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In doing so, IPONZ considers that it may for any given application under consideration take the following into account: the concerns of interest groups, evidence including appropriate public polls and research, corresponding foreign legislation, caselaw and guidelines.
As a general guide, claims to the following subject matter are likely to attract an objection under s17(1): human beings, processes which give rise to human beings and biological processes for their production; methods of cloning human beings; human embryos and processes requiring their use; transformed host cells within a human and other cells and tissues within a human.” This document provides guidelines on applications relating to the Swiss-type claims under the Patents Act 1953 (“the Act”).
In Europe and the UK, where methods of medical treatment of humans are also unpatentable, the Swiss-type claim was devised to enable second medical uses to gain some patent protection.
These claims were termed “Swiss-type” claims since they were allowed in a decision of the Swiss Intellectual Property Office which was subsequently followed in a corresponding decision by the European Patent Office (EPO) Enlarged Board of Appeal in G 05/83 (EISAI/Second medical use OJEPO 1985, 64).
Every application and patent will, as always, be considered on its own merits in light of legislation, case law, these Guidelines and any other information as may be considered relevant in view of the particular facts of each application or patent.
Swiss-type claims are used to effectively protect the use of an active substance or composition in the manufacture of a medicament for the treatment of a “new use”, where the substance or composition had previously been used for the treatment of a different condition i.e. Providing that the new use is not known, such claims are considered to be novel.
These Guidelines supersede all previous practice notes, guidelines and the like.
The Guidelines do not constrain the judgment and discretion of the Commissioner of Patents.
The novelty of a Swiss-type claim is assessed using the same criteria as those applied to claims for active substances per se i.e. For a Swiss-type claim to be anticipated, there should be clear and unmistakable directions found in the prior art to make or do that which is claimed in the claim in question.
Therefore, the prior art should specifically disclose the use of the active substance in the purported new therapeutic application.