Securing a fair protection term for pharma patents

Declan McKeveney

By Declan McKeveney

The process of getting a new pharmaceutical to market is a long and complex one. This can create a problem for those seeking to protect a new pharmaceutical innovation; a significant portion of the term of a standard pharmaceutical patent could be used up in the process of obtaining regulatory or marketing approval before sales of the related drug can commence.

However, in order to avoid pharmaceutical patentees having an unfairly short term of protection in which to recoup the substantial R&D investment they have made, the Australian Patents Act (the Act) has provisions for extending the term of standard patents which relate to pharmaceutical substances per se.

Contradictory decisions from the courts and Patent Office have made obtaining these extensions more difficult to navigate in Australia. Understanding what extensions are available, their conditions, and how to get one can be vital to making pharmaceutical R&D investment profitable.

What Types of Patent are Eligible for Extension of Term?

Under Section 70 of the Act, to be granted an extension of term, a patent must meet three conditions:

  • the patent must disclose and claim one or more pharmaceutical substances per se or one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology;
  • goods containing, or consisting of, the pharmaceutical substance must be included in the Australian Register of Therapeutic Goods which is administered by the Therapeutic Goods Administration (the TGA);
  • the time between the filing date of the patent and the date on which the first regulatory approval for the pharmaceutical substance is issued must be at least 5 years.

If all of these conditions can be met then an extension of term is possible.

When Should an Application for Extension of Term be Made?

An application for an extension of the term must be carefully timed in order to meet the necessary conditions. The application must be made prior to the expiry of the term of the patent and within 6 months of whichever is the later of

(i)                   the date of grant of the patent; or

(ii)                 the date of first regulatory approval of any goods containing the relevant pharmaceutical substance.

A registered patent attorney should be able to advise when this window of opportunity falls for any specific innovation.

What protection does the extension provide and for how long?

It is important to realise that the rights afforded to the patentee during the extension period are more limited than during the standard term. For example, it is not considered an infringement to exploit the patented substance for any purpose other than a therapeutic use, or to exploit any form of the invention other than the pharmaceutical substance per se.

The Act allows for an extension of term which is equal to the time period between the filing date of the patent and the date of first regulatory approval minus 5 years. The extension of term period is capped at a maximum of 5 years. Should an extension of term be granted it will be advertised to give others the option to oppose the extension.

What Special Considerations exist for applications in Australia?

The law surrounding pharmaceutical extension of term applications in Australia is muddied with often contradictory decisions issuing from the Patent Office and the courts. There has been considerable debate within the courts regarding what is meant by the term “pharmaceutical substance per se” and whether that meaning should be restricted to the active substance only or interpreted more broadly to include mixtures of substances, delivery systems comprising the active ingredient and the like.

Equally, the reference to “goods containing, or consisting of, the substance” in the section of the Act dealing with when an extension application should be made has been interpreted in a narrow sense. Inclusion of only minor amounts of the relevant substance, even as an impurity within the main active substance registration, may be enough to start the six-month clock ticking on the window for an application for extension.

Given these, and other, significant nuances of Australian practice it is wise to seek advice on extending the term of your pharmaceutical patent early on, and certainly in advance of your patent being granted.