The extension of time provisions under s223 of the Patents Act 1990 (‘the Act’) are regarded as beneficial provisions to be applied for the benefit of the s223 applicant. In exercising this provision, the Commissioner requires not only that the statutory elements be shown out but also a full and frank disclosure by the s223 applicant of all relevant events.
The danger in not satisfying the Commissioner’s requirements is evidenced in Amicus Therapeutics, Inc.  APO 4. Amicus Therapeutics, Inc. (‘Amicus’) filed a request under s223 for an extension of time to file a complete application in order to invoke the grace period for a potentially invalidating self-disclosure. The s223 request was rejected by an examining officer. Amicus sought to be heard on the matter.
Under s24(1)(a) of the Act, a public disclosure by the Applicant or a predecessor in title may be disregarded when assessing novelty or inventive step if an Australian complete application is filed within 12 months of the earliest public disclosure. This is unlike the U.S. where the grace period is enlivened by filing a U.S. provisional application within 12 months of the earliest public disclosure.
Amicus filed the application under consideration, AU2018220047 (‘the Application’), on 22 August 2018 as a patent of addition from AU2009214648 filed on 12 February 2009. The Application claims priority from US Provisional Application No. 62/512,458 filed on 30 May 2017.
The subject matter of the Application relates to Fabry’s disease, which is a genetic disorder that causes a deficiency of the enzyme α-galactosidase A that processes sphingolipids. Overproduction of sphingolipids can result in heart and kidney dysfunction. Broadly, the Application relates to a method of treating Fabry’s disease by administering a molecule marketed under the brand name Galafold to a patient having one or more specific mutations in α-galactosidase A. The Application includes a number of further mutations not disclosed in AU2009214648.
Galafold was launched in Germany on 30 May 2016, which constitutes the first public disclosure of the invention as claimed in the Application.
On 30 May 2017, Amicus filed US Provisional Application No. 62/512,458 and subsequently filed a PCT application claiming priority from this application.
On 12 July 2018, the US counsel acting for Amicus became aware of the grace period provisions in Australia through a meeting with the Australian attorney representing the Application. In particular, the US counsel was informed that filing of a US provisional application would not invoke the grace period provisions in Australia, and that filing of an Australian complete application within 12 months of the Galaford launch date would be required to invoke the grace period. At the time, the US counsel was advised that an extension of time would be required to file the complete application.
The Application was filed with a concomitant request for an extension of time under s223 to extend the deadline to file a complete application, seemingly from 30 May 2017 to 22 August 2018.
s223(a) of the Act provides that where, because of an error or omission by the person concerned or by his or her agent or attorney, a relevant act that is required to be done within a certain time is not, or cannot be, done within that time, the Commissioner may extend the time for doing the relevant act.
Since s223 is a fertile ground for applicants and patentees to remedy a deficiency that would otherwise result in a loss of patent rights, this section of the Act has attracted much judicial attention. The following summarises the guiding principles:
- For an extension to be granted under section 223(2)(a), there must be an error or omission and a causal connection between the error or omission and the relevant act that is required to be done within a particular time. (Kimberly-Clark Ltd v. Commissioner of Patents and Minnesota Mining and Manufacturing Co (No 3)  FCA 421).
- The failure to do the act or take the step, cannot itself be the error or omission by which the failure occurred. (Kimberly-Clark Ltd supra)
- A deliberate policy or decision that leads to the failure to perform the relevant act does not constitute an “error or omission”. (Re Weir Pumps Ltd and Commissioner of Patents and Stork Pompen BV  AATA 331).
- Most errors and omissions which lead to a failure to do an act or take a step are the result of negligence or incompetence. Where such errors and omissions are made against a clearly demonstrated desire to maintain the application (and thus not have it lapse), and where attempts are made to remedy the error or omission as soon as its consequences are discovered and the existence of the error or omission learnt…the considerations in favour of an extension seem to…be quite persuasive. (G S Technology Pty Limited v Commissioner of Patents  FCA 1017).
- An applicant for an extension of time must demonstrate that they had an intention to do the relevant act within the time prescribed, and that an error or omission on their, or their agent’s, behalf reasonably could be said to have frustrated that intention. However, there will be exceptional circumstances where the relevant error precluded the formation of a specific intention. In such cases the required causal connection is satisfied if the error contributed to the failure to form the intention to perform the relevant act. (Kimberly-Clark Ltd supra).
- There must be a full and frank disclosure of, inter alia, all the conduct, knowledge, beliefs and mental processes of the applicant. This is relevant to an understanding of the way the failure to do the act or take the step occurred, or relevant to an evaluation of the reasonableness of that conduct. (Kimberly-Clark Ltd supra).
- The phrase “error or omission” has a broad scope and includes 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. (Knauf Plasterboard Pty Ltd v CSR Building Products Limited  APO 64)
According to Amicus, the error was that their US counsel should have made enquiries concerning the Australian grace period provisions prior to the grace period deadline and failure to do constitutes an error that falls within the scope of s223. That is, the US counsel only became aware of the Australian grace period provisions on 12 July 2018 and that enquiries as to the grace period provisions should have been made before 30 May 2017.
However, the examining officer and delegate were not persuaded by the declarations and evidence adduced by Amicus to support this assertion.
The examining officer noted that Amicus did not identify any intention to rely upon the grace period provisions in any other country other than the US, and certainly not Australia. Moreover, the Application was filed more than 12 months after the US provisional application, which suggests that Amicus had no intention to file the application in Australia. The apparent lack of intention to file in Australia was not addressed by Amicus in submissions for the hearing despite the requests by the examining officer to provide further information on this point.
In the hearing officer’s determination, the term “should” as used by Amicus suggests an expectation or obligation on the part of US counsel to have made an enquiry regarding Australian grace period provisions at the time that the US provisional application was filed.
Unfortunately for Amicus, no reasons why US counsel was in any way expected to have made this enquiry were provided. An expectation to make this enquiry may have been in the form of standard practice or some other reason why it would have been obligatory or otherwise expected of US counsel to enquire as to the grace period provisions in Australia. In the absence of such a reason, the hearing officer could not conclude that US counsel erred in not undertaking such an enquiry.
Accordingly, the request for the extension of time was refused.
The hearing officer made some additional observations that are informative to potential s223 applicants.
In the hearings officer’s view, the material provided by Amicus to support the request for extension of time fell short of a full and frank disclosure of the circumstances surrounding the need to obtain the extension of time. Mere statements by Amicus that had they been aware of the Australian grace period provisions then steps would have been taken to satisfy the requirements were insufficient, particularly considering that examining officer sought further evidence to support these statements.
In the penultimate paragraph of the decision, the hearing officer took the unorthodox step of placing Amicus on notice regarding future s223 requests as follows at paragraph 34:
“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. Section 223(2)(a) is a beneficial provision and it should be exercised beneficially, but 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. If the applicant files another request, I would expect there to be a full and frank disclosure addressing these issues and that establishes that the alternative strategy was intended to be followed but an error or omission thwarted that intention or prevented its formation.”
The decision in Amicus is a reminder that although s223 can be a generous provision, it should not be regarded as a safety net that can be enlivened at whim.