IPA patent 7.12.1-section-70-considerations — IP Australia Patent Manual of Practice and Procedure – 7.12.1 Section 70 Considerations

Also in this Chapter: ​​​​​​​ 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 Sub-chapters: 7.12.1.1 Pharmaceutical Substance per se 7.12.1.2 Meaning of Pharmaceutical Substance 7.12.1.3 Meaning of ＂when produced by a process that involves the use of recombinant DNA technology＂ 7.12.1.4 Meaning of ＂mixture or compound of substances＂ 7.12.1.5 Meaning of ＂in substance disclosed＂ 7.12.1.6 Meaning of ＂in substance fall within the scope of the claim＂ 7.12.1.7 Included in the Goods 7.12.1.8 First Regulatory Approval Date ​​​​​​​ Key Legislation: ​​​​​​​Patents Act: s65 Date of patent ​​​​​​​ s70 Applications for extension of patent Section 70 sets out certain requirements for obtaining an extension of term. Under s70(2) , either or both of the following conditions must be satisfied: one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification; one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification. In addition, s70(3) provides that the following criteria must be satisfied in respect of at least one of those pharmaceutical substances: goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods (ARTG); the period beginning on the date of the patent (as determined under s65 ) and ending on the first regulatory approval date must be at least 5 years.