Alphapharm Pty Ltd v Gilead Sciences, Inc - [2016] APO 50

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Alphapharm Pty Ltd v Gilead Sciences, Inc. [2016] APO 50

Patent Application: 2012296622

Title:Tenofovir alafenamide hemifumarate

Patent Applicant:                   Gilead Sciences, Inc.
Opponent:  Alphapharm Pty Ltd
Delegate:  Dr S.D. Barker
Decision Date:  22 July 2016
Hearing Date:  4 May 2016, in Sydney
Catchwords:  PATENTS – opposition to the grant of a patent – the invention relates to a hemifumarate salt – the hemifumarate is thermodynamically more stable than the monofumarate – citation reports the formation of the monofumarate – it is inevitable that the hemifumarate would have formed, at least in part – lack of novelty – would not have been a matter of routine to repeat the work of the citation or to alter it to prepare the hemifumarate – no lack of inventive step – opposition succeeds – no award of costs

Representation: Counsel for the applicant: Mr B Caine QC and Mr J Cooke
Patent attorneys for the applicant: Mr M Caine and Mr P Dewar of Davies Collison Cave
Counsel for the opponent: Mr A Fox
Solicitor for the opponent: Dibbs Barker

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2012296622

Title:Tenofovir alafenamide hemifumarate

Patent Applicant: Gilead Sciences, Inc.
Date of Decision: 22 July 2016
DECISION
The opposition succeeds to the following extent:
claims 1, 6, 11, 14, 16, 17, 27 and 29 lack novelty in the light of AU 2001282941.

I allow Gilead Sciences, Inc. a period of two months from the date of this decision to file amendments to the specification.
I make no award of costs.
REASONS FOR DECISION

Patent application number 2012296622 (the present application) was filed on 15 August 2012 under the provisions of the Patent Cooperation Treaty. The applicant is Gilead Sciences, Inc. (Gilead). The application claims priority from application US 61/524,224 (the priority document) which was filed on 16 August 2011. No challenge was raised against the priority claim, and I accept that the priority date for the present application is 16 August 2011.
The application was examined and accepted by the Commissioner, and subsequently opposed under section 59 of the Patents Act 1990 (the Act) by Alphapharm Pty Ltd (Alphapharm). A hearing was held on 4 May 2016 in Sydney to decide the opposition. Gilead was represented by Mr B Caine QC with Mr J Cooke. Alphapharm was represented by Mr A Fox of counsel.
The opposition
The statement of grounds and particulars identified six grounds of opposition: manner of manufacture, novelty, inventive step, utility, sufficiency and clarity. At the hearing, the opposition was limited to the grounds of novelty, manner of manufacture and inventive step.
The parties relied upon evidence by several declarants. Evidence in support consists of declarations by:
Jonathan A V Coates (Coates 1),
Alan D Robertson (Robertson 1) and
Helen Grimes (Grimes).
Evidence in answer consists of declarations by:
Alistair George Draffan (Draffan) and
Nair Rodriguez-Hornedo (Rodriguez-Hornedo).
Evidence in reply consists…

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: [2016] APO 50
Decision Date: 22 July 2016

CaseChat Overview and Summary

This case involved an opposition by Alphapharm Pty Ltd (Alphapharm) to the grant of a patent to Gilead Sciences, Inc. (Gilead) for tenofovir alafenamide hemifumarate. The patent was for a pharmaceutical compound useful as an antiviral agent. The opposition was based on lack of novelty, inventive step and manner of manufacture. The opposition was heard on 4 May 2016. The decision was handed down on 22 July 2016. The opposition succeeded in respect of claims 1, 6, 11, 14, 16, 17, 27 and 29 for lack of novelty in the light of AU 2001282941. Gilead was granted a period of two months to file amendments to the specification. Gilead was not awarded costs. The decision was made by Dr S.D. Barker, a Delegate of the Commissioner of Patents.

Orders