Dr Jim Onishi and Michael Houlihan
The normal twenty (20) year exclusive monopoly of a Pharmaceutical Patent may be extended by up to five (5) years under Section 70 of the Patents Act 1990.
Such Extensions of Term are intended to compensate a Patent owner for regulatory delays in the marketing of new pharmaceutical products. Extending the Term of a Patent can be of significant commercial value to a Patent Owner.
However, certain requirements must be met for an Extension of Term Request to be successfully granted and to remain valid.
In this article, we set out the requirements for obtaining an Extension of Term, and the strict deadlines relating thereto.
Requirements for an Extension of Term Request
Under Section 70 of the Patents Act 1990, a Patent Owner must meet the following requirements upon submission of the Extension of Term Request:
1. the claimed invention must be directed to one or more pharmaceutical substances per se, or one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology (Section 70(2));
2. goods containing, or consisting of at least one of those pharmaceutical substances must be included in the Australian Register of Therapeutic Goods (ARTG) (Section 70(3)(a));
3. the period from the date of the Patent to the date of the first regulatory approval for at least one of those pharmaceutical substances must be at least five (5) years (Section 70(3)(b)); and
4. the term of the Patent has not previously been extended (Section 70(4)).
We address each of these requirements separately below:
1. The claimed invention must be directed to one or more pharmaceutical substances per se
An Extension of Term can only apply to a claim directed to the “pharmaceutical substance” itself.
A “pharmaceutical substance” has been defined under Schedule 1 of the Patents Act as:
“A substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:
(a) a chemical interaction, or physico-chemical interaction, with a human physiological system; or
(b) 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.”
The term “therapeutic use” as it appears in the above definition is in turn defined as:
“for the purpose of:
(a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in person; or
(b) influencing, inhibiting or modifying a physiological process in person; or
(c) testing the susceptibility of persons to a disease or ailment.”
Further, the pharmaceutical substance must be for therapeutic use in a human body.
Accordingly, the patent term for medical devices and new treatment methodologies cannot be extended.
2. Included in the Australian Register of Therapeutic Goods (ARTG)
In order to qualify for a Patent Term Extension, goods containing or consisting of the pharmaceutical substance of interest must be included in the ARTG. The phrase “containing or consisting of” has been confirmed by the Australian Federal Court to include any impurity present in a registered goods (Merck & Co Inc v Arrow Pharmaceuticals Ltd  FCA 1344; Alphapharm Pty Ltd v H Lundbeck A/S  FCA 559). This includes any impurity from manufacturing processes, decomposition products, and isomers present in the registered goods. It is also irrelevant that the specific pharmaceutical substance of interest had not been listed in the Register, or that only a minute amount of the pharmaceutical substance of interest, is present in the goods.
It is noteworthy that being “included in the Australian Register of Therapeutic Goods (ARTG)” for the purposes of section 70(3)(a) of the Patents Act 1990 is fulfilled by simply being on the Register for any reason, including export listing (Pfizer Corp v Commissioner of Patents (No 2)  FCA 1176).
The stringent interpretation in Australia for determining the date of first regulatory approval means that an Application for an Extension of Term may be invalid if it is based on an incorrect first regulatory approval date due to earlier registered goods containing the pharmaceutical substance in question. For example, the pharmaceutical substance may have been in fact been included in earlier registered goods as an impurity.
3. The period from the date of the Patent to the date of the first regulatory approval for at least one of those pharmaceutical substances must be at least five (5) years
The filing date of the Patent and the date of first regulatory approval must be no less than five (5) years apart.
4. The term of the Patent has not previously been extended (Section 70(4))
Any request for an Extension of Term for a Patent that has already previously been extended will be refused by the Australian Patent Office.
How the Extension of Term is calculated
Section 77(1) of the Patents Act 1990 provides that the Term of Extension is calculated as the period from the date of the Patent (i.e. the filing date) to the date of first regulatory approval, reduced by five years. Section 77(2) of the Patents Act 1990 stipulates that the Term of the Extension cannot be longer than five years (i.e. a maximum of 25 years of patent protection is potentially available).
The deadline for filing a Request for an Extension of Term
Section 71(2) regulates the deadline for filing a Request for an Extension of Term. Under this provision, an Application for an Extension of Term must be made during the term of the Patent and within six (6) months of the latest of:
(i) the date of patent grant;
(ii) the date of commencement of the first inclusion of the product in the ART; or
(iii) the date of commencement of the Extension provision (i.e. 27 January 1999).
For practical purposes, only (i) and (ii) are now relevant.
It is important to note that the general Extension of Time provisions under Section 223 of the Patents Act 1990 (error/omission or circumstances beyond the control of the applicant or its agent) cannot be used to gain extra time in which to file an Application for an Extension of Term (Boehringer Ingelheim International GmbH  APO 60). Also, an Application for an Extension of Term must be filed prior to expiry of the Patent(Alphapharm Pty Ltd v H. Lundbeck A/S  APO 36).
Patentee Rights during the Extension of Term
If the Application for an Extension of Term is granted, then the exclusive rights of the Patentee during the extended period are limited to the pharmaceutical substance. However, Sections 78(a) and 78(b) of the Patents Act 1990 provide that it is not an infringement to exploit the pharmaceutical substance for a purpose other than for a (human) therapeutic use, and any form of the invention other than for the pharmaceutical substance. Therefore, it is not an infringement to exploit a non-therapeutic use, or any form of the invention that is not a pharmaceutical substance, during the Extended Patent Term.
Extensions of Term for Patents involving recombinant DNA technology
The Australian Patent Office has strictly limited the Extension of Term provisions for pharmaceutical substances to those that include products involving single pharmaceutical actives.
This was not always the case. In the past, owners of Patents claiming substances involving the use of recombinant DNA technology received more liberal consideration. In those cases, the Extension of Term provisions have been considered to be satisfied even when the claimed pharmaceutical substance is defined by reference to method or process steps (ImmunoGeb, Inc.  APO 88). This position has recently been overturned and is no longer followed.
If you would like more information or are considering filing an Extension of Term for an Australian Patent, please do not hesitate to contact us. It is essential that the deadline for filing an Application for an Extension of Term is not missed, since it is not possible to extend this deadline under Section 223 (iCeutica Pty Ltd  APO 77).