Bristol-Myers Squibb Australia Pty Ltd v Astra Pharmaceuticals Pty Ltd [1999] FCA 256

FEDERAL COURT OF AUSTRALIA

Bristol-Myers Squibb Australia Pty Ltd v Astra Pharmaceuticals Pty Ltd

[1999] FCA 256 PRACTICE & PROCEDURE – application for interlocutory injunction – publication of representations in advertising and promotional material – whether misleading or deceptive conduct contrary to s 52 Trade Practices Act 1974 (Cth) – whether making of false representations contrary to s 53(a) and (c) Trade Practices Act 1974 (Cth) – whether serious question or questions to be tried – balance of convenience. Trade Practices Act 1974 (Cth), ss 52, 53(a) and (c) Bullock v The Federated Furnishing Trades Society of Australasia (No 1) (1985) 5 FCR 464 referred to Telstra Corporation Limited v Optus Communications Pty Limited (1997) ATPR 41-541 at 43,513, 43,514-5, 43,516-7 applied Colgate-Palmolive Pty Ltd v Rexona Pty Ltd (1981) 37 ALR 391 at 395 referred to Duracell Australia Pty Limited v Union Carbide Australia Limited (1988) ATPR 40-918 at 49,858, 49,861, referred to Sterling Winthrop Pty Limited v The Boots Company (Australia) Pty Limited (1995) ATPR 41-433 at 40,877 referred to

BRISTOL-MYERS SQUIBB AUSTRALIA PTY LTD v ASTRA PHARMACEUTICALS PTY LTD V 80 of 1999 WEINBERG J MELBOURNE 18 MARCH 1999

IN THE FEDERAL COURT OF AUSTRALIA

VICTORIA DISTRICT REGISTRY V 80 OF 1999

BETWEEN: BRISTOL-MYERS SQUIBB AUSTRALIA PTY LTD (ACN 004 333 322)

Applicant

AND: ASTRA PHARMACEUTICALS PTY LTD (ACN 009 682 311)

Respondent

JUDGE: WEINBERG J

DATE: 18 MARCH 1999

PLACE: MELBOURNE

INTERLOCUTORY JUDGMENT 1 The applicant, Bristol-Myers Squibb Australia Pty Ltd ("BMSA") is responsible for having developed an anti-hypertension drug known as Irbesartan. That drug was introduced as a reimbursed drug on the Pharmaceutical Benefits Scheme ("PBS") on 1 May 1998. BMSA markets Irbesartan in Australia under the trade name AVAPRO. 2 Irbesartan is one of a range of drugs developed over the years which are effective in reducing elevated blood pressure towards normal. It is one of a class of drugs known as Angiotensin II receptor antagonist (blocking) drugs ("AII antagonists"). These AII antagonists superseded an earlier class of drugs known as Angiotensin converting enzyme inhibitors ("ACE inhibitors") which had proved to be effective in controlling hypertension but which had severe side effects. The AII antagonists are said to be as effective as ACE inhibitors in controlling hypertension, but to have minimal side effects. However, because AII antagonists have only been introduced to Australia relatively recently, most patients suffering hypertension in Australia today still use ACE inhibitors and earlier classes of drugs. 3 AII antagonists react against Angiotensin II which is a powerful hormone which causes narrowing of blood vessels thereby leading to an increase in blood pressure. This narrowing of the blood vessels results from a binding between Angiotensin II and certain receptors (AT1receptors) on the surface of muscle cells in the walls of blood vessels. This induces a contraction of the muscle cells and therefore the blood vessels, making them narrower, and increasing the workload on the heart. 4 The AII antagonist drugs bind to the AT1receptors in place of AII. They thereby prevent AII from binding and from exerting its vasoconstricting effect. 5 The first drug in the AII antagonist class was Losartan which was marketed by Merck, Sharp, & Dohme. Losartan was launched in Australia in November 1997, and was extremely successful. In August 1998 it was withdrawn from the PBS market in Australia largely, it would seem, because it was too expensive. Patients who had been taking Losartan started taking Irbesartan. The market for Irbesartan has grown strongly since then. It is currently being prescribed for approximately 150,000 patients. There are presently about 2.5 million people being treated for hypertension in this country. 6 Because of the strong increase in sales, BMSA has budgeted sales of Irbesartan worth $40.5 million for 1999. Sales of Irbesartan presently constitute 98.8% of the total sales of AII antagonists in Australia. 7 The respondent, Astra Pharmaceuticals Pty Ltd ("Astra") is a trade competitor of the applicant in the development and distribution of pharmaceutical drugs. It has developed its own AII antagonist which is known as Candesartan. That drug was introduced as a reimbursed drug on the PBS in Australia on 1 February 1999. It is sold here under the trade name ATACAND. In essence, it shares with Irbesartan the characteristics of all AII antagonists described above. There is no suggestion that Candesartan is anything other than a very effective treatment for hypertension. 8 The applicant has brought proceedings under various provisions of the Trade Practices Act 1974 (Cth) ("the Act") seeking declaratory and injunctive relief against the respondent, and damages. These proceedings arise out of the publication by the respondent of various representations in certain advertising and promotional material concerning Candesartan. The applicant contends that the publication of this material constitutes misleading or deceptive conduct contrary to s 52 of the Act, and also constitutes the making of false representations in connection with the supply or use of goods in contravention of s 53(a) and (c). 9 The advertising and promotional material said to contain the representations which contravened the provisions of the Act consists of the following items: · Brochure · First newsletter · Booklet · Fact sheet · Second newsletter · Advertisement · Retail Pharmacy Article. 10 The applicant also contends that the respondent, by its servants or agents, made a series of oral representations concerning its product each of which contravened ss 52 and 53(a) and (c) of the Act. It has, by notice of motion, brought an application for interlocutory relief seeking to have the respondent restrained from continuing to make the representations, both written and oral, said to contravene the relevant provisions of the Act. 11 Each side has filed with the Court a number of affidavits, together with several voluminous exhibits. Some of the affidavits have been sworn by highly qualified experts. They deal with complex scientific and medical matters. On some issues the experts have arrived at diametrically opposed views. There has been no cross-examination of any of these witnesses. I am left to resolve the questions raised in this application upon material which is essentially untested. I have been asked by the parties to deal with this application as a matter of urgency, even at the cost of endeavouring to do full justice to the many thorough and helpful submissions raised before me. I have, for that reason, prepared this judgment in far less time than the matters dealt with would normally warrant.