4 min read

The abolition of Australia’s second-tier “innovation patent” system has been well publicised and comes with a “magic date” of 25 August 2021.  But what does “abolition” really mean, and what can’t you do come 26 August 2021 that you could do one day prior?  In this article, we break it all down and let you know what you really need to know – so that there are no nasty surprises down the line.

What must I do on or before 25 August 2021?

This is perhaps the most critical (and misunderstood) aspect of the changes.  In order for a new innovation patent to be filed validly, it must come with a filing date of 25 August 2021 or earlier.  Now, for applications already filed in Australia (convention or national phase) or existing PCT international phase applications designating Australia, this is not a problem – your ability to make use of the innovation patent system is maintained (subject to certain caveats, see below).

However, for inventions currently covered by provisional applications (or even awaiting provisional filing), this is where things start to get interesting.  You will need to file “early” (i.e., obtain a filing date of 25 August 2021 or sooner) in order for your invention to remain innovation patent-eligible.  Practically speaking, foreign applicants may struggle to justify bringing their international phase filing forward simply to preserve their rights in Australia’s second-tier patent system.  Rather, they may prefer to file early in Australia (as a standard patent application that can later be converted to an innovation patent, or as a direct-filed innovation patent application), leaving the PCT international phase to run its natural course.

We have attempted to capture this in the graphic below:

What can I still do come 26 August 2021 and after?  

As noted above, for applications already filed in Australia (convention or national phase) or indeed existing PCT international phase applications designating Australia, this is not problem – your ability to make use of the innovation patent system is maintained.  As shown on the timeline below, you can convert an existing standard patent application (i.e., having a filing date of 25 August 2021 or earlier) into an innovation patent, or can have a divisional innovation patent filed from it. That said, one further misconception stems from the fact that this divisional innovation patent can be filed at any time on or after 26 August 2021 (so long as the would-be 8-year term of the divisional innovation patent has not expired).  Whilst this is technically correct, delaying filing does come with consequences in that your ability to claim damages (remembering that one of the principal uses of the innovation patent is as a “litigation weapon”) only dates back to the date of publication of the innovation patent, meaning this is very much a case of “the sooner the better”.

Further reading

Reading about the innovation patent ranks second only to writing about it as a cure for insomnia.  In that respect, we’ve been following things closely over the past few years and have published insights here (Abolition is a bit harsh – rather, why not let the punishment fit the crime), here (The legislation finally passes in Federal Parliament), here (Optimistic and pessimistic views of the innovation patent system), here (Just as Australia moves to abolish the innovation patent, New Zealand considers adding one) and here (Timeline for the phasing out of the innovation patent system).  It looks like someone’s going to have to find something new to write about!

Commentary

The bottom line is that whereas the innovation patent system could have been “fixed” (which may have in turn given it a chance of achieving its stated goal of stimulating R&D amongst local SMEs), the Government had long-since decided its fate.  It was always going to die and attempts to recover it, whilst deserving of a better outcome, ultimately amounted to little more than a fool’s errand.  That we’ve landed where we have is a sad but inevitable consequence of a system that sounded good in theory, but was imperfect in design – and in this respect we need look no further than innovation patent 2001100012, which was “granted” (although later revoked) for a “circular transportation facilitation device” – a wheel.  In many ways, the only surprise is that it’s taken us 20 years to get to where we are now. 

Authored by Shan Sun, PhD and Gareth Dixon, PhD

5 min read

Australia’s Federal Court Decision, Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643, overturns the Patent Office Decision, Ono Pharmaceutical Co., Ltd. et al [2020] APO 43, in which the Patent Office had found that the substance with the first regulatory approval date for the purpose of the patent term extension request was a competitor product.  In a Judicial Review of the Patent Office decision, the Federal Court found instead that the substance with the first approval date was the patentee’s own, later-approved product.

Patent Term Extensions (PTEs) in Australia

Australia’s Patents Act provides patent term extensions (PTEs) to account for the delays that can occur when obtaining regulatory approval for pharmaceuticals.  A PTE can last for up to five years and is available when the following requirements are met:

  • the patent, in substance, discloses and claims a pharmaceutical substance per se, or a pharmaceutical substance when produced by recombinant DNA technology;
  • goods containing or consisting of the pharmaceutical substance are included in the Australian Register of Therapeutic Goods (ARTG);
  • the PTE application is made within six months after the later of (a) the date the patent was granted and (b) date of the first inclusion in the ARTG; and
  • the first regulatory approval for the pharmaceutical substance occurred more than five years after the filing date of the patent.

The length of a PTE is equal to the period between the filing date of the patent and the date of the first regulatory approval, reduced by five years.  A patent cannot be extended more than once.

Background

Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643 concerned a request to extend the term of Australian patent 2011203119.  The patent claims encompassed two blockbuster cancer drugs: Merck Sharp & Dohme’s KEYTRUDA and the patentee’s OPDIVO, both of which received regulatory approval in Australia, but on different dates.  Thus, the question at issue was which regulatory approval date was relevant for deciding the patentee’s PTE request.

To cover all of its bases, the patentee simultaneously filed two PTE requests: one based on the competitor product, KEYTRUDA, which had received regulatory approval on 16 April 2015, and another based on its own product, OPDIVO, which had a regulatory approval date of 11 January 2016.  The PTE request based on KEYTRUDA was accompanied by a request for an extension of time. 

From the patentee’s perspective, the request based on OPDIVO was preferred as it would result in a longer extended term (an additional 8 months, 26 days). 

The Overturned Patent Office Decision

Initially, the Patent Office refused the PTE request based on OPDIVO, finding that KEYTRUDA was included on the ARTG first and therefore should form the basis of the request.  The patentee disagreed and requested to be heard.

At the Patent Office hearing, and as previously reported, the patentee’s request for a PTE based on OPDIVO was again refused (Ono Pharmaceutical Co., Ltd. et al [2020] APO 43).

The Federal Court Decision: Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643 (11 June 2021)

Justice Beach of the Federal Court observed that PTEs are “designed to remedy the mischief of a shortened period for an effective monopoly that has been caused by delays in obtaining regulatory approval”. 

Justice Beach framed the question at issue as follows:

“… it is whether an application for an extension must be filed within 6 months of the first inclusion in the ARTG of goods containing or consisting of any pharmaceutical substance falling with the claims of the patent:

(a)          where the goods were those of the patentee (the applicants’ position); or

(b)          irrespective of whether the goods were those of the patentee, that is, they could be the goods of a third party that had nothing to do with the patentee and, moreover, might be a competitor [the position taken by the Patent Office]”

Answering this question involved consideration of the intended meaning of the relevant provisions and the history of the legislation, including the 1997 Explanatory Memorandum (EM), the second reading speech to the Bill that became the 1998 Amendment Act (the speech) and the now-repealed s 76A of the Patents Act 1990. 

Justice Beach noted that PTEs are intended to provide an effective patent life for pharmaceutical products and the reference to “product” was “clearly not that of a stranger let alone a competitor”.  His Honour rhetorically asked how the legislation would provide an effective patent life if the product on the ARTG triggering the start of the extension was not that of the patentee, but rather that of a stranger or indeed a competitor, concluding, “[t]hat would not provide an “effective life” for the patentee at all”.

Justice Beach also determined that it is for the patentee to specify the pharmaceutical substance for the purposes of requesting a PTE (which can be any pharmaceutical substance that is in substance disclosed and claimed in the patent). 

His Honour reasoned that the drug which is the subject of the PTE application is intended to be the drug of the patentee, not that of a third party.  His Honour considered that the Patent Office’s interpretation of the law would place an unreasonably onerous burden on the patentee who would need to review each and every ARTG listing to identify those that contain a pharmaceutical substance falling within the scope of the claims (to the extent possible, noting also the dearth of information provided in ARTG public summaries), and to determine whether another relevant substance was previously listed on the ARTG but later removed, as can occur in certain circumstances. 

Justice Beach acknowledged, however, that the Patent Office’s approach was understandable in light of the text being construed and that a Delegate of the Patent Office is not as free as a Judge to reject any perceived ordinary meaning of the legislation by reason of manifest absurdity or unreasonableness. 

Conclusion

Justice Beach agreed with the patentee and favoured a liberal rather than a literal construction of the legislation, commenting in summary that a liberal construction can fit within the ordinary meaning of the statutory language and is consonant with the legislative purpose.

It was therefore concluded that the term of the patent should be extended based on the regulatory approval date of the patentee’s own pharmaceutical substance, OPDIVO, even though KEYTRUDA was approved earlier. 

Implications

This decision lifts the burden for patentees of the need to monitor the ARTG for approval of third party drugs.  In circumstances where a patent covers more than one approved pharmaceutical substance, the decision implies that a PTE request does not have to be based on the substance that was approved earliest. 

Authored by Serena White, DPhil and Michael Christie, PhD

2 min read

Managing Intellectual Property (MIP) IP Stars publication has listed Shelston IP once again as a Tier 1 firm for both patent and trade mark prosecution. Four of our Principals have been recognised individually as IP Stars.

MIP’s IP Stars is the leading resource and most respected guide in the IP profession. Their worldwide survey of IP practitioners is used as a key benchmark for the industry.

Congratulations to all our IP Stars for being recognised as leaders in the IP industry:

Paul Harrison

Paul is a Principal and head of the chemical biotechnology team. He has over 35 years’ experience in the protection and enforcement of IP rights in Chemical Engineering and Chemistry technologies and is valued by his clients for his strategic and pragmatic approach to intellectual property.

Sean McManis

Sean heads Shelston IP’s Trade Marks team. He has extensive experience in assisting clients with trade mark protection and selection. He has been recognised by Managing Intellectual Property as an IP Star for the last 6 years and was a finalist in the 2020 Client Choice Awards for Best IP Specialist.

Charles Tansey, PhD

Charles is a Principal and experienced patent attorney with 25 years’ experience in the drafting, prosecution, enforcement and defence of patents in Australia and overseas. His technical experience across a wide range of chemistry related technologies is sought out by domestic and multinational clients.

Peter Treloar

With over 25 years of experience, Peter is an authority in Patents in Australia and New Zealand for complex electronics, computer science, and optics, with a particular bent for complex mathematical material.

4 min read

You’ve found a patent of interest but how do you know if it’s dead or alive, and if alive, when it expires, and what exactly do those kind codes indicate?

I’ll explore all these in a three part series of articles, starting with where to find status information and what it means.

Statuses

Some patent offices explicitly report the status of an application, while others make you dig a little deeper, and some make you work hard for that information.  Before we get to who’s who and what’s what, let’s look at what the language around statuses is.

At the most basic level a patent is dead or alive, but within those labels there are a number of ways to describe where in the patent lifecycle they are.  Statuses in both categories are split into pre-grant and post-grant.  Every patent office has its own language around statuses.  Here’s a selection.

Pre-grantPost-grant
AliveAccepted
Filed
Pending
Under examination
Under opposition
Unexamined
Certified
Granted
Issued
No opposition filed
Patented
Registered
Sealed
DeadAbandoned
Converted
Lapsed
Refused
Rejected
Void
Withdrawn
Ceased
Dead
Ended
Expired
Revoked

Although data aggregators such as commercial patent databases often have status data, the recognised place to go for accurate status information is the national register for the patent of interest.  In Australia that’s AusPat, and in New Zealand it’s IPONZ.  Other sources include PAIR (United States), the European Patent Register, KIPRIS (South Korea), J-Plat-Pat (Japan), and thanks to Brexit, Ipsum (United Kingdom) now has more relevance than it used to.  Of course the list of national registers is far too long to mention every one here, but you can find a list at the WIPO Patent Register Portal.

In some national registers all you need to do is search for a patent number (or any search) and the status will be provided as part of the search results or record view, such as AusPat below.

Others in this group include IPONZ, KIPRIS and Ipsum.

National registers in the next group don’t explicitly state the status of a patent, and usually require a single click, or maybe two, from the search results page through to the record view.  For example the search results page for J-Plat-Pat is shown below, and a click on ‘Details’ will take you to the information required.

Others in this group include In-PASS (India), PRV (Sweden) and the Canadian Patents Database.

The last group of national registers make you work harder to find the status of a patent.  I’m looking at the European Patent Register, and giving death stares to the United States’ PAIR in particular, and for different reasons.

First to the European Patent Register.  The initial view is straightforward as shown here.

The status ‘No opposition filed within time limit’ refers to the period after acceptance where an application can be opposed before grant, and in this case that time has expired and the patent has been granted.  Simple isn’t it?  Not quite.  Europe is a group of countries, and a number of these get designated so that the EP patent is applicable in each of them, so your country of interest has to be on that list, as shown below.  To find this list just scroll down the register page for this application.

Are we there yet?  Sorry, no.  We still need to scroll down the page a little further.  The list of designated countries is essentially an ambit claim, hedging that the patent is going to make it big.  They usually don’t so many of the designated states find themselves on the ‘lapsed’ list, shown here in part.

Now you need to conduct a reverse search to see if the country of interest is on the list or not, made all the harder by having the list in date order, not alphabetical order.  If the country of interest is here, the patent is dead, if not, possibly still alive.  At first glance I can see Germany, France, Great Britain and Ireland are still potentially alive.  A trip to their respective registers (Depatis, INPI, Ipsum and IPOI) is necessary to confirm that.

Now to PAIR.  Many national registers will change the status of a patent when a significant event such as ceasing through non-payment of renewal fees, or expiry after the full term of the patent, but the USPTO do not. Take the example shown below where the initial view in PAIR indicates it is a ‘Patented Case’.

The image doesn’t show the application filing date or the earliest effective filing date but it is 3 May 1999 for both.  If you’ve read my previous article on calculating United States patent expiries you’ll know the expiry date is 3 May 2019.  That’s a date in the past so this patent has expired, but PAIR does not say so.  You have to do all the work here.

There’s always the possibility of a patent term adjustment of more than two years, but with an issue date just over three years after filing, that’s unlikely, so you can assume it is well and truly dead.

This example is for a patent around the end of its expected life, but for others, in addition to calculating the expected expiry date, you may need to check the patent maintenance fees to see if they are up to date.  You can access that information through PAIR.

That’s a brief rundown on statuses, where to go to find them, and what language is used to describe them.  I touched briefly on patent expiry dates for the United States.  In Part 2 I’ll look at patent expiries in other parts of the world.

Authored by Frazer McLennan and Gareth Dixon

4 min read

Females make up half of the population of the world, but many of the issues they have to deal with, from menstruation to menopause, have often been considered taboo subjects. In fact, until very recently, medical technology and devices for women have been considered niche.

For many years, medical technology and products have historically been developed by men, tested on men and for men, with women expected to adapt. As a result, many diagnoses in women are still undetermined, and it takes several years longer to establish comparable diagnoses in women than in men.

The rise of trailblazing innovators and entrepreneurs creating, designing and developing products and apps for women has started a women’s health revolution by lifting health taboos around the world and giving rise to a global “Femtech” industry worth many billions.

What is Femtech

Femtech, also called female technology, is a newly recognised health sector that relates to technology such as mobile apps, wearables, diagnostic tools and software that is specifically geared towards the needs of women.

Opportunities in Femtech sectors

Today, Femtech accounts for more than 200 start-ups worldwide, many of which have been founded and led by women. 

Numerous spaces and new opportunities in areas such as sex and reproduction, menstruation, fertility, and pregnancy have emerged as age-old issues are being addressed by the unification of modern technology and a focus on women’s health.

While the Femtech industry is still relatively young and underfunded, it is predicted that the industry will grow exponentially in the coming years. Revolutionary steps are continually being taken to balance out gender disparities in the healthcare industry, propelling the agenda of Femtech into the modern world.

In fact, the topic of Femtech has been searched more than ever previously recorded and is on an upwards trajectory.


(Graph obtained from Google trends. Numbers represent search interest relative to the highest point on the chart for the given region and time. A value of 100 is the peak popularity for the term. A value of 50 means that the term is half as popular.)

The shift towards women’s health has also coincided with the next wave of wearable tech products prompting an explosion of wearable technology focused on women’s health, for example, wearable smartwatches to track mensuration and pregnancy and temperatures trackers to identify fertility phases.

On the other hand, the menopause market is an area of enormous opportunity as technology is lacking and largely unexplored. While all women will experience menopause at some point, the availability of products to assist wth tracking symptons is poor, including analogue charts, and very little technology exists for treating symptoms. For that reason, we expect to see this area thrive in the future.

Ongoing challenges in Femtech

While the medical technology and device industry is shifting a considerable amount of time and effort towards women’s health, the industry still faces many challenges.

Breaking down barriers, taboos and getting health data into the hands of those who can utilise it has been a real hurdle within the industry. A particular challenge within Femtech is securing funding. In essence, this requires overcoming the hurdle of pitching female specific products to mostly male investors which solve a problem they don’t understand and can’t relate to.

Other challenges include:

  • Receiving public support about subjects people are less likely to talk about.
  • Fewer researchers in women health fields mean fewer people to apply for grants.
  • Concerns about trust, security and privacy and fear of repercussions if sensitive data was released.

Future of Femtech

The future of Femtech is bright as the awareness of female-oriented health and technology continues to gain momentum, while the taboo around women’s health dissipates.

So far we have only seen the tip of the iceberg in female-focused technology. Notably, the developments in AI and the Internet of Things have largely contributed to the rise of Femtech and will continue to do so. Only recently have tech juggernauts, Fitbit and Apple, developed technology aimed at women’s health. In April 2018, Fitbit unveiled a woman focused smartwatch which allows women to track their menstrual cycle, followed by Apple in June 2019, who added a reproductive health tracking feature to their operating platform.

According to a report by research consultancy Frost & Sullivan, the value of the industry is increasing rapidly. It was estimated that the Femtech industry was worth US$200 million in 2018 and will skyrocket to a potential worth of US$50 billion by 2025.

Conclusion

As Femtech continues to pave the future, we will continue to explore other aspects of Femtech in Australia and Femtech in relation to Intellectual property through a series of focused articles.

Authored by Connie Land and Allira Hudson-Gofers

3 min read

Following a cacophony of dire warnings and lobbying over the past decade from the Australian biotechnology and medical sectors, and the sudden sharp focus of middle Australia on the critical importance of onshore manufacturing facilities such as those capable of mRNA vaccine production, the Federal Government has announced the introduction of a $206.4m patent box for Australian medical and biotechnology industries as part of the 2021-2022 Federal Budget handed down on 11 May 2021.

Named quite literally after a tick box historically present on income tax forms, a patent box provides tax incentives designed to encourage companies to commercialise and manufacture patented technology locally. From 1 July 2022, Australia’s proposed patent box is slated to tax income derived from eligible patents at a concessional corporate tax rate of 17%, rather than the standard corporate tax rate of 30%, or 25% for small and medium enterprises (SMEs).

While the specifics are yet to be established, the patent box is proposed to apply to income derived from granted Australian patents in the medical and biotechnology sectors filed after the budget announcement (ie, after 11 May 2021), providing that at least a portion of the research and development (R&D) of the technology occurred in Australia. The following example was provided with the Federal budget papers: A company selling a patented product makes $175 million in net income directly attributable to the patent. If 80% of the R&D associated with the patented product occurred in Australia, then 80% of the income (ie, $140 million) would enjoy the concessional 17% tax rate. 

The measure is intended to incentivise Australian companies to invest in and perform their R&D, commercialisation and manufacturing of patented technologies onshore. It has been warmly received by the Australian biotechnology sector with Lorraine Chiroiu, CEO of AusBiotech, stating that the organization whole-heartedly commends the initiative: “This tax incentive will address the gap that leaves our IP vulnerable, retain home-grown IP, and support Australian innovators and manufacturers. It will make the commercialisation of IP and manufacturing in Australia more genuinely viable for businesses.”

Cochlear’s CEO, Dig Howitt, has similarly commented: “Incentivising companies of all sizes to keep their intellectual property and manufacturing in Australia will generate substantial economic benefits through royalties, licence fees, tax revenues, supply chains, jobs, and capital investment.”

CSL CEO Dr Andrew Nash concurs, stating, “CSL welcomes the introduction of a patent box which will help decrease the flow of intellectual property from local medical research going overseas. It will drive the growth of advanced manufacturing jobs, capital intensive investment and sovereign capacity in medical technology and biotechnology manufacturing.”

A number of countries already have patent box regimes, including the UK, Belgium, Spain, France, the Netherlands, Luxembourg, Switzerland, and China. Australia’s patent box is set to follow the Organisation for Economic Co-operation and Development (OECD)’s guidance on patent boxes to meet internationally accepted standards.

The Government has indicated that it will consult with industry on the design of the patent box and explore whether the regime should be extended to include clean energy patents. Lobbying from that sector is already well underway.

On a technical note, several years typically elapse between patent filing and patent grant. Accordingly, it could be some three or four years before the patent box regime begins to provide significant benefit. Patent grant can, however, be brought forward by various means including requesting early national phase entry in Australia followed by expedited examination. If you require advice on this issue, Shelston IP would be happy to help.     

Authored by Karen Heilbronn Lee, PhD and Allira Hudson-Gofers

WIPO’s annual “World IP Day” is 26 April 2021.  This year’s theme is “IP & SMEs: Taking your ideas to market”.  Now, in most developed countries, one could develop a compelling narrative around this.  But it’s slightly more complicated here in Australia, because the two don’t mesh quite as they should.  By this, I mean that it’s SMEs that had a whole second tier patent system developed around them (Australia’s “innovation patent”), it’s SMEs that (allegedly) failed to make use of the system, and that it’s (apparently) SMEs that are responsible for its abolition later this year.  However, a quick peek under the bonnet suggests that much of this is political rhetoric and that despite the Government clearly thinking otherwise, SMEs are as IP-dependent here in Australia as they are anywhere in the world.   

Innovation patents 101

From its introduction in 2001, the “innovation patent” has been held up as a symbol of the Australian Government’s commitment to encouraging innovation amongst Australian SMEs. 

The innovation patent is Australia’s second-tier patent system.  Novelty, written description and industrial applicability criteria are the same as for the first-tier “standard” patent system.  However, in exchange for offering the public only an “innovative step” (a pseudo-novelty test requiring differences amounting to a “substantial contribution to the working of the invention”), a patentee is afforded only an 8-year term as opposed to the standard 20 years.

Proponents of the innovation patent system note that not all inventions are of the “Eureka” quantum leap variety befitting a standard patent.  Rather, many are iterative – making slow but steady advances on what came before it.  Others are in short lifecycle technologies such as televisions, smartphones and the like.  The argument is that such iterative advances may be “obvious” for the purposes of a standard patent, but still invite substantial RD&E expenditure on a patentee’s part – and so why shouldn’t the patentee be compensated with some measure of monopoly right?  To my mind, this seems fair – a patent system designed around Australia’s iconic “backyard” or “garage” inventors.

Innovation patents are “granted” shortly upon filing (a potential problem in itself), but are not enforceable at law until such time as they have been “certified” (i.e., examined).  However, once certified, the enforcement remedies available to a patentee are the same as those for a standard patent.  For this reason, innovation patents – particularly innovation patents divided out from standard patent parents, can be effective “litigation weapons” because the low innovative step threshold makes them somewhat difficult to revoke in a counter-claim for invalidity (and suing against a divisional innovation patent will not expose the parent standard patent to a revocation cross-claim).  Thus, innovation patents provide a legitimate strategic tool for those looking to enforce their Australian patent rights.   

The innovation patent system is “dead man walking”

Following a lengthy review, the Australian Government has opted to phase out the innovation patent system from 26 August 2021.  The transitional provisions are summarised below, but there are three principal dates of which applicants should be aware:

  • The legislation was passed into law (i.e., received the required Royal Assent) on 26 February 2020.  For the purposes of filing new innovation patents, the legislation takes effect from 26 August 2021, which is 18 months from the date of Royal Assent.
  • At any time prior to 26 August 2021, new innovation patent applications can be filed.  In other words, nothing changes until the legislation takes effect.
  • As of 26 August 2021, no new innovation patent applications can be validly granted.  However, an existing and pending standard patent application (i.e., having a filing date prior to 26 August 2021) can still be converted into an innovation patent, or can have a divisional innovation patent filed from it. 

Why is the innovation patent being phased out?

The perceived “problem” with the innovation patent was three-fold. 

  • Firstly, there has been a perception that the threshold test for innovative step (essentially a pseudo-novelty test, as noted above) was too low and that this, in turn, may give rise to a proliferation of difficult-to-revoke certified innovation patents that were enforceable at law.  However, this could be easily remedied by raising the threshold for an innovative step.  That’s strictly outside the scope of this article, so we might leave it for another day.    
  • Secondly, that the “granted upon filing” status rendered the system susceptible to abuses such as foreign applicants potentially being able to claim Government subsidies in their country of origin for obtaining a “granted” patent.  Again, this has little to do with SMEs, but surely, seeing as pending standard patents have the status of “filed”, perhaps non-certified innovation patents could be “pending”, “pre-certification”, awaiting examination”, etc., – in short, anything other than the present misrepresentation of “granted”.
  • Thirdly – and most significantly in respect of this article – there had been a perception that local SMEs were not making use of the innovation patent system (and even if they were, they were not deriving tangible benefits from it). 

Ultimately, it is the third perceived problem that has been considered terminal, and this is the reason why IP and SMEs are somewhat strange bedfellows in Australia at present.

Local SMEs were (allegedly) not making use of the system… 

This appears to be the primary justification for abolishing the innovation patent system.  A 2014 review conducted by ACIP (the Advisory Council on Intellectual Property) had recommended – somewhat surprisingly at the time, that the innovation patent system be abolished.  Following a protracted review process stretching back to 2011, ACIP eventually concluded by way of economic modelling that the innovation patent system was not meeting its stated objectives.  Such objectives, of course, were to stimulate innovation in Australian SMEs by providing easier, quicker and cheaper patent rights as well as an avenue to protect their lower level inventions. 

Objectively, it appears that the data presented in the economic report may have been open to a number of interpretations, and that disproportionate weight may have been attributed to certain factors.  For example, the fact that there are a relatively high proportion of self-filed innovation patent applications cloud the data relating to the calculated total regulatory cost of the system and the assessment of commercial success of innovation patent filing entities.  This obviously has an effect on the concluded net economic impact, which appears to have been a major factor influencing the stand taken by ACIP.  Notwithstanding, the Productivity Commission and the Australian Government have subsequently backed this position, which effectively meant the writing was on the wall for the innovation patent system.

…which meant that the innovation patent system was not meeting its stated objectives

In recommending the innovation patent system be abolished (and then acting on its own recommendation), the Government merely assumed the position of both the Productivity Commission and ACIP before it.  Both had opined that the innovation patent system (as it stood) was unlikely to provide net benefits to the Australian community or to the SMEs who are the intended beneficiaries of the system.  The Productivity Commission found that the majority of SMEs who use the innovation patent system do not obtain value from it and that the system imposes significant costs on third parties looking to navigate around thickets of low-level patents. 

The Government noted that the innovation patent system was established with the express objective of stimulating innovation amongst Australian SMEs.  Rather than “fix” the innovation patent system, the Government was of the opinion that more targeted assistance may better assist SMEs, while avoiding the broader costs imposed by the innovation patent system. 

So, what’s the Government doing to support SMEs protect their IP?

Along with initiatives to support SMEs introduced through the National Innovation and Science Agenda (NISA) and existing programs such as the R&D Tax incentive, the Government noted that it had already implemented a number of measures to support SMEs such as the IP Toolkit for Collaboration, Source IP, the Patent Analytics Hub and grants and advisory services for businesses in certain industry sectors looking to leverage their IP.  Moreover, IP Australia has established an IP Counsellor to China, is trialling patent analytics services and is raising education and awareness of IP issues with local start-ups.

More recently, IP Australia has introduced its Portal for small and medium enterprises (SMEs), which comprises sections aimed at helping SMEs navigate the maze that is IP. 

What are we doing to assist SMEs?

Your innovation patent can still be filed up until 26 August 2021 and will run for the full eight-year term.  Any SMEs thinking this path might be right for them should get in touch with their patent attorney as soon as possible.

Alternatively, or in combination with the Government resources mentioned above, many patent attorneys (such as us) are happy to point SMEs in the right direction, at no cost and with no obligation – after all, Mr Gates, Mr Musk and their mates all had to start somewhere…

Happy World IP Day, everyone.

2 min read

IP Australia has been providing free, streamlined extensions of time of up to three months if a deadline cannot be met due to the effects of COVID-19.  However, streamlined extensions will not be available after 31 March 2021.

Streamlined extensions (until 31 March 2021)

The streamlined process has been available at IP Australia for requesting an extension of time of up to three months when an IP Rights holder is unable to meet a deadline due to the disruptive effects of the COVID-19 pandemic.  Many deadlines for patents, trade marks and designs have been covered by the streamlined extensions of time.

No declaratory evidence or fee has been required; it has been possible to simply check the relevant box on IP Australia’s eServices system to declare that the deadline cannot be met due to disruptions from the pandemic. 

Requesting extensions of time at IP Australia for patents, trade marks and designs from 1 April 2021

If you are unable to meet a deadline due to the COVID-19 pandemic, it will still be possible to request an extension of time.  However, from 1 April 2021, a declaration will be required to explain why you cannot meet the deadline.

The grant of an extension of time due to the effects of the pandemic does involve an element of discretion.  For patents, such extensions fall under section 223(2)(b) of the Patents Act 1990, according to which an extension of time “may” be provided if a deadline is missed because of “circumstances beyond the control of the person concerned”. 

Requests for extensions of time due to COVID-19 made from 1 April 2021 will be considered on a case-by-case basis and the Commissioner’s/Registrar’s review will consider the impacts of the pandemic.  

We can help

For more information about extensions of time in Australia, see our earlier article here: https://shelstonip.com/insights/publications/missed-an-australian-patent-deadline-heres-what-to-do/.

If you require assistance with your IP Rights, please contact us. 

Authored by Serena White, DPhil and Gareth Dixon, PhD

3 min read

The Therapeutic Goods Administration (TGA) has commenced a timely public consultation into the repurposing of prescription medicines, which seeks to better understand the incentives and potential hurdles influencing sponsors’ decision-making on whether to extend the approved indication for an existing medicine. Of particular interest to the TGA is the viability of repurposing medicines for rare diseases or less commercially profitable indications, or in circumstances where the new indication is already accepted clinical practice, albeit ‘off-label’ in Australia or elsewhere.

As part of its consultation paper the TGA has proposed far-reaching changes that have the potential to significantly reduce the regulatory burden on sponsors when applying for the inclusion of a new indication, improve information sharing and access to related international regulatory and reimbursement approvals, and implement open access to Australian medicine usage data.

Repurposing and ‘off label’ use

Repurposing, also referred to as second medical use, is the use of a known drug for a new therapeutic purpose. Repurposing is a promising avenue in drug discovery and has been an active area of growth in the last decade for a variety of drug classes, particularly chemotherapeutic agents.

Among the most visible recent examples of potential repurposing have been the investigation of known medicines such as chloroquine and hydroxychloroquine (both anti-malarials), remdesivir (an antiviral developed to treat Ebola) and tocilizumab (a monoclonal antibody developed to treat rheumatic conditions) and numerous other existing medicines as potential COVID-19 treatments.

Repurposing has the important benefit of decreasing the overall cost of bringing a new treatment to market and broadening access to it by Australian prescribers and patients, as the safety and pharmacokinetic profiles of the repurposed candidate have already been tested and established in connection with its original indication(s). 

In recent years, the TGA has worked with innovator sponsors to enable them to make submissions based on peer-reviewed literature, rather than clinical data, for registration of new indications for existing medicines on the Australian Register of Therapeutic Goods (ARTG). This in turn has enabled reimbursement for the indication through listing on Australia’s Pharmaceutical Benefits Scheme (PBS). 

In one such example, the TGA worked with the sponsor of Tamoxifen, a well-known breast cancer hormonal treatment in clinical use since the 1970s, to submit a literature-based application for a new indication (the prevention of breast cancer in high-risk women), which is an off-label use supported by recommendations in both Australian and international clinical care guidelines.

However, the TGA cannot compel sponsors to seek ARTG registration for a new indication that does not meet the sponsor’s business objectives, even where widespread and clinically-supported off-label use exists. Commercial imperatives are therefore one of the main barriers to less profitable second medical use indications becoming registered and subsidised.

Proposed approaches to facilitating and encouraging repurposing of medicines

The TGA has outlined three broad approaches to encouraging ARTG regulatory and PBS reimbursement applications for repurposed medicines, summarised below.

Proposal 1 – Reduce regulatory burden

  • Develop and provide specific regulatory support and guidance for repurposing medicines, including clinical trial design and scientific advice.
  • Assist with the development of literature reviews to simplify literature based submissions.
  • Facilitate access to comparable overseas evaluation reports, where they exist.
  • Improve the coordination of multi-jurisdictional submissions with other regulators.
  • Provide fee relief (currently a TGA application and evaluation for an extension of indication is approximately $148,000), for submissions for medicines that have low commercial returns but high public health gains.
  • Streamline simultaneous submissions for regulatory and reimbursement evaluation.
  • Provide exclusivity periods for the first sponsor of new indications of repurposed off-patent medicines.

Proposal 2 – Enhanced information sharing and access

  • Facilitate open access to Australian medicine usage data.
  • Provide a simple mechanism to find related international regulatory and reimbursement approval assessment reports or decision summaries.

Proposal 3 – Actively pursue registration and review

  • Seek public expressions of interest for sponsorship of new indications of a medicine, potentially limited to non-commercial organisations.
  • Compelling sponsors to make an application for an additional indication.
  • Pharmaceutical Benefits Advisory Committee (PBAC) to have the ability to approve the inclusion of an additional indication without the need for an application by the sponsor.

The issues raised by this consultation paper have important and far-reaching implications for both innovator and generic sponsors, and it will be of interest to see the outcome of this first round of pubic consultation, which concludes on 30 March 2021.

Authored by Duncan Longstaff

4 min read

Patent classification titles are usually pretty boring, but occasionally one will jump out at you and fire up your imagination.  A62B33 is one of those.  Its full title is Devices for allowing seemingly-dead persons to escape or draw attention; Breathing apparatus for accidentally buried person.

See what I mean?  Right now your mind is conjuring up images such as:

This one isn’t even that old.  It dates back to 2013, and it’s not even the most recent disclosure of this type.

Generally though, devices such as these have a very long history with the first recorded back in the late 18th century.  The earliest patent I can find dates to about one hundred years later, in 1892, but it’s just one of a flurry of patents in this area over the next decade or so.

It’s a simple mechanism comprising a bush of feathers in a tube, protruding above the ground, and triggered essentially by the seemingly dead person attempting to sit up, and as such bumping their head, releasing the bush of feathers out of the tube to be noticed by eagle-eyed cemetery goers.  It’s not all bad though as the point at which one bumps their head has been thoughtfully padded.  An egg on your head is probably the least of your worries in that situation.

If we switch for a moment to filings in the class over time, you can see three distinct periods: from the late 1800s to the mid 1960s, from there to the mid 1990s, and from there to today.  The number of families filed within these periods steps up four-fold each time, so is this by necessity or technological advance?

If I was to generalise regarding the subject matter within these three distinct periods, I would have to say that the first period corresponds with what are known as safety coffins.  These are coffins with mechanical mechanisms that allow someone to signal that they are indeed alive, and breathe while waiting for that signal to be seen.  Here are a few more examples: US500072, GB191006409 and FR1065868.

The second period would appear to coincide with the rise of electronics and personal devices.  There is also a move away from safety coffins, and towards buried persons of other types such as avalanche or landslide victims or lost scuba divers.  Advancements in the field of electronics mean beacons carried by skiers or mountaineers allow a person to be located by rescuers easily when there is no visible sign of their presence, but other personal devices still rely upon a mechanical device in the same way a safety coffin would have.  Gas canisters with balloons on long ropes can be activated in the event of an avalanche to expand the balloon to provide a visible signal to rescuers.  The balloons also serve as possible buoyancy aids while you’re sliding down the mountain, leaving you close to the surface, or as possible snow free refuge and air providers if they end up close to the person and can be deflated.  Examples in this group include CH450499, US3786406, US3911913 and US5490501.

The third period still appears to electronics driven, although now the devices are getting smaller, more sophisticated, and reliant upon communication networks, even those being filed in the safety coffin space.  There is also a focus on wearables such as jackets and helmets, with more features such as air bags, an air supply or illumination, providing more time before rescue.  Here are some examples from this period:  DE19957408, US2003208890, US2009121930, and US2018326233.

I’ve drawn the line for the most recent period as flat, but really filings are trending positively.  Much more than the previous two periods did.  One of the first things to do is see where these patent families are originating from.  As Chinese originating applications are surging in general, I looked to see if that is the case here, and it’s not.  No one country appears to stand out.  Some of the higher filing jurisdictions are the European Patent Office, the United States, Germany and China. 

The highest of those is the European Patent Office, and the majority subject matter is wearable airbag systems, so perhaps that’s where the trend has been in recent years.

Lastly, the award for the ultimate in ‘on trend’, or serendipity or opportunism, has to go to the applicant for DE102018005497

As you can see it’s a rescue system for people trapped in caves enclosed by water.  Sound familiar?  It was filed just one day after the Tham Luang cave rescue in Thailand.

This patent class, A62B33, sounds funny, and early examples do look ridiculous these days, but today the subject matter is quite serious and along very different lines, which shows just how much a broadly titled, long forgotten class can change over time.

Authored by Frazer McLennan and Charles Tansey