Two recent Australian Patent Office decisions have clarified the criteria on patent term extension for patents covering combinations of active ingredients.
Patents normally have a maximum term of 20 years from their filing date. However, IP Australia may extend a patent’s term beyond 20 years if it covers therapeutic goods which have had their market entry delayed due to regulatory approval processes. In Australia, medicines cannot be sold or used until they have been registered on the Australian Register of Therapeutic Goods (ARTG). To compensate medicine developers for the time taken to gain regulatory approval, the Australian Patents Act allows the patent lifetime for these medicines to be extended in some circumstances.
The decisions, The Regents of the University of California & Regeneron, Inc.  APO 33 and Aventis Pharma S.A.  APO 34, concern two related patents for cancer treatments comprising a combination of active ingredients, being 1) a VEGF inhibitor and 2) an additional chemotherapeutic agent (in particular, certain fluoropyrimidines and their derivatives). The patentees sought extensions to the terms of their patents based on the time taken to obtain regulatory approval for a marketed anti-cancer medicine called ZALTRAP®, which is a VEGF inhibitor registered on the ARTG.
In determining eligibility for an extension of term, section 70 of the Patents Act 1990 requires that:
One or more pharmaceutical substances (either per se, or when produced by recombinant DNA technology) must in substance be disclosed and fall within the claim of the patent (s70(2));
Goods containing or consisting of the pharmaceutical substance must be included in the ARTG (s70(3)).
A third requirement of section 70 is that the time between patent filing and the first regulatory approval of a product containing the pharmaceutical substance be at least five years, but this point was not at issue in these cases.
On the first point, both patents describe and claim the combination of a VEGF inhibitor and chemotherapeutic agent, both of which fall within the definition of “pharmaceutical substance” in Schedule 1 of the Patents Act. Consequently, the Delegate found that the criteria of section 70(2) were satisfied.
The decisions turned on the second point; being whether the marketed medicine ZALTRAP® was a good “containing or consisting of the substance” claimed in the patents at issue.
Although ZALTRAP® is a VEGF inhibitor registered on the ARTG, it does not contain the additional chemotherapeutic agent necessary to bring it within the claims of the patents at issue. The patentees accepted this point, but argued that even though ZALTRAP® does not fall within the claims of the patents at issue, the product information for ZALTRAP® showed that it is indicated for use in combination with chemotherapeutic agents (specifically the claimed fluoropyrimidines), and this combination is within the scope of the claims. On this basis, the patentees argued that the claimed combinations were goods included in the ARTG and these patents were eligible for term extension.
The Delegate disagreed, and cited with approval earlier decisions* which distinguish between the goods and their therapeutic indications. The Delegate held that, as ZALTRAP® does not actually contain a combination of the VEGF inhibitor and the additional chemotherapeutic agents as claimed, the patentees had not established that ZALTRAP® was a good that “contained or consisted” of the claimed combination.
In summary, Australia takes a narrow interpretation of the wording of section 70(3) of the Patents Act, and pharmaceutical term extensions are only available in cases where goods registered in the ARTG literally consist of or contain the pharmaceutical substance as it is claimed. However, the decisions confirm that patents covering combinations of actives satisfy the requirements for term extension under section 70(2).