Novartis AG v Hospira Pty Limited (No 2) [2012] FCA 1113

FEDERAL COURT OF AUSTRALIA

Novartis AG v Hospira Pty Limited (No 2) [2012] FCA 1113 Citation: Novartis AG v Hospira Pty Limited (No 2) [2012] FCA 1113

Parties: NOVARTIS AG and NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED (ACN 004 244 160) v HOSPIRA PTY LIMITED (ACN 107 058 328)

File numbers: NSD 1048 of 2012 NSD 1207 of 2012

Judge: YATES J

Date of judgment: 12 October 2012

Legislation: Patents Act 1990 (Cth) s 117

Date of hearing: 9 October 2012

Place: Sydney

Division: GENERAL DIVISION

Category: No catchwords

Number of paragraphs: 10

Counsel for the Applicants: Mr RC Macaw QC and Ms HMJ Rofe

Solicitor for the Applicants: Clayton Utz

Counsel for the Respondent: Mr B Caine SC

Solicitor for the Respondent: King & Wood Mallesons

IN THE FEDERAL COURT OF AUSTRALIA NEW SOUTH WALES DISTRICT REGISTRY GENERAL DIVISION NSD 1048 of 2012

BETWEEN: NOVARTIS AG

First Applicant

NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LIMITED (ACN 004 244 160)

Second Applicant

AND: HOSPIRA PTY LIMITED (ACN 107 058 328)

Respondent

JUDGE: YATES J DATE OF ORDER: 12 OCTOBER 2012 WHERE MADE: SYDNEY

THE COURT NOTES THE FOLLOWING UNDERTAKINGS GIVEN TO THE COURT BY THE APPLICANTS: (a) To submit to such order (if any) as the Court may consider to be just for the payment of compensation, to be assessed by the Court or as it may direct, to any person, whether or not a party, adversely affected by the injunctions in paragraphs 1, 2 and 3 below or any continuation (with or without variation) thereof. (b) To pay the compensation referred to in (a) to the person there referred to. (c) Should they be informed or become aware of any other party seeking to exploit in Australia a pharmaceutical product other than ZOMETA or ACLASTA which includes the active ingredient zoledronic acid, they will forthwith take all reasonable steps to prevent such exploitation, including if necessary commencing proceedings in the Court to seek preliminary injunctive relief restraining such exploitation. THE COURT ORDERS THAT pending the hearing and determination of thIS proceeding or further order: 1. The respondent, whether by itself, its directors, officers, servants, agents or otherwise, be restrained from selling, supplying, offering to sell or supply, soliciting or taking orders for, advertising or promoting, in Australia, any pharmaceutical product which includes the active ingredient zoledronic acid, without the licence or authority of the applicants. 2. The respondent, whether by itself, its directors, officers, servants, agents or otherwise, be restrained from taking any steps to obtain listing of any pharmaceutical product which includes the active ingredient zoledronic acid under the Pharmaceutical Benefits Scheme maintained by the Commonwealth Government under the National Health Act 1953 (Cth) (the PBS). 3. The respondent immediately give notice withdrawing its application for inclusion on the Schedule of Pharmaceutical Benefits of any pharmaceutical product which includes the active ingredient zoledronic acid, and take any other necessary steps to withdraw the application and, by no later than 5.00 pm on 17 October 2012, serve on the applicants an affidavit made by a proper officer of the respondent verifying that such notice has been given and identifying any other necessary steps that have been taken to withdraw the application. 4. The applicants give the respondent: (a) at least one month's written notice before the applicants (or either of them) or any person authorised by the applicants (or either of them) exploits in Australia a pharmaceutical product (other than the ZOMETA or ACLASTA products currently listed under the PBS) which includes the active ingredient zoledronic acid; (b) at least one month's written notice before the applicants (or either of them) or any person authorised by the applicants (or either of them) makes application to obtain listing under the PBS of a pharmaceutical product which includes the active ingredient zoledronic acid, including (for the avoidance of doubt) a ZOMETA 4mg/100ml product. (c) written notice of any person (other than the applicants or either of them or any person authorised by the applicants or either of them) known to the applicants (or either of them) who seeks to exploit in Australia a pharmaceutical product which includes the active ingredient zoledronic acid. 5. In Order 4 the word "exploit" bears the meaning given to it in the Patents Act 1990 (Cth). THE COURT FURTHER ORDERS THAT: 6. The costs of and incidental to the applicants' claim for interlocutory relief be the applicants' costs in the proceeding. 7. There be liberty to apply. 8. The proceeding be listed for directions by arrangement between the parties and the Associate to Yates J. Note: Settlement and entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011. IN THE FEDERAL COURT OF AUSTRALIA NEW SOUTH WALES DISTRICT REGISTRY GENERAL DIVISION NSD 1207 of 2012