Extending the 12-month grace period for filing patent applications – what you need to know

A recent decision by the Australian Patent Office, Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd,[1] resulted in the granting of an extension of time to allow the holder of an accepted patent application to take advantage of the 12-month “grace period”. Under certain circumstances, the “grace period” is available to Australian patent applicants who wish to avoid novelty-destroying self-disclosure.

Neurim (the requester) had been alerted to an unauthorized disclosure but had not communicated this information to the relevant person within the company. However, despite this fact, Neurim convinced the commissioner’s delegate that this failure was a real mistake on his part, with the belief that they had informed this person concerned or at least should have, weighing heavily on the favorable 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 by an eight-month extension. The decision has significant implications for the validity of the patent application in question, as self-disclosure can no longer form part of the prior art basis for the assessment of novelty and potency. inventive.

The decision highlighted that the time extension provisions available to Australian patent applicants in respect of the grace period can be lenient and flexible in nature.

Grace periods and time extensions

Information made public before the filing date of a patent application (that is to say state of the art) can be fatal to the validity of a patent application or granted patent. Indeed, for an invention to qualify as a patentable invention, among other requirements, it must be new and have inventive step (not be obvious) based on the prior art.

Section 24(1) of the Patents Act 1990 (Cth) (“the Act”), provides for a 12-month “grace period” that allows any information made public, with or without the consent of the applicant, patent holder or inventor, within 12 months prior to the actual filing date of a complete applicationto be discarded from the prior art basis for the assessment of novelty and inventive step.

In addition, Section 223(2) of the Act also authorizes the extension of time limits for a “relevant person” (e.g. patent applicant or proprietor) to perform certain acts (e.g. payment of fees or the filing of a divisional patent application), but only if that person can show that an “error or omission” has occurred, or where circumstances beyond a person’s control have prevented him or her from performing the act in question before the deadline. Besides the decision in Ashmont Holdings Limited v American Home Products and Nature Vet Pty Limited,[2] the Australian Patent Office has previously pointed out that the filing of a patent application is an appropriate “relevant act” for the grant of an extension of time under section 223(2), as has been shown in Mark Johnson vs. Paul Weingarth, Spiro Rokos and Paul Scully-Power.[3]

However, while it is technically possible to obtain an extension of the grace period beyond 12 months in situations where an error or omission, or circumstances beyond a person’s control, have led to the rendering certain publicly available information, the decision of the Australian Patent Office dated 21 January 2020 in Amicus Therapeutics, Inc.[4] recalls that the general extension of the deadlines for the Act (i.e. Section 223(2)(a)) does not apply to correct all errors or omissions.

The context and the evidence

Neurim filed the pending application, AU2016426598 (the “application”), relating to melatonin mini-tablets and a process for the manufacture thereof, on April 26, 2018 (from PCT/IB2016/057190), on behalf of Neurim Pharmaceuticals Pty Ltd. (the applicant”). The application has an effective filing date of November 29, 2016 (PCT filing date) and an earliest priority date of October 31, 2016.

Prior to filing their patent application, Neurim had entered into a confidential agreement with the Center 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, the CDHR electronically published a thesis on April 15, 2015 (more than 19 months before the PCT filing date), which unknowingly disclosed the study as Chapter 8. The chapter was meant to be embargoed, but that was irrelevant to the facts of the case at hand.

Neurim’s Vice President of Clinical and Regulatory Affairs has been made aware of the posting and has pledged that the situation will be corrected immediately. The CDHR subsequently redacted the thesis chapter, but this redaction was not sufficient to end the continued availability of unredacted copies of the thesis in electronic form.

The Neurim employee, who was not involved in the management of the company’s intellectual property, did not communicate knowledge of the disclosure to the vice president of drug discovery and development, the person at Neurim who was responsible and had experience in intellectual property.

After the application was granted, Generic Partners Pty Ltd filed a notice of objection to the grant of the application under Section 59 of the Act, citing a chapter of the published thesis as a key part of the basis of the state of the art for the opposition.

Neurim filed a request for an extension of time under Section 223(2)(a) and Section 223(2)(b) to avail itself of the grace period under Section 24, seeking to remove the chapter of the thesis from the basis of the state of the art.

Once the request for an extension of time was deemed admissible by the Commissioner’s Delegate, Generic Partners opposed the granting of the extension, which brings us to this decision.

decision

In Objection to the Extension of Time, and in addition to numerous other objections advanced by the Opponent, Generic Partners Pty Ltd primarily asserted that:

  • the alleged act is not a relevant act for the purposes of section 223(2)(a); and
  • the alleged error is not established by the evidence.

In the view of the delegate, it was considered that the filing of a complete application within twelve months of an unauthorized disclosure of the information to claim the benefit of the grace period under Article 24(1)(b ) constitutes a relevant act for the purposes of s. 223(2)(a), for which the time to do the act may be extended. This was in accordance with friend.

All of the Opponent’s assertions have been rejected, as the Delegate believes that the omission or error departed from Neurim’s usual practice of clearly relaying important information about products in development between Neurim’s teams. The evidence presented by Neurim was sufficient to establish that the employee in question was aware that he had to bring things such as the publication of a thesis to the attention of the persons concerned and that he usually would.

It was concluded that, overall, the failure of the Neurim employee to communicate the publication of the thesis to the person concerned was in fact causal with respect to the failure to file the application in time to claim the benefit of the grace period, and was therefore a causal error for the purposes of section 223.

The delegate was satisfied that a proper case had been made out and exercised his discretion to grant the extension in favor of the applicant, although the public interest precludes the exercise of discretion, although the interests of the parties were considered to be equally balanced. . Importantly, the delegate noted that it was not “a matter of simply calculating how many considerations necessarily go one way or the other, but of understanding the material importance of each consideration to whether the discretion must be exercised or not”.

Take home points

It is possible to extend the grace period under section 223 of the Act if the failure to file a complete patent application in Australia within the time limit was due to a genuine error or omission.

The error in question was determined to be the failure of a person to communicate the known disclosure of an invention to the person concerned.

This decision highlights that “errors or omissions” can take a wide variety of forms, and further reinforces the commonly held belief that the provisions available to Australian patent applicants in respect of time extensions can be quite generous.

We anticipate that we have not heard the last of this decision, as the Opponent, Generic Partners, is likely to appeal the decision before the February 4, 2022 deadline.

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