Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd [2022] APO 2

The Australian Patent Office recently granted Neurim Pharmaceuticals an extension of time for filing a complete application to claim the benefit of the grace period under s 24(1)(b) of the Patents Act 1990 (Cth) and reg 2.2D of the Patents Regulations 1991 (Cth). The extension of time was unsuccessfully opposed by Australian wholesaler of generic pharmaceuticals Generic Partners, which is currently opposing the grant of Neurim Pharmaceuticals' patent application for melatonin mini tablets.1

This decision aligns with the Patent Office's general approach of allowing reliance on s 223 to extend the grace period, despite there being some doubt over whether the grace period requirements under s 24(1)(b) amount to "a relevant act that is required to be done within a certain time" for the purposes of a s 223 extension of time application.

The outcome of this opposition provides some comfort as to the validity of extensions to the grace period made under s 223, although it is advisable that patent applicants remain somewhat circumspect until the law is clarified by a judicial decision or legislative amendment.

A thesis is published – Neurim needs the grace period

In May 2015, Neurim's Vice President of Clinical and Regulatory Affairs, Dr Nir, discovered that a thesis containing information from a study undertaken while developing the prototype product for Neurim's patent application had been electronically published. Though Dr Nir was concerned about that publication, he failed to inform Dr Laudon, who was Neurim's Vice President of Drug Discovery and Development and was responsible for intellectual property matters. The patent application was not filed until 29 November 2016, with an earliest priority date of 31 October 2016 – well over 12 months after the information in the thesis was made publicly available.

By 2019, Generic Partners had filed an opposition to the grant of Neurim's patent application. The opposition included novelty and inventive step grounds, and cited the published thesis as prior art. Accordingly, Neurim sought to exclude the thesis from being considered as prior art by relying on the grace period under s 24(1)(b):

24 Validity not affected by making information available in certain circumstances

(1) For the purpose of deciding whether an invention is novel or involves an inventive step or an innovative step, the person making the decision must disregard:

(b) any information made publicly available without the consent of the nominated person or patentee ... but only if a complete application for the invention is made within the prescribed period.

As emphasised above, that grace period could only shield Neurim's patent application from the published thesis "if a complete application for the invention [was] made within the prescribed period" of 12 months after publication. As Neurim's patent application was not filed within 12 months of the thesis being published, Neurim could only rely on the grace period if it was granted an extension of time for the filing of the complete application.

Neurim applies for an extension of time

Section 223(2) provides for extensions of time in the event of a person's error or omission, or other circumstances beyond their control:

223 Extensions of time

(2) Where, because of:

(a) an error or omission by the person concerned or by his or her agent or attorney; or

(b) circumstances beyond the control of the person concerned;

a relevant act that is required to be done within a certain time is not, or cannot be, done within that time, the Commissioner may, on application made by the person concerned in accordance with the regulations, extend the time for doing the act.

Under s 223, Neurim requested an eight month extension to the period in which their complete application could be filed to benefit from the grace period. Generic Partners opposed that application on a number of grounds, including that the alleged act relied on by Neurim for the extension of time was not a "relevant act required to be done", as is necessary for an application under s 223.

Generic Partners argued that the grace period could not be extended using s 223 because s 24(1)(b) "does not require a patentee to do anything".2 Rather, s 24(1)(b) merely provides a direction to a decision maker to disregard information ordinarily considered as prior art. Whether that information is disregarded depends on what Generic Partners described as an "entirely voluntary step of filing a complete application".3

However, the Delegate did not agree with Generic Partners' view. He emphasised that s 24(1)(b) does not permit reliance on the grace period unless a complete application is filed within 12 months of the information concerned becoming publicly available. In this sense, the Delegate considered that the filing of a complete application is an action required to be done within a legislated time period.4

The Delegate was further satisfied that Neurim had made a relevant error or omission that caused their failure to file an application within the relevant period, being Dr Nir's failure to inform Dr Laudon of the publication of the thesis.5 He was therefore satisfied to grant Neurim the extension of time.

What does this decision tell us?

This decision confirms that the Australian Patent Office's current practice is to treat the act of filing a complete application to rely on the grace period as a "relevant act" for which the time for performance may be extended under s 223. Thus, for the time being it appears the Patent Office is likely to grant an extension of time in relation to the grace period if an applicant can demonstrate an error or omission that caused their failure to file a complete application within 12 months of certain information becoming publicly available.

That said, the Delegate's decision is unable to shed light on whether the courts will be similarly willing to accept that the grace period can be extended using s 223. It would therefore be wise to treat the Patent Office decision with caution, and not seek to rely on extending the grace period unless truly necessary. As always, publication of information relevant to any possible future patent applications should be identified as early as possible so those applications can be prepared and filed in an appropriately timely manner.

You can read the decision here.


1. Australian application number 2016426598.
2. Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd [2022] APO 2, [32].

3. Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd [2022] APO 2, [33].

4. Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd [2022] APO 2, [38].

5. Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd [2022] APO 2, [90].

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