Proposed amendments to Australian patent law: Infringement exemption for acts for obtaining regulatory approval

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An exemption to Australian patent infringement is proposed in respect of acts done solely for purposes connected with obtaining regulatory approval of a relevant product. The exemption is to apply to acts done in relation to agrochemicals, veterinarian medicines, medical devices, diagnostics and any other non-pharmaceutical subject matter for which there is a legally established regulatory approval regime. This proposal would significantly broaden the current narrow exemption that only applies to acts connected with obtaining regulatory approval of a pharmaceutical.

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