Federal Court of Australia
FEDERAL COURT OF AUSTRALIA
Merck & Co., Inc. v Arrow Pharmaceuticals Ltd [2004] FCAFC 152 MERCK & CO., INC. v ARROW PHARMACEUTICALS LTD N277 OF 2004 EMMETT, GYLES & ALLSOP JJ 26 MARCH 2004 SYDNEY
IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY N277 OF 2004
ON APPEAL FROM A SINGLE JUDGE OF THE FEDERAL COURT OF AUSTRALIA
BETWEEN: MERCK & CO., INC.
APPLICANT
AND: ARROW PHARMACEUTICALS LTD
RESPONDENT
JUDGES: EMMETT, GYLES & ALLSOP JJ
DATE OF ORDER: 26 MARCH 2004
WHERE MADE: SYDNEY
THE COURT ORDERS THAT: 1. The application be dismissed. 2. The applicant for leave to appeal pay the costs of the respondent to the application for leave. Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.
IN THE FEDERAL COURT OF AUSTRALIA
NEW SOUTH WALES DISTRICT REGISTRY N277 OF 2004
ON APPEAL FROM A SINGLE JUDGE OF THE FEDERAL COURT OF AUSTRALIA
BETWEEN: MERCK & CO., INC.
APPLICANT
AND: ARROW PHARMACEUTICALS LTD
RESPONDENT
JUDGES: EMMETT, GYLES & ALLSOP J
DATE: 26 MARCH 2004
PLACE: SYDNEY
REASONS FOR JUDGMENT
EMMETT j: 1 We have before us an application for leave to appeal from orders made by Conti J dismissing a notice of motion filed 10 November 2003. The applicant for leave, Merck and Co., Inc. ('Merck'), is the registered proprietor of Australian Patent No. 741818 ('the Patent'). The respondent to the leave application, Arrow Pharmaceuticals Limited ('Arrow'), has commenced a proceeding for revocation of the Patent. 2 The invention the subject of the Patent is concerned with a dosage regimen for treating or preventing osteoporosis by administration of alendronate. Alendronate was known before the priority date of the Patent to be highly efficacious for treating or preventing osteoporosis. However, the regimen was a difficult one and was associated with a relatively high incidence of substantial adverse side effects. 3 The invention is said to arise from work done by Merck, which showed that alendronate could be administered safely for the treatment and prevention of osteoporosis in larger doses, but less frequently than in the earlier regimens. In the application, Arrow asserts that the Patent is invalid on various grounds, including lack of novelty. In its particulars of invalidity, Arrow has furnished particulars, in purported compliance with O 58 r 15, and r 12.4, concerning acts of prescribing doses of alendronate by various medical practitioners to patients. In its motion, Merck sought, amongst other things, a declaration that the further amended particulars of invalidity do not comply with O 58 r 15 of the Federal Court Rules. 4 Underlying the relief claimed in the notice of motion was a contention on the part of Merck that the construction of the Patents Act 1990 (Cth) ('the Act') adopted in Arrow's particulars of invalidity is bad as a matter of law. Order 58 r 15(2) relevantly provides as follows: 'If one of the grounds referred to in subrule (1) is that an invention is not a patentable invention because of information about the invention through the doing of an act, the particulars must specify
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