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3.12.1 Section 70 Considerations

Date Published

Section 70 sets out certain requirements for obtaining an extension of term.

Under sec 70(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, sec 70(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 sec 65) and ending on the first regulatory approval date must be at least 5 years.
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