Patents

Alice corp

The Full Federal Court has reserved its decision in Research Affiliates’ appeal; the Commissioner’s appeal in RPL Central is still pending.[1]

In the USA, Alice Corp. had a patent for a computerised method of reducing “settlement risk”, a type of escrow arrangement: the 10 judges in the Federal Circuit Court of Appeals came up with 5 different opinions of which Justice Newman memorably said:

[The 5 judgments have] propounded at least three incompatible standards, devoid of consensus, serving simply to add to the unreliability and cost of the system of patents as an incentive for innovation. With today’s judicial deadlock, the only assurance is that any successful innovation is likely to be challenged in opportunistic litigation, whose result will depend on the random selection of the panel.

Now, the US Supreme Court has agreed to try to sort it out.

ALICE CORPORATION PTY. LTD. V. CLS BANK INTERNATIONAL, ET AL., Docket No. 13–298 (Supreme Court 2013) via Patently-O


  1. The Full Court has also reserved in Cancer Voices re isolated DNA (although one might think there’s little scope for that to get up after Apotex v Sanofi.  ?

Alice corp Read More »

Patenting computer programs or business methods in Australia

At the end of August, Middleton J overturned the Commissioner’s refusal to grant an innovation patent for RPL’s computerised method entitled ‘Method and System for Automated Collection of Evidence of Skills and Knowledge’. Instead, his Honour held that the method was a manner of manufacture and, novelty and inventive step having been satisfied, patentable.

What the claimed invention was

In essence, the claimed invention allowed a user to access a single point of entry (for example, over the internet using his or her browser), retrieve information about particular qualifications, which was presented in the form of questions to the user, then provide answers and supporting documentation (still for example over the internet), which was then processed by a relevant certifying institution and, if the relevant criteria were satisfied, the relevant qualification would be awarded or, if not, the user could be presented with information about what further steps needed to be undertaken to satisfy the necessary criteria.[1]

This bald summary hardly does justice to what was involved. For example, there are a large number of registered training organisations or TAFEs (RTOs). Collectively, they offer some 3,500 different qualifications and some 34,000 Units of Competency. Any individual RTO therefore offered only a very small set of qualifications or units. RPL’s method, first, circumvented the need for an individual user to identify which RTO was appropriate as RPL’s method retrieved all the necessary information from online databases. Then, RPL’s method converted the criteria into a form of questions which the user could answer. So, to take an example from the judgment, the element of competency required for a particular unit relating to aged care:

demonstrate an understanding of the structure and profile of the aged care sector

became:

Generally speaking and based upon your prior experience and education, how do you feel you can demonstrate an understanding of the structure and profile of the aged care sector?

and a particular performance criterion associated with that:

all work reflects an understanding of the key issues facing older people and their carers

was converted in RPL’s method to:

How can you show evidence that all work reflects an understanding of the key issues facing older people and their carers?[2]

for enabling individuals to get their competency or qualifications recognised under the nationally accredited Unit of Competency scheme.

The specification identified the advantages flowing from this method with its single point of contact:[3]

Individuals are provided with a service which simplifies the identification of relevant Units of Competency, and the gathering of associated assessment information to enable [recognition of prior learning] to be performed. Training organisations are relieved of much of the administrative cost associated with performing [recognition of prior learning]. By the time the training organisation is contacted, the relevant Unit of Competency has already been identified, and required information associated with each of the assessable criteria has already been gathered and packaged in a form enabling an efficient assessment in relation to the [recognition of prior learning] process.

Why this constituted a (patentable) manner of manufacture

Middleton J noted at [127] that the test for “manner of manufacture” laid down in NRDC, CCOM and Grant required that the claimed invention result in an artificially created state of affairs in which a new and useful effect may be observed. This had to be of utility in practical affairs or be of an industrial, commercial or trading character and belong to the useful arts, not the fine arts, so that its value lay in a field of economic endeavour.

These criteria were satisfied. The results of the method were useful because at [129] it overcame difficulties involved in seeking out education providers and enabled recognition of prior learning. This was relevant to a field of economic endeavour: the education sector of the economy and thus had the necessary industrial, commercial or trading character.

While the information about RTOs and particular Units of Competency could be accessed individually in undifferentiated form over the internet, the method provided a single point of entry. In addition to the single point of entry:

[141] The computer programmed in accordance with the Patent further operates to process the retrieved information and to automatically generate data comprising an alternate means of presentation. This alternate means comprises a series of questions which can be presented to an individual user along with user interface elements which implement an online form suitable for the receipt of responses to those questions. An assessment server is programmed, again according to the teaching of the Patent, to present the form to the computer of an individual user, who preferably requires only conventional web browser software to access the assessment server via the internet. In particular, the form provides not only for user-entered responses, but also for upload of one or more files stored on the user’s computer which may comprise, for example, evidence of the user’s competency with regard to the recognised qualification standard. This access to an online form occurs as a result of the retrieval, processing and presentation steps being conducted according to the teaching of the Patent.

The various stages in this process each gave rise to the physical effect required under Grant in the various changes of state in the computer’s memory.[4] Grant itself of course involved no such transformation since it did not involve any use of any computer – just a scheme for the use of a trust.

The Commissioner had recognised that such a transformation did take place, but it was not sufficient. In a line of decisions beginning with Invention Pathways, the Commissioner had ruled that: [5]

the “concrete effect or phenomenon or manifestation or transformation” referred to must be one that is significant both in that it is concrete but also that it is central to the purpose or operation of the claimed process or otherwise arises from the combination of steps of the method in a substantial way. Consequently while the step of building a house involves a concrete physical effect it is peripheral to the method of acquiring a house and indeed could hardly be said to characterise the subject matter of the method such that it is considered an artificially created state of affairs. I consider the same to apply to a business scheme implemented in some part by computer and do not believe the patentability of such a method can arise solely from the fact that, in a general sense, it is implemented in or with the assistance of a computer or utilises some part a computer or other physical device in a incidental way.”

The Commissioner argued that the use of the computer here was not central to the method, being merely a “common mechanism to carry out the method in a convenient way.”

At [147], Middleton J rejected the Commissioner’s view that NRDC, CCOM and Grant required the requirement of substantiality or centrality of a physical effect in the sense the Commissioner contended for.

In addition, Middleton J rejected the Commissioner’s argument that the claimed invention could not be a manner of manufacture as it could be performed without the use of a computer. His Honour rejected this as a matter of principle at [157]: it was not an appropriate way to approach the assessment required under NRDC, CCOM and Grant. In any event, as a matter of fact, the magnitude of the task meant it wasn’t practicable without the use of a computer:

[158] … as a matter of fact I accept that the magnitude of the task performed by the invention (as previously described) and the express terms of the claims themselves mean that the computer is an essential part of the invention claimed, as it enables the method to be performed.

While his Honour accepted that US cases could be persuasive, he noted he was required to apply the tests developed under Australian law and did not find any assistance in the present context.[6]

At [171] – [172], Middleton J distinguished the recent rejection by Emmett J of Research Affiliates claims for a method of generating an index of securities and assets. In Middleton J’s view the central difference was that the specification in Research Affiliates “contained virtually no substantive detail about how the claimed method was to be implemented by a computer”.[7] In contrast, there was detailed information about these matters in RPL’s specification and the computer was central to the method’s working.

RPL Central Pty Ltd v Commissioner of Patents [2013] FCA 871


  1. The terms of claim 1 are set out here.  ?
  2. Taken from [21] and [24] of the Reasons.  ?
  3. At [42] of the Reasons.  ?
  4. At [143] – [144].  ?
  5. Myall at [53].  ?
  6. While his Honour did not put it this way, that is perhaps unsurprising given the rather uncertain state of the US case law, e.g.  here and here.  ?
  7. An application for leave to appeal from Emmett J’s decision has been filed: NSD328/2013.  ?

Patenting computer programs or business methods in Australia Read More »

Dosing up children, overturning interlocutory injunctions and the balance of convenience

An IPwars first: my colleague, Susan Gatford, provies an update in which a Full Court overturned an interlocutory injunction against an alleged patent infringement. Do you agree with Sue that a trend seems to be developing?

Remember way back at the start of the Apple v Samsung litigation the Full Court dissolved the interlocutory injunction granted to Apple? Well, they did it again earlier this month in GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser Healthcare (UK) Limited.

The proceeding concerns an invention for accurately serving up doses of liquid medicines for children. Apparently children don’t like taking medicine from syringes with nozzles because they remind them of bad things (injections). But syringes are the most accurate way to measure doses of medicine accurately. Solution: design a syringe that doesn’t quite look like one. The syringe in the patent looked like this

Patented embodiment
Patented embodiment

It was designed by Reckitt and called a flat nosed syringe (i.e. one without a nozzle). It fits into a plastic attachment inserted into the neck of a medicine bottle. The syringe fits tightly into the neck attachment and allows accurate dosages to be measured and then administered. Reckitt has patented its bottle-syringe-bottle neck arrangement. It uses it to sell nurofen for children. This has apparently given their nurofen product a substantial competitive advantage over Glaxo’s panadol (the medicines are largely interchangeable and parents chose the one that is easiest to use in terms of dose measurement and child acceptance).

Interestingly, despite being aware of and seeking to emulate the Reckitt product, Glaxo didn’t do any patent searches. It seems that this was because it was told by the third party manufacturers of the syringe and of the bottle and neck attachment that they as manufacturers held all of the relevant patents.[1] (They were wrong.)

Two injunctions were granted. On 28 May 2013 a Glaxo product that substantially replicated the Reckitt product was injuncted.[2] According to the Court’s reasons Reckitt’s only complaint was the similarity of the bottle neck liner.[3] This wasn’t, however, only what the patent claimed as its invention (remember, the aim was to design a syringe that didn’t look like one).

Version 1
Version 1

Glaxo then re-designed the shape of the syringe and advised Reckitt that it intended to sell their panadol with the offending bottle neck liner but with a different syringe. The re-designed syringe looked like this

Version 2
Version 2

Reckitt went back to Court to argue that this fell within claim 1 of the patent, which relevantly read:

A liquid dispensing apparatus comprising a bottle, a bottle neck liner and a flat-nosed syringe having a plunger and a barrel, the barrel terminating at its distal end in a generally flat face having a diameter corresponding to the diameter of the syringe and being perpendicular to the longitudinal access of the barrel….

The trial judge held that there was a sufficiently strong argument that the words

“having a diameter corresponding to the diameter of the syringe barrel and being perpendicular to the longitudinal access of the barrel”

would be understood by an addressee skilled in the art at the time of the patent to apply to the distal end of the barrel.[4] Accordingly, his Honour held that Reckitt had a sufficiently strong prima facie case that warranted the grant of an injunction. His Honour rejected Glaxo’s application to lead further evidence as to the balance of convenience and made orders restraining the sale of the re-designed product. Glaxo appealed.

It argued that the trial judge’s interpretation required the additional words “at its distal end” to be added to the above extract, and that this was impermissible. The Full Court agreed. Put simply, its view of the strength of Reckitt’s infringement case on the design-around syringe was substantially lower than that of the trial judge. It also said that the trial judge erred procedurally by forcing Glaxo to rely only on its balance of convenience evidence from the May hearing, and by rejecting the further balance of convenience evidence on which it sought to rely in July. At the May hearing the trial judge had rejected Glaxo’s evidence as to balance of convenience in strong terms and made findings in accordance with of evidence filed by Reckitt in reply to it. The Full Court said

It was, of course, a matter for the primary judge to make findings of fact based on the evidence before him. But having made strong findings of fact, which were directly contrary to Ms Tomkins’ first affidavit, in the context of assessing the balance of convenience at the first hearing, it is difficult to understand why GSK should be prevented at the second hearing from relying upon additional evidence from Ms Tomkins in the form of her second affidavit which expanded upon the reasons why the primary judge’s suggested option was impracticable and posed public health and safety risks (see further below). All the more so in circumstances where the second hearing took place more than six weeks after the first hearing and related to an allegation of patent infringement in respect of a different apparatus. These considerations are not displaced or diminished by s 37M of the FCA Act.

The case is a timely reminder that:-
1. leave to appeal against interlocutory orders in patent and like cases is a serious option;
2. applications relating to “design around” products need to be considered both substantively and procedurally as the separate applications that they are in fact; and
3. it is worth paying very careful attention to balance of convenience evidence, which is often a moving feast, and doing your best to make sure that the Court does too. Referring the Court to this case might just help in that endeavour.

GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser Healthcare (UK) Limited [2013] FCAFC 102

Susan Gatford is barrister on Gordon & Jackson’s list at the Victorian Bar. She practices out of Owen Dixon Chambers in Melbourne and is also a registered trade mark attorney.


  1. Reckitt Benckiser Healthcare (UK) Ltd v GlaxoSmithKline Australia Pty Ltd [2013] FCA 583 (Reckitt (No.1)) at [36].  ?
  2. Reckitt (No.1).  ?
  3. Reckitt (No.1) at [37].  ?
  4. Reckitt Benckiser Healthcare (UK) Ltd v GlaxoSmithKline Australia Pty Ltd (No 2) [2013] FCA 736 at [20].  ?

Dosing up children, overturning interlocutory injunctions and the balance of convenience Read More »

Innovation Patents: what to do?

ACIP has released an options paper on what to do about the innovation patent system.

An innovation patent is a uniquely Australian contribution towards encouraging innovation. You can get one (if you apply for it) for pretty much anything[1] unless it differs from the prior art only in ways that “make no substantial contribution to the working of the [ahem] invention” as explained by the Full Court in the Delnorth case.

As recounted in the options paper, the basic objective of the innovation patent system is to encourage and promote investment in innovation by Australian (especially) SMEs.

The options paper is full of interesting statistics and there is an accompanying economics paper, the Verve report attempting to get some empirical data. For example, only about 25% of innovation patents ever get certified. Also, more than 50% of innovation patents are allowed to lapse by the end of their third year. The proportion of innovation patents granted to foreigners is 35% and rising.

Insofar as the options paper takes a position, it would seem that there is pretty much universal agreement that the level of innovation required to get an innovation patent is too low.

The options paper also appears to discern evidence that innovation patents are being used “strategically” or “tactically”, at least by some applicants.

ACIP is now seeking your views on what to do.

ACIP itself identifies 3 broad options:

(1) do nothing (option A);

(2) abolish the innovation patent system (option B); or

(3) change the innovation patent system (option C).

Option A: do nothing

ACIP notes that it is too soon to tell how the Raising the Bar reforms will affect those seeking innovation patents. Those changes do nothing, of course, to the level of “innovative step”.

The Verve report received 517 responses to its survey of the 3,195 Australian inventors who have taken out innovation patents to protect their “inventions”. Bearing in mind that these are the people that the innovation patent system is supposed to be encouraging, ACIP notes:

The Verve survey has shown that individuals and SME user-groups appear to be generally satisfied with the innovation patent system—albeit this survey occurring prior to the full impacts of the Raising the Bar Act being felt by users of the system.

The biggest problem with this do nothing option, however, is that it doesn’t do anything to address the apparently widely recognised issue that the innovation threshold is too low.

As ACIP notes, letting people get an innovation patent in Australia for something which is not patentable anywhere else does nothing to encourage Australian businesses to compete overseas. It should also be borne in mind that an innovation patent over something will probably have the effect of meaning its price will be higher than it would otherwise have been.

Option B: abolish the innovation patent system

There is a nice catalogue of what one might think were compelling reasons why this is a good option. There is also a summary of arguments against it.

This (or a variation on it) is widely perceived to be the option proposed late last year by IP Australia. The options paper indicates that the majority of non-confidential submissions to IP Australia and to ACIP didn’t support IP Australia’s proposal.

The options paper also includes a curious page suggesting that the designs registration system could be amended to permit the registration of functional designs. I (perhaps mistakenly) had thought the Franki Committee’s recommendations were implemented by the Designs Amendment Act 1981 s 11 (inserting new s 18) and s 5 (inserting a new definition of ‘design’) and find their current embodiment in s 7(2) of the Designs Act 2003. The “problem”, if it be a problem, with designs registration is that it protects only the visual appearance of a product, not its function. The new Act doesn’t seem to be any different in that respect to the old Act and it was plainly a deliberate policy choice.[2]

Option C: change the innovation patent system

The problem here, at least insofar as the level of innovation is concerned, is what should that new level be and how on earth would the Courts ever work it out. ACIP plainly didn’t like the suggestions of the Law Council, IPTA or FICPI on this front.

The options paper also raises for further consideration changing or limiting the remedies: no injunction or no interlocutory injunctions, but continued exposure to pay damages or account for profits; limiting the ability to recover pecuniary remedies to the period after certification. Oh dear!

ACIP would like to hear your views by 4 October 2013. It is also planning to hold workshops for public consultation during September.

Options Paper here (pdf)

Verve report here


  1. Patents Act 1990 s 18(2) and (3) exclude some things from patentable subject matter and, apart from the level of innovation prescribed in s 7(4), there are a few other largely technical requirements to satisfy too.  ?
  2. See e.g. recommendations 24, 25 and 26 of the ALRC’s Designs report. Of course, the limitation of the designs registration system to visual appearance only seemed to be one of the main complaints about the system identified by the ALRC: see e.g. 2.44 of the ALRC’s report and 3.49 and 6.5.  ?

Innovation Patents: what to do? Read More »

Patent trolls

are in the news.

The This American Life podcast did a fascinating exposé on Intellectual Ventures, including that good old Current Affair/Today Tonight ambush attempt.

But seriously:

According to the website:

Two years ago, we did a program about a mysterious business in Texas that threatens companies with lawsuits for violating its patents. But the world of patent lawsuits is so secretive, there were basic questions we could not answer. Now we can. And we get a glimpse why people say our patent system may be discouraging, not encouraging, innovation.

There’s a fascinating visit (for those of us that don’t get to go there) to the Eastern District of Texas.

Even more interesting, despite the patent searcher’s report that there were more than 5,000 patents pending at the time the “poster patent” under investigation was filed, the invalidity argument that got up was the entitlement issue.

Wonder what would happen under our new rules if the true inventors came along to  join in with the patentee?

Download or listen from itunes or  the website

Lid dip: Andrew Woods

p.s. Patentology wonders if a patent “troll” lurks in a sunburnt country

Patent trolls Read More »

Another designs case

Well, a patents and designs case, but really it’s a case about entitlement: Kenny J has upheld the validity of patents and registered designs for “beer taps” which one company in the Fosters group – Foster’s Group Ltd – applied for “most likely [by] mistake”[1] as one of its subsidiaries, Fosters Australia, was the owner.

Fosters Australia commissioned another party to design some new beer taps for it, on terms that it would own the resulting IP.

When the applicatins for the patents and designs were filed, however, they were filed in the name of Fosters Group Ltd, Fosters Australia’s parent and the holding company of the group.

When the mistake was discovered, Fosters Group assigned everything to Fosters Australia. By then, however, the designs had been registered in Fosters Group’s name, although innovation patent applications were still pending.

Fosters Australia has sued Cash’s for infringing its patents and designs. Cash’s defences asserted invalidity on the basis, amongst other things, that Fosters Group was not an entitled person or the grant was obtained by fraud, false suggestion or misrepresentation.[2]

Kenny J rejected the attack on the patents on the basis that s 29 did not require an applicant for the patent to be the entitled person or someone claiming through him or her; it was necessary only that the patent was granted to someone who qualified under s 15. Kenny J further held that Fosters Group could assign the benefit of its applications to Fosters Australia.

Similar reasoning would apply to the designs s 21 and s 13, but the designs were already registered before Fosters Group assigned its rights to Fosters Australia. However, Kenny J found in circumstances that Fosters Group held the applications and registrations on constructive trust for Fosters Australia.

Patentology makes the point that, while all’s well that ends well, care needs to be taken in deciding who should make the application before it is filed.

Foster’s Australia Limited v Cash’s (Australia) Pty Ltd [2013] FCA 527


  1. [2013] FCA 527 at [127].  ?
  2. Patents Act 1990 s 138(3) and Designs Act 2003 s 93(3).  ?

Another designs case Read More »

Compulsory Licensing of Patents – Productivity Commission

The Productivity Commission’s report on Compulsory Licensing of Patents has been published.

One key recommendation is to replace the compulsory licence provisions in the s 133 of the Patents Act with a compulsory licence regime in the Competition and Consumer Act:

The Australian Government should seek to remove s. 133(2)(b) from the Patents Act 1990 (Cwlth), so that a compulsory licence order based on restrictive trade practices of the patent holder is only available under the Competition and Consumer Act 2010 (Cwlth). The remedy provisions in the Competition and Consumer Act should be amended to explicitly recognise compulsory licence orders to exploit a patented invention as a remedy under the Act.

The Productivity Commission also recommends that the “reasonable requirements of the public” test in s 135 of the Patents Act be replaced with a “public interest” test:

The Australian Government should seek to amend the Patents Act 1990 (Cwlth) to replace the ‘reasonable requirements of the public’ test for a compulsory licence with a new public interest test. The new test should specify that a compulsory licence to exploit the patented invention would be available if the following conditions are met:

  • Australian demand for a product or service is not being met on reasonable terms, and access to the patented invention is essential for meeting this demand.
  • The applicant has tried for a reasonable period, but without success, to obtain access from the patentee on reasonable terms and conditions.
  • There is a substantial public interest in providing access to the applicant, having regard to:
    • –  benefits to the community from meeting the relevant unmet demand
    • –  commercial costs and benefits to the patent holder and licensee from

      granting access to the patented invention

    • –  other impacts on community wellbeing, including those resulting from greater competition and from the overall effect on innovation.

Section 136 should be repealed and future Treaty obligations should be incorporated into the Patents Act directly.

The Productivity Commission would also like to see s 51(3) of the CC Act repealed:

but any changes to s.51(3) will need to be based on a consideration of the implications for all types of intellectual property, including those beyond this inquiry’s terms of reference.

Further recommendations relate to Crown Use,which appear to have been largely adopted already in the Intellectual Property Laws Amendment Bill 2013.

Download Full Report, or interesting chapters, here.

Compulsory Licensing of Patents – Productivity Commission Read More »

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.  ?

Oh won’t you stay … Read More »

Did the Earth move for you too?

Most of the substantive Raising the Bar amendments came into force today.

Amongst other things, schedule 1 of the Raising the Bar Act introduced a raft of changes designed to raise the threshold of patentability – i.e., make it harder to get a patent.

These include:

  • introducing the really diligent searcher of prior art for obviousness via changes to s 7(3)[1] so that it will be permissible to combine any piece of prior art with common general knowledge (if the skilled addressee could reasonably be expected to combine the two), not just those elements of the prior art that the skilled addressee could be reasonably expected to have found;
  • a new concept of utility based on the US approach; and
  • doing away with the ’old’[2] fair basis requirement in s 40 as interpreted by the High Court in that Lockwood ruling.

Instead of fair basing, a patent will be required by s 40(2) to disclose:

(a) the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the relevant art; and

(aa) the best method known to the applicant of performing the invention; and …

and s 40(3) will read:[3]

“The claim or claims must be clear and succinct and [fairly based on the matter described] supported by matter disclosed in the specification.”

Provisional specifications will have to meet the requirements set out above in s 40(2)(a) also.

This is intended to introduce into Australian law the requirements under the UK’s 1977 Act: s 72(1)(c).

The Court of Appeal[4] provides an interesting example of how these new rules should work in it Merial ruling. Merial had (at least) 2 patents relating to its Frontline brand of flea-treatment products. One of these, the 881 patent survived the attack on sufficiency of description, but the other, the 564 patent did not.

Kitchin LJ identified the crucial difference between the 2 patents at [85] – [86]:

…. This was a matter to which the judge expressly referred at [77]:

”77. In contrast to the examples in 881, the examples of 564 simply specify different concentrations of the active ingredients. The examples do not contain any formulation details beyond saying that there should be present a crystallisation inhibitor, an organic solvent and an organic co-solvent.”

This then was the critical difference between the disclosures of the two patents. Omnipharm failed to establish that the practical guidance given by the examples of the 881 patent was not sufficient to enable the skilled team to work across the breadth of the claims. But the 564 patent claimed a combination of actives and did so without any worked examples at all. It provided no real practical assistance over and above the common general knowledge.

Kitchin LJ accepted Merial’s argument that the UK Act did not impose an obligation to include examples of the way the claimed invention worked. However, his Lordship considered that was not why the trial judge, Floyd J, upheld the attack. Rather, the description was insufficient because it did not give sufficient guidance about which ingredients to choose and in what proportions. So, Kitchin LJ explained at [89]:

I reject these submissions. I think it is clear from [151] – [152] that the judge did not find that the absence of any detailed examples was, in itself, fatal to the sufficiency of the 564 patent. What rendered it insufficient, in his view, was the absence of proper exemplification of a formulation of the invention in the context of a specification which was generally inadequate to guide the skilled person to success and provided no real practical assistance beyond the teaching of the prior art and the common general knowledge. The specification contains no more than a very broad indication of the components of the formulation and, as the judge found, it is not a sufficient description to enable the skilled person to arrive at formulations across the breadth of the claims without undue effort.

One illustration of the problem with the 564 patent was set out earlier at [83]:

The disclosure in relation to solvents and co-solvents is something the judge also had well in mind, as is clear from [66]-[67]. Here he referred to the dielectric constant ranges which the solvent and co-solvent must meet, and that the co-solvent must have a boiling point below 100°C. He also referred to the lists of suitable solvents and co-solvents. This information would not, however, be of any practical use to the formulator who, as Dr Walters explained, would have to fall back on his general knowledge of solvents and techniques for enhancing spreading and skin penetration in order to decide on the appropriate solvent system to use.

Neither the Court of Appeal nor Floyd J at first instance set out at length the legal principles underlying insufficiency for these purposes. However, Floyd J had earlier set out his understanding of ‘classical insufficiency’, Biogen insufficiency and ‘insufficiency through ambiguity’ at [361] – [454] in Zipher.

Omnipharm Ltd v Merial [2013] EWCA Civ 2 via IPKat

ps.: those who attended David Brennan’s talk last year will find his ‘Monash paper’ in 38(1) Monash University Law Review 78.


  1. Austlii doesn’t seem to have caught up with all the minutiae yet.  ?
  2. The ‘old’ rules will continue to apply for all standard patents granted before 15 April and any pending applications for which a request for examination had been made before 15 April. (This the pre–15 April 2013 version of s 40 will break when the new rules come in.)  ?
  3. where the words in between [ and ] are deleted by the new Act  ?
  4. For England and Wales (of course).  ?

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Pharmaceutical Patents Review

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.

Pharmaceutical Patents Review Read More »