A recent decision brings into sharp focus the need to promptly apply to amend patents as soon as you become aware of any problems in the patent family. Leaving Australia until later may not end up being a cost saving measure.
CSL Limited and Monash University (the Applicants) brought proceedings for infringement of Australian patent number 716747 (the Patent) against Novo Nordisk Pharmaceuticals Pty Ltd and related entities (the Respondents) on 10 March 2009. The Respondents cross-claimed.
In a subsequent, separate application on 24 November 2009, the Applicants sought leave to amend the Patent in suit pursuant to s105 of the Patents Act 1990 (the Act). The parties agreed that the amendments would be allowed under s102 of the Act, leaving only the question of whether the broad discretion of the Court which arises under s105(1) of the Act should be exercised in favour of the Applicants.
Jessup J refused to exercise the discretion to grant leave primarily because the Applicants had unreasonably delayed in filing their application to amend the Patent and had attempted to take an unfair advantage of the Patent.
In coming to his conclusion, His Honour considered the five principles set out in the decision of Aldous J in Smith Kline and French Laboratories Ltd v Evans Medical Ltd [1989] 1 FSR 561, which are as follows:
- the patentee must establish through 'full disclosure of all relevant matters' that the amendment should be allowed;
- the amendment must be permitted under the Act and there should be no circumstances which would lead the Court to refuse the amendment;
- it is in the public interest that amendment be sought promptly. Accordingly, amendment should not be granted where the patentee has unreasonably delayed any application for amendment;
- amendment should not be granted where the patentee has sought to obtain an unfair advantage from a patent it knows should / should have known should be amended; and
- the Court is to be concerned with the conduct of the patentee and not with the merit of the invention.
Applying these principles, His Honour pointed to a number of relevant circumstances including (in summary):
- the Applicants' awareness since about 2001 of certain prior art cited against the Patent by various patent examiners and that the prior art may be fatal to the validity of at least one of the claims in question;
- the Applicants' awareness of the need to amend the Patent, particularly after examiners in multiple jurisdictions expressed the view that claim 1 should not be granted;
- the Applicants having previously sought to amend the equivalent patents elsewhere to the same effect;
- the Applicants not previously having sought any legal advice on whether the claims now sought to be amended would withstand a validity challenge;
- the Applicants sought advice and brought the infringement proceedings against the Respondents despite knowing of the potential weaknesses in the claims of the patent; and
- the Applicants' evidence in support of the application for amendment indicated that they were content with prosecuting the infringement proceeding based on the patent without the amendments sought.
Where significant issues for amendment have arisen previously but no amendment has been sought, patentees should carefully consider whether to apply to do so, at least before commencing infringement proceedings.
To understand how this decision impacts on your business or for patent advice generally, please contact:
Melissa McGrath | Senior Associate
T +61 2 8233 9567
F +61 2 8233 9555
Scott Sloan | Partner
T +61 2 8233 9554
F +61 2 8233 9555
