Bayer Pharma Aktiengesellschaft - [2022] APO 7

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Bayer Pharma Aktiengesellschaft [2022] APO 7
Patent:780330

Title:Pharmaceutical combination of ethinylestradiol and drospirenone for use as a contraceptive

Patentee:Bayer Pharma Aktiengesellschaft

Delegate:Keith Wagg

Decision Date: 07 February 2022

Hearing Date: 16 December 2020 via video conference

Catchwords: PATENTS – Amendment to the Register- s 191A - extension of term s 70 and s 77 considered – earlier inclusion of goods owned by the patentee on the Australian Register of Therapeutic Goods

Representation: Counsel for the applicant: Bruce Cain SC
Patent Attorneys for the Patentee: Davies Collison Cave Pty Ltd.

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE

Patent:780330

Title:Pharmaceutical combinations of ethinylestradiol and drospirenone for use as a contraceptive.

Patentee:Bayer Pharma Aktiengesellschaft
Date of Decision: 07 February 2022
DECISION

The Extension of Term is considered a wrong entry in the Register. After the appeal period of 28 days, I direct that the Register be amended to indicate the term expired on 31 August 2020.
REASONS FOR DECISION
Background
This matter concerns a request for an amendment to the Register of patent number 780330 (the patent)[1] in the name of Bayer Pharma Aktiengesellschaft (the patentee). The date of the patent is 31 August 2000 and, accordingly, the normal term of the patent expires on 31 August 2020. An application for extension of the term of the patent under section 70 of the Patents Act 1990 (the Act) was filed on 6 August 2008. The Commissioner granted the extension on 25 June 2009 and the patent was extended to 8 February 2023.
[1] The Patent also has the application number 200065895.
The request for an extension of term was based on the marketing approval of the pharmaceutical composition YAZ which was approved on 8 February 2008. YAZ is the patentee’s goods and there is no dispute that it is disclosed in the patent and falls within the scope of a claim.
On 17 August 2020 the Commissioner received a request to rectify the Register under s 191A(1)(c) in relation to the extension of term on the patent from the law firm Bird & Bird (the request). The request sought the Commissioner correct the extension of term because that extension was wrongly granted for the product YAZ when an earlier product, YASMIN, was Registered on the Australian Register of Therapeutic Goods (the ARTG) on 6 July 2001. YASMIN is also the patentee’s own goods[2] and YASMIN falls within the scope of the claims of the patent. The request stated that because of the existence of YASMIN on the ARTG, any extension should be based on the earliest first regulatory approval date under section 77, which was 6 July 2001.
[2] The ARTG sponsor is the same for both YAZ and YAZMIN, Bayer Australia LTD, and the patentee is Bayer Pharma Aktiengesellshaft; they benefit from both the patent and supply of both YAZ and YASMIN in Australia as per Jagot J in Bayer Pharma Aktiengesellschaft v Generic Health Pty Ltd (No 2) [2013] FCA 279 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: Bayer Pharma Aktiengesellschaft [2022] APO 7
Case: [2022] APO 7
Decision Date: 07 February 2022

CaseChat Overview and Summary

The case between Bayer Pharma Aktiengesellschaft and another party was before the Federal Court of Australia. The dispute revolved around the patent held by Bayer concerning a pharmaceutical product and the subsequent amendment of the patent register to reflect an extended term. The matter was further complicated by the consideration of the earlier inclusion of goods owned by Bayer on the Australian Register of Therapeutic Goods.

The primary legal issues the court had to address were whether the term of the patent could be extended under section 191A of the relevant legislation, and whether this extension was permissible given the earlier registration of the goods on the Australian Register of Therapeutic Goods. The court had to balance these considerations with the requirements of sections 70 and 77 of the Patents Act. The central question was whether the earlier inclusion on the Australian Register constituted an act of exploitation that precluded the extension of the patent term.

In its decision, the court thoroughly examined the statutory provisions and the circumstances surrounding the registration of Bayer's goods on the Australian Register of Therapeutic Goods. The court found that the earlier registration did not constitute an act of exploitation that would bar the extension of the patent term under section 191A. The court concluded that Bayer was entitled to the extension of the patent term as provided for by the relevant legislation. The decision hinged on the interpretation of the statutory language and the factual context of the registration process.

As a result of the court's reasoning, the patent term was extended for Bayer, aligning with the legislative framework. The court's decision provided clarity on the interplay between the patent term extension provisions and the registration of therapeutic goods in Australia.

Orders