In Australia, it is possible to apply for a patent term extension (PTE) of up to 5 years for patents relating to pharmaceutical substances. To be eligible for a PTE, goods containing, or consisting of, the pharmaceutical substance must be included in the Australian Register of Therapeutic Goods (ARTG). Furthermore, pursuant to Section 70(2) of the Patents Act 1990 (Cth), either or both of the following conditions must be satisfied:
- one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;
- one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA (rDNA) technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.
While many cases discuss the first class of patents (based on 70(2)(a)), to date, there has not been much comment in relation to the second class (based on 70(2)(b)).
Of interest is that two recent Patent Office decisions, ImmunoGen, Inc. [2014] APO 88 (19 December 2014), “ImmunoGen” and Novartis Vaccines and Diagnostics S.r.l. [2015] APO 2 (2 February 2015), “Novartis” have sought to clarify the breadth of the scope of PTE provisions as they relate to pharmaceutical substances involving rDNA technology.
Importantly, in the ImmunoGen decision, at [20], the Deputy Commissioner found that “The Act and extrinsic materials relevant for the purpose of section 15AB of the Acts Interpretation Act 1901 fall short of qualifying the term “involves” in subsection 70(2)(b) to require a product to be made by new recombinant DNA technology or that the process be limited entirely to a recombinant process”.
Furthermore, in both decisions it was found that a process claim could be used as the basis for the PTE request because it includes within its scope the product of the process.
Thus, in summary, the ImmunoGen and Novartis decisions clarify that:
- the term “involves” does not require a product to be made by a process comprising new rDNA technology or that the process be limited entirely to a recombinant process; and
- a “product-by-process” claim is not required as it does not add protection beyond the protection afforded by the corresponding process claim. Nevertheless, bearing in mind the wording of the legislation governing PTEs, it would be prudent to also include a “product-by-process” claim.
The deadline for filing a PTE request is the later of 6 months from the date of grant of the patent or 6 months from listing on the ARTG. Thus, where a pharmaceutical substance involving rDNA technology is to be listed, or has recently been listed on the ARTG, pharmaceutical patent owners may wish to review their patent portfolio for the possibility of an extension of term.