review

Parmaceutical Patents Review

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Last month, the Parliamentary Secretary for Industry and Innovation, Mark Dreyfus, has appointed a panel to review the patenting of pharmaceuticals in Australia.

Now the Panel have published a Background and Issues Paper.

The Panel’s initial impressions of key issues include:

  • a number of concerns have been raised about the length and breadth of protection provided by the extension of term provisions, that is, the duration of the extension and the types of pharmaceutical patents eligible.
  • Are the recent amendments to increase the thresholds for the grant of an Australia patent appropriate in the context of pharmaceuticals? If not, why not and what further changes are necessary?
  • Do the systems for opposition and re-examination provide appropriate avenues for challenging the granting and validity of a pharmaceutical patent?
  • Do interlocutory injunctions, as the law is currently applied, provide appropriate relief in cases involving pharmaceuticals?
  • Is Australian law on contributory infringement appropriate in relation to pharmaceuticals?
  • Are follow-on patents being used to inappropriately extend protection for pharmaceuticals? If so, how? And, if they are, is this sound policy and what changes, if any, are needed?
  • should the period of data exclusivity be extended in line with the patent term
  • patent certificates: a generic company must provide a certificate stating that it believes that it is not marketing, and does not propose to market, the therapeutic goods in a way that would infringe a valid patent, or that the generic company has given the patent owner notice of the application
  • the mess arising from copyright in product information documents

Be warned: submissions are due by 21 January 2013, hearings are proposed for February 2013, a draft report in March 2013 and the final report in April 2013.

They also have a blog – don’t forget to bookmark it!

Parmaceutical Patents Review Read More »

Access to affordable medicines or new review of pharmaceutical patents

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The Parliamentary Secretary for Industry and Innovation, Mark Dreyfus, has appointed a panel to review the patenting of pharmaceuticals in Australia.

According to the Terms of Reference, the review:

will evaluate whether the system for pharmaceutical patents is effectively balancing the objectives of securing timely access to competitively priced pharmaceuticals, fostering innovation and supporting employment in research and industry.

Central to this will be an analysis of the pharmaceutical extension of term provisions of the Patents Act 1990 (s.70).

The review will also consider whether there is evidence that the patent system is being used to extend pharmaceutical monopolies at the expense of new market entrants. In doing this, the review will consider how patents for new formulations are granted, consider the treatment of new methods of manufacturing and new uses of known products, the impact of contributory infringement provisions and the impacts of extending patent monopolies on entry of generic pharmaceuticals into the market.

The panel consists of 3 members:

  •  Mr Tony Harris, former NSW Auditor-General and Parliamentary Budget Officer, as Chair
  • Professor Dianne Nicol, Associate Dean, Research, of the University of Tasmania, and
  • Dr Nicholas Gruen, CEO of Lateral Economics.

A public consultation process will form part of the review which appears to include consultation with stakeholders and an opportunity for public submissions.

According to the press announcement, the panel is due to submit its final report by April 2013.

Of course, there is already a review of compulsory licensing under way following the BRCA controversy. I do not know if it is related to this review or not, but back in May, Senator Heffernan questioned the Director-General of IP Australia about what steps the Government may have been taking to recover payments under the Pharmaceutical Benefits Scheme to pharmaceutical companies for patents subsequently found invalid. The Senator alleged that the sums involved amounted to hundreds of millions of dollars. The Director-General referred the Senator to the Department of Health and Aging, which has responsibility for these matters.

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ALRC’s Copyright and Digital Economy Issues Paper

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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).

ALRC’s Copyright and Digital Economy Issues Paper Read More »

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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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.

ALRC terms of reference finalised Read More »

Convergence Review

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The Commonwealth Government has released the Final Report of the Convergence Review (pdf).

While initially there were some indications that this review might relate to intellectual property issues, especially copyright, the Final Report focuses on the areas of regulation traditionally covered by labels like “broadcasting”, telecommunications, “spectrum allocation”, “media ownership” and “local content” requirements.

The Minister’s Press Release notes that:

The release of the report provides an opportunity for stakeholders to engage with the Committee’s recommendations. I expect the recommendations will generate robust public debate

and indicates the Government will respond in due course

Links to various preliminary documents and Word version of Final Report.

Lid dip: Copyright Council

Convergence Review Read More »

ALRC to get new copyright reference

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The Commonwealth Attorney General has announced the appointment of Prof. Jill McKeough to lead a review by the Australian Law Reform Commission into the operation of copyright in the digital environment.

Prof. McKeough is Dean of the University of Technology Sydney and a well known IP luminary.

According to the Press Release:

“The Gillard Government is determined to get the balance right between providing incentives for creators and innovators and encouraging new opportunities within a digital economy including via the National Broadband Network.

“The inquiry will consider whether the exceptions in the Federal Copyright Act are adequate and appropriate in the fast paced digital environment,” Ms Roxon said.

Draft terms of reference are to be released soon, for consultation.

The ALRC has famously produced the excellent Designs report which led to the Designs Act 2003 and also a report into Gene Patenting. Hopefully, this inquiry will get the resources and the time to meet the high standard set by those efforts.

Lid dip: Peter A. Clarke

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Copyright safe harbour scheme review Mk 2

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Last Friday, the Commonwealth Attorney-General released a Consultation Paper on ‘Revising the Scope of the Copyright Safe Harbour Scheme’.

As reported then, there were two components to that review.

Over the weekend, the second component – streamlining the notice and take down procedures – has been edited out of the revised version (pdf) (doc version via here).

So now, the consultation paper just relates to re-defining “carriage service provider“.

There’s a fact sheet on how the scheme currently works. Unfortunately, the links to the previous review and submissions seem to have been taken down.

Last Friday’s post referred to the US-Australia Free Trade Agreement. The relevant provision is in chapter 17. So far as the protections apply to service providers, Art. 17.11 paragraph 29 provides:

(xii) For the purposes of the function referred to in clause (i)(A), service provider means a provider of transmission, routing, or connections for digital online communications without modification of their content between or among points specified by the user of material of the user’s choosing, and for the purposes of the functions referred to in clause (i)(B) through (D), service provider means a provider or operator of facilities for online services or network access.

This may be contrasted with the corresponding provision in the “parent” of article 17.11, §512(k) (pdf) of the US Copyright Act which defines service provider for the purposes of the DMCA safe harbours as follows:

(1) Service provider.—(A) As used in subsection (a), the term “service provider” means an entity offering the transmission, routing, or providing of connections for digital online communications, between or among points specified by a user, of material of the user’s choosing, without modification to the content of the material as sent or received. (B) As used in this section, other than subsection (a), the term “service provider” means a provider of online services or network access, or the operator of facilities therefor, and includes an entity described in sub- paragraph (A).

At least, the US definition appears to make it clear that a service provider may be one who provides services not just, as the Australian legislation seems to have been drafted to reflect, only providers, or operators, of facilities for such services. Given the nebulous nature of the term ‘facilities’, however, that may be a difference more imagined than real.

Although it doesn’t provide any “binding” authority like the Free Trade Agreement, the EU directives proceed on the basis of persons providing “information society services”. See e.g. art.s 12 -15 of the E-Commerce Directive, DIRECTIVE 2000/31/EC (pdf).

Lid dip: Leanne O’Donnell.

Copyright safe harbour scheme review Mk 2 Read More »

Government responses to ACIP enforcement reviews

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The Government has announced its responses to ACIP’s reviews of:

On a quick skim, the main recommendation to introduce a Patents Tribunal to determine “IP” disputes has been found non-viable due to the limitations on the Commonwealth’s repository of judicial powers. With WIPO’s arbitration and mediation service in mind, however, IP Australia is to work with alternative dispute resolution providers to provide a new ADR resource. In the PBR context, the Government states that it does not consider it appropriate for IP Australia, as a regulatory agency, to provide post-grant mediation services itself.

The review on PBR has received rather mixed results.

The Government has not accepted the proposal to introduce a “purchase” right.

The PBR Act will be amended to clarify that harvested material which can also be used as propagating material qualifies as propagating material for the purposes of the Act’s prohibitions.

The Government accepts that no changes to the operation of ss 14 and 15 are required.

At this stage, the Government considers that the making of “mendacious” declarations of PBR is adequately covered by the prohibitions on misleading or deceptive conduct in trade or commerce.

Lots of recommendations for more education.

No doubt, you will have your own favourite recommendation(s), but (as I am not a Kat, ip or otherwise) that is all there is time for today!

The Minister’s Getting Tougher on Imitators press release.

ACIP’s “patents” review (pdf).

ACIP’s PBR review (pdf).

Government responses to ACIP enforcement reviews Read More »

Framing the Convergence Review

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On 28 April, the Government’s Convergence Review (noted here) issued a Framing Paper.

According to p. 4 of this curious document:

This initial consultation paper seeks to identify the principles that should guide media and communications regulation in Australia, and provide stakeholders with the opportunity to raise the key issues arising from the principles. Its intent is to invite big-picture thinking about the Australian media and communications environment in its global context and how it may need to be shaped in order to achieve principles that serve the public interest. The committee will use these principles as a starting point to advise government of its preferred alternative policy framework

Accordingly (from p. 11):

the committee considers it appropriate to develop and consult with stakeholders on a set of principles to guide the committee’s consideration of specific issues. These principles have two main aims: to provide a consistent and transparent basis on which to consider specific issues and to ultimately form the basis of a set of policy objectives suitable for a converging media environment.

So your comments on the Framing Paper are sought by 10 June 2011. Then, the timetable is:

  • Emerging Issue paper : June 2011
  • Hearings: July 2011
  • detailed Discussion Papers: August 2011
  • Final Report: March 2012.

For the most part, the Framing Paper appears to relate to the regulatory regimes for broadcasting and telecommunications.

When announcing his intention to refer aspects of copyright law to the ALRC, the Attorney-General appeared to indicate that the reference (if any) will be subject to what happens in this Convergence Review. It is not so easy to identify from the Framework Paper, however, what areas might be cut across by the ALRC reviewing copyright law.

The Framework Paper does refer in several papers to “legitimate content services”. May be, it is to be found in “principle 6” which is (proposed to be):

Principle 6: Australians should have access to the broadest range of content across platforms and services as possible

This principle is taken from paragraph 5(e)(ii) of the Terms of Reference and is consistent with the objects in the BSA12, and s.3(1)(a) of the Telecommunications Act to ‘Promote the long-term interests of end-users of carriage services or of services provided by means of carriage services.’ The committee considers that a guiding principle for the review is to maximise the range of legitimate content services available to Australians. A consideration is that regulation should be flexible and adaptable to changing market and technological circumstances, and constructed with a view to enhancing audiences and consumer choice.

Principle 7 appears to be directed more to the question of ‘net neutrality.

Convergence Review Framing Paper (pdf)

The Convergence Review’s home page

Framing the Convergence Review Read More »