IP SPOTLIGHT MARCH 2020

IP SPOTLIGHT NEWS FROM AUSTRALIA

31 March 2020

OUR ‘BUSINESS AS USUAL’ APPROACH

As the COVID-19 outbreak continues to make an impact at both a public health and safety level and across the Australian and New Zealand economies and around the globe, we are writing to update you on the measures that Wrays is taking, as an organisation, to ensure the well-being of our employees, clients, and our community and to ensure that our client’s receive the seamless high quality service that they expect.

contacted on their direct lines as if they were sitting in their office. While it is fair to say that no one can predict when the COVID-19 outbreak will end, it will end. When it does end, we look forward to engaging with you to recognise your continuing support and to celebrate our 100th Birthday. In the meantime, please stay safe and look after yourself. You are all part of the Wrays’ family, which means your well-being, health and safety are of paramount concern to us.

Like many Australian businesses have done, Wrays temporarily closed it offices in Sydney, Melbourne, Adelaide and Perth. We did this because it was the socially responsible thing to do. Looking after our staff has been paramount in our decision making. Also, we knew that we had the IT and business infrastructure to deliver exceptional IP services through a virtually run business. Fortunately, our firm has maintained risk management contingencies like this for some time, which enabled our Board to easily move the entire firm to work remotely. This has ensured the health of our people, whilst maintaing uninteruppted service for all of our clients and associates. As part of our infrastructure, all our remote access staff continue to have full access to your highly secure electronic files and electronic mail, to our telephone system, and everything else required to operate in a remote environment. Also, our staff can still be

GARY COX Chairman & Principal

CELEBRATING 100 YEARS OF INNOVATIVE MINDS.

CONFERENCES IN 2020

With the global COVID-19 viral outbreak, Wrays made the considered decision in February 2020 to cancel all conference travel for the forseeable future. However, we are incredibly hopeful that when COVID-19 is under control we can again connect with you in these forums.

Optimistically, we are planning on attending the following conferences and hope to see you there.

Wrays is a strong supporters of APAA. Principal and head of our trade marks team, Jennifer McEwan is on the conference organising committee.. We are looking forward to the opportunity to acknowledge our 100 year milestone at APAA and hosting an event to share the occasion with you. If you are attending any of the above conferences and would like to connect with our team, please contact us at events@wrays.com.au.

SEPTEMBER The IP Owners Conference 21s t - 23rd SAN DIEGO, CALIFORNIA, USA

Experts in IP since 1920.

NOVEMBER INTA

TBA

Even though COVID-19 has done its best to put a dampener on all business operations in 2020, this year still marks the 100th anniversary of Wrays. We are incredibly proud of this achievement. This centenary year is a hugely important and exciting milestone for us. There are not a lot of Australian or New Zealand patent & trademark firms that survive to make 50 years of operation, let alone 100 years. Most are either subsumed by other organisations such as Wrays, or they naturally grind to a halt when their principals retire.

In reaching 100 years of business operations, Wrays has had to evolve, grow, re-invent itself and withstand both a Global Financial Crisis and, now COVID-19. One thing that all this has done is make Wrays resilient, agile and well-founded. From a small firm of humble beginnings, we have grown to become one of the largest independent IP firms in Australia and New Zealand providing end-to-end IP services not only as patent attorneys and trademark attorneys but also as IP lawyers where we deliver specialised patent and trademark litigation and commercial IP transaction services. Once the COVID -19 outbreak is over, we will be recognising our 100 years of operation, and we intend to do so in our own special way. We hope that you will also join us in those celebrations, whenever and whenever they may be. In the meantime, please stay safe.

USA

The Asian Patent Attorneys Association (APAA), Annual Conference 13th - 17th GOLD COAST, AUSTRALIA

T he first article I penned regarding the potential demise of Australia’s innovation patent system was at least as early as the 2016 Productivity Commission report on Australia’s IP Regimes. So the innovation patent system has been in the cross-hairs since at least that time. In reality they were being targeted much earlier, with a stand-alone enquiry into the innovation patent system having been conducted in the years leading up to the 2016 Productivity Commission report. All this despite only having been introduced in 2002.

SENTENCE FOR AUSTRALIA’S INNOVATION PATENT FINALLY HANDED DOWN

THE SENTENCE Despite several false starts since that 2016 Productivity Commission report, the Australian Government has now passed and enacted legislation that will see the phase out of the Australian innovation patent from 26 August 2021. The innovation patent won’t cease to exist at that time, but will rather commence a slow tip-toeing from the Australian intellectual property landscape. – – Existing innovation patents will not be impacted by these latest changes and are entitled to live out their full 8 year term, subject to renewal and other requirements. – – Applications for innovation patents filed before 26 August 2021 will similarly be entitled to live out their full 8 year term, subject to renewal and other requirements. – – Innovation patent applications will continue to be able to be filed as divisional applications from pending standard applications with an effective filing date of earlier than 26 August 2021. – – Standard patent applications pending at 26 August 2021 may be converted to innovation patents (as they may be presently) at that time or thereafter. – – The overarching feature is that whilst you may be able to file, or convert to, an innovation patent after 26 August 2021, the protection afforded by way of that innovation patent will not extend beyond 25 August 2029. THE GOOD F IGHT It has been widely reported that our Institute of Patent & Trade Mark Attorneys had been waging a campaign to retain the innovation patent. Indeed, The key points are as follows:

they were supported by a wide range of small to medium enterprises (SMEs) in this campaign but it ultimately came to (almost) nothing. THE REWARD? The ‘almost’ refers to the recent announcement of several “dedicated support services” for SMEs, including: – – An SME fastrack (which is in fact regular expedited examination of a standard application). – – SME case management. – – An SME portal offering 24/7 support for SMEs. – – An outreach program dedicated to SMEs (an information or education program). EX POST FACTO ANALYS I S The recently enacted legislation also provides that the effectiveness of these measures, and the accessibility of the intellectual property system for SMEs in Australia, will be reviewed by way of a ‘Ministerial Review’ that is required to consider at least the following:

– – Cost – – Processing times – – Advice – – Awareness

Whilst the undertaking to provide such a review is welcome, it will be particularly interesting to see how rigorously the required review is undertaken. At this point it is difficult not to imagine that it runs a real risk of being little more than perfunctory – given the manner in which the innovation patent has been pursued and ultimately killed off.

PETER CAPORN Principal

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FALLING IN LINE WITH REG 5.9 What does COVID19 mean for your patent opposition?

(i) Reasonable efforts

On 19 March 2020, IP Australia issued a statement that extensions of time may be available to Applicants affected by COVID-19. Requests for extensions of time need to be made in the normal way, including filing a declaration setting out how the COVID-19 outbreak interfered with responding in time. They also went so far as saying that requests for fee relief will also be considered on a case-by-case basis. The statement made by IP Australia did not limit the type of extension of time, rather it was directed broadly to any extension of time sought within the confines of the Australian patent legislation. In this article we explore more specifically how such extensions of time might be required during a patent opposition. THE REQU I REMENTS FOR AN EXTENS ION OF T IME Regulation 5.9 specifies that a party requesting an extension will need to convince the Commissioner that: – – despite having acted promptly and diligently at all times, and despite having made all reasonable efforts, they were unable to meet the filing deadline; or – – there are exceptional circumstances that warrant the extension. Thus, an application for an extension of time to serve evidence in a patent opposition can be founded on either of two different premises: – – the party seeking the extension has made all reasonable efforts to comply with the deadline, acting promptly and diligently at all times but was unable to meet the filing deadline; or – – exceptional circumstances arose that prevented the evidence being completed in the specified period. This raises a question as to what these different arms of the extension of time provisions might require for each to be satisfied.

The “reasonable efforts” provision requires that the parties act reasonably at all times. Therefore, parties need to plan for absences and consider alternative measures if there is a delay, such as the absence of an expert 4 . Expert absences later in an opposition will be better tolerated than early in the opposition since there may be significant value in using the same expert as in earlier evidence stages 5 . Importantly, parties must provide sufficient information about the steps taken to accommodate an absence or their absence may still be considered unreasonable 6 .

(ii) Exceptional Circumstances

An exceptional circumstance is a matter outside the normal evidentiary process, and outside the control of the party, where it would be unreasonable to insist on the party filing their evidence.

According to Reg 5.9(5), “exceptional circumstances” include:

a. circumstances beyond the control of the party that prevent the party from complying with a filing requirement; b. errors or omissions by the Commissioner that prevent the party from complying with a filing requirement; or c. an order of a court, or a direction by the Commissioner, that the opposition be stayed pending the completion of a related proceeding or action under the Act. Predictable events, busy work periods, national holidays and diversion of attention will not be considered exceptional circumstances if they could have been anticipated and acted upon 7 .

Following the implementation of the Raising the Bar Act in 2013 1 , IP Australia tightened the reins on granting extensions of time 2 to file evidence during patent oppositions under restrictions governed by Reg 5.9 of the Patents Regulations 1991. The purported aim of the tougher restrictions was to minimise unnecessary delays and create greater transparency and certainty for the public as a result of faster decisions 3 .

COV I D-19 AND EXTENS IONS OF T IME On 11 March 2020, COVID-19 was declared a global pandemic by the World Health Organisation. It is the largest world health crisis seen in a generation. COVID-19 has caused restrictions on the movement and circulation of persons, as well as on services, exchanges and public life in general, resulting in unprecedented lockdowns, social distancing and restrictions across the globe. This situation is rapidly evolving in Australia and has resulted in the closure of many non-essential services and the loss of countless jobs. As COVID-19 proceeds to shut down nations at an alarming rate, it is only natural to question what affect this will have on IP rights.

1 Intellectual Property Laws Amendment (Raising the Bar) Act 2012. 2 Explanatory Statement to the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (Explanatory Statement) at p 1. 3 Explanatory Statement to the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (Explanatory Statement) at p 1. 4 Merial Ltd v Novartis [2013] APO 65 (Merial)

4 Merial Ltd v Novartis [2013] APO 65 (Merial) 5 Innovia Security Pty Ltd v Visual Physics LLC14 (Innovia), 6 Merial Ltd v Novartis [2013] APO 65 (Merial) 7 Tabcorp and Cantarella Bros Pty Ltd v Nestec SA (Cantarella)

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WHAT DOES I P AUSTRAL I A’S SAY ABOUT COV I D-19? IP Australia has stated that: “…the effects of the COVID 19 outbreak is an unprecedented situation that may have an impact on the ability of applicants and their representatives to process applications. Where an applicant cannot carry out an action within time due to the COVID 19 outbreak an extension of time may be available.” The announcement by IP Australia then noted that some time periods cannot be extended but fell short of providing any specific examples. The statement by IP Australia is notable in that it does not provide a guaranteed extension. Instead IP Australia has largely said that it will consider each application for an extension of time on its merits. Therefore, it remains to be seen how this statement will interplay with the elements for granting an extension of time to serve evidence in a patent opposition. Filing an extension of time in a patent opposition and relying on COVID-19 Extensions of time to file evidence during patent oppositions have in the past been notoriously difficult to obtain. Clearly, the COVID-19 pandemic has caused significant disruption to the business, scientific and engineering community. One does not have to look too hard to see that this unprecedented pandemic could constitute an “exceptional circumstance” within the provisions of reg 5.9; being a circumstance beyond the control of a party that prevents that party from complying with an evidentiary filing requirement. That said, IP Australia’s notice to the Australian IP community does not reach that far. IP Australia merely states that applications will be considered on their merits.

While the COVID-19 pandemic might form the basis for establishing the existence of exceptional circumstances for granting an extension of time, we strongly believe that an applicant wanting to obtain an extension of time will need to show that they have made “all reasonable efforts” to act “promptly” and “diligently at all times” to prepare their evidence. Applicants should not assume that the COVID-19 pandemic is automatically going to provide a basis to extend a time limit in an opposition. Evidence of diligent effort to pursue the collection of evidence will most likely be essential to the grant of any extension of time application. A request for an extension of time due to a COVID-19 related delay should be filed as early as possible and preferably before the deadline. It should also be accompanied by a declaration setting out the exact details of how the COVID-19 pandemic caused the delay. As with all extensions requested during a patent opposition, a chronology of events and a detailed description of what was done, when it was done and how it was done should be provided together with a detailed description of how COVID-19 affected the strategy. A detailed description of the reason for any gaps should also be provided to support the request. Regarding absences and illness of experts, the Explanatory Statement to the new provisions states that “if a preferred expert becomes suddenly unavailable but other experts could be called on to complete the evidence in time, then the sudden loss of the preferred expert is not an exceptional circumstance”. This was also followed in the Tred decision 8 . Therefore, in and of itself, the illness of an expert due to COVID-19 may not be considered an exceptional circumstance if other experts could have been called upon. It is noteworthy that the surprise illness of an expert late during the evidentiary period has been considered an exceptional circumstance in the past because the illness occurred at a time when it was too late to call another witness 9 . Importantly, what became clear, was that it was essential to the requestor’s case to provide detailed support regarding when the illness occurred and whether or not other experts could have been used. We anticipate that the same may apply for applicants, opponents and their attorneys during the COVID-19 pandemic. Thus, in the event

– – prepare evidence on the understanding that any applications for extensions of time may be denied; – – request extensions as early as possible; preferably so that the matter can be decided before the evidence deadline; – – file what you have, or if you are the patent applicant, consider attempting to resolve the opposition by amending the claims and requesting a stay in proceedings; and – – most importantly, do not expect the delegate to presume you have acted in a prompt, diligent and reasonable manner, but rather provide evidence to convince them of it. Despite the tough approach employed by IP Australia, it appears that the trend in recent decisions is currently towards the grant of an extension. However, it is clear from these decisions that the days of short and easily obtainable extensions are behind us. Oppositions are becoming a specialised area of practice, requiring sophisticated project management strategies. While extensions are still obtainable, they are no longer a fait accompli and instead should be regarded as an absolute last resort. The manner in which IP Australia will view delays caused by COVID-19 is yet to be seen. However, we recommend that parties proceed with caution and presume that the same detailed evidence to support the request will still be required during the COVID-19 pandemic and beyond. If you have any questions on how COVID-19 may affect your opposition proceedings, please contact Wrays.

that a party becomes affected by COVID-19 in any way, it will be necessary to show why other persons could not be used in their place. Based on IP Australia’s decisions, we consider that it is going to take more than a simple throw-away line that COVID-19 caused delays to obtain the extension. Parties will still need to show that; – – they have acted promptly, diligently and made all reasonable efforts to comply with the deadline at all times; and – – that despite a carefully executed and adaptable strategy, delays caused by COVID-19 could not be avoided. However, given the unpredictability of the current situation, we do consider that the office may take a more lenient approach to what is considered prompt, diligent and reasonable during the COVID-19 pandemic, compared to other circumstances. – – Immediately prepare a formal COVID-19 strategy for managing the entire opposition, outlining the critical pathway, key milestones and nominal deadlines; presume your entire strategy will be managed remotely and explain how technology may affect your strategy; modify the strategy as necessary; – – record all activity, including action taken to address potential delays and modifications to the strategy; explain any periods of apparent inactivity; problem solve quickly as any obstacles arise; – – engage experts early; enquire regularly about their health and any other interfering events; plan for delays and absences; identify and/or retain back-up experts; – – show that you have acted reasonably, promptly and diligently at all times (not just sometimes); – – where possible, always continue preparing evidence, in spite of any distractions, setbacks or settlement negotiations; if a member of your party contracts COVID-19, obtain a medical certificate as proof and look for alternative solutions; Useful tips for navigating an opposition during the COVID-19 pandemic

CRAIG HUMPHRIS Principal

DONNA MEREDITH Associate

8 TRED Design Pty Ltd v Julie-Anne McCarthy and Bradley McCarthy [2013] APO 57 (11 November 2013) 9 UON v Taranis Power group [2019] APO 6

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IP Australia is looking to update its fees, and have released a draft Cost Recovery Implementation Statement (CRIS). The fee changes seek to bring about cost recovery arrangements for delivering IP Services. IP Australia has also updated hearing costs that may be awarded for Patents, Trade Marks and Designs.

PLANT BREEDERS RIGHTS

PATENTS

TRADEMARKS

DESIGN

RESTRUCTURE OF APPLICATION FEES Standard non-picklist

RENEWALS An increase from $345 to $400 when filed by preferred means or otherwise $395 to $450. QUALIFIED PERSON Designating an approved person fee will go up from $50 to $80 and renewing the designation from $50 a year to $240 for three years.

PATENT RENEWAL Introduction of annual increases to renewal fees. PATENT EXCESS CLAIMS Still no excess fee until 20 claims are reached but the fee will increase from $110 per claim to $125 for 20-30 claims and $250 per claim after that. PRELIMINARY SEARCH & OPINION This will reduce from $2,200 to $950 per search request. FILING A PATENT APPLICATION BY ANOTHER MEANS An increase from $470 to $570.

APPLICATION FOR MORE THAN ONE DESIGN The fee will reduce after the first design. FILING AN APPLICATION BY ANOTHER MEANS Increase from $350 to $450 DESIGN RENEWALS An increase of $320 to $400 if filing by preferred means or otherwise an increase of $370 to $450.

application will increase from $330 a class to $400 a class, $350 to $400 per class to import a Madrid application and $350 to $450 a class for an application by another means. OPPOSITIONS & HEARINGS Request for hearing fee will drop from $600 to $400 while the fee for appearing and being heard at an oral hearing in person will go up to $800 or $600 if it’s attending by other means. The $400 request fee will be deducted. If there’s no hearing, there’s no fee.

NEW ZEALAND

There have been a couple of changes on the New Zealand front: – – changes to patent and trade mark fees – the New Zealand Patent and Trade marks office has issued a new schedule of fees; – – egulatory Systems (Economic Development) Amendment Act 2019 has come into force – this Act updates the way in which trade marks past their renewal dates are referred.

PROPOSED FEE CHANGES AT IP AUSTRALIA

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BREXIT WHAT DOES IT MEAN FOR YOUR IP?

With the UK now leaving the EU, business has entered a transition period which will end on 31 December 2020, at which time the BREXIT Withdrawal Agreement will take effect.

In this update, we explore what this means for your IP rights.

PATENTS Patents are not affected as patent registrations are done through the European Patents Office (EPO) which is not an EU agency. TRADE MARK AND DES IGNS WIPO has issued a statement that trade mark and design registrations designating the EU will continue to have effect in the UK during this period and the UK will be taking measures to make sure that the protection continues after the transition period ends.

Over the coming nine months you should consider the following:

BREX I T

No action is required

Registrations

If you have a European TM registration or a registered

community design as at 1 January 2021, the UK Intellectual Property Office (IPO) will create a comparable, national trade mark or design in the UK. If you have a European TM application or a community design application as at 1 January 2021, you will have 9 months to apply for a comparable, national trade mark or design in the UK If you have an International Registration designating the EU as at 1 January 2021 where you have granted protection in the UK by 1 January 2021, the IR will continue to be protected in the UK. If you have an International application designating the EU as at 1 January 2021, the application is not granted in the UK by 1 January 2021, it is unclear what will happen, but the UK is still in negotiations with WIPO.

Action is required

Applications

No action is required

International Registration

Unclear what will happen - the UK is still in negotiations with WIPO.

International Application

COPYR IGHT & OTHER GLOBAL TREAT I ES As for copyright and other global treaties, there won’t be too much of a change except in relation to arrangements unique to the EU.

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THE AUSTRALIAN PATENT OFFICE MAKES CLEAR THAT PRODUCTS WITH TWO PHYSICALLY SEPARATED PARTS ARE NOT ELIGIBLE FOR PHARMACEUTICAL PATENT TERM EXTENSIONS.

SEPARATELY STORED COMPONENTS ARE NOT PHARMACEUTICAL SUBSTANCES PER SE However, despite the Delegate’s above accepted positions, the Delegate concluded that the pharmaceutical substance per se was not the reconstituted solution. The Delegate concluded that a pharmaceutical substance per se as stated in the PTE legislation must be an “an integrated dosage form” and cannot be in the form of physically separated components, or “a “deconstructed” formulation intended for later reconstitution” (which she characterised as a kit). To support this finding, the Delegate referred to a number of Federal Court decisions and in particular relied on Celgene Corporation [2011] APO 37, 93 IPR 309 ( Celgene ). This somewhat facile citation of the Celgene decision bears further examination. In the cited passage of Celgene, the patentee relied on a claim for a drug “when used” to treat a specific indication as the “pharmaceutical substance per se” . The patentee in Celgene pointed to indications listed in the Product Information leaflet (PI) for which the drug was administered. The Delegate, in that case, said that he was unable to look to the indications of the goods in the PI in order to ascertain what the actual goods were. In our respectful view, the delegate’s finding in Celgene is divorced from looking at what substance is actually administered to the patient by reference to its ARTG public summary document. Indeed in the Decision, the Delegate went on to cite Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, 81 IPR 228 at [239] where Her Honour said: The level of enquiry required by s 70(3) … is a simple comparison of the pharmaceutical substance with the ‘ingredients’ of the goods on the ARTG. Curiously, had the Delegate taken that approach it would seem logical that the ingredients of the administered dosage form of the goods be ascertained by reading the ARTG public summary document. Nevertheless, the Delegate for the Decision concluded that this approach is impermissible because the definition of “directions for use” in the Therapeutic Goods Act 1989 ( TG Act) includes “appropriate doses of the goods” and “the method of administration or use of the goods” , albeit that that definition does not actually include ‘dosage form’ , which is used as a separate term in the TG Act.

active ingredient plitidepsin in powder form, and (2) a vial containing a solution for reconstituting the plitidepsin powder. The invention of AU 754073 lies in the particular combination of reconstitution solvents, which allow the preparation of a stable aqueous solution. The reconstituted solution is not stable, and so must be reconstituted only shortly before administration to the patient. Importantly, the claims of the patent and the description describe and define both the reconstituted solution and the component parts of the solution. The ARTG documentation notes that the reconstituted solution is the composition that is ultimately administered to the patient and is, therefore, the composition that was ultimately approved. As we describe in further detail below, these important points were not accepted by the Delegate as supporting the extension application. WHAT I N SUBSTANCE FALLS WI TH I N THE SCOPE OF THE CLA IMS? As noted above, one of the first conditions that must be met before a PTE is granted is that the claimed pharmaceutical substance must be “be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification”.

Claim 1 of AU 754073 reads:

This note provides a brief summary on the recent decision of a Delegate of the Commissioner of Patents reported as Pharma Mar S.A. [2020] APO 8. Wrays acted for the applicant. BACKGROUND Pharmaceutical patent term extensions (PTE) are available to patentees in Australia where a patentee has been delayed in bringing a pharmaceutical substance to market. This may happen through delays caused by Australia’s rigorous clinical trial process, which must be navigated before marketing approval for a pharmaceutical substance is acquired. Australia’s PTE patent legislation thus compensates patentees for marketing approval delays, providing them with an effective patent term similar to patent terms observed for other technologies outside the pharma industry. A PTE may be achieved for up to five (5) years, on top of the 20-year regular patent term.

A PTE will be granted if the following conditions, amongst others, are satisfied:

1. A pharmaceutical composition of a didemnin compound, comprising firstly a lyophilised didemnin preparation including water-soluble material and secondly a reconstitution solution of mixed solvents.

– – one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification (s70(2)(a) Patents Act 1990). – – goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods (s70(3)(a) Patents Act 1990). These conditions were considered in the recent decision of a Delegate of the Commissioner of Patents, Pharma Mar S.A . [2020] APO 8 (the Decision ). THE PHARMA MAR S . A . [2020] APO 8 DECI S ION Pharma Mar S.A. applied for PTE for Australian patent 754073 on the basis of a listing on the Australian Register of Therapeutic Goods ( ARTG ) of the product APLIDIN, which is indicated for the treatment of multiple myeloma. APLIDIN is sold as two separately stored components: (1) a vial of the

Plitidepsin is a didemnin compound.

In the decision, the Delegate accepted that claim 1 covers: (1) a kit comprising two vials, wherein the first vial contains plitidepsin and a second vial containing a reconstitution solution; and can also cover (2) the reconstituted solution (that is plitidepsin already reconstituted and ready for administration to the patient). The Delegate also acknowledged that the ARTG documentation for APLIDIN made clear that the product that was listed on the ARTG was both the separately stored components and also the reconstituted solution. The Delegate also acknowledged that the product that was ultimately administered to the patient was the reconstituted solution and not the separately stored components.

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WHO TO CONTACT If you require any assistance or additional advice in relation to PTEs in Australia, please get in touch with the authors of this article.

Accordingly, the PTE application was refused.

It is interesting to observe that while the Delegate acknowledged that claim 1 covered the reconstituted solution, the Delegate nonetheless concluded that the pharmaceutical substance per se for the purpose of s70(2) could not be the reconstituted solution. It is difficult to appreciate the methodology and analysis used to reach this conclusion. The patentee submitted in that regard: ‘It would be entirely perverse if a claim to a new formulation of a known stable and soluble drug that does not require reconstitution prior to administration […] could form the basis of a term extension, but not a claim to a new formulation of a drug that has stability and/or solubility issues and which formulation overcomes difficulties arising from those issues.’ (at 43) Despite any lack of clarity around the methodology used to reach this decision, the Delegate’s decision does make it clear that IP Australia is unfortunately of the view that extensions of term are not available where the pharmaceutical substance per se is a composition comprising components physically separated during storage or transport. We hope, for the sake of Australian innovation in this space and the patentees engaged in it, that the Federal Court of Australia will not support this view, when this question eventually arises for determination.

TIM FRANCIS Principal

CRAIG HUMPHRIS Principal

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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