Recent decisions in the Australian Patent Office have clarified the circumstances under which patent term extensions will be granted for patents that are directed to pharmaceuticals produced by a process involving recombinant DNA technology. These decisions will reassure innovators in the biotechnology sector that Australia’s pharmaceutical patent term extension regime affords sufficiently strong protection to ensure that patent rights are not prejudiced by delays in obtaining regulatory approval.
CRITERIA FOR PATENT TERM EXTENSIONS IN AUSTRALIA
Patent term extensions can be obtained in Australia in relation to standard patents that disclose and define a pharmaceutical substance per se or a pharmaceutical substance produced by recombinant DNA technology.
The term of a standard Australian patent can only be extended if the patent satisfies the following criteria (Section 70):
- one or more pharmaceutical substances per se, and/or one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA 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; and
- goods containing, or consisting of, the pharmaceutical substance must have regulatory approval; and
- at least five years must have passed between the date of the patent (this is usually the date that the application for the patent was filed), and the date of first approval of any product containing the pharmaceutical substance; and
- the term of the patent must not have previously been extended.
An application for a patent term extension must be made within six months of grant of a patent, or six months from first regulatory approval, whichever is later (Section 71).
The period of extension
The maximum patent term extension that can be obtained in Australia is five years, making the maximum term for a standard Australian patent 25 years (Section 77). The period of the extension is determined by calculating the period beginning on the date of the patent and ending on the date of first regulatory approval, minus five years (to a maximum period of five years) (Id). For example, if the period between the date of a patent and the date of regulatory approval is seven years, the term of extension will be two years.
Importantly, although the term of the entire patent will be extended if it satisfies the above criteria, the rights of a patentee during the extended term are limited as compared with the exclusive rights the patentee enjoys during the ordinary term of the patent. during the extended term, the following activities do not constitute patent infringement (Section 78):
- exploitation of any form of the invention that is not a pharmaceutical substance; and
- exploitation of the pharmaceutical substance for non-therapeutic uses.
There is no limit on the number of patents that may be extended in relation to a pharmaceutical product, provided the aforementioned criteria are satisfied.
PHARMACEUTICAL SUBSTANCES PER SE
A “pharmaceutical substance” is defined in the Australian Patents Act as a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:
- a chemical interaction, or physico-chemical interaction, with a human physiological system; or
- action on an infectious agent, or on a toxin or other poison, in a human body.
but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing (Schedule 1).
The use of the term “per se” requires that the patent claim be to the substance alone, unqualified by, for example, process or method components. Therefore, a claim that claims pharmaceutical substances produced by a particular method or process (other than processes that involve the use of recombinant DNA technology) will generally not satisfy this requirement.
PHARMACEUTICAL SUBSTANCES PRODUCED By PROCESSES INVOLVING THE USE OF RECOMBINANT DNA TECHNOLOGy
Recent Australian Patent Office decisions have clarified the requirements for determining whether a pharmaceutical substance is “produced by processes involving the use of recombinant DNA technology.”
In ImmunoGen, Inc.  APO 88, ImmunoGen, Inc sought to extend the term of a patent directed to the preparation of antibody-maytansinoid conjugates. The basis for ImmunoGen’s patent term extension request was the inclusion in the ARTG of its breast cancer drug KAdcYLA®, the active ingredient of which is trastuzumab emtansine.
A delegate of the commissioner of Patents initially rejected ImmunoGen’s application for a patent term extension on the basis that the process defined in the claims for preparing the antibody-maytanisnoid conjugate was a crosslinking process which did not involve recombinant DNA technology.
In answer to the delegate’s rejection, ImmunoGen argued that the humanised monoclonal antibody trastuzumab in its KAdcYLA® product was indeed produced by recombinant DNA technology, and that the use of that particular antibody in the process was both described and claimed in the relevant patent.
The Deputy Commissioner noted:
“in simply requiring a process that involves the use of recombinant DNA technology the legislation appears to encompass a range of scenarios including the present one where the processes described includes forming a conjugate from an antibody produced by known recombinant techniques.”
The Deputy Commissioner held that a pharmaceutical substance “produced by a process that involves the use of recombinant DNA technology” was disclosed in the complete specification, and within the scope of the claims, of ImmunoGen’s patent.
Like the ImmunoGen decision, the Novartis Vaccines and Diagnostics S.r.l.  APO 2 decision also involved a patent directed to processes of producing a composition. The basis for the patent term extension was the inclusion in the ARTG of the meningococcal B vaccine Bexsero® which contains, amongst other ingredients, four antigenic ingredients, three of which are produced using recombinant technology.
The application for a patent term extension was initially rejected on the basis that the claims were not specifically restricted to a recombinantly produced pharmaceutical substance. Following a hearing in the matter, the delegate found that processes for preparing antigenic ingredients using recombinant DNA technology were incorporated by reference into the specification, and that a substance produced by a process involving recombinant DNA technology was “amongst the things claimed.” The delegate held that this was sufficient for the purposes of satisfying the requirement that a pharmaceutical substance produced using recombinant DNA technology must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of its claims.
AbbVie Biotechnology decision
In AbbVie Biotechnology Ltd  APO 45, AbbVie Biotechnology Ltd (AbbVie) applied for extensions of term in respect of patents which included “Swiss-type” claims characterised by the manufacture of a medicament comprising a recombinant human antibody for use in the treatment of ankylosing spondylitis, crohns disease or ulcerative colitis. The patents were, according to the decision, part of a “larger chain of divisional patents… that have already been granted an extension of term” based on the initial listing on the ARTG of AbbVie’s blockbuster auto-inflammatory product humira® (adalimumab).
The new extensions were sought on the basis of regulatory approval for humira® for new indications for treating ankylosing spondylitis, crohns disease and ulcerative colitis. AbbVie argued that the patents’ “claims expressly require the human antibody be produced by a process that involves the use of recombinant DNA technology.”
Citing his same day decision in ThromboGenics NV  APO 44, the Deputy Commissioner of Patents rejected AbbVie’s arguments and held that while the “Swiss- type” claims of the patent were notionally directed to a method or process of manufacturing a medicament, they were characterised by a therapeutic use. The Deputy Commissioner noted that there was no support for the proposition that the extension provisions were intended to provide extensions for methods of treatment that are merely “in some way associated with recombinant techniques”.
The Deputy Commissioner noted that, on the contrary, “the intention seems clearly to exclude therapeutic methods and to provide extensions only for new and inventive pharmaceutical substances per se and, as an exception, substances produced by new and inventive processes involving recombinant technology.” As such, the Deputy Commissioner concluded that no “substance” produced by a process involving the use of recombinant DNA technology fell within the scope of the Swiss-type claims of AbbVie’s patent.
The above decisions provide clarity for the biotechnology sector where the significant amount of time spent obtaining regulatory approval can greatly affect the “time to market” (or commercialisation and marketing) of a product containing a new active substance.
In particular, the ImmunoGen and Novartis decisions confirm that extensions of term will be granted in respect of patents that encompass products of recombinant DNA techniques (including process claims resulting in such products) even if the recombinant DNA technique is not recited in the claims, and even if a product produced by DNA recombinant techniques is merely “amongst the things claimed”.
In contrast, the AbbVie decision will act as a cautionary tale, confirming that the Australian Patent Office will not deem a Swiss-type patent claim directed to a method or process of manufacturing a medicament to encompass a substance produced by a process involving the use of recombinant DNA technology for the purposes of Australia’s patent term extension regime.