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Treatment of Patentability Overseas


This Document is Archived


Patenting of Biotechnological Inventions

Putahi Associates Ltd, Wellington
[ Last Updated 17 October 2005 ]


A number of exceptions to patenting of life forms are used in overseas patent legislation. A brief summary of some of the approaches taken overseas follows below.

Inventions Contrary to Morality or Ordre Public

Some international treaties and States impose a 'contrary to morality' test in relation to patentability. Article 53(a) of the European Patent Convention denies European Patents for: "inventions the publication or exploitation of which would be contrary to ordre public or morality...".

The application of this test has been held to involve a balancing of the costs and benefits of the invention. In the Harvard Mouse case, a patent application was made for a mouse that was genetically altered to be predisposed towards developing cancer (the onco-mouse).

The Appeal Board of the European Patent Office said that consideration of the patentability of the onco-mouse under article 53(a) required "a careful weighing up of the suffering of animals and possible risks to the environment on the one hand, and the invention's usefulness to mankind (sic) on the other".

Exclusion for Plant or Animal Varieties

Article 53(b) of the European Patent Convention denies European Patents for plant and animal varieties. This provision does not apply to microbiological processes or products of microbiological processes.

Article 53(b) has been interpreted narrowly by the European Patent Office to effectively exclude only patent applications which specifically claim varieties. Claims in relation to species, which may include a number of varieties, have been allowed by the European Patent Office.

Specific Exclusion for Human Beings

Australia

Section 18(2) of the Australian Patents Act 1990 provides a specific exclusion from patentability for human beings and the biological processes for their generation. This provision has not been the subject of any court cases.

The Australian Patent Office has interpreted this provision in its internal guidelines to exclude patent claims to foetuses, embryos and fertilised eggs. The Australian Patent Office also treats "... processes beginning with fertilisation and ending with birth, which are wholly biological, and result in a human being" as excludable under this provision.

United States

In the US there is no specific exclusion from patentability for human beings in federal patent law, and no general "contrary to morality" exception. However, constitutional provisions forbidding slavery prevent the patenting of human beings in the US.

European Parliament

The European Parliament has just passed new legislation allowing biotechnology inventions. The legislation does not, however, allow patents to be granted "for procedures to clone human beings, commercial use of embryos, genetic engineering that causes animal suffering without substantial medical benefits, and therapies that would transmit genetic changes to a person's descendants."


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