A recent Australian Patent Office decision, Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd,[1] has resulted in the grant of an extension of time to allow the owner of an accepted patent application to take advantage of the 12 month ‘grace period’. In certain circumstances, the ‘grace period’ is available to Australian patent applicants wanting to avoid a novelty destroying self-disclosure.
Neurim (the Applicant) had been alerted to an unauthorised disclosure but failed to communicate this information to the relevant person within the company. However, despite this fact, Neurim convinced the Delegate of the Commissioner that this failure was a genuine error on their part, with the belief that they did inform that relevant person or at least should have done so, weighing heavily into the favourable decision. The net result is that an initial failure to file a patent application in time to take advantage of the grace period has been rectified through an eight-month extension. The decision has significant consequences for the validity of the patent application in question, as the self-disclosure can no longer form part of the prior art base for the assessment of novelty and inventive step.
The decision has highlighted that the extension of time provisions available to Australian patent applicants with respect to the grace period can be lenient and flexible in nature.
Grace Periods & Extensions of Time
Information made publicly available before the filing date of a patent application (i.e. prior art) can be lethal to the validity of a patent application or granted patent. This is because, for an invention to qualify as a patentable invention, among other requirements, it must be novel and have an inventive step (be non-obvious) over the prior art base.
Section 24(1) of the Patents Act 1990 (Cth) (‘the Act’), provides a 12 month ‘grace period’ which allows any information made publicly available, with or without the consent of the applicant, the patentee, or the inventor, within 12 months before the effective filing date of a complete application, to be disregarded from the prior art base for assessment of novelty and inventive step.
Further, section 223(2) of the Act, also permits the extension of deadlines to a ‘person concerned’ (for example, an applicant or patent owner) to do certain acts (e.g. payment of fees, or filing a divisional patent application), but only if that person can demonstrate that an ‘error or omission’ has occurred, or when circumstances beyond a person’s control have prevented the person from performing the relevant act prior to the deadline. In addition to the decision in Ashmont Holdings Limited v American Home Products and Nature Vet Pty Limited,[2] the Australian Patent Office has previously reinforced that filing a patent application is a ‘relevant act’ suitable for the grant of an extension of time under s 223(2), as was shown in Mark Johnson v Paul Weingarth, Spiro Rokos and Paul Scully-Power.[3]
However, although it is technically possible to obtain an extension of the grace period beyond 12 months in situations when an error or omission, or circumstances beyond a person’s control, have led to certain information becoming publicly available, the Australian Patent Office’s 21 January 2020 decision in Amicus Therapeutics, Inc.[4] reminds us that the general extension of time provision of the Act (that is, s 223(2)(a)) does not apply to fix every error or omission.
The Background & Evidence
Neurim filed the application under consideration, AU2016426598 (the “Application”), relating to Melatonin mini-tablets and a method of manufacturing the same, on 26 April 2018 (from PCT/IB2016/057190), in the name of Neurim Pharmaceuticals Pty Ltd (the “Applicant”). The Application has an effective filing date of 29 November 2016 (PCT filing date), and an earliest priority date of 31 October 2016.
Prior to filing their patent application, Neurim had entered into a confidential agreement with the Centre for Human Drug Research (CDHR), relating to a pharmacokinetic study of the prototype product of the future patent application (a new age appropriate formulation of Circadin). Without Neurim’s consent, CDHR electronically published a thesis on 15 April 2015 (over 19 months before the PCT filing date), which unknowingly disclosed the study as Chapter 8. The chapter was meant to be embargoed, but this was not relevant to the facts of the case at hand.
The Vice President of Clinical and Regulatory Affairs at Neurim was made aware of the publication and undertook to have the situation immediately corrected. The CDHR subsequently redacted the chapter from the thesis, but this redaction was not sufficient to put a stop to the ongoing availability of unredacted copies of the thesis in electronic form.
The employee of Neurim, who was not involved in managing the company’s intellectual property, failed to communicate the knowledge of the disclosure to the Vice President of Drug Discovery and Development, the individual at Neurim who was responsible for and had experience regarding intellectual property.
After the Application was accepted, Generic Partners Pty Ltd filed a notice of opposition to the grant of the application under s 59 of the Act, citing a chapter of the published thesis as a key part of the prior art basis for the opposition.
Neurim filed a request for an extension of time under s 223(2)(a) and s 223(2)(b) to rely upon the grace period under s 24, seeking to remove the chapter of the thesis from the prior art base.
Once the request for the extension of time was deemed allowable by the Delegate of the Commissioner, Generic Partners opposed the grant of the extension, which brings us to the current decision.
The Decision
In the Opposition to the extension of time, and in addition to numerous other objections put forth by the Opponent, Generic Partners Pty Ltd mainly asserted that:
- the alleged act is not a relevant act for the purposes of s 223(2)(a); and
- the error as asserted is not established by the evidence.
In the Delegate’s view, it was considered that filing a complete application within twelve months of an unauthorised disclosure of the information to claim the benefit of the grace period pursuant to s 24(1)(b) comprises a relevant act for the purposes of s 223(2)(a), for which the time to perform the act may be extended. This was in accordance with Amicus.
All of the Opponent’s assertions were rejected, with the Delegate forming the view that the omission or error was one which deviated from Neurim’s usual practices of clearly relaying important information about products under development between Neurim’s teams. The evidence put forth by Neurim was enough to establish that the employee in question had an awareness that they should bring things like the publication of a thesis to the attention of the relevant people and would ordinarily do so.
It was concluded that on balance, the failure of the employee of Neurim to communicate the publication of the thesis to the relevant person was in fact causative with respect to the failure to file the Application in time to claim the benefit of the grace period, and thus was a causative error for the purposes of s 223.
The Delegate was satisfied that a proper case has been made out and exercised their discretion to grant the extension in favour of the applicant, despite the public interest being against the exercise of the discretion, although the interests of the parties were seen to be equally balanced. Importantly, the Delegate noted that it was not a “…matter of simply calculating how many considerations necessarily fall one way or the other, but understanding the material import of each consideration to whether the discretion should be exercised or not”.
Take Home Points
It is possible to extend the grace period under s 223 of the Act if the failure to file a complete patent application in Australia in time was due to a genuine an error or omission.
The error in question was determined to be the failure of one person to communicate the known disclosure of an invention to the relevant person.
This decision emphasizes that ‘errors or omissions’ can assume a wide variety of forms, and further reinforces the commonly held belief that the provisions available to Australian patent applicants with respect to extensions of time can be quite generous.
We expect that we have not heard the last of this decision, as the Opponent, Generic Partners, is likely to appeal the decision by the deadline of 4 February 2022. If you have any questions regarding this case or topic or would like to know more about the options available to you or your clients regarding extensions of time, please get in touch with our team.
[1] Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd [2022] APO 2
[2] Ashmont Holdings Limited v American Home Products and Nature Vet Pty Limited [2002] APO 24
[3] Mark Johnson v Paul Weingarth, Spiro Rokos and Paul Scully-Power [2020] APO 32
[4] Amicus Therapeutics, Inc. [2020] APO 4
