[Ip-health] A Crowning Glory: Patent Law and Public Health: Matthew Rimmer on the Australian IP Laws Reform Bill

Matthew Rimmer drmatthewrimmer at gmail.com
Wed Jun 19 20:34:37 PDT 2013


 20 June 2013, 12.18pm EST A crowning glory: patent law and public health

The Conversation

Australian patent law reforms are critical to ensuring Australians have
access to vital health-care services and technologies and that people in
developing countries have access to affordable, life-saving medicines. This
week, the Australian Parliament is debating a bill on patent law and public
health…
 Author

   1.   Matthew Rimmer

   ARC Future Fellow and Associate Professor in Intellectual Property at
   Australian National University
    <https://theconversation.com/profiles/matthew-rimmer-4398>


[image: Mscsnz9n-1371689407] The legislation currently before parliament
aims to safeguard access to scientific inventions protected by patents. Image
from shutterstock.com

Australian patent law reforms are critical to ensuring Australians have
access to vital health-care services and technologies and that people in
developing countries have access to affordable, life-saving medicines.

This week, the Australian Parliament is debating a bill on patent law and
public health entitled the Intellectual Property Laws Amendment Bill 2013
(Cth)<http://www.aph.gov.au/Parliamentary_Business/Bills_Legislation/Bills_Search_Results/Result?bId=r5076>
.

The legislation gives Australian governments greater powers to exploit
patents without authorisation from the patent owner via stronger provisions
for Crown use and compulsory licensing.

Crown use allows federal and state governments to access patents without
the patent owners' permission. Compulsory licensing compels patent owners
to provide access to patented inventions. Both require adequate
compensation to be paid to the patent holder.

The reforms will improve access to cancer testing and treatment and
essential medicines for diseases such as HIV/AIDS, tuberculosis, and
malaria.

The House of Representatives Standing Committee on Social Policy and Legal
Affairs<http://www.aph.gov.au/Parliamentary_Business/Committees/House_of_Representatives_Committees?url=spla/bill%20intellectual%20property%20laws/report.htm>handed
down its report yesterday recommending the bill be passed. The House
of Representatives is debating the bill today.

The reforms implement the recommendations of the Australian Law Reform
Commission <http://www.alrc.gov.au/inquiries/gene-patenting>, the Advisory
Council on Intellectual
Property<http://www.acip.gov.au/library/review_of_Crown_Use_provisions.pdf>,
the Joint Standing Committee on
Treaties<http://www.aph.gov.au/Parliamentary_Business/Committees/House_of_Representatives_Committees?url=jsct/9may2007/report/chapter9.pdf>,
and the Productivity Commission<http://www.pc.gov.au/projects/inquiry/patents>
.
Crown use and gene patents

The Crown use reforms will clarify the power of governments to provide
access to patents for public services.

The proposed legislation will improve access to technology to test for
breast cancer BRCA1 and BRCA
genes<https://theconversation.com/angelina-jolie-has-had-a-double-mastectomy-so-what-is-brca1-14227>which
increase the risk of breast and ovarian cancer. This is significant
because of two international challenges to the validity of patents on gene
testing.

Last week, the Supreme Court of the United States delivered its decision on
patenting genetic testing for breast cancer and ovarian cancer in Association
for Molecular Pathology v. Myriad
Genetics<http://www.scotusblog.com/case-files/cases/association-for-molecular-pathology-v-myriad-genetics-inc/>
.

In the lead judgment, Justice Thomas commented:

Myriad did not create anything. To be sure, it found an important and
useful gene, but separating that gene from its surrounding genetic material
is not an act of invention.

There has been a parallel long-running controversy in Australia over
patents covering genetic testing for breast cancer and ovarian cancer.

Back in 2008, Melbourne-based Genetic Technologies Limited, the commercial
licensee for patents on the BRCA1 and BRCA2 breast and ovarian cancer
genes<https://theconversation.com/angelina-jolie-has-had-a-double-mastectomy-so-what-is-brca1-14227>,
sought to enforce its patent claims over the state and territory
laboratories, which were providing genetic testing services.

Although the company withdrew its claim, there was uncertainty at the time
as to whether Crown use provisions could be invoked to provide Australian
women with access to genetic testing services.

In 2013, the Federal Court of Australia held that patents can be granted
for genes, in a dispute between Cancer Voices Australia v. Myriad Genetics
Inc. <http://www.austlii.edu.au/au/cases/cth/FCA/2013/65.html>. The Full
Court of the Federal Court of Australia will hear an
appeal<https://theconversation.com/top-us-court-blocks-patents-on-breast-cancer-genes-15193>against
that decision in August.

In its report, the House of Representatives Standing Committee on Social
Policy and Legal
Affairs<http://www.aph.gov.au/Parliamentary_Business/Committees/House_of_Representatives_Committees?url=spla/bill%20intellectual%20property%20laws/report.htm>supported
reforms to Crown use:

The Committee is aware there have been difficulties with the existing Crown
use provisions and believes that maintaining the status-quo could result in
continued uncertainty about when Crown use could be invoked.

The committee “welcomes the idea that its use is clarified so that in
future, where necessary, the provision can be used with more certainty.”
Compulsory licensing and access to essential medicines

There has been much debate about compulsory licensing and access to
essential medicines – particularly to deal with public health epidemics,
such as HIV/AIDS, tuberculosis and malaria. Countries such as Brazil,
India, Thailand, Indonesia and Ecuador have used compulsory
licensing<http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001154>to
reduce the prices of pharmaceutical drugs for their citizens.

There has also been controversy over patenting the genetic sequences of
viruses – such as the SARS virus<http://works.bepress.com/matthew_rimmer/17/>,
avian influenza<http://www.twnside.org.sg/title2/wto.info/twninfo110705.htm>,
and the MERS-Coronavirus<http://www.bloomberg.com/news/2013-05-23/coronavirus-found-in-saudi-patented-by-dutch-scientists.html>.
Countries have been concerned that such patents may slow or delay responses
to pandemics.

The Australian bill also introduces a compulsory licensing regime to allow
for the export of essential medicines to developing countries and
least-developed countries. The bill will:

advance the human right to health for everyone, including children, in
developing countries by assisting with the treatment of serious health
problems such as HIV/AIDS, malaria and tuberculosis.

The bill will fulfil Australia’s obligations under the World Trade
Organization (WTO) General Council Decision
2003<http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm>.
A number of developed countries, members of the BASIC group (Brazil, South
Africa, India and China), and regional groups have established domestic
regimes to implement the WTO General Council Decision 2003.

In 2013, three major international institutions – the WTO, the World
Intellectual Property Organization, and the World Health Organization –
released a joint report, Promoting Access to Medical Technologies and
Innovation <http://www.wto.org/english/tratop_e/trips_e/trilat_5feb13_e.htm>.
The report emphasised that the export mechanism provided “an additional
legal pathway for access to medicines” and “has special significance as the
sole amendment proposed to any of the WTO multilateral trade agreements
since their adoption in 1994.”

There is bipartisan support for Australia adopting a mechanism for the
export of essential medicines. In 2013, the House of Representatives
Standing Committee on Social Policy and Legal
Affairs<http://www.aph.gov.au/Parliamentary_Business/Committees/House_of_Representatives_Committees?url=spla/bill%20intellectual%20property%20laws/report.htm>welcomed
“the actions of the Government to ensure that developing countries
experiencing a health crisis can access vital medicines quickly and
reasonably.”

The committee commented:

Introducing regulation to implement the TRIPS protocol in Australia to
provide for another avenue for developing countries to obtain vital
medicines is a worthy and entirely necessary step in the view of the
committee.

It is a matter of urgency that Australia fulfil its international
obligations, and establish a fast, effective, and flexible mechanism for
access to essential medicines.

It is critical that the House of Representatives and the Senate pass the
vital bill on patent law and public health, before Parliament winds up next
week, and the election.

Ideally, in the future, the Australian Parliament should consider further
issues raised by the Productivity
Commission<http://www.pc.gov.au/projects/inquiry/patents>in respect of
patent law and compulsory licensing relating to competition
and the public interest. There is also a need to develop a flexible
mechanism to allow for compulsory licensing to deal with a wide range of
issues of humanitarian aid and development.

Disclosure Statement

Dr Matthew Rimmer is an Australian Research Council Future Fellow, working
on Intellectual Property and Climate Change. He is an associate professor
at the ANU College of Law, an associate director of the Australian Centre
for Intellectual Property in Agriculture (ACIPA), and a member of the ANU
Climate Change Institute. Dr Matthew Rimmer receives funding as an
Australian Research Council Future Fellow working on "Intellectual Property
and Climate Change: Inventing Clean Technologies".

Australian National University does not contribute to the cost of running
The Conversation. Find out
more.<https://theconversation.com/who-funds-the-conversation-13921>

*The Conversation is funded by* CSIRO, Melbourne, Monash, RMIT, UTS, UWA,
Canberra, CDU, Deakin, Flinders, Griffith, JCU, La Trobe, Massey, Murdoch,
Newcastle. QUT, Swinburne, UniSA, USC, USQ, UTAS, UWS and VU.

-- 
Dr Matthew Rimmer
Australian Research Council Future Fellow,
Associate Professor, ANU College of Law
Associate Director, the Australian Centre for Intellectual Property in
Agriculture

Postal Address:
Fellows Road
The Australian National University
Canberra
ACT Australia 0200

Telephone: (02) 61254164

Electronic Mail:
Gmail: DrMatthewRimmer at gmail.com
Email: matthew.rimmer at anu.edu.au

Web: http://law.anu.edu.au/staff/matthew-rimmer
BePress Selected Works: http://works.bepress.com/matthew_rimmer/
SSRN: http://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=358042



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