01 December 2006
Key Points:
The Federal Court has recently held that entry of a patent term extension in the Patent Register does not give the patentee an indefeasible right to that extension and where the Register records an incorrect extension, the Commissioner of Patents must correct it. In a decision expected next year, the Federal Court will determine whether an extension granted on the basis of an application that appeared on its face to be timely but which was in fact untimely is invalid and subject to cancellation.
The Federal Court has recently resolved a number of important issues concerning pharmaceutical patent term extensions, and will address a remaining unresolved issue in a decision expected next year.
This article will discuss two cases involving H Lundbeck on one side and either the Commissioner of Patents or Alphapharm Pty Ltd on the other, both of which concern Lundbeck's patent covering the (S)-enantiomer of citalopram.[1]
In H Lundbeck a/s v Commissioner of Patents ("Lundbeck II"), the Federal Court was called on to decide for the first time whether a patentee has a property right in a patent term extension it has been granted, as recorded in the Patents Register, or whether, if the entry in the Register is incorrect, the Commissioner must correct it pursuant to a regulation requiring her to do so.
In Alphapharm Pty Ltd v H Lundbeck A/S ("Lundbeck I"), the Federal Court will determine next year whether an extension granted on the basis of an application that appeared to be timely but which was in fact out of time is invalid and subject to cancellation.
The patent term extension process
The Patents Act 1990 (Cth) (the "Act") provides a regime for extending the term of a pharmaceutical patent by up to five years beyond the standard patent term. In order for a patent to qualify for an extension, it must comply with section 70(3) of the Act such that:
The Act defines the first regulatory approval date as the date of commencement of the first inclusion in the ARTG of goods that contain, or consist of, the substance (section 70(5)).
The maximum length of an extension is five years. The length of the extension is calculated according to the amount of time between the date of the patent and the earliest first regulatory approval date; reduced by five years but not below zero. The earlier the first regulatory approval date, the shorter the length of the extension.
The application for extension must be made within six months of the latest of a) the date the patent was granted, b) the first regulatory approval date, or c) the date of commencement of section 71. (section 71).
The question of exactly what constitutes the first regulatory approval date is therefore of fundamental importance.
Lundbeck II
On 22 December 2003, Lundbeck applied for an extension of the term of its 1989 patent relating to the (S)-enantiomer of citalopram (escitalopram) and processes for preparation thereof (the "Lundbeck patent"). In its application for extension, Lundbeck represented that the first goods included on the ARTG containing or consisting of that pharmaceutical substance was its product escitalopram oxalate (brand name Lexapro), which was registered on 16 September 2003. On 27 May 2004, the Commissioner granted Lundbeck an extension of the term of that patent until 13 June 2014 on the basis of that application. No opposition was entered to the grant of the extension within the time provided by the Patent Regulations 1991 (Cth) ("Regulations").
Almost 14 months after the Commissioner granted this extension, Alphapharm informed the Commissioner that Cipramil, rather than Lexapro, was the first product included in the ARTG that contained or consisted of the (S)-enantiomer of citalopram. According to Alphapharm, Cipramil (citalopram hydrobromide), the racemic mixture comprised of both the (S)- and (R)- enantiomers of citalopram, was first registered on the ARTG almost six years prior to the registration of escitalopram oxalate.
Regulation 10.7(7) requires the Commissioner to amend the Register if she becomes aware that the first regulatory approval date in relation to the substance in question is earlier than the date of first regulatory approval supplied with the application for the extension of term.
Accordingly, the Commissioner notified Lundbeck of her intention to amend the Register to shorten the length of the extension by 18 months to 9 December 2012. Lundbeck commenced proceedings to prevent the Commissioner from amending the Register, contending, inter alia, that the regulation is invalid.
The Court noted that irrespective of whether the "first regulatory approval date" was that of Lexapro or that of Cipramil, the period from the date of the patent to the first regulatory approval date is a period of at least five years, and thus Lundbeck's application for extension of term satisfied section 70(3)(b).
Pursuant to section 71, the Court noted that if the date of first inclusion in the ARTG is the date of registration of Lexapro, then Lundbeck had until 16 March 2004 to file its application for an extension, and therefore its application made on 22 December 2003 was in time. However, if the date of first inclusion in the ARTG is the date of registration of Cipramil, then Lundbeck only had until 9 June 1998 to apply for an extension, and thus its 22 December 2003 application was out of time.[2] As Lundbeck filed its application on the basis of the first inclusion of Lexapro in the ARTG, its application appeared at the time it was filed to satisfy the requirements of s 71.
The Court then noted that the Commissioner must accept an application for extension if upon a formal checking of the information supplied by the patentee the requirements of sections 70 and 71 appear to be satisfied.
The Court then noted that whilst the Commissioner must grant an extension if sections 70 and 71 appear to be satisfied on the face of the application, and in the absence of opposition, she does not have to specify the term of the extension and the actual extension is not necessarily the period of time applied for. Due to the prima facie nature of the Register as evidence of the particulars of an extension, the legislative intention is that it should be correct and reliable.
As to Regulation 10.7(7), the Court held that that regulation was not invalid and that the Commissioner should be allowed to amend the Register so as to reflect the true extension of the term of the patent where the information currently on the Register does not do so.
The Court rejected Lundbeck's submission that by reason of entry into the Register, Lundbeck was indefeasibly entitled to the extension entered on the basis that an amendment to the Register would do no more than remove a false entry and enter the correct term as fixed by section 77:
"The true extension is that brought about by the operation of s 77. The register does not give an indefeasible title and is only prima facie evidence of any particulars registered in it: s 195(1). A patentee has no right to insist that the Register continue to record an extension greater than it truly is."
The Court also dismissed Lundbeck's argument that amending the Register to zero was contrary to section 76(1), noting that the possibility of the extension being zero was expressly envisaged by section 77.
Lundbeck I
In Lundbeck I, Alphapharm commenced proceedings against Lundbeck seeking revocation of six claims of the Lundbeck patent or an order that the Register be rectified to remove the extension of the term of the Lundbeck patent.
Alphapharm contends that Lundbeck obtained the extension of the Lundbeck patent by making a misrepresentation to the Commissioner as to what was the "first regulatory approval date" for the purpose of section 70. As discussed above, in Lundbeck II, the Commissioner argued that the effect of the incorrect entry in the Register is a requirement that she amend the Register to reflect the correct extension. By contrast, Alphapharm argues in Lundbeck I, that the consequences of Lundbeck's actions is that the extension was invalidly granted and that all references to it should be removed from the Register.
The Lundbeck I Court will also determine whether an extension granted on the basis of an application for an extension that appears to have been filed within six months of the first regulatory approval date, but which was in fact filed out of time, is invalid.
Lundbeck I and Lundbeck II are to be heard together in a 15 day hearing commencing on 27 November 2006.
Consequences
Lundbeck II establishes that a patentee has no proprietary right in the term of the patent term extension recorded on the Register. Rather, the Register merely provides prima facie evidence of what the extension is. If the Register is incorrect, then pursuant to Reg. 10.7(7), the Commissioner must correct it.
Lundbeck II presents one scenario where the need to rectify the Register may arise - where an extension was applied for and granted on the basis of the registration/listing of a particular product, when in fact a different product containing the same pharmaceutical substance was registered/listed earlier.
Such a need may also arise where an extension was applied for and granted on the basis of the registration of a particular product, when in fact that same product was listed on the ARTG prior to its registration. This issue arose in Pfizer Corp v Commissioner of Patents (No 2) (discussed here), in which the Federal Court addressed for the first time whether the listing of a pharmaceutical product on the ARTG constitutes a first regulatory approval date for the purposes of an application for a patent term extension.
[1] A third related proceeding is currently on foot. In Lundbeck Australia v Secretary of the Department of Health & Ageing of the Commonwealth ("Lundbeck III"), Lundbeck commenced proceedings against the Secretary of the Department of Health & Ageing of the Commonwealth seeking orders restraining the Secretary from using what it contends is "protected information" within the meaning of section 25A of the Therapeutic Goods Act 1989 (Cth) in considering an application by Alphapharm for registration of goods containing the (S)-enantiomer of citalopram.
[2] As discussed below, in Lundbeck I, Alphapharm seeks rectification of the Register by removal from it of any reference to the extension on the basis that Lundbeck's application was untimely.
Thanks to Dominic Carew who helped research this article.
For further information, please contact Mary Still.
