Recent Developments in Australian & US Patent Law & their Impact ...

Regulatory approval –
pharmaceuticals
Ausbiotech 2012 – Australian and US Patent Law 1 November 2012 29
s 119A
No infringement of a pharmaceutical patent if the invention is being exploited solely for
purposes connected with obtaining registration on the ARTG, or similar regulatory
approval under the law of a foreign country, for goods intended for therapeutic use.
Pharmaceutical Patent:
• pharmaceutical substance;
• a method, use or product relating to
a pharmaceutical substance,
including any of the following
• method of producing raw material
needed to produce the substance;
• raw material need to produce the
substance; or
• pro-drug; metabolite or derivative
of the substance.
Registration cannot be in
relation to a medical or
therapeutic device.
Exception does not apply to
exporting goods for overseas
registrations unless:
• there has been a patent term
extension; and the goods either
• contain a pharmaceutical
substance per se claimed in a
patent; or
• contain a pharmaceutical
substance when produced by
recombinant DNA technology
claimed in a patent