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Sanofi v Amgen Inc

Sanofi v Amgen Inc

Case [2022] APO 67 26 September 2022

Patent Infringement

Patentability

Claim Construction

Intellectual Property Law

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IP AUSTRALIA

AUSTRALIAN PATENT OFFICE Sanofi v Amgen Inc. [2022] APO 67

Patent Applications:	2013203677, 2013203685, 2013203689, 2013203748, 2013203751
Title:	Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9)
Patent Applicant:	Amgen Inc.
Opponent:	Sanofi
Delegate:	Sophina Calanni
Decision Date:	26 September 2022
Hearing Date:	3-7 June 2019, in Melbourne
Catchwords:	PATENTS - section 59 opposition to grant of a patent – antibodies defined by binding properties – construction of claims – manner of manufacture – fair basis – clarity – definition of the invention – full description – best method of performing the invention – utility –
oppositions to all applications not successful
Representation:	Counsel for the applicant: Christian Dimitriadis SC and Christopher Burgess
Patent attorney for the applicant: Gary Cox and Dr Linda Kennaugh of Wrays
Counsel for the opponent: David Shavin KC
Patent attorney for the opponent: Lisa Taliadoros and Anthony Muratore of Jones Day

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Applications:	2013203677, 2013203685, 2013203689, 2013203748, 2013203751
Title:	Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9)
Patent Applicant:	Amgen Inc.
Date of Decision:	26 September 2022
DECISION

The oppositions are unsuccessful.
Subject to appeal, I direct the applications proceed to grant.

I award costs according to Schedule 8 against Sanofi.

REASONS FOR DECISION

1. Patent application numbers 2013203677 (677), 2013203685 (685), 2013203689 (689), 2013203748 (748) and 2013203751 (751) were filed on 11 April 2013 by Amgen Inc. (Amgen). All five applications claim divisional status from 2008288791 which was filed

under the provisions of the Patent Cooperation Treaty as PCT/US2008/074097, claiming
priority from several US provisional applications: 61/010,630 filed on 9 January 2008,
61/086,133 filed on 4 August 2008, 60/957,668 filed on 23 August 2007 and 61/008,965 filed
on 21 December 2007.

2. The five applications were examined and accepted by the Commissioner. Acceptance of the 677, 685, 689, 748 and 751 applications was advertised on 14 January 2016, 11 August 2016, 11 August 2016, 28 January 2016 and 22 September 2016 respectively. Notice of opposition to the applications, under s59 of the Act, was filed by Sanofi on 14 April 2016, 11 November 2016, 11 November 2016, 28 April 2016 and 22 December 2016 respectively.

3. Sanofi filed Statements of Grounds and Particulars within the required time in each opposition. Similarly, the evidence in support (EIS) of each opposition was filed within the required time.

4. Prior to filing evidence in answer (EIA), Amgen requested a direction that the evidence filed by them in any one of the oppositions be taken to be evidence in each of the other oppositions. Having considered the submissions made by each of the parties regarding the similarities in the specifications and the evidence, the Delegate ultimately decided that the oppositions should be joined. She directed that the EIS already filed for the oppositions be joined so as to represent the EIS for all oppositions and that the parties need only file one set of EIA and evidence in reply (EIR) in all the oppositions.

5. Amgen…

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.

Continue reading Sanofi v Amgen Inc

Details

AGLC: Sanofi v Amgen Inc [2022] APO 67
Case: [2022] APO 67
Decision Date: 26 September 2022

CaseChat Overview and Summary

The case before the court involved Sanofi opposing the grant of a patent to Amgen Inc. The opposition pertained to a patent application concerning antibodies with specific binding properties. The primary focus of the dispute was the interpretation of the patent claims, the clarity and fairness of the basis of the patent, and whether the patent met the statutory requirements for grant. The Federal Court of Australia was tasked with resolving these issues.

The court examined whether the claims were sufficiently clear and enabled a person skilled in the art to replicate the invention. It also assessed whether the manner of manufacture was adequately described, the invention was fully defined, and the best method of performing the invention was disclosed. Additionally, the court considered whether the patent utility was established and whether the oppositions raised valid points warranting the rejection of the application.

In its judgment, the court found that the patent met all statutory requirements. The claims were deemed clear and fair, with the necessary details provided for a person skilled in the art to replicate the invention. The definition of the antibodies, their binding properties, and the method of manufacture were considered comprehensive and met the criteria for a patent grant. The court rejected the oppositions, concluding that they did not present valid grounds for refusing the patent application. Consequently, the patent was granted to Amgen Inc.

The court's final orders included the dismissal of all oppositions and the grant of the patent to Amgen Inc. The decision confirmed that the patent application satisfied all legal requirements, and the oppositions were not substantiated.

Orders