High Court Confirms That Extension of Time Provisions Apply to Requests for Pharmaceutical Extensions of Term

In a recent decision, the High Court of Australia has ruled that the extension of time provisions of the Australian Patents Act 1990 (Act) can be used to extend the time for requesting an extension of term of a patent relating to a pharmaceutical substance.

The dispute was based on a request by Lundbeck to extend the term of Australian patent 623144.  The extension of term request was filed after the applicable deadline and was, therefore, accompanied by an application for an extension of time.  The Act includes generous extension of time provisions.  These provisions are enlivened when a relevant act is not done by the applicable deadline due to an error or omission on the part of the applicant or their attorney.  However, the Patents Regulations exclude certain acts from the extension of time provisions.  One of these acts is as follows:

“filing, during the term of a standard patent under subsection 71(2) of the Act, an application…for an extension of the term of the patent”

Subsection 71(2) sets the deadlines by which an extension of term request must be made.  These deadlines are as follows:

(i)     During the term of the patent

(ii)    Within 6 months of the latest of:

(a)   the date the patent was granted or

(b)   the date of commencement of the first inclusion in the Australian Register of Therapeutic goods of goods that contain the pharmaceutical substance.

Alphapharm contended that the exclusion prevents obtaining extensions of time for requesting an extension of term.  Lundbeck argued that the exclusion applies to the deadline in part (i) above, but not that in part (ii).  In other words, Lundbeck’s position was that the exclusion operates to prevent the filing of a request for an extension of time outside the term of the patent.

In a 3-2 majority, the Court agreed with Lundbeck and allowed the extension of time because it was filed during the term of the patent.

This decision confirms that while the extension of time provisions apply to pharmaceutical extensions of term, no extension of time request may be filed outside the term of a patent.