CSL Limited v Isconova AB et al - [2016] APO 82

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

CSL Limited v Isconova AB et al [2016] APO 82

Patent Application: 2011280259

Title:Influenza vaccine

Patent Applicant: Isconova AB and Erasmus University Rotterdam Medical Center

Opponent: CSL Limited

Hearing Officer: P M Spann Deputy Commissioner of Patents

Decision Date: 18 November 2016

Hearing Date: 20 October 2016 by written submissions.

Catchwords: PATENTS – request under regulation 5.16 to amend the statement of grounds and particulars – whether amendment should be made – discretionary considerations – amendment allowed in part – costs awarded against the opponent.

Representation: Patent applicant: Spruson & Ferguson
Requestor:Davies Collison Cave

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application: 2011280259

Title:Influenza vaccine

Patent Applicant: Isconova AB and Erasmus University Rotterdam Medical Center

Date of Decision: 18 November 2015

DECISION

I allow the amendments to the statement of grounds and particulars identified in the request filed on 24 August 2016. The request for amendment filed on 17 August 2016 is refused.

I direct the Opponent to file within 14 days of the date of this decision a revised statement excluding the amendment identified in the request filed 17 August.

I award costs in accordance with Schedule 8 against the Opponent.

REASONS FOR DECISION

Background

Patent Application 2011280259 was filed under the provisions of the Patent Cooperation Treaty on 25 July 2011. It was examined and advertised accepted on 22 May 2014. On 22 August 2014 a notice of opposition was filed followed by a statement of grounds and particulars on 21 November 2014. Following the filing of evidence in support of the opposition, the applicant sought amendment of the complete specification and these amendments were allowed on 17 December 2015 without opposition. Relevantly, one aspect of these amendments was the addition of the limitations that ectodomains within the claimed vaccine composition were recombinant and do not contain a streptaviding tag.

The evidentiary stages of the substantive opposition were completed on 21 March 2016 and the opposition set for hearing on 31 August 2016. However, an amendment of the statement of grounds and particulars was filed on 30 June 2016 (subsequently allowed) followed by further requests on 17 and 24 August 2016. The applicant objected to these further requests and the substantive hearing was deferred to allow them to be determined, as well as a request by the applicant for the Commissioner to consider further information under regulation 5.23.

The present matter concerns only whether the amendments of the statement of grounds and particulars filed on 17 and 24 August 2016 should be allowed. I will refer to the submissions of the parties where relevant in my reasons below.

The requests

The substance of the amendment requested on 17 August 2016 is the addition of a further particular under the ground of non-compliance with section 40, that is:
“(viii)The best method known to the applicant for performing the invention of claims 1, 7-12 and 14-28 is not described in the specification because the specification does not provide the best method for producing HA and NA…

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 82
Decision Date: 18 November 2016

CaseChat Overview and Summary

CSL Limited v Isconova AB et al is a patent opposition case concerning the patentability of an influenza vaccine. The case was heard before P M Spann, Deputy Commissioner of Patents, who was required to decide whether certain amendments to the statement of grounds and particulars should be allowed under regulation 5.16 of the Patents Regulations 1991. The opposition was filed by CSL Limited against Isconova AB and Erasmus University Rotterdam Medical Center, the patent applicants. The primary legal issue was whether the amendments sought by the opponent, CSL Limited, were justified under the regulations and whether they would unduly prejudice the applicants.

The court considered the timing and substance of the proposed amendments. The first amendment, proposed on 17 August 2016, sought to add a particular under the ground of non-compliance with section 40 of the Patents Act 1990, specifically regarding the best method known to the applicant for performing the invention. The second amendment, proposed on 24 August 2016, sought to move particulars of a document from under the ground of lack of inventive step to the ground of lack of novelty. The applicants objected to these amendments, arguing that they were filed at an unduly late stage and would prejudice their ability to prepare a response.

The Deputy Commissioner found that the amendments sought on 17 August were not justified as they were filed too late in the proceedings, causing significant disruption and prejudice to the applicants. The court considered that the opponent's delay in seeking the amendment was unreasonable, given the timing and the relevance of the best method requirement was not a new issue. Consequently, the amendment request dated 17 August was refused.

In contrast, the amendment sought on 24 August was allowed. Although also filed late, this amendment aimed to correct a clerical error and caused less prejudice as the document in question was already being considered in the opposition. The court found that allowing this amendment would not unduly prejudice the applicants and was in the interest of a correct determination of the opposition.

In conclusion, the Deputy Commissioner refused the amendment of the statement of grounds and particulars filed on 17 August 2016 but allowed the amendments identified in the request filed on 24 August. The opponent was directed to file a revised statement excluding the amendment sought on 17 August. Costs were awarded against the opponent for their actions in seeking amendment of the statement of grounds and particulars so late in the proceedings.

Orders