IP Spotlight - April 2025

April 2025 NEWS FROM AUSTRALIA IP SPOTLIGHT

Page 2

We are thrilled to welcome you to the first edition of IP Spotlight for 2025. In this edition, we bring you a round-up of news, insights and developments from across the Australian intellectual property landscape. From emerging technologies and shifting legal frameworks, to evolving commercial strategies for protecting and leveraging IP, we aim to keep you informed, inspired, and ahead of the curve. This week, Wrays proudly celebrates our 105 year anniversary. Our success wouldn’t have been possible without the support of our international network, clients, and associates. Thank you for being part of 105 remarkable years - and here’s to many more to come!

Around Australia in a Minute

Page 4

Firm Announcements

Page 6

In the Spotlight with Senior Associate Bindhu Holavanahalli

Page 8

Empowering First Nations- Australia's Move to Protect Indigenous Cultural and Intellectual Property Unlocking Australia’s $100bn Agritech Future - Overcoming Challenges and Leveraging Smart Farming Innovation Navigating the Future - Australia's Emergence in the Semiconductor Sector Antibody Patent Protection in Australia - Is the inventive step threshold for antibodies in Australia designed to stifle innovation?

Page 10

Page 12

Page 18

Paula Adamson CEO

Page 22

Artificial Intelligence - The Ethics of Using it in Legal Practice

Page 26

As Ever, Trade Marks can be Complex - The Duchess of Sussex and the Journey to a Registrable Brand

1 | wrays.com.au

AROUND AUSTRALIA IN A MINUTE

The Australian Intellectual Property profession is experiencing significant developments with many of the changes aimed at enhancing the IP system's efficiency and alignment with international standards.

Gary Cox Chairman & Principal

2 | wrays.com.au

KEY DEVELOPMENTS IN THE AUSTRALIAN IP INDUSTRY

protecting early-stage innovations. The clean energy sector emerged as a significant area of growth. Australia ranked as the second-fastest-growing destination among 19 major economies for patents related to clean energy generation and storage (Australian IP Report 2024). This surge aligns with the nation's strategic focus on renewable energy technologies, including solar, wind, and energy storage systems. Semiconductors also saw substantial growth, with both Australian and Chinese residents increasing their filings in this field. Semiconductors are crucial for powering advanced technologies such as artificial intelligence, telecommunications, and consumer electronics. These trends underscore Australia's commitment to fostering innovation and positioning the nation as a growing hub in clean energy, semiconductors, and early-stage technological developments. IP Australia Fee Adjustments. XXXXXXX The most recent IP Australia fee adjustments were implemented on 1 October 2024. These changes affected patents, trade marks, designs, and plant breeders' rights. While some fees increased, others decreased, with the goal of incentivising early filings and reducing administrative burdens. ​As of April 2025, there have been no new announcements regarding changes to IP Australia fees for the current year. Australia's adoption of the Madrid Goods and Services (MGS) List in March 2024 marked a significant shift in the nation's trade mark classification system. Since the adoption of the MGS List, Australian trade mark classifications are now more consistent with those of other Madrid System member countries, simplifying the process for Australian businesses to protect their marks internationally and improving the efficiency of the application process. Indigenous Knowledge and IP. In May 2024, IP Australia initiated a pilot Indigenous Knowledge Panel to advise on IP applications involving Indigenous Knowledge. The panel’s primary functions include advising on internal processes and policies related to Indigenous Knowledge, assessing IP applications involving Indigenous Knowledge, and promoting awareness and understanding of Indigenous Knowledge within the IP system. For more information on this topic visit our article here. Adoption of the Madrid Goods and Services List.

Introduction of New Patent Proceedings Directions – Federal Court of Australia.

Scam Emails Targeting Trade Mark Holders. In early 2025 the Australian IP Industry was significantly impacted by a fraudulent email campaign targeting trade mark rights holders. These scam emails appeared to be sent by registered patent and trade mark attorneys and typically claimed to offer assistance in protecting an organisation’s intellectual property rights from a purported third-party attempt to infringe upon them. The content of these emails was often misleading and contained incorrect information. A second fraudulent campaign in March 2025 involved ‘address for service’ details being changed in the IP Australia online system without consent. IP Australia took immediate action to freeze and reverse the automatic updates for impacted customers. Unfortunately, scam emails are still circulating within the industry, continuing to create headaches for Australian IP firms. In October 2024, the Full Federal Court delivered a landmark judgment in Sandoz v Bayer, addressing the inventive step requirement for pharmaceutical patents. The court unanimously invalidated two of Bayer’s Xarelto® (rivaroxaban) patents, ruling that they lacked inventive step based on prior art and common general knowledge. This decision provides clarity on assessing inventive step under the pre-"Raising the Bar" Patents Act, influencing future pharmaceutical patent disputes in Australia. Provisional Patent Filing Trends. In 2024 there was a resurgence in provisional patent filings, rising by 2.2% indicating a renewed interest in 3 | wrays.com.au In early 2025, the Federal Court of Australia initiated a pilot program for new Standard Directions in patent proceedings. These directions aim to streamline the litigation process, making it more efficient and predictable. The pilot was launched following consultations led by Justices Stephen Burley and Helen Rofe. A key feature of the new directions is the allocation of a trial date within 14 days of the first case management hearing. This approach contrasts with the traditional model, where trial dates are often set much later in the process. The goal is to expedite proceedings and reduce delays. Clarification of Inventive Step in Pharmaceutical Patents.

FIRM ANNOUNCEMENTS What’s New at Wrays

WRAYS CELEBRATES PRESTIGIOUS INDUSTRY RECOGNITIONS Wrays is proud to share a series of recent accolades that highlight our commitment to excellence in intellectual property. We are delighted to announce that Wrays has once again retained its high ranking in the World Trademark Review 1000 for Firms: Prosecution & Strategy. This recognition reaffirms our position as a leading firm in trade mark protection and strategy. In addition, our esteemed trade mark experts, Marie Wong and Jennifer McEwan , have been recognised as Recommended Individuals in Prosecution & Strategy, acknowledging their expertise, dedication, and outstanding service to clients.

Wrays has been recognised in the 2026 edition of The Best Lawyers in Australia, with Marie Wong, Andrew Goatcher, Judith Miller , and Natalie Shoolman honoured for their excellence. Selected through a rigorous peer-review process, the awards celebrate top legal talent across the Asia-Pacific. Marie Wong received special recognition as "Lawyer of the Year" for Intellectual Property Law. We are also thrilled to celebrate Senior Associate Bindhu Holavanahalli , who has been recognised as one of Australasian Lawyer’s Future Legal Leaders, a testament to her exceptional talent and contributions to the field. Turn to page 6 for a feature on Bindhu’s achievements and insights into her career journey.

4 | wrays.com.au

WRAYS APPOINTS NATALIE SHOOLMAN AS HEAD OF LITIGATION & DISPUTE RESOLUTION Wrays is delighted to announce the appointment of Principal Natalie Shoolman to the role of Head of Litigation and Dispute Resolution, effective 1 October 2024. Natalie, who joined Wrays’ Sydney IP Litigation practice in August 2022, brings more than 20 years’ experience to the role. Natalie succeeded Wrays’ Chairman Gary Cox, who has led the IP Litigation team for many years.

Wrays CEO Paula Adamson announced the promotion saying Natalie’s appointment underscores her status as one of Australia’s top IP lawyers, with a distinguished track record in IP and technology disputes, particularly multi-jurisdictional patent disputes for pharmaceutical and biotechnology companies. Her leadership in managing our integrated litigation and dispute resolution practice will be instrumental as we continue to grow. I am confident that Natalie will excel in supporting our clients and advancing the firm’s strategic goals. Paula went on to say, I would like to take this opportunity to express my gratitude to Gary for his pivotal role in leading the group to date and establishing it as one of Australia’s leading IP litigation teams. Gary will continue to serve as a prominent IP litigation lawyer, focusing on contentious IP matters both in Australia and internationally, while also dedicating more time to his Chairman duties across Wrays, Wrays Lawyers, and Life Sciences WA. WRAYS WELCOMES SPECIAL COUNSEL KATE LEGGE Wrays is pleased to announce the appointment of Kate Legge as Special Counsel, further strengthening our intellectual property team with her extensive experience across a broad spectrum of IP rights. Kate joined Wrays in November 2024, bringing with her a distinguished career spanning private practice, academia, and in-house roles. Prior to joining Wrays, Kate was part of the legal team at The University of Melbourne, where she XXX played a pivotal role in managing intellectual property matters within the research and innovation ecosystem. Her career also includes experience at top-tier and boutique IP firms, as well as in-house positions at global pharmaceutical companies Pfizer and Hospira. With a deep understanding of patents, copyright, trade secrets, and the protection of confidential information, Kate offers strategic and commercially focused advice to clients across diverse industries. Her ability to navigate complex IP challenges - from the protection and enforcement of rights to IP commercialisation - positions her as a key asset to the Wrays team.

WRAYS EXPANDS TRADE MARKS EXPERTISE WITH THE ADDITION OF SENIOR ASSOCIATE KATHY MYTTON The Trade Marks team at Wrays continues to grow with the strategic appointment of Kathy Mytton as Senior Associate in 2024. Kathy brings 26 years of experience in trade mark law, having started her career in paralegal roles before qualifying as a Solicitor in 1997 and a Trade Marks Attorney in 1998.

Kathy’s career in intellectual property spans multiple decades, beginning in a secretarial and paralegal role, where she developed a strong foundation in trade mark practice. She went on to qualify as a Solicitor in 1997 and subsequently registered as a Trade Marks Attorney in 1998. Before joining Wrays, Kathy honed her expertise within the trade mark groups of two other leading Australian specialist IP firms, advising a diverse client base on complex brand protection matters. Throughout her career, Kathy has developed a deep specialisation in the selection, clearance, filing, prosecution, and enforcement of trade marks, delivering strategic, commercially-focused advice to local and international clients. Her extensive industry experience covers sectors including aerospace and defence, automotive, banking and finance, building and construction, education, entertainment, fashion, FMCG, gaming, manufacturing, and software and technology.

5 | wrays.com.au

IN THE SPOTLIGHT With Senior Associate Bindhu Holavanahalli

ACHIEVEMENTS OVER THE LAST 12 MONTHS

Bindhu is an intellectual property lawyer and patent & trade marks attorney working in our dispute resolution team. Bindhu is highly sought after by the clients of Wrays who value having an experienced dispute resolution lawyer provide their IP attorney advice, ensuring maximum protection should they ever enter a dispute. In addition to her Law degree, Bindhu also has a Bachelor of Science which ensures that she has a true understanding of the scientific innovations she is protecting. Bindhu provides advice to a diverse range of clients, from local small businesses and start-ups establishing their brands, right through to large multi-national corporations with patent litigation matters, or those who require management of their global trade mark portfolios. Bindhu’s patent litigation work includes complex pharmaceutical litigation and mining technology matters. In the brand protection space, Bindhu assists clients with trade mark application and prosecution matters, brand disputes, domain name issues and other related intellectual property matters such as consumer law, passing off and copyright advice.

Bindhu delivered an award-winning presentation on the Infringement of Non-Traditional Trade Marks at the IPTA Conference, demonstrating her leadership in emerging IP topics. She played a crucial role in successfully defending Amgen in a complex Federal Court litigation involving anti-PCSK9 antibody patents, one of Australia's largest life sciences IP cases in the past year.

Bindhu contributed significantly to a high-stakes patent infringement and revocation matter for MMD Australia, which reached the Full Federal Court.

She led a successful proactive revocation action on behalf of TCT Group, protecting it from unjustified patent infringement threats and securing a comprehensive win.

She presented to the Indigenous Business Council to empower Indigenous entrepreneurs with accessible IP strategies.

Bindhu mentors early-stage entrepreneurs through Curtin Ignition, guiding them on IP fundamentals critical for business success.

Bindhu regularly volunteers for pro bono work, including recent trade mark advice to SAFE Perth, a not-for-profit animal welfare organisation.

6 | wrays.com.au

In addition to her client work, Bindhu actively supports the growth of our firm through her business development and profiling efforts. Her achievements in this area were recognised with a rapid promotion to Senior Associate at Wrays.

BINDHU’S ACTIVE CONTRIBUTION TO THE PROFESSIONAL COMMUNITY Bindhu has distinguished herself within the intellectual property field through both her legal acumen and her unwavering commitment to advancing the industry and supporting her professional community. Beyond her typical responsibilities, Bindhu actively engages in initiatives that expand the reach and understanding of intellectual property, particularly among underrepresented groups and budding entrepreneurs. One of her most impactful contributions this year has been her involvement with the Indigenous Business Council, where she recently led a presentation designed to make complex IP issues more accessible to Indigenous businessowners. Additionally, Bindhu’s dedication to fostering new business ideas is showcased by her ongoing involvement with Curtin Ignition, an annual program run by Curtin University which is focused on supporting 100 aspiring entrepreneurs. Bindhu’s commitment to the firm’s pro bono initiatives deserves special recognition, as she is consistently one of the first to volunteer her time to support not-for-profit organisations. A notable example of her pro bono work is her recent trademark infringement advice to SAFE Perth, an organisation committed to rehoming animals and preventing euthanasia. Further, Bindhu’s thought leadership extends to her prolific writing on current IP trends, where she covers emerging legal challenges, industry shifts, and practical IP strategies in a way that is accessible to professionals and laypeople alike. By sharing her knowledge widely, Bindhu fosters an informed IP community, bridging gaps in knowledge that often hinder effective IP management.

7 | wrays.com.au

EMPOWERING FIRST NATIONS Australia's Move to Protect Indigenous Cultural and Intellectual Property

This

article

highlights

the

ICIP includes a broad range of practices, expressions, and knowledge systems, including dance, languages, designs, and art as well as traditional medicines, foods, and biological/ecological knowledge. The Australian Government, in January 2023, announced a commitment to develop new laws to help protect ICIP. A critical factor in ensuring any new legislation is fit for purpose is to ensure that its development is First Nations-led. In view of this, the Aboriginal and Torres Strait Islander Expert Working Group on Indigenous Cultural and Intellectual Property was announced in December 2024. The working group, comprised of eight first nations experts and cultural leaders will inform the development of the legislation.

shortcomings

of

Australia’s

current in protecting Indigenous cultural and intellectual property and explores the long-overdue solutions proposed by the newly announced First Nations-led working group. It has long been acknowledged that current intellectual property systems are not sufficiently adapted to protect indigenous cultural and intellectual property (ICIP). IP frameworks

8 | wrays.com.au

WHY ISN’T THE EXISTING INTELLECTUAL PROPERTY FRAMEWORK SUFFICIENT TO PROTECT ICIP? Existing intellectual property rights (such as patents, copyright, trade marks and designs) can be used to protect some forms of ICIP, but often fall short for a range of reasons, including: ICIP is not usually “owned” by any single person or entity, but are held by groups of people who are the custodians of such knowledge whereas existing intellectual property rights usually require the identification of specific owners; there are customary laws around the appropriate use and dissemination of such knowledge, which is not usually recognised in existing intellectual property rights; the knowledge may have been publicly known and used for thousands of years, meaning that it is not sufficiently “novel” to qualify for protection such as patent rights; and the duration of rights for existing intellectual property regimes are not consistent with timeframes for ICIP which have been and will continue to be practiced for thousands of years. WHAT ARE THE PROPOSED NEW LAWS? A range of different proposals to protect ICIP around the world have been raised over the years, which can generally be grouped into two types – positive protection and negative protection: Positive protection seeks to use existing intellectual property mechanisms and new types of rights to protect the content of ICIP themselves. Negative protection seeks to prevent outside users of ICIP from misappropriation of such information and knowledge.

The new laws under development are proposed to address both positive and negative protection. In particular, the negative protective mechanisms will focus on the significant issue of fake and misappropriated indigenous souvenirs and merchandise sold in Australia, with up to half of such items currently estimated to have not been made by aboriginal or Torres Strait Islander artists. The second stage will relate to broader positive protection for ICIP more generally. However, the initiative is at an early stage, and there is no proposed legislation for consideration yet. Given the complexities in this area of law, the development of a cohesive set of new provisions will take time, as has been observed around the world. The World Intellectual Property Organisation (WIPO), for example, approved a historic new treaty on intellectual property, genetic resources and associated traditional knowledge after almost 25 years of negotiations in May 2024. Further negotiations remain ongoing in relation to the development of legal instruments to protect traditional cultural expressions. Nevertheless, the establishment of the working group is a small first step in the development of long overdue laws to protect ICIP in Australia. FOR FURTHER INFORMATION For further information about the protection of Indigenous Cultural and Intellectual Property; please contact the author of this article Bindhu.Holavanahalli@wrays.com.au. Another recent article on a similar topic can be viewed here

New WIPO Treaty

Bindhu Holavanahalli Senior Associate

9 | wrays.com.au

UNLOCKING AUSTRALIA’S $100BN AGRITECH FUTURE Overcoming Challenges and Leveraging Smart Farming Innovation

With an objective of reaching A$100bn agritech output by 2030, Australia’s agricultural productivity can be expected to increase significantly. But how is this to be achieved efficiently? A closer look at the growing role of ‘smart farming’ and the associated technological, intellectual property, and regulatory challenges provides insight into the path forward. DEFINING AGRITECH: THE RISE OF SMART FARMING The term ‘agritech’ has been defined in several different ways across Australian jurisdictions. A working definition is technology directed to the efficient farming and distribution of agricultural products, in particular food and beverage (also known as ‘agrifood’). In the digital era, the term ‘smart farming’, also known as ‘precision farming’ or ‘precision agriculture’, seems to capture the essence of agritech. ‘Smart farming’ implies the primacy of digitalisation of agricultural processes. The development of intellectual property (IP) supporting ‘smart farming’ looks, at least from the engineering perspective, very different from the hardware focus of the agricultural revolution which tended to involve individual inventor/entrepreneurs rather than today’s large agriculturally focussed corporations.

Such large corporations have easier access to the resources to develop and commercialise hardware, for example in the form of drones, robotics and mobile devices. This is also true of the development and commercialisation of agricultural chemicals (‘agrochemicals’) as well as life science related products including genetically engineered products including micro-organisms and seeds. Smart farming and the accompanying growth of digitalisation (including artificial intelligence and machine learning) supporting an Agriculture 4.0 framework for agricultural production, opens new avenues for productivity but it also introduces complexities, especially in relation to IP considerations and technological access. AGRITECH IN AUSTRALIA Leaving aside issues with the ownership, protection and use of data collected from farmers to fuel digitised agricultural processes, the country faces several hurdles in fully capitalising on the benefits of smart farming. These include issues of access to technology, freedom to operate, and the need for continued innovation across various aspects of the agrifood supply chain. CHALLENGES AND OPPORTUNITIES FOR

10 | wrays.com.au

THE ROLE OF SMES AND INDIVIDUALS IN AGRITECH INNOVATION The advantaged position of the agriculturally focused multi-national corporation does not mean no opportunities for individuals and small and medium sized enterprises (SMEs) to contribute to ‘smart farming’ or ‘farm to fork’ strategy. Indeed, capture and protection of intellectual property developed by such individuals will be critical to technology transfer and commercialisation, most likely by corporations with the necessary farming customer base to make such commercialisation possible. CONCLUSION: A PATH FORWARD FOR AUSTRALIA’S AGRITECH GROWTH Australia’s goal of reaching A$100bn in agritech output by 2030 is within reach, but achieving this target will require overcoming several challenges. Ensuring access to the best technologies, protecting intellectual property, fostering innovation, and maintaining a focus on sustainability will be key drivers of success. By creating an environment that supports collaboration between large corporations, SMEs, and individual innovators, Australia can unlock its full agritech potential and position itself as a global leader in the digital agriculture revolution. FOR MORE INFORMATION Should you wish to contact our Wrays agritech expert to discuss your own IP opportunities, please contact Richard Baddeley (richard.baddeley@wrays.com.au).

Freedom to Operate Barriers: Freedom to operate may impact farming in a number of ways. For smaller scale farming, use of genetically modified seeds and seed planting equipment could potentially trigger patent infringement litigation as in the United States and Canada. Tort litigation concerning GMO seeds and impacts on organic certification has already occurred in Australia: Marsh case. Patents for new genomic techniques could also potentially cause barriers for plant breeders so freedom to operate is an important issue. These are just examples. Innovation Opportunities: Innovation, as has been spurred by the farm to fork (F2F) strategy in Europe where sustainability considerations create IP opportunities, for example, in: farming methods avoiding antibiotic microbial resistance issues waste processing to biogas and other products biofuels for example through algal capture of carbon dioxide carbon sequestration reduction in agrochemical usage food related innovation at the ‘fork’ end of the F2F spectrum. Access to technology: Most agritech technology originates in US, Canada, China and Republic of Korea with Australia relatively less active. A survey of US patents related to digital technology showed that a number were not filed in Australia despite the technology having potential utility in the country. Patenting computer implemented inventions is challenging in Australia. There is a risk of limited access to technology where it cannot be patented in a particular jurisdiction. Therefore, Australia may not get access to the best technology for adoption in smart farming and will potentially need to pay more for inferior technology due to resulting limitation of competition.

Richard Baddeley Principal

11 | wrays.com.au

NAVIGATING THE FUTURE Australia's Emergence in the Semiconductor Sector

Semiconductors underpin almost every aspect of our modern lives, playing a critical role in next generation technologies. Australia's semiconductor sector is in a unique position, driven by its commitment to high-quality research and niche capabilities in growth areas such as telecommunications, healthcare and quantum technologies. In this article we take a closer look at the rise and fall of the photonics and semiconductors sectors in Australia, and the challenges that will need to be addressed if the country is competitiveness landscape. THE RISE OF AUSTRALIA’S PHOTONICS TECHNOLOGIES The Australian semiconductor industry, while smaller in scale compared to global giants like the US or Taiwan, has been developing niche capabilities, particularly in areas that complement photonics technologies. The photonics industry in Australia is closely intertwined with the country's semiconductor sector, as both fields deal with the manipulation of light and electrons for various technological applications. In Australia, the photonics industry has been growing steadily, driven by increasing demand for optical and photonic technologies in various sectors such as telecommunications, healthcare, defence, environmental monitoring and quantum technologies. The industry encompasses a range of technologies including lasers, optical fibres, sensors, and imaging systems. Beginning with raw materials such as glass and semiconductor substrates, the photonics value chain advances via optical components and subsystems to photonics products and products enabled by photonics, including smart phones, self-driving cars, lighting systems, quantum computers, and AR/VR vision systems.

These end-use goods provide the foundation of the worldwide photonics-enabled economy, which in turn supports photonics-enabled services, usually based on the internet. The internet uses light, either through free space or optical fibre, to carry its data. For example, cloud computing, streaming video and music, and e-commerce are among the enabled services. There are numerous applications for photonics, many of which are underpinned by and reliant upon semiconductor technologies, including consumer electronics (smart phones, AR/VR headsets, smart doorbells), telecommunications (fibre optics, lasers, Li-Fi), health (eye surgery, medical imaging, wearables), manufacturing (3D printing, laser cutting, robotics and vision), defence and security (night vision, satellites, autonomous systems), and sustainability (climate monitoring, solar photovoltaics, lidar for wind turbines, LED lighting, to name a few). In 2022 SPIE reported [1] that the size of the global photonics industry across all sectors was approximately 368B and growing with a strong annual growth rate of about 7.3% compared with the global GDP growth rate over the same 10-year period of about 3% pa. Similar studies [2] on the Australian and New Zealand Photonics landscape place the size of local industry at about $6.2 B (AU ~$4.7B, NZ ~1.5B) and growing at an annualised rate over the past 10 years of about 2.8% per annum. For comparison, following a sales record of $574.1 billion in 2022, global semiconductor sales in 2023 decreased by 8.2% to $526.9 billion. However, driven by an increased demand for chips for the automotive, artificial intelligence and industrial applications, estimates from the World Semiconductor Trade Statistics (WSTS) project worldwide semiconductor industry sales will increase to $611 billion in 2024, a 16% increase compared to 2023 [3]. The COVID years saw a temporary retraction of the global photonics industry, however the industry has made a strong recovery since and continues to grow [1, 4].

13 | wrays.com.au

This growth is reflected in the extremely strong growth in global patent filings for the inventions in the optics and photonics industry, showing steady growth of about 13% annually over the 10 years between 2012 and 2022. This is a similar trend seen in the broad semiconductor and quantum technology industries which has seen very rapid growth in the past 10 years globally: an average of approximately 6.5% growth per year for the semiconductor industry and more than 11% growth per year for quantum technologies across all quantum applications including quantum computing and quantum sensing etc.

GLOBAL PATENT FAMILY FILINGS FOR OPTICS AND PHOTONICS

GLOBAL PATENT FAMILY FILINGS FOR SEMICONDUCTOR TECHNOLOGIES

GLOBAL PATENT FAMILY FILINGS FOR QUANTUM TECHNOLOGIES

14 | wrays.com.au

SEMICONDUCTOR

PATENT

TRENDS

IN

Acquisition of Skilled Workers: The lack of skills in photonic and quantum technologies remains a key issue for both countries and both are seeking to either teach, retain or attract skilled workers from overseas. As a future career, photonics is almost entirely hidden yet, the CSIRO forecasts that quantum information science and technology could create 16,000 jobs to be filled by 2040. Australia’s Chief Scientist, Dr Cathy Foley says there’s currently a tension between new ideas emerging from fundamental research and a focus on areas of competitive advantage. She says Australian universities need to act with clearer intent and focus if they’re to create opportunities for PhD’s. Access to Infrastructure: The Australian Strategic Policy Institute in 2022 released a Policy Brief outlining Australia’s Semiconductor Moonshot. This briefing note outlines the case for local sovereign semiconductor Moonshot to provide Australia with sovereign semiconductor capabilities. Such desired capabilities include local semiconductor manufacturing facilities to ensure access to semiconductor components without the reliance upon external trading partners, as well as uplifting other areas of the semiconductor ecosystem including critical minerals and microchip design. the establishment of the National Collaborative Research Infrastructure Strategy (NCRIS), an AU$4 billion government initiative designed to maximize Australia's national research infrastructure investments through the coordination of open access facilities, specific scientific fields, and co funding throughout the nation. The NCRIS is a sponsor of the Australian National Fabrication Facility (ANFF), which makes the Heavy Ion Accelerators (HIA) network and micro and nanofabrication equipment freely accessible for high-energy ion beam research in areas of national importance, such as advanced materials science, quantum computing, and space and astronomy. This effort is supported by

AUSTRALIA Australia's semiconductor patent filings are relatively modest compared to global leaders like the US, China, and South Korea. However, there has been a gradual increase in filings over the past decade, indicating growing activity in the sector. Key areas of patent filings originating from Australia include: Quantum computing: A significant portion of Australia's semiconductor-related patents are in quantum technologies, particularly silicon-based quantum computing. Photonics and optoelectronics: Reflecting Australia's strength in this field, many patents relate to photonic integrated circuits and optical communication technologies. Specialised sensors: Patents for advanced sensing technologies, often for environmental or medical applications. Power electronics: Growing number of filings in wide bandgap semiconductors, e.g., SiC, GaN, and energy-efficient power devices. OVERCOMING CHALLENGES: HOW AUSTRALIA CAN STAY COMPETITIVE To increase the global market share of semiconductor, photonics and/or quantum technologies in Australia requires improvements across the research and development sector including: Government Support and Funding: The Australian government has recognised the strategic importance of both photonics and semiconductor industries. Figures from the OECD Directorate for Science, Technology and Innovation demonstrate a global slowdown in government R&D investment during 2023 and no real growth in business R&D. However, the first half of 2024 has shown [5] an increase in demand for photonic technologies in the defence and communications sectors.

15 | wrays.com.au

A BRIGHT OUTLOOK FOR AUSTRALIA’S SEMICONDUCTOR SECTOR Despite the challenges to developing local sovereign capabilities in semiconductors, photonics and quantum manufacturing and development, the future outlook for Australia’s semiconductor industry is promising, While Australia's semiconductor patent filings may be fewer in number compared to global leaders, they often represent high-quality, innovative research, particularly with a particular emphasis on next-generation technologies in specialised fields like quantum computing and photonics that could have significant long-term impact. The patent activity in this sector reflects its focus on niche, high-value areas rather than mass-market semiconductor production. The combination of steady market growth, technological innovation, and supportive policies positions Australia’s semiconductor industry for a bright future. Should you have any questions about protecting the intellectual property of your semiconductor innovation, please contact our author Dr Phil Burns (phil.burns@wrays.com.au).

Dr Phil Burns Principal

REFERENCES

[1] SPIE Global Industry Report 2024 – Optics and Photonics https://spie.org/community-support/industry resources/global-industry-report#_= [2] ANZOS Photonic and Quantum Technologies In Australia And New Zealand - 2024 Industry Report https://optics.org.au/2024-industry-report [3] SIA 2024 State of the U.S. Semiconductor Industry https://www.semiconductors.org/2024-state-of-the-u-s semiconductor-industry/ [4] The Australian Photonics Industry: Current Status & Future Opportunities – Simon Poole presentation to the Sydney Photonics Industry Network (SPIN) 16 May 2024 [5] Ceres Technology Advisors https://cerescom.net/articles/first-half-2024-mergers acquisitions-in-photonics

ANTIBODY PATENT PROTECTION IN AUSTRALIA Is the inventive step threshold for antibodies in Australia designed to stifle innovation?

INTRODUCTION Antibodies have become significant therapeutic treatments for a broad range of diseases including cancer, inflammatory conditions and infectious diseases. This antibody success story, which includes blockbuster drugs such as Humira (AbbVie) Keytruda (Merck) Opdivo (BMS/Ono Pharmaceutical, Infliximab (JnJ/Janssen) and Dupixent (Sanofi) has turbo-charged the development of a multitude of next-generation antibody therapeutics. However, the unique structure/function relationship of antibodies and how they are generated presents patenting challenges, including how the inventiveness of antibodies is determined.

BACKGROUND

In a previous article by Wrays titled ‘Maximising Antibody Patent Protection in Australia’, we reviewed the current situation that exists at IP Australia, which generally requires Australian antibody claims to define 6 specific CDR sequences. In this article, we consider the inventiveness of antibody claims in light of IP Australia practice, which appears to be aligning to that currently employed at the European Patent Office (EPO). Under EPO practice, a novel antibody that binds to the same antigen as a known antibody is not considered inventive unless a surprising technical effect beyond that of the known antibody is demonstrated. According to Chapter 6.2 of the Guidelines for Examination in the EPO, examples of surprising technical effects can include “unexpected improvement over prior-art antibodies in one or more properties, such as therapeutic activity, stability or immunogenicity or an unexpected property not exhibited by prior-art antibodies”.

18 | wrays.com.au

In our experience, antibody inventive step objections raised by Australian Examiners, may include the following: The claimed subject matter can be distinguished from D1, in that D1 does not disclose the recited CDRs. However, it is not apparent that this confers an inventive step. It cannot be considered inventive to produce a mere alternative to that already known in the art. As such, the claimed subject matter lacks an inventive step. This approach to antibody patentability evokes consideration of two key issues: Is this practice consistent with Australia inventive step jurisprudence; an Does it support sound innovation policy in Australia? INVENTIVE STEP IN AUSTRALIA The precedent law in relation to inventive step in Australia developed around the reformulated Cripps Question, namely: “Would the notional research group at the relevant date, in all the circumstances, directly be led as a matter of course to try [the claimed invention] in the expectation that it might well produce [a solution to the problem]?“. Aktiebolaget Hassle v Alphapharm Pty Ltd (2002) HCA 59; (2002) 212 CLR 411 and approved in Olin Mathieson v Biorex (1970) RPC 157. The High Court in Aktiebolaget Hassle (AB Hassle) also considered an earlier decision from Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262, which stated that: “ The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not.”;

The Wellcome test focuses on whether the steps taken by the person skilled in the art (PSA) in the face of the same problem are routine, whereas the Cripps question focuses on whether the PSA would have been directly led to the invention with an expectation of success. Ultimately the High Court found that the approach in the Wellcome decision was similar to the Cripps question and accepted that as the correct approach for the determining an inventive step. In other words, the High Court confirmed that the inventive step threshold under Australian law requires an expectation of success. INVENTIVE STEP AND ANTIBODIES Applying the inventive step threshold, in a general sense, to antibody claims that define new sequences means that a finding of lack of inventiveness should be found only if the skilled person is led directly as a matter of course to the claimed sequences in the expectation that they might well produce a useful alternative or a better product than the prior art. In this regard, Australian law does not require an invention to be superior to what is already known for it to be inventive – it is sufficient that it is a “useful alternative”. Thus, a different antibody with different CDR sequences should, as a first point, be considered a “useful alternative” even if it is not shown to be an improvement on existing antibodies. Further and relevantly, the generation of antibodies is not conducted with CDR sequences in mind, because extrapolation of CDR sequences to antibody binding and function is not currently possible. Therefore, in defending an antibody claim that defines CDR sequences, a strong position can be advanced that the skilled person cannot be directly led to the “invention” (that being the specific CDR sequences claimed) with any expectation of success. This means that a useful alternative antibody to one that is already known should be considered inventive under Australian law. In other words, there should be no need for a new antibody that binds to a known antigen to exhibit an unexpected or surprising functional effect over an existing antibody for it to be considered inventive.

19 | wrays.com.au

GENERATION OF ANTIBODIES: NOT ROUTINE Even if it is acknowledged that known methodologies exist that produce antibodies, it is not routine that such methodologies will produce or are even likely to produce antibodies exhibiting characteristics that make them suitable as antigen binding clinical candidates. The reason for this is that generation of antibody CDR sequences in an immunised animal is an exceedingly complex process that includes consideration of, for example: the selected immunisation methodology; how the antigen may be presented, and the relevant region of the antigen to target; the type of animal used; whether humanisation is required, appropriate or functionally possible; suitable methodologies to initially screen potential clinical candidates; and suitable assays to test for relevant antibody functionality. The antibody generation process is further complicated because the potential antibody diversity that exists in a mammal considerably exceeds the estimated number of circulating B cells in the blood. Moreover, there is a constant turnover of B cells in the circulation. This means that antibodies generated in a specific immunised animal will differ depending on when they are exposed to an antigen. In other words, exposing an animal to the same antigen at different times will inevitably lead to the generation of different antibody repertoires. As such, it is extremely unlikely that two antibodies exhibiting the same sequences will be produced even if identical antibody generation methods are employed on identical animals. It is also relevant that antibodies generated by one immunisation experiment can result in antibodies exhibiting distinctly different functionalities. For example, antibodies can act as receptor agonists, antagonists or neither, and there is no way of predicting which types of these antibodies will be produced by the antibody generation process.

Thus, taking a position that an alternative antibody is not considered inventive unless it exhibits a surprising technical effect beyond that of a known antibody appears to be inconsistent with Australia inventive step jurisprudence, as well as the complex technical aspects of producing antibodies that may ultimately be suitable for pharmaceutical applications. INNOVATION POLICY If Australia proceeds with a practice that requires new antibodies that bind to known antigens to exhibit unexpected or surprising functional effects over known antibodies, it is likely to disincentivise others from investing in research programs to develop antibodies to the same target, because of the uncertainty about being able to obtain patent protection. This would in turn detrimentally impact the development and commercialisation of new alternative antibody treatments. This is a situation that is not in the best interest of innovation stakeholders including the general public. CONCLUSIONS Because antibody pharmaceuticals have become uniquely valuable as contemporary medicines for the treatment of diseases, it is critical that the development and commercialisation of new alternative antibody medicines be supported by a patent system that is consistent with the precedent law and designed to incentivise innovation. With this in mind, judicial consideration of antibody inventiveness is keenly anticipated in Australia.

Dr Grant Shoebridge Principal

Bindhu Holavanahalli Senior Associate

20 | wrays.com.au

ARTIFICIAL INTELLIGENCE The Ethics of Using it in Legal Practice

22 | wrays.com.au

New artificial intelligence (AI) tools are continually being rolled out for lawyers and attorneys with promises to revolutionise the way that practitioners undertake legal research, discovery, due diligence, and legal drafting, and offer exciting opportunities for practitioners. But what do practitioners’ ethical obligations say about the use of AI in legal practice? The situation is complex with recognition that while AI provides a useful framework, deciding how to use AI in legal practice requires significant care and judgment. WHEN DO LAWYERS AND ATTORNEYS HAVE A DUTY TO USE AI? Practitioners have a duty to act in their clients’ best interests, deliver their services diligently and as promptly as reasonably possible, and not overcharge clients. AI can dramatically reduce the time required to complete some applications such as legal research, discovery and summarising large documents. Where firms charge by time (as many do), using AI tools could significantly reduce costs and raises the question whether doing it without the assistance of AI conflicts with a practitioners’ ethical obligations. IS AI FOOLPROOF? The standards expected of practitioners are, quite rightly, very high. Practitioners have duties to deliver their services competently and with due skill and care. Practitioners also have a paramount duty to the court and administration of justice, to not mislead the court and not diminish public confidence in the administration of justice. Answers provided by AI are not reliable. For many reasons, they need to be treated with significant caution before being used in everyday legal practice as AI models are only as good as the dataset upon which they are trained. If the dataset does not include the answer to a question, some AI models are prone to making up a fictitious answer (called hallucinations). In

addition, not all AI models are trained on up-to date data, a unique issue in legal practice, where legislation, regulations, case law, policies and practice are constantly changing. Any biases in the training data set will also affect the quality of the AI’s output. What this means is that there are instances where using AI does not make sense. By the time a practitioner has finished (a) corroborating AI generated information, (b) reviewing irrelevant information generated by AI, (c) ensuring the AI has not missed anything important (d) amending drafts created by AI and/or (e) finding the set of prompts required to generate the desired answer, incorporating AI into a task could end up taking longer, and cost more, than undertaking all of the work manually. WHAT DO I NEED TO CONSIDER BEFORE USING AI IN LEGAL PRACTICE? Before using AI for any particular task, practitioners need to exercise their judgment to decide whether AI will be truly helpful and also draw upon previous experience (i.e., trial and error). Other issues to consider before you use AI in legal practice: At the moment, AI tools are best suited for high-level, simple tasks. AI is unable to match a skilled practitioner with technical or complex matters. Generally speaking, where a task has many moving parts to take into consideration, involves difficult legal or factual questions or requires a high degree of precision (such as drafting a challenging clause in an agreement), AI could well hinder more than help. practitioner. Using appropriate prompts will improve the accuracy of the answer, increase confidence in that answer and therefore potentially reduce the time required to validate that answer. For practitioners that can effectively use AI, it will be more helpful, and should be used more often. This emphasises the importance of practitioners training in the use of AI. The quality of the output from AI depends on the quality of the prompts input by the

23 | wrays.com.au

The level of scrutiny required for an AI generated answer depends on the task. Sometimes in legal practice a broad answer is enough, and an AI output may not need to be scrutinised in minute detail. In other instances, it is critical to have absolute accuracy, and a significant amount of time will be required verifying any answers given by AI. model’s dataset and algorithm. This information will allow practitioners to make a more informed decision about whether to use AI for a particular task. It will also assist are prewarned of any structural issues that they should watch for when reviewing answers provided by AI. This will require AI providers to disclose the disadvantages of their systems. Whilst this level of honesty may make some AI providers uncomfortable, it is critical to ensuring practitioners can effectively use their AI. algorithms of existing AI tools constantly being improved, the point at which practitioners should use these AI tools will constantly shift. Practitioners need to continually monitor developments in AI technology to ensure that, consistent with their ethical obligations, they are using it in appropriate situations and using it effectively. With the speed of changes in AI technology, this will require a significant, ongoing investment of time for practitioners. It will be helpful for practitioners to understand the limitations of an AI With new AI tools constantly being released, and the capability and CONFIDENTIALITY AND PRIVILEGE ISSUES FOR AI TOOLS Lawyers and attorneys are obliged to maintain the confidentiality of their clients’ information, and maintain their clients’ privilege. Currently, accessing most AI services involves sending data to the AI provider’s servers. This arrangement creates a couple of potential issues. First, confidential and privileged information should never be uploaded to an AI provider’s servers unless the provider has expressly agreed to keep all users’ prompts and inputs confidential. As an example, some providers use prompts to train their model. This makes it

possible for client information to appear in answers generated by the AI for other users. Uploading information to these servers will be a clear breach of practitioners’ ethical obligations. Second, even if a provider agrees to keep users’ prompts confidential, there is still a risk of information stored on their servers being hacked by third parties or misused by the provider’s officers. Some providers store users’ prompts long-term, whilst others delete the information shortly after the AI has finished delivering its answer. Uploading confidential information to an AI provider puts that information at risk. The magnitude of that risk depends on, among other things, the time that the information spends on the provider’s servers and the security measures put in place by the provider. Even if the perceived risk is low, clients must be allowed to control of that risk. Clients should provide consent before any of their information is uploaded to an AI provider. Before using an AI provider, practitioners require a thorough understanding of the provider’s terms of service and how the provider treats information uploaded to their servers. This will take a substantial amount of time, and AI providers must be prepared to be open about their practices. In the future, it may be better for AI providers to develop software that allows all AI processing to be conducted entirely on the practitioner’s own computer (rather than uploading to the AI provider’s servers). This is the best way to reduce the risk of clients’ information being misused. For AI providers that require that information is uploaded to their servers, practitioners may be assisted by the creation of an accreditation system, administered by a third party (such as a professional body), that certifies which AI providers take adequate measures to protect confidential information. This will both save practitioners time scrutinising the providers’ terms of service and give practitioners confidence that they can upload confidential information to the AI provider without breaching their ethical duties to their clients.

24 | wrays.com.au