The Full Federal Court has dismissed yet another appeal in the Alphapharm v Lundbeck (escitalopram) saga:
You will recall that Lundbeck had applied (10 years late) for an extension of the term of its escitalopram patent under s 70 of the Patents Act, escitalopram being the (+) enantiomer of citalopram.
The issue in this appeal was whether escitalopram satisfied the requirement in s 70(2)(a) that:
one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification
Alphapharm’s argument was that Lundbeck’s patent was a claim to a pharmaceutical substance – the isolated or pure enantiomer – but it was not a claim to a pharmaceutical substance per se. Rather, Alphapharm characterised the claim as a claim to the substance limited by a requirement of purity of manufacture.
Bennett, Nicholas and Yates JJ rejected Alphapharm’s characterisation.
Claim 1 of the escitalopram patent is to:
(+)–1-(3-dimethylaminopropyl)–1-(4’-fluorophenyl)–1,3-dihydroisobenzofuran–5-carbonitrile and non-toxic acid addition salts thereof.
Their Honours pointed out that the claim did not itself use the word “isolated” or “pure”. Nonetheless, the skilled addressee would understand the claim to be referring to the substance constituted by the isolated enantiomer, not as existing in the racemate. That substance was a new chemical entity with different characteristics and properties to the racemate.
92 …. the claim is to the (+)-enantiomer and nothing else. The term “pharmaceutical substance per se” simply means the pharmaceutical substance “in itself”. In Boehringer, Heerey J observed that per se meant ‘by or in itself’ ‘intrinsically’ or ‘essentially’ (at ). The Full Court approved that approach on appeal (at ).
93 Semantics aside, it is clear that the claim describes a pharmaceutical substance per se. The substance was, as explained by Lindgren J at , a new chemical entity. The racemate and the (+)-enantiomer had different physico-chemical interactions manifested in different pharmacodynamics and pharmacokinetics (the Decision at ). The claim is to (+)-citalopram, irrespective of how it is produced. The isolated (+)-enantiomer plainly qualifies as a pharmaceutical substance per se and the primary Judge was correct in concluding that it satisfies s 70(2)(a) of the Act.
It looks like things are now getting down to the sharp pointy question of how much will have to be paid in terms of pecuniary remedies. As this was an appeal from a single judge who, in turn, was hearing an appeal from the Commissioner, Alphapharm needed leave to appeal. While cases granting “leave” are not quite as rare as hen’s teeth, the Full Court noted leave should be granted because:
35 This application also represents Alphapharm’s only course in challenging the extension of term of the Patent, which has significant consequences to Alphapharm. If Lundbeck is successful, the term of the Patent will be extended and Lundbeck’s infringement proceedings against Alphapharm can proceed.
Alphapharm Pty Ltd v H Lundbeck A/S  FCAFC 138 (Bennett, Nicholas and Yates JJ)
- The High Court held that Lundbeck was not “out of time” in making its application last year. ?
- Lundbeck patented the racemate citalopram in 1980 and marketed it in Australia as Cipramil. The racemate being a mixture of both the (+) and (-) enantiomers. Lundbeck marketed escitalopram as Lexapro. ?
- Patents Act s 158(2). ?