Posts Tagged ‘extension of term’

Alphapharm may have a big bill coming

Tuesday, November 18th, 2014

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].  ?

A patents case goes to the High Court

Thursday, June 12th, 2014

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 …

Thursday, May 2nd, 2013

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.  ?

Pharmaceutical Patents Review

Tuesday, April 2nd, 2013

The Commonwealth Government’s Pharmaceutical Patents Review has published a draft report.

The draft Report is some 200 or so pages long; contains 4 draft findings and 15 draft recommendations (although recommendation 5 relating to the extension of term regime proposes 2 different alternatives).

There appears to be considerable, fascinating data reported. The scope and detail of the draft report will plainly require much further consideration.

At the policy level, the draft report considers there has been a significant failure of co-ordination between the various regulatory bodies that deal with issues relating to pharmaceuticals and patent protections:

Draft recommendation 10.1: The Government should establish a non-statutory Pharmaceutical System Coordinating Committee (PSCC) that reports to Parliament on an annual basis on the success and effectiveness of the patent, marketing approval and PBS systems, particularly where these interface. The PSCC should ensure there is sufficient engagement and coordination between the relevant agencies and take account of costs to government, efficiency of registration and approval processes and respond to issues raised by industry. The PSCC should comprise senior officials from at least DIICCSRTE, IP Australia, DoHA (Pharmaceutical Benefits Division and TGA), DFAT, Finance and Treasury (as chair).

This appears to reflect a general concern with the need for greater policy and practical concern throughout the report. See e.g. draft recommendation 7.2 (calling for an external (to IP Australia) patent oversight committee) and draft recommendation 3.2.

Recommendation 6.1 proposes retaining extension of term just for pharmaceutical products and not extending it to methods of use or manufacture. The bipolar recommendations 5.1 and 5.2, however, explore different ways of prescribing the term of the extension.

Other topics addressed in the draft report include: the impact of international agreements on Australia’s welfare, evergreening and follow-on patents, data protection

Comments on the draft report are required to be submitted by 30 April 2013.

Access to affordable medicines or new review of pharmaceutical patents

Wednesday, October 17th, 2012

The Parliamentary Secretary for Industry and Innovation, Mark Dreyfus, has appointed a panel to review the patenting of pharmaceuticals in Australia.

According to the Terms of Reference, the review:

will evaluate whether the system for pharmaceutical patents is effectively balancing the objectives of securing timely access to competitively priced pharmaceuticals, fostering innovation and supporting employment in research and industry.

Central to this will be an analysis of the pharmaceutical extension of term provisions of the Patents Act 1990 (s.70).

The review will also consider whether there is evidence that the patent system is being used to extend pharmaceutical monopolies at the expense of new market entrants. In doing this, the review will consider how patents for new formulations are granted, consider the treatment of new methods of manufacturing and new uses of known products, the impact of contributory infringement provisions and the impacts of extending patent monopolies on entry of generic pharmaceuticals into the market.

The panel consists of 3 members:

  •  Mr Tony Harris, former NSW Auditor-General and Parliamentary Budget Officer, as Chair
  • Professor Dianne Nicol, Associate Dean, Research, of the University of Tasmania, and
  • Dr Nicholas Gruen, CEO of Lateral Economics.

A public consultation process will form part of the review which appears to include consultation with stakeholders and an opportunity for public submissions.

According to the press announcement, the panel is due to submit its final report by April 2013.

Of course, there is already a review of compulsory licensing under way following the BRCA controversy. I do not know if it is related to this review or not, but back in May, Senator Heffernan questioned the Director-General of IP Australia about what steps the Government may have been taking to recover payments under the Pharmaceutical Benefits Scheme to pharmaceutical companies for patents subsequently found invalid. The Senator alleged that the sums involved amounted to hundreds of millions of dollars. The Director-General referred the Senator to the Department of Health and Aging, which has responsibility for these matters.