4 min read

FemTech is surging around the world with new start-ups and technology entering the marketplace every day, but what’s going on Down Under?

Need for FemTech

As of June 2019, just over half of Australia’s population faced complicated genetic, physiological and hormonal factors making them prone to and more severely affected by certain conditions in comparison to the other half of the population.

Conditions such as heart diseases, osteoarthritis, cancers, strokes and autoimmune diseases present in women differently and pose considerable health risks. 

While FemTech is rapidly growing in Australia, increased health technology options are still needed to support Australian women. This has become even more apparent during the pandemic where existing inequalities in healthcare for women have been laid bare. 

Research is currently well placed in Australia with the Australian Government announcing they will be investing $354 million over the next four years to support the health and wellbeing of Australia’s women, including funding for cervical and breast cancer, endometriosis and reproductive health.

Current market snapshot

FemTech in Australia is still relatively new and unchartered territory. No official study has been conducted about Australian FemTech companies, however, the rise of new FemTech companies and products is undeniably on an upward trajectory.

The Women’s Health Summit 2021 hosted by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists highlighted issues and deficiencies in the Australian healthcare system about health equity for women; access to mental health, contraception, abortion, sexual health and reproductive services; preventative approaches to chronic diseases; and areas in the medical industry where data about women lack.

Australian companies

FemTech typically spans across medical devices, digital health applications and direct to consumer products. Even though medical related digital health applications have only entered the market within the last decade, they are fast becoming the front runner for providing women with access to crucial information about medical conditions, including their diagnosis, treatment and management. Their popularity, which has reached new heights, is primarily due to their accessibility and ease of use.

The following Australian companies have redesigned, reinvented and recycled technology to benefit the health of women:

Menstrual pain

Transcutaneous electrical nerve stimulators (TENS) have typically been used for musculoskeletal pain, such as chronic back pain or knee joint arthritis.

Ovira, a female owned start-up had other ideas for TENS and have developed a non-invasive and instant period pain relief through their device, Noha. The Noha device sends low-level pulses of electric vibrations to the abdomen to block pain signals from being sent to the brain.

Menstruation

Since their conception, menstrual products have made their way from rags to riches. Starting off from cloth, bandages, cotton and wool in the 1800’s to disposable pads, winged pads, and tampons in the 1900’s, menstrual products have come a long way.

Modibodi, are at the forefront of menstrual technology and provide reusable and sustainable leak-proof period apparel that replaces the need for disposable products such as panty liners, tampons, pads, and incontinence products.

Juju, a socially responsible and environmentally conscious company manufactures Australia’s only made menstrual cup.

Payment solutions for the adult industry

Businesses and workers operating in the sex industry find themselves facing discrimination and often struggle to get finance or financial services.

Intimate.io, a blockchain startup, has taken this issue into their own hands. Intiamte.io is focused on solving issues inherent in the adult industry by establishing a cryptocurrency to operate as a digital payment option for adult or sexual products, services or offerings.

Fertility solutions

Despite major technological advancements in IVF, the success rates of IVF still remain very low.

Life Whisperer, an AI focused company, has been using AI to increase the chance of pregnancy through IVF by identifying morphological features that constitute a healthy embryo.

Future of FemTech Down Under

With women comprising over 50% of the population, these emerging companies have a huge opportunity to improve the health and wellbeing of millions of Australians. We expect the Australian FemTech market to continue to grow with local start-ups and from the expansion of international FemTech companies.

It is encouraging to observe the recognition by the Australian Government of the need for better understanding of pressing health challenges faced by women and the injection of money into the women’s health sector to combat some of the challenges.

Companies like Ovira, Modibodi, Juju, Intimate.io and Life Whisperer continue to break boundaries and use technology to find solutions to age old women’s health issues.

Shelston IP are proud supporters of FemTech, assisting FemTech businesses to protect their innovative new products and develop and implement intellectual property strategies to achieve a sustainable competitive advantage.

Authored by Connie Land and Allira Hudson-Gofers

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

Welcome to Shelston IP’s wrap-up of the most notable patent law decisions in Australia and New Zealand delivered during 2020 – a remarkable year indeed. The High Court delivered its first decision in a patent case since 2015, and there was an interesting spread of Full Federal Court, Federal Court, Australian Patent Office and Intellectual Property Office of New Zealand decisions relating to issues of patent validity, infringement and amendment as well as procedural issues.

Read our full report

  • The High Court of Australia has endorsed the doctrine of exhaustion in favour of the longstanding doctrine of implied licence with respect to patented products in Australia, but made clear the critical question remains whether the modifications made to a product in each case are properly characterised as permissible repair or impermissible re-making (Calidad v Seiko Epson).
  • An enlarged Full Federal Court has confirmed that a protocol for a clinical trial that is publicly available can be novelty-defeating, provided the information disclosed is sufficiently specific and complete to disclose the invention that is later claimed. The Full Court has also provided important guidance on the nature and scope of Swiss-style claims, and the circumstances under which such claims may be infringed (Mylan v Sun).
  • The Full Court of the Federal Court has found that a computer-implemented method that linked website users to online advertising was not a manner of manufacture and therefore not patentable subject matter (Commissioner of Patents v Rokt). In separate decisions, a computer-implemented method relating to “sandboxing” (Facebook) and an invention relating to the hardware and software components of an electronic gaming machine (Aristocrat v Commissioner of Patents) were held to be patent-eligible subject matter, while a modified roulette table was found not to be patent-eligible (Crown).
  • The Full Court of the Federal Court has confirmed that section 105(1A) of the Patents Act 1990 (Cth), introduced by the Raising the Bar reforms, confers on the Federal Court the power to direct amendments to patent applications during the course of an appeal hearing (Meat and Livestock Australia v Branhaven).
  • In the long-running patent dispute relating to Lundbeck’s antidepressant, Lexapro (escitalopram), the Full Court of the Federal Court overturned a decision that had found Sandoz liable for patent infringement during the extended term of a patent after it was restored, and awarded damages. Lundbeck has recently been granted special leave to appeal to the High Court of Australia, which for the third time will hear an appeal regarding an aspect of this long-running litigation (Sandoz v Lundbeck).
  • The Federal Court provided its first detailed analysis of the Raising the Bar reforms to Australian patent law concerning sufficiency and support. A subsequent judgment on final relief, delivered in November 2020, highlights the challenges facing a defendant who seeks to resist final injunctive relief on public interest grounds (Merck Sharp & Dohme v Wyeth). Those sufficiency and support requirements, as well as best method, were also considered in detail by the Australian Patent Office (University of British Columbia, Gliknik v CSL).
  • In an unprecedented decision, the Federal Court of Australia has considered and dismissed a claim by the Commonwealth Government for compensation from sponsors of innovator pharmaceutical products, pursuant to undertakings as to damages given in exchange for an interlocutory (preliminary) injunction restraining the launch of the first generic product (Commonwealth v Sanofi).
  • A party which gave undertakings not to launch an allegedly infringing biosimilar without first giving notice successfully resisted an application for preliminary discovery (Pfizer v Sandoz). Conversely preliminary discovery was granted against a former employee, but limited in scope due to the prevailing financial circumstances (Sovereign v Steynberg).
  • Extension of term applications were refused for pharmaceutical patents (Pharma Mar, Ono).
  • An opposition to an Australian patent application based solely on a challenge to entitlement was successful (Liquid Time v Smartpak).
  • The Federal Court considered the applicability of the Crown use defence to infringement, and the effect of prior disclosures by the Crown on validity (Axent v Compusign).
  • The nature and detail of disclosures in prior art and the common general knowledge proved determinative of the validity in decisions concerning a combination pharmaceutical product (Boehringer v Intervet) and a parking management system (Vehicle Monitoring Systems v SARB).
  • The construction of claims in the context of the entire specification proved determinative of issues of infringement and validity in several decisions (Caffitaly v One Collective, Nufarm v Dow, CQMS v ESCO).
  • The Intellectual Property Office of New Zealand has delivered decisions demonstrating the difficulty of opposing an application under the “old” 1953 Act (Lonza v Koppers), the high burden for computer-implemented methods (Thomson Reuters) and the more onerous support requirements under the “new” 2013 Act (Taiho Pharmaceutical).

As we continue into 2021 (and away from 2020), we hope this review provides a practical and comprehensive resource. Please do not hesitate to take the opportunity to contact our authors, all subject-matter experts in their respective fields, for advice on the issues raised by these important decisions.

Authored by Duncan Longstaff

5 min read

The America’s Cup (the “Auld Mug”) is the world’s oldest sailing trophy and enjoys a storied history of fierce competition – both on and off the water.  Whereas legal drama throughout the years was previously restricted to claims of sabotage, subterfuge, cheating or some far-fetched interpretations of the “rules”, the upcoming 2021 event has thrown up yet another reason to get off the water and into the courtroom – allegations of patent infringement.

Background

The 36th edition of the America’s Cup is scheduled to be held in Auckland, New Zealand, between 6 and 21 March 2021.  It pits the holders, Emirates Team New Zealand (ETNZ), up against the winner of a challenger series to be contested between Luna Rossa (Italy), Ineos Team UK and American Magic.  The concept of the challengers sailing off before matching up against the holder is nothing new.  However, what is unique to this event is the category of yacht in which the event will be contested – the new “AC75” (America’s Cup 75 class) is a 75-foot (23 metre) hydrofoil monohull vessel.  To the layperson, it’s a regular yacht that “flies” just above the waterline.

Again, the concept of a flying (or more correctly, “foiling”) yacht is nothing new.  For example, the 34th (2013) and 35th (2017) editions (held in San Francisco and Bermuda, respectively) used a class of foiling catamarans (double-hulled yachts), which, when conditions and crew-work were optimised, was able to get up on its foils (i.e., lift the hulls out of the water), thereby minimising drag and increasing speed.  The ultimate goal, of course, was to complete the entire course on foils, which was referred to as a “dry lap”.  Foiling catamarans certainly provided for spectacular racing over the two events.

Following the narrowest of misses in 2013, the 2017 event was won by ETNZ.  In accordance with the “rules” of the event, ETNZ not only got to host the next edition, but also had the authority to decide upon the class of boat in which the event would be contested.  Following lengthy consideration (much of which was centred upon conditions likely on the Hauraki Gulf where the 2021 event would be contested), ETNZ opted for a new class of boat – the AC75 foiling monohulls.

What’s a “foil”?

As shown on the official America’s Cup website, the hull of the AC75 lacks the traditional centred keel, but instead has a retractable “foil” on either side. When one of the foils is engaged with the water, and provided sufficient speed is reached, it acts in combination with the rear rudder foil to force/lift the hull out of the water, which in turn imparts the speed advantages mentioned above.  In operation, the leeward (on the side opposite to which the wind is coming from) foil is engaged with the water whilst the windward foil is retracted or held out of the water.

Shown below is an example of ETNZ’s test boat “Te Aihe” (a 50-foot scaled-down version of the AC75) foiling successfully during testing.

Despite the conceptual imagery linked above, all four syndicates are employing similar, although subtly different, foil designs.

So, what’s the patent problem?

Manoel Chaves, a Brazilian naval architect and boatbuilder, is the patentee in respect of New Zealand patent 740860, dated 31 October 2016.  NZ’860 is a granted patent derived from PCT/BR2016/050275 via WO 2017/083947.  It is entitled “Sail boat propulsion and stabilisation system and device”, which is more specifically characterised by IPONZ as a “Sail boat hydrofoil with pair of wings on opposite hull sides with downward keel and outstanding lift wing, with pivoting of keels and wings independently”.

According to media reports, Mr Chaves believes the canting foil system used in the AC75 boats is covered by NZ’860.  Mr Chaves’ representatives are understood to have contacted ETNZ in this regard.  However, the same article quotes ETNZ as having already denied patent infringement as of July 2020.

What does NZ 740860 describe and claim?

Figure 1 of NZ 740860 appears to illustrate, broadly, a hydrofoiling system arguably similar to those found on the AC75 yachts:

As we know, “similar” is a subjective term. That said, claim 1 of NZ 740860 is reasonably wordy, and construing it would no doubt account for several days’ court time should the matter ever proceed to trial:

  1. A system for propelling and stabilizing a sail boat, comprising a control panel, standard or electronic stabilization, actuated by a battery connected to a hydraulic aggregate that is connected to directional valves and solenoids through which each device of a pair of devices for propelling and stabilizing the sail boat is independently actuated respectively to larboard and starboard, and each device is provided with a wing keel, a counterweight or “lift” wing joined by a bulb, a cylindrical actuator of the counterweight or “lift” wing, a rotary hydraulic actuator for hoisting the assembly, an articulation shaft, which runs in the direction of the counterweight or “lift” wing and transverse to the keel, and a tilting shaft for the assembly, which is coupled to the boat broadside or to a mounting base provided for the boat broadside of already existing boats, beside sensors of the angle of attack of the counterweight or “lift” wing.

The dependent claims (claim 2, in particular) are even longer.  According to the above-linked media, ETNZ’s July 2020 response to Mr Chaves was that NZ’860 defines features not found on the AC75 yachts.  Quite what those features may be based upon my “elementary” understanding of the foiling system used on the AC75s and chemist’s understanding of claim 1, is uncertain.

Legal permutations

As noted above, all three challengers (Luna Rossa, Ineos Team UK and American Magic) are employing hydrofoils broadly similar, albeit subtly different to ETNZ.  If ETNZ is held to infringe, then does it necessarily follow that the three challengers are infringing also?  Alternatively, as the entity that created the new AC75 class, does ETNZ bear any responsibility for the challengers infringing?  Of course, until such time as the matter is formally contested in a New Zealand court, these questions are all strictly hypothetical.

A continuing history of more fun off the water than on it

In my time following the America’s Cup, which dates back to 1983, when Australia II defeated Dennis Conner’s Liberty, the event has been beset with a series of courtroom battles that, depending on one’s perspective, either amplify or detract from the drama on the racecourse.  From Australia’s winged keel (1983), to New Zealand’s “plastic fantastic” fibreglass boats (1987), to New Zealand’s “big boat” challenge (1988), to all the legal jostling regarding the citizenship rule, the use of technology, where the event should be staged when the Cup was held by landlocked Switzerland, etc., this has always been more than just a yacht race.

Watch this space.  The America’s Cup equals high stakes and big money. Whilst not your traditional battlefield for a patent dispute, it does have almost every other ingredient.

Authored by Gareth Dixon, PhD

2 min read

To celebrate International Women in Engineering day (23 June 2020), Shelston IP would like to highlight our outstanding female patent attorneys and patent engineers qualified in this field.

With 30 years of experience in the patent profession, Caroline Bommer is the female engineer that we aspire to be. She provides a wonderful example of the possibilities for our young female attorneys and is appreciated by all of her clients, particularly in her effective communication and her ability to understand their business strategies. Caroline’s mechanical engineering expertise is also extensive, including practical knowledge acquired prior to joining the patent profession in the industries of building, transport, aerospace, and defence. She has a keen interest in green technologies, with many years of personal involvement in solar car racing. Ask her to take you for a spin!

Tam Huynh works in the fields of electrical engineering and information technology patents. Growing up, Tam would find any excuse to integrate electronics into her arts and crafts projects. This included raiding her Dad’s electronics kit to make LED greeting cards for her family. She went on to study Computer Engineering at University and undertook a project exploring the use of solar power technologies and their application with mobile devices. Tam now assists with the ongoing management of patent portfolios in a range of fields, including electrical power systems, information and software systems, mining and automation, and medical devices. Tam also holds a Bachelor of Commerce degree and her accounting background adds additional depth to her handling of financial-system related inventions.

With childhood memories of jumping off a red billy cart and yelling “Newton’s third law”, Allira Hudson-Gofers brings her enjoyment of physics and engineering into her role as the head of Shelston IP’s Engineering and ICT Patents Group. Allira studied both mechatronics and biomedical engineering at University, going on to develop particular expertise in research, product development, regulatory affairs, and intellectual property in the medical technology space. She now applies this expertise, together with her recent MBA studies, to help her clients protect and commercialise their innovations.  

Connie Land had her interest in the human body and medical devices sparked in high school, which lead her to pursue a degree in Biomedical Engineering. Connie started her career with hands-on experience maintaining, repairing, and programming medical devices.  Last year, after discovering that the role of a patent attorney was a career option for engineering graduates, she hung up her tools and joined Shelston IP as a Patent Engineer. Connie now works with medical devices in a different capacity and uses her passion and knowledge of medical devices and technology to help her clients navigate the path to obtaining patent and design protection. She is currently studying a Masters in Intellectual Property and is looking forward to becoming a registered patent attorney in Australia and New Zealand. 

Authored by Allira Hudson-Gofers, Caroline Bommer, Tam Huynh and Connie Land

1 min read

Welcome to Shelston’s wrap-up of the most notable patent decisions in Australia and New Zealand delivered during 2019. It was a busy year for patent jurisprudence with some interesting themes emerging – in particular, it has been a banner year for decisions on the “manner of manufacture” requirement for patentable subject matter.

Read our full report

  • An expanded Full Federal Court clarified the “manner of manufacture” test for computer-implemented methods to be patentable (Encompass), a topic that was also central to several other Federal Court (TettmanRepipeWatson) and Patent Office (Apple) decisions.
  • There were also important “manner of manufacture” decisions in the life sciences space, with single judges finding both a diagnostic method involving a process of detecting genetic material (Sequenom) and use of genetic information to infer traits (Meat & Livestock Australia) to be patentable subject matter.
  • The Full Court confirmed there is no doctrine of patent exhaustion in Australia, the critical distinction being between repairs permitted by implied or express licence terms brought home to the purchaser of a product, and the impermissible re-making of the product beyond the scope of any licence (Calidad (No. 1)).
  • The Full Court confirmed that a permanent injunction framed in general form by reference to the claims of an infringed patent is generally appropriate and may be ordered in addition to a specific injunction describing products or conduct found to infringe (Calidad No. 2).
  • The Full Court overturned an award of additional damages for flagrant patent infringement on the basis that the infringer had believed, on objectively reasonable grounds, that its conduct did not infringe the patent (Oxworks).
  • The tide continued to turn against pharmaceutical patentees being granted interlocutory injunctions (MylanSanofi-Aventis).
  • Patentees learned some harsh lessons as the Full Court dismissed infringement claims based on the construction of the terms “contains” (construed exhaustively in Nichia) and “recognise” (construed broadly in Davies).
  • There were several applications by patentees to amend patent claims and specifications after commencing infringement proceedings (Meat & Livestock AustraliaNeurimBlueScope), with mixed success.
  • Consideration was given in the Patent Office to Australia’s “raised bar” requirements for support and sufficiency (Gary CoxUniversal Polymers).
  • Both clinical trial patient consent forms (InterPharma) and academic conference posters (Regeneron) were considered prior art documents in life sciences cases.
  • There were further decisions regarding families of patents that have been litigated for a decade or more (GlobaltechSNF).
  • There were also decisions regarding the admissibility of “WayBackMachine” evidence (Dyno Nobel), summary dismissal of an infringement case (Pilkin), a successful application for preliminary discovery (MMD), a failed cross-claim for unjustified threats (Liberation), a failed attempt to withdraw admissions relating to infringement (Juno), a “strawman” opponent to a patent application having to pay security for costs in an appeal despite winning the opposition (Toolgen) and a party commencing infringement proceedings despite not being a proper exclusive licensee having to pay indemnity costs (Vald).
  • Two recent decisions issued by the Intellectual Property Office of New Zealand provide new hope that, in certain circumstances, it may be possible to obtain an extension of time to file a divisional patent application (PrimapakMagic Leap).

As 2020 gets underway, we hope this provides a useful and practical resource and, of course, please do not hesitate to take the opportunity to contact our authors, all subject-matter experts in their respective fields, for advice on the issues raised by these important decisions.

Authored by Duncan Longstaff and Onur Saygin

It seems the abolition of Australia’s second-tier patent system, the innovation patent, (as detrimental as this will be for Australian business) could be considered a high-profile distraction to divert attention away from new laws that will potentially render patents claiming chemical compounds, with reference to a structural formula, vulnerable to invalidation.

This issue relates to new laws that apply to Section 40(3A) of the Patents Act 1990, which was originally introduced in 2013 to remove the use of claims that refer to examples in a specification, i.e. omnibus claims. At that time, Section 40(3A) recited that “the claim or claims must not rely on references to descriptions or drawings unless absolutely necessary to define the invention”. More recently, the Intellectual Property Bill (Productivity Commission Response part 1 and other Measures) Bill 2018, expanded the scope of Section 40(3A) to cover claims referring to “drawings, graphics or photographs”.

Relevantly, Section 40(3A) does not refers to “parts” of the specification – it simply refers generally to “descriptions, drawings, graphics and photographs”. Thus, current Section 40(3A) appears to go beyond its initial purpose of removing the use of omnibus claims and potentially renders claims that include drawings, graphics and photographs unacceptable. This arguably includes frequently used chemical claims that refer to a structural formula as a graphic representation of the molecular structure of a chemical compound, or an X-ray diffraction pattern, i.e. drawings or graphics.

Currently, Section 40(3A) can only be considered during examination and, in our experience, the Patent Office is only enforcing it against claims that refer to parts of the specification. However, when the Intellectual Property Bill (Productivity Commission Response part 2 and other Measures) Bill 2019 comes into force, most likely at the end of November 2019, Section 40(3A) will become a ground for re-examination, opposition and revocation.

At the very least the new laws, as they relate to Section 40(3A), introduce considerable uncertainty as it is not clear how they will be interpreted judicially. The explanatory memorandum to the Bill is not helpful because it only considers Section 40(3A) as covering omnibus claims. Moreover, as there is a reasonable argument that reference to a structural formula in a claim is not absolutely necessary to define the invention because compounds can be defined by chemical names, future patentees of chemical compounds have a right to feel nervous. For this reason, it may be prudent for applicants of chemical compound applications to cover their most commercially relevant embodiments in independent claims that define a chemical compound by its IUPAC name, in addition to relying on claims that define a structural formula. Notwithstanding, that a claim that refers to a chemical structure is more succinct than one that refers to a long and potentially unclear chemical name.

Shelston IP will, of course, continue to monitor the introduction of the new laws and provide necessary updates.

Authored by Gareth Dixon, PhD

In July 1969 the United States of America put two men on the moon. Years later in 2011, the then Prime Minister of Australia, Julia Gillard, stood before US Congress and recalled the same moon-landing memory and with acquiescence wept that “Americans could do anything!” Today, the US seems to have entered, what was once described in an episode of Seinfeld as, “Bizzaro world” – Donald Trump is in the White house and, even more astonishingly, researchers are unable to protect what have been described judicially as “truly meritorious” and “ground breaking” innovations in the diagnostics and personal medicine space. Today it is Australia that reigns supreme over the US, as the Federal Court in Sequenom, Inc. v Ariosa Diagnostics, Inc. [2019] FCA 1011 (27 June 2019) confirmed that a non-invasive method of detecting fetal characteristics and abnormalities is patent eligible subject matter in Australia!

The set up

The inventors of the patent-in-suit, Australian Patent No 727919, in the name of Sequenom, Inc., discovered that the cell-free fractions of a pregnant woman’s blood contain surprisingly large amounts of cell-free fetal DNA (cffDNA). Traditionally, this portion of the plasma or serum was discarded as medical waste. This pioneering discovery led to the development of the claimed non-invasive method to determine fetal characteristics and abnormalities, such as Down syndrome. Ariosa Diagnostics Inc, who sought to revoke Sequenom’s Patent, conducts and licenses others to conduct a non-invasive prenatal diagnosis test, marketed under the name “Harmony”, which Sequenom claims infringes their patent.

The significance of the Australian Sequenom decision has been fuelled by the corresponding US case where the claims of the Sequenom’s patent were found to be patent ineligible because they were held to be directed to naturally-occurring matter. The ensuing detrimental impact on US diagnostics industry has subsequently resulted in a proposal for changes to the patentable subject matter legislation, which is currently being considered by US congress.

Issues and findings

Under Australian law, patent eligibility is guided by the principles of the High Court’s decision in National Research Development Corporation v Commissioner of Patents(‘NRDC’) [1959] HCA 67. In that landmark decision, it was held that subject matter was considered patent eligible if it was “an artificially created state of affairs” having “economic significance”.

Ariosa’s case relied heavily on the approach that proved successful in the US, namely that the claims cover a mere discovery, that being the presence of cffDNA, which can be detected in the plasma or serum of pregnant women, and that the end result of each claim is not an artificially created state of affairs. Ariosa further submitted that the claims involve nothing more than the use of well-known techniques to detect cffDNA in maternal blood.

Ariosa also suggested that the Court should follow the US position, which they suggested was in harmony with the Australian Myriad decision. Judge Beach’s response was an emphatic, “I hardly think so”. In fact, in considering the Australian High Court Myriad decision, Beach J emphasised the difference between the gene product claims considered in Myriad and the method defined in the claims of Sequenom’s patent. In particular, he stated that “in nature, the presence of cffDNA in the maternal blood has not and cannot be detected without human action. Accordingly, unlike the claims considered in Myriad, the invention claimed adds to human knowledge and involves the suggestion of an act to be done which results in a new result, or a new process”.

The Court also agreed with Sequenom that the substance of the claimed method is distinct to simply the identification of a natural phenomenon, namely the presence of cffDNA in maternal blood. This, the Judge said, is made clear by the patent specification, which explains that the invention offers a new approach for non-invasive prenatal diagnosis, which only occurs through human intervention and provides a significant advantage over existing fetal DNA detection methods, thus producing a result possessing economic utility.

Consistency with foreign law

Given the intense spotlight that has illuminated patentability issues in the US for diagnostic methods in recent times, the consistency of the Australian decision and the corresponding UK proceedings between Ariosa and Sequenom (Illumina, Inc v Premaitha Health Plc[2017] EWHC 2930), will likely go unnoticed. Those, however, looking for controversy in the conflicting Australian/US findings should look no further than Judge Beach’s swatting away of the issue by stating that the conclusion reached in the US decision is problematic because of the US Court’s dissection of the claims into their constituent parts, which is contrary to Australia’s NRDC and Myriad decisions, – end of story.

Conclusions

This decision, and the recent decision in Meat & Livestock Australia Limited v Cargill, Inc [2018] FCA 51, make it clear that claims directed to practical applications of naturally-occurring phenomena, including gene sequences, used in methods of diagnosis and prognosis are patent eligible subject matter in Australia. This will come as a welcome relief to the diagnostics and personal medicine industry and can be considered as “one small step” forward for Australian patent law but also, hopefully, “one giant leap” that influences beneficial change to the patent eligibility laws in the US.

Shelston IP congratulates its valued client Finisar Australia on being the recipient of the Prime Minister’s Prize for Innovation. The team at Finisar, which included Dr Simon Poole, Mr Andrew Bartos, Dr Glenn Baxter and Dr Steven Frisken, were awarded the prize at a ceremony on 17 October 2018 for their development of wavelength selective optical switches in the early 2000s. The switches use a dispersive prism to separate different colours of light and a liquid crystal on silicon chip to switch the different colours between optical fibres. The optical switches are now in use across the globe and have helped to increase the capacity and reliability of communications networks.

Shelston IP is proud to have assisted Finisar with the protection of their IP around the wavelength selective switch technology and many other inventions.

Authored by Peter Treloar