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
The relevant claims of the two patents defined
combinations of a VEGF antagonist and another
compound, either fluorouracil 5-FU (Aventis) or an
anti-proliferative agent (The Regents of the University of
California & Regeneron). Patent term extension applications
were filed for the two patents on the basis of the ARTG listing of
ZALTRAP, which contains only the VEGF antagonist,
The patentees submitted that the claimed combinations are
"included in the ARTG" by way of the therapeutic
indications for ZALTRAP and by references to the claimed
combination in the product information associated with ZALTRAP.
Thus, the question considered by the Delegate for the Patent Office
was whether the reference to the claimed combination in the ZALTRAP
product information satisfied the requirement that the
pharmaceutical substance be listed on the ARTG.
Ultimately, the Delegate was not satisfied that the relevant
requirement was fulfilled. In reaching this decision, reference was
made to precedent case law that confirmed that the requirement
necessitated a simple comparison of the claimed pharmaceutical
substance with the "ingredients" of the goods
listed on the ARTG. As the patentees did not
establish that ZALTRAP, as listed on the ARTG, included the claimed
combination compositions, the patent term extension applications
These Patent Office decisions clarify that for a patent to be
eligible for a term extension a pharmaceutical substance covered by
the claims must be explicitly listed on the ARTG – reference
to a claimed pharmaceutical in the product information of an ARTG
listed pharmaceutical will not suffice.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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