Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth

Link copied
Case Copied 33 min read

FEDERAL COURT OF AUSTRALIA

Sigma Pharmaceuticals (Australia) Pty Ltd (ACN 004 118 594) v Wyeth [2009] FCA 595

Patents Act1990 (Cth) s 117

Aktiebolaget Hassle v Alphapharma Pty Ltd (2002) 212 CLR 411 cited
Appleton Papers Inc v Tomasetti Paper Pty Ltd (1983) 3 NSWLR 208 followed
Australian Broadcasting Corporation v O’Neill (2006) 227 CLR 57 applied
B Braun Melsungen AG v Terumo Corporation (2004) 61 IPR 71 applied
Beecham Group Ltd v Bristol Laboratories Pty Ltd (1968) 118 CLR 619 applied
GenRx Pty Ltd v Sanofi‑Aventis (2007) 73 IPR 502 followed
Interpharma Pty Ltd v Commissioner of Patents (2008) 79 IPR 261 followed
Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274 applied
Merck & Co Inc v Arrow Pharmaceuticals Ltd (2006) 154 FCR 31 cited
Merck & Co Inc v GenRx Pty Ltd (2006) 70 IPR 286 cited
NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655 cited
Pharmacia Italia SpA v Interpharma Pty Ltd (2005) 67 IPR 397 cited
Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd (1988) 81 ALR 79 applied
Tidy Tea Ltd v Unilever Australia Ltd (1995) 32 IPR 405 cited

SIGMA PHARMACEUTICALS (AUSTRALIA) PTY LTD (ACN 004 118 594) v WYETH and WYETH AUSTRALIA PTY LTD

VID 195 of 2009

SUNDBERG J
3 JUNE 2009
MELBOURNE


IN THE FEDERAL COURT OF AUSTRALIA

VICTORIA DISTRICT REGISTRY

VID 195 of 2009

BETWEEN:

SIGMA PHARMACEUTICALS (AUSTRALIA) PTY LTD (ACN 004 118 594)
Applicant/Cross‑Respondent

AND:

WYETH
First Respondent/First Cross‑Claimant

WYETH AUSTRALIA PTY LTD
Second Cross‑Claimant

JUDGE:

SUNDBERG J

DATE OF ORDER:

3 JUNE 2009

WHERE MADE:

MELBOURNE

UPON the cross‑claimants by their Counsel undertaking:

(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 any operation of the order below or any continuation (with or without variation) thereof, and

(b)to pay the compensation referred to in (a) to the person there referred to;

THE COURT ORDERS THAT:

1.Pending the determination of the proceeding or further order the cross‑respondent whether by itself, its directors, officers, servants, agents or otherwise be restrained from marketing, taking orders for, selling, supplying, offering to supply or otherwise exploiting in Australia the products listed on the Australian Register of Therapeutic Goods under the name Evelexa‑XR or any other product comprising the same generic modified release formulation of venlafaxine hydrochloride, without the licence of or authority of the cross‑claimants.

2.Each party’s costs of the application for interlocutory relief be its costs in the cause.

Note:Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.


The text of entered orders can be located using eSearch on the Court’s website.


IN THE FEDERAL COURT OF AUSTRALIA

VICTORIA DISTRICT REGISTRY

VID 195 of 2009

BETWEEN:

SIGMA PHARMACEUTICALS (AUSTRALIA) PTY LTD (ACN 004 118 594)
Applicant/Cross‑Respondent

AND:

WYETH
First…

CaseChat AU logo

Keep reading for free

Create a free CaseChat account to read Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth and more:

  • Read every judgment in full
  • Ask AI and get answers linked to paragraphs
  • See how each paragraph was cited in later cases
  • Download judgments as PDF or Word
Continue with Google

One click creates your free account or signs you in.

By continuing you agree to the Terms and Privacy Policy.

Details
Case
[2009] FCA 595
Decision Date

CaseChat Overview and Summary

In the case of Sigma Pharmaceuticals (Australia) Pty Ltd v Wyeth, the dispute involved the launch of a generic drug product, Evelexa-XR, by Sigma Pharmaceuticals, which Wyeth, the original patent holder for the drug, sought to prevent. The case was heard by the Federal Court of Australia. Wyeth applied for interlocutory relief to prevent Sigma from marketing its product, alleging infringement of its patent. Sigma argued that Wyeth's delay in seeking relief should result in the application being dismissed.

The central legal issues the court needed to address were whether Wyeth’s delay in seeking interlocutory relief disqualified it from obtaining the injunction, and whether Sigma’s actions in preparing to launch the product constituted an infringement of Wyeth's patent. The court considered the balance of convenience and the potential detriment to both parties if the injunction were granted or denied. The court found that while Wyeth could have acted more promptly, Sigma’s readiness to launch the product indicated that it was unlikely to voluntarily cease its activities, thus favoring the granting of relief.

The court ruled that Wyeth was not disentitled to relief due to its delay, as no significant detriment was identified as a result of the delay. The court accepted that Sigma proceeded with its launch preparations knowing about Wyeth's patent, which suggested that Sigma was prepared to proceed regardless of the patent. Consequently, the court decided to grant Wyeth the relief it sought, with the exception of including importation in the restraint, as per Wyeth's counsel's observations.

The final orders of the court included a restraint on Sigma from marketing or selling its product Evelexa-XR in Australia without Wyeth's license or authority. Additionally, each party was ordered to bear its own costs for the interlocutory application.

Orders

Orders of the court

1. Pending the determination of the proceeding or further order the cross‑respondent whether by itself, its directors, officers, servants, agents or otherwise be restrained from marketing, taking orders for, selling, supplying, offering to supply or otherwise exploiting in Australia the products listed on the Australian Register of Therapeutic Goods under the name Evelexa‑XR or any other product comprising the same generic modified release formulation of venlafaxine hydrochloride, without the licence of or authority of the cross‑claimants.

2. Each party’s costs of the application for interlocutory relief be its costs in the cause.

Note:

Background

Background to the litigation

Full text does not contain this section.

Evidence

Evidence Before The Court

Full text does not contain this section.

Decision

Reasons for decision

SUNDBERG J
Sigma contends that Wyeth’s application should be dismissed because of its delay in seeking interlocutory relief. It says that Wyeth was put on notice on 14 April 2009 that Sigma intended to launch Evelexa‑XR on 29 April 2009. Wyeth did seek interlocutory relief until 28 April. I do not regard this delay as disentitling Wyeth to relief. It could have moved with greater speed, but no detriment is identified as having resulted from the delay complained of. It is apparent from what I have said about Sigma proceeding with its eyes open, that it was never going to voluntarily cease its preparations to launch its product and enter the market.CONCLUSION Upon the usual undertakings by both cross‑claimants I will grant the relief sought. Having regard to Wyeth’s Counsel’s observations about the form of relief, I will not include importation in the restraint.

Ratio Decidendi

Legal Principle Established

Established by: SUNDBERG J

Full text does not contain this section.