The concept of patent term extensions is one that is widely known amongst those in the pharmaceutical industry. It refers to an extension granted to a patent that covers a pharmaceutical product that has undergone regulatory approval. The purpose of a patent term extension (PTE) is to compensate for the delays that have occurred during the process of obtaining regulatory approval, so as to encourage pharmaceutical research and development.
We have prepared a brief reference guide, in four parts, to help explain the process in Australia and key jurisdictions, including the US and Europe.
Not all countries provide for patent term extension, for example New Zealand. However, those countries that do provide such provisions include Europe, the United States, Singapore, Japan, Taiwan, South Korea, Israel, Russia, Ukraine and several others. This article discusses patent term extensions in Australia, and how this differs relative to patent term extensions in major jurisdictions, including the United States and in Europe, so that patentees can better protect their pharmaceutical products across international markets.
The basics of regulatory approval for pharmaceutical drug products
For pharmaceutical products to be sold in Australia, it is essential that the product is included in the Australian Register of Therapeutic Goods (ARTG), which is regulated by the Therapeutic Goods Administration (TGA). The role of the TGA is to assess therapeutic goods to ensure that they are safe and effective prior to receiving approval for use in Australia. The process of regulatory approval often takes many years, during which time the patent term has already commenced. Aside from pharmaceutical products, the same process also applies to medical devices and in vitro diagnostic manufacturers.
In the United States, the Food and Drug Administration (FDA) is the equivalent of Australia’s ARTG, in that drug approval must be sought via the FDA prior to marketing the relevant product in the US.
In Europe, marketing authorisation is obtained either via the European Medicines Agency (EMA) or the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Since the UK left the European Union on 31 January 2020, and during the transition period up until 1 January 2021, UK marketing authorisations obtained by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) were converted into Great Britain marketing authorisations. Post-Brexit, following expiry of this transition period, the process of obtaining marketing authorisations in the UK now differs slightly. Specifically, UK marketing authorisations obtained by MH7RA are valid across the whole of the UK, whereas Great Britain marketing authorisations obtained by the MHRA are valid only in Great Britain (England, Scotland and Wales), and for marketing authorisation in Northern Ireland these continue to be obtained via the EMA, despite Northern Ireland being part of the UK.
Thus, many of the products that are approved for marketing in the UK may be covered by both a Great Britain marketing authorisation, as well as a Northern Ireland EMA marketing authorisation. Post-Brexit, this also means that marketing authorisation granted by MHRA, does not count as “first authorisation” for placing the product on the European market.
How long is the patent term extension?
In Australia, the standard patent term is 20 years from the date of filing. Upon grant of an extension of term, pharmaceutical patents can further benefit from an extension of up to 5 years.
Calculating the actual length of an extension, involves working out the period between the date of the patent and the date of the earliest first regulatory approval, reduced by 5 years (section 77 of the Patents Act).
Essentially this means that where the period between the two dates is 5 years or less, an application cannot be made for an extension of term. Likewise, where the period between the two dates is 10 or more years, this would allow for the full 5-year extension of term to be applied. Any period between 5 and 10 years, will be calculated and an extension of term will be granted for between 0 to 5 years.
In the US and in Europe, the maximum patent term extension is also 5 years, and the calculations for determining the extension are similar. However, if the regulatory product is for paediatric use, the term can be further extended for an additional 6 months, which gives a total patent term extension of up to 5 years and 6 months for paediatric drug products.
Post-Brexit, the UK has retained this provision, so that UK patents covering a product that has received marketing authorisation for paediatric use, are eligible for a further 6 month extension. However, advantageously post-Brexit, the requirement to provide evidence of marketing authorisation in all European Economic Area (EEA) states (Iceland, Liechtenstein, Norway and Switzerland) has been removed, so that it may now be possible to receive grant of a 6 month extension of term, even though approval for paediatric use was not obtained in all these EEA states.
Given that Australian patent laws follow European patent laws quite closely, it is surprising that the provisions concerning patent term extensions do not currently extend to provide additional term protection for paediatric products, although this could change in the future.
In part 2, we will be providing more detail about eligibility in major jurisdictions, including Australia, United States of America and Europe