In the long-running escitalopram patent battle, which has been fought all over the world, Australia’s highest court has affirmed the general remedial power of Australia’s extension of time provisions as they apply to extensions of patent term.

Australia’s general remedial provision and extension of patent term law

Australia’s Patents Act 1990 (the Act) includes a general remedial provision (under s 223) that allows applicants and patentees to extend the time for doing an act, where the applicant or patentee failed to do the act because of an error or omission on the part of the Patent Office or the applicant (or the applicant’s agent). The extension period is effectively unlimited provided there was always an intention to carry out the act and there was no undue delay once the applicant became aware of the error or omission.In Australia, the term of a patent covering a pharmaceutical substance can be extended by up to five years, provided that the application for the extension of term is made during the original term of the patent, and within six months of one of the following: grant of the patent, date of regulatory approval in Australia or the date of commencement of the relevant section (s 71)1. Regulation 22.11(4)(b)2 limits the operation of s 223 in relation to applications for extension of term.

The issue

The issue before the High Court in this case (Alphapharm Pty Ltd v H Lundbeck A-S [2014] HCA 42) was the extent of the limitations placed upon the operation of s 223 by reg 22.11(4)(b) – did the regulation relate only to applying for an extension of term after the original 20-year term had expired, or did it also apply to the six month window (from patent grant, regulatory approval or date of commencement)?

Background of the decision

In December 2003, Lundbeck made an application for an extension of term of its Australian patent covering escitalopram on the basis of the registration of its “Lexapro” product (containing the enantiomer escitalopram) on the Australian Register of Therapeutic Goods (ARTG). In July 2005, Alphapharm commenced proceedings against Lundbeck alleging, among other things, that the extension of term had been incorrectly founded. Alphapharm contended that the extension of the term of the patent should not have been based on Lexapro, but on Lundbeck’s earlier-registered product “Cipramil” (because it was a racemic mixture that contained escitalopram and therefore was, in accordance with the requirements of Australia’s extension of term provisions, the first inclusion in the ARTG of goods that contained the claimed active). The Full Federal Court found in favour of Alphapharm, and, on the day before the 20-year term of the patent was due to expire, Lundbeck filed an application for an extension of term of the patent based on Cipramil.However, because of the timing requirements set out in ss 71(2) of the Act, the six month window within which Lundbeck could lawfully have made the “correct” application for an extension of term (i.e. based on Cipramil) had by then closed. Lundbeck therefore sought to extend the six month window for filing an application for an extension of term – the length of the extension sought was nearly 10 years (going back to six months from the date of commencement of the section). There was no question that the application for extension of term was filed prior to expiry of the patent.  At the appeal, the merits of the applicant's basis for requesting an extension of time were not at issue.  The sole question was whether the exclusion to s 223 of reg 22.11(4)(b) applied to both the six month window and the date of patent expiry, or only to the date of patent expiry (our article on an earlier decision of the Administrative Appeals Tribunal in this case can be found here).

The decision

In a very close (3:2) decision, three justices of the High Court found in favour of Lundbeck, holding that while the prohibition does apply to the filing of the application for an extension of term after the original term of the patent has expired, it does not prohibit the use of the provision for extending the three other timing requirements set out in ss 71(2) (provided that the application for an extension of time is made within the original term of the patent). In essence, the justices “split” ss 71(2) into two “actions” or “relevant acts” – the first (which was filing the application within the term of the patent) was not extendable, while the second (which was filing the application within six months of one of the specified time periods, mentioned above) was extendable. The justices considered that this interpretation of the provision was consistent with the remedial nature of the extension of time provisions, with earlier versions of the extension of term provisions and with extrinsic materials (including the various policy debates on simplifying the extension of term provisions).In contrast, the two dissenting justices considered that “There is but one action referred to in s 71(2) – making an application for an extension of the term of a patent. That one action is to be done on a date that satisfies the two requirements as to time set out in s 71(2)”, and that this is the interpretation that is consistent with the policy that it is “necessary to minimise the period of uncertainty as to whether an application for extension of term would be made.”

Going forward

The Australian provisions in respect of extension of term were recently under review (see here and here for our related articles) and, while the review did not specifically consider the intersection of the extension of time provisions with the extension of term requirements, it will be interesting to see whether there will be any consideration of this decision if the review progresses.