To compensate patent owners for the time it takes to
obtain regulatory and marketing approval for new drugs, the
Australian Patents Act provides for patent term extensions of up to
five years. However, in order to have an extension of term granted,
a number of requirements need to be satisfied.
These requirements include:
- that a patent discloses and claims a pharmaceutical substance
per se or a pharmaceutical substance produced by a process that
involves the use of recombinant DNA technology; and.
- that the pharmaceutical substance be listed on the Australian
Register of Therapeutic Goods (ARTG) before the patent
expires.
Two recent Australian Patent Office decisions, namely the Regents
of the University of California & Regeneron, Inc. [2016] APO 33
(10 June 2016) (The Regents of the University of California
& Regeneron) and Aventis
Pharma S.A. [2016] APO 34 (10 June 2016) (Aventis), considered
whether product information included with an ARTG
