4 min read

Combe International Ltd v Dr August Wolff GmbH & Co. KG Arzneimittel [2021] FCAFC 8

Following on from our previous article, in a successful appeal by Combe International Ltd, the Full Federal Court disagreed with the primary judge’s approach to assessing deceptive similarity. As a result, it refused registration of the VAGISAN trade mark by Dr August Wolff GmbH & Co. KG Arzneimittel.

Background

Dr August Wolff GmbH & Co. KG Arzneimittel(Dr Wolff) is a German pharmaceutical company. It filed an application for VAGISAN on 27 May 2015 for the following goods:

Class 3: Soaps and cosmetics, all aforementioned goods not for the indication and application of tired legs and/or arms

Class 5: Pharmaceutical products, sanitary products for medical purposes; dietetic substances for medical purposes, all aforementioned goods not for the indication and application of tired legs and/or arms

Combe International Ltd (Combe) is a US company that markets and sells a range of personal cleansing, health and grooming products and is the owner of prior registrations for or incorporating VAGISIL. These registrations include the following goods:

Class 3: Medicated lotions and medicated creams; non-medicated products for feminine use

Class 5: Medicated products for feminine use; vaginal lubricants; medicated creams, gels, lotions

A delegate of the Registrar of Trade Marks refused registration of the VAGISAN trade mark on 29 September 2017 under s60 of the Trade Marks Act 1995 based on Combe’s prior reputation in its VAGISIL trade mark.

Federal Court Decision

The primary judge disagreed with the delegate’s decision and decided that Combe had failed to establish any ground of opposition.

On the issue of deceptive similarity (section 44), the primary judge found that the VAGISAN and VAGISIL trade marks are likely to be understood as indicating products to be used in relation to the female genital area. The primary judge took the view that the prefixes VAG and VAGI are descriptive, and that, as a consequence, the words VAGISAN and VAGISIL do not have a close phonetic resemblance. In his view neither of the words lends itself to mispronunciation, and the suffixes SIL and SAN are quite distinct.

Combe was also not able to establish that a significant or substantial number of potential customers might be confused or deceived by the VAGISAN mark such as to wonder whether there is any connection between it and VAGISIL, given Combe’s reputation (section 60) in the VAGISIL trade mark

Regarding the final opposition ground (section 59), the primary judge considered the fact that soap and cosmetic products were proposed to be introduced into Australia was sufficient intention to use the VAGISAN trade mark in respect of the designated goods.

The Federal Court decision is reported here.

Appeal to the Full Federal Court

In its Notice of Appeal, Combe claimed that the primary judge erred in his assessment of deceptive similarity between VAGISIL and VAGISAN by:

  • comparing the two words side by side;
  • engaging in a meticulous comparison of the two words, letter by letter and syllable by syllable with a clear pronunciation;
  • failing to give proper consideration to the notional consumer’s imperfect recollection of VAGISIL;
  • failing to give proper regard to the importance of the first syllable of each word and the tendency of English speakers to slur the endings of words;
  • breaking each word into component parts, assessing the descriptive and distinctive qualities of those parts and thus failing to pay proper regard to the whole of each mark;
  • failing to assess the whole of each mark as a coined term with no actual meaning; and/or
  • assessing the SAN element of VAGISAN as a distinctive and not descriptive feature, despite finding that SAN is readily understood as a reference to sanitary.
  • not giving sufficient weight to the high-volume and low-value nature of the VAGISAN Goods when making his assessment.

Section 44 – Deceptive Similarity

After consideration of the primary judge’s reasoning regarding deceptive similarity, the Full Court disagreed with the primary judge’s approach for a number of reasons.

Firstly, the VAGISAN and VAGISIL trade mark both have the same first five letters, they both have three syllables, and the VAGIS component is pronounced the same way. The only differences between the marks is the final two letters “AN” and “IL, and the only aural difference, being that between SIL and SAN, may be mispronounced or slurred.

Secondly, the idea of the mark is important in the consideration of deceptive similarity. In this case, consumers are likely to consider VAG or VAGI to be a reference to the vagina. Further, the first two syllables of both marks are likely to be remembered. While a similarity in idea may be insufficient for a finding of deceptive similarity if there is an absence of visual or aural similarity, in this case, the VAGISAN and VAGISIL marks also have visual and aural similarity.

Thirdly, the primary judge appeared to wrongly assume that the classes 3 and 5 goods of both the VAGISAN and VAGISIL trade marks were confined to goods for vaginal use, due to the descriptive nature of the prefixes VAG and VAGI. However, when assessing deceptive similarity, the notional use of the respective marks should have been considered, and the range of goods went beyond those for vaginal use.

In light of the above, the Full Court concluded that VAGISAN was deceptively similar to VAGISIL. The VAGISAN trade mark was refused.

Section 60 – Reputation

This ground of opposition was not considered, as the matter had already been decided by the Full Court’s findings on the conflict with Combe’s earlier registrations.

Takeaway and final comments

The Full Court decision provides guidance on the various factors that should be considered when assessing the deceptive similarity of trade marks. In particular, it is a reminder that marks should be considered and compared in their entirety.

In a further development, Dr Wolff has filed an application for the composite mark DR WOLFF’S VAGISAN, covering similar goods in classes 3 and 5 to its VAGISAN word mark. This application has been opposed by Combe.

Authored by Danielle Spath and Sean McManis

4 min read

In addition to Australia and New Zealand, Shelston IP has extensive experience in managing trade mark portfolios in other countries in the South Pacific region.

IP registration systems vary significantly around the South Pacific region with some countries operating under independent trade mark legislation, others allowing for re-registration of United Kingdom marks, while some of the smaller Pacific Island nations are yet to adopt a formal registration system and must rely on common law use and publication of a cautionary notice.

While outwardly, the procedures for securing trade mark protection in the South Pacific appear relatively straightforward, extended delays are often experienced when dealing with the smaller Pacific Island nations which have limited resources and which, from time to time, are affected by political instability and natural disasters.

Following is a brief overview of the IP protection systems available in key Pacific Island nations.

Fiji

Shelston IP use a local agent in Fiji to file trade mark applications.

Trade mark protection in Fiji can be sought by way of an independent national application under the Fiji Trade Marks Act or by an application based on an existing registration in the United Kingdom.

Fiji adopts the old British classification of goods (50 classes). Upon filing an application for registration of a trade mark designating goods under the International Nice Classification, they need to be reclassified according to the relevant Fiji class.

Service marks are not registrable and multi-class applications are not permitted.

Filing for re-registration of a United Kingdom registration is often a simpler and quicker process than filing a national application in Fiji.

Papua New Guinea

Shelston IP acts directly before the Intellectual Property Office of Papua New Guinea to file trade mark applications under the Papua New Guinea Trade Marks Act.

Service mark registration is possible but multi-class applications are not available.

Samoa

Shelston IP use the service of a local agent for trade mark filings in Samoa.

Trade mark protection can be obtained in Samoa by way of an independent national application under the Samoa Trade Marks Act. Since 4 March 2019, it is also possible to designate Samoa as part of an International Application under the Madrid Protocol registration system.

Service mark registration is possible and multi-class applications are accepted.

Tonga

Shelston IP use the service of a local agent for trade mark filings in Tonga.

Tonga has its own independent registration system for trade marks. Service mark registration is possible and multi-class applications are accepted.

Vanuatu

Shelston IP act directly before the Vanuatu Registry although we maintain a local address for service for transmission of correspondence from the Registrar.

Trade mark protection can be sought in Vanuatu by way of an independent national application under the Vanuatu Trade Marks Act. It is no longer possible to apply for trade mark registration based on a United Kingdom registration.

Service mark registration is possible and multi-class applications are accepted.

Kiribati, Solomon Islands and Tuvalu

Shelston IP act directly before the Registries in Kiribati, Solomon Islands and Tuvalu in trade mark matters.

These countries have no independent trade mark legislation and registration may only be obtained by re-registration of a United Kingdom trade mark registration. The resulting registration is entirely dependent on the corresponding UK registration and should that be cancelled for any reason, the corresponding right in the South Pacific country will also lapse.

There is no provision for service mark registration in these countries and multi-class registrations are not permitted.

Cook Islands, Marshall Islands, Micronesia, Niue, Palau and Tokelau

A registration obtained under the New Zealand Trade Marks Act 2002 automatically extends protection to Niue. While the 2002 Act does not apply to the Cook Islands or Tokelau at this time, a registration obtained under the former Trade Marks Act 1953 will cover these island countries.

There is no trade mark legislation in the Marshall Islands, Palau or Micronesia. Trade mark rights in these countries are based on the common law and may be asserted through use of the mark in the relevant jurisdiction and the periodic publication of cautionary notices in a local newspaper or government journal.

New trade mark legislation in Nauru

Until recently, trade mark registration was not possible in Nauru and the only means of protecting trade mark rights was under the common law. After many years in development, on 10 November 2020, the Republic of Nauru Trademarks Act 2019 and implementing regulations were brought into force and the Registry is now accepting applications for registration of trade marks.

Service mark registration is possible but it appears that multi-class applications may not be available.

Shelston IP can act directly before the Nauru Trade Marks Registry to obtain registration of trade marks for our clients.


While trade mark registration in the Pacific Island countries can often present challenges, Shelston IP is well placed to navigate around any difficulties to secure protection for your trade marks throughout this region.

If you require further information or assistance, please let us know.

Authored by Kathy Mytton and Sean McManis

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

10 min read

Office of the Retirement Commissioner v Cash Converters Pty Ltd [2020] NZIPOTM 27 (23 December 2020)

This recent decision provides helpful guidance on the principles for partial revocation of trade mark registrations in New Zealand and the determination of a “fair description” for goods and services.

The decision also highlights important differences between the law and practice on non-use removal proceedings in Australia and New Zealand.

Background

Cash Converters Pty Ltd (“Cash Converters”) sought partial revocation of the Office of the Retirement Commissioner’s (ORC) Registration No. 637400 SORTED. It covered Class 36 services in providing advisory, consultancy and information services relating to finance, investment and financial planning for and during retirement, and providing financial information relating to retirement.

They also sought partial revocation of Registration No. 976028 SORTED, which covered broadly worded Class 36 services “financial affairs; monetary affairs; real estate affairs” and various services in providing advice, consultancy and information the areas of finance, monetary affairs, retirement, real estate, property and insurance and Class 41 educational services and services in providing educational material and information relating to insurance, financial affairs, monetary affairs, real estate affairs.  The full specifications for the registrations are at [1].  

Revocation was sought on the basis of non-use of the SORTED mark for a continuous period of three years.

Facts/evidence

ORC started using its SORTED mark in 2001, when it established its website www.sorted.com for providing information and tools, such as online calculators, to help New Zealanders prepare for, and manage, their finances during retirement. 

From at least 2013 ORC’s use of SORTED expanded to a broader range of services in providing information, advice and resources to promote “the life-long financial literacy of New Zealanders”.  With this expansion in 2013, ORC obtained the later Registration No. 976028 SORTED for the broader range of services. 

ORC’s evidence of use included use of the SORTED mark on guides, booklets, seminar and course details, on online tools and calculators and on an online forum.  [2]

Discussion

As the SORTED mark had not been used on all of the services covered by the registrations, partial revocation was in order.   

The Assistant Commissioner noted the High Court decision in Sky Network Television Ltd v Sky Fiber Inc (Sky Network) confirming how partial revocation applications should be considered:

The case law establishes that the first task is to find as a fact what goods or services there has been genuine use of the trade mark in relation to; and then to ‘arrive at a fair specification of goods having regard to the use made’.”  [3]

ORC was found to have used the SORTED mark to provide generalised information, advice and education on retirement planning and financial literacy generally.  ORC was also found to have used the mark to provide online calculator tools and an online community forum which provided users with more specific information and recommendations. 

In considering what was a “fair description” of those services provided under the mark, the Assistant Commissioner identified the principles set out by Mallon J in Sky Network:

“(a) The assessment has “nothing to do with the defendant.” Defining the goods negatively by reference to the defendants’ activities is therefore not the approach. 

(b) The proprietor has protection outside his or her specification of goods in areas where he or she can demonstrate a likelihood of deception under other provisions. “There is no pressing need, therefore, to confer on the proprietor a wider protection than his [or her] use warrants by unduly broadening the specification of goods.

(c) The width of the surviving specification “must depend largely upon questions of fact and degree.”  “Wide words can cover what are commercially quite different sorts of articles”.  If there is shown to be use of just one of those things “it would be commercially nonsense to maintain the registration for all goods caused by the wide words”. [4]

In summary, and further quoting Mallon J in Sky Network, the Assistant Commissioner noted that:

The “fair description” is one “which would be given in the context of trade mark protection” and depends on the nature of the goods, the circumstances of the trade and the breadth of use proved” and should be approached as ““objective and impartial, balancing the competing interests” and “a view from the trade”.[5]

The Assistant Commissioner recognised the important “balancing exercise” of competing interests of the owner, competitors and the public:

  1. to have the Register uncluttered with unused marks or with registrations with overly broad specifications;
  2. to prevent parties being unjustifiably exposed to infringement of registrations with overly broad specifications; and
  3. “the owner’s interest in protecting its brand” which “aligns with the public interest in consumers not being deceived or confused by use of another trade mark” and the owner’s entitlement “to commercially realistic protection, remembering the test for infringement, extends to similar goods and services”.  [6]

Findings 

The scope of the original specifications was considered to “extend well beyond the actual use that had been made of the SORTED mark”.  [7]

The Assistant Commissioner considered that a “fair description” of the services offered under the SORTED mark could be reached by considering the “functions (the way the mark has been used) and the generalised, rather than personalised, nature of the education, information and advice ORC provides”.  [8] 

ORC was not using the SORTED mark in relation to all types of information, education and advisory services in the areas of insurance, finance, money, real estate and investment.  Those services were all provided in giving advice and information focusing on retirement and personal financial literacy, and not on all aspects of insurance, finance, money and other matters.

The Assistant Commissioner found that it was appropriate to limit the specifications to reflect the focus of the use and reworded the services more narrowly and as all “relating [or related] to retirement and personal finance”.

Further, ORC’s advice was not personalised advice given to individuals.  Rather, it was generalised advice and information.  The general description “advisory services relating to…” in the original Class 36 specifications for both registrations was considered too broad.  The Assistant Commissioner considered that it would be fair to describe those services as “general advice relating to…”.

The original term “consultancy services relating to…” used in the Class 36 specifications for both registrations was removed because ORC would not be reasonably understood to be a consultancy business.  The Assistant Commissioner noted that “there is no aspect of the ORC business that technically requires the description to be used. ORC is able to have commercially realistic protection without the reference to consultancy”.  [9]

The full specifications as amended are at footnote  [10].

Earlier cases considering partial revocation

The Assistant Commissioner provided a helpful summary of earlier partial revocation cases and what was found to be a “fair description” for the goods and services.  This can be found at paragraph 71. 

These decisions show that precise descriptions are applied in partial revocation actions and that broad and unqualified descriptions are unlikely to be allowed under New Zealand practice. 

Comparison with Australian law

The decision highlights some important differences between the law on revocation/non-use removal actions in Australia and New Zealand. 

1. Discretion to remove or restrict a registration

The Assistant Commissioner noted in the decision that there is no “overriding discretion to refuse to revoke or partially revoke a registration”, which follows from the decision Crocodile International Pte Ltd v Lacoste [2017] NZSC 14 at [97].  [11]  Under New Zealand law, a trade mark owner must show use during the three year non-use period, or special circumstances that justify non-use of their mark, to successfully oppose a revocation application.

Unlike New Zealand, under Australian law the Registrar has the discretion under s 101(3) of the Trade Marks Act 1995 not to remove a registration even where there has not been use of the mark if “satisfied that it is reasonable” not to remove the registration.  Further, s 101(4) provides that in deciding under subsection (3) not to remove a registration the Registrar may take into account use of the mark on similar goods or closely related services or similar services or closely related goods. 

2. Standing to apply for removal for non use

New Zealand law requires that only an “aggrieved person” can apply for revocation of a registration.   As noted in the decision “the term “aggrieved person” is given a wide and liberal interpretation.  This will generally include trade rivals.  As well as someone who is disadvantaged in a legal or practical way.”  [12]

However, under Australian law any person can apply for removal of a registration for non-use and there is no requirement for the removal applicant to show aggrievement to have standing to apply for removal. 

3. Date of revocation

In the New Zealand decision, the Assistant Commissioner noted that “the result of revocation is that the owner’s rights cease to exist on the date the application revocation was filed, or at an earlier date if the Commissioner is satisfied the non-use ground has been made out at an earlier date.”  [13]

Under Australian law, the date of removal of a registration for non-use is the date of the Registrar’s decision and the Registrar does not have the discretion to determine an earlier date for removal.

Takeaway

There are important differences in relation to standing and discretion in revocation/non-use removal proceedings in New Zealand and Australia which trade mark owners should note.

When defending a non-use removal action in Australia, and there has been no use of the mark during the 3 year non-use period, trade mark owners should still consider whether there are grounds for convincing the Registrar to refuse removal of the registration, such as some residual reputation in the mark from earlier use or possibly overseas reputation.

In New Zealand, it is much more likely than it is in Australia that broad descriptions will be restricted to more specific and limited descriptions.


[1] Services covered by Registration No. 637400 SORTED:

Class 36:Providing advisory, consultancy and information services relating to finance, investment and financial planning for and during retirement; providing financial information relating to retirement by means of telecommunication and electronic networks including online, via a global or other communications network, the world-wide web, an intranet or the Internet

Services covered by Registration No. 976028 SORTED:

Class 36: Financial affairs; monetary affairs; real estate affairs; providing advisory, consultancy and information services relating to finance, investment and financial planning for and during retirement; advisory services relating to real estate ownership; providing financial information relating to retirement by means of telecommunication and electronic networks including online, via a global or other communications network, the world-wide web, an intranet or the Internet; consultancy services relating to insurance; information services relating to insurance; insurance advisory services; insurance information; provision of insurance information; consultation services relating to real estate; providing information, including online, about insurance, financial and monetary affairs and real estate affairs; provision of information in relation to real estate; provision of information relating to property (real estate); provision of information relating to real estate; real estate advisory; services; real estate investment advice

Class 41: Dissemination of educational material; education services; educational services; life coaching (training or education services); provision of educational information; provision of education services via an online forum; publication of educational materials; publication of educational texts; the aforementioned relating to insurance, financial affairs, monetary affairs, real estate affairs

[2] Arguing that ORC did not provide financial advisory services, Cash Converters’ evidence in support of the revocation application referred to ORC’s disclaimers on its website that its information and tools “should be treated as a guide only” and should be used before seeking professional advice.  It was also noted that ORC’s “Investor Kickstarter” guide is referred to on the website as a guide only which  “does not constitute investment advice to any person”.  The evidence also noted that ORC is not a registered financial services provider under the Financial Services Provider (Regulation and Dispute Resolution) Act 2008 (RDR Act). 

In reply, ORC filed evidence that it is not required to be registered under the RDR Act as it is not a business which provides financial services as defined under the Act.  ORC also noted that their “Investor Kickstarter” tool asks high level questions to categorise participants into one of five types of investors and that their disclaimer clarifies that the advice given through this tool is not the type of financial advice to which the Financial Advisors Act 2008 would apply. 

[3] Office of the Retirement Commissioner v Cash Converters Pty Ltd [2020] NZIPOTM 27 (23 December 2020), paragraph 39.

[4] ibid, paragraph 44.

[5] ibid, paragraph 45.

[6] ibid, paragraph 52.

[7] ibid, paragraph 110.

[8] ibid, paragraph 113.

[9] ibid, paragraph 96.

[10] Registration No. 637400

Class 36: Providing information services and general advice relating to finance, investment and financial planning for and during retirement; providing financial information and general advice relating to retirement by means of telecommunication and electronic networks including online, via a global or other communications network, the worldwide web, an intranet or the Internet

Registration 976028

Class 36: Providing information and general advice, including online, about insurance, financial and monetary affairs and real estate affairs related to retirement and personal finance; provision of financial calculation services relating to retirement and personal financial planning including budgeting, personal debt, home buying, mortgages, superannuation, investment and savings, including by way of online; calculators; providing information services and general advice relating to finance, investment and financial planning for and during retirement; providing financial information and general advice relating to retirement by means of telecommunication and electronic networks including online, via a global or other communications network, the world-wide web, an intranet or the Internet.

Class 41: Education services related to retirement and personal financial matters including financial planning and budgeting, debt, home buying, mortgages, superannuation, investment and savings; provision and dissemination of educational material and information related to retirement and personal financial matters, including by way online communication, websites, web blogs, social media, forums, publications (including texts, guides and brochures), news articles, training, courses, seminars and meetings.

[11] ibid, paragraph 12 quoting  Crocodile International Pte Ltd v Lacoste [2017] NZSC 14 at [97]

[12] ibid, paragraph 28.

[13] ibid, paragraph 11.

Authored by Michelle Howe and Sean McManis

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 Dr Roshan Evans and 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

3 min read

.au Domain Administration Limited (the administrator of .au domain names) is introducing a new set of rules for those who wish to hold, or continue to hold, a .au domain name. 

The new rules will come into effect on 12 April 2021.

The new rules introduce several changes to the previous eligibility rules applying to .au domain names. One of these changes may have implications in particular for foreign persons or entities wishing to hold a .com.au or .net.au domain name.

Under the previous rules, a person or entity must be “Australian” (as defined by certain criteria set out in the rules) to be eligible to hold a .au domain name. This requirement would be satisfied for .com.au and .net.au domain names if the domain name was an “exact match, abbreviation or acronym” of a registered or pending Australian trade mark held by that person or entity.

Reliance on an Australian trade mark to satisfy the eligibility requirements under the previous rules has been a useful option for foreign persons or entities that cannot meet other available criteria satisfying the “Australian” requirement.    

Under the new rules, a person or entity who wishes to rely on an Australian trade mark to support its eligibility to hold a .com.au or .net.au domain name can now only do so if the domain name is an exact match of its Australian trade mark. Essentially, the domain name must be “identical to the words which are the subject” of the Australian trade mark. This means that all the words that appear in the Australian trade mark must also appear in the domain name in the exact same order, with the exception of:

  • DNS identifiers such as com.au”;
  • punctuation marks such as an exclamation point or an apostrophe”;
  • articles such as ‘a’, ‘the’, ‘and ’or ‘of’”; and
  • ampersands”. 

It will no longer be possible to rely on an Australian trade mark to support eligibility for a .com.au or .net.au domain name if the domain name is an abbreviation or acronym of the trade mark.

The rule changes may be significant for any person relying on their Australian trade mark to support eligibility to hold their .com.au or .net .au domain name. This is especially the case for foreign persons or entities that may have no other option available to support their .com.au or .net.au domain name registrations. Importantly, domain name rights could be lost if the domain name is not an exact match of their Australian trade mark.

Although the new rules come into effect on 12 April 2021, current domain name registrants will have until renewal of their existing domain name to ensure compliance with the new rules.

If you intend to rely solely on an Australian trade mark to support eligibility for a .com.au or .net.au domain registration, you should ensure that your Australian trade mark meets the new requirements. Similarly, if you already hold a .com.au or .net.au domain name and may be affected by the changes, you should consider seeking advice on whether your existing Australian trade marks satisfy the new rules or whether any steps need to be taken to ensure you are not at risk of losing your domain name registration before it is renewed.

Feel free to contact us if you need any advice about your domain name eligibility or Australian trade marks.   

Authored by Felipe Pereira and Michael Deacon

10 minute read

In Australia, there are different options to challenge the validity of a patent application or granted patent.  This can be of significant interest from a freedom to operate perspective when a business is planning to launch or commercialise a product or process, regardless of whether the product or process is covered by its own intellectual property.

Challenging a patent application or patent

(i)           Third party submissions

A patent application can be challenged pre-acceptance (prior to being allowed by the examiner during prosecution) by filing third party submissions.  Any party may file third party submissions up to three months following the date of advertised acceptance of a patent application in Australia.  The Notice is filed with any documents relevant to the assertion that the invention claimed is not novel and/or does not involve an inventive step. 

(ii)          Re-examination

It is also possible to request re-examination between acceptance and grant which is at the Commissioner’s discretion. 

On the other hand, if a third party requests re-examination following grant, re-examination must be conducted and either an adverse or non-adverse report must be issued.

During re-examination, an examination report will issue which outlines the examiner’s findings.  In the case of an adverse report, the patentee will be given the opportunity to respond with its own written submissions and/or amendments.  If the patentee cannot resolve outstanding issues encountered during re-examination, the Commissioner will typically set the matter for a hearing prior to revoking the patent either wholly or in so far as it relates to a particular claim if the patentee is unsuccessful.  

Hearings are typically rare during re-examination as most outstanding issues can be resolved by a patentee by filing written submissions or amendments in reply to a re-examination report.  The most common grounds which are difficult to resolve as they are subjective are issues relating to inventive step (obviousness) and patentable subject matter (such as manner of manufacture for software patents).

(iii)         Opposition proceedings

The validity of a patent application can also be challenged by commencing (pre-grant) opposition proceedings.  This involves filing a notice of opposition, which must be filed within three months of the date on which acceptance of the (opposed) application is advertised.

Opposition proceedings typically involve the preparation of expert evidence.

(iv)         Revocation

If a patent application proceeds to grant, a third party has the option of challenging the validity of the patent claims by commencing revocation proceedings before an Australian court or, alternatively, seeking revocation of the claims during infringement proceedings commenced by the patentee. 

Ex-parte

Under Australian practice, third party submissions and re-examination requests are ex-parte.  That is the requestor is not a party to the process and there is no opportunity for further iterations of evidence.

Re-examination considerations and advantages

In this article, we will focus on the advantages of filing a request for re-examination as a cheaper and more time efficient route to challenge validity of patent claims. 

Compared to opposition and revocation proceedings, re-examination can be orders of magnitude cheaper and generally issues can be resolved in a matter of months rather than years.  This can provide more clarity for a party’s commercial objectives in a shorter time frame which would otherwise delay product launches and commercial activities.

Traditionally, re-examination was a less popular route because prior to the commencement of the new Patents Act (Raising the Bar) which came into effect on April 2013, re-examination was limited only to the grounds of novelty and inventive step.  Unless a party had “knock-out” prior art for novelty purposes, challenging inventive step was notoriously difficult as assessing inventive step in Australia requires expert evidence from expert witnesses as discussed above and is highly subjective. 

Accordingly, most Australian attorneys would not recommend re-examination if the main ground of challenge was inventive step.  This is highlighted by the Merck & Cie decision below.

However, as a result of the changes to our law, the grounds which could be considered during re-examination were expanded to include full description (including best method of performance), clarity and succinctness, patentable subject matter and fair basis/support.  Usefulness is also considered, but in context of whether the claimed invention achieves the promised benefit. 

Difficulty with inventive step – Merck & Cie [2020] APO 45

A recent Patent Office decision (Merck & Cie) highlights the high bar demanded of third parties to invalidate a granted patent when requesting re-examination in relation to the ground of inventive step.  The Delegate dismissed the ground of inventive step after oral hearing proceedings on the basis that the Delegate could not be practically certain that the granted patent was invalid in view of the evidence provided despite issuance of three re-examination reports maintaining lack of inventive step during re-examination proceedings.

This decision reinforces the already accepted notion of the difficulty third parties face when relying on re-examination at the Patent Office to invalidate a granted patent in respect of inventive step.

The claims of the Australian Patent 2012200512 filed in the name of Merck & Cie (the Patentee) are directed to formulations of a specific polymorph of the compound (6R)-L-erythro-tetrahydrobiopterin dihydro-chloride (referred to as Form B).  The formulations comprise one, or both, of the pharmaceutical excipients polyvinylpyrrolidone (PVP) and/or dicalcium phosphate (DCP).

On 23 October 2017, a third party (the Requestor) filed a request for re-examination.  Objections were raised by the Examiner under the ground of inventive step.  Three rounds of submissions were filed by the Patentee to address the lack of inventive step objection, however, the submissions were not considered to be persuasive.  

As a result, the Examiner assigned the matter to a hearings officer to consider revocation and that the Patentee could request a hearing to contest the decision.  A hearing was requested by the Patentee.

(i)           The Arguments

The Requestor raised the following grounds for re-examination:

a)            the claimed invention lacked novelty;

b)            the claimed invention lacked an inventive step; and

c)            the claims are not fairly based on the disclosure of the specification.

Nine prior art documents were filed with the request including expert evidence in the form of declarations by three expert witnesses. 

The only ground raised in the re-examination reports by the Examiner was inventive step and was the primary ground during hearing.  Additional documents had been cited by the Examiner to support lack of inventive step.

The Examiner asserted that the claims lacked an inventive step because the polymorph Form B was known from the cited documents, and that its outstanding properties make it “especially feasible” for pharmaceutical application. 

Similarly, the Examiner considered that the use of active pharmaceutical ingredients in combination with excipients PVP and DCP (either alone or in combination) was routine based on the teachings of the cited art.  Accordingly, a person of ordinary skill would be expected to simply substitute the active pharmaceutical ingredients described in the cited art with the improved polymorphic Form B in combination with the excipients disclosed.

The major issue in determining whether the claimed invention had an inventive step was that the Examiner asserted that the specification did not describe a problem to be solved (namely stability).  The Examiner noted that the “specification does not appear to suggest any particular problem when formulating compositions of the polymorphic Form B, nor does it indicate that there is any particular difficulty in formulating Form B” and that as a consequence “there are no proposed solutions which have a need for invention when preparing a pharmaceutical composition” and therefore the claimed invention is obvious.

Similar issues had been raised during prosecution that the selection of polymorph Form B in combination with excipients PVP and DCP were routine.  However, the Patentee had drawn analogies to the circumstances of Bristol Myers Squibb v Apotex and argued that these excipients (either alone or in combination) provided improved hygroscopicity (absorption of moisture from surrounding atmosphere) that could not have been predicted.  The application was accepted in view of this argument.  However, the Examiner considered that the supplementary material provided by the Requestor established that the use of these ingredients was obvious. 

(ii)          The Decision

Despite the arguments raised by the Requestor and the Examiner that a specific problem was not identified by the specification and particularly not by any reformulation development around Form B with any advantageous excipients, the Delegate was satisfied that the problem to be solved, as provided by the Patentee, is the provision of a formulation of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride that has high storage stability.

The evidence before the Delegate indicated that while (6R)-L-erythro-tetrahydrobiopterin dihydrochloride was known to exist as a white crystalline solid, this was the only crystal form described in the prior art.  The Delegate found that polymorphism requires at least two different crystal forms and it was only once the Patentee discovered different crystal forms that the white crystal of the prior art could be considered a polymorph (form B).  Polymorph forms was therefore not common general knowledge. 

No evidence was provided regarding the storage stability of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride and that tablets comprising (6R)-L-erythro-tetrahydrobiopterin dihydrochloride together with PVP and/or DCP were known or even common general knowledge.

The Delegate found that the problem in the present case is the provision of a formulation of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride that has high storage stability.  The Delegate noted that the claimed combination as a whole must be considered when considering inventiveness and not the individual features.

The evidence from the experts indicated that there were a number of alternative strategies that could be employed to formulate the active ingredient, and even if seeking an excipient to improve the stability of the formulation, there were a number of alternatives that could be employed. 

As a result, the Delegate found that on balance there was insufficient evidence to determine that the claims are invalid on the ground of lack of inventive step in view the cited art and the common general knowledge. 

Implications

This decision reinforces the understanding by practitioners that re-examination should be relied on as an alternative to opposition and revocation proceedings when the matters to be considered are relatively straightforward.  That is, the substantive grounds relied upon by a third party is inter alia novelty and support.

Reliance of re-examination proceedings are typically difficult when attempting to invalidate a patent based on the ground of inventive step. 

This difficulty was also noted by the Delegate which stated that “[t]he present determination has also not been helped by the evidentiary constraints of re-examination where the requestor is not a party to the process and there is no opportunity for further iterations of evidence or, in the case of post-grant court proceedings, cross examination to further explore the issues in contention”.[1] 

For matters relating to the ground of inventive step, it is recommended that invalidity be established by opposition proceedings (pre-grant) or revocation in Court (post-grant) proceedings as these are inter partes proceedings such that a third party can have the opportunity to heard in full.

Alternative grounds

Despite the high bar encountered during re-examination in the context of inventive step, re-examination can still be a useful and cost-effective tool when relying on the alternative expanded grounds as discussed above.

This was highlighted in an earlier Patent Office decision of Huping Hu (2014) APO 17.  Unusually in this case, the Commissioner exercised their discretion in requesting re-examination after grant compared to a request filed by a third party.  During re-examination, the Commissioner raised additional grounds relating to utility, patentable subject matter (lack of manner of manufacture) and full description.

In this decision, the Delegate found that the patent lacked utility, patentable subject matter and the specification did not fully describe the invention.

The Delegate revoked the patent as the Delegate considered that the deficiencies could not be addressed by amendment.

Recommendation

As a result of the expanded grounds, re-examination can be a useful tool to challenge validity.  If a potentially infringing commercial product relies only on a specific embodiment such as using specific chemical compositions, re-examination can be used to potentially force a patentee to amend the claims which may exclude a potential commercial product by relying on the grounds of support and disclosure for example.

For instance, if a patent application or patent has unduly broad claims potentially covering the embodiment but is arguably not supported or enabled by the description and examples (often observed in the Chemical and Life Sciences space), raising the ground of support can potentially force the patentee to amend claims by narrowing which are no longer covered by the scope of the amended claims and avoid potential infringement.

Since more grounds are now available under the post-Raising the Bar Act, the prospects for successfully challenging validity through re-examination have improved but the thresholds remain high and patentees are given ample opportunity to save their claims through amendment.  This can make a potential infringer’s position better from a freedom to operate perspective but worse from a revocation perspective.

If you are interested in requesting re-examination of a patent or would like further information, please contact one of our expert attorneys.


[1] Merck & Cie [2020] APO 45, [98].

Authored by David Hvasanov, PhD and Charles Tansey, PhD

24 March 2021

2:00 PM (Los Angeles)

5:00 PM (New York)

25 March 2021

8:00 AM (London)

5:00 PM (Tokyo)

9:00 AM (Berlin)

7:00 PM (Sydney)

4:00 PM (Beijing)

9:00 PM (Auckland)

Abstract

Australia has long been regarded as a favourable jurisdiction for those seeking to enforce patent rights. However, there are important differences between patent law and litigation practice in Australia, compared to jurisdictions such as the US, Europe and Japan.  Those differences present both risks and opportunities for parties litigating patents in Australia. In this webinar, Principal Duncan Longstaff and Special Counsel Andrew Rankine, both specialist patent litigators, will identify aspects of Australian patent law and litigation practice that present potential traps for the unwary, and provide practical guidance on steps which can be taken before commencing litigation, or in its early stages, to maximise prospects of success. Topics addressed will include patent ownership and licensing, standing, pre-action discovery and preliminary injunctions, as well as post-grant patent amendments. Principal and ICT/EE patent attorney Tam Huynh will facilitate the discussion.

Authored by Duncan Longstaff and Andrew Rankine

Welcome to Shelston IP’s round up of Australian and New Zealand trade mark cases for 2020.

While there were plenty of cases in 2020, we have selected a few which we think are interesting and provide an indication of the types of issues dealt with by the Courts and Trade Marks Office throughout the year.

Please click here for a quick snapshot of each case followed by a more detailed discussion of the main issues that arose in each case.

Read our full report

Authored by Sean McManis and Michael Deacon