H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70

FEDERAL COURT OF AUSTRALIA

H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70 PATENTS – construction of claims – whether reference to (+)-enantiomer in claim is a reference to (+)-enantiomer isolated from the (-)-enantiomer – relevance of degree of purity – whether primary judge added integers to claim – relevance of text of specification to construction of claims PATENTS – novelty – whether a racemate anticipates an enantiomer – clarity – whether claims are clear – whether claims define the invention – utility – range of dosage in claim – whether entire range of dosage claimed has to be useful – whether entire range of dosage is useful PATENTS – infringement – method for preparation of a compound – whether method claim in patent-in-suit excluded possibility of substituting another halogen or pseudo-halogen for the cyano group disclosed in the claim – whether the cyano-diol was an essential integer PATENTS – extension – whether pharmaceutical substance per se – whether (+)-enantiomer disclosed in patent is contained in racemate included in Australian Register of Therapeutic Goods

Evidence Act 1995 (Cth) s 55 Patents Act 1952 (Cth) Patents Act 1990 (Cth) ss 7, 18, 40, 65, 67, 70, 71, 72, 74, 75, 76, 77, 78 Patents Act 1977 (UK) s 2 Therapeutic Goods Act 1989 (Cth) s 9A

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