7.12.1.3 Meaning of "when produced by a process that involves the use of recombinant DNA technology"

Also in this Chapter:

• 7.12.1.1 Pharmaceutical Substance per se
• 7.12.1.2 Meaning of Pharmaceutical Substance
• 7.12.1.4 Meaning of ＂mixture or compound of substances＂
• 7.12.1.5 Meaning of ＂in substance disclosed＂
• 7.12.1.6 Meaning of ＂in substance fall within the scope of the claim＂
• 7.12.1.7 Included in the Goods
• 7.12.1.8 First Regulatory Approval Date

Key Legislation:

​​​​​​​Patents Act:

• s70 Applications for extension of patent  

Under Section 70(2)(b), an extension of term is available in respect of a pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology.

The issue of whether a process involves the use of recombinant DNA technology was considered in ImmunoGen, Inc. [2014] APO 88.  In this case the pharmaceutical substance was an antibody conjugated to a cytotoxic drug.  The Deputy Commissioner held that the requirement that a process “involves” the use of recombinant DNA technology does not mandate that the process involve new recombinant DNA technology, or that the process be limited entirely to recombinant techniques (ImmunoGen supra at [20]).  The process for preparing the conjugate as a whole was new but the antibody was produced via known recombinant techniques and this was found to satisfy the requirement of s70(2)(b).

Similarly, in Novartis Vaccines and Diagnostics S.r.l. [2015] APO 2 a pharmaceutical substance comprising “a protein antigen” was held to encompass the antigen produced by recombinant means that was disclosed in the specification.

In Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 and Thrombogenics NV [2015] APO 44, it was found that Swiss claims were not directed to substances when produced by a process that involves the use of recombinant DNA technology. The substance is further limited by the therapeutic use.  Claim types that have been found to be directed to a substance when produced by recombinant DNA technology include:

Claim types that have been found to be directed to a substance when produced by recombinant DNA technology include:

• Process for preparing a substance (by a process that does not relate to recombinant DNA in the claim, but can only be carried out by recombinant DNA technology) – ImmunoGen, Inc. [2014] APO 88
• A substance prepared by a process (that does not refer to recombinant DNA technology, but can include recombinant DNA technology) – Novartis Vaccines and Diagnostics S.r.l. [2015] APO 2

Claim types that have been found not to be directed to a substance even when involving recombinant DNA technology include:

• Swiss type claims – Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129​​​​​​​