Posts Tagged ‘inquiry’

Productivity Commission on Compulsory Licensing: Draft Report

Wednesday, December 19th, 2012

The Productivity Commission has released its draft Report on Compulsory Licensing of  Patents.

There are 10 chapters and 4 appendices.

The main (draft) recommendations at this stage are the repeal of s 133(2)(b), 135 and 136 of the Patents Act. The Productivity Commission also in substance renews the call to repeal s 51(3) of the Competition and Consumer Act.

The primary object to these recommendations is to make the avenue for relief against the restrictive trade practices (antitrust conduct) of a patentee the Competition and Consumer Act 2010 (Cth). The Productivity Commission also recommends that the Competition and Consumer Act 2010 be amended “to explicitly recognise compulsory licensing of a patent as a remedy under that Act.

The Productivity Commission considers that the current requirements under s 135 requiring demonstration that the reasonable requirements of the public are not being met and consideration of the interests of Australian industry to be inconsistent with promoting community-wide welfare.

In its place, the Productivity Commission proposes that a new test be introduced into the Competition and Consumer Act making a compulsory licence available where:

(a) Australian demand for a product or service is not being met on reasonable terms, and access to the patented invention is essential for meeting this demand.

(b) The applicant has tried for a reasonable period, but without success, to obtain access from the patentee on reasonable terms and conditions.

(c) There is a public interest in providing access to the applicant, having regard to:

• costs to the patentee from granting access to the patented invention

• benefits to consumers and the licensee from the licensee’s access to the invention

• longer-term impacts on community wellbeing.

(d) The terms of any compulsory licence order are consistent with public interest, having regard to:

• the right of the patentee to obtain a return on investment commensurate with the regulatory and commercial risks involved

• the right of the public to the efficient exploitation of the invention.

Bearing in mind that there have been very few private actions based on the antitrust or restrictive trade practices provisions and even fewer successful actions (and, for that matter, very few, if any, applications for a compulsory licence under the Patents Act), this new test plainly has the potential to significantly change the nature of a patentee’s rights. That could be very well affected by the interpretation applied to “being met on reasonable terms” in para (a) and “long term impact on community wellbeing” in para (c) and the extent, if any, that the proposed test is applied based on incentives to innovate before the invention is made (ex ante) or after the invention has already been made (ex post).

A change in this balance would appear to be intended as the Productivity Commission is concerned that the existing competition test in s 133 of the Patents Act is triggered only by anti-competitive behaviour where what is needed, according to the Productivity Commission, is a test based on enhancing competition.

If you wish to make a submission, it should be submitted by 8 February 2013 as the Final Report is due to be submitted to Government by 29 March 2013.

So far, there have been 35 submissions.

Share Button

Access to affordable medicines or new review of pharmaceutical patents

Wednesday, October 17th, 2012

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.

Share Button

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).

Share Button

Compulsory licensing of patents

Wednesday, July 18th, 2012

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).”  ?
Share Button

ALRC to get new copyright reference

Wednesday, February 8th, 2012

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

Share Button

ACIP reviews innovation patents

Wednesday, August 24th, 2011

On 28 February, the Minister directed ACIP to report on the innovation patent system.

On 17 August, ACIP published an issues paper (pdf) and now seeks your comments by 14 October 2011.

According to the announcement of the issue paper’s release:

In recent years a variety of concerns have been raised about the innovation patent system and whether it is meeting its original objectives. A key concern is that an innovation patent is overly difficult to invalidate and the remedies for infringement are overly generous. Another concern is that innovation patents are being used to obtain a form of quick protection for higher level inventions while a standard patent is being pursued. Also, the innovation patent system has never been reviewed to assess whether it remains effective and appropriate for Australia now and in the future.

Innovation patents (which are not for business schemes) are difficult to invalidate after Dura-Post? The Full Court confirmed that the test of ‘innovative step’ does not involve a sort of obviousness penumbra over common general knowledge. Rather, the patent is innovative unless it can be shown that the difference between the patent and the prior art do not make a substantial contribution to the working of the ‘invention’. This was apparently derived from Griffin v Isaacs. As the trial judge explained with the apparent approval of Kenny and Stone JJ at [70] and [79]:

Be that as it may, the feature of what Dixon J said was the disjunctive nature of the concepts – one was ‘make no substantial contribution to the working of the thing’; the other was ‘involve no ingenuity or inventive step’. The first alternative has been taken by Parliament virtually verbatim from the judgment. The focus is upon working of the invention (as claimed) not to the degree or kind of variation from the kinds of information set out in s 7(5). In other words, the variation from the kinds of information might be slight but, if a substantial contribution is made to the working of the invention, then there is an innovative step. … In my view the provenance of the phrase ‘make no substantial contribution to the working of the invention’ indicates that ‘substantial’ in this context means ‘real’ or ‘of substance’ as contrasted with distinctions without a real difference.

Rather than a modified inventive step test, it is a modified novelty test.

The Issues Paper runs to some 28 pages.

Interestingly, just over 11,000 innovation patents have been granted and 1,790 certified.Over 80% are to Australian inventors and around half are to Australian individuals as opposed to corporations (the proportion of certifications falls to 41%). The proportion of Australian grantees vs foreign appears to be falling over time.

1,011 of the grants are divisionals from applications for standard patents. For the first few years, that was about 5% of all divisional applications, but it has been at least 10% since 2006 with a couple of years getting closer to 14%. This leads to concerns that innovation patents are being used to get ‘quick’ rights.

There are also concerns that the pharmaceutical industry is using the system to ‘evergreen’ its patent portfolios.

The questions (although ACIP would like to take this opportunity to provoke discussion generally):

  1. Effectiveness in stimulating innovation
  2. Does Australia need a utility model?
  3. Does it cost too much?
  4. Is the cost of certification dissuading people from seeking certification?
  5. How do (people in) other jurisdictions jurisdictions perceive the innovation patent?
  6. Are there concerns about the uncertainty arising from the delays in getting certification?
  7. Are the current remedies appropriate?
  8. If the available remedies are reduced (e.g. you couldn’t get an injunction) would costs of (getting) an innovation patent be justified?
  9. How do you think the use of divisionals is working (and why did you do it)?

ACIP announcement

Issues paper (pdf)

Share Button

Senate sends tobacco bill to Committee

Monday, August 22nd, 2011

The Senate has referred the Trade Marks Amendment (Tobacco Plain Packaging) Bill 2011 to the Legal and Constitutional Affairs committee.

This bill would give the Government power to “fix” gaps in the Tobacco (Plain Packaging) Bill by simply making regulations. The House of Representatives Health and Ageing committee has recommended the bill be passed.

The Committee is due to report by 2 September with the Committee’s report due by 19 September.

Share Button

Gene patents

Friday, December 24th, 2010

The Commonwealth Senate’s Community Affairs committee tabled its report into the patenting of genes towards the end of last month.

After commenting on the still continuing cases (in both the USA and here), the Committee noted:

The Committee will continue to monitor these important international and national legal developments, and notes that these cases may bring greater clarity to the application of the invention-discovery distinction to isolated genetic materials. As part of its watching brief on this area, the Committee may wish to revisit this issue if the area remains problematic following the outcomes of these cases.

The, after referring to the private members bill (see below), the Committee recommended:

The Committee believes that the introduction of the Bill to the Senate will provide a further, and much-needed, opportunity for the arguments and questions around the impacts and effectiveness of an express prohibition on gene patents to be considered. The Committee is of the view that a Senate inquiry into the Bill should be undertaken, with a focus on the specific terms of the proposed amendments and the implications of their implementation for human health and other potentially affected fields of innovation. The Committee notes that its inquiry into gene patents has served a valuable purpose in bringing the issue of gene patenting to the light of public interest and attention, and provides a sound basis on which a targeted inquiry into the Bill can build. Accordingly, Recommendation 3 of the report requests that the Senate refer the Bill to a relevant Senate Committee for inquiry and report.

Then, there are a bundle of recommendations:

  • increase the threshold requirements of patentability (improve patent quality);
  • reduce the scope of patent claims;
  • reinforce mechanisms and policies by which governments can and should intervene with the rights of patent holders; and
  • assist judicial interpretation of the Act and establish an external accountability and quality control mechanism for the patent system.

Recommendation 9 appears directed at the Lockwood No 1 ruling:

5.175    The Committee recommends that the Patents Act 1990 be amended to introduce descriptive support requirements, including that the whole scope of the claimed invention be enabled and that the description provide sufficient information to allow the skilled addressee to perform the invention without undue experimentation.

Recommendation 16 called for the establishment of a patent audit committee.

Patentology commented here.

In the same week, Senators Heffernan, Coonan, Stewart and Xenophon and introduced their private members’ bill, Patent Amendment (Human Genes and Biological Materials) Bill 2010, which (according to the Parliamentary bills summary) is intended prevent the patenting of biological materials which are identical or substantially identical to materials as they exist in nature.

As Patentology reports here, it has been referred to the Senate’s Legal and Constitutional Affairs Committee for inquiry. Your comments are requested by 25 February 2011 and the Committee is scheduled to report by 16 June 2011.

In a different environment, the US Justice Department, perhaps surprisingly, filed an amicus brief in the Myriad appeal supporting the District Court’s conclusion that the patent was invalid.

Share Button

IPRIA and gene patents

Sunday, May 3rd, 2009

Kwanghiu Lim has posted a link to some video podcasts from IPRIA’s seminar on gene patenting here.

Share Button

Gene Patenting Inquiry

Monday, December 1st, 2008

The Commonwealth Senate has launched an inquiry into the patenting of genes.

According to the terms of reference:

The impact of the granting of patents in Australia over human and microbial genes and non-coding sequences, proteins, and their derivatives, including those materials in an isolated form, with particular reference to:

(a)     the impact which the granting of patent monopolies over such materials has had, is having, and may have had on:

(i)     the provision and costs of healthcare,

(ii)    the provision of training and accreditation for healthcare professionals,

(iii)   the progress in medical research, and

(iv)   the health and wellbeing of the Australian people;

(b)     identifying measures that would ameliorate any adverse impacts arising from the granting of patents over such materials, including whether the Patents Act 1990 should be amended, in light of the any matters identified by the inquiry; and

(c)     whether the Patents Act 1990 should be amended so as to expressly prohibit the grant of patent monopolies over such materials.

The terms of reference do not say so but, presumably, the inquiry has been triggered by the recent controversy when Genetic Technologies announced it was going to commence enforcing its exclusive licence to patents relating to breast cancer detection.  It would seem, however, that the company rescinded its threat.

The Senate Community Affairs committee is due to report by the last sitting day of 2009.  Written submissions have been sought, however, by 19 March 2009.

Anyone else looking forward to learned consideration of TRIPS art. 27, 30 and 31 after all that hard work that’s been done by the ALRC.  See now ACIP’s review of patentable subject matter (pdf) which includes some notes on the AUSFTA obligations.  Then, of course, there is always Patents Act s 163.

Share Button