Bioverativ Therapeutics Inc. - [2023] APO 64

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Bioverativ Therapeutics Inc. [2023] APO 64

Patent Application: 2022228110

Title:Factor IX polypeptide formulations

Patent Applicant: Bioverativ Therapeutics Inc

Delegate:Felix White

Decision Date: 14 December 2023

Hearing Date: 13 September 2023, by videoconference
Catchwords: PATENTS – extension of time – request for extension of time under s223(2)(a) to file a divisional application – error or omission – erroneous understanding of eligibility for patent term extension – whether error prevented formation of intention to carry out relevant act – whether error frustrated existing strategic intention – determination of strategic intention – request refused

Representation: Katrina Crooks & Daniel Sieveking, Spruson & Ferguson

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE

Patent Application: 2022228110

Title:Factor IX polypeptide formulations
Patent Applicant: Bioverativ Therapeutics Inc.
Date of Decision: 14 December 2023
DECISION
The provisions of section 223(2)(a) cannot be enlivened as I cannot conclude on the basis of the evidence presented that but for a causative error, a divisional application would have been filed by the required time. There is no need to consider discretionary factors. I refuse the request for extension of time.
REASONS FOR DECISION

This decision relates to a request for an extension of time (“the request”) under section 223(2)(a) of the Patents Act 1990 (“The Act”)[1] for claiming divisional status from Australian patent application 2019208273 (“the ‘273 application”).
[1] Any reference to legislation herein refers to this Act, or the associated Patents Regulations 1991

History

The ‘273 application was accepted on 10 September 2021 and this acceptance was advertised on 30 September 2021. Pursuant to Reg 6A.1, any divisional application must have been filed by 30 December 2021.
Australian patent application 2022228110 (“The present application”) was filed on 6 September 2022 in the name of Bioverativ Therapeutics Inc (“Bioverativ” or “The Applicant”), accompanied by a request for a 9 month extension of time for claiming divisional status from the ‘273 application.
A first declaration from Mr James Velema (“Velema #1”) in support of the s223 request was filed on 14 November 2022.
In this first declaration, Mr Velema, a registered US patent attorney, stated that he is responsible for the worldwide management of Bioverativ’s patent portfolio, including the ‘273 application which relates to pharmaceutical formulations marketed and sold under the drug name ALPROLIX®.[2] Inter alia, claims 1 and 2 of the ‘273 application are respectively directed to the two highest dosage forms (3000 IU and 4000 IU) of ALPROLIX® registered in Australia.[3] According to Mr Velema, “Bioverativ’s position is that all relevant subject matter relating to products and therapies for which regulatory approval is being sought, or has been obtained, should be suitably claimed and that possible extensions of patent term should be sought when available.”[4] He had an “understanding at the time of acceptance that the patent issuing on AU ‘273 would be eligible for an extension of term based on the regulatory approval of ALPROLIX® in Australia.”[5]
[2] Velema #1 at…

Grounds of appeal

[14] The appellant contends that the primary judge erred in finding that the respondent had discharged the onus of establishing the matters required under the relevant provision.

[15] It was submitted that his Honour failed to give adequate weight to the evidence of the second witness, and that the findings of fact were not reasonably open on the material before the Court.

[16] The respondent, for its part, submits that no error is disclosed, and that the conclusions reached were well within the range of outcomes available to the primary judge.

Consideration

[17] It is convenient to deal first with the question of construction, as the resolution of that issue informs the remaining grounds advanced by the appellant.

[18] For the reasons that follow, we are of the view that the appeal should be allowed in part and the matter remitted for further determination.

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Details

AGLC: Bioverativ Therapeutics Inc. [2023] APO 64
Case: [2023] APO 64
Decision Date: 14 December 2023

CaseChat Overview and Summary

Bioverativ Therapeutics Inc. sought an extension of time to file a divisional patent application from Australian patent application 2019208273, which was granted on 14 March 2014. The deadline for filing a divisional application was 30 December 2021. The applicant filed Australian patent application 2022228110 on 6 September 2022, accompanied by a request for a 9-month extension of time under section 223(2)(a) of the Patents Act 1990. The delegate refused the request. The applicant sought a review of the decision. The delegate refused to extend the time, finding that there was no error or omission by the applicant or their agent that prevented the filing of the divisional application within the prescribed time. The delegate found that the applicant's strategic objective was to seek patent term extensions for ALPROLIX® when available, and that the alleged error did not frustrate this overarching course of action. The delegate concluded that the error did not prevent the formation of an intention to file a divisional application by the relevant date, and that the error did not frustrate the existing strategic intention. The delegate refused the request for extension of time. The final orders of the court were that the applicant's request for an extension of time be, and is hereby, refused.

Orders