1 min read

IAM Patent 1000: The World’s Leading Patent Professionals 2021 has again Highly Recommended Shelston IP for Patent Prosecution.

Shelston IP has not only been Highly Recommended by IAM Patent 1000 for Patent Prosecution, we have also been Recommended for both our Litigation and Transaction work.

Our attorneys also continue to be ranked with Michael Christie, PhD, Paul Harrison and Greg Whitehead listed as Highly Recommended for Patent Prosecution together with Chris Bevitt for his Transaction work.

Congratulations to all our ranked attorneys.

Authored by Chris Bevitt, Michael Christie, PhD, Paul Harrison and Greg Whitehead

1 min read

Shelston IP is very pleased to announce their promotions from 1 July 2021.

Ean Blackwell is our newly appointed Principal.

Ean works within our Biotechnology and Chemistry team. Ean is an AU/NZ Patent Attorney, a Chartered UK and a European Qualified Patent Attorney with industry experience as a research scientist. Ean’s IP career has spanned three continents, having practiced in Asia, Europe and Australia. He has particular experience in the plant molecular biology, biotechnology and Big Pharma industry sectors.

Kathy Mytton has also been elevated to Senior Associate.

Kathy is a solicitor and registered trade mark attorney with over 20 years’ experience across a broad range of industries for protection of trade mark rights in Australia, New Zealand and other foreign jurisdictions. She has extensive proven experience in providing strategic and commercially focused advice to clients.

Congratulations on this important milestone in your career.

Authored by Ean Blackwell and Kathy Mytton

1 min read

Shelston IP has once again been named as a finalist in the Australian Law Awards for Intellectual Property Team of the Year.  

The Australian Law Awards, run in partnership with Principal Partner UNSW Law & Justice. The awards program identifies the finest lawyers and firms across Australia, recognising the depth of talent and outstanding achievements.

The annual event presents an invaluable opportunity to highlight the notable achievements of lawyers at the height of their career who demonstrate leadership, technical expertise, mentorship and business development skills – the only national awards program to do so.

The awards program bestows some of the industry’s most respected and sought-after accolades showcasing outstanding performance by partners, or partners equivalent, across individual practice areas within the Australian legal profession.

Once again this recognition reinforces the strength of our formidable team. They consistently build strong relationships with their clients, who then in turn have confidence in service we provide.

Authored by Duncan Longstaff

4 min read

The abolition of Australia’s second-tier “innovation patent” system has been well publicised and comes with a “magic date” of 25 August 2021.  But what does “abolition” really mean, and what can’t you do come 26 August 2021 that you could do one day prior?  In this article, we break it all down and let you know what you really need to know – so that there are no nasty surprises down the line.

What must I do on or before 25 August 2021?

This is perhaps the most critical (and misunderstood) aspect of the changes.  In order for a new innovation patent to be filed validly, it must come with a filing date of 25 August 2021 or earlier.  Now, for applications already filed in Australia (convention or national phase) or existing PCT international phase applications designating Australia, this is not a problem – your ability to make use of the innovation patent system is maintained (subject to certain caveats, see below).

However, for inventions currently covered by provisional applications (or even awaiting provisional filing), this is where things start to get interesting.  You will need to file “early” (i.e., obtain a filing date of 25 August 2021 or sooner) in order for your invention to remain innovation patent-eligible.  Practically speaking, foreign applicants may struggle to justify bringing their international phase filing forward simply to preserve their rights in Australia’s second-tier patent system.  Rather, they may prefer to file early in Australia (as a standard patent application that can later be converted to an innovation patent, or as a direct-filed innovation patent application), leaving the PCT international phase to run its natural course.

We have attempted to capture this in the graphic below:

What can I still do come 26 August 2021 and after?  

As noted above, for applications already filed in Australia (convention or national phase) or indeed existing PCT international phase applications designating Australia, this is not problem – your ability to make use of the innovation patent system is maintained.  As shown on the timeline below, you can convert an existing standard patent application (i.e., having a filing date of 25 August 2021 or earlier) into an innovation patent, or can have a divisional innovation patent filed from it. That said, one further misconception stems from the fact that this divisional innovation patent can be filed at any time on or after 26 August 2021 (so long as the would-be 8-year term of the divisional innovation patent has not expired).  Whilst this is technically correct, delaying filing does come with consequences in that your ability to claim damages (remembering that one of the principal uses of the innovation patent is as a “litigation weapon”) only dates back to the date of publication of the innovation patent, meaning this is very much a case of “the sooner the better”.

Further reading

Reading about the innovation patent ranks second only to writing about it as a cure for insomnia.  In that respect, we’ve been following things closely over the past few years and have published insights here (Abolition is a bit harsh – rather, why not let the punishment fit the crime), here (The legislation finally passes in Federal Parliament), here (Optimistic and pessimistic views of the innovation patent system), here (Just as Australia moves to abolish the innovation patent, New Zealand considers adding one) and here (Timeline for the phasing out of the innovation patent system).  It looks like someone’s going to have to find something new to write about!

Commentary

The bottom line is that whereas the innovation patent system could have been “fixed” (which may have in turn given it a chance of achieving its stated goal of stimulating R&D amongst local SMEs), the Government had long-since decided its fate.  It was always going to die and attempts to recover it, whilst deserving of a better outcome, ultimately amounted to little more than a fool’s errand.  That we’ve landed where we have is a sad but inevitable consequence of a system that sounded good in theory, but was imperfect in design – and in this respect we need look no further than innovation patent 2001100012, which was “granted” (although later revoked) for a “circular transportation facilitation device” – a wheel.  In many ways, the only surprise is that it’s taken us 20 years to get to where we are now. 

Authored by Shan Sun, PhD and Gareth Dixon, PhD

In a previous article, we noted the enactment of the Republic of Nauru Trademarks Act 2019 (the Act) and Trademarks (Forms and Fees) Regulations 2020 (Regulations).

In this article, we delve a little deeper and provide a brief outline of the registration process.

The Act allows for registration of a “mark” which includes a sign, slogan, device, brand, heading, label, ticket name, word, letter, numeral, aspect of packaging, shape, colour, sound, scent, hologram, motions, textures, or any combination of these. Collective marks are available but certification marks are not.

It is possible to register both goods and services, but multi-class applications are not available.

An application for registration must be signed by the applicant and include a declaration for use or intention to use the trade mark.

Provided the application meets formality requirements, details are published in the Gazette for opposition purposes. Interested parties then have 21 days to file opposition against the application.

If an opposition is filed, the Registrar will provide a copy of the Notice of Opposition to the applicant, who then has 21 days to file a response. Failure to do so may result in the application being abandoned. If the applicant files a response within the prescribed time, the Registrar will provide this to the opponent and require the parties to provide such other information necessary to make a decision.

If no opposition is filed, or is deemed unsuccessful, the application undergoes examination on both absolute and relative grounds. If there are any objections to acceptance, the Registrar will issue a non-compliance notice and the applicant has a short period of 30 days from the date of receipt of the notice to resolve them.

If the application passes examination without objection(s), or once any identified issues are overcome, the Registrar will issue a Notice of Decision (Acceptance) and subsequently a Certificate of Registration.

The application process is anticipated to take no longer than 90 days from the date of filing. The Registrar has the power to reject an application and deem it abandoned where the applicant fails to complete the registration process within this timeframe.

Registration is deemed to have come into effect from the date of filing and, subject the payment of a prescribed annual maintenance fee, the trade mark is registered for a period of 10 years.

It is possible to claim convention priority based on a foreign application filed within the preceding six months of the application in Nauru. It remains to be seen how this will work in practice in the context of competing rights given the prescribed three month trade mark registration process.

A unique feature of the Act is the possibility of adding goods or services to the registration, thus extending the scope of protection. The application for addition of goods or services is published in the Gazette and third parties have 14 days to oppose the request, failing which the Registrar may alter the registration.


Shelston IP can act directly before the Nauru Trade Marks Registry to obtain trade mark registrations for our clients.

If you require further information or would like assistance with the filing of a trademark application in Nauru, please let us know.

Authored by Kathy Mytton and Sean McManis

2 min read

Managing Intellectual Property (MIP) IP Stars publication has listed Shelston IP once again as a Tier 1 firm for both patent and trade mark prosecution. Four of our Principals have been recognised individually as IP Stars.

MIP’s IP Stars is the leading resource and most respected guide in the IP profession. Their worldwide survey of IP practitioners is used as a key benchmark for the industry.

Congratulations to all our IP Stars for being recognised as leaders in the IP industry:

Paul Harrison

Paul is a Principal and head of the chemical biotechnology team. He has over 35 years’ experience in the protection and enforcement of IP rights in Chemical Engineering and Chemistry technologies and is valued by his clients for his strategic and pragmatic approach to intellectual property.

Sean McManis

Sean heads Shelston IP’s Trade Marks team. He has extensive experience in assisting clients with trade mark protection and selection. He has been recognised by Managing Intellectual Property as an IP Star for the last 6 years and was a finalist in the 2020 Client Choice Awards for Best IP Specialist.

Charles Tansey, PhD

Charles is a Principal and experienced patent attorney with 25 years’ experience in the drafting, prosecution, enforcement and defence of patents in Australia and overseas. His technical experience across a wide range of chemistry related technologies is sought out by domestic and multinational clients.

Peter Treloar

With over 25 years of experience, Peter is an authority in Patents in Australia and New Zealand for complex electronics, computer science, and optics, with a particular bent for complex mathematical material.

3 min read

Following a cacophony of dire warnings and lobbying over the past decade from the Australian biotechnology and medical sectors, and the sudden sharp focus of middle Australia on the critical importance of onshore manufacturing facilities such as those capable of mRNA vaccine production, the Federal Government has announced the introduction of a $206.4m patent box for Australian medical and biotechnology industries as part of the 2021-2022 Federal Budget handed down on 11 May 2021.

Named quite literally after a tick box historically present on income tax forms, a patent box provides tax incentives designed to encourage companies to commercialise and manufacture patented technology locally. From 1 July 2022, Australia’s proposed patent box is slated to tax income derived from eligible patents at a concessional corporate tax rate of 17%, rather than the standard corporate tax rate of 30%, or 25% for small and medium enterprises (SMEs).

While the specifics are yet to be established, the patent box is proposed to apply to income derived from granted Australian patents in the medical and biotechnology sectors filed after the budget announcement (ie, after 11 May 2021), providing that at least a portion of the research and development (R&D) of the technology occurred in Australia. The following example was provided with the Federal budget papers: A company selling a patented product makes $175 million in net income directly attributable to the patent. If 80% of the R&D associated with the patented product occurred in Australia, then 80% of the income (ie, $140 million) would enjoy the concessional 17% tax rate. 

The measure is intended to incentivise Australian companies to invest in and perform their R&D, commercialisation and manufacturing of patented technologies onshore. It has been warmly received by the Australian biotechnology sector with Lorraine Chiroiu, CEO of AusBiotech, stating that the organization whole-heartedly commends the initiative: “This tax incentive will address the gap that leaves our IP vulnerable, retain home-grown IP, and support Australian innovators and manufacturers. It will make the commercialisation of IP and manufacturing in Australia more genuinely viable for businesses.”

Cochlear’s CEO, Dig Howitt, has similarly commented: “Incentivising companies of all sizes to keep their intellectual property and manufacturing in Australia will generate substantial economic benefits through royalties, licence fees, tax revenues, supply chains, jobs, and capital investment.”

CSL CEO Dr Andrew Nash concurs, stating, “CSL welcomes the introduction of a patent box which will help decrease the flow of intellectual property from local medical research going overseas. It will drive the growth of advanced manufacturing jobs, capital intensive investment and sovereign capacity in medical technology and biotechnology manufacturing.”

A number of countries already have patent box regimes, including the UK, Belgium, Spain, France, the Netherlands, Luxembourg, Switzerland, and China. Australia’s patent box is set to follow the Organisation for Economic Co-operation and Development (OECD)’s guidance on patent boxes to meet internationally accepted standards.

The Government has indicated that it will consult with industry on the design of the patent box and explore whether the regime should be extended to include clean energy patents. Lobbying from that sector is already well underway.

On a technical note, several years typically elapse between patent filing and patent grant. Accordingly, it could be some three or four years before the patent box regime begins to provide significant benefit. Patent grant can, however, be brought forward by various means including requesting early national phase entry in Australia followed by expedited examination. If you require advice on this issue, Shelston IP would be happy to help.     

Authored by Karen Heilbronn Lee, PhD and Allira Hudson-Gofers

1 min read

It has been proven again that Shelston Lawyers are a formidable team.

Congratulations to our law team members for being recognised in Doyle’s Guide 2021.

Chris Bevitt for being recommended as a Leading Non-Contentious Intellectual Property Lawyer in NSW.

Mark Vincent for being recommended as a Leading Contentious Intellectual Property Lawyer in NSW.

Andrew Rankine for being recommended as an Intellectual Property Rising Star in Australia.

Doyle’s Guide compile their research on the back of initial online peer-review based surveys as well as extensive interviews with clients, peers and relevant industry bodies.

Chris Bevitt, Mark Vincent and Andrew Rankine are supported by an experienced team who have contributed to this recognition.

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 Duncan Longstaff