Case: Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647 ; (2001) 112 FCR 595
Outcome: discussed
refers to three authorities as being relevant to the construction of the expression "pharmaceutical substance per se ": Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647 ; (2001) 112 FCR 595 ( Boehringer ); Prejay Holdings Ltd v Commissioner of Patents [2003] FCAFC 77 ; (2003) 57 IPR 424 ( Prejay ); and Pharmacia Italia SpA v Mayne Pharma Pty Ltd (2006) 69 IPR 1 ( Pharmacia ). Boehringer is not entirely on point. The patent claims were for a container comprising an aerosol or spray composition for nasal administration. The composition comprised as its active ingredient a certain pharmaceutical substance. The primary Judge, Heerey J, held that s 70(2)(a) was not satisfied because the pharmaceutical substance itself ( per se ) was not disclosed in the complete specification and did not fall within the scope of a claim of the patent specification ( Boehringer Ingelheim International v Commissioner of Patents (2001) AIPC 91-670). His Honour examined the legislative history behind ss 70 79 and concluded that patents for new and inventive processes or new and inventive modes of treatment of old or known products are not the subject of s 70: it is only patents for new and inventive products that are. Accordingly, the expression per se showed that an extension of term is to be available only where the claim is for a pharmaceutical substance as such, not a substance forming part of a method or process. The Full Court in Boehringer agreed (at [37]). Their Honours noted (at [39]) that the Second Reading Speech relating to the Intellectual Property Laws Amendment Bill 1997 (Cth), which inserted the relevant sections into the Act, spoke of "development of a new drug" and of the research and testing required before a "product" could enter the market. Their Honours also noted (at [40]) that the Explanatory Memorandum relating to that Bill spoke of the expression "pharmaceutical substance per se " as being usually restricted to "new and inventive substances". They considered that the expression "fall within the scope of the claim or claims of that specification" in s 70(2)(a) means "[b]e included amongst the things claimed " (at [42]). The decision in Boehringer does not govern the present case because claims 1 to 5 are indisputably product claims, and the pharmaceutical substance per se in question is indisputably the (+)-enantiomer of citalopram. In my view, Lundbeck seeks to draw more from the expression " per se " than was necessary in Boehringer . In Boehringer , the Court was concerned only to distinguish between a pharmaceutical substance that is the subject of a product claim (which they held to be within s 70(2)(a)) and a substance that forms part of a method or process claim (which they held not to be within s 70(2)(a)). The Court was not concerned, as I am, with a competition between two arguable "first regulatory approval dates" and with the question whether the substance the subject of a product claim in a later patent was contained in goods previously included in the ARTG. In Prejay a Full Court of this Court followed Boehringer . All of the claims were method claims, not product claims. The Commissioner's delegate refused an application for an extension. The Full Court agreed with the delegate that a substance that is mentioned in the context of a method claim does not meet the requirement of s 70(2)(a) that the substance per se fall within the scope of a claim (at [23] [24] per Wilcox and Cooper JJ, [28] per Allsop J). In Pharmacia , Weinberg J accepted the distinction drawn in Boehringer , but held (at [99]) that claim 1 of the patent before him did state "a claim to a new and inventive substance, and not to a novel process or method". Weinberg J was also not concerned with rival first regulatory approval dates or with the associated questions that are before me.