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

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.

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