Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559

Lindgren J’s decision in Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559 (24 April 2008)… has been handed down.
PATENTS – validity – patent for (+)-enantiomer of the racemate, citalopram, and for method of obtaining that enantiomer – patentee also held previous patent for the racemate – both the racemate and the enantiomer, drugs for the treatment of depression – (+)-citalopram claimed to be therapeutically more effective than citalopram – challenge to validity of claim for (+)-citalopram – construction of claim – whether for (+)-enantiomer as an independently existing molecule or whether also for (+)-enantiomer when part of racemate – whether claim for (+)-enantiomer anticipated by patent for citalopram – whether (+)-enantiomer as an independent molecule was obvious – Australian test for obviousness – application of that test to product claims for the (+)-enantiomer, and to method claim for the method of obtaining it – lack of utility – product claim for a dosage that, inter alia, was less than and more than a useful dosage range.
Held: (1) upon its proper construction, product claimed was the independently existing enantiomer; (2) the invention of the independently existing enantiomer was not anticipated by the patent for the racemate; (3) the Australian “matter of routine” test for obviousness, when applied to the invention of the product, equated to the question whether those skilled in the art, as a matter of routine, would have had the goal of obtaining separate enantiomers in the expectation that one would be a desirable drug for the treatment of depression; (4) one of the product claims relating to dosage failed test of utility; (5) on the evidence, neither the (+)-enantiomer nor the method for obtaining it was obvious at the priority date.
PATENTS – extension of term – patent for (+)-enantiomer of the racemate, citalopram,