Like other patent frameworks, Australian pharmaceutical patents may be eligible for an extension in term from 20 years to a maximum of 25 years, to compensate for a lag in regulatory approval for such pharmaceuticals or biological products.
Under the Patents Act 1990 (Cth) (Act) such extensions of term are only available for patents in respect of a “pharmaceutical substances per se” (new and inventive substances.
Importantly, eligibility for an extension is strictly regulated by requirements including that an application can only be made if the period between the date of filing of the patent and regulatory approval is at least 5 years. If the patent is eligible for an extension, the extension is the difference between the date of the patent and the “earliest first regulatory approval date in relation to any of the pharmaceutical substances” less 5 years.
Numerous cases have considered the meaning of the term “pharmaceutical substance per se”, and these two recent decisions of the Federal Court grapple with the identification of the actual “first regulatory approval date” of a pharmaceutical substance.
While in practice the patentee provides the details of the registration of its reference product for this purpose, these two recent cases open up a relevant enquiry as to whether a different and earlier registered product can scuttle the patentee’s request for an extension of term. Specifically, where the patent discloses and claims more than one pharmaceutical substance per se that are each the subject of ARTG listings, the application of the regime has been controversial.
Two recent decisions of single judges of the Federal Court considered the provisions.
For further information, please contact:
Jane Owen, Partner, Bird & Bird
jane.owen@twobirds.com
