A patents case goes to the High Court

The High Court has granted special leave to Alphapharm to appeal from the Full Federal Court’s decision to allow Lundbeck to apply to extend the term of its Lexapro patent 10 years late. The High Court was not interested at all in the exercise of the discretion to allow a 10 year extension. the question is whether a power to extend time exists at all.

The extension of term provisions for pharmaceutical patents are found in s 70 and s 71(2). Section 71(2) provides that:

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.

It was common ground that Lundbeck’s application was outside the latest of the possible dates.

However, the Patents Act also provides a power to grant extensions of time in s 223.

Lundbeck’s problem – if it turns out to be a problem – is that s 223(11) says that s 223 cannot be used to extend the time for doing “prescribed actions” and reg. 22.11 specifies as one of the prescribed actions:

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;

In the Federal Court,[1] Yates J at [50] found that Lundbeck’s “application” for an extension of time fell outside this because it really involved 2 requirements:

The making of an application under s 70(1) of the Act is governed by two time limits: the application must be made “during the term of the patent” and within six months of the applicable date in s 71(2)(a) to (c). Both time limits must be observed in order to make an application.

While the requirement that the application be made “during the term of the patent” was caught and so excluded by s 223(11), the second requirement – within 6 months of the applicable date – was not.

The High Court (Kiefel J and Keane J) have granted Alphapharm special leave to argue that, as a matter of construction, there was really only one application.

Lundbeck boldly tried to argue that special leave should not be granted because the issue raised no question of general importance: there not that many applications for an extension of time to apply for an extension of the term of a pharmaceutical patent. Kiefel J retorted sharply:

KIEFEL J: But the extension of a patent is itself an important matter, is it not?

MR NIALL: It is.

KIEFEL J: Very important.

It does raise an interesting question. The extended term expired back in December 2012. Alphapharm and others, however, had entered the market when the original term of the patent expired on 13 June 2009 and before Lundbeck’s application for an extension of time in which to file its application to extend the term had been finalised. Therefore, it would appear that the potential exposure of the generics companies to damages awards (or an account of profits) is up for grabs; i.e., another 3 years.

Alphapharm Pty Ltd v H Lundbeck A/S [2014] HCATrans 79

Lid dip: Opinions on High

Some other commentaries: here, here and here.


  1. Aspen Pharma Pty Ltd v H Lundbeck A/S [2013] FCAFC 129 (Jessup and Jagot JJ agreeing).  ?

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.