A review by David Tadgell
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David Tadgell, a partner within the Chemical Group, recently presented a paper on developments in Australia with respect to the extension of term provisions.
This presentation provides an overview of what the Courts and Patent Office are currently thinking with respect to extension of term in Australia and how the legislation is to be applied.
The ground has not shifted dramatically through the course of interpreting the current legislation since the first significant decision, namely Boehringer's application for a nasal spray.
However, in David's view there has been a slight softening in the approach taken by the Australian Courts and the Patent Office as to the definition of a pharmaceutical substance per sé, for example:
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- Whereas a claim must still define a pharmaceutical substance per sé, the Courts have allowed that substance to be defined by process steps, if those steps are necessary in order to define the particular substance. For example, a solution that is defined by the step that it has "not been reconstituted from a lyophilisate" is still considered to be a claim to a pharmaceutical substance per sé. (Pharmacia Italia v. Mayne Pharma). The Federal Court found that references to various processes in the claim were "merely referring incidentally to some element of the process, that are not themselves novel, in order to better describe the new and inventive substance."
- The Patent Office has confirmed previous practice that compositions or combinations are entitled to an extension of term in that they did allow an extension for a bi-layered tablet having a quick release and a slow release component (Sanofi Aventis).
- The Patent Office also allowed a pharmaceutical formulation where the transdermal delivery system is integral with the pharmaceutical (N.V. Organon). A claim to a pharmaceutical with a backing layer however (Lohmann Therapie-Systems [2009]), was disallowed, but is being appealed.
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These decisions at least give some hope that the interpretation of a pharmaceutical substance per sé may be relaxed to allow some other integers to be included within the claim, but we are probably not there yet.
The Lohmann Therapie-System [2009] appeal early next year may provide some greater guidance.
The Courts have also spent much time considering what is meant by "contain" with respect to the ARTG Registration. The Courts have found that registration of a racemate will "contain" the isolated enantiomer. This test has worked both for the patentee (Merck v. Arrow) and against the patentee (H. Lundbeck v. Alphapharm). Lundbeck are seeking leave to appeal to the High Court so we will keep a watch on things.
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