Compulsory licensing of 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).”  ?

Gene patents

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.

Gene patents invalid in USA

District Court Judge Robert Sweet has ruled that Myriad’s patents for the BRCA1 and 2 isolated gene sequences are invalid on the grounds that isolation of the “pure” form of the gene is insufficient to confer patentability.

The New York Times has a lengthy report.

Patently-O summarises, with a link to the 152 page judgment. Prof. Crouch goes on to note that the reasoning effectively invalidate almost all gene patents but expresses the view that the Federal Circuit will reverse, setting up the matter for the US Supreme Court.

These are the patents which sparked controversy in Australia in 2008 and 2009 as a result of which the Senate is now holding an inquiry, currently due to report by 17 June 2010. The ALRC had earlier in 2004 recommended that patents should continue to be available for genetic material.

Association for Molecular Pathology and ACLU v. USPTO and Myriad (S.D.N.Y. 2010) (Judge Sweet)