7.12.1.6 Meaning of "in substance fall within the scope of the claim"

Also in this Chapter:

• 7.12.1.1 Pharmaceutical Substance per se
• 7.12.1.2 Meaning of Pharmaceutical Substance
• 7.12.1.3 Meaning of ＂when produced by a process that involves the use of recombinant DNA technology＂
• 7.12.1.4 Meaning of ＂mixture or compound of substances＂
• 7.12.1.5 Meaning of ＂in substance disclosed＂
• ​​​​​​​7.12.1.7 Included in the Goods
• 7.12.1.8 First Regulatory Approval Date

Key Legislation:

Patents Manual:

• s70 Applications for extension of patent  

The test for whether a pharmaceutical substance in substance falls within the scope of a claim was considered in Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647. At [42] it is stated as:

“in the context of s 70(2)(a), we think that falling within the scope of a claim in a patent specification means included amongst the things claimed.”

This means that the things that are within the scope of a claim are not the integers that appear within the claim, but the total invention that the claim defines.

In Prejay Holdings Ltd v Commissioner of Patents [2003] FCAFC 77, all of the claims were directed to methods.  Wilcox and Cooper JJ (Allsop J concurring) held (at [24]) that a substance that is mentioned in the context of a method claim does not per se fall within the scope of a method claim:

“for a substance to fall within s 70(2)(a) it must itself be the subject of a claim in the relevant patent.  It is not enough that the substance appears in a claim in combination with other integers or as part of the description of a method (or process) that is the subject of a claim.”

In Idenix Pharmaceuticals, Inc., L’Universite Montpellier II and Centre National De La Recherche Scientifique [2012] APO 113, the delegate considered a “when used’ claim and stated:

“I conclude that a pharmaceutical substance per se will not in substance fall within the scope of a claim that is directed to a method.”

The meaning of “in substance fall within the scope of the claim” was recently considered in the context of s70(2)(b).  In ImmunoGen, Inc. [2014] APO 88, a claim was directed to a process for producing an antibody conjugate, the process involving recombinant DNA technology.  The Deputy Commissioner concluded that a claim to a product made by a particular process is substantially indistinguishable in scope from a claim to the particular process used to make the product.  Consequently, it was held that the conjugate, when produced by a process that involves the use of recombinant DNA technology, in substance falls within the scope of a claim to a process for preparing the conjugate.

In Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 and Thrombogenics NV [2015] APO 44, it was found that a pharmaceutical substance when produced by a process that involves recombinant DNA technology did not in substance fall within the scope of a Swiss claim, since such a claim includes a method or process element directed to the intended purpose of the pharmaceutical substance.  See also 7.12.1.3 Meaning of "when produced by a process that involves the use of recombinant DNA technology".