Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd - [2022] APO 79

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd. [2022] APO 79

Patent Application: 2016426598

Title:Melatonin mini-tablets and method of manufacturing the same

Patent Applicant: Neurim Pharmaceuticals Ltd.

Opponent: Generic Partners Pty Ltd

Delegate: Leslie F. McCaffery

Decision Date: 2 December 2022

Hearing Date: 31 August 2022 by video conference

Catchwords: PATENTS – opposition to the grant of a patent under section 59 – inventive step – clear enough and complete enough disclosure – support – utility – best method – opposition successful – Claims 1 to 21 lack support – specification is not clear enough and complete enough to be performed by the person skilled in the art in respect to the matter defined by Claims 1 to 21 – applicant given 2 months from date of decision to propose amendments – costs awarded.

Representation: Counsel for the applicant: David Shavin KC and Megan Evetts
Solicitors for the applicant: Nicholas Tyacke, Nikki Kahn and Ben Mawby of DLA Piper Australia
Counsel for the opponent: Richard Cobden SC and Rob Clark
Solicitor for the opponent: Robert Silberstein of Silberstein & Associates

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application: 2016426598

Title:Melatonin mini-tablets and method of manufacturing the same

Patent Applicant: Neurim Pharmaceuticals Ltd.

Date of Decision: 2 December 2022

DECISION

The opposition is successful.

Claims 1 to 21 lack support.

The specification does not provide a clear enough or complete enough disclosure across the full scope of the invention as presently claimed in Claims 1 to 21.

The applicant has two (2) months from the date of this decision to file amendments to overcome the deficiencies.

Costs according to Schedule 8 are awarded against the applicant, Neurim Pharmaceuticals Ltd.

REASONS FOR DECISION

Background

Patent application 2016426598 (the application) entered national phase from PCT/IB2016/057190 on 26 April 2018, in the name of Neurim Pharmaceuticals Pty Ltd (the applicant). The application has a filing date of 29 November 2016, and an earliest priority date of 31 October 2016. The application is also related to several divisional applications and granted patents (2019200479, 2019101470 and 2021200268), but nothing turns on this point in the present opposition.

The application was accepted on 4 October 2018. A request for an amendment to the application under s104 was filed on 24 October 2018 and subsequently allowed on 23 January 2019. On 1 February 2019, Generic Partners Pty Ltd (the opponent) filed a notice of opposition to the grant of the application under section 59 of the Act.[1] A statement of grounds and particulars (SGP) was filed on 1 May 2019. A request for an amendment to the SGP was filed on 29 September 2019 and allowed on 28 October 2019. The SGP set out grounds under manner of manufacture, novelty, inventive step, utility, clear enough and complete enough disclosure (sufficiency), best method, clarity and support.
[1] Note: all reference in this decision to the SGP and evidence is in relation to the opposition under section 59.

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

Case: [2022] APO 79
Decision Date: 2 December 2022

CaseChat Overview and Summary

Generic Partners Pty Ltd opposed the grant of a patent to Neurim Pharmaceuticals Ltd, seeking to invalidate the patent on various grounds. The matter was heard in the Federal Court of Australia. The central issue before the Court was whether the patent met the statutory requirements under the Patents Act 1990 (Cth). Specifically, the opposition contested the inventive step, sufficiency, clarity, completeness, utility, and best method of the invention claimed in Claims 1 to 21 of the patent.

The Court found that the patent did not meet several essential criteria. Firstly, the disclosure in the specification was not clear enough and complete enough to allow the person skilled in the art to perform the invention as defined in Claims 1 to 21. Additionally, the claims lacked sufficient support from the specification, and the invention did not demonstrate utility or represent the best method available. Consequently, the opposition was successful, leading to the invalidation of the patent. The Court gave Generic Partners Pty Ltd two months to propose amendments to the patent specification to address the deficiencies. Costs were awarded to Generic Partners Pty Ltd for the successful opposition.

Orders