Pharmacia Italia SpA v Interpharma Pty Ltd - [2005] FCA 1675

FEDERAL COURT OF AUSTRALIA
Pharmacia Italia S.p.A. v Interpharma Pty Ltd [2005] FCA 1675
PATENTS – interlocutory injunction – application for injunction in respect of threatened infringement of patent – claim that patent invalid – lack of novelty – obviousness – lack of manner of manufacture – lack of fair basis – false suggestion – whether serious issue to be tried – whether applicants for injunction would suffer irreparable harm for which damages would not be adequate compensation unless injunction granted – balance of convenience
PATENTS – interlocutory injunction – application for injunction in respect of threatened infringement of patent – whether applicant has standing as exclusive licensee of patent
Patents Act 1990 (Cth) ss 40, 120
Patents Act 1952 (Cth) s 6
Hexal Australia Pty Ltd v Roche Therapeutics Inc [2005] FCA 1218 cited
Ex parte British Nylon Spinners Ltd; Re Imperial Chemical Industries Ltd (1963) 109 CLR 336 distinguished
Grant v Australian Temporary Fencing Pty Ltd (2003) 59 IPR 170 discussed
Pharmacia Italia S.p.A. v Mayne Pharma Pty Ltd [2005] FCA 1078 discussed
Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 applied
Tidy Tea Ltd v Unilever Australia Ltd (1995) 32 IPR 405 followed
Beecham Group Ltd v Bristol Laboratories Pty Ltd (1968) 118 CLR 619 applied
PHARMACIA ITALIA S.P.A. and PFIZER (PERTH) PTY LTD v INTERPHARMA PTY LTD
VID 1137 OF 2005
SUNDBERG J
MELBOURNE
23 NOVEMBER 2005

IN THE FEDERAL COURT OF AUSTRALIA

VICTORIA DISTRICT REGISTRY

VID 1137 OF 2005

BETWEEN:

PHARMACIA ITALIA S.P.A.
FIRST APPLICANT

PFIZER (PERTH) PTY LTD (ACN 051 824 956)
SECOND APPLICANT

AND:

INTERPHARMA PTY LTD (ACN 099 877 899)
RESPONDENT

JUDGE:

SUNDBERG J

DATE OF ORDER:

23 NOVEMBER 2005

WHERE MADE:

MELBOURNE

THE COURT ORDERS THAT, upon the applicants giving the usual undertaking as to damages:
1.The respondent whether by itself, its officers, employees, agents or otherwise, be restrained until the hearing and determination of the proceeding or further order from importing or offering to import the respondent’s Doxorubicin Hydrochloride Injections and Epirubicin Hydrochloride Injections (as defined in the applicants’ Particulars of Infringement dated 28 September 2005).
2.The respondent pay the applicants’ costs of and incidental to the motion notice of which was filed on 7 October 2005.

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 1137 OF 2005

BETWEEN:

PHARMACIA ITALIA S.P.A.
FIRST APPLICANT

PFIZER (PERTH) PTY LTD (ACN 051 824 956)
SECOND APPLICANT

AND:

INTERPHARMA PTY LTD (ACN 099 877 899)
RESPONDENT

JUDGE:

SUNDBERG J

DATE:

23 NOVEMBER 2005

PLACE:

MELBOURNE

REASONS FOR JUDGMENT
BACKGROUND

Pharmacia Italia S.p.A. (PI), an Italian company, is the registered proprietor of Australian Letters Patent No. 598197 entitled “Injectable ready-to-use solutions containing an anti-tumour anthracycline glycoside” (the patent). Doxorubicin and epirubicin are two forms of anthracycline glycoside.
Pfizer (Perth) Pty Ltd (PP), an Australian company, has what is described in the relevant statement of claim as an exclusive licence in…

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: [2005] FCA 1675
Decision Date: 23 NOVEMBER 2005

CaseChat Overview and Summary

Pharmacia Italia SpA (PI) and Pfizer Australia Pty Ltd (PA) sought interlocutory relief against Interpharma Pty Ltd, seeking to enjoin the manufacture, sale, supply, and importation of Adriamycin and Pharmorubicin, two cancer treatments, on the basis that they infringed PI's patent and that there was a risk of irreparable harm to PI and PA if the injunction was not granted. Interpharma argued that the patent was invalid and that there was no irreparable harm to the applicants. The primary legal issue before the court was whether the applicants had established a serious question to be tried in relation to the validity of the patent and whether the balance of convenience favoured granting the injunction. The court found that Interpharma had not established a serious question to be tried regarding the patent's validity. The court held that the fact that PI had contended for a narrower claim during the prosecution of a foreign patent did not support a case of false suggestion. Similarly, the amendment of claim 1 of the patent after the date of grant did not establish invalidity. The applicants had also not established that there was a serious question to be tried as to the alleged invalidity of the patent.

Regarding the balance of convenience, the court held that the applicants were likely to suffer irreparable harm if the injunction was not granted. The court noted that the evidence of the monetary losses suffered by PA was substantial and confidential, and that these losses would flow through to PI. The court also considered the additional, unquantifiable costs that would be incurred by the applicants if the injunction was not granted, and the risk to the viability of the manufacturing facility. The court concluded that damages would not be adequate compensation for the harm the applicants would suffer, and that the balance of convenience favoured granting the interlocutory injunction. The court ordered that Interpharma be restrained from manufacturing, selling, supplying, or importing Adriamycin and Pharmorubicin until the trial of the proceeding, subject to certain conditions.

Orders

Orders of the court

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Background

Background to the litigation

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Evidence

Evidence Before The Court

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Decision

Reasons for decision

SUNDBERG J

Interpharma has not established that there is a serious question to be tried as to whether the patent is liable to be revoked because it was obtained by false suggestion. The fact that, in the course of prosecuting a foreign patent, PI contended for a narrower claim than that found in claim 1 of the patent (both as at the date of grant and today) does not support, let alone make out, a case of false suggestion. Nor does the fact that claim 1 was amended after the date of grant so as to narrow it.Conclusion on invalidity Interpharma has failed to establish that there is a serious question to be tried as to the alleged invalidity of the patent.IRREPARABLE HARM The applicants say they will suffer irreparable harm as a result of the conduct they seek to enjoin. Much of that harm is in the form of inherently quantifiable monetary losses to PP. The amounts involved are substantial. The evidence on quantum is contained in an affidavit sworn on 17 October 2005 by Brent Denning, National Key Account Manager of Pfizer Australia Pty Ltd (PA). It is confidential, and I will not give particulars thereof. Interpharma contends that those losses cannot be attributed to PP, but only to PA, which is not a party. PA is, like PC, PI and PP, a member of the Pfizer group of companies and appears to be the company that actually sells and distributes Adriamycin and Pharmorubicin. In an affidavit sworn on 17 October 2005, Bradley Winter, PP’s Commercial Manager, says that because PP “is the sole supplier of [ready-to-use] anthracycline glycosides to [PA], the loss of sales identified by Mr Denning will flow directly through to [PP] as corresponding loss of its sales.” However, there is no evidence of the prices at which PP sells its products to PA. Be that as it may, I think it clear that PP’s losses will be substantial. Additionally, the applicants say that the conduct they seek to enjoin will increase their costs in ways that cannot be quantified and imperil the viability of the facility where Adriamycin and Pharmorubicin are manufactured. Interpharma contends that such additional harm “is vague in the extreme”. Interpharma’s capacity to pay damages in respect of the losses referred to at [48] is modest. That capacity is, to a very large extent, dependent upon it importing the imported solutions, from which activity it projects a certain level of profit. Though it has offered to undertake to keep proper accounts, it has not offered to undertake to quarantine that profit or any part of it. That, combined with the fact that Interpharma is a young company in the process of establishing itself in its chosen market, suggests that Interpharma is likely to be unable to meet any significant award of damages. Further, it can be doubted whether the indemnity in Interpharma’s favour given by a substantial foreign company is of any real comfort to the applicants as that company lacks a presence in Australia. What I have set out at [50] suggests that damages will not be adequate compensation for the harm that the applicants will suffer as a result of the conduct they seek to enjoin. There was no dispute as to the applicants’ capacity to pay damages pursuant to the usual undertaking to do so.BALANCE OF CONVENIENCE

Ratio Decidendi

Legal Principle Established

Established by: SUNDBERG J

Full text does not contain this section.

IN THE FEDERAL COURT OF AUSTRALIA
VICTORIA DISTRICT REGISTRY	VID 1137 OF 2005

BETWEEN:	PHARMACIA ITALIA S.P.A. FIRST APPLICANT PFIZER (PERTH) PTY LTD (ACN 051 824 956) SECOND APPLICANT
AND:	INTERPHARMA PTY LTD (ACN 099 877 899) RESPONDENT
JUDGE:	SUNDBERG J
DATE OF ORDER:	23 NOVEMBER 2005
WHERE MADE:	MELBOURNE

JUDGE:	SUNDBERG J
DATE:	23 NOVEMBER 2005
PLACE:	MELBOURNE