Rokt take 2

As noted last week, the Full Court has allowed the Commissioner’s appeal and ruled that Rokt’s patent application for a digital advertising method is in fact an unpatentable scheme. Disagreeing with the trial Judge, the Full Court considered the case was no different to Encompass and just involved a scheme using the well-known and understood functions of computer technology.

Perhaps, the point of general application arising from this decision (barring a successful application to the High Court for special leave) is the very limited role for evidence in assessing whether a claim is a claim to a manner of manufacture for the purposes of s 18(1)(a).

The claim

Claim 1 is involved and was characterised by the Court as involving 12 integers:

(1) A computer implemented method for linking a computer user to an advertising message by way of an intermediate engagement offer which is operable to drive a higher level of engagement with the advertising message than if the advertising message was presented without the offer, the method comprising:

(2) providing computer program code to be delivered with publisher content to a computing device operated by the computer user and which computing device comprises an interface arranged to display the publisher content, the computer program code operable to be implemented by a processor of the computing device to perform the additional steps of:

(3) gathering engagement data associated with the user, the engagement data derived from interactions made by the user with the interface and related to at least one of the following:

an attribute of the publisher content;

an interaction with the publisher content by the computer user; and

an attribute of the user;

(4) communicating the engagement data as it is gathered to a remote advertising system implementing an engagement engine, the engagement engine operable to:

(5) continuously evaluate the engagement data to determine whether a predefined engagement trigger has occurred, the predefined engagement trigger being representative of a user response or action that is contextually relevant for presentation of the engagement offer;

(6) responsive to determining that the predefined engagement trigger has occurred, selecting an engagement offer from a pool of different engagement offers stored by the remote advertising system that is relevant to the evaluated engagement data and wherein,

(7) where multiple engagement offers are deemed to be relevant, the engagement engine implements a ranking algorithm operable to dynamically rank the relevant engagement offers based on at least one of: > >(a) an engagement score determined from one or [more] performance metrics recorded from past user interactions with the corresponding engagement offers; > >(b) a revenue score determined from one or more revenue metrics recorded from past user interactions with the corresponding engagement offers, and

wherein the engagement engine selects which engagement offer to present based [on] the rankings;

(8) causing the interface to insert the selected engagement offer into the publisher content for displaying to the computer user;

(9) implementing the computer program code to determine an acceptance of the engagement offer by the computer user based on a user interaction with the engagement offer; and

(10) following the determined acceptance, presenting an advertising message comprising one or more advertisements selected from a pool of different advertisements on the interface and

(11) wherein user interactions with each of the presented advertisements are gathered by the widget script and communicated to the remote advertising system for use in selecting subsequent advertisements, and

(12) whereby the selection of [sic] engagement offer is additionally made such that there is no direct advertising benefit to the subsequent advertisers of the selected advertisements through presentation of the selected engagement offer to the computer user other than encouraging positive engagement by the user with the advertising system prior to presentation of the advertising message.

According to Rokt, one of the particularly clever, if not the clever, insight in this combination was the “engagement offer”. As the specification explained:

Through extensive testing, it has been found that initiating engagement with the advertisement system 10 by way of an engagement offer results in a more positive and deeper engagement with advertisements subsequently presented to the consumer (i.e. during the engagement journey) than if those advertisements were presented in the traditional search or display based manner, as described in the preamble. In turn, the consumer is more likely to continue to engage with the advertisement system 10, thus creating a sustainable advertising revenue module which is of benefit to each of the advertisement system 10, publishers 12 and advertisers 14.[1]

The Full Court explained that engagement offers could take any of numerous forms “including coupons, discounts, vouchers, scratch and win prizes, surveys and polls, competitions, video images, free games and the like.” Or, as their Honours summed up, “click bait”.

The trial judge

Based on the expert of evidence of Professor Verspoor, the trial judge had allowed Rokt’s appeal from the Commissioner’s rejection of the application on the basis that the claims were not directed to a “manner of manufacture”.

Given the Full Court’s ruling it is worth noting what Professor Verspoor had been asked to do. Professor Verspoor had given evidence directed to four questions:

(1) What is the “substance” of the invention? In other words, what specifically lies at the heart of the invention?

(2) Does the invention solve a technical problem?

(3) Is the use of a computer (or computers) integral to carrying out the invention, or could the invention be carried out in the absence of a computer (or computers)?

(4) Does the invention involves [sic] steps that are foreign to the normal use of computers (as at December 2012)?[2]

Based on Professor Verspoor’s evidence in answer to these questions, the trial judge had found that the introduction of the intermediate “engagement offer” to provide an alternative advertising technique was the key feature of the claimed invention.

The Commissioner argued that the method was merely an unpatentable scheme to solve a business problem. The trial judge held, however, that the claim solved both a business problem and a technical problem. At [205], his Honour said:

The invention solved not only a business problem but also a technical problem. As to the latter, it provided a single platform in which user engagement data could be coupled with transactional data and user context data to provide a personalised ranking of engagement offers to the user. This technical problem of providing this single platform was solved by introducing the tracking database and the objects database and designing the ranking engine and the engagement engine which accessed and manipulated the data in the two databases to rank and select engagement offers. The ranking engine optimised the personalised output for the consumer. Critically, the ranking engine implemented a ranking algorithm which ranked the retrieved object by a combination of an engagement score and revenue score. I also accept the evidence Professor Verspoor gave, which is summarised at [46]-[54], [104]-[107], [134]-[135] and [145] above.

and at [207]:

I find that there was a business problem of attracting the attention of the user and having the user choose to interact with the advertiser, but this problem was translated into the technical problem of how to utilise computer technology to address the business problem. The invention aimed to solve this technical problem through the introduction of the engagement offer and identifying what steps the software needed to execute in order to modify dynamically the website that the user was browsing while they were browsing it to, first, implement in the web browser or device the concept of the engagement offer, second, to implement in the computer system the necessary software for selecting engagement offers and advertisements for the given user based on the previous interactions with the system and the interactions of other similar users and, third, to have that system interact with the widget in the web browser in real time.

Accordingly, his Honour found at [208] that the use of the computers was integral, rather than incidental, to the invention and so qualified as patentable subject matter.

The Full Court

As already noted, the Full Court allowed the Commissioner’s appeal from the trial judge’s decision. Rokt’s invention is not a manner of manufacture and so not a patentable invention.

Before the trial judge, the parties had advanced a substantial body of expert evidence, leading the trial judge to characterise the problem before him “as one that lay in the realm of fact”.

According to the Full Court at [72], that was wrong.

Whether a claim is directed to a manner of manufacture is a question of construction. Construction of a claim is a matter of law, to be determined by the Judge. The role of evidence is limited.

At [71], the Court stated:

it is fundamentally a matter for the Court to determine and characterise the invention having regard to the principles of construction that are now well settled.[3]

At [73], the Court explained:

The role of expert evidence in construing the patent specification and the claims is limited. It is to place the Court in the position of the person acquainted with the surrounding circumstances as to the state of the art and manufacture as at the priority date: Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1 at [24]; Myriad Genetics at [12]. Typically, the Court will read the specification with the benefit of expert evidence as to the meaning of words that are terms of art, or with an explanation of technical concepts relevant to the understanding of the invention as described and claimed. The question of construction remains with the Court. However, in his reasons, the primary judge adopted the approach of preferring the expert opinion evidence of Professor Verspoor over that of Mr Ries, and then adopting Professor Verspoor’s view as to the identification of the invention as claimed and characterised in the specification. It is not apparent that his Honour separately gave consideration to these matters. In our respectful view, that is an error in approach.

There is, however, at least this anomaly. If one is engaging in an exercise in legal construction, how does one decide whether the claim is nothing more than the implementation of a scheme by the use of a computer for its “well-known and understood functions”?[4] This is, apparently, not a function of evidence or even common general knowledge. At [91], the Full Court explained:

It is apparent that where the cases refer to “generic software” or to the use of computers for their “well-known” purpose, it is not a finding as to common general knowledge. Rather, it is a reference to computer technology that is utilised for its basic, typical or well-known functions. The means of determining that this is so is primarily by a careful review of the specification in order to ascertain, by construing that document, whether the invention described and claimed is in substance any more than a scheme that utilises computers in such a way. This is a question of characterising the invention as set out in the specification.

What appears to have been decisive in this case, as in Encompass, was that the hardware and the software to be used in implementing the method was “uncharacterised”. All that was identified in the claim was a series of high level instructions, leaving it to the user to write their own program.

Rokt argued that the High Court’s decision in Data Access[5] had differentiated between the realms of copyright and patent by identifying that patents are concerned with function, while copyright is concerned with forms of expression. Rokt submitted therefore, that there was no requirement for a claim to incorporate specific programming code.

At [114], however, the Full Court explained at [114] that Encompass was unpatentable because it was “just” an instruction to use computer technology for its well-known and understood functions”:

In Encompass the Full Court found that where the claims in suit do not secure, as an essential feature of the invention, any particular software or programming that would carry out the method and the method is entirely left to those wishing to use the method to devise and implement a suitable program for that purpose and all the specification teaches is that the processing system may be “suitably programmed” then the method is really an idea for a computer program, it being left to the user to carry out the idea in a computer system …. By the claim and the specification leaving entirely to those wishing to use the method to devise and implement a suitable computer program for purpose, it was apparent that the invention did not rise above the level of being an instruction to use computer technology for its well-known and understood functions to implement the scheme.

So, in Rokt, at [115]:

In the present case, the claim amounts to an instruction to carry out the marketing scheme. The level of abstraction at which it is expressed demonstrates that it does no more than provide a list of steps to be implemented using computer technology for its well-known and understood functions. Nothing in the specification suggests otherwise. This may be seen from the instructions explained as steps S1a to S10a in the specification (see [26] above). They comprise a list of general instructions to write software. Even if the scheme is new and ingenious, it is not made patentable merely because it can or must be implemented using computer technology. Rather, the language of the specification and the broad statements of steps required to be taken in claim 1 do no more than locate the scheme in computer technology, using its well-known and understood functions. The position is not distinguishable from that in Encompass. In our respectful view, the learned primary judge erred in finding otherwise. (emphasis supplied)

Another point to worry at

In addition to rejecting the relevance of the kind of expert evidence led (on both sides) before the trial judge, the Full Court was also critical of what Professor Verspoor’s evidence did address.

For example, having set out [205] of the trial judge’s analysis, the Full Court considered that Professor Verspoor had not even addressed the relevant question of what was actually claimed in claim 1, but had instead based her opinions on what was disclosed in the body of the specification. Their Honours said at [95]:

It is apparent that his Honour was not at this point adverting to the method of the claim, which refers to an engagement engine but contains no integer requiring a ranking engine (only a ranking algorithm). Nor does the claim require that there be a tracking database or an objects database. Those features are present in the system architecture identified in figure 3 in the specification, but not in claim 1. Section 18(1)(a) of the Patents Act draws attention to whether the invention so far as claimed in any claim is a manner of manufacture. That is, while the claims must be read with reference to the body of the specification, the invention is defined by the claims. Professor Verspoor, and the primary judge, relied upon the technical problem and solution identified in the specification, and the primary judge did not address the important question of whether the technical solution was claimed.

This with respect appears potentially difficult. Claim 1 with its concatenation of integers is not exactly straightforward. On what basis, for example, do lawyers or other patent advisers conclude that the reference in the claim to a “ranking algorithm” means *and* is something different to a “ranking engine”. Integer 7 for example refers to the “engagement engine” implementing a ranking algorithm “*operable to dynamically rank the relevant offers based on*” various criteria. [Edit]

These may not be the same things. The point is, understanding the claim may well not be simply an exercise in grammar and syntax which a person skilled in the tools of the lawyer’s trade can carry out.

More generally, one might wonder if the stipulation of those features in the claim, or a dependent claim, would have introduced sufficient detail into the claim to elevate the claim from unpatentable scheme to patentable manner of manufacture.

Some concluding comments

The clarification of the correct approach to determining whether a claim is to a manner of invention should be welcome. On the approach to this issue taken since at least Grant, however, it does mean that there is great scope for the Tribunal’s discretion to decide whether something should be patentable or not. That is of course inherent in the ‘proper question’.[6] For that reason, it could be argued that the NRDC Court sought to confine the inquiry – somewhat ironically undermined by Myriad – to a very limited examination of whether the claim was directed to “a mode or manner of achieving an end result which is an artificially created state of affairs of utility in the field of economic endeavour.”[7]

It is difficult with respect to see why, if a claim consisting entirely of a combination of known integers in some new and inventive way can be valid subject matter,[8] the same should not apply equally to a new and ingenious combination of computer technologies. It has long been recognised that there can be invention in the idea or concept or principle even where the means of carrying it into effect are themselves not new or inventive. [9]

The difficult path we are travelling down is evident in the previously unheard of volume of cases we now have about manner of manufacture issues, no doubt exacerbated by the innovation patent. The problems are not confined to Australia. Indeed, matters have reached the state in the United States where a claim to a garage-door-opener, devices which have been patentable subject matter for 150 years (to quote Patently-O) has been held unpatentable as an abstract idea.

The issue becomes even more difficult of resolution where, accepting that Australia is a net importer of intellectual property generally and patent claiming technology, it becomes undesirable to grant patents in Australia for “things” which do not qualify for patent protection overseas, particularly in the patent applicant’s “home” jurisdiction. Given the lack of harmonisation internationally, however, there is no certainty that all, or even many, jurisdictions will reach the same result.

Commissioner of Patents v Rokt Pte Ltd [2020] FCAFC 86 (Rares, Nicholas and Burley JJ)


  1. The numerals are references to elements illustrated in Figure 1 (shown at paragraph 13 of the Reasons).  ?
  2. The Full Court extracted key parts of the evidence of Professor Verspoor’s and the Commissioner’s expert, Mr Ries, at [36] – [44].  ?
  3. See also [93]. At [71], the Court cited [Jupiters Ltd v Neurizon Pty Ltd][jup] (2005) 222 ALR 155 at [67] as summarising “many” of the principles.  ?
  4. Rokt Full Court at [84] citing Commissioner of Patents v RPL Central Pty Ltd (2015) 238 FCR 27 at [96] and Encompass at [95].  ?
  5. Data Access v Powerflex Services (1999) 202 CLR 1 at [20].  ?
  6. ‘whether the subject matter in issue is “a proper subject of letters patent according to the principles which have been developed for the application of s 6 of the Statute of Monopolies”’. Perhaps borne down under the weight of so-called “innovation patents”, however, one might feel some skepticismto the notion that it is to be answered “consistently with a “widening conception of the notion [which] has been a characteristic of the growth of patent law”.  ?
  7. NRDC]nrdc 102 CLR at 275–277; CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 at 295 and Welcome-Real Time v Catuity. Ironically, since undone by the High Court in Myriad.  ?
  8. For example, AB Hässle v Alphapharm Pty Ltd at [6].  ?
  9. For example, Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) (2007) 235 CLR 173 at [59] – [60].  ?

Yellow tops and labels

It’s not exactly front page news, but over at news.com.au they have a short video explaining the battle between Kraft and Bega over who can market peanut butter in that yellow get-up. This follows news that Kraft has applied for special leave to appeal the dismissal of its complaint.

A Current Affair also has a go with a lot more flag waving and some gruesome finger dipping.

If you’re looking for the more formal legal analysis, the Full court decision is here.

So far, the moral of the story is that an unregistered trade mark is not property in its own right. Such a “thing” can be assigned only as part of the transfer of the goodwill of a business as a going concern. If you are going to sell your business, or its assets, but you don’t want to the purchaser to use an unregistered name, or get-up, after the sale, you will need to impose appropriate contractual restraints.

Kraft Foods Group Brands LLC v Bega Cheese Limited [2020] FCAFC 65 (special leave application pending)

Rokt loses the Commissioner’s appeal

The Full Court (Rares, Nicholas and Burley JJ) has upheld the Commissioner’s appeal against the ruling that Rokt’s digital advertising system was patentable subject matter as a manner of manufacture. So, barring special leave), another computer implemented “invention” isn’t patentable.

More analysis later.

Commissioner of Patents v Rokt Pte Ltd [2020] FCAFC 86

The Commonwealth gets nothing on Sanofi’s undertaking as to damages

Nicholas J has dismissed the Commonwealth’s application for Sanofi to pay it compensation under the undertaking as to damages when Sanofi obtained an interlocutory injunction against Apotex’ plans to launch clopidogrel in Australia, but the patent was ultimately ruled invalid.

The decision is some 698 paragraphs long, so this going to be the briefest overview of some highlights only.

Some litigious background

Clopidogrel is a medication which can be used to inhibit blood clotting. Sanofi (then called Sanofi-Aventis) had patents protecting it around the world and had generated over US$1 billion in revenues. Sales in Australia being under Sanofi’s Plavix trade mark and BMS’ Iscover trade mark.

In August 2007, Apotex commenced proceedings for the revocation of Sanofi’s Australian patent.[1] Shortly after, Apotex also obtained registration of its generic version of clopidogrel on the Australian Register of Therapeutic Goods. In September 2007, it then applied for listing of its generic clopidogrel in the Pharmaceutical Benefits Scheme (PBS), through which the Commonwealth government subsidises the price of drugs in Australia.

As it missed the cut off date for the next round of listings in the PBS, it withdrew that application with the intention of making a further application before the next round closed on 1 December 2007. An application made in the December round would be for listing on the PBS from 1 April 2008.

In September 2007, however, Sanofi obtained an interlocutory injunction restraining Apotex from importing or selling in Australia pharmaceuticals which included clopidogrel as their active ingredient. Sanofi gave the usual undertaking as to damages as the price for that interlocutory injunction.

At the hearing for the interlocutory injunction, Apotex also gave an undertaking not to make an application for listing in the PBS pending the outcome of the trial. Apotex did not obtain from Sanofi an undertaking as to damages for that undertaking.

At the substantive trial, Gyles J dismissed Apotex’ application for revocation and instead found that it had infringed Sanofi’s patent. In September 2009, however, the Full Court upheld Apotex’ appeal and ordered the patent be revoked.[2] Sanofi’s application for special leave was dismissed by the High Court on 12 March 2010.[3]

Sandoz obtained PBS listing for its generic clopidogrel on 1 April 2010. Apotex did not obtain listing of its product until 1 May 2010. So, in addition to whatever sales it lost between 1 April 2008 and the lifting of the injunction in 2010, Apotex also lost whatever advantages may have flowed from being the first generic mover.

Sanofi and Apotex settled Apotex’ claims for compensation on the undertaking as to damages out of court.

The Commonwealth’s claims

The Commonwealth also claimed compensation under the undertaking as to damages.

Its case was that Apotex would have been listed on the PBS from 1 April 2008 if Sanofi had not been granted the interlocutory injunctions and so, as a result of the interlocutory injunction, the price payable for clopidogrel:

(a) was not reduced by the statutory reduction to the Approved Price to Pharmacists of 12.5%[4] (i.e. in very loose terms, the Commonwealth paid a price 12.5% higher than it should have been on all sales of clopidogrel between 1 April 2008 and 1 May 2010);

(b) further statutory reductions of 2% each were not triggered on, respectively, 1 August 2009 and 1 August 2010; and

(c) additional price reductions consequent upon the triggering of a statutory price disclosure regime which should have occurred on 1 April 2008.

(From [653] in his Reasons, Nicholas J discusses various scenarios for the calculation of how much the grant of the interlocutory injunction cost the Commonwealth. The lowest amount his Honour would have found in terms of compensation was in the order of $15 million.)

To succeed in its claim, Nicholas J held (at [196]) that the Commonwealth had to show:

· Would the relevant loss have been sustained but for the grant of interlocutory injunction?

· Did such loss flow directly from the interlocutory injunction?

· Could loss of the kind sustained have been foreseen at the time the interlocutory injunction was granted?

Why the Commonwealth lost

The Commonwealth was able to secure a number of witnesses from Apotex. These included the managing director of Apotex Australia, a Mr Millichamp, whose affidavit evidence was to the effect that Apotex was committed to launch its generic clopidogrel in Australia if, having been notified of Apotex’ plans to launch, Sanofi did not obtain an interlocutory injunction.[5]

The problem for the Commonwealth was that Apotex Australia is part of a corporate group controlled by Apotex Canada and the decision on whether or not to launch the product in Australia was to be made by Apotex Canada – specifically its founder and managing director, Dr Barry Sherman.

The evidence did show that in February 2007, Dr Sherman did plan for Apotex to launch its generic clopidogrel in Australia if Sanofi did not get an interlocutory injunction against it. Over time, however, the situation developed further. For example, the evidence included an email Mr Millichamp sent to one of his offsiders on 27 June 2007 when it appeared that the TGA listing was imminent (emphasis supplied) which stated:

[redacted]

[redacted] If we are successful in avoiding an injunction we will plan to launch subject to Barry’s further advice / approval.

If anything changes I’ll let you know.

“Barry” being Dr Sherman. At [251], Nicholas J considered this email indicated that Apotex had not yet decided whether it would launch its clopidogrel product in Australia if Sanofi did not succeed in getting an interlocutory injunction to restrain it.

Secondly, Apotex appears to have been planning to supply Australia from US stocks, but the shelf life of those products would not extend beyond August 2008 which was not very practical – especially when the earliest launch date would be April 2008.

Thirdly, Apotex’ challenge to Sanofi’s patent in the USA had been rejected by the trial judge.

Fourthly, Apotex’ communications to pharmacies did not definitely commit to a launch of the product.

Fifthly, Apotex had not exposed its legal advice on its prospects so Mr Millichamp’s evidence that “we always believed that all of the claims of the patent were invalid”

are not persuasive in circumstances where any legal advice upon which such a belief was based is not in evidence particularly in circumstances where the validity of the US Patent had already been upheld by the US District Court in a decision that was later affirmed on appeal.

Sixthly, at the time of the hearing for the interlocutory injunction in September 2007, the judge had indicated the final trial of substantive issues would be heard in April 2008 and he would give judgment by August 2008.[6] That is, the trial would take place in the same month as the earliest date that Apotex could be in the market if it re-submitted its PBS application before 1 December 2007.

In these circumstances, Nicholas J considered at [286]:

In the absence of evidence from Dr Sherman, I am not persuaded that he would have authorised a launch at risk in circumstances where an interlocutory injunction had been refused, but a final hearing was fixed to commence on 28 April 2008. ….

Rather, Nicholas J considered there was every reason for Dr Sherman to have deferred Apotex’ decision whether to launch or not until the last possible moment.

At this point, the failure (or inability) of the Commonwealth to call Dr Sherman as a witness became decisive all the more so as the Commonwealth was able to produce for cross-examination other Apotex witnesses who did travel from Canada and India. Nicholas J concluded at [347] – [349]:

I conclude that Dr Sherman was a witness who I would have expected to have been available to the Commonwealth and who would have had a close knowledge of relevant facts. In circumstances where the Commonwealth’s decision not to call Dr Sherman was wholly unexplained, I infer that the Commonwealth chose not to call him because it considered that his evidence would not have assisted its case.

I am not prepared to infer, based on the 20 February 2007 email, or any of the subsequent correspondence in evidence which was said to justify the drawing of such an inference, that Dr Sherman was likely to have instructed Mr Millichamp to procure the listing of Apotex’s clopidogrel products with effect from 1 April 2008.

In my opinion, the Commonwealth’s case suffers from an evidentiary deficiency which cannot be made good by drawing inferences from correspondence written by Dr Sherman in the lead up to the hearing of the interlocutory application. In particular, I do not think it can be inferred that if Dr Sherman had known that the trial of the patent proceeding would commence in the same month that Apotex Australia obtained a PBS listing of its clopidogrel products (triggering a 12.5% statutory price reduction), that he would have, in those circumstances, authorised Apotex Australia to obtain such a listing before judgment was delivered or, at least, until the trial had concluded (by which time he and his colleagues and his legal advisers may have had a clearer view of the strength of Sanofi’s case).

In the result, at [351], Nicholas J held that the Commonwealth’s claim must be dismissed.

Some other matters

Having dismissed the claim, Nicholas J went on to consider a number of other matters, albeit by way of obiter dicta.

Apotex’ undertaking not to seek PBS listing was not direct loss

The fact that Sanofi did not give an undertaking as to damages in return for Apotex’ undertaking not to seek PBS listing if an interlocutory injunction restraining sale was made would have provided a second basis for dismissing the Commonwealth’s claim.

Nicholas J accepted that the losses claimed by the Commonwealth were a foreseeable consequence of the interlocutory injunction, however, they were not a sufficiently direct consequence of it.

Apotex had recognised that, if an interlocutory injunction restraining sale was granted, there was no point seeking PBS listing. It would not be able to give the guarantee of supply required to obtain PBS listing and so any listing would fail or be revoked. In addition, it might expose it to increased damages having to compensate Sanofi for the profits lost on the automatic 12.5% reduction in price.

While Nicholas J accepted the Commonwealth’s loss was a reasonably foreseeable consequence of the interlocutory injunction, his Honour held it did not result directly from the injunction in the relevant sense. At [445], his Honour explained:

Even if it is accepted, as I have found, that the first Apotex undertaking would never have been given if the interlocutory injunction had not been granted, it does not follow that the Commonwealth’s loss flowed directly from the interlocutory injunction. The terms of the interlocutory injunction did not prevent Apotex Australia from applying for a PBS listing of its clopidogrel products or from taking any other steps to obtain such a listing. Doing so would not have involved a breach of the interlocutory injunction. The Commonwealth’s loss was a natural and direct consequence of Apotex Australia not being able to apply to list its clopidogrel products on the PBS with effect from 1 April 2008, which was the precise conduct to which the first Apotex undertaking was directed, but not something the interlocutory injunction expressly or implicitly prohibited. This strongly suggests, in my view, that the loss alleged by the Commonwealth in this case was an indirect consequence of the interlocutory injunction.

It is worth considering the ramifications of that conclusion. First, it has been held that it is not an infringement of the patent for someone to apply for PBS listing of a drug containing the protected invention.[7] Further, the Commonwealth is not in a position to require a generic company to refrain from giving an undertaking not to seek PBS listing unless there is an undertaking as to damages. Thirdly, His Honour’s reasoning would apply equally to the losses claimed by Apotex under the undertaking as to damages, not just the Commonwealth’s. If you are acting for a ‘generic’ in this situation, therefore, make sure any undertaking as to damages extends to any undertaking not to seek PBS listing.

Sanofi argued that, even if it did not get an interlocutory injunction, the Minister (or delegate) would refuse listing of Apotex’ product in the PBS on the grounds of patent infringement until the outcome of the proceeding was known. Sanofi’s own witnesses, however, admitted such an outcome was unlikely. Instead, Nicholas J considered an application for listing would most likely have been approved if Apotex had given the necessary guarantee of supply. At [419], Nicholas J said:

I do not think it likely that the Delegate would have refused the application on the basis that a trial of the patent proceedings would shortly take place or that a judgment might be expected to be given some time between May 2008 and August 2008. In my view the Delegate is likely to have been most influenced by two matters: first, the willingness of Apotex Australia to provide an assurance of supply and, second, the absence of any interlocutory injunction restraining any such supply. I think it unlikely that a Delegate would have questioned the ability of Apotex Australia to either comply with its assurance of supply or comply with its obligations under the guarantee of supply. So far as the latter was concerned, I consider it most likely that the Delegate would have proceeded on the basis that, in the event that there was some failure on the part of Apotex to supply during the guaranteed period, then it would be open to the Minister in that situation to exercise one or more of the powers available under the relevant provisions of the NHA including the power to delist the Apotex Australia clopidogrel products and the power to reverse the 12.5% statutory price reduction.

Another area of dispute between the parties was what would have happened if the interlocutory injunction had not been granted but, as in fact happened, the trial judge found Apotex infringed. Mr Millichamp from Apotex gave evidence Apotex would have applied to have the Apotex product delisted. Sanofi argued that, in that situation, it would have been able to get the 12.5% automatic price reduction reversed. The Commonwealth contended that reversal was unlikely. There was a at least one prior case where the price reduction had been reversed before the price reduction became automatic. In the unexplained absence of the person who was the relevant decisionmaker within the Government at the time,[8] Nicholas J considered at [529] the chance the Commonwealth would not have reversed the price reduction to be less than 10%.

Sanofi disputed that interest was payable on compensation ordered under the undertaking as to damages. While his Honour did not finally decide the point, Nicholas J indicated at [697] that he would have ordered Sanofi to pay simple interest on the sum awarded on the basis that it would have been just and equitable to do so.

In light of the evidence that it would take only 2 to 3 weeks for Apotex to have written its own Product Information, Nicholas J would not have denied the Commonwealth recovery because the Product Information (and other stipulated regulatory disclosures) infringed Sanofi’s copyright.[9] His Honour considered at [643] there was “good reason to believe” that no interlocutory injunction would have been granted to restrain copyright infringement in that time frame.

Commonwealth of Australia v Sanofi (formerly Sanofi-Aventis) (No 5) [2020] FCA 543


  1. Australian Patent No 597784 for the dextro-rotatory enantiomer of methyl alpha–5 (4,5,6,7-tetrahydro (3,2-c) thieno pyridyl) (2-chlorophenyl)-acetate, a process for its preparation, and pharmaceutical compositions containing it.  ?
  2. One curiosity of this outcome is that Sanofi’s corresponding patents in Canada and the USA were both upheld as valid and infringed.  ?
  3. Further interlocutory injunctions were put in place pending the outcomes of the appeals.  ?
  4. In essence, while there was only one source of clopidogrel – Sanofi (and BMS as a licensee) – clopidogrel was listed in the PBS in formulary F1. As soon as a second, competing source obtained listing, Sanofi’s listing would be moved into formulary F2 with an automatic price reduction of 12.5% imposed by statute. See [144] – [145]. Paragraphs [36] – [77] contain a useful explanation of how the pricing of products listed on the Pharmaceutical Benefits Scheme works and, in particular, the automatic reductions on pricing that apply when a second (usually generic) drug is listed.  ?
  5. The evidence disclosed that Apotex’ strategy, having successfully developed its generic clopidogrel (and having at least a further 18 months to complete development of a product based on a different salt), was (1) to secure ARTG listing then in short order (2) to apply for PBS listing, (3) to launch to the trade on an “at risk” basis – i.e. ensure the trade knew Apotex might have to withdraw the product if Sanofi’s patent was valid and (4) then to put Sanofi on notice of its plans to launch by bringing the revocation proceeding. An explicit part of the strategy was to secure the benefit of the undertaking as to damages if Sanofi did block sales through an interlocutory injunction.  ?
  6. The trial judge reached the statutory age for retirement in that month.  ?
  7. Warner-Lambert Company LLC v Apotex Pty Ltd (2017) 249 FCR 17  ?
  8. The fact that the person was no longer working for the Commonwealth was not a sufficient justification for the failure to call her.  ?
  9. The Copyright Act 1968 was subsequently amended to preclude the use of copyright against such materials. See now s 44BA.  ?