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

Defence export controls (limitations on exporting “sensitive” Australian technologies) and intellectual property (especially patents) have been linked for the best part of a decade.  A 2018 review predicated on strengthening the restrictions appeared to go nowhere – that is, until an interesting article in this morning’s Guardian hinted that tightening the laws is still very much on the cards.

Local inventors (and indeed, patent attorneys) may think “so what?  Unless I’m looking to patent a weapon, how is this remotely relevant to me?”  Well, if your invention falls into what’s termed the “dual use” category – inventions having potential downstream military application (and it’s the Government that decides this – not you, and not us), then please read on…     

The status quo

The Defence Trade Controls Amendment Act 2015 entered into Australian federal law on 16 May 2015 and amended the original Defence Trade Controls Act 2012 (“the DTC Act”).  The (criminal) sanctions for non-compliance took effect from 2 April 2016.  In regulating the extent to which one can communicate new technologies overseas – and in providing criminal sanctions for non-compliance, the legislation stands to impact significantly upon the day-to-day activities of Australian patent attorneys – and their clients.  On this basis, the fact that defence export controls has raised its head again places this little-known piece of legislation squarely in the public eye and provides an opportunity to issue a reminder as to the scope and significance of the DTC Act.    

Criminal sanctions for non-compliance with the restrictions

The DTC Act regulates the overseas supply and publication of Defence and Strategic Goods List (DSGL) technologies and the brokering of DSGL goods and technology.

Shelston IP actually worked closely with Defence Export Controls (DEC) throughout the 2015 public consultation process, and as a consequence, our internal systems have been fully compliant with the restrictions imposed for the best part of five years.  In short, when dealing with Shelston IP, local clients can rest assured that we fully understand the situation and will have taken the necessary steps to minimise any risks to the parties involved.

Communicating technology – restrictions on our “day jobs”

As patent attorneys, the communication and publication of “technology” is a staple of our everyday work.  Often, such communications are sent offshore.  Other times, we communicate new technologies in the form of patent specifications to our local clients, who in turn, send these documents overseas.  Depending on the nature of the “technology”, the DTC Act stands to criminalise such activities.

Because the offence provisions for supplying and publishing DSGL technology and for brokering DSGL goods and technology took effect from 2 April 2016, individuals and organisations are required to seek permits for any otherwise-offending activities. 

Why have export controls in the first place?

The DTC Act is a little-known document having significant, wide-reaching consequences.  Australia’s export control system aims to stop goods and technologies that can be used in military applications from being transferred to individuals, states or groups of proliferation concern.  As a member of various international export control regimes, Australia is part of a global effort to regulate the export of items of concern, many of which have potential terrorism or weapons of mass destruction applications.

Australia already regulates the physical export of certain military and dual‐use items under Regulation 13E of the Customs (Prohibited Exports) Regulations 1958.  However, the DTC Act is Australia’s means of closing any gaps that have appeared in the interim (as required by the Wassenaar Arrangement, to which Australia is a signatory).

Accordingly, the DTC Act regulates three main activities:

  • The intangible supply (transmission by non‐physical means, such as e-mail) of controlled technology from a person in Australia to a person outside of Australia;
  • Publishing controlled military technology; and
  • Brokering (akin to enabling another to communicate overseas) controlled military goods or technology.

How do I know if my technology is covered under the DTC Act?

The DTC Act applies to different stakeholders, depending on whether their activities involve military or “dual‐use” items listed in the Defence and Strategic Goods List (DSGL).  The DSGL, accessible here, is a 338-page legislative instrument defining as “dual use” a broad range of otherwise fairly benign-sounding technologies.  As such, one could assume (fairly reasonably) that a technology was exempt on the basis that it had no immediate or apparent primary military end use.  However, as noted above, it’s the Government that has the final say by way of the DSGL listing being the sole arbiter.  It is important to note that secondary or incidental military applications may suffice, hence the term “dual use” technologies.

International export control regimes are generally conscious of their impact upon people’s day-to-day activities, and so the controls are designed to only capture what is considered necessary.  For example, the DSGL lists computers that are specifically designed to operate below ‐45 °C or above 85 °C.  The DTC Act controls only apply to the technology which is necessary for the computer to operate at these extreme temperatures.  Technology that does not influence the computer’s ability to function at these temperatures is not controlled.  Using the above example, an Australian inventor who has created such technology for the primary purpose of, say, exploring the surface of Mars, would need to be acutely aware of the restrictions imposed by the DTC Act – as would his/her patent attorneys.

All things in perspective…

As mentioned, the offence provisions specified in the DTC Act came into force from 2 April 2016.  Although the sanctions for non-compliance are criminal in nature, this should be tempered with the knowledge that being hit with the full extent of the sanctions (10 years’ imprisonment) would require prosecutors to prove the requisite levels of intent, knowledge, recklessness and negligence.  The operation of the Criminal Code Act 1995 means that a person who mistakenly supplies, publishes or brokers controlled technology contrary to the DTC Act after diligently following institutional compliance processes would be unlikely to be prosecuted, much less to the full extent of the law.  The Code applies general principles of criminal responsibility to Commonwealth offences; in particular, the knowledge requirement is akin to having received fair warning. 

If the goods or technology at issue are listed in the DSGL, a permit or approval may be required from DECO.  The qualifier “may” is dependent upon:

  • The activity being undertaken (“supply”, “brokering”, or “publication”); and
  • Whether it is a military or a “dual‐use” DSGL technology; and
  • Whether an exemption applies (such as “basic scientific research” or material that has been lawfully placed into the public domain).

As readers will appreciate, a simple “yes/no” answer as to whether a permit is likely to be required is necessarily dependent upon the unique circumstances that each scenario presents.  

Patent-specific exemptions

As mentioned, a staple of our day-to-day activities as patent attorneys is the exchange of information relating to “technology”.  On a daily basis we communicate technology internally, domestically and internationally – and our clients do the same.  It is useful, therefore, to understand the activities that are exempted under the DSGL regulations.

Firstly, the “pre-publication” exemption amounts to recognition, on the Government’s part, that they cannot regulate the publication of information.  As such, the communication of information contained in a patent document that will later be published (e.g., a draft convention application or a draft PCT application) appears to fit comfortably within the definition of “pre-publication”.  On the other hand, provisional patent applications do not appear to fit within this category – and as such, another exemption must be invoked.

To this end, the “patent application exemption” covers activities “directly related to seeking a patent”:

This exemption applies to the supply of DSGL technology where it is done for the purpose of “seeking a patent” in Australia or overseas. “Seeking a patent” includes lodging a patent application and the supply of DSGL technology to a person or organisation (e.g., a Patent Office, patent attorney, research collaborator or a patent review panel) that is directly associated with the lodging (or potential lodging) of a patent application, or as a result of the patent examination process.

Supply for a purpose that is not directly related to seeking a patent will require a permit (unless other exemptions apply). This includes supply of DSGL technology to a research collaborator located overseas before a decision is made to seek a patent. Once a provisional patent application is filed, any supplies of DSGL technology to further develop an invention prior to preparing/submitting a complete patent application will require a permit. Supplies of DSGL technology to locate investors and determine overseas markets (including forwarding a recently-filed provisional application) will require a permit.

The process of publishing a patent (or an unsuccessful application) into the public domain is covered by this exemption. Until such time as that information exists in the public domain, it is still controlled and would require a permit to be supplied if it is not for the purpose of “seeking a patent” and no other exemptions applied.

As such, the Government would appear to have intentionally extricated the acts of overseas communication for the purposes of preparing a patent application (exempt) and communication with a view to ancillary business activities such as seeking investor funding (not exempt).

We will keep abreast of any changes to, or unusual interpretations of this new exemption.  As it is, it is clearly important to the manner in which we – and our clients – go about our everyday professional activities.    

Shelston IP’s proactive approach to the DTC Act restrictions

Being aware of the potential impact of the DTC Act, Shelston IP has closely monitored progress throughout the public consultation process (dating back to 2014).  We have liaised with DEC on a regular basis and have developed an internal best practice guide.  Adherence to such best practice will protect not only our interests, but also those of our clients.  This, in turn, means that clients dealing in controlled or dual-use technologies can be assured that their interests are in safe hands.

Based on our experience and understanding, compliance with the DTC Act can be as easy as following a few simple rules.  In some instances, a deeper consideration of the specific circumstances and legislative requirements will be necessary.  Those concerned about their own internal procedures under the DTC Act are invited to make contact with their Shelston IP patent attorney. 

Our specialist patent searcher, Frazer McLennan, is an expert in assessing technologies against what is prescribed in the DSGL register.

Authored by Gareth Dixon, PhD and Frazer McLennan

The Principals and Staff of Shelston IP wish to thank you for your support in a year filled with challenges.

Throughout this season, and as we move into a new year, we would like to wish you, your family and colleagues strength, health, and as much happiness as these times can allow!

As part of our ongoing commitment to the community, we have made a donation to Aussie Ark, the largest independently owned and operated conservation organisation in New South Wales.

All the very best to you in 2021.


Office Closure

Shelston IP is closed during the Christmas and New Year period:

Friday, 25 December 2020

Monday, 28 December 2020

Tuesday, 29 December 2020 and

Friday, 1 January 2021.

The Australian Intellectual Property Office (IP Australia) will be closed from Friday, 25 December 2020, until Friday, 1 January 2021.

All deadlines that fall due during this time will automatically be extended to Monday, 4 January 2021.

The New Zealand Intellectual Property Office (IPONZ) will be closed from Friday, 25 December 2020, until Monday, 4 January 2021.

All deadlines that fall due during this time will automatically be extended to Tuesday, 5 January 2021.

The World Intellectual Property Organisation (WIPO) have been adding a range of useful tools for many aspects of intellectual property for a while now, including searching databases for patents, trademarks and designs; classifications; statistics; and multilingual terminology across patent documents.  I’ve written before about where you might go to conduct a search, sticking mainly to free sources, but WIPO have just introduced a new tool called WIPO Inspire that is a collection of reports on patent databases and their features.

There are only 24 databases at present but I’m sure that list will grow as new entrants establish themselves in the market.  It’s weighted slightly in favour of fee paying, or commercial, databases, and the free ones are currently restricted to the IP5 (the five largest intellectual property offices), but not either of PatFt or AppFT from the United States, but including WIPO’s own PatentScope, and a few others such as The Lens.  If you need to look further afield, WIPO Inspire has incorporated the older Patent Register Portal page, so you can still locate the relevant national databases for jurisdictions outside the IP5.

The reports on each database are quite extensive, and go into detail regarding the jurisdictions covered, which patent classifications can be used, how their patent families are structured, and how you can manipulate your results through sorting, export or analysis features, plus a lot more.

While it is a short list of databases, and quickly scanned, it is also possible to filter the databases by their features.  For example if you are looking for a database that allows semantic searching, to find those that do involves checking a box within the menu on the left hand side.

WIPO Inspire includes a comparison tool that sits up to four database selections side by side so the features of particular interest can be compared easily.

WIPO Inspire looks like a good tool to help if you are unfamiliar with patent databases, in terms of knowing what their names are, and what they can do.  You may just find one that has the combination of features you’re after.

Authored by Frazer McLennan and Gareth Dixon, PhD

Introduction

IP Australia is providing free extensions of time of up to 3 months if a deadline cannot be met due to the effects of COVID-19.  As reported here https://www.shelstonip.com/news/covid-19-update-ip-australia-now-extended-streamlined-relief-measures-31-january-2021-provide-certainty-holiday-period/, the period for requesting such an extension currently ends on 31 January 2021 with the prospect of the period being further extended. 

A streamlined process has been implemented for requesting COVID-19-related extensions.  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 (equating to circumstances beyond control).  Although these COVID-19 extensions of time have so far been routinely allowed, they are nonetheless subject to the Commissioner’s discretion. 

New decision from IP Australia

A recent decision from IP Australia, Shell Internationale Research Maatschappij B.V. v Yara International ASA [2020] APO 55, http://www.austlii.edu.au/cgi-bin/viewdoc/au/cases/cth/APO//2020/55.html, relates to a request for a COVID-19 extension in the context of a patent opposition.  It provides a reminder that care is required when requesting COVID-19 extensions at IP Australia, both in terms of the timing of the request and the reasoning.

Shell Internationale Research Maatschappij B.V. (the Opponent) filed a Notice of Opposition and, at the same time, requested a COVID-19 extension of 3 months for filing the Statement of Grounds and Particulars (SGP), which was due to be filed within 3 months of the Notice of Opposition. 

In accordance with usual procedure under Australian law, Yara International ASA (the Applicant) was afforded the opportunity to comment on the Opponent’s request for an extension of time.  The Applicant opposed the Opponent’s request for an extension of time. 

The Opponent’s submissions

The Opponent filed a declaration which provided a general overview of the COVID situation in the UK and at Shell.  The declaration noted that, as a consequence of the pandemic, the responsible in-house attorney had commenced working at home in April 2020, solely with the use of a laptop, without access to printers or desktop monitors, and that he did not have access to numerous physical documents that were required for the opposition.  The declaration also reasoned that, due to COVID-19, obtaining mandates and financial approvals for the opposition at Shell had become more difficult. 

The Applicant’s submissions

The Applicant, however, noted that the Opponent had filed two rounds of third-party observations at the EPO on the corresponding European application.  The Applicant argued that, although another Shell attorney had filed those third-party observations, the Opponent had not provided any reason why that attorney could not have prepared or assisted with the preparation of the SGP or why the task could not have been delegated to the Australian representative.  The Applicant pointed out that preparation of the SGP does not need expert witnesses and that the amount of time required to prepare the SGP is significantly less than that required for the preparation of evidence.  Furthermore, the Applicant argued that an undue delay would lead to an extended period of uncertainty for the Applicant and would not be in the public interest. 

Decision to grant a shortened extension and reasoning

The Commissioner commented that it was “not the existence of the pandemic, but rather the specific impacts on the responsible person, that must be taken into consideration”. 

The Commissioner considered that the extension request was “largely prospective and based on conjecture of circumstances that might arise in the future”.  The fact that the extension request had been filed at the same time as the Notice of Opposition did not work in the Opponent’s favour.  In this regard, the Commissioner observed that “if a party can anticipate on-going delays, and even quantify those delays in requesting an extension upfront, then presumably they can also plan and take action to mitigate their impact”.  The Commissioner expressed concern that “a party obtaining an upfront extension and working to an extended deadline may not be as diligent in completing their work, or as motivated to consider and implement mitigating strategies that could enable them to meet the original deadline”.

In the concluding remarks, the Commissioner adjudged that, whilst there were circumstances that had impacted on the Opponent’s ability to complete the SGP in time, the request was made at the beginning of the period for preparing the SGP when the impacts and the extent of delay were uncertain.  Further, the Commissioner was not satisfied that the Opponent had provided a sufficiently detailed disclosure of the circumstances to justify the request for an extension at that time, including the reasons why no strategies were available to mitigate the impacts. 

On balance, the Commissioner decided to allow an extension but the length of the extension allowed was less than the 3 months requested.

The Commissioner noted that the decision to allow the extension of time of course does not preclude the Opponent seeking a further extension based on current circumstances that may prevent completion of the SGP by the extended due date.

Conclusion

Whilst a shortened extension was granted in this circumstance, this decision serves as a stark reminder that IP Australia’s COVID-19 streamlined extension provisions are not a simple free-for-all.  An element of discretion does apply. 

A requestor must be able to provide genuine reasons and evidence to justify the grant of the extension and the timing of the request can also be of significance. 

In addition, it is worth mentioning IP Australia’s warning that a false declaration could put the validity of an IP right at risk.

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 Michael Christie, PhD

A recent YouTube spat over an AI created cover of Britney Spears’ 2004 song “Toxic” demonstrates that AI has now made it possible for one artist to sing a cover of another artist, no human required! In this case, a group called DADABOTS, which describes itself as “a cross between a band, a hackathon team and an ephemeral research lab”, created the rendition using software enabling generation of audio content in the voice of a particular artist, in a particular genre or as a novel fusion. The end result was a Frank Sinatra cover of the Britney Spears song.

Whilst this is a prospect that is bound to be exciting to some, from the perspective of conventional copyright law (and perhaps defamation law), the path to creating such a custom cover track using AI is fraught with complexity and uncertainty.

Yet that didn’t stop DADABOTS rendition being met with something a little more conventional, a copyright takedown notice and subsequent removal from YouTube, as Futurism’s Dan Robitzski recently reported. Futurism noted that GreyZone Inc., a company which offers copyright infringement identification and reporting services, was responsible for the complaint but wasn’t able to identify on whose behalf.

Appeal of YouTube take down

The basis for the original takedown notice is unclear – presumably representatives of either Frank Sinatra or Britney Spears’ respective record labels took the view that their copyright was infringed in some form. In Australia, their songs are likely to be covered by a suite of copyright and related rights, potentially including copyright in the lyrics, the musical work, performance rights and recording rights.

In this case, DADABOTS appealed YouTube’s decision to remove the rendition, calling in aid the US copyright doctrine of fair use. This doctrine is codified in the US Copyright Act and allows “fair use” of copyright works without infringing copyright. Unlike in Australia where the equivalent “fair dealing” is limited to quite specific circumstances, the US Courts have a broad discretion to determine what use is “fair”, depending on factors such as the nature of the copyright work, the purpose of the use and the effect of the use on the potential market for the copyright work. YouTube accepted the appeal and DADABOTS upload was reinstated, albeit with YouTube flagging it as a cover of “Toxic”. YouTube offers a service which allows eligible copyright holders to set up rules dealing with any third party copies of their exclusive copyright content uploaded on YouTube. This might include blocking the uploaded media, taking ad revenue from it or tracking the viewership information. YouTube’s flag of the DADABOTS version presumably makes it subject to any such controls in place in respect of “Toxic”.

Use of copyright works during development of AI powered applications

To make the rendition, DADABOTS used an AI software tool developed by California based OpenAI. Known as “Jukebox”, the software utilises neural networks, a form of machine learning. To become competent, Jukebox was trained by processing various datasets, which in turn allowed it to create the rendition on the basis of what it learnt from that data processing. In this case Jukebox then performed lyrics (of “Toxic”) in the voice and/or genre of the artist on which the software had been trained (Frank Sinatra). According to Open AI’s website, Jukebox was trained on 1.2 million songs, corresponding lyrics and metadata, including artist, genre, year and associated keywords.

Interestingly, Futurism’s article suggests the YouTube appeal arguments were crafted without reference to the use of AI to create the DADABOTS rendition. The fair use arguments were focussed on the end result (i.e. the new rendition) as a fair use in itself, rather than by reference to the method used to create it. Separate to issues around copyright ownership of works created wholly or substantially by AI technologies, the use of copyright works for AI related functions, such as machine learning and datamining is very much a live issue globally. The extent to which such uses are thought to be “fair uses”, is likely to influence the development of the fair use doctrine in copyright, the bounds of which already vary considerably from country to country, if not lead to specific copyright provisions. One notable mover in this space is Japan, which from 1 January 2019 enacted various provisions in its Copyright Act aimed at exempting computer data processing and analysis of copyright works from infringement in certain circumstances. The way in which the law on this topic develops globally may well be a factor which influences where companies with a focus on developing AI powered applications choose to base themselves (if it is not already). Differences in the law on this topic around the globe may also lead to potentially complicated questions of jurisdiction where AI generated material is exported from one country to another.

In Australia, the current law is likely to be less friendly to machine learning and AI powered applications, as a result of the stricter confines on fair dealing, and other limited exceptions to copyright infringement. Certainly where AI applications are used for development which is commercial in nature, it is unlikely that Australian copyright exemptions would apply. While section 40 of the Copyright Act 1968 (Cth) does provide an exemption for fair dealing for research purposes, it has generally been given a narrow reach.

Indeed, extension of the fair dealing provisions in Australia was a topic considered extensively by the Productivity Commission in its review of intellectual property laws in Australia and consequent report issued in 2016. Submissions made on this issue included those from tech companies supporting a broader fair use exception and specifically referring to machine learning in this context. The Productivity Commission ultimately recommended significant reforms in this area paving the way for a US-style fair use exception. However following two years of further consultation, the Government announced in August 2020 only a limited extension of the fair dealing exceptions for non-commercial quotation.

As a consequence, use of datasets to train AI systems in Australia appears likely to carry with it a significant risk of copyright infringement for the foreseeable future, in the absence of an appropriate licence. As the law in this area continues to develop worldwide, this is clearly a space to watch for both copyright owners and anyone using databases of copyright material to power or utilise AI technologies.

Authored by Onur Saygin and Katrina Crooks

Pfizer suffered a setback last week in its Australian battle to protect ENBREL (etanercept), when its preliminary discovery application against Sandoz was dismissed by Justice Burley in the Federal Court. The reasons for the dismissal are not yet public, subject to the parties seeking suppression orders over any confidential information contained in them, but are likely to be released in coming days.

ENBREL is Pfizer’s blockbuster autoimmune disorder therapy, used to treat various chronic diseases including rheumatoid arthritis. Commercially available in Australia since 2003, ENBREL was the only etanercept product registered on the Australian Register of Therapeutic Goods until 2016 when Samsung Bioepis registered BRENZYS, followed by Sandoz’s registration of ERELZI in 2017.

Given ENBREL’s success it is not surprising that patents covering the product are also being litigated elsewhere. In the United States, where Amgen holds the patent rights, ENBREL is its top selling product. The US Federal Appeal Court recently issued its judgment upholding the validity of the ENBREL patents and restraining Sandoz from entering the market there.  Amgen has also filed proceedings against Samsung Bioepis in the US, where Samsung’s ETICOVO is not yet on the market pending the outcome of that litigation.

In Australia, Pfizer launched its preliminary discovery application against Sandoz in November 2019, after winning a similar application against Samsung Bioepis in late 2017. In the Samsung case, Pfizer sought discovery of documents submitted to the Therapeutic Goods Administration in order to ascertain whether BRENZYS infringed three patents covering methods of producing polypeptides and/or proteins in the upstream bioprocessing phase.

The relevant Australian rules provide that preliminary discovery can be sought before a substantive proceeding is commenced, for discovery of documents directly relevant to the question of whether the applicant has a right to obtain relief from the Court. It is necessary to show that the applicant reasonably believes that they may have a right to such relief and that, after making reasonable inquiries, does not have sufficient information to decide whether to start a proceeding to obtain that relief. The Court has a discretion as to whether it makes a preliminary discovery order.

The key issue in the Samsung case was whether Pfizer had the requisite belief that it may have a right to obtain substantive relief; that is, in this case, a belief that Samsung was infringing its patents. The parties filed extensive affidavit evidence, including from experts on this topic. Pfizer advanced six contentions which it argued supported its reasonable belief, including the fact that BRENZYS had been registered on the basis of its biosimilarity with ENBREL, that specific characteristics of BRENZYS were similar to ENBREL, in particular it had similar glycosylation profiles, and that since ENBREL fell within the scope of the relevant patent claims, so must BRENZYS. Considering these arguments in detail, and noting that he had not had the benefit of cross examination of the witnesses, Justice Burley ultimately found that he was not convinced that there was a “reasonable basis” for Pfizer’s belief of patent infringement, as opposed to a mere suspicion (see Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCA 285). However, an appeal by Pfizer to the Full Federal Court was upheld (see Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd [2017] FCFCA 193). The Full Court emphasized that the inquiry was not to determine the dispute between the experts, or who was more persuasive, but rather whether Pfizer had a reasonable basis for a belief that it may have a right to obtain relief. Noting the very substantial evidence filed on the application, Allsop CJ emphasised that “these are summary applications not mini-trials”. The High Court subsequently refused special leave for a further appeal. After the matter was remitted to the primary judge to determine the final form of orders, those orders were made in May 2019 and the proceeding still continues after orders were made earlier this year for any application for further discovery to be filed.

In light of the more generous approach to preliminary discovery applied by the Full Court in the Samsung case, it will be interesting to see the reasons for Justice Burley’s decision in the Sandoz case. It certainly seems plausible that another appeal to the Full Court is on the horizon. More generally, we expect to see more preliminary discovery applications in patent disputes in years to come, given the increasing significance in Australia (as elsewhere) of biosimilar patent litigation. In that sphere, patents covering manufacturing processes are likely to assume greater importance in light of 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 weapon in many such cases. It also remains to be seen whether we will see more applications to be released from the general undertaking only to use information obtained in an Australian proceeding for the purpose of that proceeding, in order to allow, for example, preliminary discovery obtained in Australia at an early stage to be used for the purpose of corresponding US proceedings.

We look forward to providing a further update when the judgment is released in this case.

Authored by Katrina Crooks

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 31 January 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.

Many deadlines for patents, trade marks and designs are covered by these 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

Register here

Authored by Greg Whitehead and Allira Hudson-Gofers

Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477

Summary

Australia’s Federal Court has delivered judgment in a dispute concerning patents covering improvements in vaccines against Streptococcus pneumoniae, a leading cause of serious infections, particularly in children.  The judgment provides the first detailed analysis by a Federal Court judge of the Raising the Bar reforms to Australian patent law concerning sufficiency and support.  The decision demonstrates the profound implications of those reforms for permissible claim breadth in Australian patents.

Key takeaways

  • Australian patent law concerning sufficiency of description and support for claims underwent significant changes in 2012 as a result of the Raising the Bar amendments to the Patents Act 1990 (Cth) (Patents Act).
  • Due to generous transitional provisions, the amended law is only now coming before Australia’s Federal Court for interpretation and application.
  • European and UK authorities provide guidance on how the amended provisions of Australia’s Patents Act are likely to be interpreted and applied. In some cases, the amendments will result in a reduction in permissible claim breadth for Australian patents.
  • As a result of the transitional arrangements, many Australian patent disputes between now and least 2033 are likely to involve both patents subject to the pre-Raising the Bar law and patents subject the post-Raising the Bar Amendments may be required to avoid the latter patents being held invalid under the new, more stringent standards of sufficiency and support.

On 14 October 2020, Justice Stephen Burley delivered the judgment of the Federal Court of Australia in Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477.  The case concerned three patents owned by Wyeth LLC (Wyeth) relating to improvements in immunisation against infection by Streptococcus pneumoniae, a bacterium responsible for meningitis, pneumonia and other serious illnesses, especially in children.

Justice Burley’s decision provides the first detailed analysis by the Federal Court of Australia concerning amendments made in 2012 to Australian patent law on the topics of sufficiency of description and support for claims.  The decision highlights the significant implications of those amendments for patent validity and claim scope.

The technology

Streptococcus pneumoniae (also referred to as “pneumococcus”) has an outer capsule that incorporates complex sugars known as polysaccharides.  Differences in capsular polysaccharides distinguish variants of pneumococcus, called “serotypes”.  More than 90 distinct serotypes have been described.  A more limited group of virulent serotypes are responsible for most serious pneumococcal infections.

The antibody response to capsular polysaccharides is generally poor in young children.  As a result, they are particularly susceptible to pneumococcal infections, which globally account for around 1 to 2 million childhood deaths each year.

To address this problem, “polysaccharide-protein conjugate vaccines” were developed with the aim of stimulating immunity against serotypes of pneumococcus known to be responsible for a high proportion of human infections.  In such vaccines, capsular polysaccharides are joined (“conjugated”) to a carrier protein, leading to a stronger antibody response than is achievable with vaccines based on capsular polysaccharides alone.

A polysaccharide-protein conjugate vaccine against pneumococcus developed by Wyeth, known as Prevnar 7®, was in clinical use before the priority date of the Composition Patents.  That product is a “7-valent” vaccine.  It comprises capsular polysaccharides from 7 different pneumococcus serotypes, in each case conjugated to a single protein (known as “CRM197”).  Evidence led in the case indicated that, before the priority date, steps had been taken to develop 9-valent and 11-valent polysaccharide-protein conjugate vaccines against pneumococcus, but no such products had yet been licensed or launched.

The patents

Three patents were at issue in this proceeding.  Two of them, referred to by Burley J as the “Composition Patents”, were related members of the same patent family.  The more senior family member (referred to here as the “Parent Composition Patent”) was subject to the provisions of Australia’s Patents Act as they stood prior to the Raising the Bar amendments.  The more junior family member (referred to here as the “Child Composition Patent”) was subject to the post-Raising the Bar Patents Act.  The body of the specification was substantially the same in the parent and child patents.  It described multivalent immunogenic compositions (that is, vaccines) comprising 13 distinct polysaccharide-protein conjugates, thereby providing increased coverage of pneumococcal serotypes compared to the existing Prevnar 7® vaccine.

A third patent asserted by Wyeth in the proceeding, referred to by Burley J as the “Container Patent”, disclosed siliconized container means for the stabilization of polysaccharide conjugates.  The issues raised in the proceeding in relation to the Container Patent are not discussed here.

The proceedings

Merck Sharp & Dohme (MSD) sought revocation of Wyeth’s Composition Patents on a variety of grounds, including lack of novelty, lack of inventive step (i.e., obviousness), false suggestion, lack of clarity, lack of fair basis (in relation to the pre-Raising the Bar Parent patent) and lack of support (in relation to the post-Raising the Bar Child patent).

By a cross-claim, Wyeth alleged that a 15-valent pneumococcal vaccine which MSD proposed to launch and market in Australia would infringe selected claims of all three of the asserted patents.

Wyeth’s allegation that the Composition Patents would be infringed by marketing of MSD’s 15-valent vaccine in Australia gave rise to a critical issue of claim construction in the proceeding, namely, whether the claims of those patents were limited to 13-valent vaccines (as MSD contended) or extended to vaccines covering 13 or more serotypes (as Wyeth submitted).

The construction issue

Claim 1 of the Parent Composition Patent was in the following terms:

A multivalent immunogenic composition, comprising: 13 distinct polysaccharide-protein conjugates, together with a physiologically acceptable vehicle, wherein each of the conjugates comprises a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to a carrier protein, and the capsular polysaccharides are prepared from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and wherein said carrier protein is CRM197.

Insofar as is presently relevant, claim 1 of the Child Composition Patent was in similar (although not identical) terms.

The specification of each of the Composition Patents included text (standard in Australian patents) indicating that “comprising” is used in an inclusive sense (“including”) rather than an exhaustive sense (“consisting of”).  That text provided the basis for Wyeth’s submission that, because MSD’s 15-valent vaccine included the 13 serotypes identified in the claims of the Composition Patents, it fell within those claims.  On Wyeth’s construction, the presence of two additional serotypes in MSD’s 15-valent vaccine was irrelevant to infringement.

Arguing to the contrary, MSD submitted that its construction (limiting the claims to 13-valent vaccines) was the only construction consistent with the description of Wyeth’s invention in the specification taken as a whole.  A corresponding submission, based on similar (but not identical) claim language, had been accepted in related UK proceedings between MSD and Wyeth (see Merck Sharp & Dohme Limited v Wyeth LLC [2020] EWHC 2636 (Pat) at [251]-[270]).

However, on this key issue, Burley J preferred Wyeth’s construction.  In his Honour’s analysis, the inclusive definition of “comprising” was decisive.  Provided that a vaccine included each integer of Wyeth’s claims (including, relevantly, the 13 specified serotypes), it would infringe – a conclusion not altered by the presence in the infringing product of additional serotypes.

What is notable for present purposes is the very substantial breadth given to Wyeth’s claims on the construction adopted by Burley J.  On that construction, the range of valences covered by Wyeth’s claim would appear to have no upper bound.

Unsurprisingly, in view of this broad construction, a question arose as to whether the claims were fairly based on, or supported by, the disclosure contained in the body of the Composition Patent specification.  On that legal issue, the Raising the Bar amendments have brought about a profound shift in Australian law, as Burley J’s judgment demonstrates.

Raising the Bar reforms

The Raising the Bar reforms were introduced to address concerns that Australia’s patent standards were lower than those of its major trading partners, causing Australia’s innovation landscape to become cluttered with unduly broad patents.  The amendments were expressly directed at aligning key aspects of Australian patent law, including on sufficiency of disclosure and support for claims, with the standards applied by UK courts and the European Patent Office (EPO) Boards of Appeal.

Although the Raising the Bar amendments were enacted in April 2012, lengthy transitional provisions mean that many of the key reforms, including those concerning sufficiency and support, are only now coming before the courts for interpretation and application.

The law pre-Raising the Bar

Prior to the Raising the Bar reforms, the relationship between the disclosure in the body of a patent specification and the breadth of the claims was governed by the legal requirement for “fair basis”.  The leading authority on that requirement (Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274) established that fair basis does not turn on any inquiry into the patentee’s “technical contribution to the art”, but rather on whether each claim corresponds textually with what the patentee has described as their invention in the body of the patent specification.

The practical effect of Lockwood’s permissive interpretation of the fair basis requirement was amplified by the equally permissive interpretation of the sufficiency requirement given in the leading authority pre-Raising the Bar (Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1).  That case stands as authority for the proposition that a patent specification will have adequately described the invention if it would enable a person skilled in the relevant art to produce “something” falling within each claim (referred to colloquially as the “one way rule”).

That body of law is of continuing relevance for Australian standard and innovation patents for which examination was requested before 15 April 2013.  In the present case, that “old” body of law applied to the Parent Composition Patent.

Applying those authorities, Burley J found little difficulty in concluding that, notwithstanding his Honour’s broad interpretation of the claims of the Parent Composition Patent, those claims were fairly based.  Reflecting the essentially textual nature of the pre-Raising the Bar test for fair basis, that conclusion followed from the fact that the description of the invention in the body of the Parent Composition Patent employed the same inclusive language (“comprising”) as appeared in the claims.

The law post-Raising the Bar

Following the Raising the Bar amendments, the provisions of Australia’s Patents Act dealing with sufficiency and support are in substantially the same terms as the corresponding provisions of the European Patent Convention and the United Kingdom’s Patents Act 1977.  Parliamentary records make clear that those provisions were intended to have substantially the same effect as their European and UK counterparts, and that Australia courts are expected to have regard to decisions of the EPO Boards of Appeal and of UK courts in interpreting those provisions.

Burley J reviewed a number of EPO and UK authorities, including the recent decision of the UK Supreme Court in Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27, to interpret the post-Raising the Bar requirement that the claims be “supported by matter disclosed in the specification”.

Referring to the landmark decision of the House of Lords in Biogen Inc v Medeva Plc [1997] RPC 1, Burley J observed that the claim support obligation has come to be understood as falling “under the umbrella of the requirement that the patent specification contain an enabling disclosure”.  His Honour noted that, although the requirement for sufficient description is directed to the specification as a whole, while the requirement for support is directed specifically to the claims, both requirements serve to ensure that a person skilled in the relevant art, armed with the patentee’s specification, is enabled to perform the invention over the whole area claimed without undue burden.

Referring to the decision of the EPO Board of Appeal in Exxon/Fuel Oils (T 409/91) [1994] EPOR 149, Burley J noted that the requirement for enablement across the full claim scope has been recognised as reflecting the general legal principle that the scope of a patent monopoly, as defined by the claims, should correspond to the patentee’s technical contribution to the art, as disclosed in their specification.

Applying those authorities, Burley J concluded that the claims of the Child Composition Patent were not supported by the matter disclosed in the specification.  On the construction advanced by Wyeth and accepted by His Honour, those claims encompassed any polysaccharide-protein conjugate pneumococcal vaccine comprising 13 or more serotypes (provided the other claim integers were satisfied).  While there was no dispute that the specification of the Composition Patents would enable a skilled person to make and use a 13-valent vaccine, uncontested evidence established that the disclosure of the specification could not be extrapolated to vaccines containing other, additional serotypes.  Manufacture of polysaccharide-protein conjugate vaccines comprising more than 13 serotypes was not enabled.

In the result, the asserted claims of the Parent Composition Patent were held to be valid and infringed, while the asserted claims of the Child Composition Patent were held invalid for lack of support.

Significance of the judgment

The disparate conclusions reached in this case concerning the Parent and Child Composition Patents serve to illustrate the profound changes to Australian law brought about by the Raising the Bar reforms.

Observers in other jurisdictions may find it curious that such starkly different findings could be made on the basis of very closely similar patent specifications.  The principle upon which the Child Composition Patent was held invalid (i.e., the requirement that claim breadth correspond to the patentee’s technical contribution to the art) is said to reflect the “essential patent bargain” whereby the patent holder is granted a time-limited monopoly in return for disclosing their invention in terms sufficiently clear and complete for it to be performed by those skilled in the art.  The fact that this requirement did not apply to the Parent Composition Patent serves to illustrate the extent to which, in the pre-Raising the Bar era, Australian patent law had diverged from the law applied by its major trading partners.

Such disparate outcomes are likely to remain a feature of Australian patent disputes for some years to come.  Australian patents subject to the pre-Raising the Bar law are expected to remain in force until at least 2033.

This decision also demonstrates that the post-Raising the Bar incarnations of Australia’s written disclosure requirements in s 40 of the Patents Act 1990 (Cth) can be a much more powerful weapon in the arsenal of a party seeking to revoke an Australian patent.  Historically, the low thresholds for fair basis and sufficiency have provided relatively wide scope for Australian patentees in advancing positions on claim construction to capture alleged infringements.  This main constraint for patentees in advancing claim construction under the pre-Raising the Bar body of law has been (and will remain) potential novelty and inventive step consequences arising from constructions being so broad as to capture prior art or common general knowledge.  The onerous post-Raising the Bar support and sufficiency requirements will add an extra dimension to these construction “squeezes” and another powerful validity ground which must be fended off.

Furthermore, notwithstanding parliament’s intention that the post-Raising the Bar provisions concerning sufficiency of description and claim support be interpreted so as to have substantially the same effect as the corresponding provisions of European and UK law, lingering disparities between the law of those jurisdictions and the terms of Australia’s Patents Act mean that some independent development of Australian law on sufficiency and support appears inevitable.  Two examples may be noted.

First, under the UK’s Patents Act 1977, although both sufficiency and support are requirements for a valid patent application, only lack of sufficiency is available as a ground of revocation for granted patents.  UK courts have remedied that “logical gap” by recognising both requirements as aspects of a single unifying requirement for an enabling disclosure.  No such logical gap exists in Australia’s Patents Act, where both lack of sufficiency and lack of support are available as grounds for revocation.  Whether this difference will lead Australian courts to seek to disentangle the threads of sufficiency and support in the UK authorities remains to be seen.

Secondly, by contrast to the requirements of European and UK law, Australia’s post-Raising the Bar Patents Act continues to impose a requirement to disclose the “best method”.  European and UK authorities provide no guidance on how that requirement is to be accommodated with the law regarding sufficiency and support.  For such guidance, it may be necessary for Australian courts to look to United States authorities.  Whether they will choose to do so remains to be seen.

Given the significant commercial interests at stake, and the complexity of the legal and factual issues raised by the Prevnar® case, the likelihood of an appeal appears reasonably high.  Whether any appeal judgment casts further light on Australian patent law post-Raising the Bar is likely to depend upon whether the appeal court upholds the broad construction of Wyeth’s Composition Patent claims that was accepted by Burley J.

Authored by Andrew Rankine, Charles Tansey, PhD, Duncan Longstaff