2 min read

IP Australia has been providing free, streamlined extensions of time of up to three months if a deadline cannot be met due to the effects of COVID-19.  However, streamlined extensions will not be available after 31 March 2021.

Streamlined extensions (until 31 March 2021)

The streamlined process has been available at IP Australia for requesting an extension of time of up to three months when an IP Rights holder is unable to meet a deadline due to the disruptive effects of the COVID-19 pandemic.  Many deadlines for patents, trade marks and designs have been covered by the streamlined extensions of time.

No declaratory evidence or fee has been required; it has been possible to simply check the relevant box on IP Australia’s eServices system to declare that the deadline cannot be met due to disruptions from the pandemic. 

Requesting extensions of time at IP Australia for patents, trade marks and designs from 1 April 2021

If you are unable to meet a deadline due to the COVID-19 pandemic, it will still be possible to request an extension of time.  However, from 1 April 2021, a declaration will be required to explain why you cannot meet the deadline.

The grant of an extension of time due to the effects of the pandemic does involve an element of discretion.  For patents, such extensions fall under section 223(2)(b) of the Patents Act 1990, according to which an extension of time “may” be provided if a deadline is missed because of “circumstances beyond the control of the person concerned”. 

Requests for extensions of time due to COVID-19 made from 1 April 2021 will be considered on a case-by-case basis and the Commissioner’s/Registrar’s review will consider the impacts of the pandemic.  

We can help

For more information about extensions of time in Australia, see our earlier article here: https://shelstonip.com/insights/publications/missed-an-australian-patent-deadline-heres-what-to-do/.

If you require assistance with your IP Rights, please contact us. 

Authored by Serena White, DPhil and Gareth Dixon, PhD

3 min read

The Therapeutic Goods Administration (TGA) has commenced a timely public consultation into the repurposing of prescription medicines, which seeks to better understand the incentives and potential hurdles influencing sponsors’ decision-making on whether to extend the approved indication for an existing medicine. Of particular interest to the TGA is the viability of repurposing medicines for rare diseases or less commercially profitable indications, or in circumstances where the new indication is already accepted clinical practice, albeit ‘off-label’ in Australia or elsewhere.

As part of its consultation paper the TGA has proposed far-reaching changes that have the potential to significantly reduce the regulatory burden on sponsors when applying for the inclusion of a new indication, improve information sharing and access to related international regulatory and reimbursement approvals, and implement open access to Australian medicine usage data.

Repurposing and ‘off label’ use

Repurposing, also referred to as second medical use, is the use of a known drug for a new therapeutic purpose. Repurposing is a promising avenue in drug discovery and has been an active area of growth in the last decade for a variety of drug classes, particularly chemotherapeutic agents.

Among the most visible recent examples of potential repurposing have been the investigation of known medicines such as chloroquine and hydroxychloroquine (both anti-malarials), remdesivir (an antiviral developed to treat Ebola) and tocilizumab (a monoclonal antibody developed to treat rheumatic conditions) and numerous other existing medicines as potential COVID-19 treatments.

Repurposing has the important benefit of decreasing the overall cost of bringing a new treatment to market and broadening access to it by Australian prescribers and patients, as the safety and pharmacokinetic profiles of the repurposed candidate have already been tested and established in connection with its original indication(s). 

In recent years, the TGA has worked with innovator sponsors to enable them to make submissions based on peer-reviewed literature, rather than clinical data, for registration of new indications for existing medicines on the Australian Register of Therapeutic Goods (ARTG). This in turn has enabled reimbursement for the indication through listing on Australia’s Pharmaceutical Benefits Scheme (PBS). 

In one such example, the TGA worked with the sponsor of Tamoxifen, a well-known breast cancer hormonal treatment in clinical use since the 1970s, to submit a literature-based application for a new indication (the prevention of breast cancer in high-risk women), which is an off-label use supported by recommendations in both Australian and international clinical care guidelines.

However, the TGA cannot compel sponsors to seek ARTG registration for a new indication that does not meet the sponsor’s business objectives, even where widespread and clinically-supported off-label use exists. Commercial imperatives are therefore one of the main barriers to less profitable second medical use indications becoming registered and subsidised.

Proposed approaches to facilitating and encouraging repurposing of medicines

The TGA has outlined three broad approaches to encouraging ARTG regulatory and PBS reimbursement applications for repurposed medicines, summarised below.

Proposal 1 – Reduce regulatory burden

  • Develop and provide specific regulatory support and guidance for repurposing medicines, including clinical trial design and scientific advice.
  • Assist with the development of literature reviews to simplify literature based submissions.
  • Facilitate access to comparable overseas evaluation reports, where they exist.
  • Improve the coordination of multi-jurisdictional submissions with other regulators.
  • Provide fee relief (currently a TGA application and evaluation for an extension of indication is approximately $148,000), for submissions for medicines that have low commercial returns but high public health gains.
  • Streamline simultaneous submissions for regulatory and reimbursement evaluation.
  • Provide exclusivity periods for the first sponsor of new indications of repurposed off-patent medicines.

Proposal 2 – Enhanced information sharing and access

  • Facilitate open access to Australian medicine usage data.
  • Provide a simple mechanism to find related international regulatory and reimbursement approval assessment reports or decision summaries.

Proposal 3 – Actively pursue registration and review

  • Seek public expressions of interest for sponsorship of new indications of a medicine, potentially limited to non-commercial organisations.
  • Compelling sponsors to make an application for an additional indication.
  • Pharmaceutical Benefits Advisory Committee (PBAC) to have the ability to approve the inclusion of an additional indication without the need for an application by the sponsor.

The issues raised by this consultation paper have important and far-reaching implications for both innovator and generic sponsors, and it will be of interest to see the outcome of this first round of pubic consultation, which concludes on 30 March 2021.

Authored by Dr Roshan Evans and Duncan Longstaff

3 min read

.au Domain Administration Limited (the administrator of .au domain names) is introducing a new set of rules for those who wish to hold, or continue to hold, a .au domain name. 

The new rules will come into effect on 12 April 2021.

The new rules introduce several changes to the previous eligibility rules applying to .au domain names. One of these changes may have implications in particular for foreign persons or entities wishing to hold a .com.au or .net.au domain name.

Under the previous rules, a person or entity must be “Australian” (as defined by certain criteria set out in the rules) to be eligible to hold a .au domain name. This requirement would be satisfied for .com.au and .net.au domain names if the domain name was an “exact match, abbreviation or acronym” of a registered or pending Australian trade mark held by that person or entity.

Reliance on an Australian trade mark to satisfy the eligibility requirements under the previous rules has been a useful option for foreign persons or entities that cannot meet other available criteria satisfying the “Australian” requirement.    

Under the new rules, a person or entity who wishes to rely on an Australian trade mark to support its eligibility to hold a .com.au or .net.au domain name can now only do so if the domain name is an exact match of its Australian trade mark. Essentially, the domain name must be “identical to the words which are the subject” of the Australian trade mark. This means that all the words that appear in the Australian trade mark must also appear in the domain name in the exact same order, with the exception of:

  • DNS identifiers such as com.au”;
  • punctuation marks such as an exclamation point or an apostrophe”;
  • articles such as ‘a’, ‘the’, ‘and ’or ‘of’”; and
  • ampersands”. 

It will no longer be possible to rely on an Australian trade mark to support eligibility for a .com.au or .net.au domain name if the domain name is an abbreviation or acronym of the trade mark.

The rule changes may be significant for any person relying on their Australian trade mark to support eligibility to hold their .com.au or .net .au domain name. This is especially the case for foreign persons or entities that may have no other option available to support their .com.au or .net.au domain name registrations. Importantly, domain name rights could be lost if the domain name is not an exact match of their Australian trade mark.

Although the new rules come into effect on 12 April 2021, current domain name registrants will have until renewal of their existing domain name to ensure compliance with the new rules.

If you intend to rely solely on an Australian trade mark to support eligibility for a .com.au or .net.au domain registration, you should ensure that your Australian trade mark meets the new requirements. Similarly, if you already hold a .com.au or .net.au domain name and may be affected by the changes, you should consider seeking advice on whether your existing Australian trade marks satisfy the new rules or whether any steps need to be taken to ensure you are not at risk of losing your domain name registration before it is renewed.

Feel free to contact us if you need any advice about your domain name eligibility or Australian trade marks.   

Authored by Felipe Pereira and Michael Deacon

1 min read

We are pleased to announce that Shelston IP has again ranked in World Trade Mark Review 1000 (WTR 1000) for Prosecution and Strategy as well as Enforcement and Litigation in Australia.

Also being ranked in both areas, our Trade Mark head Sean McManis. Proving once again to be a top Trade Mark Attorney within Australia.

Trademarks and brands group leader Sean McManis is “not only proactive, responsive, thorough and knowledgeable, he provides comprehensive, diverse trademark services”.

3 min read

IP Australia is providing free, streamlined extensions of time of up to three months if a deadline cannot be met due to the effects of COVID-19.  Whilst the maximum length of extension that can be requested at one time is three months, additional extensions of time of up to three months are available if needed.

The period for requesting a streamlined extension has been extended until 31 March 2021.  However, IP Australia now indicates that, subject to any further developments in the COVID-19 pandemic, streamlined extensions will not be available after 31 March 2021.

What are the streamlined extensions?

IP Australia has implemented a streamlined process for requesting an extension of time of up to three months when an IP Rights holder is unable to meet a deadline due to the disruptive effects of the COVID-19 pandemic.  No declaratory evidence or fee is required; all that is needed is to check the relevant box on IP Australia’s eServices system to declare that the deadline cannot be met due to disruptions from the pandemic. 

However, the streamlined extensions are not a simple free-for-all (see our earlier article here).  If asked, a requestor must be able to provide genuine reasons and evidence to justify the grant of the extension.  In addition, IP Australia warns that a false declaration could put the validity of an IP right at risk.

Many deadlines for patents, trade marks and designs are covered by the streamlined extensions of time, including deadlines associated with oppositions and hearings processes (such as periods to file evidence).  However, there are some exceptions.  For example: these extensions of time do not apply to deadlines for payment of renewal fees for patents, trade mark and designs, for which the usual 6 month grace period applies.  For trade marks, these extensions are also unavailable for filing of divisional applications.

What if I want to request an extension of time after 31 March 2021?

If you are unable to meet a deadline due to the COVID-19 pandemic, it will still be possible to request an extension of time after 31 March 2021.  However, such an extension will not be available via the streamlined process and a declaration will be required to explain why you cannot meet the deadline.

The grant of an extension of time due to the effects of the pandemic does involve an element of discretion.  Such extensions fall under section 223(2)(b) of the Patents Act 1990, according to which an extension of time “may” be provided if a deadline is missed because of “circumstances beyond the control of the person concerned”. 

Requests for extensions of time due to COVID-19 made after 31 March 2021 will be considered on a case-by-case basis and the Commissioner’s/Registrar’s review will consider the impacts of the pandemic.  

We can help

For more information about extensions of time in Australia, see our earlier article here.

If you require assistance with your IP Rights, please contact us. 

Authored by Serena White, DPhil and Gareth Dixon, PhD

2 min read

IP Australia is providing free extensions of time of up to three months if a deadline cannot be met due to the effects of COVID-19.  The period for requesting such an extension has been extended until 28 February 2021.  Depending on the ongoing impact of the pandemic, both in Australia and overseas, this period could be extended further. 

Whilst the maximum length of extension that can be requested at one time is three months, additional extensions of time of up to three months are available if needed.

IP Australia has implemented a streamlined process for requesting an extension of time of up to three months when an IP Rights holder is unable to meet a deadline due to the disruptive effects of the COVID-19 pandemic.  No declaratory evidence or fee is required; all that is needed is to check the relevant box on IP Australia’s eServices system to declare that the deadline cannot be met due to disruptions from the pandemic. 

However, these COVID-19 extension provisions are not a simple free-for-all (see our earlier article here: https://shelstonip.com/insights/briefings/ip-australias-covid-19-extensions-of-time-a-word-of-caution/).  An element of discretion does apply and, if asked, a requestor must be able to provide genuine reasons and evidence to justify the grant of the extension.  The timing of the request can be of significance too.  In addition, IP Australia warns that a false declaration could put the validity of an IP right at risk.

Many deadlines for patents, trade marks and designs are covered by the streamlined extensions of time, including deadlines associated with oppositions and hearings processes (such as periods to file evidence).  However, there are some exceptions.  For example: these extensions of time do not apply to deadlines for payment of renewal fees for patents, trade mark and designs, for which the usual 6 month grace period applies.  For trade marks, these extensions are also unavailable for filing of divisional applications.

For more information, or if you have been affected by the COVID-19 pandemic and require assistance with your IP Rights, please contact us. 

Authored by Serena White, DPhil and Gareth Dixon, PhD

The Principals and Staff of Shelston IP wish to thank you for your support in a year filled with challenges.

Throughout this season, and as we move into a new year, we would like to wish you, your family and colleagues strength, health, and as much happiness as these times can allow!

As part of our ongoing commitment to the community, we have made a donation to Aussie Ark, the largest independently owned and operated conservation organisation in New South Wales.

All the very best to you in 2021.


Office Closure

Shelston IP is closed during the Christmas and New Year period:

Friday, 25 December 2020

Monday, 28 December 2020

Tuesday, 29 December 2020 and

Friday, 1 January 2021.

The Australian Intellectual Property Office (IP Australia) will be closed from Friday, 25 December 2020, until Friday, 1 January 2021.

All deadlines that fall due during this time will automatically be extended to Monday, 4 January 2021.

The New Zealand Intellectual Property Office (IPONZ) will be closed from Friday, 25 December 2020, until Monday, 4 January 2021.

All deadlines that fall due during this time will automatically be extended to Tuesday, 5 January 2021.

2 min read

IP Australia is providing free extensions of time of up to three months if a deadline cannot be met due to the effects of COVID-19.  The period for requesting such an extension has been extended until 31 January 2021 Depending on the ongoing impact of the pandemic, both in Australia and overseas, this period could be extended further.

Whilst the maximum length of extension that can be requested at one time is three months, additional extensions of time of up to three months are available if needed.

IP Australia has implemented a streamlined process for requesting an extension of time of up to three months when an IP Rights holder is unable to meet a deadline due to the disruptive effects of the COVID-19 pandemic.  No declaratory evidence or fee is required; all that is needed is to check the relevant box on IP Australia’s eServices system to declare that the deadline cannot be met due to disruptions from the pandemic.

Many deadlines for patents, trade marks and designs are covered by these streamlined extensions of time, including deadlines associated with oppositions and hearings processes (such as periods to file evidence).  However, there are some exceptions.  For example: these extensions of time do not apply to deadlines for payment of renewal fees for patents, trade mark and designs, for which the usual 6 month grace period applies.  For trade marks, these extensions are also unavailable for filing of divisional applications.

For more information, or if you have been affected by the COVID-19 pandemic and require assistance with your IP Rights, please contact us.

Authored by Serena White, DPhil and Gareth Dixon, PhD

3 min read

Counterfeiting can be a significant problem for brand owners and legitimate rights holders. It directly undermines legitimate business through lost sales revenue and has the potential to strain relationships between IP owners and their licensees. The sale of counterfeit products can also damage the value of the associated brand in various ways. This could be where the counterfeit products are defective or of poor quality compared with the genuine article; or where unauthorised trade mark uses disrupt brand owners from effectively controlling the use of their brands, resulting in brands being presented to the market unfavourably or in a way that is inconsistent with the brand owner’s interests.

Even consumers seeking to do the right thing by purchasing legitimate products can be confused about whether a particular product is authentic or being traded through an authorised channel. This is especially the case in the context of online retail.

To help with combatting counterfeiters, IP Australia has begun trialling its “Smart Trade Mark” initiative with industry and government partners. The expectation is that the Smart Trade Mark will become an effective tool to identify and authenticate genuine products and sales channels, thereby resolving the potential for consumer confusion and allowing consumers to be confident that they are purchasing the genuine article from a legitimate source.

What is Smart Trade Mark?

The Smart Trade Mark is a digital platform that uses blockchain technology to enable businesses to verify that certain products, sales channels and trade mark uses are legitimate by linking them to their registered trade marks as published on the Australian Trade Marks Register.

How Smart Trade Mark works

The platform currently being trialled involves 3 main steps:

  1. The trade mark owner submits certain product information and/or domain addresses to IP Australia;
  2. IP Australia stores the details and authenticates the trade mark by linking the details provided by the trade mark owner to the Australian Trade Marks Register; and
  3. A Trust Badge is displayed on the relevant websites notified to IP Australia. Consumers can verify the Smart Trade Mark digitally by referring to the Trust Badge, which links through to details of the registered trade mark and information confirming that the website is verified.

NRL

The NRL (Australian Rugby League Commission Limited) is one of the key industry partners trialling the Smart Trade Mark. Shaun McMartin, NRL’s General Manager Consumer Business, sees the Smart Trade Mark as a potential “game changer” for similar businesses, stating that:

NRL members and fans are the lifeblood of our sport who want to buy the genuine article when supporting their club – the Trust Badge helps NRL fans identify authentic and licensed products online

The Smart Trade Mark is currently used by the NRL at www.nrlshop.com and by one of its authorised distributors at www.savvysupporter.com.au to indicate that both are legitimate sources of authentic NRL merchandise.

Shelston IP is proud to act for NRL in connection with protection and maintenance of its trade mark portfolio. Along with the NRL, we are excited by the prospects of Smart Trade Mark becoming an effective tool in the fight against counterfeiters.

Smart Trade Mark will be made available to all Australian trade mark owners if the trials are successful. IP Australia has not provided a specific timeframe for completion of the trials. However, trade mark owners can register their interest and subscribe to receive further updates at – https://smarttrademark.search.ipaustralia.gov.au/.

Authored by Felipe Pereira and Michael Deacon

2 min read

The Australian Trade Marks Office (‘IP Australia’) has recently announced official fee changes effective from 1 October 2020.

The most significant change is an increase to trade mark application fees.

The official fees payable (per class) for a standard application are being raised from AU$330 to AU$400. This provides an even greater incentive to utilise IP Australia’s option of a pick list of goods and services, whose classifications have been pre-approved. If the pick list option is selected at the time of filing, the official fees charged are only AU$250 per class. While the pick list does not allow for tailored or very precise descriptions, the broad descriptions available are suitable for use in a majority of cases.

Another key change is the modified fee schedule for trade mark hearings. Among other changes, parties seeking to rely solely on written submissions will need to pay a fee to have those submissions considered. There are also additional charges for attending a hearing in person (when those eventually become available), rather than by video or teleconference.

Further changes relate to the filing of International Registrations designating Australia, series applications, and the renewal of registrations in the unusual case of the application process taking more than 10 years. The full list of relevant fee changes being implemented may be found in the table below.

Shelston IP utilises the “Preferred Means” option for relevant items, which incurs lower fees than other means.

If you have any questions about these fee changes, or wish to file a trade mark application in Australia prior to the increases, please feel free to contact our team for advice and assistance.

Australian Trade Mark Fee Changes – from 1 October 2020

Fee Description

Old Fee (AUD)

New Fee (AUD)

Madrid Import Application – First Class*

*Please note: Changes to Madrid Import Application fees are not scheduled to commence until  12am AEDT, 7 November 2020

$350

$400

Madrid Import Application – Additional Classes*

$350

$400

Standard TM Application – First Class -No Pick List – Preferred Means

$350

$400

Standard TM Application – Additional Classes – No Pick List – Preferred Means

$350

$400

Series TM Application – First Class – No Pick List – Preferred Means

$480

$550

Series TM Application – Additional Classes – No Pick List – Preferred Means

$480

$550

Renewal of registration (registration delayed for 10 or more years after filing date) – Preferred Means

$450

$400

Late renewal of registration (registration delayed for 10 or more years after filing date) – Preferred Means

$450

$400

Trade Mark Hearing Fees

Request for a hearing under regulation 5.17, 6.9, 9.17, 9.20, 17A.34M, 17A.48S, 17A.48V or 21.20E

$600

Replaced by new item

Request for an oral hearing in relation to any other matter

$440

Replaced by new item

Attendance at an oral hearing under regulation 5.17, 6.9, 9.17, 9.20, 17A.34M, 17A.48S, 17A.48V or 21.20E

$600 for each day, or part of a day, less any amount paid under item 14in relation to the hearing

Replaced by new item

Attendance at an oral hearing to which item 16 does not apply

$400 less any amount paid under item 15 in relation to the hearing

Replaced by new item

Filing a request for a hearing

New item

$4000

Appearing and being heard at an oral hearing in person:
(a) for the first day
(b) if the hearing runs for more than a day

New item

$800 less any amount paid to request the hearing;
$800 for each day, or part of a day, after the first day

Appearing and being heard at an oral hearing in by means other than in person:
(a) for the first day
(b) if the hearing runs for more than a day

New item

$600 less any amount paid to request the hearing
$600 for each day, or part of a day, after the first day

Being heard on the basis of written submissions only

New item

$400 less any amount paid to request the hearing

Decision with reasons issued in accordance with section 55, section 101, regulation 17A.34N or 17A.48D

New item

$400 less any amount paid to request, attend or file submissions in relation to the hearing

Expedited Post Option for Document Requests

Expedited post option for urgent document requests

New Fee

$20

This article was written by Kasumi Champion, Trade Mark Assistant to Principal, Sean McManis at Shelston IP

Authored by Sean McManis