Abilify interlocutory injunction continues pending appeal

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.  ?

Productivity Commission to review all IP laws

The Harper Review[1] recommended that the Government should direct the Productivity Commission to undertake an overarching review Australia’s IP laws.

The Treasurer and the Minister for Small Business have now announced that review.

According to the Harper Review:

an appropriate balance must be struck between encouraging widespread adoption of new productivity-enhancing techniques, processes and systems on the one hand, and fostering ideas and innovation on the other. Excessive IP protection can not only discourage adoption of new technologies but also stifle innovation.

Given the influence of Australia’s IP rights on facilitating (or inhibiting) innovation, competition and trade, the Panel believes the IP system should be designed to operate in the best interests of Australians.

The Panel therefore considers that Australia’s IP rights regime is a priority area for review. (emphasis supplied)

In reaching that view, the Harper Review flagged concern about entering into new treaties with extended IP protections.

The terms of reference state:

In undertaking the inquiry the Commission should:

  1. examine the effect of the scope and duration of protection afforded by Australia’s intellectual property system on:

    a. research and innovation, including freedom to build on existing innovation;

    b. access to and cost of goods and services; and competition, trade and investment.

  2. recommend changes to the current system that would improve the overall wellbeing of Australian society, which take account of Australia’s international trade obligations, including changes that would:

    a. encourage creativity, investment and new innovation by individuals, businesses and through collaboration while not unduly restricting access to technologies and creative works;

    b. allow access to an increased range of quality and value goods and services;

    c. provide greater certainty to individuals and businesses as to whether they are likely to infringe the intellectual property rights of others; and

    d. reduce the compliance and administrative costs associated with intellectual property rules.

Then follows a catalogue of 9 matters for the Commission to have regard to. These include the Government’s desire to retain appropriate incentives for innovation, the economy-wide and distributional consequences of recommendation and the Harper Review’s recommendations in relation to parallel imports.[2]

The Commission must report within 12 months.


  1. The Competition Policy Review, recommendation 6.  ?
  2. Rec. 13 and section 10.6 of the Competition Policy Review: i.e., repeal any remaining restrictions unless the benefits outweigh the costs and the objectives of the restrictions can only be achieved by restricting competition. Cue diatribe about “restricting competition” especially given the oft mouthed formula that IP rights rarely (if ever) restrict competition.  ?

Dallas Buyers’ Club: no sale (yet)

Perram J has refused to allow Dallas Buyers Club LLC to send out its proposed letters of demand to the account holders identified through its preliminary discovery application.

Under pressure from the judge, Dallas Buyers Club LLC was forced to disclose that it would be seeking to claim compensation under 4 heads:

  1. the lost licence fee on the copy downloaded by the (alleged) infringer;
  2. a licence fee for each copy shared (uploaded) by the (alleged) infringer;
  3. an amount for additional damages;
  4. compensation for the costs incurred in detecting the (alleged) infringer’s involvement and the preliminary discovery application.

Perram J considered that (1) and, perhaps more surprisingly, (4) were legitimate. (2) and (3), however, were not.

Perram J also indicated his Honour would be prepared to lift the stay on sending the letters out if limited to (1) and (2). Bearing in mind that Dallas Buyers Club LLC is not in the jurisdiction, however, his Honour would require Dallas Buyers Club LLC to post a bond of $600,000 as surety for its compliance with his Honour’s orders about the use of the information.

His Honour did get informed what sum Dallas Buyers Club LLC actually had in mind demanding if some (alleged) infringer did contact it in response to the proposed letter. Other than disclosing that it was “substantial”, his Honour did not spill those beans to the public.

At [7] and [8], his Honour further indicated the Court’s considerable unwillingness to embark on the type of supervisory role over the use of the discovered information that the English and Canadian courts have been willing to undertake. Perram J thought those courts might be more willing to engage in such supervision as a result of the human rights protections for privacy in those jurisdictions. Perram J accepted that the discretionary nature of the preliminary discovery remedy permitted privacy issues to be taken into account. Rather than embark in close, ongoing supervision, however, it would appear that an Australian court will not afford the rights holder too many chances to satisfy the Court that it would use the discovered information appropriately

Dallas Buyers Club LLC v iiNet Limited (No 4) [2015] FCA 838

lid dip @mslods

Program formats and copyright

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

Innovation patent consultation on the consultation

IP Australia has issued a consultation paper seeking the public’s view on (the now departed) ACIP’s recommendations for the innovation patent. Specifically:

IP Australia is seeking feedback from interested stakeholders on:

  • the ACIP recommendation that the government should consider abolishing the innovation patent system
  • any alternative suggestions to encourage innovation amongst SMEs.

Get your comments in by 25 September 2015

IP Australia’s consultation paper here (pdf or word). The ACIP report being “consultated” upon, via here and updated here.