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Patent Term extensions for (pharmaceutical) regulatory delay and delay in the Intellectual Property Office of New Zealand

Since 1994, New Zealand has provided all patents with a non-extendible term of 20 years from the filing date. However, under the Trans Pacific Partnership Agreement, the New Zealand government agreed to provide for an extension of the term a patent in certain circumstances. The Trans-Pacific Partnership Amendment Bill is currently before the Select Committee and the corresponding regulations have been made available for public submissions.

In brief, the government intends to introduce very limited Patent Term extensions for both delay in the Intellectual Property Office and regulatory delay of pharmaceuticals including small drug molecules and recombinant molecules (biologics).

Pharmaceutical term extension

In terms of regulatory delay for pharmaceuticals, an extension of time will only be available when the period between the grant of marketing approval and the application for marketing approval is greater than 5 years for biologics or greater than 3 years for any other drug substance, less any periods which our outside the directions or control of the marketing regulator. Moreover the extension period is proposed to be the shortest of:

• the period equal to the interval between the date of grant of the patent and the date on which marketing approval is published,

• the period by which the period of marketing approval exceeds 5 years for biologics and 3 years for pharmaceutical substances (less periods outside the direction or control of the marketing regulator), or

• 2 years.

Extension due to delay in the Office

An extension of term for delay in the Intellectual Property Office is proposed to be available only if the patent is granted more than 5 years after the patent date and more than 3 years from the date of requesting examination. Moreover, the Commissioner must disregard any periods of time which are outside the control of the Commissioner, including re-examination and pre-grant opposition proceedings. Given that the Intellectual Property Office of New Zealand is generally quite efficient in examining and granting patents, these provisions are likely to be used rarely.

In practice, neither of the above extensions will give substantial relief to Patentees. Whilst they may technically meet the wording of the Articles 18-46 and 18.48 of TPPA, they fall well short of provisions in other jurisdictions, including Australia.