Commonwealth seeks $60 million on the undertaking as to damages

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

Australian Intellectual Property Report 2015

IP Australia has released its Australian Intellectual Property Report 2015.

In addition to reporting on a range of statistics and some commentary, the report includes a number of “interactive” graphs that you may explore. Much, if not all, of the data is available through the Government Open Data initiative.

The headline point is that applications for trade marks and plant breeder’s rights increased over 2013, while applications for patents and registered designs decreased. The report attributes the decline in patent applications to the increased threshold arising from the commencement of most of the substantive reforms in the Raising the Bar and the rush to file before their commencement.

Australians are the largest source of filings for trade mark, registered designs and pbr. US-based applicants the largest source of patent applications; Australian residents being the second largest.

There were 25,947 applications for standard patents in 2014, a decrease of 13% on 2013. 19,034 standard patents were granted; an increase of 13% over 2013. Over 94% were granted to non-residents. The average number of months from filing to request for examination fell from 16.3 to 13.6 months; the average time from request to first report is just over 9 month and, on average, the time from first examination report to acceptance was a further 14 months. Australians filed 9,012 patent applications abroad in 2013 (41% in the USA), up 3% on 2012.

There were 1523 applications for innovation patents, down from 1676 in 2013. Australians accounted for 66% of the filings.

There were 64,381 trade mark applications filed in Australia in 2014, up 2% from 2013; correspondingly, Australians filed 16,267 applications overseas (in 2013). The top 3 filing destinations were the USA, China and NZ – accounting for 50%. The USA supplanted China as the “top destination”. Apparently, this is in line with a global trend.

6550 designs were registered in 2014, and 1452 were certified – almost double the number certified in 2013. IP Australia speculates that there are few applications to register designs because:

According to Lim et al (2014) the role of IP rights in the market for designs is limited.9 Buyers and sellers in the market view designs as a service that is co-created. As IP rights protect the artefact, not the service, IP rights are perceived as a secondary issue in the marketplace. This view of design rights provides insights into the low volume of design registrations relative to patents and trade marks.

The number of applications for plant breeder’s rights skyrocketed from 330 in 2013 to 341!

The report notes that IP Australia is aiming in 2015 to complete research projects into innovation trends in the mining industry, who and in which areas in the textile, clothing and footwear industry is filing patents and the role of geographical indicators.

Blocking injunctions – the Bill

The Commonwealth Government has introduced into Parliament the Copyright Amendment (Online Infringement) Bill 2015. This bill will implement the second (or third) of the Government’s online infringement proposals.

The Bill would insert a new s 115A into the Act. Under s 115A, a copyright owner would have a right to apply to the Federal Court for an injunction against a carriage service provider[1] requiring the carriage service provider to take reasonable steps to block access to on online location outside Australia the primary purpose of which is to infringe copyright (whether in Australia or not).

The EM is at pains to stress that the website must be outside Australia – otherwise the copyright owner could sue directly – and its primary purpose must be copyright infringement. Thus, the EM says services like Youtube, iTunes and so on would not be exposed to the risk of injunction.

The bill does not prescribe what steps would be reasonable (to attempt) to block access, but presumably guidance may be sought from English decisions on this issue.

In deciding whether or not to grant the injunction, the Court will be directed to take into account a range of factors including, in particular, the flagrancy of the infringement and the proportionality of blocking access to the extent of the infringement.

Provision is also made for the person operating the website to be, or become, a party to the proceeding and to apply after an injunction has been granted for it to be rescinded or varied.

The carriage service provider will be liable for costs only if it enters an appearance and takes part in the proceedings. The bill does not make provision for whom should bear the costs of implementing and maintaining the injunction.

The injunctions provided by the English courts include a mechanism for copyright holders to “update” the webiste addresses so that, if the website operator changes the URL, it is an administrative exercise to notify the ISP. The Bill does not appear specifically to contemplate this, and it is unclear whether the Federal Court would, or should, adopt such a mechanism.

In addition to discussion of blocking methods, the Cartier[2] ruling in England includes an interesting discussion of the costs of such applications and also the costs incurred by the ISPs in implementing the injunctions. Apparently, after the initial cases, such an application typically cost the copyright owners around £14,000 with a further fee of around £3,600 per year per website for monitoring. The costs to ISPs reported by the judge ranged from a “low four figure sum per month” to a “low six figure sum a year”.

The Cartier case concerned websites infringing trade marks, not copyright. One might wonder whether the Australian law should also extend to trade marks?

The Senate has referred the Bill to its Legal and Constitutional Affairs committee for review. There is plainly not much to discuss about the bill, as the committee is due to report back by 13 May 2015 and you must make your submissions, if any, by 16 April 2015.

Copyright Amendment (Online Infringement) Bill 2015 (pdf)
Explanatory Memorandum (pdf)


  1. For you and me, that’s Telstra, Optus, iiNet/TPG, Foxtel etc., but real lawyers should go via s10 to here (take a tent and all necessary provisions and we’ll see you in several years).  ?
  2. Also known as Richemont after the third claimant.  ?