2012

Apotex v Sanofi: the (un)implied licence

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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

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The Chief Justice’s address

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

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TPM exceptions review

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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

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Google v ACCC

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Following on from yesterday’s post, @davidstarkoff points out that:

  • the transcript of the special leave application can be found here; and
  • in due course, the submissions will appear here.

The hearing of the appeal has been fixed for 11 September 2012.

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ACCC v Google

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Apparently, back on 25 June the High Court granted Google special leave to appeal from the Full Federal Court’s ruling that Google is liable for the misleading ads placed by advertisers.

Maybe the internet will be able to keep working in Australia after all.

Austlii is only up to 20 June, at the time of posting.

Lid dip “Law Geek Down Under“

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Apotex v Sanofi

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The Full Court (Keane CJ, Bennett and Yates JJ) has unanimously dismissed Apotex’ appeal from Jagot J findings that it had infringed Sanofi-Aventis’ patents and copyright. Bennett and Yates JJ delivered a joint opinion, Keane CJ his Honour’s own reasoned opinion.

Patent

Sanofi’s patent had just one claim:

A method of preventing or treating a skin disorder, wherein the skin disorder is psoriasis, which comprises administering to a recipient an effective amount of pharmaceutical composition containing as an active ingredient a compound of formula I or II … [i.e., leflunomide]

Manner of manufacture

Keane CJ recorded at [25] that Apotex did not press orally its argument that methods of medical treatment are not patentable in Australia. Both judgments, however, explicitly refused to re-open the question following Rescare and Bristol-Myers Squibb in light of long standing practice and Parliament’s lmitation of the exclusion from patentability in s 18(2) to humans and the biological processes for their generation.

Keane CJ, Bennett and Yates JJ would also have granted leave to Apotex to argue on appeal that “methods of medical treatment for a “second or later medical use” not limited by the purpose of the treatment are not patentable inventions.”

Whatever the merits of that ground “(a matter on which we express no view)”, however, Bennett and Yates JJ considered at [195] it could not succeed in this case as there was no disclosure on the face of the specification to found the Microcell argument as interpreted in Bristol-Myers Squibb. Keane CJ at [27] considered the ground as argued failed because, properly construed, the claim did not extend to any use of leflunomide that inevitably had some incidental beneficial effect on psoriasis.

Infringement

The Court unanimously rejected Sanofi’s argument that the claim covered any administration of leflunomide which happened to (or also to) result in the treatment of psoriasis. In this context, their Honours were concerned about giving Sanofi a “monopoly” wider than its disclosure or the consideration for the grant of the patent.

This didn’t help Apotex, however.

First, Apotex’ product was approved for, and its product literature stated it was indicated for the treatment of active rheumatoid arthritis and active psoriatic arthritis. The product literature also stated “Apo-Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.”

Use of leflunomide to treat rheumatoid arthritis itself would not infringe. However, those treating psoriatic arthritis knew that the patient would also have psoriasis or, if not treated, would develop psoriasis. Thus, the Full Court agreed with Jagot J that the plain meaning to those skilled in the art of the statement “Apo-Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease” was an instruction to use Apo-Leflunomide for the treatment of psoriasis in conjunction with the treatment or prevention of psoiratic arthritis.

Secondly, use for the purpose of treating, or preventing, psoriasis in conjunction with psoriatic arthritis would be an infringing use. Their Honours were not overwhelmed by the supposed terrors of determining the purpose for which leflunomide was prescribed, bearing in mind that it was a prescription drug. Bennett and Yates JJ saw this at [126] is simply a question of characterising the impugned conduct. Keane CJ questioned at [38] to [40] whether the proposition from Merrell Dow that infringement did not depend on the infringer’s state of mind was in fact “absolute” and noted that, in circumstances where a prescription only drug was being prescribed by medical practitioners, the purpose of administration should be reasonably ascertainable.

Accordingly, Apotex infringed on the basis of (at least) s 117(2)(c).

Copyright

May be the subject of a later post.

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

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Compulsory licensing of patents

2 Comments / Enforcement, Patents / / / , , , , , , ,

The Assistant Treasurer has referred the operation of the compulsory licence regime within the Patents Act 1990 to the Productivity Commission for review.

At present, sections 133 to 140 of the Patents Act provide for applications to be made to the Federal Court for a compulsory licence to work a patent where

(i) the applicant has tried for a reasonable period, but without success, to obtain from the patentee an authorisation to work the invention on reasonable terms and conditions;

>(ii) the reasonable requirements of the public with respect to the patented invention have not been satisfied;

(iii) the patentee has given no satisfactory reason for failing to exploit the patent; or

the patentee has contravened the anti-competitive provisions in Part IV of the Competition and Consumer Act 2010.

The Terms of Reference require the Productivity Commission to:

  1. Assess whether the current Australian provisions can be invoked efficiently and effectively to deal with circumstances where reasonable requirements of the public are not being met or where the patentee engages in anti-competitive conduct. This includes, but is not limited to, consideration of concerns that gene patents may hinder access to affordable healthcare, including access to medical advice that relies on the identification and use of gene sequences related to human health and disease.
  2. Advise on the frequency, and impact, of the issue of compulsory licences in comparable markets and the common features in such compulsory licenses.
  3. Recommend any measures that may be required to efficiently and effectively exercise these safeguard provisions and invoke their use in a manner consistent with Australia’s international obligations, without limiting access to overseas technologies, technology transfer, research and development investments or substantially reducing the patent incentive for innovation.
  4. Recommend any alternative mechanisms deemed necessary to ensure that the balance between incentives to innovate and access to technology best reflect objectives of ensuring reasonable access to health care solutions, maximising economic growth and growing the Australian manufacturing industry.
  5. Recommend measures to raise awareness of these provisions and their purpose, including the specific challenges of raising awareness among small businesses and the healthcare sector.

The genesis of the reference seems to lie in the uproar resulting from the attempt to charge licence fees for diagnostic kits based on the BRCA 1 patent and, more recently, the smartphone wars.[1]

A number of submissions to the Senate’s Community Affairs committee claimed that there were a range of deficiencies with the present scheme. In addition, IP Australia told the Senate’s Community Affairs committee when it was investigating these (and other matters) that, in the 100+ years our law has had such provision, there had been only 3 applications for the grant of a compulsory licence. The ALRC had also recommended that the scope of ‘reasonable requirements of the public’ be clarified (the recommendation to make the competition test a basis for licensing having been sort of implemented when s 133(2)(b) was inserted in 2006.

The Terms of Reference also note that Australia is a net importer of technology with, for example, only 1,178 (or 8%) of the 14,557 patents granted in 2010 being granted to Australian residents.

The TRIPS Agreement allows us to do something in this sphere. See art. 40 and art. 27.2 even goes so far as to allow us to exclude from patentability things necessary to protect ordre public “including to protect human … life or health”.

Of course, the multi-million dollar question in all of this is what that elastic word “reasonable” might mean?

Do also note paragraph 4 of art. 40, which gives a country that is concerned its nationals are being prejudiced by the exercise of such rights an “opportunity for consultations”. Of course, such a country might just move straight to the dispute resolution processes. I wonder how a more liberal use of compulsory licensing, or the threat of it, would play with those of our trading partners who consider compulsory licences of patents to be anathema?

According to the Productivity Commission’s website:

1 an issues paper will be released in August;
2 initial submissions will be due by 28 September;
3 there will be a draft report released in early December;
4 public hearings will be held in February 2013; and
5 the final report will be delivered to the government on 29 March 2013.

  1. According to the Press Release amongst other things: “Of concern to government is a perception that patents over genetic technologies, or a perceived lack of licences to use these patents in Australia, unreasonably restricts or delays patient access to medical advice based on the latest diagnostic tests. Other areas of sensitivity include climate change mitigation, food security and alternative energy technologies, and technical standards essential patents (for example, in telecommunication technologies).”  ?

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A few exercises in parody?

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Gotye and Kimbra had that smash hit “Somebody I used to know“.

via Prof. Tushnet at the 43(B)log, there comes “The Star Wars I used to Know” (99USc or $1.69 in the Oz iTunes store).

Prof. Tushnet gives extra points for the artwork. I wonder about that, does it go too far? I guess there is that dig at the artwork too …

While we’re having fun:

Walk off the Earth did this theatrical cover of Gotye/Kimbra.

Then, in the Key of Awesome really took the sledgehammer to it.

Copyright Act 1968 (Cth) s 41A.

(see: it was IP related)

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ALRC terms of reference finalised

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The Government has announced the finalised terms of reference for the Australian Law Reform’s inquiry into copyright:

I refer to the ALRC for inquiry and report pursuant to subsection 20(1) of the Australian Law Reform Commission Act 1996 the matter of whether the exceptions and statutory licences in the Copyright Act 1968, are adequate and appropriate in the digital environment.

Amongst other things, the ALRC is to consider whether existing exceptions are appropriate and whether further exceptions should:

  • recognise fair use of copyright material;
  • allow  transformative, innovative and collaborative use of copyright materials to create and deliver new products and services of public benefit; and
  • allow appropriate access, use, interaction and production of copyright material online for social, private or domestic purposes.

As one might expect, the ALRC is directed not to duplicate work being undertaken by other inquiries and the like. It turns out that, amongst other things,  these include

not duplicate work being undertaken on: unauthorised distribution of copyright materials using peer to peer networks; the scope of the safe harbour scheme for ISPs; a review of exceptions in relation to technological protection measures; and increased access to copyright works for persons with a print disability.

Anyone know what that work is?

The ALRC is required to deliver its report by 30 November 2013.

Terms of reference here.

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ACTA in trouble in Australia

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The Age is reporting that a Parliamentary committee has “struck down” Australia’s signing of ACTA.

As it turns out, the Joint Standing Committee on Treaties has unanimously recommended that Australia should not ratify ACTA at this time. Recommendation 8 states:

That the Anti-Counterfeiting Trade Agreement not be ratified by Australia until the:

  • Joint Standing Committee on Treaties has received and considered the independent and transparent assessment of the economic and social benefits and costs of the Agreement referred to in Recommendation 2;
  • Australian Law Reform Commission has reported on its Inquiry into Copyright and the Digital Economy; and
  • the Australian Government has issued notices of clarification in relation to the terms of the Agreement as recommended in the other recommendations of this report.

Recommendation 9 goes on to exhort any future Committee on Treaties to take into account what is happening with ACTA in other jurisdictions including the EU and the USA.

Recommendations 3 to 7 relate to more specific matters such as, for example, a need to clarify the meanings of ‘aiding and abetting’ and ‘commercial scale’.

Apart from specific matters of particular detail, the Joint Standing Committee seems to have had two main concerns about ratification:

First, the Treaty was tabled in Parliament with a National Interest Assessment  (NIA). However, the NIA did not include an analysis of the economic impact that ratifying ACTA would have on Australia.

One reason why there was no economic analysis feeds into the Joint Standing Committee’s second major concern: the NIA stated that ACTA would not require any changes to existing Australian law. The benefit of ratifying ACTA (early) was that it would give Australia influence:

2.13 The NIA encourages the early ratification of ACTA, so as to enable Australia to play an influential role in the ACTA Committee, which will consider, inter alia, rules and procedures for reviewing the implementation and operations of ACTA.

In the absence of an economic assessment, however, the Joint Standing Committee noted there was an absence of reliable evidence that there is a “problem” that needs to be addressed. See [3.6] and reference to the concerns expressed, amongst others, by the US Government Accountability Office.

Secondly, the Joint Standing Committee received a number of submissions which challenged the view that no changes would be required to Australian law. For example, what does “aid and abet” or “commercial scale” mean? To what extent, if at all, are patents caught up in what is counterfeit?

How valid those concerns are may require further investigation but, as As. Prof. Weatherall pointed out, the ACTA Committee will have a role in developing more detailed enforcement mechanisms. The Joint Standing Committee also noted in several places that ACTA does not include the defences or exceptions expressed in TRIPS.

So far as I can work out (it is a long time since I studied constitutional law so let me know if you know better), the Joint Standing Committee has not in fact “struck down” ACTA or Australia ratifying it. The Committee’s recommendations do not constitute a resolution of a House of Parliament and ACTA is not a legislative instrument subject to disallowance on such a resolution.

As a treaty, ACTA would become part of our domestic law only if Parliament passed a statute to implement it. The Government could still ratify ACTA but the Joint Standing Committee’s recommendations are the unanimous recommendations of a cross-party committee so they plainly reflect a level of disquiet with ACTA within Parliament at a high level: a level of disquiet which appears to be felt even within the EU (one of the IP-exporting parts of the world one might think likely to support such a regime).

Download copies of the Committee’s report from here (pdf).

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