Case: Merck &amp; Co Inc v Arrow Pharmaceuticals Ltd [2003] FCA 1344 ; (2003) 59 IPR 226
Outcome: discussed
Barker decided that the decision of Wilcox J in Merck &amp; Co Inc v Arrow Pharmaceuticals Ltd [2003] FCA 1344 ; (2003) 59 IPR 226 ( Merck ) governed the issue before him. As Dr Barker understood the position, Merck produced the result that it did not matter that escitalopram was a new chemical entity having properties different from those of the racemate, citalopram, or that the registration of citalopram under its brand name Cipramil on the ARTG did not give the right to market escitalopram except as part of the racemate. All that mattered was that Cipramil did in fact "contain" escitalopram, or put another way, that escitalopram was present (to some extent) in Cipramil, and that Cipramil was included in the ARTG. It was also immaterial, according to Dr Barker, that escitalopram was not responsible for all of the activity of Cipramil. Dr Barker concluded that since citalopram hydrobromide, marketed under the brand name Cipramil and containing escitalopram, was first registered on the ARTG on 9 December 1997, the Commissioner was required by reg 10.7(7) to amend the relevant entry in the Register to reflect the correct extension of the term of the Patent as expiring on 9 December 2012 (see [32] above). Lundbeck complains that the Dr Barker erred in finding that the first regulatory approval date was the date on which Cipramil was registered on the ARTG, and that Dr Barker ought to have found that it was the date on which Lexapro was so registered (see [33] above). Which legislative r&eacute;gime applies? For its part, Alphapharm relies on Merck &amp; Co Inc v Arrow Pharmaceuticals Ltd (2003) 59 IPR 226 ( Merck ). A patentee, Merck &amp; Co Inc (Merck), appealed against the Commissioner's delegate's refusal of an extension. The appeal was undefended, the respondent having withdrawn from the proceeding. Wilcox J allowed the appeal. Sankyo Company Pty Ltd (Sankyo) had held a patent that claimed a compound of a particular formula, commonly referred to as Lovastatin. Lovastatin was entered on the ARTG. It was used for the control of cholesterol levels. Sankyo's patent expired on 19 February 2000, and no extension was sought in respect of it. Merck applied for a patent on 3 June 1980 with priority dates in 1979 and 1980. The patent was granted on the basis of the exclusion of certain claims which related to Lovastatin. On appeal, Wilcox J disagreed, saying (at [25]) that Merck's LHA argument was "irrefutable", and that, if only on that ground, the delegate's decision must be reversed. His Honour stated (at [26]) that LHA was a pharmaceutical substance per se disclosed in the complete specification of the patent and falling within its claims, and that the undisputed evidence was that Mevacor contained LHA. Wilcox J considered that it was irrelevant whether or not LHA itself was included in the ARTG: that for s 70(3)(a) purposes it was enough that it was contained in some other good (Mevacor) that was included in the ARTG (at [27]). His Honour thought that it did not matter that LHA was present in Mevacor only in minute quantities (at [28]). Having regard to his conclusions supporting Merck's LHA argument, his Honour did not need to address its argument concerning Lovastatin, although he expressed the view that it seemed to him that the delegate had been right to reject that argument. In Merck , as in the other cases referred to above, the question before the Court did not concern a competition between two arguable first regulatory approval dates. However, Wilcox J's construction of "containing" in s 70(3) must be applicable to the word "contain" in s 70(5). If I were to follow Wilcox J, I would hold that Cipramil "contained" (+)-citalopram. Consideration of Lundbeck's "pharmaceutical substance per se " submission The Latin expression "per se" means "by or in itself; intrinsically. Opposed to PER ACCIDENS [defined relevantly to mean "By virtue of some non-essential circumstance; contingently, indirectly"]": Oxford Dictionary of Foreign Words and Phrases (OUP, 1997). It is not every disclosure of every substance falling within the definition of "pharmaceutical substance" to which s 70(2)(a) refers. A non-essential or incidental disclosure of a pharmaceutical substance will not satisfy s 70(2)(a). The pharmaceutical substance must be of the essence of a disclosure made in the specification. This construction is consistent with the requirement that it fall within the scope of the claim or claims. The racemate, citalopram, is the pharmaceutical substance per se disclosed in the specification of the Australian Citalopram Patent, whereas the (+)-enantiomer of that racemate is the pharmaceutical substance per se disclosed in the specification of the Patent, in each case for the purpose of s 70(2)(a). Moreover, the inclusion in the ARTG of Cipramil on 9 December 1997 clearly signified the inclusion in the ARTG of goods that consisted of or contained the pharmaceutical substance citalopram, and the inclusion of Lexapro in the ARTG on 16 September 2003 clearly signified the inclusion in the ARTG of goods that consisted of or contained the pharmaceutical substance (+)-citalopram, in each case for the purpose of s 70(3)(a). The precise question before the Court, however, is whether Cipramil was goods that contained the pharmaceutical substance (+)-citalopram for the latter purpose.