scope

The undertaking as to damages: Cth v Sanofi

The High Court (by 3:2) has dismissed the Commonwealth’s attempt to claim $325 million from Sanofi on the undertaking as to damages Sanofi gave when granted an interlocutory injunction against Apotex’ introduction of generic clopidogrel.

In the High Court, the main point was when it is appropriate for the High Court to overturn concurrent findings of fact by the primary (trial) judge and the intermediate court of appeal (here, the Full Federal Court). Apart from that (somewhat rarefied) issue, there are two more generally applicable points to consider.

Some background

Sanofi had a patent in Australia (amongst other places) for the drug clopidogrel which Sanofi marketed as Plavix and was used for the treatment of heart attacks and stroke.

Around the time Apotex obtained registration of its generic clopidogrel in the Australian Register of Therapeutic Goods (ARTG), it began Court proceedings against Sanofi seeking revocation of Sanofi’s patent. Sanofi cross-claimed for infringement and sought an interlocutory injunction.

On 25 September 2007, Gyles J granted Sanofi the interlocutory injunction restraining Apotex from infringing the patent pending trial on Sanofi giving “the usual undertaking as to damages”.[1] Earlier, in the course of the hearing on the interlocutory injunction application, Apotex in effect gave an undertaking not to apply to register its clopidogrel in the Pharmaceutical Benefits Scheme (PBS) if Sanofi was granted the interlocutory injunction against infringement.

After the trial on substantive issues, Gyles J found Sanofi’s patent valid and infringed. In August 2008, therefore, Gyles J granted a final injunction against Apotex infringing the patent.

On appeal, however, the Full Court found Sanofi’s patent invalid so it was revoked and the injunction was rescinded.

First, Apotex claimed damages on the undertaking on the basis that it had lost sales as a result of the interlocutory injunction. Sanofi and Apotex reached agreement compromising that claim without a Court determination.

Secondly, although it was not a party to the litigation, the Commonwealth also brought a claim under the undertaking. The basis of its claim was that Sanofi’s clopidogrel was listed in the PBS. Therefore, the Commonwealth paid pharmacists a subsidy for each prescription of clopidogrel.

When the first generic product was listed in the PBS, however, that would automatically trigger a 12.5% reduction in the subsidy payable for prescriptions of the drug.[2]

Because Apotex did not apply to list its generic clopidogrel in the PBS, those price reductions were not triggered. Accordingly, the Commonwealth claimed that it had suffered loss by reason of the granting of the interlocutory injunction amounting to (for present purposes) the 12.5% price reduction that did not occur multiplied by the volume of Sanofi’s sales between the date of the interlocutory injunction and the patent being declared invalid. Something like:

$ = (P – 0.875P[3]) x Q

where:

P = the price payable by the Commonwealth to phatmacies by subsidy through the PBS; and

Q = the volume or number of units sold by Sanofi between 1 April 2008 and 1 April 2010 when Apotex was finally granted a listing in the PBS. (1 April 2008 was the earliest date, but for the interlocutory injunction, Apotex could have been listed in the timings of these things.)

The Courts below

Both Nicholas J and the Full Federal Court dismissed the Commonwealth’s application.

The Commonwealth’s claim was dismissed because Nicholas J found that the Commonwealth did not prove Apotex would have sought PBS listing and commenced selling its generic clopidogrel if the interlocutory injunction had not been granted.

The Commonwealth failed on this point because as the claimant it had the onus of proving that it had actually suffered loss. However, it failed to discharge that onus because it did not call as a witness, Dr Sherman, who was the founder and CEO of the Apotex group of companies and, the evidence showed, it would have been his decision whether or not Apotex would launch “at risk” of being sued for infringement.[4] There was some evidence in February 2007 Dr Sherman had directed Apotex proceed with launching its product in Australia. There was some further evidence from June / July 2007, however, suggesting some doubt whether Apotex would in fact launch especially in light of litigation between the parties in the USA and Canada (which Apotex eventually lost).

The High Court

The decisive issue in the High Court was whether or not the circumstances warranted the High Court intervening to overturn concurrent findings of fact made by the primary judge and not disturbed by the Full Federal Court on appeal.

At [1], the plurality (Gordon A-CJ, Edelman and Steward JJ) summarised the principle:

The principled approach taken by this Court, reaffirmed in these reasons, is common to many ultimate appellate courts in the common law tradition. That principle is that, absent special or exceptional circumstances such as plain injustice or clear error, this Court will not engage in a detailed review of concurrent factual findings of lower courts.

Their Honours went on to find that the appeal did “not concern any individual rights, nor expose any plain injustice or clear error.” At [44] – [123], their Honours reviewed the findings and concluded at [124] that the facts found in the lower courts were “not only open and free from clear error but also are compelling.”

On the other hand, both Jagot J and Beech-Jones J considered there had been such an error.

Some observations of significance

Although the Court’s conclusions meant it was unnecessary to deal with Sanofi’s notice of contention, all Judges expressed views on some aspects “because it is important to do so”.

The Commonwealth was entitled to claim under the undertaking as to damages

The first significant point is that all judges considered the Commonwealth was a “person” which could legitimately claim the losses it claimed to have suffered on the undertaking as to damages even though it was not a party to the litigation.

Sanofi had argued that the losses claimed by the Commonwealth did not “directly flow” from the grant of the interlocutory injunction and so were outside the scope of the undertaking.

All judges were concerned that the test for who could claim on the undertaking not be rigidly confined to a formulaic approach. As the plurality explained at [169], the losses claimed by the Commonwealth (if they had been proved) fell plainly within the scope of the undertaking as to damages:

…. If, absent the interlocutory injunction, Apotex would have applied for listing of its clopidogrel products on the PBS (which the concurrent findings below were that it would not have) then it was common ground at the time of the hearing of the interlocutory injunction that it would have been inevitable that Apotex’s products would have been listed and that, consequently, there would have been a 12.5% price reduction for clopidogrel products listed on the PBS and subsidised by the Commonwealth. As Sanofi accepted in this Court, Sanofi, Apotex and Gyles J knew that a loss that the Commonwealth might suffer as a result of the interlocutory injunction would be loss arising from this price reduction. This was therefore the very loss to third parties “adversely affected” that was reasonably contemplated at the time the interlocutory injunction was granted and therefore within the scope of the undertaking. ….

How much could the Commonwealth have claimed for

The second point of has wider ramifications as applies to any interlocutory injunction and does not turn on the Commonwealth’s role in subsidising the price payable for medicines.

While the Commonwealth claimed $358 million, the plurality explained that if the Commonwealth had proved Apotex would have launched “at risk”, the Commonwealth’s losses would have been $11 million only.

This was because the undertaking as to damages applied only to losses flowing from the grant of the interlocutory injunction. In this case, however, the interlocutory injunction was extinguished by the grant of the final injunction in August 2008. So the Commonwealth could not claim damages after the final injunction was granted and the undertaking as to damages released.

David Shavin KC points out that in Sigma v Wyeth (No 3), the Full Court (Bennett, Nicholas and Yates JJ) explained that any release from the undertaking as to damages should be stayed pending the outcome of any appeal. In response to the primary Judge and a subsequent single Judge sitting in the appellate jurisdiction on an interlocutory basis, their Honours said at [10]:

The effect of the primary judge’s orders was to release the respondents from the undertakings as to damages even though the appellants made clear an appeal would be brought and there existed the possibility that the injunctive relief granted by the primary judge might be set aside on appeal. In such circumstances we think it would seldom, if ever, be appropriate to order that a party be released from an undertaking as to damages. The preferable course is for the undertaking to be left in place to operate in accordance with its terms.

Wyeth argued that the supersession of the interlocutory injunction by the final injunction and the release from the undertaking as to damages followed as a result of the primary judge’s findings that the patent was valid and infringe. At [13], Bennett, Yates and Nicholas JJ rejected this bluntly:

The respondents were unable to point to any authority in support of this submission. In our opinion it must be rejected. The respondents’ submission seeks to give the usual undertaking as to damages an operation that has the potential to cause substantial injustice in circumstances where an interlocutory injunction is obtained on the basis of a case which cannot be sustained on appeal. In the present case, the primary judge released the respondents from the undertakings as to damages on the basis that they had in each case established an entitlement to injunctive relief on a final basis. Once it was determined, as it was on appeal, that the respondents were not entitled to such relief then there can be no basis for not setting aside the primary judge’s order releasing the respondents from their undertaking as to damages.

Subsequently, Nicholas J refused to release an undertaking as to damages pending any appeal. In a different proceeding, Yates J specifically ordered that the undertaking as to damages remain in place “until further order”.

If you have the benefit of an undertaking as to damages and lose the trial but may be appealing at the very least therefore seek to preserve the undertaking as to damages until further order.

Commonwealth of Australia v Sanofi [2024] HCA 47


  1. GPN-UNDR: the applicant undertakes to the Court “to submit to such order (if any) as the Court may consider to be just for the payment of compensation, (to be assessed by the Court or as it may direct), to any person, (whether or not that person is a party), affected by the operation of the order or undertaking or any continuation (with or without variation) of the order or undertaking” and to pay the compensation so assessed.  ?
  2. Further reductions could and would be triggered when other events happened.  ?
  3. The 12.5% was just the initial reduction on the listing of the first generic product in the PBS. A cascading series of reductions came into play as other events occurred.  ?
  4. Dr Sherman and his wife appear to have died in suspicious circumstances but that was in December 2017 some months after the hearing on the Commonwealth’s claim and well after deadlines for filing evidence.  ?

The undertaking as to damages: Cth v Sanofi Read More »

Should Michelin’s X block Continental’s Xking?

Over at the IPKat, there is a report about a CJEU decision upholding Michelin’s opposition based on its “X” trade mark to the registration of Continental’s “XKING” mark (below on the right), both in respect of tyres.

Michelin X v Continental Xking

You should read the report, if for no other reason, than the revelation of the EU’s “scientific” approach to trade mark conflicts.

Putting to one side the peculiar procedural posture the CJEU seems to take in these kinds of ‘appeals’, Merpel quite rightly thunders about scope afforded to ‘descriptive’ marks. After pointing out that it has taken 5 years to get to this point, Merpel says:

The end result here is that one trader with a weakly distinctive trade mark for the single letter X, distinguished from the letter of the alphabet only by the merest stylisation, can prevent the registration (and potentially use) of a stylised mark XKING. It must also follow that the same trader can prevent other X-formative marks, especially if the other element is in some way laudatory (and the word “king” is hardly at the top of the laudatory scale). Might it be said that this hands too strong a right to the trader?

Merpel makes a cogent case for the rejection of the opposition. What I wonder about, however, is what is the ordinary consumer likely to recall imperfectly? Would the ordinary consumer recall the mark is just an “X” alone so that the inclusion in Continental’s mark of rather bland “KING” is sufficient to dispel any potential for confusion? Or is the putative consumer likely to be struck by the common use of the hollow (or white) X? Under our version of trade mark law, all that is required is a (significant?) number of people being caused to wonder and the nature of the recollection is explained by Latham CJ:[1]

They will compare the actual mark which they see upon goods which are offered to them with the memory of the other mark, which they will retain in a more or less distinct form… The court must endeavour to put itself in the position of ordinary purchasers of goods who have noticed a trade mark as being distinctive of particular goods, but who have not compared that mark with any other mark, and who are quite probably not aware of the fact that another more or less similar mark exists.

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If you’re really motivated, leave a comment explaining why!


  1. Jafferjee v Scarlett [1937] HCA 36; 57 CLR 115 at 122.  ?

Should Michelin’s X block Continental’s Xking? Read More »

Trying to appeal a finding that you copied

(and therefore infringed???) is very hard:

Carlisle lost its appeal against the finding that it infringed Barrett Property Group’s copyright int eh Seattle and Memphis – the second of the alfresco cases.

51 In our opinion, the appellant’s submissions must fail.

52 The context in which the appellant’s submissions must be considered is an appropriate starting point. Two points are important. First, it is not suggested by the appellant that a judge, after a proper examination of the evidence, could not reach the conclusions which were in fact reached by the primary judge. In our opinion, a judge, after a proper examination of the evidence, clearly could reach the conclusions which were in fact reached by the primary judge. The handwritten notes of Mr Megens and of Mr Feldman make no mention of the Rochester and neither of them had any recollection of any mention of the Rochester. It is undoubtedly true to say, as the primary judge did, that, in view of the alleged importance of the Rochester to the derivation of the design, one would have expected that the legal practitioners at the conference would have made a note of it had it been mentioned. Secondly, Mr Megens gave his evidence in chief by affidavit and by way of a limited number of oral answers to questions. His affidavit referred to his handwritten notes and typed notes of the conference which notes were exhibited to his affidavit. He did not give any further evidence of his recollections of the conference in his affidavit.

The Court then considered each of the appellant’s arguments and rejected them or found that the primary judge had taken the point into account.

Carlisle Homes Pty Ltd v Barrett Property Group Pty Ltd [2009] FCAFC 31

Kim on the monopoly in the alfresco.

Trying to appeal a finding that you copied Read More »

Innovation review

I’m still wading my way through the Innovation Review.

Meanwhile Duncan Bucknell is highly critical, particularly of recommendation 7.2:

Recommendation 7.2: Patent law should be reviewed to ensure that the inventive steps required to qualify for patents are considerable, and that the resulting patents are well defined, so as to minimise litigation and maximise the scope for subsequent innovators.

As Duncan points out, what does this actually mean?  Well, Ben Roxborough at IPRoo thinks we should pay much more attention to this recommendation as it appears to be, or be very close to, what IP Australia thinks should happen.  Follow Ben’s link from here.

If that is right, then there must be a very good chance that, whatever it means, it is going to happen.

One certainly can’t quibble with the idea that patents should be certain and clear in scope.  Indeed, Besson & Meurer contend that one of the main reason why the patent system in the USA is not working properly is precisely because patents there are not clear and certain in scope. (Blog summaries here and here.)

Given Australia’s role as an IP importer, and bearing in mind we have the innovation patent too, one can’t really quibble with the idea that we shouldn’t be granting standard or “real” patents for things that wouldn’t get patented overseas – well, I suppose one can quibble, but I’m not at all sure what would be the justification for allowing patents in Australia which are not patentable elsewhere.  

(As an aside, I wonder how requiring more inventiveness, if it can be defined, fits in with having innovation patents – which are certainly real – but for rather more limited, limited terms.)

In the Alphapharm case (see esp. [80 -81], however, the majority of the High Court pointed out that there didn’t seem to be a “standard” international approach.  On the other hand, there is some evidence emerging that it may be easier to get patents in Australia than Europe and Japan but, possibly, not the USA.

If that is what the evidence does suggest, one might then have to go on to ask (amongst other things) how much of the difference is due to, say, EU-centric rules like no patents on computer programs as such?

Now, I have previously mentioned that Prof. Mark Lemley provides one of the clearest explanations I have come across on whay that is not a good idea (listen to podcast #62).  And that was in the context of considering patentable subject matter.

And guess what, that is the subject of another Australian governmental review.  So, it looks like change is coming.  Perhaps, you should get involved?

On recommendation 7.3:

Recommendation 7.3:  Professional practitioners and beneficiaries of the IP system should be closely involved in IP policy making.  However IP policy is economic policy. It should make the same transition as competition policy did in the 1980s and 90s to being managed as such.

I can’t do better than quote the new DG:

In this regard, it is useful to remember that intellectual property is not an end in itself. It is an instrumentality for achieving certain public policies, most notably, through patents, designs and copyright, the stimulation and diffusion of innovation and creativity on which we have become so dependent, and, through trademarks, geographical indications and unfair competition law, the establishment of order in the market and the countering of those enemies of markets and consumers: uncertainty, confusion and fraud. In the end, our debates and discussions are about how intellectual property can best serve those underlying policies: whether modifying the international framework will enhance or constrain innovation and creativity and contribute to their diffusion, and whether it will add confusion, rather than clarity, to the functioning of the market.

Unfortunately, that doesn’t tells us in any particular case whether more protection or better exceptions are required.  It does, however, remind us what the rules are trying to balance.

Innovation review Read More »

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