The Gatherer V10

Volume 10

NO NATION IS AN ISLAND

Using Honeybee Venom to Fight Breast Cancer PIONEERING TECH FOR COMMON MEDICAL PROBLEMS HYDROGEN: Australia’s Next Expor t Success? HOW TO GET THROUGH THE VALLEY OF DEATH

CEO MESSAGE W elcome to the latest edition of The Gatherer – our flagship publication talking all things intellectual property. In this edition, we bring you a

EDITORIAL TEAM

REBECCA HEMBLING Head of Marketing & Business Development rebecca.hembling@wrays.com.au

This is an extraordinary find that will undoubtedly result in positive outcomes for cancer sufferers around the world. We are also joined by guest contributor, Steve Carroll – founder of The Unleashed Zone. In his article, Steve explores the vital factors that a business owner needs to address across the innovation journey to avoid ‘the valley of death. Proudly, as we celebrate this year’s annual Women in Technology Western Australia Annual Conference, we put the spotlight on the women of Wrays. They share with us what inspired them to follow a the pathway to a STEM based career, and who they drew encouragement from along the way.

As we all set our sights on the finish line for 2020, which some might justifiably describe as the most difficult year for some time, we reflect on the resilience, creativity, and compassion that surrounds us – paving the way for ongoing innovation. We hope you enjoy this edition!

JULIA HOGAN Business Development Consultant julia.hogan@wrays.com.au

HELEN EVANS Marketing & Communications Coordinator helen.evans@wrays.com.au LOUISA TAYLOR-BOND Graphic Designer, Reflect Design louisa@reflectdesign.com.au CONTRIBUTORS RICHARD BADDELEY Principal richard.baddeley@wrays.com.au HELEN EVANS Marketing & Communications Coordinator helen.evans@wrays.com.au

diversity of insights and perspectives across a range of topics including why you should protect your trade marks outside of Australia, and a deep dive into hydrogen as a possibility as Australia’s next export success. As innovation continues to be the buzz word on everyone’s mind, we speak to some of those who are making it happen. We talk with our friends at the Harry Perkins Institute who have made a breakthrough discovery on the impact of bee venom on breast cancer cells. Through their incredible research study, they found that a specific concentration of honeybee venom can induce 100% breast cell cancer death, while having minimal effects on normal cells.

CONTENTS

ROBERT PIERCE CEO T +61 8 9216 5115 robert.pierce@wrays.com.au

CEO Message

3

In the Spotlight: Richard Baddeley

4

Using Honeybee Venom to Fight Breast Cancer

8

No Nation is an Island: Consider Trade Mark Protection Beyond Australia

12

BINDU HOLAVANAHALLI Associate bindu.holavanahalli@wrays.com.au JENNIFER MCEWAN Principal jennifer.mcewan@wrays.com.au ROBERT PIERCE CEO robert.pierce@wrays.com.au MARIE WONG Principal marie.wong@wrays.com.au Guest Contributors STEVE CARROLL Founder of The Unleashed Zone

Pioneering Tech For Common Medical Problems

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How to get through The Valley of Death in the shortest possible time

18

Hydrogen: Australia’s Next Export Success?

20

PIONEER: An Extract of an Interview with Lyndsey Scott, Software Developer, Tech & Diversity Advocate, Actress and Model

26

MEET THE WOMEN OF WRAYS.

D-I-Y Trade Marking vs Getting in the Professionals

28

ProFound Incubator: Nurturing Neurodiverse Entrepreneurs

30

Recognising Innovative Minds; Meet the Women of Wrays

34

TO FIGHT BREAST CANCER

As we celebrate the WiTWA 2020 conference!

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#seeherbeher

W rays is pleased to announce the Technology Team as a Principal. Richard provides advice on all aspects of intellectual property and has built an impressive track record acting for a range of clients from start-ups to large multinationals. Richard’s background in both chemical and mechanical engineering provides a platform to understanding the technical merits of innovation across a wide range of fields including the energy, mining and automotive sectors. We sat down with Richard to find out more about his past, present and plans for the future. Richard, you started out as a research metallurgist with CRA Services Pty Ltd, a subsidiary of what we now know as Rio Tinto, at what point did you decide that intellectual property was going to become your new career? I had always been interested in technology, especially through chemical engineering, and law but, at the beginning of my career, could not find a way to unite them. Then I discovered – quite by accident really – that intellectual property was a perfect way to unite technology and law. I love both fields by the way. An added bonus is that intellectual property introduces all sorts of ideas and creative people. It’s wonderful to help clients succeed with their creative ideas, whether through technology or branding. After spending over 30 years at your previous firm, it’s been a while since you had your first day at work! What were you looking forward to most about joining Wrays? I have long admired the ambition and drive behind Wrays. As a formidable competitor to my previous firm, our team was always looking for ways to step ahead. I would often find that the Wrays team, with its brand strength had already got there. This propelled my efforts to come up with new ideas. Now, I look forward to joining that step ahead team culture and making things happen with the Wrays team. appointment of Richard Baddeley who has joined the Perth Engineering and

On the energy side, for example, I see great potential for developing our energy practice. Mary Turonek joined Wrays earlier in the year and has as much experience as I do, so we can share ideas and gain new ideas from the engineering and technology group as well. We’re going to be busy! How do you develop a creative approach to IP whilst also aligning with a client’s business strategy? A client is nearly always competing with others. So doing what the competitors are doing does not offer differentiation and a road to better margins. The way to better margins is intellectual property – as that term is used in both a legal and business sense. So immediately, there is a need to develop an IP strategy that differentiates those competitors. That opens the door to being creative whilst being perfectly aligned with business strategy. IP is a platform for that strategy. Being creative could include looking at a particular industry with a new perspective, looking at new geographies for client products and services and using new techniques – such as analytics and AI – to optimise client IP strategy. You have extensive knowledge of the use hydrogen as a clean fuel across a number of industries. What excites you about the potential for this form of energy? I am really excited by hydrogen and I have recently had a short abstract with my perspectives in the published APPEA Journal. It offers wonderful possibilities for the energy industry. A particular appeal is the clean nature of ‘blue’ and ‘green’ hydrogen. Hydrogen is a building block for important chemicals based around ammonia for example. It is also a powerful fuel that will become competitive within the next ten or so years. What is not to like? Through your role as Governor and Honorary Secretary of the Petroleum Club WA, what do you think is the greatest challenge the energy industry is facing? The energy industry is so important to society which needs energy for a high or even basic quality of living. One of the challenges for the energy industry is building social acceptance. This can be done through consultation, education on benefits to the industry and a commitment to more efficient production and use of energy. That brings us back to technology and intellectual property because

IN THE SPOTLIGHT RICHARD BADDELEY

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technological advances in the energy industry are critical to its future. I think that is well recognised by the energy industry which is also doing quite a bit of work on its branding, e.g. through the Bright-R programme. You have presented on innovations in Floating LNG (FLNG) technology and hydrogen. What are the key intellectual property considerations in this area? I was introduced to FLNG technology as a client considered exploitation of the Scarborough field off North West Western Australia. I found the idea of processing plant integration with ship design of great interest at a time when FLNG technology was still developing from concept to implementation. Now of course, we have Shell operating its Prelude field through FLNG technology. I think the FLNG approach has many benefits but will need collaboration between ship builders and the energy industry to develop the dream FLNG vessel. Patent landscaping is a way to find potential areas for collaboration as I presented to an APPEA conference in 2017. In your experience providing IP strategy advice to the automotive industry, what new innovations and opportunities will the Australian automotive industry need to embrace to ensure its future? Wow – there is no short answer to this question. The economics certainly seem to be against large scale vehicle manufacture in Australia. The trend, from my discussion with people familiar with the field, is towards manufacture in China, India and other Asian countries. That said, Europe has been able to maintain a viable automotive industry. There is room for niche developments though, possibly in electric vehicle or hydrogen vehicle design and operation. For example, if we take electric vehicles, how can charging be made efficient and attractive so that we can overcome the range problem with current electric vehicles? On hydrogen, work needs to be done on efficient onboard systems. Australia can be a leader in addressing these issues without having a huge manufacturing industry. Rather, we would supply technology rather than end product vehicles. A great example of a WA company that developed important engine technology is Orbital Engine Corporation that developed leading edge fuel injection technology. There’s lots of potential.

As a regular presenter and author on IP topics what do you enjoy most when you are sharing your passion and knowledge with your audiences? I really enjoy presentations – both the research that goes into a quality presentation but also the event of presentation itself. What I am really looking for is audience engagement, so I like questions, especially tougher questions that allow presenter and audience members to learn together. To do that needs passion which you can’t script but, focussed on a topic you enjoy, it tends to come across. And finally, when you are not providing IP advice to your clients how do you keep yourself busy? That’s an easy question to answer with the recent COVID-19 shutdowns, cooking! I have spent a lot of time trying to perfect a chicken curry. I’m also experimenting with new things, trying to make falafel as I write this actually…Also, I love wine and will endlessly search for the perfect pinot noir. Then, there is nothing like a walk along the waterfront or beach in Fremantle. There’s a new photo to take every day!

What IP advice do you give to start-up companies and how does it differ when advising a large multinational? While I recognise differences in scale and available resources, I advise my start-up/SME clients to operate, so far as resources allow, like a large corporation or multi-national. That is, focus on business strategy, avoid alluring diversification and act in a sophisticated way with business partners and prospects. I think this can make a big difference because others will see this as a sign of confidence and even quality. The IP strategy is key here, marshalling those scarce resources to key markets and – in the case of patent – technological developments. It is also worth remembering that even large companies are very focused on where the IP budget is spent so it is not a case of covering all potential markets. Stay with key markets and an IP advisor will be able to assist with the sometimes difficult decisions that arise. What did you learn through your role as President of The Institute of Patent and Trade Marks Attorneys of Australia (IPTA)? I learnt a lot actually. In my two years as President, I was blessed with a talented and energetic Council and we focussed – along with busy lobbying effort – on a couple of key areas. We saw and acted on expanding our work on education and professional development for younger members of the profession (also an issue for energy industry young professionals too by the way). Education has always been one of IPTA’s strengths but there are other areas of professional development on which younger professionals look for advice. They want to be involved in the process too so IPTA has worked on this. I’d like to especially acknowledge Wrays colleague, and IPTA Vice President, Jennifer McEwan for her efforts on this. We have been discussing the issues since we were young professionals ourselves.

“ Doing what the competitors are doing does not offer di fferentiation and a road to better margins. The way to better margins is intel lectual property. ”

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“ We found both honeybee venom and melittin rapidly killed triple-negative breast cancer and HER2- enriched breast cancer cells . ”

U sing the venom from 312 honeybees and bumblebees in Perth Western Australia, Ireland, and England, a team from the laboratory of Cancer Epigenetics at the Harry Perkins Institute of Medical Research (University of Western Australia) directed by Associate Professor Pilar Blancafort, tested the effect of the venom on the clinical subtypes of breast cancer. The research was led by Dr Ciara Duffy, with results published in the international journal npj Precision Oncology, revealing that honeybee venom rapidly destroyed triple- negative breast cancer and HER2-enriched breast cancer cells. Wrays worked alongside the research team and UWA’s Technology Transfer Office to draft a provisional patent application in order to protect the valuable intellectual property generated as a result of this exciting research.

Congratulations on your recent ground-breaking research studying the effects of honeybee venom on breast cancer cells. Why did you decide to use bee venom to target breast cancer? Thank you very much! For thousands of years, humans have been using products from bees for medicinal purposes, including honey, propolis, and venom. In the past few decades, interest has grown substantially into the anticancer effects of honeybee venom, but no- one had previously compared the effects of the venom across all of the different subtypes of breast cancer and normal cells, and the mechanism of action is still not fully understood. Triple-negative breast cancer is one of the main clinical subtypes of breast cancer for which there is no clinically effective targeted therapy currently available, so unfortunately this subtype is associated with some of the worst prognoses and outcomes. Therefore, in addition to the other clinical types of breast cancer (such as the hormone receptor positive and HER2-enriched subtypes), we wanted to see if the venom could kill these cancer cells more than normal cells and try to understand the molecular processes underlying these effects. The results are incredibly exciting. Can you tell us a little bit about your research and what you found? The first step was to collect honeybee venom. The bees were collected from hives at the University of Western Australia and put to sleep with carbon dioxide before the venom barb was pulled out from the abdomen of the bee and the venom extracted by careful dissection. Breast cancer and normal breast cells were also grown in tissue culture. We tested the diluted honeybee venom across 11 different cell lines and found that the venom was extremely potent. Melittin is the main component in honeybee venom, which accounts for about half of the dry weight of the venom. It’s a small, positively charged peptide that opens up pores, or holes, on cell membranes that electrically destabilise and kill the targeted cell in a matter of minutes. We reproduced melittin synthetically and found that the synthetic product mirrored the majority of the anti-cancer effects of honeybee venom. We found both honeybee

USING HONEYBEE VENOM TO FIGHT BREAST CANCER

DR CIARA DUFFY Doctor of Philosophy – PhD in the Field Of Breast Cancer Treatment

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“ Interestingly in our research, we found that a specif ic concentration of honeybee venom can induce 100% breast cancer cell death, while having minimal ef fects on normal cells. ”

venom and melittin rapidly killed triple-negative breast cancer and HER2-enriched breast cancer cells. Melittin in honeybee venom also had another remarkable effect. Within minutes, melittin was able to substantially reduce the chemical messages of cancer cells that are essential to cancer cell growth and cell division. We found that melittin modulated the signalling in breast cancer cells by suppressing the activation of the receptor that is commonly overexpressed in triple-negative breast cancer, the epidermal growth factor receptor, and it suppressed the activation of HER2 which is over-expressed in HER2- enriched breast cancer. Considering melittin forms pores in breast cancer cell membranes, we assessed whether melittin could be used with existing chemotherapy drugs, potentially enabling the entry of other treatments into the cancer cell to enhance cell death. We found that melittin can be used with small molecules or chemotherapies, such as docetaxel, to treat highly aggressive types of breast cancer. The combination of melittin and docetaxel was extremely efficient in reducing breast tumour growth in mice. One of the problems that is often seen with cancer therapies is that compounds that kill cancer cells also kill healthy cells. Did you experience the same issue with the active ingredient in honeybee venom and did you do anything to target the active compound to cancer cells? Many chemotherapy drugs used clinically today are often associated with awful side effects that can reduce the quality of life of patients. Interestingly in our research, we found that a specific concentration of honeybee venom can induce 100% breast cancer cell death, while having minimal effects on normal cells. We also further enhanced the specificity of melittin by attaching a protein sequence, RGD1, to target proteins overexpressed on the membrane of triple-negative breast cancer cells, and found that this peptide ‘RGD1-melittin’ was even more selective than melittin in targeting these aggressive breast cancers.

Your research compared honeybee venom collected from populations in Western Australia, Ireland and England. Why are Perth honeybees some of the healthiest in the world – what makes them so special? Honeybees as well as other insects are dramatically declining on a global scale, a phenomenon sometimes referred to as Insectageddon. Declines in bee health are triggered by multiple factors and interactions between them including parasites, pesticide exposure, environmental changes, as well as inferior bee keeping practices. We are very lucky in Perth to have some of the healthiest honeybees in the world, and the main reason for this is due to our isolation. Bees in Western Australia are not exposed to pesticides at the same levels as elsewhere, are primarily kept in pristine and natural environments rather than in intensified agricultural landscapes, and a number of diseases that have devastated bee populations elsewhere have not yet made landfall in Western Australia. This is why it is so important not to bring bees, honey, or other bee products into Western Australia, and I hope we can continue to protect our beautiful honeybees and native bees!

Had you had much exposure to intellectual property considerations before this research and what did you learn about IP along the way? I had learned about patents and intellectual property considerations through my courses at The Centre for Entrepreneurial Research and Innovation, and Perth Biodesign, but I had never worked on a patent before protecting our research. I now understand how important the use of language is to craft a patent and specific claims to protect your intellectual property. Identifying potentially useful compounds for treating cancer is the first step – what would be the next steps for this research to translate into clinical outcomes? The next steps would involve studies to formally assess the optimum method of delivery of melittin to breast cancer cells, as well as toxicities and maximum tolerated doses. Melittin could also be combined with other drugs to find the most effective combination for different breast cancer subtypes, and also other types of cancer.

BINDHU HOLAVANAHALLI Associate

About the Harry Perkins Institute of Medical Research | www.perkins.org.au The Harry Perkins Institute of Medical Research is one Australia’s leading medical research institutes investigating diseases affecting the community. With over 250 researchers located on three hospital campuses in Perth, the Perkins is uniquely positioned to fast track the development of new discoveries and treatments. Its wholly owned clinical trials facility, Linear Clinical Research, provides international and local pharmaceutical and biotechnology companies the facilities to trial latest drugs and treatments in healthy volunteers and patients. The Harry Perkins Institute of Medical Research is proudly West Australian, providing career opportunities to our best and brightest graduates and bringing to the State international scientists. As a registered charity, the Harry Perkins Institute relies on grants and donations to fund its medical research.

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NO NATION IS AN ISLAND CONS IDER TRADE MARK PROTECT ION BEYOND AUSTRAL IA

T he quotation “No Nation is an Island” has origins in the poem entitled “No Man is an Island” by my favourite seventeenth century metaphysical poet, John Donne. The first two lines of the poem are “No man is an island entire of itself; every man is a piece of the continent, a part of the main”. It is thought that in this poem, John Donne proposes that no-one is self-sufficient and everyone has to depend on other people in order to survive and thrive. This lesson is especially applicable in the context of doing business as most businesses want to grow and increase sales of its products. As Australia represents a limited market, that growth often has to expand to overseas territories in order to be realised. Australia as a market is part of a bigger picture. In these pandemic days, clouded by increasing projection of a deep recession, the importance of a valuable product that consumers want to buy, together with a strong brand that conveys powerful messaging to consumers is paramount. A strong trade mark can help a product “make it or break it” in a very competitive consumer market. Protecting the investment in those trade marks is prudent and businesses need to be mindful of keeping their trade mark portfolio in line with their business development.

–– Develop categories of target markets; break it down into 2 or 3 categories based on the likely consumer desire for the product – and set of planned timeframes for business entry into those markets – for example High Importance Markets (next six month - a year), Medium Importance Markets (1 – 3years) Low Importance Markets (3- 5 years) –– What is the budget? Does the business have the funds put aside for trade mark registration? Seeking trade mark registration by filing applications should follow that strategy. And for established businesses – it is never too late to start developing a strategy if you do not have one. Finally, that strategy should be reviewed every few years and tweaked, or even radically changed, as the business develops and as needs and priorities change. As we all continue to adapt to varying and ever-changing degrees of connectivity resulting from the challenges 2020 has presented, John Donne’s words feel as relevant to our modern lives as ever. In both business and in our personal lives, this year has taught us more about the power of stepping back and assessing the overall picture; to have a clear strategy and an understanding of how to join the dots to achieve success.

Clients with budding or growing international interests often ask me what they need to do to protect their trade marks and where to start. My advice, is always to start with development of robust trade mark strategy. A strategy helps businesses make decisions about their trade marks and is always there as part of a “brains trust” even as personnel changes occur. For some businesses while the present time may be a quiet for sales, we recommend that this time be seen as an ideal opportunity to think of the future. It’s a time to consider where the business wants to be when life normalises with trade marks being part of that forward thinking. I worked with a toy company based in Melbourne to develop its trade mark strategy nearly twenty years ago. Whenever there is a question about when or where to file trade mark application overseas, they go back to that strategy for clear guidance. Here are some considerations for developing your own strategy: –– Ensure your strategy is in line with the business strategy for growth and expansion –– If the business is new, think about where to next after breaking into the Australian market. Where are the next markets for the product?

NO MAN IS AN ISLAND No man is an island entire of itself; every man is a piece of the continent, a part of the main; if a clod be washed away by the sea, Europe is the less, as well as if a promontory were, as well as any manner of thy friends or of thine own were; any man’s death diminishes me, because I am involved in mankind. And therefore never send to know for whom the bell tolls; it tolls for thee. John Donne

Depending on the nature of the product that answer could be closest neighbours or niche countries or even to go global.

JENNIFER MCEWAN Principal

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D r George O’Neil is a pioneer in the seeking help with addictions. Inspired by the challenges he faced working in remote parts of Australia, Africa and cities such as Glasgow and Perth in the 1980s, Dr O’Neil began developing new products for use in obstetrics, pain management, malnutrition, catheterisation, drug delivery and addictions. This resulted in the establishment of pharmaceutical company Go Medical Industries Pty Ltd in 1986. The first products developed by Go Medical were the O’Neil® Vacuum cup and the O’Neil® Urinary Catheter, a product that revolutionised the way intermittent urinary catheterisation was carried out. Go Medical now specialises in the manufacture of infusion devices (Springfusor®, flow control tubing), Patient Controlled Anaesthesia device (Nasal PCA’s), Intravenous Tubing (V-Set), Obstetrics (Amnicot) and urinary catheters. Dr O’Neil has pioneered the use of naltrexone for opiate addiction and runs an addiction treatment clinic in Perth, now part of Fresh Start Recovery Programme. The centre concentrates on detox, relapse prevention treatment and developing a drug-free lifestyle. For the past 25 years Wrays has provided intellectual property services to Dr O’Neil and Go Medical. We sat down with Dr O’Neil to discuss his work. The goal of Go Medical is to develop innovative products to improve common medical procedures. When you identify a solution to a problem, what are the next steps? The first step is discussing the concept with people who understand the related science. Go Medical concentrates on improving common procedures because after investing a lot of effort and money in identifying the need and area of improvement, less market research is required. Once you’ve got your concept together, then you have to make a prototype. After it has been tested on the bench, you then make a series of prototypes for clinical evaluation and then get ready to set up a clinical trial or study. The next step is the regulatory work and then it is a matter of development of innovative products for the improvement of common medical procedures and treatments for those

the right product, in the right place, at the right price with the right marketing and training whilst meeting the growing regulatory requirements. Most of the work at Go Medical concentrates on going back to basic science to deal with a common procedure. For example, with malnutrition in children, traditionally if you wanted to administer a drip, you needed a hospital, doctors and nurses and expensive bags of fluid. Go Medical developed nasogastric tubing which only requires a nurse and a bit of water from the river. A simple, scientific solution to a common problem. How do you collaborate with universities and research organisations for the development of your products? Universities, within reason, are keen on teaching students how to think, and are very keen on publications and training. I personally have medical students at Fresh Start regularly and often engineers as well. I used to lecture regularly to the university engineering department on how to invent. I hardly ever put my name on the front of a publication, because I know I’m the inventor. I’m the person coming up with ideas. It’s much better that somebody else evaluates my idea, because there’s less bias. So that suits my purpose and it suits the university’s purpose. I’ll be trying to produce products and the university will be trying to help their students and get publications. To date you have treated thousands of patients with your naltrexone implant. Can you explain how the implant works? The Fresh Start clinic where I practice has treated 9,000 with implants and there are still an enormous number of people we haven’t yet reached. The implant delivers naltrexone, which blocks the effect of opioids, eliminating the need for patients to remember to take a daily pill or receive an injection every 4 months. Other commercial companies have introduced long lasting buprenorphine. We made our first buprenorphine implant seven years ago. We didn’t commercialise them, and that’s an interesting example where we didn’t go for a cash flow, because from our point of view, we didn’t want our patients to then become addicted to another addictive substance. However, from a company cash flow point

PIONEERING TECH FOR COMMON MEDICAL PROBLEMS A conversation with Dr George O’Nei l , Medical Director at Go Medical Industries

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is what our company is based on - thinking. Whenever you’re building a business, you have to do a geographical analysis of your environment. Perth has got as good a chance as Silicone Valley to be a good long-term place for developing industries. Without giving away your intellectual property, what else do you have in the pipeline? I am working with the Western Australian Department of Health who have bought a large number of Springfusors® for Covid-19. They needed to know there were more pumps available if there was a big crisis. They have asked us for report on how much money they’ll save if they use Springfusors®. In this case, the Springfusors® will have cost them in the order of $60. An ordinary pump could cost a thousand dollars or more. It means that they’re buying WA technology for WA hospitals. We will now need to invest in training for the use of the technology. We are on the verge of launching a variety of “extension” products which will improve outcomes for patients, including those needing treatment at homes. Another product will assist keep veins open over 24 hours with saline – very little effort will be required to achieve this. With the assistance of Wrays, we have succeeded in getting many patents approved. One of the most exciting is achieving the O’Neil trade mark. I am told getting a surname trade marked is almost impossible, but I am happy to tell you we use the ® with the O’Neil on our medical devices. What have you learned about innovation and product development over the past 45 years of patenting? Necessity is the mother of invention. Don’t waste your time on things that are not necessary. Go back to basic science to work out how to achieve the solution to your problem. Growth in companies will be best if you’ve got projects where you’ve got 90% chance of success. But from a project point of view, the projects that are sort of difficult to do are worthwhile hanging on to, especially if they’re really necessary and they’re really needed. I ask what’s really necessary. It’s a very important question.

of view, that may have been a smart option, but we’ve been concentrating on trying to go with a non-addictive substance. Our philosophies are based on what’s right to do. You are currently running trials to get FDA approval for your naltrexone implant. Can you tell us about these? To receive FDA approval is a big job. It costs an average of $1.4 billion dollars to develop a new pharmaceutical product. Columbia University has received a US $21 million grant to conduct trials of our naltrexone implant. The American Government has paid the university to work with us, and the product we’re trying to validate. Although Go Medical is directing and coordinating the research of Columbia University, it is a true collaboration. In the end, the American Government gets a product which is good for their people, but all of the initial technology belongs to Go Medical. What funding does the Fresh Start Clinic receive? Fresh Start costs about nine million a year to run. The reason it costs nine million is because we’re detoxing people. We’re running a hospital, we’re running a 24-hour accommodation service, multiple facilities and funding the wages for 80 people. The state government contributes $3 million dollars and at least $2 million comes from patients. The patients contribute $20 a week for something that costs us an average of $6000 or $7000 per patient. We also receive funding from the sale of medical devices from Go Medical and then of course we have our many volunteers. Western Australia has a thriving bio-technology industry. To date, Australian Universities have developed 13 drugs that have received approval from the United States Food and Drug Administration. 5 of those came from WA. Why do you think Western Australia is so successful? First of all, it is the most isolated region of the world, and that’s an advantage. We don’t have a big group of productive industries for our young people coming out of universities. If your young intelligent people are all chewed up by production work, they are not available for thinking work. When I started my company I said, “Look, I don’t want to buy any machines from America and I don’t want to buy any machines from Europe. I want us to do thinking.” That

DR GEORGE O’NEIL Medical Director at Go Medical Industries

2020 VIRTUAL CONFERENCE

#seeherbeher

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ON DEMAND UNT I L 30 NOVEMBER 2020

How to get through The Valley of Death in the shortest possible time

Every innovation goes through the Valley of Death…always…every single time. This applies as equally to SMEs and Enterprises as it does to Startups. Most Startups are aware of the Valley of Death concept, however, very few more established businesses realise precisely how and where this is occurring in their business right now, and how it is impacting them.

This is the same as what kills a business. A business may have a short term dramatic cash gap, but as long it has a budget for how to recover and that the budget will resolve the cash gap very quickly, the business will normally trade through the VOD. On the other hand, when a business has only a small negative cash balance, but has no budget to resolve the negative balance and the negative balance continues for an extended period of time, the business will not be able to trade out of the problem and will need to close. Therefore, when an innovation project does not run smoothly, it takes twist and turns, hits delays and roadblocks, the length of time it takes to get out of the VOD extends and thus its likelihood of recovering from its lack of water, starts to get very serious.

It is very rarely understood what the real challenges are with the valley of death. For those that are not aware here’s a classic image of the valley of death “VOD”. As the diagram shows, the VOD, is a representation of the different phases an innovation project goes through from idea to commercial scale success, versus the financial benefit/ cost it incurs during the journey from idea to commercial success. Following are some of the key issues that are often misunderstood with the journey through the VOD. Time is the most important factor in the VOD The most serious and substantial mistake with misunderstanding the VOD, is not the depth of the valley, its the length. It is not the lack of water that kills a person, it’s how long they don’t have the water that kills them.

PRE SEED

SEED

FUNDING GAP

EARLY GROWTH

Product launch

Technology transfer

Success as a new product

Research

Development

Commercialisation

Success as a business

Valley of death

source: Forbes

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CALENDAR OF EVENTS WHAT’S ON 2020

The VOD is not just a startup concept

The next common misunderstanding is that the VOD doesn’t just apply to startups…it more than equally applies to every business undertaking any kind of innovation. The challenge with innovation in an existing business is that it is very rare to find a business that correctly allocates all of the costs of the VOD to an innovation project when it is budgeting and as the project progresses it slowly starts to understand that the costs of the innovation project are much more than just the direct R&D costs. Innovation projects require substantial time input from leaders and experts across an organisation, which are rarely included in the initial budget. And as the project progresses, the commercialisation costs start to increase before a substantial return is achieved, again this is not normally part of the initial budget. Even if the project manages to make the financial returns it estimated, because the costs were not correctly budgeted from the beginning, the profit return will be greatly diminished for the project, which will obviously negatively impact the overall profit for the company. This can have disastrous impacts on a previously successful business when the innovation project drains financial resources before the leaders realise that the innovation is costing them much more than the budget contains.

Are you making the RIGHT decisions? It is not a question of whether an innovation project will go through the VOD, the question is will it get out? And getting out of the VOD is about making continuous good decisions. As we have found when assessing what successful and unsuccessful innovation looks like, the similarity is always around what decisions were made from beginning to the end. At The Unleashed Zone we have created a unique Diagnostic framework that businesses use to continue to analyse and assess where they are, where they want to be and what they need to do next in order to get there in the most optimal way. The optimal innovation journey is the path of least resistance through the Valley of Death.

Will the benefit be worth the effort? For an Innovation project to be worth the effort, it needs to generate substantially more cash over time, than the total cash spent in bringing the project to market. An innovation project’s total cash spend is not recovered until it has past the point where the cash recovered is greater than the cash spent. This is important to understand, it’s not a one off “break even” status where income in a period is greater than costs for the same period, its the point at which the total cash recovered is greater than the cash that has been spent on the entire project to date. This is commonly misunderstood and what many founders and innovation managers don’t realise until they look back on their project, rather than budget and look forward when they start or at regular stages of the project. The whole point of undertaking any business activity is to achieve a greater cash return than the cash spent, effectively this is the return on investment ratio of a project. Therefore, what a business owner and innovation manager must do at the beginning and throughout the innovation journey is to have a cost versus return budget and revisit it constantly to ensure that there is an appropriate cost versus benefit ratio for the project.

OCTOBER

NOVEMBER 16th Bio Connections Australia ONLINE 24th AusBiotech Industry Update SA ONLINE 25th AusBiotech Industry Update QLD ONLINE 26th AusBiotech Industry Update WA ONLINE 26th SICA (Subsea Innovation Cluster Australia) Member event. 30th Agristart: Regional Innovation Showcase PERTH

DECEMBER 30th - 6th West Tech Fest PERTH 2nd AusBiotech Industry Update VIC 3rd Freo Startup Fest FREMANTLE 4th Rotto Tech Fest 2020 ROTTNEST ISLAND

15th BioBusiness Insights: Opportunities in Regenerative Medicine, from BioMelbourneNetwork ONLINE 26th - 30th WiTWA Conference on demand until 30 November 2020 ONLINE 30th WiTWA Awards Night PERTH

STEVE CARROLL Founder of The Unleashed Zone steve@theunleashedzone.com

20|The Gatherer

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HYDROGEN AUSTRALIA’S NEXT EXPORT SUCCESS?

In Australia, industry and government interest in hydrogen is building, as a future major export and pathway to decarbonisation of the global economy. Hydrogen is the most common chemical in the world and has many uses such as fuel for transport or heating, a way to store electricity, or as a raw material in industrial processes. Hydrogen energy can be stored as a gas and delivered through existing natural gas pipelines and when converted to a liquid or another suitable material, can be transported on trucks and in ships. This means hydrogen can also be exported overseas, effectively making it a tradeable energy commodity. A number of road maps for the future of hydrogen have been developed at federal and state level such as the CSIRO National Hydrogen Roadmap . The reports find global demand for hydrogen exported from Australia could be over three million tonnes each year by 2040, which could be worth up to $10 billion each year to the economy by that time. Potential export markets for Australia’s hydrogen include Japan, South Korea and China, collectively known as ‘East Asia’, as well as Singapore and Germany. Japan, in particular, is actively engaged with becoming the world’s first “Hydrogen Society”. Australia and Germany have also just agreed to a study into the feasibility of developing a hydrogen supply chain between them. Producing hydrogen as an export commodity is not without its challenges. Producing, storing and distributing low cost hydrogen at scale and informing and understanding export value chains and market requirements are just some of the issues to be managed.

The Colour of Hydrogen Hydrogen, while colourless, can be produced at least through so-called brown or grey, green or blue methods.

BROWN OR GREY HYDROGEN

Produced through steam reforming of natural gas (methane) or coal gasification.

BLUE HYDROGEN

GREEN HYDROGEN

Produced through steam reforming of natural gas, or coal, with carbon capture and storage to address carbon dioxide produced by the reforming and gasification processes.

Produced using renewable resources, for example through electrolysis of water with power provided from a renewable resource such as solar energy. Green hydrogen methods do not produce carbon dioxide in the hydrogen production process.

The Cost of Hydrogen Hydrogen production technologies and costs have been estimated in the National Hydrogen Roadmap, representing a base case and 2025 a best case for the net present value of the unit cost of hydrogen over the lifetime of a hydrogen production asset. There is a current cost advantage for blue hydrogen though the best cases for Proton exchange membrane (PEM) and alkaline electrolysis powered by renewable energy (green hydrogen) overlap the blue hydrogen costs by 2025. Technology 2018 (A$/kg H2) 2025 (A$/kg H2) Proton exchange membrane (PEM) electrolysis 6.08-7.43 2.29-2.79 Alkaline electrolysis 4.78-5.84 2.54-3.10 Steam methane reforming with carbon capture and storage (CCS) 2.27-2.77 1.88-2.30 Black coal gasification with CCS 2.57-3.14 2.02-2.47 Brown coal gasification with CCS - 2.14-2.62

22|The Gatherer

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Green Hydrogen Patent Trends

Where is the patent activity occurring? The statistics are showing a focus on hydrogen innovation for both steam reforming and electrolysis pathways in East Asia, the target export markets for Australia. China and Japan are the largest two filing countries with the United States fitting into third place. The future of Hydrogen in Australia The potential of hydrogen is enormous, and Australia is well positioned to seize Green Hydrogen Patent Trends the opportunities of this emerging industry. Innovations in Australian hydrogen production continue and include the Hazer process which converts methane to solid carbon and hydrogen through a process catalysed by iron oxide and the CSIRO metal membrane technology extracting pure hydrogen from ammonia. Given the opportunities for hydrogen, it would be a positive to see more, and broader based Australian based innovation because it is Australian feedstocks, including natural gas and water, which have the capacity to grow Australia’s future hydrogen production and export capacity. For a copy of the report please visit Commonwealth Scientific and Industrial Research Organisation (CSIRO) National Hydrogen Roadmap (2018).

Patents: An Indicator of Growth and Strategy

Hydrogen production via electrolysis from of 2010 to June 2020, showing technology trend

Global patent statistics are showing that both blue and green pathways to hydrogen are capturing increasing industry interest. It should go without saying that industry will not typically spend a significant patent budget on technologies without a future, so patent statistics are a firm indicator of industry strategy. The statistics show an increasing trend for patent publications targeted at hydrogen production via electrolysis and via steam reforming technologies. Both hydrogen production technologies are in even competition and will remain so at least in the short term despite apparently exponential growth in patent filings relating to hydrogen produced by electrolysis. That said, most hydrogen has been industrially produced by steam reforming to date and it is reasonable to expect that this will remain the case until electrolysis costs fall further, which the patent statistics show a drive to achieve. Given the 20-year lifespan of patents, steam reforming technologies, with carbon capture and storage, will likely remain preferred until the earlier part of 2030-40 given the cost projections provided above. More recent electrolytic technology will more likely encounter the time lag that is common to innovation adoption.

Estimate 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

Actual

Forecast indicator

Blue Hydrogen Patent Trends

Hydrogen production via steam reforming of methane 2010 to June 2020, showing forecast

RICHARD BADDELEY Principal

Estimate 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021

Actual

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Forecast indicator

Source: Clarivate, Derwent Innovation

D-I-Y TRADE MARKING vs GETTING IN THE PROFESSIONALS Why engage a trade mark attorney? N owadays, the trade mark application process is just a bit of online form filling and Determining where to build and what to avoid – trade mark clearance searching and avoiding generic trade marks

registration, and for all of the goods and services claimed. Failure to use your trade marks in the manner covered by the trade mark registration may make them vulnerable to removal for non-use cancellation. An IP professional does not only monitor renewal deadlines, but can advise you on these broader issues and what to look out for and update along the way as your business and brand develops. If your portfolio is no longer achieving its optimal purpose – for example, if you need to extend protection due a brand “refresh”, or to new marks and product offerings, or to new overseas markets – an attorney can advise you on the most practical and cost-effective way to do this, having regard to your existing portfolio. Protecting your asset Like your family home, you may need to take pro-active steps to safeguard your trade mark assets from pests and predators who might seek to encroach on your patch of land from time to time. A trade mark attorney can put in place watches and strategies for monitoring the market place – such as by implementing regular watches for use of similar marks on the trade marks register, domain names register and social media platforms – and taking preventative or remedial action where necessary. It might be necessary take more assertive action to protect the value of your asset. An IP professional can assist you with preparing cease and desist letters, filing IP complaints on social media platforms, filing complaints to obtain cancellation or transfer of bad faith domain name registrations, filing trade mark opposition or removal proceedings, and, if necessary, taking Court action against trade mark infringers. Moving on – selling an appreciating asset Whilst intangible, rather than “real” property like a house, a brand or trade mark may nevertheless end up being your business’ most valuable long term asset. Provided the foundations have been set-up right and proper maintenance steps taken, when it is time to move on, you will hopefully have a valuable asset to sell.

balance along the scale of unregistrable (generic/descriptive/ laudatory) to registrable (allusive/distinctive) marks to secure the right mark for your long term business needs. Building a solid foundation – getting the mark(s) and specification right It can be tempting to D-I-Y file a trade mark application, particularly when budget is an issue. However, too often, we see clients who have self-filed and either failed to achieve registration, or obtained registration for a trade mark which does not provide appropriate coverage because: –– The mark covered by the trade mark registration is too complex, claiming all features of the brand within one application, providing very narrow coverage for the key individual elements of the brand, including the core brand name or tagline –– The incorrect goods or services have been claimed, or key goods or services omitted. This can make future enforcement extremely difficult, providing only limited value. An attorney who takes the time to understand your brand and business at its early stages should be open to giving you a practical and honest assessment of what protection is required and achievable within your budget. They can help to prioritise which aspects of your brand to protect (eg, logo, brand name, tagline) and the correct goods and services to be covered to meet both your long term needs, as well as avoid potential obstacles (eg, objections from the Trade Marks Office or prior existing marks). In this way, an attorney can help set the foundations for the most solid trade mark protection, having regard to your budget. Maintaining your trade mark portfolio Once your trade mark protection is in place, it is important to take the proper steps to maintain it. This includes ensuring that your mark is used in your marketing as an indicator of brand origin and does not become generic, applying the appropriate TM or ® symbols to notify third parties of your rights, monitoring renewal deadlines, as well as dealing with correspondence that may be received from IP Australia or third parties in connection with your trade mark registration (eg, requests for consent, notices of acceptance of similar marks, etc). To maintain the integrity of your trade mark registrations, it is also important to make sure that you continue to use your trade marks in the form covered by the trade mark

In an increasingly crowded field of brands and trade marks, finding a mark which is both available and able to convey the identity and message that you want to associate with your business is becoming increasingly difficult. In this uncertain environment, it is worthwhile engaging a professional who is familiar with traversing the local trade mark landscape to guide you towards stable ground. Even if you are an overseas trade mark attorney or you already have trade mark rights secured in another market, it can help to engage someone local for this purpose, as trade mark practices vary from country to country. There is nothing worse than launching a new brand, only to find out that you can’t protect it in the marketplace or, worse, that you are actually infringing someone else’s trade mark. A trade mark attorney can assist you with a targeted trade mark clearance strategy, analyse the search results, and provide you with practical and frank advice on the availability and risks of adopting your chosen brand, as well as the long term practicalities of enforcing it. For example, many businesses choose a brand name that tells customers exactly what their business does (eg, “Aussie Home Builders” for building services – not a good foundation for a strong trade mark), only to find out that the prospects of enforcing it are low because other competitors are equally allowed to describe their own businesses using the same words. A trade mark attorney can help ensure that your trade mark is available for both use and registration prior to committing resources to launching a new brand, and navigate the right

the click of a few buttons, right? So why engage a trade mark professional unless you get into trouble? Well, you wouldn’t start building your own home and then wait for cracks to appear before engaging a builder, so why risk one of your business’ most valuable assets starting off with shaky foundations? I was recently copied into a social media thread discussing whether engaging a trade mark attorney is a cost or an investment. Pleasingly, an overwhelming number of responders saw value in engaging a professional trade mark attorney to do the job right first up; however, perhaps unsurprisingly, the majority of responders were IP professionals themselves! Among the supporting empirical evidence referred to was the overall higher success rate of attorney filed trade marks versus self-filed trade marks proceeding to registration, as well as the generally broader coverage of attorney filed trade marks. 1 However, apart from registration success rate, the discussion got me thinking about how attorneys can convey value as creators of long term (sometimes perpetual) IP assets, in an environment where self-filing is becoming increasingly “easy” through online processes. Here are the ways in which a trade marks professional can assist and add value.

MARIE WONG Principal

1 Based on an informal analysis of trade mark filing data in Australia and the UK over the past approximately 12 months, looking at the attorney vs. DIY percentage of filed trade marks achieving registration, as well as the average number of classes covered per registration.

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