[Ip-health] IP-Watch: Developing Countries Urged To Beat Biopiracy With Patent Examination, Regulatory Frameworks

Thiru Balasubramaniam thiru at keionline.org
Fri Feb 7 02:29:34 PST 2014


http://www.ip-watch.org/2014/02/07/developing-countries-urged-to-beat-biopiracy-with-patent-examination-regulatory-frameworks/
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Developing Countries Urged To Beat Biopiracy With Patent Examination,
Regulatory FrameworksPublished on 7 February 2014 @ 10:22 am

By Catherine Saez <http://www.ip-watch.org/author/catherine/>, Intellectual
Property Watch

While World Intellectual Property Organization members seek ways to address
the issue of biopiracy, speakers at a side event to this week's
negotiations said the phenomenon is widespread. According to them, very few
patent applicants source the origin of the resources they have used and on
which they seek claims. Some measures can be taken by countries within the
intellectual property system to stem the problem, they said.

The side event, entitled, Tackling Bio-piracy: Policy and Legal Options,
was organised by the South Centre and the Third World Network (TWN) on 5
February.

The WIPO Intergovernmental Committee on Genetic Resources, Traditional
Knowledge and Folklore (IGC) is meeting from 3-7 February.

Edward Hammond, a researcher specialised in policy issues related to
biodiversity, agriculture, infectious disease, and IP rights, presented on
two items: some details of recently identified cases of possible
misappropriation, and the results of disclosure analysis of 187 recent
international patent applications claiming genetic resources.

Among the recently identified cases is a barley gene used by Sapporo, a
Japanese brewer, to give its beer a longer shelf life. The patent
application dating from 2004 simply referred to the gene as coming from a
"landrace" without identifying the country of origin. The gene appears to
have come from India.

Another case is an African microbe, a strain of *Sorangium cellulosum*,
that "has yielded a fairly important new cancer drug, which has gained
regulatory approval in the United States for use in breast cancer," he
said. The drug "Ixempra" is sold by Bristol Myers Squibb, which showed a
US$120 million annual sale for it.

There are also candidate drugs derived from the same microbe under
development by Bayer and Novartis, he underlined. This is a case of a
microbe "which has yielded lead compounds for three different
pharmaceutical companies, all of them large."

There are now more than 600 international patent applications mentioning
this drug in their claims, he said. Although a lot of those patents relate
to the administration of the drug, not to the compounds themselves, only
five of them "gave any indication of the origin of this microbe."

The ones which did, asserted that it was "collected on the bank of the
Zambezi river," he said, a river that crosses a large territory and several
countries such as Namibia and Mozambique. It appears, according to Hammond,
the sample of the microbe may in fact have been collected on a family farm
in Orange State, South Africa.

He gave other examples such as a patent from Pioneer Hi-bred International
(WO2012112411), which claims a root-specific promoter gene from sorghum. In
the patent application, he said the source was identified as BTX623, with
no indication on the country of origin or access and benefit sharing
measures.

According to Hammond, it appears that BTX623 refers to a cross made in
Texas between an Ethiopian sorghum and one "likely" from South African
origin.

*Study Shows Poor Rate of Disclosure*

Hammond also disclosed the results of a study soon to be published by TWN,
on 187 international patent applications relating to claims on genetic
resources. The search was restricted to a specific class of patents (C12N
"Micro-organisms or enzymes"), published from 2010 to 2013.

Using a conservative approach that considered as disclosure any cases where
scientific names of species included geographic references, he found that
close to three-quarters of the applications contained no disclosure at all.

*Improving Search and Application Process*

Margo Bagley, professor at the University of Virginia School of Law, said a
key issue for developing countries is to improve their search and
application process in patent offices. A set of tools could help countries
with the issue of misappropriation, she said.

In particular, developing countries should include a requirement for
information (RFI) provision in their legislation to require information
from applicants, such as the location of origin of genetic material.

Another important tool, she said, is involving third parties. This involves
publishing pending applications promptly and inviting third party
submissions of prior art, through the education of the public and
incentives such as crowd-sourcing initiative Article One Partners (*IPW*,
Innovation, 5 March
2013<http://www.ip-watch.org/2013/03/05/monsanto-v-bowman-stocktaking-after-supreme-court-hearings/>
).

She also advised to enhance the examination of patent applications.
Work-sharing, such as "patent prosecution highways," can be useful, but
using other office examination should be considered a floor, not a ceiling,
she said. This is because there is no way to know what happens to patents
at a collaborating office after examination. For example, she said, some 60
percent of challenged European Patent Office patents were revoked or
narrowed, and US courts decisions invalidate "thousands of patents".

She noted WIPO CASE <http://www.wipo.int/case/en/> (Centralized Access to
Search and Examination) as a useful tool for developing country patent
offices. An initiative born in 2008 between the IP offices of the United
Kingdom, Canada and Australia, it is now open to any patent office as
accessing office, depositing office, or both, she said.

Also of importance, she said, is the patent claim format in order to avoid
claims that are too broad and in some cases, can circumvent restrictions on
patentability. She cited the recently challenged Syngenta patent on an
insect resistant sweet pepper (*IPW*, IPW Briefs, 3 February
2014<http://www.ip-watch.org/2014/02/03/no-patents-on-seeds-serves-epo-patent-objection-and-free-pepper-soup/>
).

*Treaties Useful but Institutional Framework Key*

According to Biswajit Dhar, director general of the Research and
Information System for Developing Countries in New Delhi, very few
countries signatory to the Convention on the Biological Diversity have put
into place a specific legislation.

He said India for this purpose has enacted the Biological Diversity Act,
but this does not prevent commercial entities - which are supposed to get
permission from Indian's national biodiversity authorities - from operating
and accessing resources in any other mega-diverse country.

A major problem, he said, is that in mega-diverse countries there is
substantial use of bio-resources commercially, in particular in the area of
traditional medicines. The challenge is to check these cases of accession
without proper rules being followed.

The key issue is the setting up of regulatory structures, he said. Treaty
obligations and policies are widely discussed but the implementation is
overlooked, he said.

India has a lot of experience to share, he said, and it will be useful for
member states to look at countries like India, Brazil and South Africa,
which have been making efforts to put into place these kind of legislations
to see how the problem of biopiracy can be addressed.

"Adding new instruments will not take us very far unless ... you take real
serious steps to get the right institutions in place," he said.

TWN published a
book<http://www.twnside.org.sg/title2/books/pdf/Biopiracywebsite.pdf>
[pdf]
in August titled "Biopiracy Watch," authored by Hammond, presenting a
compilation of recent biopiracy cases.



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