The Federal Court of Australia has confirmed that an extension of patent term for Novo Nordisk's patent claiming liraglutide plus excipients (ie a formulation comprising a mixture of compounds/excipients rather than only the active ingredient of a formulation) was correctly granted, confirming the broad definition of “pharmaceutical substance per se” under the Patents Act.

In Cipla Australia v Novo Nordisk A/S, Perram J considered the validity of an extension of term for a patent claim “a pharmaceutical formulation comprising at least one GLP-1 agonist and Propylene glycol and a buffer which is disodium phosphate dihydrate…”. Following 2 previous decisions of the Federal Court, Perram J held that a pharmaceutical substance under the Act includes a formulation and has done so since introduction of the provision in 1989. 

Cipla submitted that the terminology in the Act that extensions of term applied to “pharmaceutical substances per se”  which should be found to mean to exclude additional matter and combinations of elements or matter.  Perram J diasgreed, following earlier Full Court decisions in which this term was held to exclude methods of use or delivery only.

The judgment is a very handy summary of the case law preceding this case on construction of the Act in respect of “pharmaceutical substances per se”.  

The case does not alter the current position on the law, and if Cipla wishes to agitiate the issue further then it will need to appeal the judgment to the Full Federal Court (which it may do as of right).