Comprehensive and Progressive Agreement for Trans-Pacific Partnership Amendment Act 2018

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75 New subpart 10A of Part 3 inserted

In Part 3, after subpart 10, insert:

Subpart 10A—Extension of term

Extension of term if unreasonable delay in granting patent

111A Requests for extension of patent if delay in granting patent

(1)

A patentee may, in the prescribed manner, request an extension of the term of the patent if the patent is granted—

(a)

more than 5 years after the patent date; and

(b)

more than 3 years after the date on which the request for examination is made under section 64.

Example

A convention application is made on 1 December 2025, the request for examination is made on 1 April 2029, and the patent is granted on 1 October 2031 with a patent date of 1 December 2025.

No request for extension can be made because, although more than 5 years have passed since the patent date, the time between the request for examination and the grant of the patent is less than 3 years.

(2)

The request may be made only—

(a)

during the term of the patent; and

(b)

within the prescribed time limit.

111B Grant of extension of patent on ground of unreasonable delay in granting patent

(1)

The Commissioner must grant an extension of the term of a patent if the Commissioner is satisfied that—

(a)

period A exceeds 5 years, where period A is the period between the patent date and the date of grant of the patent minus the periods that must be disregarded under subsection (2); and

(b)

period B exceeds 3 years, where period B is the period between the date that the request for examination is made under section 64 and the date of grant of the patent minus the periods that must be disregarded under subsection (2).

(2)

The Commissioner must disregard and subtract the following:

(a)

periods of time that are outside the direction or control of the Commissioner; and

(b)

periods of time that are attributable to acts or omissions of all or any of the following:

(i)

the applicant:

(ii)

a person who opposes a proposed amendment to a complete specification after acceptance of the complete specification under section 87:

(iii)

a person who makes an assertion under section 90:

(iv)

a person who opposes the grant of a patent under section 92:

(v)

a person who requests re-examination under section 94:

(vi)

a person who opposes the restoration of a void or an abandoned patent application under section 127:

(vii)

a person (other than the Commissioner) who initiates a hearing under section 208:

(viii)

a person (other than the Commissioner) who makes an appeal to the court or the Court of Appeal or the Supreme Court:

(ix)

an agent of any of the persons referred to in subparagraphs (i) to (viii); and

(c)

periods of time that are attributable to directions in force under section 132.

(3)

The Governor-General may, by Order in Council, make regulations specifying periods of time, not inconsistent with subsection (2), that must be disregarded for the purpose of this section.

(4)

The term of the extension granted must be equal to the period that the Commissioner determines to be the shortest of the following periods:

(a)

the period by which period A exceeds 5 years:

(b)

the period by which period B exceeds 3 years:

(c)

2 years.

Example

A patent application is made on 1 December 2025, the complete specification is filed on 1 April 2026, the request for examination is made on 1 April 2029, and the patent is granted following opposition proceedings under section 92 on 1 October 2033 with a patent date of 1 April 2026.

A request for extension can be made because the time between the patent date and the grant of the patent is more than 5 years and the time between the request for examination and the grant of the patent is more than 3 years.

Six months of the process were attributable to the periods of time that are attributable to acts or omissions of the applicant in responding to examination reports under section 67.

One year of the process was taken up with opposition to the grant of the patent. Of this, 6 months were attributable to acts or omissions of a person opposing the grant (including the time taken by the opponent to file a notice of opposition and to file evidence) and to acts or omissions of the patent applicant (including the time taken by the applicant to file a counter-statement and to file evidence). The other 6 months of the opposition (including the time waiting for the opposition hearing and for the opposition decision) are not disregarded time.

The term of the extension is 0.5 years, calculated as the shortest of the following periods:

  • 1.5 years, being the period by which 6.5 years (7.5-year interval between 1 April 2026 and 1 October 2033 minus 1 year) exceeds 5 years:

  • 0.5 years, being the period by which 3.5 years (4.5-year interval between 1 April 2029 and 1 October 2033 minus 1 year) exceeds 3 years:

  • 2 years.

Compare: Patents Act 1994 s 36A (Singapore); Patents Rules 1995 r 51A (Singapore)

Extension of term of patents relating to pharmaceutical substances

111C Interpretation for sections 111C to 111O

In this section and sections 111D to 111O, unless the context otherwise requires,—

biologic means a pharmaceutical substance that is produced by a process that involves the use of recombinant DNA technology

marketing approval means a consent to the distribution of a medicine that is notified in the Gazette under section 20 of the Medicines Act 1981 or a provisional consent that is notified in the Gazette under section 23 of that Act

marketing approval application means an application that complies with the requirements of section 21 of the Medicines Act 1981

marketing approval process means the process under the Medicines Act 1981 beginning with the date on which a marketing approval application is made and ending with the date on which a marketing approval is notified in the Gazette

pharmaceutical substance means a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves—

(a)

a chemical interaction, or physico-chemical interaction, with a human physiological system; or

(b)

action on an infectious agent, or on a toxin or other poison, in a human body,—

but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing

Regulator means any person or committee performing functions or exercising powers under the Medicines Act 1981 as part of the marketing approval process

therapeutic use means use for the purpose of—

(a)

preventing, diagnosing, curing, or alleviating a disease, ailment, defect, or injury in persons; or

(b)

influencing, inhibiting, or modifying a physiological process in persons; or

(c)

testing the susceptibility of persons to a disease or ailment

unreasonable curtailment has the meaning given in section 111F(1).

Compare: Patents Act 1990 s 70, Schedule 1 (Aust)

111D Requests for extension of patent if unreasonable curtailment of effective patent term as result of marketing approval process

(1)

A patentee may, in the prescribed manner, request an extension of the term of the patent if—

(a)

1 or more pharmaceutical substances per se or biologics were disclosed in the complete specification relating to the patent and were wholly within the scope of the claim or claims of that specification; and

(b)

the patentee made a marketing approval application to distribute a product containing or consisting of a substance or biologic that is one of those referred to in paragraph (a) and marketing approval of that product has been granted; and

(c)

that marketing approval is the first marketing approval for a product that contains or consists of any of the substances or biologics referred to in paragraph (a); and

(d)

the term of the patent has not been previously extended under section 111E.

Example

Company D is the owner of a patent for an invention that is a pharmaceutical substance per se (not a product). The complete specification discloses and claims substances A, B, and C.

Company D makes 3 applications for marketing approval on the same date: 1 for a product that contains substance A, 1 for a product that contains substance B, and 1 for a product that consists of substance C. The Regulator grants marketing approval first for the product that contains substance B.

Company D can request an extension under this section for unreasonable curtailment of effective patent term as a result of the first marketing approval process for the invention, that is, for the product that contains substance B. The Commissioner cannot consider a request for extension of patent term that nominates substances A or C.

(2)

The request may be made only—

(a)

during the term of the patent; and

(b)

within the prescribed time limit; and

(c)

if a certificate from the Regulator for the purpose of section 111F(2) is filed within the prescribed time limit.

Compare: Patents Act 1990 ss 70, 71 (Aust)

111E Grant of extension of patent on ground of unreasonable curtailment of effective patent term as result of marketing approval process

The Commissioner must grant an extension of the term of a patent if the Commissioner is satisfied, on the balance of probabilities, that—

(a)

there has been an unreasonable curtailment of the effective patent term as a result of the marketing approval process; and

(b)

the requirements of section 111D are satisfied in relation to the request; and

(c)

there is no opposition to the grant or, in spite of opposition, the Commissioner’s decision, or the decision on appeal, is that the extension should be granted.

Compare: Patents Act 1990 ss 74, 76 (Aust)

111F What is unreasonable curtailment

(1)

In sections 111D to 111I, there is an unreasonable curtailment of the effective patent term as a result of the marketing approval process if—

(a)

the marketing approval is obtained after the date on which the patent is granted; and

(b)

period A exceeds 5 years in the case of a biologic and 3 years in the case of any other pharmaceutical substance, where period A is the period between the date on which the marketing approval application is made and the date on which the marketing approval is notified in the Gazette minus the periods that must be disregarded under subsection (2).

(2)

In making calculations under subsection (1)(b) and section 111G(b), the Commissioner must disregard and subtract periods that are stated in the certificate from the Regulator to be periods of time that were outside the direction or control of the Regulator.

(3)

The Commissioner must rely on, and must not inquire into the accuracy of, the statements contained in the certificate.

Example

An application for marketing approval is made in respect of a higher risk medicine on 1 April 2030 and marketing approval is notified 783 days later. That 783-day period is made up of 280 days taken by the applicant in responding to requests for information by the Regulator plus 503 days taken by the Regulator to process the application. There is no unreasonable curtailment, and a request for extension of patent term cannot be made because, if the application relates to a biologic, 503 days is less than 5 years and, if the application does not relate to a biologic, 503 days is less than 3 years.

Compare: Patents Act 1994 s 36A (Singapore); Patents Rules 1995 r 51A (Singapore)

111G Calculation of term of extension

The term of an extension granted under section 111E must be equal to the period that the Commissioner determines to be the shortest of the following periods:

(a)

the period equivalent to the interval between the date of grant of the patent and the date on which the marketing approval is notified in the Gazette:

(b)

the period by which period A in section 111F(1)(b) exceeds 5 years in the case of a biologic and 3 years in the case of any other pharmaceutical substance:

(c)

2 years.

Example

A convention application for a pharmaceutical substance other than a biologic is made on 1 April 2026, the request for examination is made on 1 April 2029, the application for marketing approval is made on 1 April 2030, the patent is granted on 1 October 2030 with a patent date of 1 April 2026 (so the patent term will expire on 1 April 2046), and marketing approval is notified on 1 April 2036.

Two years of the marketing approval process is taken by the applicant in responding to requests for information by the Regulator.

The term of the extension is 1 year, calculated as the shortest of the following periods:

  • 5.5 years, being 1 October 2030 to 1 April 2036:

  • 1 year, being the period by which 4 years (6-year interval between 1 April 2030 and 1 April 2036 minus 2 years) exceeds 3 years:

  • 2 years.

Compare: Patents Rules 1995 r 51A(8) (Singapore); Patents Act 1990 s 77 (Aust)

111H Opposition to extension on ground of unreasonable curtailment of effective patent term as result of marketing approval process

(1)

Any person may, in the prescribed manner (if any), oppose the extension of the term of a patent under section 111E on the ground that 1 or more of the requirements of sections 111D to 111F are not satisfied in relation to the request for the extension.

(2)

The Commissioner must notify the person who requested the extension if a person has given notice under subsection (1) and provide the person who requested the extension with a copy of that notice.

(3)

The Commissioner must publish in the journal that a person has given notice under subsection (1) and that the notice is open to public inspection.

(4)

The Commissioner must give the person who requested the extension and the opponent a reasonable opportunity to be heard before the Commissioner decides the case.

Compare: Patents Act 1990 s 75 (Aust)

111I Exclusive rights of patentee are limited if extension granted on ground of unreasonable curtailment

It is not an infringement of the patent for a person to do either or both of the following during the term of a patent extension under section 111E:

(a)

exploit any form of the invention for a purpose other than a therapeutic use:

(b)

exploit any form of the invention for a therapeutic use other than the use for which the marketing approval referred to in section 111D(1)(c) was granted.

Compare: Patents Act 1990 s 78 (Aust)

General provisions about all extensions of term under this subpart

111J Notification and public inspection of request for extension

If a patentee makes a request for an extension of the term of a patent under this subpart, the Commissioner must enter the request in the patents register and publish in the journal a notice stating that the request has been made and is open to public inspection.

Compare: Patents Act 1990 s 72 (Aust)

111K Notification of grant or refusal of request for extension

(1)

If the Commissioner grants an extension of the term of a patent under this subpart, the Commissioner must give notice of the grant to the person who made the request, enter the extension in the patents register, and publish a notice of the extension in the journal.

(2)

If the Commissioner refuses to grant an extension under this subpart, the Commissioner must give notice of the refusal to the person who made the request, enter the refusal in the patents register, and publish a notice of the refusal in the journal.

Compare: Patents Act 1990 s 74(2), (4) (Aust)

111L Withdrawal of request for extension

(1)

A patentee who has requested an extension of the term of a patent under this subpart may withdraw the request in the prescribed manner.

(2)

If a request is withdrawn, the Commissioner must enter the withdrawal in the patents register and publish in the journal a notice stating that the request has been withdrawn.

Compare: Patents Act 1990 s 73 (Aust)

111M Rights of patentee if extension granted after patent expires

(1)

This section applies if—

(a)

a patentee requests an extension of the term of a patent under this subpart; and

(b)

the extension is granted after the term of the patent expires.

(2)

The patentee has, after the extension is granted, the same rights to start proceedings in respect of the doing of an act during the period specified in subsection (3) as if the extension had been granted at the time when the act was done.

(3)

The period is the period that commences on the expiry of the term of the patent and that ends on the day on which the extension was granted or the day on which the patent extension expires, whichever is the earlier.

Compare: Patents Act 1990 s 79 (Aust)

111N Commissioner not to make decision if certain proceedings pending

(1)

This section applies if—

(a)

a patentee of a patent applies for an extension of the term of the patent under this subpart; and

(b)

any of the following applies in relation to the patent:

(i)

relevant proceedings are pending; or

(ii)

a re-examination has been requested, directed, or otherwise commenced under section 95; or

(iii)

an application has been made to the Commissioner under section 112 to revoke the patent.

(2)

The Commissioner must not make any decision under this subpart in relation to the patent—

(a)

without the leave of the court, if relevant proceedings are pending; or

(b)

before the Commissioner has made a decision on whether to revoke the patent in whole or in part under section 99, if subsection (1)(b)(ii) applies; or

(c)

before the Commissioner has made a decision on the application for revocation of the patent made under section 112, if subsection (1)(b)(iii) applies.

Compare: Patents Act 1990 s 79A (Aust)

111O Term of patent of addition

(1)

Despite section 109(1), the extension under this subpart of the term of a patent for the main invention does not automatically extend the term of a patent of addition.

(2)

The term of a patent of addition may be extended under this subpart, even if the patent for the main invention is not extended under this subpart.

(3)

If the term of a patent of addition is extended under this subpart,—

(a)

the extension begins at the end of the unextended term of the patent for the main invention; and

(b)

when the extension begins, the patent of addition becomes an independent patent.

(4)

If—

(a)

the term of the patent for the main invention is extended under this subpart; and

(b)

the term of the patent of addition is not extended under this subpart,—

the term of the patent of addition expires at the end of the unextended term of the patent for the main invention.

Compare: Patents Act 1990 s 83(2)–(4) (Aust)