Alphapharm may have a big bill coming

The High Court has dismissed Alphapharm’s appeal from the Full Federal Court’s ruling granting Lundbeck an extension of time to apply to extend the term of the escitalopram patent. It was close though: 3 to 2.

You will recall that Lundbeck applied 10 years late to extend the term of its pharmaceutical patent. So, not only was Lundbeck applying to extend the term of its patent (under s70), it was applying for an extension of time in which to make that application. In granting special leave, the High Court accepted that, if the power were available, the circumstances justified the 10 year extension. The question was a matter of statutory interpretation: was there power to extend.

Section 71(2) specifies when an application to extend the term of a pharmaceutical patent must be made:

(2) An application for an extension of the term of a standard patent must be made during the term of the patent and within 6 months after the latest of the following dates:

(a) the date the patent was granted;

(b) the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, any of the pharmaceutical substances referred to in subsection 70(3);

(c) the date of commencement of this section.

Lundbeck’s application was made within the term of the standard patent (with 1 day to spare), but well outside the dates specified in paragraphs (a) – (c).

Section 223 confers a general power to extend the time for making an application. Under s 223(11), however, the power cannot be used to extend time in relation to “prescribed actions”.[1] One of those prescribed actions related to s 71(2):

(b) filing, during the term of a standard patent under subsection 71(2) of the Act, an application under subsection 70(1) of the Act for an extension of the term of the patent; ….

Crennan, Bell and Gageler JJ, after noting the long history in patents legislation of the power to apply for an extension of time, even after the time had expired, as an important safety valve in the system, ruled that s 71(2) specified 2 requirements. The first time requirement is that the application must be filed within the term of the standard patent. The second time requirement was that the application must also satisfy at least one of the requirements set out in paragraphs (a) – (c).

Crennan, Bell and Gageler JJ held, however, that reg. 22.11 applied only to the first requirement: that the application was made within the term of the standard patent. Their Honours considered this was important otherwise a “gap” could arise between when a patent expired but was then restored. That would be highly undesirable.[2] In contrast, there was no policy reason why reg. 22.11 should apply to the second time requirement. At [71]:

There is nothing in any of the extrinsic materials, or in the long policy debates on simplifying extensions of term, which would suggest any rationale for excluding the second time requirement from the remedial power to extend time under s 223(2)(a). Alphapharm’s senior counsel conceded, correctly, that if Alphapharm’s construction of reg 22.11(4)(b) were correct, the remedial power in s 223(2)(a) could never apply to extend time in relation to the second time requirement, no matter what the quality or provenance of any “error or omission” made in respect of that time. Alphapharm’s construction would introduce an inexplicable asymmetry between a patentee and a competitor opposing a s 70(1) application. An opponent can access the general remedial power to extend times cast upon it in mandatory terms[102]. Had it been the legislature’s intention to exclude the second time requirement in s 71(2) from the general remedial power in s 223(2)(a), that would have been simple to accomplish.

Accordingly, s 223 could be invoked as Lundbeck had satisfied the first time requirement (and so did not need it to be extended) but needed an extension in relation to the second time requirement – which reg.22.11 did not apply to.

In dissent, Kiefel and Keane JJ rather tersely said at [111]:

s 71(2) cannot reasonably be read as referring to two actions. There is but one action referred to in s 71(2) – making an application for 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). It is that action to which s 223(2) would apply, were it not for reg 22.11(4)(b).

Their Honours did explain why they considered policy and historical considerations did not lead to a different conclusion. Of potentially more general interest, however, their Honours took a different stand on the role of statutory interpretation at [121]:

In any event, as was said in Federal Commissioner of Taxation v Consolidated Media Holdings Ltd, legislative history and extrinsic materials cannot displace the meaning of statutory text; nor is their examination an end in itself. (footnote omitted)

While acknowledging the primary role of the text, Crennan, Bell and Gageler JJ invoked the more nuanced role of context espoused in CIC Insurance and Project Blue Sky.

A big bill coming? After the standard term of the patent expired but before the expiry of the extended term, Alphapharm and other generics commenced marketing their own versions of the drug.

Alphapharm Pty Ltd v H Lundbeck A/S [2014] HCA 42


  1. The “prescribed actions” are found in reg. 22.11.  ?
  2. See Crennan, Bell and Gageler JJ at [68].  ?

Oh won’t you stay …

The patent war over escitalopram in Australia is still going!

One aspect of the Alphapharm / Lundbeck case I had forgotten (if I appreciated it at the time) was that Lindgren J quashed the extension of the patent’s term under s 70ff.

In June 2009, after the Full Court upheld Lindgren J’s decision, Lundbeck made a new application for an extension of term and also applied under s 223 for an extension of time to make that application – an extension of some 10 years or so.

In June 2011, the Commissioner granted Lundbeck’s application for an extension of time over oppositions by Alphapharm, Aspen and others. The AAT dismissed an appeal Aspen et al. and Aspen et al. have appealed from the AAT’s decision to the Full Court. That appeal is still pending.

Pending the outcome of the appeal, Yates J has now refused Aspen et al. a stay on the Commissioner’s decision to extend the term of the patent.[1]

Accepting that it was not ordinarily desirable that there be parallel proceedings before both the Commissioner and the Court, Yates J considered it was not appropriate to exercise his discretion to stay the proceedings before the Commissioner in this case.

While a number of considerations were advanced by both sides, the central consideration was that Lundbeck could well lose the ability to sue for some infringements if it was successful in extending the term of its patent. The issue here is that under s 120(4) proceedings for infringement must be brought within 6 years of the infringing conduct. Aspen et al. were not able to point to any real prejudice outweighing that.[2]

It may be of interest to note that the point in common between the 2 sets of proceedings is Aspen _et al._’s contention that the Commissioner has no power to grant the extension of term now under s 70(4) as she has already exercised the power (albeit invalidly) in granting the extension quashed by Lindgren J.[3]

Aspen Pharma Pty Ltd v H Lundbeck A/S [2013] FCA 324

ps [4]


  1. The Commissioner must now decide whether an extension of term is in order and, if so, the extension of term will be advertised and Aspen _et al. have foreshadowed they intend opposing.  ?
  2. While the costs and disruption of unnecessary opposition proceedings were invoked, Yates J considered at [53] that such costs should not be substantial and, at [55], that they could “exert a real measure of restraint over the costs they will incur in the anticipated oppositions.”  ?
  3. See [40] – [43] of Yates J’s reasons.  ?
  4. I thought apologies were due to Jackson Browne, the soaring soprano and David Linley, but it seems Maurice Williams should also be in the picture.  ?

Patenting racemates and enantiomers

Lundbeck had a patent for citalopram for the treatment of depression, which it marketed in Australia under the name Cipramil

Citalopram is a chiral molecule: it can exist in two isomeric forms; a (+)-enantiomer and a (-)-enantiomer. The two forms have the same chemical structure, but they are mirror images. At its priority date, the relevant skilled addressees would have understood that the compound was a racemate or racemic mix consisting of both the (+)-enantiomer and the (-)-enantiomer.

Subsequently, Lundbeck discovered a way to make the (+)-enantiomer in isolated or pure form and, even better, it was this enantiomer that contributed the therapeutic effect of citalopram. It obtained a further patent, claim 1 of which was for:

1. (+)-1-(3-dimethylaminopropyl)-1-(4’-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile and non-toxic acid addition salts thereof.

The Full Federal Court by 2-1 (Bennett and Middleton JJ; Emmett J dissenting) has upheld the validity of this claim in the face of the prior patent for citalopram.

If resort could be made to the body of the specification, it was clear that the skilled addressees would have understood that claim was a claim to the enantiomer in its pure, isolated form and not to the product as part of a racemic mix.

Emmett J considered the claim was clear and unambiguous. Accordingly, there was no warrant to resort to the body of the specification.  Bennett and Middleton JJ, on the other hand, accepted that the trial judge was entitled to accept evidence about how the skilled addressee would have read the claim.  Bennett J approved the approach taken by Dr Barker, as delegate for the Commissioner, in Emory University v Biochem Pharma:

[152] …. He drew a distinction between a reading of the claim in the context of the specification to understand what the claim is talking about (as did Burchett J in International Business Machines Corporation v Commissioner of Patents [1991] FCA 625; (1991) 33 FCR 218), where the whole thrust of the specification makes a limitation clear, and impermissibly importing a limitation from “mere comments” in the description. ….

Her Honour further explained that the citalopram patent didn’t anticipate the claim:

193 The prior citalopram patent described the racemate. It did not describe the pure or isolated (+)-enantiomer. There is no anticipation unless the disclosure of the racemate was, to the skilled addressee, a disclosure of the (+)-enantiomer. As the primary judge pointed out at [171], the skilled but non-inventive addressee would have understood that (+/-)-citalopram consisted of the (+)-enantiomer and the (–)-enantiomer and would have been able to identify the formulae for the S and R enantiomers but would not have known in the absence of experimentation which was the (+)-enantiomer and which the (–)-enantiomer. As his Honour said, these facts would not point specifically to the independent existence of the enantiomers. They did not disclose an invention which, if performed, would necessarily infringe the Patent.
194 It is the case that the skilled addressee knew that the racemate could be resolved into the enantiomers but there was nothing to tell him or her to do so. Further, the prior citalopram patent was silent as to the means of obtaining the enantiomers and there were different methods available to try to do so. There were no clear and unmistakable directions to obtain the enantiomers. Some of the available methodology may have been successful, other methods may not.

193 The prior citalopram patent described the racemate. It did not describe the pure or isolated (+)-enantiomer. There is no anticipation unless the disclosure of the racemate was, to the skilled addressee, a disclosure of the (+)-enantiomer. As the primary judge pointed out at [171], the skilled but non-inventive addressee would have understood that (+/-)-citalopram consisted of the (+)-enantiomer and the (–)-enantiomer and would have been able to identify the formulae for the S and R enantiomers but would not have known in the absence of experimentation which was the (+)-enantiomer and which the (–)-enantiomer. As his Honour said, these facts would not point specifically to the independent existence of the enantiomers. They did not disclose an invention which, if performed, would necessarily infringe the Patent.

194 It is the case that the skilled addressee knew that the racemate could be resolved into the enantiomers but there was nothing to tell him or her to do so. Further, the prior citalopram patent was silent as to the means of obtaining the enantiomers and there were different methods available to try to do so. There were no clear and unmistakable directions to obtain the enantiomers. Some of the available methodology may have been successful, other methods may not.

That seems rather to qualify the force of the earlier point. One might even think, with respect, that it limits the patentable subject matter to some particular method of making the purified, isolated (+)-enantiomer, rather than the substance per se.

In contrast to this approach, however, Lundbeck lost its attempt to get the term of the second, escitalopram patent extended pursuant to s 70 of the Patents Act.

The problem for Lundbeck here was that s 70(2) referred to a patent for a pharmaceutical substance per se, but s 70(3) and (5) and s 71 did not. The Full Court found that s 70(2) operated to identify the subject matter of the extension application – the substance per se here being escitalopram.

Because the later sub-sections did not refer to the substance per se, when it came to working out the timing for making the application for an extension of term, the question was (in this case) the date when goods containing the substance (not the substance per se) were first included in the Australian Register of Therapeutic Goods.

Citalopram, of course, contained the (+)-enantiomer and it had been registered in the ARTG. It was first included in the ARTG on 29 December 1997. The application to extend the term of the escitalopram patent was made almost 6 years later – on 22 December 2003.

Section 71(2), however, required the extension application to be made within 6 months of the patent being granted or “the date of commencement of the first inclusion in the [ARTG] of goods that contain … the pharmaceutical substance referred to in s 70(3)” (i.e., within 6 months of the inclusion in the ARTG of citalopram).

The majority also found that claim 5 was invalid for insufficiency. However, Lundbeck did succeed insofar as Alphapharm was found to have infringed claims 1 and 3 of the escitalopram patent, presumably up to the date of expiry of the patent on 13 June 2009.