Ono Pharmaceutical Co., Ltd. et al - [2020] APO 43

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Ono Pharmaceutical Co., Ltd. et al [2020] APO 43
Patent Application: 2011203119

Title:Human monoclonal antibodies to programmed death 1 (PD-1) and methods for treating cancer using anti-PD-1 antibodies alone or in combination with other immunotherapeutics

Patent Applicant: Ono Pharmaceutical Co., Ltd. and E. R. Squibb & Sons, L.L.C.

Delegate:Greg Powell

Decision Date: 16 September 2020

Hearing Date: 16 October 2019, in Melbourne

Catchwords: PATENTS – application for extension of term of patent – first regulatory approval date – regulatory approval for a person other than the patentee –G. D. Searle [2008] APO 31 considered – scheme agnostic to ownership question – extension refused

Representation: Counsel for the applicant: Bruce Cain SC, assisted by Marcus Fleming of counsel
Solicitors for the applicant: Mr Wayne McMaster, Ms Rebecca Pereira and Mr James Webster, of MinterEllison

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE

Patent Application: 2011203119

Title:Human monoclonal antibodies to programmed death 1 (PD-1) and methods for treating cancer using anti-PD-1 antibodies alone or in combination with other immunotherapeutics

Patent Applicant: Ono Pharmaceutical Co., Ltd. and E. R. Squibb & Sons, L.L.C.
Date of Decision: 16 September 2020
DECISION

The application for an extension of term on the basis of OPDIVO is refused. This decision represents the reasons for refusal as required under subsection 74(4).
REASONS FOR DECISION

Background

This matter concerns a request for an extension of the term of patent number 2011203119 in the name of Ono Pharmaceutical Co., Ltd. and E. R. Squibb & Sons, L.L.C. (the patentee). The date of the patent is 2 May 2006 and, accordingly, the normal term of the patent expires on 2 May 2026. An application for extension of the term of the patent under section 70 of the Patents Act 1990 (the Act) was filed on 11 July 2016.
The basis for the request for an extension of term was double-barrelled. The patentee believed that there were two alternative interpretations of the requirements imposed by section 70 of the Act and had filed two requests.
The first request, and the patentee’s preferred option, was an application for extension of term based on the inclusion in the Australian Register of Therapeutic Goods (ARTG) of their own product OPDIVO, which has an ARTG start date of 11 January 2016. In the alternative, the patentee based their application for extension of term based on the inclusion in the ARTG of KEYTRUDA (a product of Merck Sharp & Dohme), which has an ARTG start date of 16 April 2015. As is clear, if KEYTRUDA was to be relied upon, the request for an extension of term should have been filed on 16 October 2015. Consequently, accompanying this request was a request under s223(2)(a) of the Act for an extension of time of 9 months.
Consistent with the practice of the Commissioner, the patent was re-examined. The first report, based upon a set of amended claims filed after the requests for extension of term were filed, noted a…

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: Ono Pharmaceutical Co., Ltd. et al [2020] APO 43
Case: [2020] APO 43
Decision Date: 16 September 2020

CaseChat Overview and Summary

The matter involved Ono Pharmaceutical Co., Ltd. and other entities, which sought an extension of the term of their patent under the Australian Patents Act 1990. The dispute centred on the calculation of the first regulatory approval date, which was pivotal in determining the eligibility for a patent term extension. The case was heard in the Federal Court of Australia.

The primary legal issue was whether the term of the patent could be extended based on a regulatory approval granted to a party other than the original patentee. This issue was particularly relevant given that the regulatory approval in question was granted to a party other than Ono Pharmaceutical Co., Ltd. The case required the court to interpret the relevant statutory provisions and determine whether the statutory scheme was ownership-agnostic, as suggested by the decision in G. D. Searle [2008] APO 31.

The court examined the statutory provisions and found that the scheme did not differentiate based on ownership of the regulatory approval. Following the reasoning in G. D. Searle, the court held that the first regulatory approval date was not contingent on the identity of the regulatory authority or the entity to which the approval was granted. Consequently, the application for an extension of the patent term was refused as the statutory criteria for an extension were not satisfied. The court's decision aligned with the statutory scheme, which did not require ownership of the regulatory approval to be held by the patentee.

Orders