FEDERAL COURT OF AUSTRALIA Smithkline Beecham Biologicals (S.A.) v Novartis Vaccines and Diagnostics Inc [2007] FCA 1837 Genetics Institute Inc v Kirin-Amgen Inc (1996) 34 IPR 513 cited Airsense Technology Ltd v Vision Systems Ltd (2007) 73 IPR 65 cited SMITHKLINE BEECHAM BIOLOGICAL (S.A.) v NOVARTIS VACCINES AND DIAGNOSTICS INC VID 43 OF 2007 HEEREY J 23 November 2007 MELBOURNE IN THE FEDERAL COURT OF AUSTRALIA VICTORIA DISTRICT REGISTRY VID 43 OF 2007 BETWEEN: SMITHKLINE BEECHAM BIOLOGICAL (S.A.) Applicant AND: NOVARTIS VACCINES AND DIAGNOSTICS INC Respondent JUDGE: HEEREY J DATE: 23 NOVEMBER 2007 PLACE: MELBOURNE THE COURT ORDERS THAT: 1. This appeal proceed on the basis of Australian Patent Application No. 709406 as amended pursuant to s 104 of the Patents Act 1990 (Cth) in accordance with the Statement of Voluntary Amendments filed by the Applicant with the Commissioner of Patents on 7 February 2007 and allowed by the Commissioner ("the Application"). 2. The respondent file and serve a Statement setting out the grounds of its opposition to the grant of a patent on the Application, by 21 December 2007 2007. 3. The applicant file and serve any affidavit material upon which it proposes to rely in support of its application for the grant of a patent on the Application, excluding material directed to the grounds of opposition specified in s 59 of the Patents Act, by 14 February 2008. 4. The respondent file and serve any affidavits upon which it proposes to rely in opposition to the grant of a patent on the Application, including any material directed to grounds of opposition specified in s 59 of the Patents Act and material in support of its Notice of Contention dated 14 February 2007, by 24 March 2008. 5. The applicant file and serve any affidavits in answer by 23 June 2008. 6. The respondent file any affidavits in reply by 23 July 2008. 7. The matter be set down for further directions on 29 July 2008. 8. Costs be reserved. Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules. IN THE FEDERAL COURT OF AUSTRALIA VICTORIA DISTRICT REGISTRY VID 43 OF 2007 BETWEEN: SMITHKLINE BEECHAM BIOLOGICAL (S.A.) Applicant AND: NOVARTIS VACCINES AND DIAGNOSTICS INC Respondent JUDGE: HEEREY J DATE: 23 november 2007 PLACE: MELBOURNE REASONS FOR JUDGMENT 1 This proceeding is an appeal from the decision of a delegate of the Patent Commissioner on an opposition to the grant of a patent in respect of application number 709406 entitled "Combined Vaccines Comprising Hepatitis B surface antigen and other antigens." 2 After the Commissioner's decision the applicant successfully obtained an amendment. The amendment had the effect of narrowing the claims. Counsel for the respondent accepts that the appeal should proceed to deal with the patent in its amended form. See Genetics Institute Inc v Kirin-Amgen Inc (1996) 34 IPR 513 at 515, which was accepted as correct, although distinguished on the facts in Airsense Technology Ltd v Vision Systems Ltd (2007) 73 IPR 65 at [13]. 3 The issue in dispute today has therefore been only the question of which party should proceed first in filing material relating to the appeal. The delegate found that the opposition was partially successful on the grounds of novelty and inventive step, but unsuccessful on all other grounds. The delegate found that certain claims lacked novelty in light of a prior publication known as the "Choi thesis". Certain other claims were found to lack an inventive step in the light of a European patent in combination with common general knowledge. The Commissioner's decision was given on 12 December 2006. The notice of appeal was filed on 24 January 2007. Following that filing, the applicant applied for amendments, which were advertised, and on 18 October 2007 allowed and incorporated into the specification on file. 4 The amendments were directed towards overcoming the delegate's decision insofar as it was based on the Choi thesis. The Choi thesis described work involving a plasma derived HBsAg antigen. Claim 1 as amended (and its dependent claims) is narrowed to the invention "wherein said HBsAg is produced by expression in yeast"; that is, a recombinant form of the HBsAg. Previously claim 1 encompassed both plasma derived and recombinant forms of HBsAg. Similar amendments were made to dependent claims. 5 I think that counsel for the applicant is correct in saying that the basic onus rests on the respondent to make out a case of invalidity as to the patent in its amended forms. Counsel for the respondent said that it would be a matter of expert evidence whether, as was submitted by the applicant, the amended claims do in fact overcome the problem initially identified by the delegate. Whether that be so, it seems to me that it poses no hardship on the respondent to go first and indicate by pleading and evidence what attack it seeks to make on the patent and in particular the issue outlined by counsel which I have just mentioned. Accordingly, I make orders in terms of the minutes submitted by counsel for the applicant. I certify that the preceding five (5) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice HEEREY. Associate: Dated: 23 November 2007 Counsel for the Applicant: H Rofe Solicitor for the Applicant: Davies Collison Cave Counsel for the Respondent: B Fitzpatrick Solicitor for the Respondent: Mallesons Stephen Jaques Date of Hearing: 23 November 2007 Date of Judgment: 23 November 2007