A hidden catch to Australia’s generous regime for extension of term of pharmaceutical patents is that requesting an extension of term can act as a trigger for re-examination.

The Australian Patent Office has discretionary power to initiate re-examination of a granted patent when it becomes aware of key matters relevant to the validity of a patent. One time, for example, when new information relevant to the validity of a patent may come to light is during the assessment of an extension of term application. In Biogen Idec International GmbH [2015] APO 17, the Commissioner instigated re-examination of a patent during the course of assessing an extension of term application and found the patent to be invalid.

Biogen Idec International GmbH filed a request for an extension of term for patent no 752733 (“the patent”). The patent relates to pharmaceutical compositions for use in transplant medicine and autoimmune diseases. Specifically the patent is directed towards dialkyl fumarate (DAF) pharmaceutical compositions.

During the course of assessing the extension of term application, the Commissioner re-examined the patent of her own volition and found the patent to be invalid. The validity of the patent turned on whether or not a whole of contents prior art document, which discloses pharmaceutical compositions comprising alkyl hydrogen fumarate (AHF) alone or in combination with DAF, anticipated the patent. Certain claims of the patent did not exclude the presence of components other than DAF in the pharmaceutical preparation. Accordingly, the patent was found to lack novelty in light of the prior art. The Commissioner provided the patentee with a period of 2 months in which to file amendments.

We recommend you seek advice as to the best way to reduce risks when requesting patent term extension. At the very least, we recommend prior to requesting an extension of term to see whether prior art has been raised on corresponding cases in other jurisdictions that may impact the validity of your patent.