2 min read

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

Streamlined extensions (until 31 March 2021)

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

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

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

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

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

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

We can help

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

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

Authored by Serena White, DPhil and Gareth Dixon, PhD

3 min read

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

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

Repurposing and ‘off label’ use

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

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

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

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

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

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

Proposed approaches to facilitating and encouraging repurposing of medicines

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

Proposal 1 – Reduce regulatory burden

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

Proposal 2 – Enhanced information sharing and access

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

Proposal 3 – Actively pursue registration and review

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

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

Authored by 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

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

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 and Dr Roshan Evans

3 min read

IP Australia is providing free, streamlined extensions of time of up to three months if a deadline cannot be met due to the effects of COVID-19.  Whilst the maximum length of extension that can be requested at one time is three months, additional extensions of time of up to three months are available if needed.

The period for requesting a streamlined extension has been extended until 31 March 2021.  However, IP Australia now indicates that, subject to any further developments in the COVID-19 pandemic, streamlined extensions will not be available after 31 March 2021.

What are the streamlined extensions?

IP Australia has implemented a streamlined process 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.  No declaratory evidence or fee is required; all that is needed is to check the relevant box on IP Australia’s eServices system to declare that the deadline cannot be met due to disruptions from the pandemic. 

However, the streamlined extensions are not a simple free-for-all (see our earlier article here).  If asked, a requestor must be able to provide genuine reasons and evidence to justify the grant of the extension.  In addition, IP Australia warns that a false declaration could put the validity of an IP right at risk.

Many deadlines for patents, trade marks and designs are covered by the streamlined extensions of time, including deadlines associated with oppositions and hearings processes (such as periods to file evidence).  However, there are some exceptions.  For example: these extensions of time do not apply to deadlines for payment of renewal fees for patents, trade mark and designs, for which the usual 6 month grace period applies.  For trade marks, these extensions are also unavailable for filing of divisional applications.

What if I want to request an extension of time after 31 March 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 after 31 March 2021.  However, such an extension will not be available via the streamlined process and 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.  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 after 31 March 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.

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

Authored by Serena White, DPhil and Gareth Dixon, PhD

11 min read

Axent Holdings Pty Ltd t/a Axent Global v Compusign Australia Pty Ltd [2020] FCA 1373 (25 September 2020) 

This decision of Kenny J of the Federal Court of Australia considers many issues including the Crown use defence; whether information published by the Crown (and made available to it by a patentee) can be novelty defeating; and the effect that requesting an extension of time to renew a patent outside of the renewal fee grace period has on the relevant period during which the patent is taken to have ceased before it is restored.

The Background

Axent Holdings Pty Ltd, trading as Axent Global (Axent), commenced proceedings against Compusign Australia Pty Ltd and Compusign Systems Pty Ltd (together Compusign) as well as Hi-Lux Technical Services Pty Ltd (Hi-Lux) (the respondents) for infringing Australian Patent No. 2003252764 titled “Changing Sign System” (764 Patent). The 764 Patent claimed an earliest priority date of 4 October 2002 and was granted on 26 June 2008. The respondents filed a cross claim asserting the 764 Patent was invalid. Except for any issues under ss 22A and 138, the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) (Raising the Bar Act) did not apply.

The invention related to a changing sign system for use as a variable speed limit sign (VSLS) on roadways. The VSLS could be used to display a lower hazard speed limit instead of the normal maximum safe speed when a certain condition is detected. When the hazard speed limit is displayed, a portion of the sign is varied to conspicuously indicate the change of conditions.

Independent claims 1, 17 and 20 described an electronic variable speed limit sign, which has a plurality of lights forming the central speed limit numerals and annulus rings around those numerals. The specification explains that a change of conditions is indicated by flashing some of the annulus outer rings while always retaining one ring on, to fulfil the criteria of being a speed display sign, that is, by always showing a number in a circle on a display panel. Dependent claims 2 to 16, 18 to 19 and 21 to 27 specified a number of further features, and claim 28 was an omnibus claim.

In September 2001, Mr Fontaine, the director of Axent and named inventor of the 764 Patent, met with Mr Bean, who worked for VicRoads, to view a demonstration of Axent’s variable speed limit sign with a partly flashing annulus. Mr Fontaine stated that he subsequently received tender documents which included a VicRoads specification (the September 2001 specification), which contained a requirement, for variable speed limit signs, that part of the inner diameter of the annulus should be capable of flashing on and off.

The issues

Product or method claims

A preliminary question arose as to whether the claims were product or method claims for the purposes of determining infringement. Axent pleaded that the claims were to a product. The respondents submitted that the claim integers formed part of a method of using a variable speed limit sign. Her Honour rejected Axent’s submissions that the claims were framed in terms of capabilities, yet still construed the majority of the claims as product claims limited by result. Claims 12, 14 and 16 were construed as method claims which describe the operation of the claimed sign system.

Clarity

The respondents contended that independent claims 1, 17 and 23 lacked clarity because of the use of the terms “normal speed”, “input criterion” and “change in conditions”. Her Honour considered that when the claims were read as a whole, in the context of the specification, the skilled addressee would have no real doubt about what is intended by the above features and that the claims were clear.

Direct Infringement

Axent’s case was in substance that the supply by Hi-Lux and Compusign of their respective variable speed limit signs infringed all the claims of the Patent. Axent was unable to establish that either the Hi-Lux signs or the Compusign signs included relevant features of the product claims or that Hi-lux or Compusign performed the relevant claimed method in making their signs. Thus, the product and method claims were not infringed.

As omnibus claim 28 was narrowed “with reference to the examples”, and the specification included no ‘examples’, her Honour considered that there can be no infringement or alternatively that claim 28 was invalid for lack of clarity.

Indirect Infringement

Axent also relied on s 117 of the Patents Act 1990 (Act) to allege indirect infringement initially on the sole basis that the supply of a sign is, in and of itself, a supply that attracts the operation of s 117. Axent subsequently sought to broaden their case for indirect infringement to instances where the invention was for a method, rather than a product. Axent also sought leave to elicit from the respondents’ witnesses in cross-examination evidence as to the directions given and steps taken by the respondents when supplying their signage. The respondents submitted that it would be unfair to permit Axent to seek to make out an infringement case based on s 117 that it had not opened or properly foreshadowed. Her Honour agreed and held Axent to the case on which it opened. The evidence given by the respondents’ witnesses by way of cross-examination was admitted, however, it was limited in its use so that it could not be used to form the basis of an infringement case by reference to s 117. Axent was not able to make out its case of indirect infringement against the respondents.

Crown use defence

Hi-Lux submitted that each of VicRoads, the South Australian Department of Planning, Transport and Infrastructure, and the City of Greater Geelong was an authority of a State for the purposes of s 163 of the Act which provides that exploitation of an invention by or for the services of the Commonwealth, or a State is not an infringement of any patent rights.

Her Honour considered that each of the organisations were an Authority of the state and that the exploitation of the sign was for the services of each Authority. However, this was subject to s 163(3) which required that the exploitation of the invention was necessary for the proper provision of the services within Australia. Her Honour considered it may be that exploitation was not strictly necessary in the sense contemplated by s 163(3) because alternative signage was available and widely used. However, this was not considered further, in any event, as Hi-Lux failed to satisfy her Honour that the infringement  was authorised in writing by an authority of the State.

In particular, the documents in relation to Hi-Lux’s supply of signs to VicRoads and the City of Greater Geelong left open the possibility that Hi-Lux had a choice as to the electronic speed sign supplied, leaving it free to perform the relevant contract without infringing the claims of the Patent. It was clear that Hi-Lux was under no contractual obligation to supply an infringing item.

The contract for the supply and installation of variable speed limit signs between the Commissioner of Highways and Hi-Lux included a specification which set out the requirements for the variable speed limit signs. Her Honour noted the possibility this contract may have required a product that infringed the 764 Patent and thus, the infringing acts may well have been authorised for the purposes of s 163. However, in the absence of submissions or evidence to this effect, her Honour was not satisfied that the contract with the Commissioner required Hi-Lux to supply goods that necessarily infringed the patent in suit. Accordingly, Hi-Lux’s defence under s 163 of the Act did not succeed.

Innocent infringement

Compusign argued that they were not aware and had no reason to believe that a patent existed for the invention before receiving the letter of demand from Axent. Compusign gave evidence to the effect that they had not expected a patent to exist in relation to the requirements of the roads authorities’ specifications without the specifications referring to the patent. Her Honour considered that there was nothing in the relevant roads authorities’ specifications that would put a reader on notice of the existence of a relevant patent. Axent did not address the issue of innocent infringement.

Accordingly, if it were necessary to do so, her Honour would have provisionally refused to make an award of damages or an order for an account of profits in respect of any infringement by Compusign prior to the date of the receipt of the letter of demand.

Lapse of patent

Axent did not pay the renewal fees for the 764 Patent by the due date of 6 October 2015; nor did it pay the fees by 6 April 2016, within the 6 month renewal fee grace period. Axent applied for an extension of time which was granted on 1 September 2016 and the renewal fees were then applied to the 764 Patent. The 764 Patent therefore ceased to be registered for a period for the non-payment of fees.

The respondents submitted that Axent could not assert infringement of the patent from the day after that on which the renewal fee for the 764 Patent was due, 7 October 2015, to the day on which an application to extend the time to pay the renewal fee was granted, 1 September 2016. Axent submitted the relevant period began on 5 April 2016 (that is, approximately 6 months after 7 October 2015) and concluded on 1 September 2016. The commencement of the relevant period turns on the construction of reg 13.6 of the Patents Regulations 1991 (Cth), which relevantly provides that the period in which the renewal fee must be paid is the period ending at the last moment of the anniversary, however, if the renewal fee is paid within 6 months after the end of the relevant anniversary the period is taken to be extended until the fee is paid. The respondents submitted, and her Honour accepted, that the period is only “taken to be” extended if the condition of the renewal fee being paid within the 6 month grace period is satisfied. Had Axent paid the renewal fee at any time before the end of the 6 month grace period, the 764 Patent would never have ceased as the prescribed period would have been extended by reg 13.6(2)(a) to end on the day Axent paid the fee. However, Axent did not pay the renewal fee before 5 April 2016, and in consequence reg 13.6(2)(a) had no application.

Therefore, the prescribed period for renewal ended on 7 October 2015 being the point after the last moment of the anniversary date for the Patent. It follows that the Patent ceased on that day. The Patent was restored on 1 September 2016, when the extension of time for the renewal fee application was granted.

Prior use

The respondents relied on s 119(1) by way of defence to Axent’s infringement case. In the absence of evidence that either Hi-Lux or Compusign Australia was “making” an infringing product or “using” an infringing process before the priority date, neither could satisfy the requirements for the prior use defence required by s 119(1) prior to the Raising the Bar Act changes.

Invalidity of the Patent

The respondents submitted the claims were not novel because the invention was disclosed by the September 2001 specification and as part of the installation process for the Western Ring Road Project. Axent submitted that the September 2001 specification was merely a “wish list” that provided insufficiently direct disclosure and in any event was excluded from being considered for the purposes of novelty and inventive step because of s 24(1)(b) and/or s 24(2). Relevantly, s 24(1)(b) provides that, when assessing novelty and inventive step, the person making the decision must disregard any information derived from the patentee and made publicly available without their consent. Under s 24(2), the person making the decision must disregard any information given by, or with the consent of, the patentee, to the Crown, but to no other person or organisation.

Axent argued that it had disclosed its invention to VicRoads confidentially and never consented to VicRoads on-disclosing it in the September 2001 specification. The respondents contended, and her Honour agreed, that s 24(2) did not apply because the September 2001 specification was a disclosure made by, and not to, the Crown and the language of s 24(2) did not support the “reach-through effect” that Axent had argued.

There was still the further question as to whether s 24(1)(b) operated. A central issue was whether the information was made publicly available without the consent of Axent. Whilst there was no evidence that Axent expressly gave consent, having regard to the circumstances and the evidence, her Honour was satisfied that Axent positively consented to the inclusion of the claimed invention in the September 2001 specification. Accordingly, s 24(1)(b) did not apply.

Kenny J rejected the contention that the September 2001 specification was part of the common general knowledge or that it could be combined with the common general knowledge. Accordingly, the critical question was, whether each of the claims lacked inventive step by reference to common general knowledge alone. The evidence was clear that, apart from the flashing annulus feature, the other features of the claims were obvious as at the priority date. However, there was clear evidence that the skilled worker was aware of a flashing annulus feature well before the priority date.

Her Honour considered that no problem was overcome or barrier crossed by the adoption of the flashing annulus feature and that the evidence indicated a person skilled in the art would have taken the steps leading from the prior art to the claimed invention as a matter of routine. The 764 Patent was found invalid for lack of inventive step by reference to the common general knowledge alone, and claims 1, 9, 10, 14, 15, 17, 20 and 27 were invalid for want of novelty in light of the disclosure of September 2001 specification.

The Decision

Ultimately, Axent failed in its infringement case, even if it had succeeded, Compusign succeeded in its innocent infringement defence and all respondents succeeded on the lapsed patent defence. The Crown use and prior use defences failed.

Significance

The decision clarified that the prescribed period to pay a renewal fee to prevent a patent ceasing is only taken to be extended to the date of payment, if the fee is paid within the 6 month grace period. Accordingly, when the renewal fee is paid after the 6 month grace period by relying on an extension of time, the patent is taken to have ceased from the point after the last moment of the anniversary of the patent.

Regarding the Crown Use defence, the decision indicated that written authorisation by the Crown to exploit an invention may be explicit or implied, but the authorisation must be specific such that the necessary exploitation of the invention is authorised and that alternatives are not possible.

For information made available to the Crown by a patentee and subsequently published by the Crown, the decision indicated s 24(2) did not provide a “reach-through effect” to exclude such a publication from the prior art when considering novelty and inventive step.

The decision also offers guidance on the evidence required to establish innocent infringement in the case that a defendant was not aware, and had no reason to believe, that a patent for the invention existed.

Authored by Tam Huynh and Dean Bradley

4 min read

In brief

In this Federal Court case, Pfizer’s attempt to obtain documentation from Sandoz regarding its ERELZI etanercept product failed, Justice Burley finding that undertakings provided by Sandoz to give notice prior to exploiting ERELZI products in Australia removed any reasonable belief that Pfizer might have the right to obtain relief as at the time of the application. The circumstances illustrate the significance of the form of undertakings given by potential generic/biosimilar entrants when patent disputes erupt.

Background

The background to this case is set out in more detail here. In short, Pfizer markets the highly successful etanercept therapy under the name BRENZYS in Australia, for conditions including rheumatoid and psoriatic arthritis. In October 2017 Sandoz obtained registration on the Australian Register of Therapeutic Goods (ARTG) for its biosimilar, ERELZI. The Department of Health’s Pharmaceutical Board Advisory Committee recommended that the products be listed in March 2018, subject to certain further information being provided. In April 2018 Sandoz informed the Department of Health that it had decided not to proceed to the next step “at this point in time”. Sandoz has taken no further steps with respect to launch of ERELZI in Australia since that time. In December 2019, Pfizer sought preliminary discovery from Sandoz for documents relating to the manufacture of ERELZI, on the basis that it may have a right to relief for infringement of three of its patents.  

The decision

The test for obtaining preliminary discovery has recently been clarified by the Full Court of the Federal Court in a case brought by Pfizer against Samsung Bioepsis in respect of its biosimilar etanercept product. The Full Court confirmed that as long as there are reasonable grounds for a belief that there may be a right to relief, it is not necessary to show, for example via expert evidence, that such a claim would succeed. Indeed the purpose of obtaining preliminary discovery is to determine whether a right to relief in fact exists.

In light of the Samsung decision, it would likely have been difficult for Sandoz to show in this case that Pfizer did not have the requisite level of belief that ERELZI may fall within the scope of the claims of its patents, and indeed Sandoz accepted that Pfizer had such belief for the purposes of the application. 

However, Sandoz relied on undertakings offered to Pfizer, pursuant to which it undertook not to exploit any ERELZI products in Australia or take steps to proceed with PBS listing, for the duration of the patent, without first giving Pfizer certain notice. The length of the notice offered is not recorded in the judgment for confidentiality reasons, however the judgment notes that in earlier correspondence Sandoz had offered to give Pfizer 150 days’ prior written notice. It is assumed therefore that the notice period offered is relatively substantial. Sandoz also agreed to provide certain discovery with a period of time after giving any such notice (the details of this undertaking were also confidential).

In these circumstances, Pfizer contended that the notice period offered was insufficient to allow it to obtain relief in time if Sandoz did in fact give notice of an intention to launch. It sought an order that Sandoz give preliminary discovery of specified schedules of documents within 7 days of giving the relevant notice and a ‘Sabre order’ requiring it to seek production of any such documents held by related companies. The issues were therefore quite confined.

Burley J refused the orders sought by Pfizer. Based on the language of the relevant Federal Court Rules governing preliminary discovery, his Honour concluded that Pfizer needed to show a reasonable belief that its rights may be infringed as at the date when the application is being assessed. Calling in aid notions of quia timet relief, Pfizer argued that the relevant question was whether it held a reasonable belief that the notice offered by Sandoz was likely to affordPfizer sufficient time to protect itself from material harm.  However Burley J held that the circumstances of the case did not warrant a reading of the Rules which would in effect provide an exception to the reluctance of the Court to answer questions based on hypothetical facts, as was the case here where Sandoz had not yet made a decision to launch. He gave examples of difficulties which could arise, in particular, the appropriate scope of any preliminary discovery could be affected by admissions which Sandoz might make with respect to infringement.

Significance

While the outcome in this case is highly dependent on the specific facts, it does highlight the effectiveness of appropriately crafted undertakings in resisting legal action, where a product has been listed on the ARTG and steps have been taken to list on the PBS, circumstances which would generally amount to a threat of patent infringement, in the absence of any undertakings.  

Preliminary discovery applications are set to become a more common weapon in patent litigation arsenal in years to come, particularly given the increasing significance in Australia (as elsewhere) of biosimilar patent litigation, where patents covering manufacturing processes are likely to assume greater importance given the additional complexities at play in claiming active biological molecules per se, and the significance of specific manufacturing processes in the production of biologics. Given the likely lack of available information as to a competitor’s manufacturing processes, preliminary discovery may be an essential prelude to patent infringement claims in such cases, assisted by the planned Therapeutic Goods Administration “transparency measures” which will introduce an earlier notification scheme for generic and biosimilar medicines. Equally we expect to see the strategies to resist such applications develop providing more case law in this area.

Authored by Katrina Crooks

7 min read

Merck Sharp & Dohme Corp v Wyeth LLC (No 4) [2020] FCA 1719

In a previous article, we discussed Justice Stephen Burley’s finding that a Wyeth patent covering certain vaccines against Streptococcus pneumoniae was valid and would be infringed by a 15-valent vaccine that Merck Sharp & Dohme (MSD) planned to launch in Australia.  By a subsequent judgment, Burley J has now granted final relief consequential on those findings, including an injunction restraining launch of MSD’s 15-valent vaccine.  The judgment is notable for his Honour’s rejection of a request, made by MSD, for a separate hearing on the question of whether injunctive relief ought to be refused on public interest grounds, given the significant medical benefits offered by MSD’s 15-valent vaccine. 

Key takeaways

  • Under existing Australian law, the starting position is that a patent owner successful in infringement proceedings will ordinarily be entitled to a final injunction restraining supply of an infringing product.  Nevertheless, in deciding whether to grant an injunction in each case, the court will have regard to all relevant considerations, including the public interest.
  • A defendant seeking to avoid final injunctive relief on public interest grounds faces both substantive and procedural hurdles.  The defendant may need to apply, at an early stage of the proceeding, to have the public interest question heard and determined separately, after the main trial on patent infringement and validity.

Background

The technology at issue in these proceedings was reviewed in our previous article.  Very briefly, more than 90 different serotypes of the bacterium Streptococcus pneumoniae (or “pneumococcus”) have been identified.  A limited number of especially virulent serotypes cause around 1 to 2 million childhood deaths globally, each year.  Wyeth’s Prevnar 13® vaccine, which is currently listed on Australia’s National Immunisation Program, targets 13 of those serotypes.  The 15-valent vaccine developed by MSD targets two additional serotypes, offering broader protection against pneumococcal disease.

In his previous judgment,  Burley J found that marketing of MSD’s 15-valent vaccine in Australia would involve infringement of one of three patents asserted by Wyeth in this proceeding (his Honour found the asserted claims of the other two asserted patents to be invalid).

Under Australia’s existing law on remedies for patent infringement, the starting position for analysis is that a patent owner successful in infringement proceedings will ordinarily be entitled to a final injunction, assuming there is a threat of ongoing infringement.  On the other hand, an injunction is an equitable, and therefore discretionary, remedy and a court will have regard to all relevant considerations in assessing whether injunctive relief is appropriate in each particular case, including considerations of proportionality.

A relatively recent decision of Australia’s Full Federal Court has confirmed that a final injunction for patent infringement will ordinarily be granted in terms which, in addition to restraining the specific conduct that was held to infringe at trial, restrains generally any further infringing conduct by the defendant (Calidad Pty Ltd v Seiko Epson Corporation (No 2) [2019] FCAFC 168, as we reported in our Best Patent Cases 2019 publication available here).  An injunction granted in that form places on the defendant the risk of being held in contempt of court if it chooses to “sail close to the wind” by engaging in further conduct that, although modified from the conduct that was found to infringe at trial, could nevertheless still be found to fall within the scope of the patentee’s claims.

In the Prevnar vaccine case, MSD did not challenge the particular form of injunctive relief sought by Wyeth.  Rather, MSD argued that no final injunction should be granted at all, or alternatively that the question of injunctive relief should be deferred until after the determination of any appeal.  MSD based those arguments on the public interest in accessing its 15-valent vaccine, given the health advantages that vaccine would confer over the currently-available Prevnar 13® product.

Public interest

The need to take account of public interest considerations in assessing injunctive relief for patent infringement has been recognised in recent case law across a number of jurisdictions. 

Recent US case law has built upon the foundation laid by the landmark decision of the US Supreme Court in eBay Inc v MercExchange LLC, 547 US 388 (2006).  The eBay case established that a patent owner seeking final injunctive relief for infringement must establish that (1) it has suffered irreparable injury; (2) damages would not be an adequate remedy; (3) the balance of hardships between patent owner and defendant favours equitable relief; and (4) the public interest would not be disserved by a final injunction – the so-called “eBay factors”.

The role of public interest considerations in the grant or refusal of final injunctive relief for patent infringement was also considered in the recent UK case of Evalve Inc v Edwards Lifesciences Limited [2020] EWHC 513.  The defendant in that case opposed the grant of a final injunction, based on evidence that some medical practitioners believe, on reasonable grounds, that the infringing medical device (used to repair leaky heart valves) performs better in certain patients than the patent owner’s device.  As a fallback position, the defendant argued that use of the infringing device in those patients should be carved out of the scope of any final injunction.

In a detailed review of the issue, UK High Court Justice Colin Birss identified the following matters as relevant to the role of public interest considerations in the grant or refusal of injunctive relief for patent infringement.

First, the UK Patents Act 1977 (in common with patents legislation in Australia and several other jurisdictions) includes a number of provisions that reflect the legislature’s assessment on public interest issues.  These include, for example, statutory exclusions from patent infringement (e.g., for experimental use), compulsory licensing provisions and the Crown use scheme.  By the latter provisions, a government may authorise use of a patented invention without the patent owner’s consent where this is deemed to be in the public interest. 

Secondly, a patent infringer who invokes the public interest as a reason to withhold a final injunction is, in effect, seeking a compulsory licence without having established the statutory grounds on which such licences are ordinarily made available.

Thirdly, to assess whether it would be just in all of the circumstances to withhold a final injunction on public interest grounds, a court must be provided with evidence concerning the adequacy of damages to compensate the patent owner in lieu of an injunction.  Speaking hypothetically, Birss J observed that, if the level of compensation required to adequately compensate the patent owner would strip the infringer of their entire profits, then refusing an injunction may be to no avail, since the infringing product is unlikely to be made available in such circumstances.

In light of these considerations, Birss J concluded that, in patent infringement proceedings, the bar for refusing a final injunction on public interest grounds is high.  His Honour expressed the view that, generally speaking, it will be necessary to establish by objective evidence that the defendant’s product is needed to protect the lives of patients for whom it is the only suitable treatment (at [87]).

MSD submitted that those conditions would be satisfied in the Australian Prevnar vaccine case.  It invited Burley J to convene a separate hearing on whether it was against the public interest to grant a final injunction, at which hearing MSD proposed to adduce additional evidence, including evidence concerning the prevalence of pneumococcal serotypes covered by its 15-valent vaccine that are not covered by Wyeth’s Prevnar 13® product.

Justice Burley refused MSD’s request for a separate hearing and determined that it was appropriate that Wyeth be granted a final injunction restraining supply of MSD’s 15-valent vaccine.  His Honour’s reasons for that decision highlight the challenges facing a defendant seeking to resist final injunctive relief on public interest grounds in a patent infringement case.

On the one hand, Burley J pointed to a number of factors suggesting it was premature to determine the public interest question.  MSD has not yet obtained regulatory approval to market its 15-valent vaccine in Australia and its intended launch date remains unclear.  Wyeth’s counsel indicated that Pfizer (the parent company of Wyeth) intends launching a 20-valent pneumococcal vaccine in Australia, which may come to market before the MSD product is approved.  Justice Burley observed that the timeline of these events would be expected to have a significant bearing on the assessment of the public interest arguments raised by MSD.

On the other hand, Burley J found that the question of whether a final injunction should be refused on public interest grounds had been raised on the pleadings for the infringement case and his Honour was not persuaded that MSD should be permitted to, in effect, re-open its case on this issue, after judgment.

It is possible that MSD may seek to test those conclusions before the Full Federal Court.  A notice of appeal against Burley J’s judgment on issues of validity and infringement was filed by MSD in late January.

Significance

Justice Burley’s decision highlights the substantive and procedural challenges faced by a defendant in patent infringement proceedings seeking to argue that final injunctive relief should be refused on public interest grounds. 

In light of this decision, defendants who wish to preserve the ability to oppose final injunctive relief on public interest grounds may need to apply, at an early stage in the proceeding, to have that question deferred for separate determination, after the main trial on infringement and validity, with the parties granted leave to file fresh evidence on the public interest considerations which apply at that time.

Authored by Andrew Rankine and Duncan Longstaff

2 min read

IP Australia is providing free extensions of time of up to three months if a deadline cannot be met due to the effects of COVID-19.  The period for requesting such an extension has been extended until 28 February 2021.  Depending on the ongoing impact of the pandemic, both in Australia and overseas, this period could be extended further. 

Whilst the maximum length of extension that can be requested at one time is three months, additional extensions of time of up to three months are available if needed.

IP Australia has implemented a streamlined process 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.  No declaratory evidence or fee is required; all that is needed is to check the relevant box on IP Australia’s eServices system to declare that the deadline cannot be met due to disruptions from the pandemic. 

However, these COVID-19 extension provisions are not a simple free-for-all (see our earlier article here: https://shelstonip.com/insights/briefings/ip-australias-covid-19-extensions-of-time-a-word-of-caution/).  An element of discretion does apply and, if asked, a requestor must be able to provide genuine reasons and evidence to justify the grant of the extension.  The timing of the request can be of significance too.  In addition, IP Australia warns that a false declaration could put the validity of an IP right at risk.

Many deadlines for patents, trade marks and designs are covered by the streamlined extensions of time, including deadlines associated with oppositions and hearings processes (such as periods to file evidence).  However, there are some exceptions.  For example: these extensions of time do not apply to deadlines for payment of renewal fees for patents, trade mark and designs, for which the usual 6 month grace period applies.  For trade marks, these extensions are also unavailable for filing of divisional applications.

For more information, or if you have been affected by the COVID-19 pandemic and require assistance with your IP Rights, please contact us. 

Authored by Serena White, DPhil and Gareth Dixon, PhD