Back in July last year, we reported on the decision in H Lundbeck A/S v Alphapharm Pty Ltd  FCAFC 70 (11 June 2009), which related to the refusal of a pharmaceutical extension 0f term for Lundbeck’s patent no. 623,144, which covers the S- or (+)-enantiomer of the antidepressant compound citalopram (see Pharmaceutical Extensions and International Inequities for further details).
A new Patent Office decision, by Hearing Officer Karen Ayres, is a direct consequence of the earlier Federal Court decision. In particular, in an attempt to recover the patent term extension it had lost as a result of the court’s decision, Lundbeck filed a fresh application for an extension of term. However, in order for this application to proceed, Lundbeck requires an extension of time of no less than 121 months, from the date upon which the request should have been filed originally.
The Patent Office initially proposed to grant the requested extension. Four parties opposed.
Following a contested opposition, and a hearing, the Patent Office has confirmed the decision to allow Lundbeck extension of time within which to apply for the extension of term.
BACKGROUNDLundbeck has regulatory approval in Australia for the racemic mixture of both enantiomers of citalopram (which is itself covered by patent no. 509,445). A pharmaceutical product comprising the racemic mixture was marketed in Australia as CIPRAMIL, which had been included on the Australian Register of Therapeutic Goods (ARTG) since 9 December 1997. The improved product comprising only the more effective (+)-enantiomer is marketed in Australia as LEXAPRO, and was included on the ARTG, subsequent to CIPRAMIL, from 16 September 2003.
An extension of term can only be based on the first inclusion of a product containing the patented compound on the ARTG. As we reported previously, the Federal Court, on appeal, confirmed a literal interpretation of this requirement – if a product contains the patented compound, even if it is not the specific subject of the patent, then that is sufficient to meet the ‘first inclusion’ requirement. This is at odds with the approach taken in most other jurisdictions that have similar provisions, e.g. in analogous circumstances in the US, the Court of Appeals for the Federal Circuit has found that a specific enantiomer is a different drug from a racemic mixture.
There are time limits for requesting an extension of term – the request must be filed by the latest of:
- six months of the date of first inclusion of a product containing the patented compound on the ARTG;
- six months of the date of grant of the patent; and
- 26 July 1999 (six months after commencement of the extension of term provisions).
Lundbeck filed its replacement request on 12 June 2009. (We calculate the required extension as 119 months, but the parties to the hearing appear to have agreed that the correct number is 121 months. Since Lundbeck originally requested a 132 month extension of time, we assume that they are happy with the reduction either way!)
LEGAL BASIS FOR OPPOSITIONThe opponents’ case was essentially that the Patents Act 1990, section 223 (which relates to extensions of time) in combination with the Patents Regulations 1991, regulation 22.11, forbids altogether the grant of an extension of time to request an extension of the patent term.
In particular, subregulation 22.11(4) sets out the prescribed acts to which section 223 does not apply, including:
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 the term of the patent.
We trust that you will agree that this is not exactly a fine example of transparent drafting! On the face of it, it might easily be read as saying that the time for filing an application for an extension of term is not extendible under section 223. But if that is so, then it would appear that the words ‘during the term of a standard patent as required by subsection 71 (2) of the Act’ are completely unnecessary.
DECISION ON LEGAL BASISThe Hearing Officer was required to determine the meaning of subregulation 22.11(4). It is generally understood that extensions of time were intended to be available, for filing applications for extensions of term, in appropriate circumstances.
As pointed out at paragraph  of the decision, ‘the Explanatory Memorandum (EM) for the Intellectual Property Laws Amendment Bill 1998 (which introduced the pharmaceutical extension of term scheme) explicitly outlines Parliament’s intent to allow the timing provisions of section 71 to be extended under section 223 provided the relevant criteria were satisfied:
‘Section 71 sets out the requirements of the form and timing of the application. The extension of time provision under s.223 of the Patents Act 1990 will apply to all acts required to be done under the extension of patent term scheme provided the relevant criteria are satisfied.’
The Hearing Officer concluded that it was appropriate to interpret the somewhat obtuse language of subregulation 22.11(4) in light of the clear intent of parliament:
In this regard, the key to construing the regulation may lie in the additional words “as required by section 71(2)” which seem to emphasise that filing during the term of the patent is a key requirement of section 71(2). This phrase provides a link to the “relevant criteria” mentioned in the EM and suggests that the purpose of regulation 22.11(4)(b) is to prescribe a specific time constraint within section 71(2) (ie: that the section 70 application must be filed during the term of the patent) which could not be circumvented by section 223.
This purposive construction would still allow a second time limit in section 71(2) (the 6 month time limit) to be extended (provided the application was filed during the term of the patent). Such extensions would be consistent with Parliament’s general intention to apply section 223 to section 70 applications. They would also properly balance private and public interest considerations by allowing patentees access to the beneficial provisions of section 223 to correct errors while still providing third parties with adequate notice about any extension to make informed decisions about when they can enter the market.
Since the replacement application for extension of term was filed one day prior to the expiry of the LEXAPRO patent, an extension under section 223 is potentially available, if all other relevant criteria are met.
DECISION ON SECTION 223 CRITERIAThe principle requirement for the availability of an extension of time under section 223 is the existence of a causative error, i.e. an error or omission on the part of the patentee, which existed prior to the original deadline, and was a direct cause of the failure to perform the required actions in time.
The Hearing Officer was readily satisfied, on the basis of evidence from persons involved in the preparation of the original application for extension of term, and the subsequent litigation and appeals, that the original deadline was missed due to a genuine misunderstanding of the law, which was not resolved until at least the decision of the Full Federal Court on 11 June 2009 (at -).
The opponents pressed the usual so-called ‘discretionary criteria’, without success:
- unreasonable delay – the Hearing Office found that the delay in requesting the extension of time was not unreasonable, considering that the law was not settled until the High Court had finally refused leave to appeal the Full federal Court decision, and that the Patent Office could not have acted on the request while any appeal was still pending (at -);
- patentee’s interests – clearly the patentee’s interests are served by granting the extension request, which would result in an additional 3.5 years of patent protection (but even then only a total effective term, from regulatory approval of LEXAPRO to patent expiry, of 9.5 years) (at -);
- third-party interests – the interested third parties were primarily generic pharmaceutical manufacturers which had brought their own products to market and, while the Hearing Officer acknowledged that they would be adversely affected, she concluded that this was the result of a deliberate strategy having a known commercial risk (at );
- public interest – the Hearing Officer concluded that the public interest in having cheap generic versions of LEXAPRO available for an additional period was outweighed by the greater interest in ensuring that adequate incentives are available for the development of new therapeutic products (at -).
CONCLUSIONWith an extension of term based on CIPRAMIL, the LEXAPRO patent will have an expiry date of 9 December 2012.
If this decision is appealed, the matter could easily remain tied up in the courts until this date. We dare say that an appeal is almost certain.