter referred to in paragraph 40(5)(c) of the Act. Subregulations 19ZL(2) and (5) relate to the form and contents of the request.
Subregulations 19ZL(3) and (4) require the consent of a mortgagee or exclusive licensee under the patent to the proposed amendment, but provide that the Commissioner may dispense with such consent if it is unreasonably refused. Subregulations 19ZL(6) and (8) provide that the Commissioner shall serve a copy of the request for amendment on a person who has requested a certification under subregulation 19ZF(1) or who has lodged a notification under subregulation 19ZK(1). Subregulation 19ZL(7) requires the Commissioner to notify a request for amendment in the Official Journal. Subregulation 19ZL(9) requires the Commissioner to give the opportunity to be heard to a person notified under subregulation 19ZL(6) or (8), to a person who notifies an interest to the Commissioner and, if necessary, to the applicant or patentee. Subregulation 19ZL(10) provides that
the Commissioner shall not comply with a request for amendment unless it would, after amendment, include a matter referred to in paragraph 40(5)(c) of the Act. Subregulations 19ZL(11) and (12) provide for the Commissioner to decide, after complying with subregulations 19ZL(6), (7), (8) or (9), whether to comply with or refuse the request, but not until after 3 months from the Official Journal advertisement under subregulation 19ZL(7). Subregulation 19ZL(13) provides that, upon a decision to comply with a request, the amendment shall be deemed to have been made. Subregulation 19ZL(14) provides for advertisement in the Official Journal of particulars of an amendment so made. Subregulation 19ZL(15) provides for notification of the persons referred to in subregulation 19ZL(9) of the decision and the reasons for the decision.
Regulation 19ZM prevents the Commissioner from making a decision on a request for amendment under subregulation 19ZL(1) while there is pending an action for infringement of the patent concerned, a proceeding for revocation, or a proceeding in which the validity of the patent or a claim of the patent is in dispute.
Subregulation 19ZN(1) provides that, in such an action or proceeding in a court, the court or a Judge of that court may direct amendment of a specification for the purpose of including a matter referred to in paragraph 40(5)(c) of the Act, and may impose terms as to costs, advertisement or otherwise.
Subregulation 19ZN(2) provides that the Commissioner has the right to appear and may be directed to appear. Subregulation 19ZN(3) provides that a copy of the court or Judge’s order is to be lodged at the Patent Office and the specification shall then be deemed to have been amended accordingly.
Regulation 19ZO prescribes periods, for the purposes of paragraph 40(7)(b) of the Act, within which steps must be taken to remedy ceased compliance with paragraph 40(5)(c) or (e) of the Act. Where the step is the making of a new deposit, the period is 3 months after:
• the applicant or patentee was given a copy of a notification under subregulation 19ZK(2) or a notification under subregulation 19ZK(3); or
• the applicant received a notification from an international depositary authority under Article 4 of the Budapest Treaty.
Where no such copy or notification has been given, the period is that which ends when the new deposit is made. Where the step is the amendment of the specification, the period is that which ends when the Commissioner complies under subregulation 19ZL(11) with a request under subregulation 19ZL(1) for the amendment of the specification, which request must, if the applicant or patentee was given a copy of a notification, or a notification, under subregulation 19ZK(2) or (3), have been lodged within 3 months of the giving of that copy or notification.
Regulation 19ZP makes provision, for the purposes of subsection 40(7) of the Act, for the compensation or protection of a person who availed himself or herself, or took definite steps by contract or otherwise to avail himself or herself, of an
invention involving a micro-organism during a period when a requirement of paragraph 40(5)(c) or (e) of the Act was not satisfied. The procedure established by regulation 19ZP includes:
• the making of an application to the Commissioner for a licence to make, use, exercise or vend the invention;
• service of a copy of the application for the licence on the patent applicant or patentee;
• provision for opposition to the application for the licence, a hearing by the Commissioner; and
• the granting by the Commissioner of a licence on reasonable terms or dismissal of the application for the licence.
Regulation 19ZQ lays down procedures relating to the making of a declaration under subsection 154A(1) of the Act, providing for matters including:
• the form and content of an application for a declaration;
• service of copies of documents on the parties (in particular, documents stating the facts relied upon to justify the making of a declaration);
• the opportunity for the patent applicant or patentee to reply;
• publication in the Official Journal of notice of a declaration or decision under section 154A(1) of the Act, and the availability of a decision or declaration for public inspection.
Regulation 5 amends existing regulation 92, which makes provision for review by the Administrative Appeals Tribunal of certain decisions, by adding reference to decisions of the Commissioner under paragraph 19ZE(1)(b) and subregulations 19ZF(2), 19ZL(4), 19ZL(11) and 19ZP(5). The regulation also adds a new subregulation 92(2) which requires the Commissioner, where required to give notice of a decision reviewable by that Tribunal to a person whose interests are affected, to include a statement drawing the person’s attention to the possible availability of review by the Tribunal. New subregulation 92(3) provides that failure to comply with subregulation 92(2) shall not be taken to affect the validity of the decision concerned. New subregulation 92(4) provides for sending of the notice by pre-paid ordinary post to the person’s last known address.
Regulation 6 amends the First Schedule to the Patents Regulations by amending existing Form 22, substituting a new Form 27, and adding new Forms 36, 37 and 38 required by the regulations.