Commonwealth Numbered Acts

PATENTS AMENDMENT ACT 1989 No. 96, 1989 - SECT 6

6. Part IX of the Principal Act is repealed and the following Part is
substituted:

"PART IX-EXTENSION OF CERTAIN PATENTS Application for extension of term of
patent relating to a pharmaceutical substance

"90. (1) Where:

   (a)  a pharmaceutical substance is in substance disclosed in the complete
        specification of a standard patent and in substance falls within the
        scope of the claim or claims of that complete specification; and

   (b)  the patentee has requested the issue of a marketing approval
        certificate in respect of that substance; the patentee may, by notice
        in writing in accordance with the prescribed form given to the
        Commissioner not later than 12 months before the end of the term of
        the patent, apply for an extension of the term of the patent in
        respect of that substance and any other pharmaceutical substance which
        is in substance disclosed in the specification and in substance falls
        within the scope of the claim or claims of the specification.

"(2) Where a patentee makes an application for an extension of the term of a
patent, the patentee shall forthwith send a copy of the application to the
Secretary to the Department of Community Services and Health.

"(3) Where a patentee makes an application for an extension of the term of a
patent, the Commissioner shall forthwith publish in the Official Journal a
notice stating that the application has been made and is open to public
inspection.

"(4) A patentee who has made an application for an extension of the term of a
patent may, by notice in writing given to the Commissioner, withdraw that
application.

"(5) Where an application for an extension of the term of a patent is
withdrawn, the Commissioner shall forthwith publish in the Official Journal a
notice stating that the application has been withdrawn. Application for
extension to lapse in certain circumstances

"91. An application for an extension of the term of a patent shall lapse if
the applicant does not, within the prescribed period, give to the
Commissioner:

   (a)  a marketing approval certificate in respect of the pharmaceutical
        substance to which the application relates; and

   (b)  a proposed claim or claims. Issue of marketing approval certificate

"92. Where:

   (a)  a patentee makes a request in writing to the Secretary to the
        Department of Community Services and Health for the issue of a
        marketing approval certificate in respect of a pharmaceutical
        substance; and

   (b)  the Secretary to the Department of Community Services and Health has
        approved the marketing of the substance, or a product containing the
        substance, in Australia; the Secretary shall forthwith give a
        marketing approval certificate in the prescribed form to the patentee
        in respect of that substance. Advertisement of application for
        extension

"93. (1) Where:

   (a)  a patentee makes an application for an extension of the term of a
        patent; and

   (b)  the patentee gives to the Commissioner the documents referred to in
        section 91; the Commissioner shall publish in the Official Journal a
        notice to the effect that the Commissioner proposes to consider the
        application.

"(2) Where such a notice is published, the following documents are open to
public inspection:

   (a)  the marketing approval certificate;

   (b)  the proposed claim or claims;

   (c)  such other documents as are prescribed.

"(3) Where, after documents relating to an application for an extension of the
term of a patent are open to public inspection under subsection (2), the
applicant sends to the Patent Office any document relating to the application,
or the Commissioner sends to the applicant any document relating to the
application, that document or a copy of that document, as the case requires,
is also open to public inspection. Opposition to extension

"94. The Minister, the Secretary to the Department of Community Services and
Health or a person interested may, in accordance with, and within the period
prescribed by, the regulations oppose the grant of an extension of the term of
a patent on either or both of the following grounds, but on no other ground:

   (a)  that the application for the extension, the marketing approval
        certificate, or the proposed claim or claims, is or are not in
        accordance with the requirements of this Act;

   (b)  that the proposed claim or claims claim matter other than the
        pharmaceutical substance or substances to which the application
        relates. Determination of application for extension

"95. (1) The Commissioner may determine an application for an extension of the
term of a patent even though the term of the patent has expired.

"(2) Where the time for opposing the grant of an extension of the term of a
patent has expired, the Commissioner shall, if the Commissioner is satisfied
that:

   (a)  the application for the extension, the marketing approval certificate
        and the proposed claim or claims are in accordance with the
        requirements of this Act; and

   (b)  the proposed claim or claims do not claim matter other than the
        pharmaceutical substance or substances to which the application
        relates; grant an extension of the term of the patent for a period of
        4 years in relation to the proposed claim or claims, but if the
        Commissioner is not so satisfied the Commissioner shall, subject to
        subsection (3), refuse to grant an extension of the term of the
        patent.

"(3) The patentee may, within such period as the Commissioner allows, amend
the proposed claim or claims.

"(4) If, after amendments are made under subsection (3), the Commissioner is
satisfied as to the matters referred to in subsection (2), the Commissioner
shall grant an extension of the term of the patent for a period of 4 years in
relation to the proposed claim or claims, but if the Commissioner is not so
satisfied the Commissioner shall refuse to grant an extension of the term of
the patent.

"(5) Where the Commissioner grants, or refuses to grant, an extension of the
term of a patent, the Commissioner shall forthwith publish in the Official
Journal a notice setting out the terms of the decision.

"(6) The Commissioner shall not grant, or refuse to grant, an extension of the
term of a patent unless the Commissioner has given to the applicant and any
person who opposed the grant of the extension under section 94 a reasonable
opportunity of being heard.

"(7) Where:

   (a)  an action or proceeding for infringement of a patent is pending in a
        court; or

   (b)  an action or proceeding in which the validity of a patent or of a
        claim of the complete specification of a patent is disputed is pending
        in a court; the Commissioner shall not determine an application for an
        extension of the term of the patent without the leave of the court.
        Limitation on infringement proceedings

"96. (1) Where the term of a patent has been extended under this Part, an
action or proceeding for infringement of the patent shall not be instituted in
respect of an act done more than 2 years after the day on which the term of
the patent expired unless the act constitutes sale, offering for sale, or
distribution for a purpose other than obtaining marketing approval, of any
pharmaceutical substance concerned.

"(2) In this section:
'marketing approval', in relation to a pharmaceutical substance, means the
approval of the Secretary to the Department of Community Services and Health
for the marketing of the substance, or a product containing the substance, in
Australia. Actions in respect of acts done where patent expires before
extension is granted "96A. Where:

   (a)  a patentee makes an application for an extension of the term of a
        patent under this Part;

   (b)  before the application is determined, the term of the patent expires;
        and (c) the extension is granted; the patentee has, after the
        extension is granted, the same rights to bring an action or proceeding
        in respect of the doing of an act during the period commencing on the
        expiration of the term of the patent and ending on the day on which
        the extension is granted as if the extension had been granted at the
        time when the act was done. Appeals

"96B. An applicant for an extension of the term of a patent, or a person who
has opposed or proposes to oppose the extension, may appeal to the Federal
Court:

   (a)  from a decision of the Secretary to the Department of Community
        Services and Health under section 92 to give or not to give an
        extension eligibility certificate; or

   (b)  from a decision of the Commissioner under subsection 95 (2) or (4)
        granting or refusing to grant an extension of the term of the patent.
        Delegation

"96C. The Secretary to the Department of Community Services and Health may, by
signed instrument, delegate to an officer of that Department all or any of the
powers and functions of the Secretary under this Part.".