Extension of time to file for extension of term refused
An application by Boehringer Ingelheim International GmbH for an extension of time to lodge an application to extend the term of a pharmaceutical patent has been refused in a decision of the Australian Patent Office. The result of this refusal is that Boehringer Ingelheim's application to extend the term of the patent will not be considered.
According to section 71(2) of the Patents Act 1990 an application for an extension of the term of a pharmaceutical patent must be made during the term of the patent and within 6 months after the latest of the following dates:
- the date the patent was granted;
- the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, any relevant pharmaceutical substances; and
- 27 January 1999 (the date of commencement of the relevant legislation).
The application to extend the term of the patent was filed on 14 July 1999, and while this date was within 6 months of the date specified in section 71(2)(c), it was not "during the term of the patent". The patent was granted on a divisional application, the parent of which had been filed on 4 July 1979. Accordingly the term of the patent expired on 4 July 1999, 10 days before the extension of term application was filed. It appeared likely to the hearing officer that the attorneys handling the extension were unaware that the patent was a divisional and accordingly believed that the final date for filing the extension application was 27 July 1999.
The Patents Act includes a general provision in section 223(2) which provides the Commissioner with the discretion to extend a time limit in circumstances where, because of:
- an error or omission by the person concerned or by his or her agent or attorney; or
- circumstances beyond the control of the person concerned;
- a "relevant act" that is required to be done within a certain time is not, or cannot be, done within that time.
The term "relevant act" is defined in section 223(11) to mean an action (other than a prescribed action) in relation to a patent application, or any proceedings under this Act (other than court proceedings), and includes the making of a Convention application within the time allowed for making such application.
Accordingly the only time limits specified in the Patents Act which cannot be extended by section 223(2) are for taking those actions which are "prescribed" for the purpose of the definition of "relevant act". Prior to the implementation of the extension of term provisions, the only actions which were "prescribed" for this purpose (under regulation 22.11(3)) were actions for which extensions of time were provided elsewhere in the Patents Act or Regulations. These were (a) the meeting of particular deadlines relating to opposition proceedings (extensions are provided for in regulation 5.10), and (b) the payment of a renewal fee during the 6 month grace period provided for in regulations 13.3(1A) and 13.6(2). Although there does not appear to be any clear statement of Government policy to the effect that the operation of section 223(2) to extension of term applications is to be excluded, on introduction of the extension of term legislation the Regulations were amended to prescribe the following additional actions for the purpose of the definition of "relevant act":
"(c) filing, during the term of a standard patent as required by subsection 71(2) of the Act, an application under subsection 70(1) of the Act for an extension of term of the patent."
Although the hearing officer conceded from the evidence filed in support of the extension of time application that the circumstances leading to the late filing of the extension of term application would ordinarily have satisfied the requirements of section 223, he decided that the operation of section 223(2) in circumstances where an extension of term application is filed outside the term of the patent was barred by regulation 22.11(3). Accordingly the extension of time was refused.
While the hearing officer suggested that section 223(2) would be available for extension of term applications filed during the term of the patent but outside the six month time limits set out in section 71(2) it would seem at least arguable that regulation 22.11(3) excludes the operation of section 223(2) even in these circumstances.
This decision serves as a reminder of the need to carefully monitor the grant of regulatory approval in Australia in respect of pharmaceutical products to ensure that applications to extend the term of relevant pharmaceutical patents are filed within the time limits prescribed in section 70(2).