Warner-Lambert Company LLC v Apotex Pty Ltd

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FEDERAL COURT OF AUSTRALIA

Warner-Lambert Company LLC v Apotex Pty Limited [2017] FCAFC 58

Appeal from: Apotex Pty Ltd v Warner-Lambert LLC (No 3) [2017] FCA 94
File number(s): NSD 239 of 2017
NSD 240 of 2017
Judge(s): JAGOT, YATES AND BURLEY JJ
Date of judgment: 13 April 2017
Catchwords: PATENTS – whether primary judge erred in finding that an application for Pharmaceutical Benefits Scheme (PBS) listing is not an infringement of patent – whether an application for PBS listing constitutes an offer to supply and an exploitation of the claimed invention
Legislation:

National Health Act 1953 (Cth) ss 84(1), 84AF, 85(6), 87, 99AC, 99ACB, 99ACF, 99ACH, 99AEA, 99AEB, 99AEC, 99AED, 99AEE, 99AEF, 99AEG, 99AEH

Patents Act 1990 (Cth) s 13(1), Sch 1

Therapeutic Goods Act 1989 (Cth)

National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009 (Cth) Reg 2.16(2)

Cases cited:

Apotex Pty Ltd v Warner-Lambert Company LLC (No 2) [2016] FCA 1238

Apotex Pty Ltd v Warner-Lambert Company LLC (No 3) [2017] FCA 94

Gerber Garment Technology Inc v Lectra Systems Ltd [1995] RPC 383

Date of hearing: 22 March 2017
Registry: New South Wales
Division: General Division
National Practice Area: Intellectual Property
Sub-area: Patents and associated Statutes
Category: Catchwords
Number of paragraphs: 20
Counsel for the Appellants: Mr A L J Bannon SC with Mr C Dimitriadis SC
Solicitor for the Appellants: Allens
Counsel for the Respondent in NSD 239 of 2017: Mr N Murray with Mr M Fleming
Solicitor for the Respondent in NSD 239 of 2017: Ashurst Australia
Counsel for the Respondent in NSD 240 of 2017: Ms A Bowne SC with Mr C Murphy
Solicitor for the Respondent in NSD 240 of 2017: Maddocks Lawyers

ORDERS

NSD 239 of 2017
BETWEEN:

WARNER-LAMBERT COMPANY LLC

First Appellant

PF PRISM CV

Second Appellant

PFIZER IRELAND PHARMACEUTICALS (and others named in the Schedule)

Third Appellant
AND:

APOTEX PTY LIMITED ACN 096 916 148

Respondent

JUDGES:

JAGOT, YATES AND BURLEY JJ

DATE OF ORDER:

29 MARCH 2017

THE COURT ORDERS THAT:

1.The appeal be dismissed.

2.The appellants pay the respondent’s costs of the appeal as agreed or taxed.

3.The parties confer and file agreed proposed orders in respect of the cross appeal and notice of contention, including counsel’s details, the estimated length of hearing, available dates in the Full Court period for August 2017, and whether it is intended to submit any Full Court decision is wrong, within 14 days.

Note:    Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.


ORDERS

NSD 240 of 2017
BETWEEN:

WARNER-LAMBERT COMPANY LLC

First Appellant

PF PRISM CV
Second Appellant

PFIZER IRELAND PHARMACEUTICALS (and others named in the Schedule)
Third Appellant
AND:

GENERIC PARTNERS PTY LTD ACN 132 833 777

Respondent

JUDGE:

JAGOT, YATES AND BURLEY JJ

DATE OF ORDER:

29 MARCH 2017

THE COURT ORDERS THAT:

1.The appeal be dismissed.

2.The appellants pay the respondent’s costs of the appeal as agreed or taxed.

Note:    Entry of orders is dealt with in Rule 39.32…

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Details
Case
[2017] FCAFC 58
Decision Date

CaseChat Overview and Summary

Warner-Lambert Company LLC initiated legal proceedings against Apotex Pty Ltd in the Federal Court of Australia, challenging a decision that an application for a Pharmaceutical Benefits Scheme (PBS) listing did not infringe upon their patent. Warner-Lambert argued that the mere act of filing an application for PBS listing constituted an offer to supply the patented product, thereby infringing their patent rights. Apotex, on the other hand, contended that filing such an application did not amount to an infringement and was merely a procedural step in the PBS approval process.

The central legal issue before the court was whether the act of applying for a PBS listing constituted an offer to supply and an exploitation of the claimed invention, thereby infringing the patent. The court was required to determine the legal nature of the PBS listing application process and its implications for patent law. Specifically, the court needed to examine whether the application process, in and of itself, was an act of infringement or if it required further steps, such as approval and subsequent supply, to constitute an infringement.

In addressing these issues, the court found that an application for PBS listing does not, by itself, constitute an offer to supply or an exploitation of the claimed invention. The court reasoned that the PBS listing process involves multiple steps, including evaluation, approval, and potential supply, and that the mere act of filing an application is not sufficient to infringe upon a patent. The court held that an application for PBS listing must be accompanied by actual supply of the product to constitute an infringement. Consequently, the court dismissed the appeal and ordered that the appellants pay the respondent's costs of the appeal as agreed or taxed.

Orders

Orders of the court

1. The appeal be dismissed.

2. The appellants pay the respondent’s costs of the appeal as agreed or taxed.

Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

Background

Background to the litigation

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Evidence

Evidence Before The Court

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Decision

Reasons for decision

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Ratio Decidendi

Legal Principle Established

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