From 24 March 2022 it will be possible to register domain names with .au as the extension. In this article, Simon Gapes discusses the release, how a .au domain can be secured, and what happens when two competing parties want the same domain.  

Up until now, it has been necessary to use a “third-level” .au domain name such as “”, “” or “”.  The impending release of .au domain names on 24 March 2022 will allow for use of shorter and sharper domain names and website addresses, which will be especially helpful for website users accessing websites on mobile phones.    

For example, Griffith Hack will be able to register and use the domain name as well as (or instead of) or 

.au domain names will be available for registration through a “Priority Allocation Process”, by which .au domain names are reserved for registration by owners of existing third-level .au domain names for six months. From 24 March 2022 to 20 September 2022, owners of existing,,,,, and domain names have priority to register the exact matching .au domain names.  For instance, Griffith Hack can register, as we are already the owner of  From 21 September 2022, .au domain names are available for registration on a first-in first-served basis. 

.au domain names which do not match existing third-level .au domain names are immediately available for registration on a first-in first-served basis. 

How can a .au domain name be secured?

In order to own a .au domain name, the owner must satisfy the “Australian presence” requirements which apply existing domain names such as  Australian presence requirements can be satisfied by a number of factors, including the owner being an Australian citizen, the owner being an Australian company or the owner holding an Australian trade mark application or registration for a trade mark which matches the domain name.     

Disputes over .au domain name ownership

Where two parties are eligible to hold a .au domain name, for instance if one party holds a domain name and the other party holds the matching domain name, then priority is given to the owner of a domain name registered before 4 February 2018 (when the release of .au domain names was first announced).

If multiple parties hold domain names dating from before 4 February 2018, then the parties must negotiate between themselves who will be allocated the .au domain name.  Where there are multiple applicants who hold matching third-level domain names dating from after 4 February 2018, then the .au domain name will be allocated to the applicant who first registered their third-level domain name.

Owners of third-level domain names registered before 4 February 2018 have priority over owners of third-level domain names registered after this date.

Need help?

If Griffith Hack can assist with registration of your .au domain name, please get in touch with us.

Important changes to Australia’s Designs Act 2003 have now come into effect – so what do designers need to be aware of? Anthony Selleck sets out what you need to know about the changed landscape for registered designs in Australia.


Recently enacted[1] changes to the Designs Act 2003 came into force on 10 March 2022. Applications for registered design protection filed on or after this date are governed by the amended Act.

The key changes implemented by the amending legislation relate to:

  • a grace period;
  • a prior use defence;
  • protection for “innocent infringement”; and
  • reforms to the application procedure.

Grace Period

A 12-month grace period now applies to registered design applications filed on or after 10 March 2022. Using the grace period, registered design applicants can, to a certain extent, recover from a self-publication of the design the subject of the application. In this regard, the grace period operates to remove a publication or use of a design from the design’s prior art base, so long as the publication or use occurred:

  • on or after 10 March 2022; and
  • no more than 12 months before the design’s priority date.

The grace period only applies to a registered owner’s own publication or use of the design, or a publication or use made by a predecessor-in-title of the registered owner, or by a person who created the design (if that person is not the registered owner or a predecessor-in-title). Like the grace period for patent applications in Australia, the designs grace period does not provide an applicant with an earlier priority date.

Importantly, the grace period does not operate to disregard a publication of a design by a foreign designs office. In practice, this means that the grace period cannot be used as a filing strategy where a Convention priority deadline is missed and the application is published by the foreign designs office before the Australian application is filed. In these circumstances, an applicant would need to establish grounds for an extension of time in which to file the Convention application in Australia, such as a genuine error or omission on the part of the applicant or their attorney.

It is also worth noting that the grace period is subject to the new prior use defence (discussed below).

Despite its limitations, a grace period is a welcome addition to registered designs law in Australia, bringing it into line with the grace period already provided to patent applicants. The grace period should also provide clarity and increased filing options to both local and overseas applicants who inadvertently disclose their designs before filing for design protection.

Prior Use Defence

Alleged infringers of a registered design with a priority date on or after 10 March 2022 can, in certain circumstances, avail themselves of a “prior use” defence.

In particular, a design owner who relied on the grace period to secure registration of the design, cannot enforce the registration against an alleged infringer who began using the design (or a comparable design) in the period between the design owner’s disclosure of the design and the filing of the design application.

The prior use defence is a very important limitation on the grace period. To avoid third parties potentially obtaining rights to use a registered design, design owners are advised to file for protection before disclosing the design, or as soon as possible after the design is disclosed.

Innocent Infringement

For designs that become registered on or after 10 March 2022, Australian courts have discretion to refuse or reduce damages, or refuse an account of profits, for infringements occurring before the design was registered. The provisions aim to provide relief to an “innocent” infringer who infringes a design in the period after an application is filed, but before the design itself is publicly available on the Register of Designs.

To take advantage of the provisions, the “innocent” infringer must satisfy the court that they were not aware, and could not reasonably have been expected to be aware, that a design application had been filed. Conversely, it is advisable for applicants of pending design applications to publicise that an application has been filed (such as by marking relevant products with the application number), so as to reduce the likelihood of the defence applying.

Application Procedure Reforms

The Designs Act 2003 brought in a system of defensive publication, under which a person could publish a design (and thus prevent others from obtaining rights in the design) without seeking registration of the design.

As this option was sparsely used, the publication regime has been abolished from 10 March 2022 onwards, leaving only the option to seek registration of a design. Under the old regime, there was a requirement to request either publication or registration of the design within 6 months of the priority date. However, with the abolition of defensive publication, it is no longer necessary to specifically request registration. Instead, designs filed on or after 10 March 2022 will automatically proceed to a formalities check 6 months after the priority date of the application.

If desired, Applicants can file a request for the design application to proceed to formalities examination (and typically registration) before the end of the 6 month period. This may be advisable in certain circumstances, such as to reduce the risk of innocent infringement occurring before the design is registered.

Our Designs Team

Please contact our Designs team if you require assistance in formulating design filing strategies for the Australian, New Zealand and overseas markets.


[1] Designs Amendment (Advisory Council on Intellectual Property Response) Act 2021 (Cth)

Female biotech founders took centre-stage at AusBiotech 2021 with the leaders of some of Australia’s most innovative start-ups coming together to discuss their experiences in the commercial scientific world.

Chaired by Griffith Hack director and principal Karen Sinclair, the Female Founders of Biotech panel featured Sam Cobb of Currus Biologics, Lynette Walter of NavBit, and Elisa Mokany and Alison Todd of SpeeDx  – all who co-founded their respective companies. The candid discussion provided illuminating views on what it takes to start a biotech company, how to be a leader while surrounding yourself with the best people, and what they think the future holds for innovation in Australia.

About the panel

Sam Cobb is the founding CEO of Currus Biologics, commercialising its next generation CAR-T cell therapy from early research and development at the Peter MacCallum Cancer Centre. Previously, she was the founding CEO of AdAlta and applied for that first CEO position with encouragement from the Chair.

Lynette Walter is CEO and co-founder of surgical technology innovator and manufacturer Navbit. She believes the ability to create and maintain a company is an innate feature in those with the requisite passion, motivation and self-belief. She and her co-founders knew they had both a good idea and the right talent to take their product to market and persevered to achieve their success.

Elisa Mokany and Alison Todd are co-founders of molecular diagnostic company SpeeDx. Their innovative background was nurtured at Johnson & Johnson Research (JJR) and provided a strong foundation to start their own company, together with assistance from Cicada Innovations.

Mokany and Todd were passionate about what they invented and had support from their former Managing Director to branch out into SpeeDx. JJR encouraged their plan and assisted them by assigning rights to the IP and funding venture capital for the new entity. Todd acknowledged the risks involved but believes perseverance was key to making forward progress – founders must face problems that arise; solutions are found when you deal with problems head on and do not shy from them.

Founders don’t have to be CEO

Contrary to the other panel members, neither Mokany nor Todd are CEO of SpeeDx, rather they hold the positions of Chief Technology Officer and Chief Scientific Officer, respectively. Prudently, Todd remarked that not every founder is the perfect CEO. She embraces her capabilities as a scientist and inventor and has worked on assembling a team of experts, each with their own relevant skill set.

Similarly, Mokany noted that the first five years of SpeeDx was all science: developing assays, collaboration, and licensing technology. She understood her expertise in product development and, like Todd, lacked the desire to play the part of CEO and “sell”. They both have confidence in the experience, knowledge and skills of their appointed CEO and note that their C-suite is united in their decision making.

These founders are not made to feel like they lack clout, rather they focus on the aspects of the company for which they have a passion and take responsibility.

Getting started and making early in-roads

For those waiting to take the leap, the panel agreed that it is necessary in a start-up to continue to put one foot in front of the other. On the job learning is a constant process, and the important thing is to get started and keep going. Recognise your strengths and crucially, surround yourself with those that have other expertise that is needed, including the right mentors and advisors.

Cobb noted that a CEO must see the big picture and get on with making it happen. She also noted the importance of having IP: you need to know that your idea is worth funding. Competitive analysis provides excellent information.

Walter emphasised the importance of resilience and also preparing and educating yourself but not waiting for perfection: ask questions, get to work and be bold and open-minded; understand that there are many different ways to get to the end goal.

Surround yourself with experts and leaders

On the topic of advisers and those you choose to provide the expertise your start-up needs, all panel members agreed that the members of your board need to be the right people who can guide and grow your business. Mokany reflected on the importance of seeking legal and IP advice from people with science backgrounds, and who are switched on in the biotechnology fields – it can be unhelpful when service providers do not understand the technology. She noted that IP advisers had even helped drive inventive concepts, emphasising that your advisers should grow with you in your journey.

Todd and Cobb appreciate positivity. They do not want to only hear problems, nor what cannot be done. They seek others who are solution oriented. In addition, Walter believes that experts who think only in the context of their field without understanding how decisions impact your business are of less value. Advisers who are willing to be part of the inner circle are worth their weight in gold.

Building the bridge between research and commercialisation

Something that all speakers acknowledged is the tenuous bridge between research and commercialisation, particularly in Australia. Walter advises working with universities to take IP out of their hands and spin-off with it into another company. Collaboration is essential to successfully enter the market. By the same token, Todd encouraged strong connections between academia and industry and noted an important factor is the mentoring of others – as you yourself seek mentors. She recommends the supervision of students between educational research programs and industry to provide an understanding of commercialisation and would also like to see better training offered to scientists to be the entrepreneurs of the future.

The role of gender

It would be remiss to gather these experts and not discuss gender. No panellist has been caused to feel that their gender has held them back, but all advocate for monitoring and supporting other women in the workplace. They agreed that female founders need the same qualities as any other, such as tenacity, focus, belief and adaptability, and acknowledged that while a gender imbalance exists, gender does not matter. If you back yourself and move forward, you will achieve.

It was noted that women tend not to talk themselves up as much as their male counterparts and likewise do not ask for as much. Funding and capital raising is hard; Cobb’s advice is to tell a story and tell it very well. As CEOs, Cobb and Walter both agreed that you must raise money when you don’t need it, raise more than you need and be aware that it takes longer than expected. Cobb recommended practicing your elevator pitch on your friends: you will need a lot of money that will come from everywhere.

Success takes courage

It was encouraging to hear that these female founders embrace risk and see failure merely as a growth and learning experience. Their courage as innovators and leaders shines through. All speakers agree that Australians need to have this courage to take that leap of faith into new technology and innovation. These leaders embrace the opportunity to support others and look forward to giving back to the biotechnology industry.

Griffith Hack has been recognised in the 2022 edition of the World Trademark Review 1000 rankings (WTR 1000) in the categories of Trade Mark Prosecution, and Enforcement and Litigation.

This marks the second year running that Griffith Hack has been honoured in both categories.

In addition to the recognition of our firm, Nicola Scheepers, Anne Makrigiorgos, Emma Mitchell and Kellie Stonier have all been named “Recommended Individuals” by WTR 1000.

WTR 1000 shines a spotlight on the firms and individuals deemed outstanding in the trade mark field. The globally-recognised guide remains the only standalone publication to recommend individual practitioners and their firms exclusively in the trademark field, and identifies the leading players in over 80 key jurisdictions globally.

This years’ edition notes that clients praised the Griffith Hack team for its communication skills:

They can easily explain IP concepts in a way which is understandable and not overly complex. Breaking it down into a way which a non-IP professional can understand is vitally important.

WTR 1000 rankings guide

You can see Griffith Hack’s full results and selected feedback at the WTR 1000 website.

Publicly disclosing a new technology, potentially an invention, before a patent application has been filed – whether purposely or accidentally – can jeopardise patent coverage, and consequently commercialisation, of the technology. But there are options available in the event of self-disclosure. Craig Don Paul and Malcolm Lyons explain why all researchers and inventors need to know about grace periods.

A commonly heard story, mainly from those involved in academic commercialisation offices, involves the good-hearted researcher who has created new technology, but has not appreciated that the technology is also an invention, before disclosing the technology publicly.

Although unfortunate from a commercial perspective, this is understandable in universities and research institutes where, as expected for an academic researcher, knowledge is disseminated. Only after some time and consideration does the researcher approach the commercialisation office asking, ‘Is my technology a patentable invention?’ Unfortunately, the researcher’s prior disclosure may have fatal consequences for a patent application covering the technology.

But it’s important to know that there are options available in the event of disclosure, including self-disclosure – namely in the form of grace periods.

What are grace periods?

Across the globe, certain countries make it possible, through the use of grace periods, to file a patent application validly after disclosure of a new technology. Without grace periods, such disclosure would render the technology unpatentable, because it would no longer be novel.

The rules around grace periods vary from country-to-country, both in terms of the time available to file an application after disclosure, and the supporting materials required.

Grace periods can also relate to various types of disclosures, for example, reasonable trial or experimentation, or display at a recognised exhibition. In the table below, however, we limit our consideration to self-disclosures and the availability and requirements of grace periods in some important jurisdictions, including Australia and New Zealand.

JurisdictionPeriodType of applicationRequirementsNotes
Australia12 monthsNon-provisional, including PCTAssert during prosecution
New Zealand12 monthsNon-provisional, including PCTAssert during prosecutionSelf-disclosure on or after on 30 December 2018.
USA12 monthsProvisional or Non-provisional, including PCTAssert during prosecution
Canada12 monthsNon-provisional, including PCTAssert during prosecution
Japan12 monthsNon-provisionalActively apply at filing.
Provide supporting documents*
Self-disclosure on or after 9 December 2017.
Supporting documents to be provided within 30 days of applying.
Malaysia12 monthsNon-provisional, including PCTActively apply at filing.
Provide supporting documents*
Taiwan12 monthsNon-provisionalAssert during prosecutionNot a member of the Patent Co-operation Treaty.
Singapore12 monthsNon-provisional, including PCTActively apply at filing.
Provide supporting documents*
Germany6 monthsUtilityActively apply at filing.
Provide supporting documents*
Supporting documents to be provided within 30 days of applying.
Utility patent has 10-year term and is not available for processes.
United KingdomN/AUK may join Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), which requires 12 m grace period, but conflicts with EPC.
Hong KongN/A
* Generally, supporting documents to include date of disclosure, location of disclosure, nature of disclosure, any other statement/ document specifying and evidencing in more detail facts concerning the disclosure, and may be required in the form of a statutory declaration or affidavit

What is self-disclosure?

In this context, a self-disclosure is a disclosure of a technology made by, or with the consent of, a potential patent applicant or patentee, prior to filing a patent application covering the technology. This often occurs via journal publications, including “as accepted”/ pre-print publications, conference proceedings, including oral and poster presentations, clinical trial publications, including mandatory clinical trial registration, marketing, or even promotions for raising capital. In many circumstances, because of the nature of the environment, particularly academic research, consent is implicit rather than explicit.

How to take advantage of grace periods?

To enliven the grace period in a particular jurisdiction, a patent application must be filed in that jurisdiction within a relevant time-period following the self-disclosure (see table above for timings).

Depending on the jurisdiction, the application may be provisional, non-provisional (referred to as “complete” in Australia and New Zealand), including PCT, or an application for a utility patent, which is a lower level patent. Generally, the application must be filed within 6 or 12 months from the date of the disclosure.

Remember, each country has different grace period requirements. A patent attorney can assist with navigation through the complex global patent landscape.

Key takeaways:

  • Even in the event of self-disclosure, researchers can still secure patent coverage of their technology in some countries through the use of grace periods.
  • Grace periods should only be relied on as a last resort. Before any disclosure of new technology, researchers should always submit that technology for review by their commercialisation office. The commercialisation office, together with its patent attorney, will be able to guide the researcher on filing a patent application – and when public disclosure can be made subsequently.
  • If you do not have access to a commercialisation office, please contact Griffith Hack for advice
    • before making any public disclosure of your technology, or
    • immediately if a public disclosure of your technology has been made.

Our patent attorneys will be able to provide you with advice and guidance to ensure the patentability of your technology is not jeopardised.

Griffith Hack will be hosting two online events as part of Melbourne Design Week 2022, focusing on the areas of ethical design, and the latest updates in designs and copyright laws.

On Tuesday 22 March, Edith Hamilton will lead a panel discussion with Dr Justine Lacey, Lou Tabacchiera and Elisa Nicolleti looking at how IP protection can support ethical design. Then on Wednesday 23 March, Jennifer Wyndham-Wheeler, Bridget Renehan and David Braund will provide updates on Designs Law reforms and use easy-to-understand scenarios on what this means for designers across several areas of application.

Both sessions are free to register – find out more secure your place via the links below.

Can intellectual property protection support ethical design?

Tuesday 22 March | 12:15 – 1:30pm

Ethical design – design that strives for greater societal good – should be fostered. Commercial pressures can influence the ability of designers and innovators to pursue environmentally sustainable products and processes. In order to support design with a positive environmental and social impact on the planet, there need to be mechanisms that address those commercial pressures. This event, held in the form of a discussion between a panel of industry leaders, brings together different perspectives on ethical and sustainable design and shares with the audience how it can be supported and grown in Victoria with intellectual property fostering collaboration.

The discussion will cover a variety of issues including:

• Whether protecting ideas can be a driver for ethical design across the sector;

• The frameworks for supporting ethical design, such as investing in greater product longevity, sustainable materials and sustainable manufacturing;

• How to facilitate investment in new, sustainable methods of production and keep these methods and techniques in Victoria;

• How to facilitate collaboration between individual designers and larger companies while protecting the ideas each party ‘brings to the table’; and

• How to maintain the integrity of the design (e.g. anti-counterfeiting) and the design process so that it increases the value of the design and production industry in Victoria.

Must-knows for designing must-haves: Designs & copyright law 2022

Wednesday 23 March | 10:15 – 11:30am

Griffith Hack takes designers through the ABCs of Designs and Copyright Law, including the pitfalls where these laws overlap in Australia and how designers can navigate around these areas. Griffith Hack will provide updates on the Designs Law reforms and use easy-to-understand scenarios on what this means for designers across several areas of application. For example, the grace period and infringement exemption for industrial designers who have used or taken definite steps to use a comparable design before the priority date. This will be particularly timely given the reforms are due to take effect in March 2022.

Also coming into the conversation is the UK-Australia free trade agreement through which Australia has agreed in principle to ratify the Hague Agreement (industrial designs). This session will explore the likelihood of this happening, and how Australia’s acceptance of the Hague Agreement may benefit designers. For example, those provisions may offer a longer term of protection for designs and protection of partial designs and virtual designs. Griffith Hack will explain what this means to designers by presenting real-life examples, including the gaming and digital design space who may benefit from these reforms from an IP stance.

This session is presented by some of Griffith Hack’s senior Patent Attorney and Legal team, holding deep experience from working closely with world-leading local and international designers and brands.

Melbourne Design Week 2022 is an initiative of the Victorian Government in collaboration with the NGV. To find out more, visit

In a recent decision of the Australian Patent Office,[1] a patent application directed to a membrane for filtering biological products was upheld following opposition.  Attacks made on various grounds failed, with the Delegate considering that the claims could be clearly construed.  The decision also provided useful guidance on ‘parameteritis’ and prior use.

Griffith Hack acted on behalf of the Applicant, Asahi Kasei Medical Co., Ltd. in the proceedings.

Background and Technology

The patent application (AU2015309939) concerns porous membranes which are used to filter and capture virus particles from biological products such as fractionated plasma products and biopharmaceuticals.  The claims of the application were directed to membranes having a particular distribution of pores within the membrane cross-section, which were associated with properties such as efficient filtration and removal of virus, together with reduced spoiling or clogging of the membrane over time.  Pore sizes and their distribution were determined by the use of scanning electron microscopy (SEM).

EMD Millipore Corporation opposed grant of AU2015309939 in 2018.  Following evidence rounds, and a procedural opposition concerning claim amendments which was decided in favour of the Applicant, a hearing was held in November 2021. Various grounds of opposition were pressed, with the main issues relating to claim construction and clarity, best method, and lack of novelty based on prior use of the Opponent’s Viresolve® Pro (VPro) membrane.

Claim construction and clarity

The claims of AU2015309939 were directed to a membrane having a pore structure defined by several parameters which required analysis by SEM, including characterising the membrane in terms of an asymmetric structure (where average pore size changes on moving through the interior of the membrane), coarse and dense layers, and a gradient index determined based on the average pore diameter in adjacent visual fields of the coarse and dense layers.

The Opponent argued that such terms were not clearly defined and that a person skilled in the art would not be able to identify membranes falling within the scope of the invention. However, the Delegate disagreed, understanding the membrane to have a dense layer defined by 1µm increments from the downstream side, the dense layer having a thickness equal to the number of 1µm visual fields that have an average pore diameter of 50 nm or less.  The coarse layer was the adjacent layer having 1µm visual fields with an average pore diameter of more than 50 nm.  Other features in the claims were then also resolved in favour of the Applicant.  In arriving at that conclusion, the Delegate referred to various passages in the description and examples, and was also assisted by expert evidence regarding the meaning of terms in the claims as supported by the specification.[2]

The Opponent also argued that the specification did not sufficiently describe how a sample should be prepared for SEM analysis, nor disclose the exact parameters to be set on the actual microscope. However, the Delegate found that a person skilled in the art would be “well equipped with objectively standard techniques”[3] and “have a common understanding of operating parameters… to create reproduceable and useful images of the scale of the present invention”.[4]

Prior use

The Opponent alleged lack of novelty based on prior use of their own commercially available VPro membrane.[5] However, the Delegate found that the evidence did not establish that the VPro membrane possessed all essential features of the claims. The Opponent used a different method of SEM analysis in their experiments, applying Euclidean distance mapping to determine pore size rather than the perfect circle method described in the specification. They also did not perform appropriate measurements to determine if the VPro membrane fulfilled other parameters in the claims, such as dense layer existence ratios and standard deviation of pore sizes. The Opponent argued that features of the claims were arbitrary parameters (discussed below), but the evidence was not sufficient to establish prior use.

The Applicant also asserted that the Opponent had not adequately established details of the alleged public disclosure, or that its membrane was reproducible by a skilled person.  Ultimately, the Delegate was able to settle the question of novelty without deciding on those points, but overall this decision serves as a reminder that the burden of establishing prior use is significant.  Care needs to be taken when preparing evidence of alleged prior use to address questions including: was there a public disclosure, if so when did it take place, and what exactly was disclosed to the public.


The Delegate also considered the issue of ‘parameteritis’ when assessing novelty. The term ‘parameteritis’ arose in the decision of Laddie J in Raychem Corp’s Patents [1998] RPC 31 and was described as a:

practice of seeking to repatent the prior art by limiting claims by reference to a series of parameters which were not mentioned in the prior art.[6]

The Opponent relied on this approach, arguing that certain parameters defined in the claims were “arbitrary”, did not achieve a technical effect and should be disregarded. However, the Delegate instead agreed with the Applicant’s position that the parameters defined in the claims combined to provide a technical advantage, could not be considered an “arbitrary convenience”, and were essential to the invention.[7] The Delegate also found that “parameteritis” is not a term found in the Patents Act, and does not represent a separate ground that a claim needs to meet.[8] Whilst at times a feature falling under the label of parameteritis may be inessential for the purposes of a novelty consideration (and only essential claim features need to be taken into account for assessing novelty under Australian practice[9]), in this case the specification made clear that the parameters were essential features.

Best method

A lack of best method attack was also raised, with the Opponent asserting that certain details were not provided in the specification relating to how SEM images of membranes were acquired.  However, the claims were product claims, and the Delegate held that the nature of the invention was not in an improvement in SEM imaging or image processing techniques, but rather was the creation of porous membrane filters with specific physical properties.  The best method enquiry was therefore directed to the creation of membranes, and the evidence did not establish that the applicant was aware of a better membrane product than those provided in the examples.[10]

How we can help you

Griffith Hack are pleased to support our clients on a range of matters from patent prosecution through to contentious matters such as opposition and litigation. We have an integrated team of patent attorneys and lawyers with strong technical and legal capabilities, and are committed to achieving the best possible outcomes for our clients.

If you would like to know more on how Griffith Hack can assist you, please get in touch.

[1] EMD Millipore Corporation v Asahi Kasei Medical Co., Ltd. [2022] APO 6

[2] Ibid, at [46].

[3] Ibid, at [54].

[4] Ibid, at [58].

[5] Ibid, at [117].

[6] Raychem Corp’s Patents [1998] RPC 31 at 37.

[7] Ibid.

[8] Ibid, at [116].

[9] Patent Manual of Practice and Procedure, 2.4.10.

[10] Ibid, at [83].

Griffith Hack is pleased to announce that Jacqui Thomas and Daniel Hsieh are now registered patent attorneys in Australia and New Zealand.

Jacqui Thomas

Jacqui, based in our Perth office, registered as a patent attorney in January 2022. She assists clients with the drafting and prosecution of patents across a range of technology areas, and has particular expertise with electrical, electronic and software patents.

Daniel Hsieh

Daniel, based in Melbourne, registered in October 2021. He is interested in the developing software patent case law and clean technology, and has assisted clients prosecute inventions related to solar energy systems, electrochromic windows, fuel cells/batteries, and improved mining resource detection/modelling.

Griffith Hack congratulates both Jacqui and Daniel on their registrations.

Bayer Pharma Aktiengesellschaft [2022] APO

In recent times, the Australian Patent Office and the Federal Court of Australia (FCA) have had a series of cases dealing with patent term extension (PTE) in which consideration of the term “earliest first regulatory approval date” was key. We have commented on these cases previously (Ono Pharmaceutical Co., Ltd. et al [2020] APO 43 (Ono 1); Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643 (Ono 2); Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2021] FCA 947 (MSD)).

On 7 February 2022, the Australian Patent Office published its decision Bayer Pharma Aktiengesellschaft [2022] APO 7 (Bayer), again considering “earliest first regulatory approval date”. This term is central to the calculation of PTE in Australia, which also requires that at least 5 years have elapsed between grant of the patent for which PTE is requested and first regulatory approval for the pharmaceutical substance upon which the PTE request is based. Issues have arisen where a patent covers more than one pharmaceutical substance with regulatory approval, i.e. listed in the Australian Register of Therapeutic Goods (ARTG). In these circumstances, the pharmaceutical substances may be listed in the ARTG by a third party as well as by the patentee.

Bayer fell in the latter group, because the patent in question covered two of the patentee’s products, each listed on the ARTG, each having a first regulatory approval date. The question then was which of the first regulatory approval dates was the earliest first regulatory approval date, the answer to which would dictate whether PTE would be granted. If the earliest first regulatory approval date was that of the pharmaceutical substance first listed in the ARTG, 5 years would not have elapsed between grant of the patent and first regulatory approval. If the earliest first regulatory approval date was that of the pharmaceutical substance second listed in the ARTG, more than 5 years would have elapsed between grant of the patent and first regulatory approval.

At the time of requesting PTE, the Commissioner of Patents was satisfied that the earliest first regulatory approval date was that of the pharmaceutical substance second listed in the ARTG, i.e. the pharmaceutical substance upon which the PTE was requested. Subsequently, a third party challenged the PTE by asserting that the patent register had an incorrect expiration date, beyond the true date of expiration. Bayer deals with the request for rectification of the register to void the PTE.

The patentee’s arguments in Bayer were akin to the FCA’s reasoning in Ono 2, which aligned with the Commissioner’s grant of PTE in the first instance based on the earliest first regulatory approval date was that of the pharmaceutical substance second listed in the ARTG.

As we noted at the time, our view was Ono 2 simplified PTE requests for patentees and provided a degree of certainty by allowing a patentee to ignore third party pharmaceutical substances listed in the ARTG. However, issues regarding a patent covering two or more pharmaceutical substances listed in the ARTG by the patentee remained.

As noted by the Delegate of the Commissioner of Patents at [26], Bayer was heard before MSD was decided and published. The FCA distinguished the facts in MSD from the facts in Ono 2, and the Delegate in Bayer has followed MSD. In short, in Bayer the Delegate held that where two pharmaceutical substances are covered by the same patent and both are listed in the ARTG by the patentee (or with the patentee’s approval), the earliest first regulatory approval date will be that of the pharmaceutical substance first listed in the ARTG. In many cases, including Bayer, this means that the patent in question will not be granted PTE (or according to the legislation, will be PTE-eligible, but will be granted PTE of zero days).

This continues to be a developing area with judgment reserved by the Full Court of the Federal Court of Australia in appeals of both Ono 2 and MSD. It is also possible that the decision in Bayer will be appealed.

In any event, as we have recommended, during patent prosecution, careful consideration should be given to the likelihood of listing in the ARTG more than one pharmaceutical substance that will fall within the scope of the claims of a patent granted on the application. If the likelihood is high, each pharmaceutical substance to be listed in the ARTG should be covered in a separate divisional application to maximise the chance of obtaining PTE for at least some of the patents. Alternatively, it should also be possible to have granted claims covering more than one pharmaceutical substance, and keep a divisional application pending. Because non-broadening amendments may be made after grant, when there is some certainty about what pharmaceutical substances will be listed in the ARTG, the granted patent could be narrowed to one pharmaceutical substance, and the divisional claims redrafted to cover the second pharmaceutical substance.

For more information on PTEs, please contact Dr Malcolm Lyons.

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