interlocutory injunction

The undertaking as to damages: Cth v Sanofi

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On appeal, however, the Full Court found Sanofi’s patent invalid so it was revoked and the injunction was rescinded.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

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

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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.  ?

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Abilify interlocutory injunction continues pending appeal

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Last month, Yates J found that Otsuka’s patent for aripiprazole was invalid.[1] As a consequence, his Honour ordered that the interlocutory injunction preventing Generic Health from listing its product on the PBS and selling it be dissolved. Otsuka has appealed and now Nicholas J has granted a stay to preserve the interlocutory injunction pending the appeal.

While not being prepared to characterise Otsuka’s prospects on the appeal as higher than arguable, Nicholas J considered the balance of convenience favoured continuation of the interlocutory injunction.

Otsuka relied principally on the fact that there would be an automatic reduction of 16% the price payable under the PBS for Abilify[2] once Generic Health’s product was listed. It contended that it would not be possible to recover that price drop if its appeal were successful.

Generic Health countered that it risked losing the benefits of first mover advantage if it were enjoined and other generic producers were not. Generic Health’s evidence was that pharmacists would usually only carry one generic brand of each drug and that was likely to be the first brand “in”. This would exacerbate the difficulties in calculating its losses. Nicholas J did not dismiss that argument, but Otsuka said it would be seeking interlocutory injunctions against any other generics who tried to enter the market pending the appeal. Nicholas J noted further that, if Otsuka failed in an injunction applications against a second or further generic, that would be a strong basis to terminate the stay.

The Commonwealth also sought a specific undertaking to pay damages from Otsuka as the price of the injunction. It argues it will suffer loss, in the form of the higher prices payable under the PBS, if Generic Health continues to be enjoined but the appeal ultimately fails.

Nicholas J noted that a case has been stated to the Full Court on whether the Commonwealth can indeed claim under the “usual undertaking as to damages”. Subject to the outcome of that case, his Honour considered the Commonwealth was sufficiently within the scope of the usual undertaking and so did not need a separate, specific undertaking.

Nicholas J increased the security for costs that Otsuka had to provide to Generic Health in the amount of an additional $8.7 million[3] and, in addition, required a security of $6 million separately to the Commonwealth. His Honour also noted that the Commonwealth could apply to extend that security if the appeal was not decied in the first half of 2016.[4]

Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd [2015] FCA 848

  1. Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634. Patentology looked at the ‘swiss claims’ aspects of his Honour’s decision.  ?
  2. The commercial name under which aripiprazole is marketed by Otsuka and its licensee.  ?
  3. Otsuka has already provided $6.5 million pursuant to the orders made by Yates J at first instance.  ?
  4. At [35], Nicholas J recored that the Commonwealth estimated its losses from the continuation of the interlocutory injunction would be $6 million over the next 12 months and $15 million over the next 18 months.  ?

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Program formats and copyright

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Channel 7 has lost its bid to get an interlocutory injunction against Channel 9’s show Hotplate.

Channel 7 claimed Hotplate infringes Channel 7’s copyright in the dramatic works consisting of the combination and series of incidents, plot, images and sounds that make up My Kitchen Rules:

  1. MKR Series 1, Episode 1;
  2.  the whole of MKR Series 1;
  3.  the whole of MKR Series 5; and
  4.  the whole of MKR Series 6.

Nicholas J found that Channel 7 had a reasonably arguable case, but did not agree with Channel 7 that it was a strong prima facie case. Then, his Honour considered the balance of convenience weighed in Channel 9’s favour.

Prima facie case

Nicholas J thought this might well cause Channel 7 some difficulties. At [15] his Honour said:

There may be a difficulty in framing the case in this way.  My understanding of Seven’s case is that it claims copyright in the dramatic work that constitutes the format for the MKR television program which was first reduced to material form in Series 1, Episode 1 (see Seven’s outline of submissions para 11). If that is correct, then one would expect subsequent episodes of MKR merely to reproduce the dramatic work (ie. the format) first seen in Series 1, Episode 1.  The alternative approach involves treating every subsequent episode of MKR as an original dramatic work that has its own original format.  This seems inconsistent with the way in which Seven has argued its case.  In any event, it is not necessary to explore this issue in any detail for present purposes.  In due course Seven will need to explain precisely how it puts its case.

Channel 9 contended that many of the key elements of MyKitchen Rules were common place and unoriginal. The makers of Hotplate, Endemol, also pointed to a catalogue of what it said were very substantial differences between the 2 shows:

(a) The Hotplate is based on professional restaurateurs, and established restaurant businesses, whereas MKR involves amateur cooks in their kitchens.

(b) The restaurants and contestants for The Hotplate were selected because they were varied examples of different restaurant styles and the best characters, not because they are from a particular State (as is the case for MKR) – as a result, two restaurants are in Sydney, one is in Brisbane, one is in Perth, one is in Mandurah (in Western Australia) and one is in regional Victoria.

(c) The restaurant businesses featured in The Hotplate focus on different cuisines in order to show different cooking styles, including Italian, Japanese, French, seafood, modern Australian and Asian fusion.

(d) In Round 1 of The Hotplate, the contestants are required to cook meals from their existing menu, and must be prepared to cook anything on the menu since they are not given advance notice of which two entrees, two mains and two desserts will be ordered by the judges, whereas in MKR the contestants select their own menu of one entree, one main and one dessert. The Hotplate shows the contestants preparing meals, but does not show them shopping for ingredients as for MKR.

(e) When their restaurant is featured, the contestants in The Hotplate wear what they generally wear in their day-to-day business – they are not provided with a branded apron as they are for MKR or for Masterchef (another well-known cooking program).

(f) In Round 1 of The Hotplate, the other restauranteur contestants provide their scores to the judges in a bill folder, but in Round 2 (after the restaurant makeovers), the other contestants must deliver their scores directly to the contestants whose restaurant is being featured on the night.

(g) The judges in The Hotplate give feedback to the contestants about everything from the ambiance and decor of the restaurant to the service to the overall menu to the specific dishes they serve – this is aimed at assisting the restaurateurs with how they can improve their businesses as a whole, not just the cooking. This is not an element of MKR since the program does not involve actual restaurant businesses.

(h) In Round 2 of The Hotplate, the contestants are given an amount of money to undertake renovations and makeovers of their restaurant’s furniture, colour scheme and decor in addition to updating of the restaurant’s menu. Again, this is not an element of MKR since the program does not involve the renovation or makeover of restaurant businesses. This information may be confidential to Nine. I have not had time to check while preparing this affidavit.

(i) In Round 3 of The Hotplate, the contestants cook meals from their newly renovated restaurants for diners. This is not an element of the MKR program since it does not involve restaurants or their diners.

Balance of convenience

Nicholas J accepted that Channel 7’s losses would be difficult to quantify. His Honour considered, however, that Channel 9’s losses would also be particularly difficult to quantify. The factor which appears to have tipped the balance, bearing in mind the problematic strength of Channel 7’s claim that its rights were infringed, was the disruption to Channel 9’s broadcasting schedule. 3 episodes of Hotplate had already broadcast and it was unrealistic to expect Channel 9 could simply resume where it left off, or start over again, if it successfully defended the infringement claim. At [41] and [42], his Honour said:

During the course of argument it was suggested by Senior Counsel for Seven that if Nine was restrained from broadcasting further episodes of Hotplate, it would be able to resume broadcasting them at a later date on the assumption that no permanent injunction was granted. I doubt that this would be as simple as the submission seemed to suggest. Presumably it would be necessary for Nine to re-broadcast the first three or more episodes. I think it would be difficult for Nine to re-establish the program’s momentum after it was abruptly halted by injunction and then “shelved” for however many months it takes to determine the proceeding and any subsequent appeal.

There is evidence from Ms Officer to show that Nine considers Hotplate to be a key piece of its programming that Nine has decided to broadcast in prime-time slots not only with a view to achieving high ratings for Hotplate itself, but also with a view to boosting the ratings of some of Nine’s other programs.

Seven Network (Operations) Limited v Endemol Australia Pty Limited [2015] FCA 800

Program formats and copyright Read More »

Interlocutory Injunction to transfer domain name

Leave a Comment / Internet, Trade marks / / / , , , , , , ,

Nicholas J has granted Thomas International an interlocutory injunction ordering Humantech to transfer the domain names, thomasinternational.com.au and thomas.co.za, to Thomas International. Thomas International had to give the usual undertakings and, as a foreign corporation, provide security for costs.

Thomas International is an English company which provides psychological testing and psychometric assessments, and competency and skills-based assessments, particularly using computerised services accessed over the internet through thomasinternational.net. It also makes its materials and services available through distributors. It appointed Humantech, a company associated with a Mr Schutte, as its master distributor/licensee for South Africa and Australia with power to exercise its rights through distributors. Humantech was permitted to use the “Thomas” trade marks, to incorporate a company in Australia under the name Thomas International (Australia) and to register the domain names. There were also obligations when the arrangements ceased or were terminated to cease use of the trade marks and change the corporate name of Thomas International (Australia) to a name which did not include Thomas.

In due course, the Schutte interests also incorporated another entity, ACT, which offered similar services to Thomas International’s assessment and training services. Thomas International alleges that, after some successful years’ trading, revenues from Thomas International (Australia) starting dropping off and the Schutte interests were diverting customers to ACT which, without permission, was using materials based on Thomas International’s materials.

Thomas International sued Humantech, Thomas International (Australia), ACT and Mr Schutte. There was a meeting between the parties and their lawyers shortly after. Thomas International said it would not discuss a new licensing arrangement until an undertaking dealing with the existing issues was provided. As a result, Humantech and the Schutte interests provided an undertaking to cease use of Thomas International’s trade marks, intellectual property and to transfer the domain names over. Thomas International also agreed to negotiate about a new licensing arrangement in good faith.

The next day Thomas International made its licence proposal to the Schutte interests. They considered it was financially unworkable and left the meeting. Later that day, they then put Humantech (and subsequently the other corporate entities) into administration and disabled the website. Shortly thereafter, Thomas International applied for interlocutory injunctions.

As noted, Nicholas J granted the interlocutory injunctions including an order that the domain names be transferred to Thomas International. The terms of the Undertaking meant it had a prima facie case to force the Schutte interests to stop using the Thomas name and trade mark and for the transfer of the domain names.

The Schutte interests’ main attempt to rebut that was their argument that the Undertaking was invalid or unenforceable. That was said to result because, it was alleged, that Thomas International extracted the Undertaking in return for its promise to negotiate a new licence arrangement in good faith. The Schutte interests contended that the terms of the licence they were offered were so unreasonable as to show that Thomas International did not negotiate, and had no intention of negotiating, in good faith. This issue was not developed in detail at this stage, but Nicholas J pointed out that, on the current state of the law in Australia, an obligation to negotiate in good faith did not require a party to subordinate its own interests to that of the other party.

On the balance of convenience, Nicholas J accepted Thomas International’s argument that:

the present state of affairs may cause TIL significant reputational damage as a result of customers who have purchased units entitling them to make use of facilities provided by TIL at the Thomas Hub being prevented from gaining access to it through the TIA website. I accept this submission. I also consider that any such damage may be irreparable and that damages will most likely not provide an adequate remedy. The financial statements of TIA for the financial year ending 30 June 2014 show that the company has net assets of just under $145,000.

On the other hand, the Schutte interests’ main argument was the disruption to their business, and that of their customers, if they could not continue to use the domain names, the main access point for provision of services both to Thomas International (Australia)’s customers and those ACT. As Nicholas J pointed out, however, the Schutte parties had already disabled access to the websites so they had already caused that problem themselves.

It would appear that Thomas International first learned something about ACT’s activities, the subject of the complaint, in May 2014 (i.e., a year earlier). However, Thomas International was able to lead evidence showing all the work it did, and the difficulties it encounted, in trying to ascertain what ACT was doing until proceedings were issued. In this context, the termination by Humantech of the main employee with responsibilities for running the Thomas part of its business may will have been highly significant.

Permission to proceed against the companies although administrators were appointed was granted as the interests of the administrators were adequately protected by the undertaking as to damages and provision for securities.

Thomas International Limited v Humantech Pty Ltd [2015] FCA 541

Interlocutory Injunction to transfer domain name Read More »

Commonwealth seeks $60 million on the undertaking as to damages

Leave a Comment / Enforcement, Patents / / / , , , , , , , , , , , ,

Sanofi sued Apotex (then known as GenRx) for infringement of its “clopidogrel patent”. It obtained interlocutory injunctions against Apotex against the sale of Apotex’ product and preventing Apotex from applying to list its product under the Pharmaceutical Benefits scheme (PBS). As a condition of the grant of those interlocutory injunctions, Sanofi gave the “usual undertaking as to damages”:

“(a)          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 a party, adversely affected by the operation of the interlocutory injunction or any continuation (with or without variation); and

“(b)          pay the compensation referred to in subpara (a) to the person or persons there referred to.”

Sanofi won at trial, but lost on appeal with the Full Court ordering its patent be revoked. Sanofi’s application for special leave to appeal to the High Court was refused on 12 March 2010.

Apotex sought compensation under the undertaking by motion in May 2010. Sanofi and Apotex resolved that application by negotiation.

The Commonwealth also sought compensation under the undertaking as to damages by application made in April 2013. If we did not know before, we now know the Commonwealth is seeking $60 million. Essentially, the Commonwealth contends that is how much less it would have had to pay out under the PBS if the interlocutory injunctions had not prevented Apotex applying to list its product under the PBS:

 

“The Commonwealth has provided some particulars of its damages. It alleges it has suffered financial loss in excess of $60 million as a result of Apotex being prevented by the various interlocutory orders and undertakings from achieving a listing for its clopidogrel products under the PBS. Most of the Commonwealth’s loss is said to flow from statutory price reductions and price disclosure reductions that would have occurred had Apotex not been the subject of the relevant interlocutory restraints.”

 

The case is a long way off resolution. Nicholas J has allowed Sanofi to amend its points of defence to the Commonwealth’s claim to rely on the Commonwealth’s delay in making its application for compensation and to rely on infringement of copyright in Sanofi’s product information documents. Sanofi will be required to particularise the prejudice its claims it suffered as a result of the delay.

Nicholas J however refused leave to amend to plead that the Full Court’s decision invalidating Sanofi’s patent was wrong in light of the Full Bench’s subsequent decision in AstraZeneca (rosuvastatin). That would be inconsistent with res judicata and the principle of finality of litigation.

Commonwealth of Australia v Sanofi-Aventis [2015] FCA 384

Commonwealth seeks $60 million on the undertaking as to damages Read More »

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

Leave a Comment / Enforcement, Patents / / / , , , , , ,

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 »

Apple and Samsung in the High Court 3

Leave a Comment / Enforcement, Patents / / / , , , , ,

As is well known by now, the High Court dismissed Apple’s application for special leave to appeal from the Full Federal Court’s dissolution of the interlocutory injunction against the Samsung Galaxy Tab 10.1. This means that Samsung can legitimately offer the Galaxy Tab 10.1 for sale in Australia pending trial and subject to an undertaking to keep full accounts.

The transcript of the High Court hearing (French CJ, Gummow and Bell JJ) is now up. In refusing special leave, French CJ said on behalf of the Court:

The organising principles upon which applications for interlocutory injunctions are determined are set out in O’Neill and, as is emphasised in those passages, the governing consideration is that the requisite strength of the probability of ultimate success depends upon the nature of the rights asserted by the plaintiff and the practical consequences likely to flow from the grant of interlocutory relief, the reference to “practical consequences” including the considerations which are present where the grant or refusal of an interlocutory injunction, in effect, disposes of the action in favour of the successful party on that application.

This appears to have been a case where the decision on the interlocutory application effectively would determine the outcome of the dispute, hence, as the Full Court emphasised, the requirement for a reasoned examination of the strength of Apple’s case. ….

That is, as both parties accepted the interlocutory injunction was effectively final relief in that the Galaxy Tab 10.1 would be well and truly superseded by the final resolution of the case (including any appeals), Apple needed to demonstrate a strong case for infringement.

While the High Court panel accepted the judge hearing an interlocutory injunction might not always be expected to forecast the outcome of the case at the interlocutory stage, the practical consequences in this case meant that was necessary. In undertaking that exercise, the Full Federal Court had made no error of principle (and, unsurprisingly, the High Court was certainly not going to engage, at this stage, in claim construction and reviewing the evidence).

Apple Inc & Anor v Samsung Electronics Co. Limited & Anor [2011] HCATrans 341

Apple and Samsung in the High Court 3 Read More »

Apple v Samsung

1 Comment / Patents / / / , , , , , ,

Belated link to Bennett J’s reasons for granting the interlocutory injunction against Samsung’s Galaxy Tab:

Apple Inc. v Samsung Electronics Co. Limited [2011] FCA 1164

It has now been reported that Samsung has appealed, with Gerry Harvey in support.

Samsung is also reported to be bringing claims of patent infringement against Australia and Japan, although the patents it is asserting in Australia are apparently counterparts to the ‘frand’ patents which a Dutch court refused to grant injunctions for. For the ‘frand’ issue in ND California.

Apple v Samsung Read More »

Customs seizure and trade marks

Leave a Comment / Enforcement, Trade marks / / / , , , , ,

In two ex parte applications, Greenwood J granted interlocutory injunctions restraining Customs from releasing imported goods which allegedly infringe a trade mark.

The interesting point is that the proceedings for infringement were not brought within the “action period” specified in by s 137 of the Trade Marks Act. Greenwood J reasoned:

Section 136 is headed “Release of Goods to Owner – No Action for Infringement and s 137 is headed “Action for Infringement of Trade Mark”. Some discussion has arisen in earlier authorities, including Jemella v Mackinnon & Another [2008] FCA 1022; 77 IPR 243, in which Logan J had to consider whether non-compliance with these provisions as to commencement and notification within the extension period, might have the effect of depriving the applicant of its standing to maintain infringement proceedings. I am satisfied that ss 136 and 137, taken together, do not deprive the applicant of its standing to maintain proceedings for infringement of the trade mark. Section 137 is not a primary empowering provision conferring rights of action in the applicant. It is permissive in the context in which it appears. Those rights are conferred by s 20 and the provisions of Part 12 of the Trade Marks Act. Section 137 recognises that a trade mark owner may elect to bring proceedings and ss 136 and 137 address what is to occur in the circumstances of those sections in respect of seized goods if the relevant steps are not taken. However, the provisions should be read subject to an order that might be made under s 137(5) to, in effect, preserve the status quo in circumstances where the Court is satisfied that there is a prima facie case of infringement. Nevertheless, a question arises as to whether it is appropriate to make an order directed to the Customs CEO preventing the goods from being released, in all the circumstances, in the exercise of discretion, when s 136 imposes a statutory obligation upon the Customs CEO to release the goods in the circumstances there identified and s 137 imposes time constraints. That directs attention to the merits.

That is, the foundation of the right to be protected by the interlocutory injunction was the right to sue for infringement of the registered trade mark – a right conferred by ss 20 and 120; s 137 merely facilitated that primary right.

Jemella Australia Pty Ltd v Bouobeid [2009] FCA 1567

Jemella Australia Pty Ltd v Daizli [2009] FCA 1566

In the Daizli action there is a further complication that the respondents seem to be out of the jurisdiction for some time. His Honour also refers to products being offered for sale on eBay. But, other than those products being alleged to be infringing, I’m not sure what particular significance that has.

Customs seizure and trade marks Read More »

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