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ausip:patent-overview [2019/02/25 13:27]
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ausip:patent-overview [2019/02/25 13:30] (current)
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 **First requirement:​** **First requirement:​**
  
-1aDisclose and claim a pharmaceutical substance per se, including compounds, active metabolites,​ a composition or a mixture of substances. ((//LTS Lohmann Therapie-Systeme Gmbh & Co KH// [2002]))+aThe first part of this requirement is that a pharmaceutical substance per se must be disclosed and claimed, including compounds, active metabolites,​ a composition or a mixture of substances. ((//LTS Lohmann Therapie-Systeme Gmbh & Co KH// [2002]))
  
 For a claim to related to a pharmaceutical substance per se, it must be unqualified by process, temporal or environmental components. ​ For a claim to related to a pharmaceutical substance per se, it must be unqualified by process, temporal or environmental components. ​
  
-1b) Pharmaceutical substance produced by a process that involves the use of recombinant DNA technology.+bPharmaceutical substance produced by a process that involves the use of recombinant DNA technology.
        
 **Second requirement:​** **Second requirement:​**
  
-2. Must be included in the Australian Register for Therapeutic Goods (ARTG). A substance can be included in the ARTG if it is included in some way. The substance does not have to be explicitly named as an active ingredient to be considered ‘included’ and can be an impurity, which has been noted. ​+Must be included in the Australian Register for Therapeutic Goods (ARTG). A substance can be included in the ARTG if it is included in some way. The substance does not have to be explicitly named as an active ingredient to be considered ‘included’ and can be an impurity, which has been noted. ​
  
 **Final requirement:​** **Final requirement:​**
  
-3. The final requirement for a pharmaceutical patent is that regulatory approval for the pharmaceutical substance must have occurred more than five years after the date of the patent. ​+The final requirement for a pharmaceutical patent is that regulatory approval for the pharmaceutical substance must have occurred more than five years after the date of the patent. ​
  
 There are specific rights that are valid during the extended term of the patent. These include that a patent will not be infringed if a person exploits the pharmaceutical substance a purpose other than a therapeutic purpose or if a person exploits any form of the invention other than the pharmaceutical substance per se. There are specific rights that are valid during the extended term of the patent. These include that a patent will not be infringed if a person exploits the pharmaceutical substance a purpose other than a therapeutic purpose or if a person exploits any form of the invention other than the pharmaceutical substance per se.
  • ausip/patent-overview.txt
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