Australian Patent Extension of Term – We’ve got the list of Applicants, Pharmaceutical Names and Expiry Dates

In Australia, the owner of a pharmaceutical patent can apply to extend the standard 20-year term for an additional period of up to 5 years.

This is good news for pharmaceutical companies who spend much of their 20 years developing and testing the products and obtaining the necessary authorisations from the health regulators.

Requirements for an Australian Patent Extension of Term

In order to obtain an extension of term for an Australian patent, you must first meet the following three requirements:

• The patent must, in substance, disclose and claim a pharmaceutical substance per se, or a pharmaceutical substance when produced by recombinant DNA technology, must in substance be disclosed in the specification and fall within the scope of the claims

• Goods containing or consisting of that pharmaceutical substance must be included in the Australian Register of Therapeutic Goods (ARTG)

• The first regulatory approval for that pharmaceutical substance must have occurred more than 5 years after the date of the patent

Pharmaceutical companies should keep in mind that only one patent term extension can be granted per Australian patent. However, multiple patents can be extended based on a single registration on the ARTG. Your patent attorney will provide guidance as to whether this is an option for you.

Who are the Key Players on the Extension List?

There are currently 659 granted Australian patents with a pharmaceutical extension of term. Around 78% of these cover small molecules, formulations and methods of treatment. About 18% of the current extension of term patents cover monoclonal antibodies and vaccines accounting for around 4%.

Novartis tops the list with 53 Australian pharmaceutical patent extensions followed by Pfizer having 44 and Merck and Roche with 33.

Who Else is on the Extension List?

The Table attached below shows the pharmaceutical and branded names as well as applicant and agents names for extension of terms having an expiry year of 2022, 2023 and 2024.

If you would like to see the expiry dates and pharmaceutical names for all 659 pharmaceuticals with an extension of term, please send an email to louisa.king@apertureinsight.com.au and we’ll email it to you.

Table – Pharmaceutical and branded names for extension of terms having an expiry year of 2022, 2023 and 2024.