IPA patent 7.12-extension-of-term-of-standard-patents-relating-to-pharmaceutical-substances — IP Australia Patent Manual of Practice and Procedure – 7.12 Extension of Term of Standard Patents Relating to Pharmaceutical Substances

Also in this Chapter: 7.1 Role and Powers of the Commissioner in Hearings 7.2 Oppositions, Disputes and other proceedings-Procedural summaries 7.3 Directions 7.4 Opposition Documents, Requirements and Amendments 7.5 Evidence 7.6 Production of Documents, Summonsing Witnesses 7.7 Withdrawal and Dismissal of Oppositions 7.8 Hearings and Decisions 7.9 Costs 7.10 The Register of Patents 7.11 Extensions of Time and Restoration of Priority 7.13 Orders for Inspection of non OPI Documents 7.14 Appeals ART, ADJR, The Courts 7.15 Computerised Decisions Sub-chapters: 7.12.1 Section 70 Considerations ​​​​​​​ 7.12.2 Applying for an Extension of Term 7.12.3 Processing an Application for an Extension of Term 7.12.4 Calculating the Length of the Extension of Term 7.12.5 Patents of Addition 7.12.6 Divisional Applications 7.12.7 Oppositions to an Extension of Term 7.12.8 Relevant Court Proceedings Pending 7.12.9 Rectification of the Register ​​​​​​​ Key Legislation: Patents Act: s70 Applications for extension of patent s71 Form and timing of an application s74 Acceptance or refusal of application s75 Opposition to grant of extension s76 Grant of extension s77 Calculation of term of extension s78 Exclusive rights of patentee are limited if extension granted Schedule 1 Dictionary Patents Regulations: reg 6.8 Information to accompany application In this topic: Relevant Legislation The Act The Regulations Overview Requirements for Obtaining an Extension of Term Rights of Patentee During the Extended Term ​​​​​​​ The Act Section 70 Applications for extension of patent Section 71 Form and timing of an application Section 74 Acceptance or refusal of application Section 75 Opposition to grant of extension Section 76 Grant of extension Section 77 Calculation of term of extension Schedule 1 Dictionary The Regulations Regulation 6.8 Information to accompany application Overview The Intellectual Property Laws Amendment Act 1998 amended the Patents Act 1990 to provide for an extension of term for pharmaceutical patents. The scheme allows patentees to apply for an extension of term of up to 5 years for a standard patent that claims a pharmaceutical substance. Requirements for Obtaining an Extension of Term In order to obtain an extension of term for a patent, the following requirements must be met: the patent must, in substance, disclose and claim a pharmaceutical substance per se, or a pharmaceutical substance when produced by recombinant DNA technology; goods containing or consisting of that pharmaceutical substance must be included in the Australian Register of Therapeutic Goods (ARTG); and the first regulatory approval for that pharmaceutical substance must have occurred more than 5 years after the date of the patent. Provided the requirements of the Act are satisfied, the term of the patent (in its entirety) may be extended. Rights of Patentee During the Extended Term The rights of a patentee during the extended term of a patent are however limited over the normal rights in a patent. Although the term of the patent as a whole is extended, exploitation of any form of the invention that is not a pharmaceutical substance and exploitation of pharmaceutical substances for non­therapeutic uses do not constitute infringement of the patent during the extended term ( s78 ).