Archive for August, 2012

No damage for infringing copyright in questionnaire

Wednesday, August 29th, 2012

Besanko J has awarded Insight SRC $32,510.00 for the infringements of its copyright in the School Organisational Health Questionnaire by the Australian Council for Educational Reseaarch (ACER). The award consisted of $10 nominal damages and $32,500 by way of additional damages. There are some interesting points about ownership, assignment and damages.

The questionnaire consisted of 57 questions arranged under 12 headings or modules. ACER reproduced some 25 of these questions from 5 modules between 2006 and October 2009 as part of a project with Independent Schools Victoria.

There was no dispute that copyright subsisted in the questionnaire or that ACER had reproduced a substantial part. Rather, ACER disputed Insight SRC’s title to the copyright and whether Insight SRC had suffered any damage.

Ownership

ACER’s basic point was that, as Dr Hart made the questionnaire in the course of his employment by the Victorian Department of Education, the Department (or the Crown) and not Dr Hart was the owner of the copyright pursuant to s 35 or the Crown Copyright provisions (here and here) of the Copyright Act 1968. If Dr Hart was not the original owner of the copyright, Insight SRC had no title since its rights depended on a chain of assignments starting with Dr Hart and not involving the Department (or the Crown).

Besanko J agreed with ACER that Dr Hart had created the questionnaire while employed by the Victorian Department of Education. However, his Honour found that Dr Hart and the Department (through Dr Hart’s superior) had agreed Dr Hart would retain ownership of the copyright and so s 35(6) and s 176 were excluded by the operation of s 35(3) and s 179.

The interesting point here is that the agreement between Dr Hart and his superior was purely oral but, as Besanko J pointed out, unlike the case with assignments pursuant to s 196 or s 197, there was no requirement for an agreement which excluded the operation of s 35(6) and s 176 to be in writing.

Besanko J did also find that s 176 would not have applied as Dr Hart, although an employee of the Department, was not acting under the control or direction of anyone in the Department in creating the questionnaire.

Assignment

Insight SRC claimed to be the owner of the copyright in the questionnaire by assignment. The assignment of copyright to it was made on 1 October 2009; that is, after ACER had ceased its infringing conduct.[1]

The main point of interest is that prior to 12 May 2011, none of the assignments – to Hart Cultural Lodges or Insight SRC – included the right to sue for past infringements. Deeds assigning the right to sue for past infringements from Dr Hart to Hart Cultural Lodges and then from Hart Cultural Lodges to Insight SRC were executed only on 12 May 2011.

After a review of the case law, including Trendtex and the High Court’s ruling in Equuscorp v Haxton, Besanko J accepted that Australian law now permitted the assignment of “bare” rights to litigation provided the assignee had a pre-existing genuine commercial interest in enforcing the claims of the assignor:

…. It must now be taken to be established in Australia that the circumstances in which a bare or mere right of action may be assigned include a case where the assignee has a pre-existing genuine commercial interest in enforcing the claims of the assignor.

While Besanko J was somewhat bemused why there was an assignment to Hart Cultural Lodges, his Honour considered that the ownership of the copyright in the questionnaire was a sufficient pre-existing genuine commercial interest to validate the late assignment of the right to sue for past infringements.

Damages

ACER generated some $213,000 in revenue from its infringing use of the questionnaire. Independent Schools Victoria in turn earned some $807,000 from supplying the questionnaire to its associated schools in infringement of the copyright.

Besanko J refused to award Insight SRC general damages; his Honour awarded nominal damages of $10 only.

The basis for this refusal to award general damages was that all Insight SRC obtained through the assignment of the right to sue for past infringements was whatever rights Dr Hart had to assign. Dr Hart himself had no right to general damages because:

118 …. Dr Hart was not personally conducting a business involving the use of the [questionnaire] between the beginning of 2006 and 1 October 2009 and it has been no part of their case before me that Dr Hart personally would have exploited any commercial opportunities with ISV. Furthermore, Dr Hart did not claim that he could recover any such loss as the major shareholder of Insight SRC and that the Court could lift the corporate veil. On the other hand, what Dr Hart did have as the copyright owner was a right to nominal damages for infringement of copyright and a right to claim additional damages under subs 115(4). An award of nominal damages is appropriate to vindicate the invasion of a copyright owner’s proprietary right….

That is, as Dr Hart was not himself in the business of selling the questionnaire, he could not claim the profits lost on the sales made by an infringing “competitor” – he was not in competition with ACER.

If general damages had been available, Besanko J would have assessed them at $130,000. Rather questionably (with respect),[2] his Honour started with the revenue earned by ACER and reduced that amount by its costs to reflect the profits it made.

Besanko J would not have made any allowance for the revenues made by Independent Schools Victoria as that was not how Insight SRC put its case. The judgment does not explain why Insight SRC did not pursue such a claim. Presumably, it would not have claimed a share of Independent Schools Victoria’s revenues if it [or its exclusive licensee, rather] had secured the contract instead of ACER.

Additional damages

Besanko J found that ACER’s infringement was flagrant and awarded $32,500 by way of additional damages pursuant to s 115(4). ACER had a permissions unit to secure copyright licences where necessary and well knew of its obligations not to use copyright for commercial purposes without an appropriate licence. The fact that the officer in charge of ACER’s program did acknowledge Dr Hart’s authorship in footnotes did not save ACER either.

The amount of any additional damages is highly discretionary and notoriously difficult to predict. Given his Honour’s finding that ACER made $130,000 profit[3] and the permissibility of taking into account that profit in assessessing the amount of additional damages,[4] the award may seem surprisingly low given his Honour’s characterisation of the infringement as flagrant.

Insight SRC IP Holdings Pty Ltd v The Australian Council for Educational Research Limited [2012] FCA 779


  1. The situation was rather more complicated: Dr Hart had assigned, or purported to assign, his copyright in the questionnaire to Hart Cultural Lodges (Dr Hart’s family trust) by two deeds, both dated 30 June 2009 and Hart Cultural Lodges in turn assigned its interests to Insight SRC by deed dated 1 October 2009. Dr Hart was the director and major shareholder of Insight SRC. To complicate matters further, Insight SRC granted an exclusive licence to another “Insight” company of which Dr Hart was also the director and major shareholder. That other Insight company having been the operating entity between 2006 and 2009, but not having a written agreement in place to qualify it as an exclusive licensee in terms of the Act.  ?
  2. See Aristocrat Technologies v DAP Services (Kempsey) [2007] FCAFC 40 at [3], [18]-[20].  ?
  3. At [190] in the face of ACER’s claim at [151] that it made no profits at all.  ?
  4. See Aristocrat Technologies v DAP Services (Kempsey) [2007] FCAFC 40 at [48]-[54] and Facton Ltd v Rifai [2012] FCAFC9 at [40]–42] and [48].  ?

Trying to sue an (alleged) overseas infringer

Monday, August 27th, 2012

Bennett J has refused Servier’s attempt to join several Apotex entities located outside Australia in its infringement action against the Apotex Australian arm.

Servier is the patentee of Australian patent No 2003200700 for the arginine salt of perindopril (perindopril arginine). Apotex Pty Ltd obtained listing with the Therapeutic Goods Administration (TGA) for a generic version of perindopril arginine. It commenced proceedings under s 138 of the Patents Act to revoke Servier’s patent.

Servier counter-claimed for infringement. Apotex Pty Ltd conceded the product it proposed to import would infringe Servier’s patent, if valid, and consented to an injunction prohibiting the importation and sale of its product pending the outcome of the revocation action.

Subsequently, Servier wished to join several related Apotex entities, all located and operating outside Australia, to its infringement allegations pursuant to Part 10.4 of the Rules. The infringements alleged were common design and authorisation. Bennett J had previously granted Servier leave to serve its infringement proceedings for another of its perindopil patents against at least 2 of the Apotex entities in question, Apotex Inc. and Apotex Pharmacem Inc.

As there can be no liability for authorisation or common design unless there is an act of primary infringement (i.e., someone must actually do something which is an act of infringement such as making or importing or selling or using the patented invention),  Servier sought relief on a quia timet basis; i.e., the risk that infringements would occur in the future.

 Servier relied principally the nature of the Apotex group as “a vertically integrated corporate group or a single worldwide organisation”, evidence from the earlier case that Apotex Inc. was the parent of Apotex Pty Ltd and directed its operations and information gleaned from Apotex Pty Ltd’s submissions to the TGA for marketing approval showing involvement by Apotex Pharmacen Inc. and several other entities whose names were redacted.
The central reasons for Bennett J’s refusal to permit service out were that:
60. The problem for Servier … is that there is no present actual or threatened primary infringement. If the Patent is valid, it is admitted by Apotex that the sale of Apotex P/L’s perindopril arginine is an infringing product. The only conduit for its sale, on the evidence, is Apotex P/L. Apotex P/L is subject to an interim injunction which will be made permanent if the Patent is valid. If the Patent is invalid, there is no question of infringement.
61. If Apotex P/L is not infringing and there is no present threat by Apotex P/L to infringe, there is no present basis for an injunction against the overseas cross-respondents to restrain any presently occurring act; there is no present infringement and no present threat to infringe.
62. Servier suggests that it could be the case that the overseas cross-respondents could produce a new product or enter into a common design with another Australian company to infringe the claims. Apart from a hypothetical suggestion made by Servier’s counsel, there is no factual basis for such a threat or such an apprehension.
63. In the present case, the threat is not imminent. There is no demonstrated real risk of wrongful conduct which would cause injury. ….
The evidence in this case, in contrast to the earlier case, showed that Apotex Inc. was not in fact the parent of Apotex Pty Ltd, they were different arms of the same corporate group.
In addition, both Apotex Inc. and Apotex Pharmacen Inc. were the subject of injunctions in Canada which precluded them from making perindopril arginine.
All of these facts distinguished the present application from the earlier case. Moreover, to date, only Apotex Pty Ltd had marketing approval from the TGA to import and offer for sale the Apotex version of perindopril arginine.

A second point is of general application.

The old rule in terms conferred a discretion on the Court whether or not to permit service out. Servier pointed out that Rule 10. , in contrast, is not expressed to be discretionary and, accordingly, it was entitled to an order for service out having satisfied the criteria specified. Bennett J was having none of that:

  • rule 10.43 set out matters an applicant for service out needed to satisfy, it did not constrain the Court;
  • after reference to s 37M, her Honour pointed that
    • Rule 1.31 empowered the Court to make any order in the proceeding having regard to the nature and complexity of the proceeding and taking into account proportionality
    • Rule 1.32 empowered the Court to make any order that the Court considers appropriate in the interests of justice (which included the power not to make an order) and
    • Rule 1.34 permitted the Court to dispense with compliance with the Rules

(Although it was unnecessary for her Honour to mention it, Rule 1.35 also permits the Court to make orders inconsistent with the rules.)

Apotex Pty Ltd v Les Laboratoires Servier (No 2) [2012] FCA 748

ALRC’s Copyright and Digital Economy Issues Paper

Monday, August 20th, 2012

The ALRC has published an Issues Paper for its inquiry into Copyright and the Digital Economy.

In an attempt to provide some structure to the anticipated submissions, the Issues Paper propounds some 55 questions over a range of topics including:

  • should (maybe that should include “can”) Australia adopt a “fair use” exception (questions 52 – 53) – an earlier assessment by the CLRC (pdf – see p.7 for the recommendations);
  • is there a need for greater freedom for “transformative uses” such as ‘sampling’, ‘remixes’, and ‘mashups’ (questions 14 – 18)
  • to what extent should copying for private and domestic use be permitted more freely, including should Optus be able to provide its Optus TV Now service (questions 7 – 13);
  • orphan works (questions 23 & 24);
  • library and archive exceptions (questions 19 – 22);
  • data and text mining (questions 25 – 27);
  • educational institutions (questions 28 – 31);
  • Crown use (questions 32 – 34);
  • retransmission of free-to-air broadcasts (questions 35 – 39);
  • do the statutory licensing schemes work efficiently in the digital environment and are new licences needed (questions 40 – 44);
  • should there be any other free use exceptions and should any existing exceptions be done away with (questions 48 – 51);
  • to what extent should people be able to “contract out” of copyright exceptions (questions 54-55) – see what the CLRC thought (pdf).

The Issues Paper is available on the web, as a pdf, an ePub and also in rtf components. (So far as I can see, it does not appear to be available in “dead tree” form.)

Submissions are sought by 16 November 2012. The ALRC itself is required to report by November 2013.

If you are looking for an overview of what is already in place, the Australian Copyright Council’s take is here (pdf).

Intellectual Property Laws Amendment Bill 2012 – exposure draft

Saturday, August 18th, 2012

IP Australia has released for public comment an exposure draft of the proposed Intellectual Property Laws Amendment Bill 2012. The Bill has 2 purposes:

  1. to amend the Patents Act 1990 in light of the DOHA Declaration / TRIPS Protocol; and
  2. to confer original jurisdiction in matters arising under the Plant Breeder’s Rights Act 1994 on the Federal Magistrates Court in addition to the Federal Court’s existing jurisdiction.

DOHA Declaration[1] / TRIPS Protocol

Article 31 (scroll down) of the TRIPS Agreement permits members of the WTO to permit the use of patented inventions without the permission of the rightholder in the circumstances set out in the article.

The HIV/Aids crisis in Africa revealed a problem in this regime in that a number of countries which needed to rely on these provisions did not have the infrastructure, or were otherwise unable effectively, to take advantage of this regime. The basic idea underlying, first, the DOHA Declaration and, then, the TRIPS Protocol is to enable such countries to take advantage of the facilities and expertise in other countries by having the relevant drug made under compulsory licence in the foreign country.

So far, only Canada has notified the WTO pursuant to the DOHA Declaration that it has granted a compulsory licence to Apotex to export TriAvir[2] to Rwanda.[3]

Following on from consultations begun in 2010, the Government announced its intention to amend the Patents Act to implement the DOHA regime in March last year. The object of the proposed amendments is to introduce a regime for the grant of compulsory licences of pharmaceutical products on public health grounds for export to least-developed or developing countries (to be defined in the Bill as “eligible importing countries”).
As the TRIPS Protocol is not yet in force,[4] schedule 1 of the Bill is intended to implement the interim regime adopted under the DOHA Declaration. When the TRIPS Protocol does come into force, the regime in schedule 1 will be superseded by the regime to be enacted by schedule 2 of the Bill.

In either case, the regime will be separate from, and independent of, the existing compulsory licensing regime relating to domestic non-use which is currently the subject of a reference to the Productivity Commission.

As with the existing “non-use” regime, any compulsory licences would be granted only on application to the Federal Court, and not the Commissioner of Patents. If the patents in question are innovation patents, it would be necessary to apply for certification (where that has not occurred already).

Federal Magistrates Court

The extension of jurisdiction over PBR matters to the Federal Magistrates Court, which “is designed to deal with less complex matters more quickly and informally than the Federal Court”, follows several years experience with copyright matters and the extension of jurisdiction over patent, trade mark and registered design matters enacted by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012, which comes into effect on 15 April 2013.

Onus in trade mark oppositions

I wonder why the bill doesn’t fix up the onus for oppositions to the registration of trade marks to the “balance of probabilities” standard in line with the amendments – see Part 2 – that will apply in patent oppositions from 1 April 2013?

Submissions should be made by 1 October 2012.

Intellectual Property Laws Amendment Bill 2012 – exposure draft

Exposure draft Explanatory Memorandum

IP Australia’s Home Page for the exposure draft process.


  1. This is not strictly accurate terminology: I am using it as shorthand to refer to the WTO Council decision in December 2003 on paragraph 6 of the DOHA Declaration made in 2001. The WTO’s overview page is here.  ?
  2. A fixed-dose combination product of Zidovudine, Lamivudine and Nevirapine, according to Rwanda’s notification: see View Notifications.  ?
  3. The compulsory licence was issued by the Commissioner of Patents on 19 September 2007 for a period of 2 years: click on View notifications.  ?
  4. Australia has already accepted the TRIPS Protocol, but it does not come into force until two thirds of WTO’s 155 members accept it. If one counts the EU as “one” member – not sure on the politics of this as there are currently 27 members of the EU, as at May this year 44 members had accepted the TRIPS Protocol.  ?

Tobacco plain packaging

Wednesday, August 15th, 2012

Quote from the High Court:

At least a majority of the Court is of the opinion that the Act is not contrary to s 51(xxxi).

Reasons (which may explain that rather cryptic quantity) to follow later.

So, by 1 December 2012, all retail cigarette packs in Australia will look something like this. – the colour is officially described as Pantone 448C.

Tobacco Plain Packaging Act 2011

Tobacco Plain Packaging Regulations 2011

Tobacco Plain Packaging Amendment Regulations 2012 – extending regime to cigars and tobacco pouches.

On the global front, Ukraine, Honduras and Dominican Republic have brought complaints against Australia before the WTO dispute resolution process and, so far, Brazil, Canada, El Salvador, the European Union, Guatemala, Indonesia, Nicaragua, New Zealand, Norway, the Philippines, Uruguay and Zimbabwe have joined in the consultations.

So far as I can work out, the arbitration between Philip Morris and Australia under the 1993 Agreement between the Government of Australia and the Government of Hong Kong for the Promotion and Protection of Investments has reached the stage where the panel of 3 arbitrators has been established.

Ambush marketing or how did …

Thursday, August 9th, 2012

… Darth Vader get past LOCOG security?

Watch

(Really starts after 00:23 and watch the crowd at 01:00 and 2:00.)

Lid dip: James McDougall

Mediaquest v Registrar

Friday, August 3rd, 2012

It turns out that the Registrar does have power to undo an assignment of a registered trade mark that has been registered wrongly.

A Mr Brailsford was the registered owner of the Peel Away trade mark for paint stripping preparations, TM No. 741047. He died in 2008.

On 23 Setember 2010, trade mark attorney McInnes filed an application to register an assignment of the trade mark to Mediaquest.

On 8 October 2010, the Registrar registered the assignment and Mediaquest became the owner of TM No. 741047.

On 12 November 2010, trade mark attorney Wilson wrote to the Registrar complaining about the registration of the assignment without notification to him and challenging it. Mr Wilson was acting for Mr Brailsford’s heirs and had been the address for service entered in the Register when the application to register the assignment was lodged.[1]

On 22 November 2010, the Registrar wrote to Mr McInness stating that the documentation relied on to establish the assignment was inadequate and so the Registrar intended to cancel the registration of assignment pursuant to s 81. Mediaquest objected to this and pointed out, amongst other things, that it had withdrawn a pending non-use action once the assignement was registered.

Further correspondence took place and, in due course, a hearing at which the delegate concluded Mediaquest had not established its entitlement to be registered as the assignee. Mediaquest appealed.

On appeal, Emmett J held that:

1 Mediaquest was not entitled to an assignment; and
2 the Registrar did have power to cancel the registration of the assignment.

Ownership

Mediaquest claimed it had an assignment from CRT. Mr Brailsford was the president and a director of CRT. Mediaquest sought to argue that his registration of TM No 741047 in Australia was in breach of his duties to CRT as a director and consequently the trade mark belonged in equity to CRT and, as a result of an assignment from CRT to Mediaquest, to it.

It seems Mr Brailsford may well have coined the mark and used it in the USA. At one point, the US mark was owned by another of Mr Brailsford’s companies, Pilgrim. In November 1992, Pilgrim assigned all its rights to Mr Brailsford and, in August 1993, Mr Brailsford assigned all his (US)[2] rights to CRT. It was after this, in 1997, that Mr Brailsford applied to register what became TM No. 741047 in Australia in his own name. In 1998, CRT applied to register a patent in the UK, identifying Mr Brailsford as the inventor and claiming entitlement through agreement with him.[3]

Emmett J found Mr Brailsford was entitled to register TM No. 741047 in his own name:

  • CRT was clearly the owner of the US trade marks;
  • both Pilgrim and CRT were creatures of Mr Bailsford;
  • while CRT was incorporated in Jersey in the Channel Islands, there was no evidence that it had ever traded anywhere other than in the USA or the UK.

At [34]:

The contention advanced on behalf of Mediaquest is that Mr Brailsford acquired the opportunity to register the Peel Away Mark in Australia by reason of his being a director of CRT. However, that can only be an inference. The circumstance that Mr Brailsford had dealings with the Peel Away mark before CRT was incorporated gives rise to a contrary inference. That is to say, it does not necessarily follow that the opportunity of registering the Peel Away mark in Australia was one that came to Mr Brailsford by reason of his being a director of CRT. Rather, an inference is at least available, and may perhaps be more easily drawn, that CRT acquired whatever opportunity it had to exploit the Peel Away Mark, and associated technology and knowhow, because Mr Brailsford chose to make it available to CRT. (emphasis supplied)

In these circumstances, his Honour concluded at [36] that the opportunity to register the trade mark in Australia did not come Mr Brailsford’s way because of his role in CRT and so CRT was not entitled to the trade mark in equity.

Power to cancel

Section [88(2)(e)] provides a power to rectify the Register on the basis that an entry in the Register “was made, or has previously been amended, as a result of fraud, false suggestion or misrepresentation.” This power, however, is conferred on the Court, not the Registrar.

Emmett J noted that under s 109 and s 110 the Registrar only had power to register an assignment of a trade mark. Whether there had been a valid assignment was a jurisdictional fact and, if there had not been a valid assignment, there was no power to register the assignment. In such a case, therefore, the Registrar had power to cancel the erroneous entry. As a result at [54]:

There was no actual assignment of the Registered Mark to Mediaquest, either from Mr Brailsford or from his executors. Accordingly, the Registrar’s decision of 8 October 2010 to record the assignment in the Register was tainted by jurisdictional error and was no decision at all. It was therefore open to the Registrar to reconsider whether the duty imposed by s 110 had been enlivened, by revisiting the question of whether there was an actual assignment or transmission of the Registered Mark to Mediaquest. Having determined that there was no actual assignment or transmission, it was open to the Registrar to take steps to cancel the earlier action. There is nothing in the Act to indicate that a decision of the Registrar under Part 10 that was affected by jurisdictional error should continue to have legal effect. Indeed the considerations outlined above suggest the contrary.

In answer to Mediaquest’s concerns about the uncertainty this would give rise, Emmett J pointed out at [56] that:

the scheme of the Act is not proprietorship by registration but registration of proprietorship. Registration under the Act is only prima facie evidence of ownership, as is provided by s 210. The registered owner is always susceptible to action being taken under Part 8 to revoke a trade mark that should never have been registered, or to substitute the true owner of the trade mark for that of a wrongful claimant. True ownership of a trade mark is a defence to infringement proceedings brought under the Act.

That is, registration was only prima facie evidence of ownership. Accordingly, all registrations were subject to an inherent level of uncertainty.

One interesting aspect of his Honour’s approach is that it does not appear to be based on the power conferred by s 81. Rather, it seems to have a much more fundamental underpinning in “jurisdictional error”.

No doubt, there is a sense here that the Court is not interested in technicalities that would force all of these types of disputes to be brought before it rather than knocked on the head in the Office. One might wonder, however, why the Registrar does not require documentation signed by the assignor as well as the assignee in the first place. This may well become more of an issue with the recordal of security interests as the Registrar’s practice is apparently to allow an interest to be recorded by the person claiming to have taken out a security interest alone.

Mediaquest Communications LLC v Registrar of Trade Marks [2012] FCA 768


  1. At the moment, as a result of Emmett J’s decision, Mr Brailsford is shown as the owner, but (presumably) Mr McInnes’ firm is shown as the address for service.  ?
  2. It is not clear from the judgment whether the agreement was in terms limited expressly to the US rights or this is an inference from the limited rights then existing.  ?
  3. The nature of the agreement is not specified in the judgment.  ?

Apotex v Sanofi: the (un)implied licence

Friday, August 3rd, 2012

In addition to finding Sanofi’s patent infringed, the Full Court affirmed Jagot J’s conclusion that Apotex had no implied licence to reproduce the copyright in Sanofi’s product information documents (PID).

Before a (medicinal) drug can be offered for sale in Australia, it must be registered in the Australian Register of Therapeutic Goods by the Therapeutic Goods Administration. One of the requirements for registration is the submission of a PID, describing the drug, what it can be used for and how and providing warnings about potential problems and risks.

Apotex argued that it was industry custom or usage for the suppliers of generic drugs simply to provide PID for their generic drugs in substantially the same terms as the originator’s PID. It provided evidence of many cases where this had happened, including a number of cases in which Sanofi’s generic arm had simply re-used a competitor’s original PID itself. This included:

13 drugs of which Sanofi-Aventis was the innovator and 22 generic versions of the same drug,
the top 10 drugs by value on the PBS and 62 generic versions of the same drug,
some eight drugs of which companies other than Sanofi-Aventis were the innovators and generic versions of those drugs of which Sanofi-Aventis was the issuer.

The TGA did not require PID submitted by generics to be in the same terms as the originator’s PID. If a generic’s PID was different in substance or terms, however, the TGA may require the generic to submit additional safety or efficacy data to support registration of its own formulation.

On the last day of trial, Sanofi was also allowed to introduce evidence showing that some generics did in fact prepare and register their own PIDs rather than just copy the originator’s PID.

In this state of affairs, the Full Court unanimously upheld Jagot J’s conclusion that the evidence of an implied licence was at best equivocal and so rejected the implication. (Keane CJ [80]-[81], Bennett and Nicholas JJ [98]-[208])

It is difficult to resist the impression that, if instead of being sober judges their Honours (at least Bennett and Nicholas JJ) were teenagers, the suggestion that a licence could be implied between parties who were not in any type of contractual or consensual relationship would have been met with:

rofl.

As to the public interest, Parliament was forced to intervene (at the legislative equivalent of the speed of light) and create yet another specific defence and, in due course, Jagot J found that Apotex could rely on it as a defence (for acts done after the amendment came into force).

So far, 2012 is not proving an easy year for those trying to claim they have an implied licence to protect themselves from infringement allegations.

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (No 2) [2012] FCAFC 102

The Chief Justice’s address

Thursday, August 2nd, 2012

A video of Chief Justice French’s 4th Annual Francis Gurry address A Public Law Perspective on Intellectual Property Law is now online.

TPM exceptions review

Wednesday, August 1st, 2012

Following my post on the ALRC’s reference re exceptions in the digital environment, a couple of people kindly pointed out the Attorney General’s department is also conducting a review of the exceptions to technological protection measures.

A technological protection measure is … well, anyway, since the Sony v Stevens stuff up, the definition has been “fixed up” to close that gulf by adding access control technological protection measure as well.

Section 116AN provides for a number of exceptions – e.g. interoperability, encryption testing, security testing, online privacy, law enforcement and national security, libraries – and s 116AN(9) provides a regulation making power to create additional exceptions.

The existing “additional” exceptions are found in Schedule 10A of the Copyright Regulations.

The US Copyright Office is currently a large way through its 5th 3 year “ad hoc” rulemaking exercise for the counterpart arrangements under the US Act.

The review’s home page is here and the pdf of the issues paper is here.

Submissions about the exceptions should be in by 17 August 2012

Responses to those submissions should be in by 5 October 2012.

(Congratulations to the AGD for a sensible, structured approach to submissions which recognises that some people will definitely have something to say about what other people submit!)

Lid dip:

Alison Bradshaw

@ADA_ellenbroad