Commonwealth Numbered Regulations - Explanatory Statements

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PATENTS AMENDMENT REGULATIONS 2005 (NO. 1) (SLI NO 51 OF 2005)

EXPLANATORY STATEMENT

 

Select Legislative Instrument 2005 No. 51

 

Issued by the Authority of the Minister for Industry, Tourism and Resources

 

Patents Act 1990

 

Patents Amendment Regulations 2005 (No. 1)

 

 

Subsection 228(1) of the Patents Act 1990 (the Act) provides, in part, that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed, or necessary or convenient to be prescribed for carrying out or giving effect to the Act and for the conduct of any business relating to the Patent Office.  Under paragraph 228(2)(e), this power includes making provision for and in relation to the amendment of an entry in the Register of Patents (the Register) to correct a clerical error or an obvious mistake, or for any other purpose.  Under paragraph 228(2)(m), this power also includes making provision for appeals against decisions of the Commissioner made under the regulations. 

 

The maximum term of a standard patent is 20 years.  For certain patents that relate to pharmaceutical substances, this term can be extended by up to five years.  The length of the extension is determined by section 77 of the Act, and is based on information supplied by the patentee.  Under regulation 6.9 of the Patents Regulations 1991 (the Principal Regulations), patentees must inform the Commissioner of Patents (the Commissioner) of the date of commencement of the ‘first inclusion’ in the Australian Register of Therapeutic Goods of goods that contain or consist of the substance.  An extension of term of a patent is one of the particulars entered into the Register of Patents, which is a public register held in the Patent Office. 

 

Recently, the Commissioner has become aware that the extensions of term granted in respect of several patents are longer than the patentees are entitled to under the Act.  This appears to be due to the Commissioner having been supplied with incorrect information by the patentees when these extensions of term were requested.  However, the Principal Regulations did not provide a specific mechanism by means of which the Commissioner could amend the Register to insert the correct extension of the term of the patent in these circumstances. 

 

The main purpose of the Regulations is to provide such a mechanism.  Schedule 1 to the Regulations gives the Commissioner the power to amend the Register to insert the correct extension of the term of the patent when he or she becomes aware that the date of ‘first inclusion’ supplied by the patentee is incorrect.  Before amending the Register, the patentee must be notified and given an opportunity to be heard.  A decision of the Commissioner under these provisions is appellable directly to the Federal Court of Australia. 

 

The effect of the Regulations is that the Commissioner can amend existing and future entries in the Register so that they accurately reflect the length of the extension of term of the affected patent as determined by section 77 of the Act.  The correction of the Register under these provisions will not affect the patentee’s legal rights — it simply corrects an incorrect entry in the Register.

 

The Regulations also contain provisions to update the text of the Principal Regulations to reflect changes made to the English text of the Patent Cooperation Treaty (PCT) Rules, and to add an additional Convention country. 

 

The PCT is an international agreement that simplifies the procedure for the filing of applications for patents internationally.  Subsection 228(5) of the Act requires the Governor-General to make regulations setting out the English text of the PCT as in force for Australia on the commencing day of the Act, and afterwards such regulations as are necessary to keep that English text up-to-date. 

 

At a meeting in 2004, the Assembly of the International Patent Cooperation Union unanimously adopted certain amendments to the English text of the PCT Rules.  These amendments simplify the protest procedure that applies when a patent applicant is invited to pay additional fees in order to have additional inventions searched or examined under the PCT, alter the procedure for dealing with international applications that disclose nucleotide or amino acid sequences, and provide some additional minor amendments relating to the PCT Rule changes which came into effect from 1 January 2004. 

 

Schedule 2 to the Regulations amends the Principal Regulations to implement these amendments to the PCT Rules by updating the English text of the PCT Rules set out in Schedule 2A to the Principal Regulations.  These amendments do not affect national law — they simply update the text of the PCT Rules. 

 

The Paris Convention for the Protection of Industrial Property (Paris Convention), of which Australia is a Contracting Party, is an international agreement that facilitates simultaneous protection of industrial property in member countries (‘Convention countries’).  Schedule 4 to the Principal Regulations lists the Convention countries by name.  This schedule must be updated each time a country accedes to the Paris Convention.   On 3 January 2005 Comoros deposited its instrument of accession to the Paris Convention.  Comoros will become bound by the Paris Convention from 3 April 2005.

 

Schedule 3 to the Regulations amends the list of Convention countries in Schedule 4 to the Principal Regulations to insert ‘Comoros’.  This change meets Australia’s international obligations under the Paris Convention. 

 

No consultation was undertaken prior to making these Regulations.  This is because the Regulations are of a minor or machinery nature only, and do not substantially change the law.  The amendments made by Schedule 1 merely provide a means of enabling the Commissioner to correct the Register to insert the correct extension of the term of a patent, when an incorrect extension has been identified.  The amendments made by Schedule 2 reflect changes to an international treaty and do not change Australian law.  The amendment made by Schedule 3 is required in order for Australia to meet its international obligations under the Paris Convention.

 

Details of the Regulations are in the Attachment.

 

Schedule 1 to the Regulations commenced on the day after they were registered, Schedule 2 to the Regulations commences on 1 April 2005, the day the changes to the PCT rules come into effect, and Schedule 3 to the Regulations commences on 3 April 2005, the day from which Comoros becomes bound by the Paris Convention.                  


 

ATTACHMENT

 

Patents Amendment Regulations 2005 (No. 1)

 

Regulation 1 identifies the Regulations as the Patents Amendment Regulations 2005

(No. 1).

 

Regulation 2 provides that Regulations 1 to 4 and Schedule 1 commence on the day after they are registered, Schedule 2 commences on 1 April 2005 and Schedule 3 commences on 3 April 2005.

 

Regulation 3 specifies that Schedules 1 to 3 to the Regulations amend the Patents Regulations 1991 (the Principal Regulations). 

 

Regulation 4 provides for transitional arrangements in relation to the amendments made by the Schedules 1 and 2.  The amendments made by Schedule 1 apply to any entry in the Register, whether it was made on or after the commencement of the Regulations, or before the commencement of the Regulations.  The amendments made by Schedule 2 apply to an international application the international filing date of which is on or after 1 April 2005.  However, certain of these amendments also apply to an international application that was filed before 1 April 2005 if a demand for international preliminary examination of the application is filed on or after 1 April 2005.

 

Schedule 1 – Amendments commencing on registration

 

Item 1 inserts new subregulations 10.7(7), (8) and (9). 

 

Under subregulation 10.7(7), the Commissioner of Patents (the Commissioner) is required to amend an entry in the Register to insert the correct extension of the term of a patent if the following conditions are met:

 

(a) an extension of term of that patent has been granted under section 76 of the Patents Act 1990 (the Act); and

(b) the Commissioner becomes aware that the first regulatory approval date in relation to the pharmaceutical substance to which the patent relates is earlier than whichever of the following is applicable:

(i)   the date of the commencement of the first inclusion in the Australian Register of Therapeutic Goods (the ARTG) supplied under subregulation 6.9(2) of the Principal Regulations with the application for the extension of term; or

(ii) the date of the first approval supplied under subregulation 6.10(2) of the Principal Regulations with the application for the extension of term.

 

Under subregulation 10.7(8), the Commissioner is required, before amending the Register under new subregulation 10.7(7), to give notice to the patentee, and to act in accordance with regulations 22.22 to 22.24 of the Principal Regulations as if those regulations applied to a decision to amend the entry.  Therefore the patentee is given notice of the Commissioner’s intention to amend the Register to correct the extension of term, and has an opportunity to be heard before the Register is amended. 

                                                                                                    

Under subregulation 10.7(9), the decision of the Commissioner under subregulation 10.7(7) is appellable directly to the Federal Court of Australia. 

 

As an example of the operation of this provision, the Commissioner would be obliged to amend the entry in the Register to insert the correct extension of term of a patent if, for a patent for a particular pharmaceutical substance:

·        the date of commencement of the first inclusion in the ARTG supplied under subregulation 6.9(2) of the Principal Regulations with the application for the extension of term corresponds to an inclusion in the ARTG of goods containing or consisting of the pharmaceutical substance (as either a registered good or as a listed good); and

·        the Commissioner becomes aware of an earlier inclusion in the ARTG of goods that contain or consist of that pharmaceutical substance, as either a registered good or as a listed good (for example, a listing for the purposes of export only); and

·        an extension of term had been granted on the basis of the later inclusion date. 

 

In this case, the Commissioner would be required to amend the entry in the Register to insert the correct extension of the term of the patent as calculated under section 77 of the Act based on the earlier date of first inclusion in the ARTG (being either the date of inclusion as a registered good or as a listed good, whichever is earlier). 

 

In some situations, the correct extension of the term of the patent may be reduced to zero — in such cases, the Commissioner would be required to insert this correct extension of the term of the patent in the Register. 

 

Item 2 inserts into subparagraph 22.26(2)(a)(vaa) of the Principal Regulations a reference to proposed subregulations 10.7(7) and (8).  This ensures that a decision of the Commissioner under these subregulations will not be reviewable by the Administrative Appeals Tribunal.

 

Schedule 2 – Amendments commencing on 1 April 2005

 

Item 1 amends subregulation 1.4(2) of the Principal Regulations to specify that the English text of the PCT in force for Australia as at 1 April 2005 is the text set out in Schedules 2 and 2A to the Principal Regulations.

 

Items 2 to 23 amend Schedule 2A to the Principal Regulations to update the text of the PCT Rules to accord with the changes made to the PCT Rules by the Assembly of the International Patent Cooperation Union at the meeting from 27 September 2004 to 5 October 2004.

 

Schedule 3 – Amendments commencing on 3 April 2005

 

Item 1 inserts ‘Comoros’ into the list of Convention countries in Schedule 4 to the Principal Regulations to reflect the accession of this country to the Paris Convention for the Protection of Industrial Property.

 

 


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