Merial Australia Pty Limited v Fort Dodge Australia Pty Limited [2001] FCA 1796

FEDERAL COURT OF AUSTRALIA

Merial Australia Pty Limited v Fort Dodge Australia Pty Limited [2001] FCA 1796

AGRICULTURAL AND VETERINARY CHEMICALS – label approved for registered product – Injectable chemical for prevention of heartworm in dogs – Application for injunction to restrain making of claims inconsistent with approved label – Whether advice on CD-ROM distributed by respondent to veterinarians is inconsistent with instructions on approved label – Whether respondent has reasonable excuse for making the claim. Agricultural and Veterinary Chemicals Code Act 1994, Schedule ss 10, 14, 84, 130 MERIAL AUSTRALIA PTY LIMITED v FORT DODGE AUSTRALIA PTY LIMITED N 1408 of 2001 WILCOX J SYDNEY 14 DECEMBER 2001

IN THE FEDERAL COURT OF AUSTRALIA

NEW SOUTH WALES DISTRICT REGISTRY N1408 of 2001

BETWEEN: MERIAL AUSTRALIA PTY LIMITED

APPLICANT

AND: FORT DODGE AUSTRALIA PTY LIMITED

RESPONDENT

JUDGE: WILCOX J

DATE OF ORDER: 14 DECEMBER 2001

WHERE MADE: SYDNEY

THE COURT ORDERS THAT:

1. The respondent, Fort Dodge Australia Pty Limited, by itself, its servants and agents, be restrained from: (a) making any claim in respect of the chemical product ProHeart SR-12 Injection that is inconsistent with the terms of the label for such product approved from time to time by National Registration Authority for Agricultural and Veterinary Chemicals ("the NRA"); and (b) in particular, unless and until such a claim is accepted by the NRA in connection with an application for variation of the approved label for the said product, making any claim that suggests the product provides heartworm protection for a dog later than the expiration of seven days after the first anniversary of the previous injection of the product into the dog. 2. Not later than 31 January 2002 and at its own expense, the said respondent publish a notice, in the form set out in the schedule hereto: (a) as an advertisement in The Veterinarian magazine; and (b) by posting a copy of the notice to all persons to whom the respondent supplied a copy of its CD-ROM relating to the said product. 3. Liberty to apply be reserved in relation to orders 1 and 2. 4. The said respondent pay to the applicant, Merial Australia Pty Limited, its costs of the proceeding. THE SCHEDULE In October 2000 Fort Dodge Australia Pty Limited released to veterinarians a CD-ROM concerning ProHeart SR-12 Injection. One section of the CD-ROM was headed "Frequently Asked Questions". It contained the question "What if a dog is not presented for retreatment with ProHeart SR-12 Injection within a week of the due date?" The stated answer to this question included claims that, when moxidectin (the active constituent of the product) is injected into dogs with tissue stages of Dirofilaria immitis, "it can 'reach back' to inactivate L3, L4 and early L5 stages as old as 60-70 days" and "dogs may be confidently retreated (with ProHeart SR-12 Injection) up to 2 months after the due date". The Federal Court of Australia has held these claims are inconsistent with the terms of the label for ProHeart SR-12 Injection approved by the National Registration Authority for Agricultural and Veterinary Chemicals and the claims were published without reasonable excuse. The approved label advises that a repeat dose of ProHeart SR-12 Injection should be given within seven days of the anniversary of the dog's previous treatment with the product. The Court has ordered that, unless and until such a claim is accepted by the National Registration Authority in connection with an application for variation of the approved label of ProHeart SR-12 Injection, Fort Dodge Australia Pty Limited be restrained from making any claim that suggests the product provides heartworm protection in a dog later than the expiration of 7 days after the first anniversary of the previous injection of the product into the dog. Fort Dodge Australia Pty Limited has made application to the National Registration Authority for variation of the approved label. That application is not yet resolved. In the meantime, this notice is published, by order of the Court, for general information. *********************** Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.