H Lundbeck A/S v Commissioner of Patents [2006] FCA 163

FEDERAL COURT OF AUSTRALIA H Lundbeck A/S v Commissioner of Patents [2006] FCA 163 PATENTS – Patents Regulations 1991 – reg 10.7(7) – whether valid – whether ultra vires s 228 of the Patents Act 1990 (Cth) – whether retrospective subordinate legislation – whether amendment of the Register as required by reg 10.7(7) affects substantive rights of patentee, by reducing extended term of patent.

Patents Act 1990 (Cth) ss 70, 71, 74, 75, 76, 77, 187, 191, 192, 228. Patents Regulations 1991 (Cth) reg 10.7(7) Carbines v Powell (1925) 36 CLR 88 cited Morton v Union Steamship Co of New Zealand Ltd (1951) 83 CLR 402 cited Project Blue Sky Inc v Australian Broadcasting Authority (1998) 194 CLR 355 cited Shanahan v Scott (1957) 96 CLR 245 cited Utah Construction and Engineering Pty Ltd v Pataky [1966] AC 629 cited Willocks v Anderson (1970) 124 CLR 293 cited H LUNDBECK A/S v COMMISSIONER OF PATENTS NSD 1704 OF 2005

LINDGREN J 1 MARCH 2006 SYDNEY

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY NSD 1704 OF 2005

BETWEEN: H LUNDBECK A/S

APPLICANT

AND: COMMISSIONER OF PATENTS

RESPONDENT

JUDGE: LINDGREN J

DATE OF ORDER: 1 MARCH 2006

WHERE MADE: SYDNEY

THE COURT ORDERS THAT:

1. The application be dismissed. 2. The applicant pay the respondent's costs. Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY NSD 1704 OF 2005

BETWEEN: H LUNDBECK A/S

APPLICANT

AND: COMMISSIONER OF PATENTS

RESPONDENT

JUDGE: LINDGREN J

DATE: 1 MARCH 2006

PLACE: SYDNEY

REASONS FOR JUDGMENT

INTRODUCTION 1 This proceeding is one of three related 'Lundbeck' proceedings before the Court. 2 The first proceeding to be commenced was NSD 1120 of 2005 ('the revocation proceeding'), between Alphapharm Pty Ltd ('Alphapharm') as applicant and the present applicant, H Lundbeck A/S ('Lundbeck'), as respondent. In that proceeding, Alphapharm seeks a declaration that claims 1 – 6 of Lundbeck's Australian Patent No 623144 ('the Patent') are invalid and an order that they be revoked, or, in the alternative, an order that the Register of Patents ('the Register') be rectified pursuant to s 192 of the Patents Act 1990 (Cth) ('the Act') to remove an extension of the term of the Patent from the Register. Alphapharm seeks another supportive declaration related to the extension of the term of the Patent, of which I need say no more. Lundbeck and its Australian subsidiary, Lundbeck Australia Pty Ltd ('Lundbeck Australia'), the exclusive licensee of the Patent in Australia, cross-claim against Alphapharm for infringement of the Patent. 3 The second proceeding to be commenced is this present proceeding, between Lundbeck and the Commissioner of Patents ('the Commissioner'). Lundbeck seeks relief designed to prevent the Commissioner from amending the entry in the Register in relation to the extension of the term of the Patent. The Commissioner wishes to consider and decide whether reg 10.7(7) of the Patents Regulations 1991 (Cth) ('the Regulations') requires her to amend it, but Lundbeck contends that reg 10.7(7) is invalid. (Regulation 10.7(7) is set out at [17] below.) 4 Alphapharm contends that Lundbeck obtained the extension by making a misrepresentation to the Commissioner as to what was the 'first regulatory approval date' for the purposes of s 70 of the Act (s 70 is, so far as relevant, set out at [21]) and of reg 10.7(7). It was Alphapharm which drew to the attention of the Commissioner the alleged error as to what was the true 'first regulatory approval date'. The Commissioner takes the position that if Alphapharm is correct in its contention that that date is earlier than the one on which she acted when she entered particulars of the extension in the Register, reg 10.7(7) requires her to amend the entry. Alphapharm contends that the consequence of the alleged error is that the extension was invalidly granted and that all reference to it should be removed from the Register, whereas the Commissioner contends that the consequence is only that the entry reflects an excessively long extension, and that the Register should be amended only so as to refer to a shorter period. 5 The third proceeding is NSD 1870 of 2005 ('the TGA proceeding') between Lundbeck Australia as applicant and the Secretary of the Department of Health & Ageing of the Commonwealth of Australia as respondent. In that proceeding, Lundbeck Australia applies for orders restraining the respondent ('the Secretary') from using what it contends is 'protected information' within the meaning of s 25A of the Therapeutic Goods Act 1989 (Cth) ('the TGA') in considering any application made by any third party for registration of therapeutic goods containing (+)-citalopram. On 15 June 2005, Alphapharm had applied to the Secretary for the registration of such therapeutic goods under the TGA. 6 By orders made on 28 November 2005, I ordered that Alphapharm be joined as second respondent in the TGA proceeding. On 23 December 2005, I ordered that the revocation proceeding and the TGA proceeding be heard together. They have been fixed for a 15 day hearing from Monday, 27 November until Friday, December 15 2006.