Pharmaceutical
Patent - Extension of Term Provisions Patent Term
Term of a standard patent is 20 years from date of filing. Patents valid on 1 July 1995
were extended by 4 years from their previous term of 16 years.
Pharmaceutical Patent
Extension?
Yes. The Intellectual Property Laws Amendment Act (1998) came into force on 28 January
1999. An extension of up to 5 years is available for pharmaceutical standard patents in
which the active ingredient(s) are first registrations under the Therapeutic Goods Act,
1989.
Section 70 of the Patents Action allows for applications for extension of patent if the
following requirements are met:
1. Either or both of the following conditions must be satisfied:
(a) one or more pharmaceutical substances per se must in substance be
disclosed in the complete specification of the patent and in substance fall within the
scope of the claim or claims of that specification;
(b) one or more pharmaceutical substances when produced by a process
that involves the use of recombinant DNA technology, must in substance be disclosed in the
complete specification of the patent and in substance fall within the scope of the claim
or claims of that specification.
2. Goods containing, or consisting of, the substance must be included in the Australian
Register of Therapeutic Goods.
3. The period beginning on the date of the patent and ending on the first regulatory
approval date for the substance must be at least 5 years.
4. The term of the patent must not have been previously extended under this Division.
Bolar Provision
Yes.
Schedule 7 of the Intellectual Property Laws
Amendment Act 2006 amended the Patents Act 1990 to introduce a new
“springboarding” provision in relation to all 'pharmaceutical patents',
irrespective of whether the patent has been granted, or is even eligible
for, an extension of term.
New section 119A of the Patents Act introduced in October 2006, provides
that a pharmaceutical patent is not infringed by exploitation of an
invention for purposes solely in connection with obtaining inclusion of
goods intended for therapeutic use in the ARTG or obtaining a similar
foreign regulatory approval. However, where foreign regulatory approval
is sought, the pharmaceutical product cannot be exported from Australia
for regulatory purposes unless the relevant patent has been granted an
extension of term.
Section 119A broadens the class of patents to which springboarding is
permitted in Australia and brings the legislation closer to that of
other jurisdictions such as Canada and New Zealand.
References
http://www.derwent.com/patentguides/gpe/au_april.htm
http://scaletext.law.gov.au/html/pasteact/1/545/top.htm
Prepared for IP Organisers by Dr Grace Chan, David Tadgell and Virginia Beniac-Brooks, Phillips Ormonde & Fitzpatrick - November 2007. |
