IP SPOTLIGHT MAY 18

IP SPOTLIGHT NEWS FROM AUSTRALIA

18 May 2020

IP AUSTRALIA’S ANNUAL REPORT 2020 – A BRIEF OVERVIEW ON IP AUSTRALIA’S FILING STATISTICS

IP Australia recently released their annual report which takes a look at the role of IP rights in the Australian economy. In brief, 2019 saw only a minor drop in the number of patent applications filed in Australia. However, trade mark applications dropped by 5% and designs dropped by 4% from the previous year.

In general, 2018 was a record year for Australians filing IP rights overseas with an increase in both trade marks (up 6%) and patent filings (up 3%) from the previous year. What the report did show, however, was that Australian businesses are filing three times more patent applications overseas than they are domestically.

The top patent filers into IP Australia by country of origin for 2019 were:

The top trade mark filers into IP Australia by country of origin for 2019 were:

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2

3

4

5

1

2

3

4

5

UK

USA

USA

CHINA

CHINA

JAPAN

GERMANY

GERMANY

AUSTRALIA

AUSTRALIA

In addition, the report indicates that growth in the world’s advanced economies slowed noticeably in 9 out of 10 major international markets in 2019; the impact of which has been felt throughout the Australian economy. As world output growth fell by 0.7 % from 2018 to 2019, fewer IP rights were filed in Australia in 2019 by international businesses compared to 2018.

The full report can be viewed online or downloaded here.

DONNA MEREDITH Associate

AUSTRALIA’S EMERGENCY USE PATHWAYS FOR MEDICAL DEVICES

Medical devices and in vitro diagnostic medical devices (IVDs) are regulated by the Therapeutic Goods Administration (TGA) in Australia. The standard process for approval includes providing evidence of conformity assessment from the TGA, or acceptable overseas regulator, to obtain an Australian Register of Therapeutic Goods (ARTG) listing number (which is TGA approval). In response to the COVID-19 outbreak, the TGA has implemented emergency exemptions that allow for the importation and sale of some devices intended to assist in reducing the transmission of infection between individuals (particularly patients and health care professionals) and COVID-19 IVD test kits without the normal registration requirements, or with expedited registrations. The exemptions only apply in relation to goods that are not already included in the ARTG.

EMERGENCY EXEMPT IONS FOR VENT I LATORS The new emergency exemption is also applicable to ventilators that are not already included on the ARTG and can demonstrate compliance with minimum technical requirements. The exemption does not permit the general supply of these ventilators to healthcare facilities or consumers outside the context of the COVID-19 emergency. CL I N I CAL TR I AL PROCESSES The TGA has announced the prioritisation of clinical trials related to COVID-19, along with relevant advice/ instructions for Sponsors. The TGA also specified that certain variations to a Clinical Trial Notifications (CTN) caused by COVID-19 conditions (e.g., change to the trial start/finish date) do not need to be notified.

These exemptions will remain in effect until 31 January 2021.

EMERGENCY EXEMPT IONS FOR COV I D-19 TEST K I TS IVDs for the diagnosis, confirmatory testing, prevention, monitoring, treatment, or alleviation of COVID-19 can now be supplied more broadly to “accredited pathology laboratories” under the exemption conditions. However, this does not permit the general supply of unapproved IVDs, including serological rapid tests intended for use at the point-of-care, to any other laboratories/clinics. EMERGENCY EXEMPT IONS FOR FACE MASKS AND OTHER PROTECT I VE ART I CLES Disposable face masks, gloves, and gowns, as well as protective eyewear (goggles, glasses, or visors), that are designed to be worn by individuals to prevent the transmission of organisms for use in a clinical setting are now exempt from certain provisions of the Therapeutic Goods Act 1989. However, non-sterile protective or safety apparel/ equipment for use at home, or for occupational use do not fall within these exemptions.

PENELOPE FARBEY Senior Associate

Australia has a rich history of innovation when it comes to medical technologies. And now, in this time of greatest need, that culture of innovation is empowering manufacturers to move rapidly to meet the challenges before them. An innovation journey, culminates in the creation of IP rights. A vital asset that needs to be protected and managed throughout commercialisation. Wrays has a dedicated team of medical technology experts guiding manufacturers and innovators.

Click here to discover more about how they can assist.

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GEOGRAPHICAL AND SURNOMINAL TRADE MARKS STILL

In the Australian Trade Mark Office decision of Ramsay Health Care Investments Pty Limited [2020] ATMO 11, the applicant, Ramsay Health Care Investments Pty Limited ( Ramsay ), sought to register the mark RAMSAY PHARMACY ( Mark ) for various pharmacy and related retailing services in classes 35 and 44. During examination, the application received a: – – s.41 objection on the basis that the word “RAMSAY” was a common Australian surname (occurring 2854 times as an Australian surname) as well as being a place-name reference, being the name of a small town in Queensland and an electorate in South Australia; and – – s. 44 objection on the basis of numerous “RAMSAY” formative marks, which were owned by Ramsay Health Care Limited, a related entity to Ramsay. The delegate dismissed the s.41 geographical name objection, forming the view that the word RAMSAY lacked any ordinary geographic significance given the small population of Queensland (consisting of 310 people) and because none of the suburbs within the South Australian Ramsay electorate were called RAMSAY. The delegate did not consider these geographic references as important or direct enough to engender the Mark with an ordinary geographical significance. However, the delegate found that the s.41(4) distinctiveness objection was appropriate due to the surnominal relevance of the word “RAMSAY”, and considered the mark to be to some extent, but not sufficiently adapted to distinguish Ramsay’s claimed services. The delegate then conducted a “practical evaluative judgment” of what the mark RAMSAY PHARMACY would signify, taking into account: – – Ramsay’s reputation in “RAMSAY” and its history of use of the RAMSAY PHARMACY trade mark in around 40 dispensaries within private hospitals owned by, and in 60 retail pharmacies franchised by, Ramsay since 2013/14; – – Ramsay’s prior registrations for RAMSAY formative marks in connection with hospital services owned by entities related to Ramsay. In this regard, the delegate considered that the relationship between Ramsay’s core private hospital services and the provision of the claimed

pharmacy services was a close and intimate one; and – – the significant barriers to entry for suitably qualified traders of pharmacy services, being, the regulatory framework and start-up costs associated with this type of enterprise, such that the name “RAMSAY” is likely to be considered the name of a specific provider (being Ramsay given its reputation), rather than any number of persons with this surname. While a good deal of the evidence provided by Ramsay incorporates a logo or design element in addition to the words (which the examiner noted was a defect which might be fatal to the application), the examiner considered the Mark had sufficient capacity to distinguish Ramsay’s claimed services to qualify the application for registration, taking into account the correct balance of the use, the degree to which the words themselves show some inherent adaptation to distinguish the services, and the weight of the Applicant’s very closely allied core business under “Ramsay”- formative marks. Accordingly, the application was registered subject to a s. 41(4) endorsement. This decision by the trade marks office is a reminder that trade mark owners may still be able to obtain registration for their mark even where their marks have some geographic or surnominal relevance, depending on: – – the extent of the geographic significance of the mark – where the mark is also the name of a geographic location, the population size, industry and significance of the location will be factors which will be taken into consideration in determining the geographic significance of the mark; – – the history and extent of the owner’s use of the mark in Australia. In this regard, the owner of a mark which is not inherently adapted to distinguish its goods/services may be able to achieve registration of its mark by demonstrating that the mark has come to distinguish its goods and services, through its significant use of the mark in connection with its claimed goods and services; and – – the nature of the owner’s trade and industry – where it is unlikely that mark refers to a geographic location or surname because of the nature of the industry or goods/ services sold, the geographic or surnominal relevance of a mark may be low.

AVAILABLE FOR REGISTRATION

GRACE NG Lawyer

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PIVOTING RESPIRATORY RESEARCH TO UNDERSTAND COVID-19

Wrays recently sat down with Professor Phil Hansbro from the Centenary UTS Centre for Inflammation in Sydney. This Centre is a collaboration between the Centenary Institute and the University of Technology Sydney, Faculty of Science and is Australia’s first research centre dedicated exclusively to studying the mechanisms underlying inflammation. Wrays asked Phil to tell us a little bit about the COVID-19 global pandemic and the work he and his team have been doing to pivot their respiratory disease research with the hope of unlocking the mechanisms of this virus. Phil leads a team of scientists studying respiratory diseases, such as emphysema, asthma and lung cancer, and has been the recipient of several awards for his outstanding contribution to the advancement of knowledge in respiratory medicine and science.

How is COVID-19 different from other respiratory diseases that we know about? Every virus infection is different from each other. They’re all unique, they all infect in different ways and they all have different effects as well. So each one has a characteristic way it infects, and a characteristic disease course that it induces. This particular one, this coronavirus, it binds to a specific receptor, it’s called the ACE-2 receptor, and it has a particular protein in that virus that binds specifically to that receptor. Then some cellular things need to happen for the cells to bring the virus inside the cell. And then it uses the host cell biology to make more virus particles, and then the virus grows, and grows, and grows. And it escapes from that cell and infects other cells. Now, that’s all okay. And at the moment, at that point in the disease, it’s still not really causing symptoms. What it does then, it induces an immune response to the virus. And that immune response, hopefully, and in most people, it effectively clears the virus. But in some people, and the ones that go on to get the severe disease, that doesn’t happen. And so you get this increased and ongoing immune response that induces inflammation, and that just grows, and grows, and grows. And as well as trying to kill the virus, it damages your own cells and tissues as well, it damages the lungs. And that’s what causes the severe lung disease in COVID-19. Can you tell us a little bit about your team and the research that you’re currently doing specifically with the COVID-19? I’m trained as a microbiologist, and we’ve done a lot of work on bacteria and viruses. I’m also a respiratory researcher. So we also look at all the respiratory diseases as well. What’s notable is that people with asthma and emphysema are more susceptible to respiratory infections. And we’ve done a lot of work on influenza, that’s kind of similar to coronavirus. And so we’re applying our skills and expertise into studying the coronavirus, with the intent to try and develop new treatments for it.

Below is just part of the interview. To listen to the full podcast click here.

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Join us IP in FOCUS Webinar Series

There are several ways that we can address this virus and the infections; we can try and develop a vaccine, we can try and develop antivirals, or we can try and develop treatments that suppress inflammation, that really causes the disease. And so what we’re focusing on is developing new treatments for the inflammation. Now, we have some real advantages where we are. This is a highly infectious virus. And in order to work with it, we need a high containment laboratory. And we have one of those that our institute, that enables us to work with the virus and infect cells and mice with it. And if we can do that, then we can start to learn more about how the virus causes the disease and inflammation. And most importantly, we can try and test treatments in those cells and mice, and we can do that quite rapidly and under highly controlled conditions. Then we can do direct comparisons between different treatments to find out which ones we think are the best. I don’t know, but undoubtedly it will be. And this is what happens all the time with these viruses. This is a brand new pandemic. This is a big thing. The biggest thing since Spanish flu. What we tend to forget, is that there’s an outbreak with pandemic potential once every 18 months. It happens all the time. People have forgotten about the MERS, which was Middle Eastern respiratory symptoms. The first SARS virus because they weren’t capable of human-to-human transmission, they killed 400 to 500 people and then it died out because the virus mutates so that it becomes less and less pathogenic, and less and less disease causing. And this is usually what happens. That when these things emerge, they’re often highly pathogenic, but it’s not in the virus’ best interests to kill the person that is growing in. If it kills the person that it’s growing in then it’s dead itself. Do you think the virus is mutating?

Why is it that young healthy people, particularly children, seem to only be experiencing milder symptoms? Are you able to speculate on the mechanism behind that? Yes and no. So yes, because a lot of it is to do with the receptor, and being able to control the infection. The more of the receptor you have, then the more the virus combined, and the more susceptible you become. In normal healthy people, and particularly young people who don’t have much of this receptor, you’ve got a very strong immune response, and so you’re able to clear the virus, so it’s not a problem. Recently we are seeing more and more kids being infected, it’s still quite rare, and they get a different infection, it’s more gastrointestinal infections and it causes more gastrointestinal disturbances than a respiratory tract infection. And that’s very new, so we’re still not sure what’s happening there.

We know that during this time many people are proactively enhancing their knowledge in diverse areas of interest. Join the Wrays’ webinar series, where our intellectual property experts will share their knowledge and give you insight into the practical considerations to manage your IP and commercial arrangements with confidence.

To listen to the full interview click here.

DONNA MEREDITH Associate

Join the Wrays’ webinar series, where our intellectual property experts will share their knowledge and give you insight into the practical considerations to manage your IP and commercial arrangements with confidence.

Short, sharp learning with direct connection to the speakers to ask your questions – done virtually.

PROF. PHIL HANSBRO Centenary Institute

Pick as many or few sessions as you’d like. Just clear your diary for 30 mins and bring along a tea or coffee.

Register here.

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PATENTS

Who are you? Trade Marks and why they matter. Let’s explore what makes a strong brand and how to protect it.

An exploration of the five most common clauses & what you need to know to secure your position.

Understanding & managing your valuable IP assets and the importance of an IP strategy.

We’ll debunk the myths surrounding the patent process and provide tips to help secure your patent protection.

Thursday 28 May 2020 12pm (AEST)

Wednesday 27 May 2020 12pm (AEST)

Thursday 28 May 2020 11am (AEST)

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WHO TO CONTACT

HELEN EVANS Marketing and Communications Coordinator +61 2 8415 6525 helen.evans@wrays.com.au

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INTERNAL VALIDITY REQUIREMENTS FOR PATENTS UNDER THE RAISING THE BAR ACT

GROUNDS OF OPPOS I T ION AND OUTCOME Clarity The Delegate found the claims to be clear in the face of two arguments from the Opponent. The structure of the primer was defined by reference to its ability to hybridise with an unfixed target sequence, so for any given primer, it was not possible to assess whether it fell within the scope of the claim without reference to the target sequence. The Delegate held that this did not render the claims unclear because the primers could only be designed once the relevant target sequences (and variants) were identified. The Applicant also argued that different “corresponding conventional primers” may yield different results leading to a different comparative baseline. However, the Delegate found that the opponent failed to provide sufficient evidence to establish this argument. Clear Enough and Complete Enough: Previous cases established that the relevant questions for this ground were (a) whether it was plausible that the invention could be worked across the full scope of the claim and; (b) whether it could be performed across the full scope without undue burden. The specification provided a universally applicable theory as to why primers with the claimed structure would preferentially amplify any rare target sequence. The Delegate held that it was not necessary to show that every possible primer with the claimed structure would meet the functional requirements - it was sufficient that it was plausible that additional primers having the claimed structural features would meet the functional requirements of the claim, in light of the theory set out in the specification. The Opponent had not shown otherwise. The experiments that a skilled person would undertake to design further primers falling within the scope of the claims were explained in the specification. The specification also explained variations to the primer which enhanced selectivity. The Delegate found that these experiments were routine and not a research programme, and that the Opponent had failed to satisfy its burden of proof. Undue Burden Plausibility

Support

The Applicant’s technical contribution to the art was not so narrow as to only cover the particular primers exemplified in the specification. The Delegate found that the technical contribution was much broader, and in line with the breadth of the claims. Therefore, the Delegate found the claims to be supported across their breadth. Manner of Manufacture: The opponent argued that the kit claims were not a manner of manufacture because they included only a combination of known integers. However, the kits comprised the multi-part primers of the invention, which were not known. Therefore the opponent also failed on this ground. KEY TAKEAWAYS – – The opponent bears the onus of proof in oppositions, and it is not for the applicant to disprove the grounds of opposition. The Opponent here failed to adduce sufficient evidence to satisfy its burden. – – Explanations in the specification of how and why the theory underlying the invention provides a principle of general application can be helpful for establishing the “plausibility” requirement for the clear enough and complete enough ground. – – Examples in the specification of how the skilled person can design and test additional embodiments, including the relevant experiments they would use, can be useful for refuting that there would be an “undue burden” for the clear enough and complete enough ground.

The recent Patent Office decision of SpeeDx Pty Ltd v Rutgers, The State University of New Jersey [2020] APO 20 is the latest opposition case to consider the internal validity requirements under the Raising the Bar Act, which applies to all patent applications for which a request for examination was filed on or after 15 April 2013.

The application was opposed on the grounds of clarity, clear and complete enough disclosure for the invention, support and manner of manufacture. However, the opponent failed to satisfy its burden in establishing any of the grounds, and the applicant was successful. THE I NVENT ION AND CLA IMS The patent application related to “multi-part primers” for primer dependent nucleic acid amplification methods (such as PCR), which were able to selectively amplify a rare sequence in a large population of an abundant common sequence. The primers comprised three parts – an anchor sequence, a bridge sequence and a foot sequence. The claims defined the primer by reference to the three part structure, as well as two functional requirements, being that the primer could distinguish between the rare target sequence and the abundant variant, and a comparison to PCR using a corresponding conventional primer.

BINDHU HOLAVANAHALLI Associate

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About Wrays

Wrays is one of the largest independent IP specialist firms in Australia – bringing together the right combination of experts to protect, grow and defend our client’s intellectual property assets locally and globally for 100 years.

And when you combine our passion for achieving the best result with our broad capability across the IP spectrum, it’s our clients who enjoy the benefits. In day-to-day reality, this means bringing the right people in the room every time and working together across disciplines to deliver what’s needed.

It doesn’t stop there. Through our extensive local and global networks, we can connect clients with like-minded experts who deliver supporting services, such as private equity, tax advisors, corporate and employment law, as well as IP specialists around the world servicing other jurisdictions. wrays.com.au

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