The Australian Patent Office's 21 January 2020 decision in Amicus Therapeutics, Inc. [2020] APO 4 reminds us that the generous general extension of time provision of the Australian Patents Act (that is, Section 223(2)(a)) does not apply to fix every error or omission.
The decision also highlights the importance of establishing a fully informed patent strategy early, particularly when commencing an international filing program.
The GALAFOLD launch – timeline of events
| 30 May 2016: | Amicus Therapeutics, Inc (Amicus) launched GALAFOLD, a drug used to treat Fabry's disease, in Germany. Normally, any subsequently filed patent applications for GALAFOLD would be rejected. However, some countries, including the United States of America and Australia, have grace periods to deal with this circumstance. |
| 30 May 2017: | Amicus filed a provisional US patent application
to take advantage of the US grace period provisions. Since Amicus
filed the US patent application within 12 months of the GALAFOLD
launch, the prior public availability of GALAFOLD does not count
against the validity of the US patent application.
Amicus also filed several further applications claiming priority from the US filing, including international and Australian applications. |
| July 2018: | Amicus discussed the filing of the US provisional patent application with its Australian patent attorney, who informed Amicus that the only way of invoking the Australian grace period was to file a complete Australian patent application within 12 months of the disclosure (that is, before May 2017) and that the filing of the US provisional application was not sufficient for this purpose. |
| 8 August 2018: | Amicus filed an Australian patent application together with a request for an extension of time to claim priority from the US provisional patent application (that is, for the application to have been considered filed within the Australian 12 month grace period). |
What did Amicus need to demonstrate to obtain the extension of time?
Essentially, Amicus needed to show that there had been a causally relevant error or omission. Generally, an error or omission covers: accidental slips, inadvertences and errors caused by faulty reflection; an unexpected failure to exercise due diligence and/or a flaw in mental function in carrying out an intention; and a breakdown in procedure in effecting an intention.1
Where there has been a failure to invoke the Australian grace-period provisions, generally the applicant must demonstrate that at all relevant times they intended to file a complete Australian patent application within the 12-month grace period, but were unable to do so due to an error or omission.2 However, in the present case, Amicus could not say that it had originally intended to file an Australian complete application before 30 May 2017 as it did not know it had to do so to invoke the Australian grace period provisions. In such circumstances, it would be sufficient for Amicus to show that an error or omission prevented Amicus from forming the relevant intention.
Could failure to make enquiries constitute the error or omission?
Amicus explained that their US counsel had failed to make enquiries about the Australian grace period, and without this information, Amicus was unable to form a specific intention to file the complete specification within 12 months of filing the US provisional patent application, and thereby invoke the Australian grace period.3
Amicus also stated that it is possible for an infinite number of circumstances to arise during prosecution of a patent internationally, and that it would be too onerous and unrealistic to expect there to be processes in place to cover every possible event.4
A simple failure to do something is not enough
The Delegate found that for Amicus to succeed, it would need to demonstrate that there was an error or omission in not making the relevant enquiries in the context of there being an obligation, expectation or standard practice that the enquiries were made. That is, the mere failure to make enquiries is not a sufficient error or omission, unless those enquiries are normally made or are expected to be made. In this context, the Delegate noted that Amicus had failed to explain why their US counsel was expected to make enquiries as to the Australian grace period, particularly if it was not standard practice or obligatory to do so.5
The Delegate went further by commenting that Amicus 'appears to have followed a particular strategy for patent protection, but the benefit of hindsight suggested an alternative or additional strategy could have been employed' and that while the extension of time provision should be interpreted to the benefit of the applicant for the extension of time, 'it is not a general power of extension to enable potentially mercurial changes in strategy as new information or circumstances come to light or, as it appears in the present case, hindsight suggests a missed opportunity.6
Next steps
Although Amicus was unsuccessful in this instance, all is not lost. Amicus may file a new extension of time request, which includes more information to address the Delegate's concerns.
However, the Delegate cautioned that should Amicus file another request, he would expect there to be a full and frank disclosure which establishes that an alternative strategy was intended to be followed, but 'an error or omission thwarted that intention or prevented its formation.7
Footnotes
1. Amicus Therapeutics, Inc. [2020] APO 4 at [13].
2. Patents Act 1990 s223(2)(a).
3. Amicus Therapeutics, Inc. [2020] APO 4 at [25] citing Magnum Magnetics Corporation [2019] APO 3.
4. Ibid at [29].
5. Ibid at [30].
6. Ibid at [34].
7. Ibid at [34].
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