[A2k] SUNS: WHO-linked centre lays patent claims on bird flu virus

[Sangeeta]

WHO-linked centre lays patent claim on bird flu virus

Published in SUNS #6539 dated 15 August 2008

Bogota, 14 Aug (Edward Hammond*) -- In a development that is likely to raise
more pressing questions about reform of the WHO Global Influenza
Surveillance Network (GISN), an international patent application has
surfaced in which the US Centres for Disease Control (CDC) and US National
Institutes of Health claim ownership of Indonesian influenza genes.

A recent patent search has revealed that the CDC, which is a WHO
collaborating centre, is applying for a patent for a new vaccine against
influenza, particularly for bird flu (H5N1). The vaccine incorporates genes
from a H5N1 strain isolated from an Indonesian human victim of bird flu in
2005.

The strain that contains the genes was transferred to the WHO GISN by
Indonesia for characterization for public health purposes, but may wind up
as the property of the US government.

Under US law, the US government agencies would offer licenses to the
technology to pharmaceutical companies. The patent application indicates
that the US government intends to pursue the claim in most countries of the
world, including Indonesia itself, as well as neighboring countries.

The application was first lodged in the United States on 16 February 2006,
and then filed with the World Intellectual Property Organization (WIPO) on
16 February 2007. It was first published as application WO2007/100584 on 7
September 2007 on a WIPO internet database, but is only now coming into
public light.

The patent application claims a new vaccine against influenza, particularly
for Bird Flu (H5N1). The vaccines incorporate one to four genes from a H5N1
strain isolated from an Indonesian human victim in 2005 (denominated
A/Indonesia/5/05).

The patent application also claims similar vaccines that incorporate genes
of flu strains from Thailand (A/Thailand/1(KAN-1)/04) and
A/Ck/Thailand/1/04), Hong Kong (A/Hong Kong/156/97) and South Korea
(A/Ck/Korea/ES/03).

The vaccine is of a new type called a DNA vaccine. These stimulate the
immune system like others vaccines, except instead of using a traditional
approach, such as injecting a dead virus, they consist of lengths of
genetically engineered DNA called plasmids. This type of vaccine is under
development in a number of biotech labs.

Influenza has eight genes in total, so the US government's DNA vaccines will
incorporate up to 50% of the flu strain's genome. In order for the H5N1
genes to work in the DNA vaccine, they are "codon optimized", meaning that
small genetic changes are made to the natural H5N1 genes. These changes are
mostly designed to enhance the key natural genetic properties of the flu
strain.

The patent application raises specific questions about the US CDC, which is
a WHO Collaborating Centre for influenza virus studies. The WHO
Collaborating Centres receive influenza viruses from donor countries for
public health characterization purposes, and not for the purposes of making
proprietary claims.

The US patent claims are especially relevant to the ongoing discussions of
the WHO Pandemic Influenza Preparedness Inter-Governmental Meeting (WHO PIP
IGM). The WHO PIP IGM was formed by the World Health Assembly in 2007, in
response to developing country concerns about the WHO GISN, particularly the
appropriation of GISN materials for making commercial vaccines that are
costly and un-affordable to developing countries, and a lack of benefit
sharing related to influenza viruses. The next negotiating session of the
PIP IGM is scheduled to begin in Geneva on 9 November.

The question of WHO Collaborating Centres asserting patents related to WHO
system viruses has been raised repeatedly in the PIP IGM's deliberations. In
addition to the US CDC, there is evidence that another US-based WHO
Collaborating Centre, St. Jude Children's Research Hospital in Memphis,
Tennessee, has improperly capitalized on its WHO status in order to make
proprietary claims.

According to sources, in a closed session at the WHO Interdisciplinary
Working Group on Pandemic Influenza Preparedness, convened in Singapore from
31 July through 4 August 2007, the Director of the WHO Collaborating Centre
at the US CDC stated to governments that the Centre had no interest in
patents related to GISN materials. The Working Group meeting took place more
than a year after the US CDC filed for patent related to the Indonesian,
Thai, Hong Kong, and Korean H5N1 genes.

In addition to ownership of this patent application, the US CDC website
lists several proprietary H5N1-related technologies for sale, raising
further questions about CDC's handling of WHO GISN influenza materials.

In the DNA vaccine patent application, the vaccine bearing the Indonesian
H5N1 genes is the exemplary embodiment, and the application's front page
focuses on a large graphic with "A/Indonesia/5/05" in the title.

Another issue that may raise concerns is that, according to the application,
the US government intends to assert ownership of the patent in most of the
world, including Indonesia itself, as well as most other developing
countries. This includes other developing countries affected by H5N1, such
as China, Vietnam, Malaysia, Egypt, and Nigeria.

In total, the application designates over 100 states, including most Latin
American, African, and Asian countries. In practice, patent applicants do
not always follow through on all such national designations.

As was recently discussed at the WIPO Symposium on Public Policy Patent
Landscaping in the Life Sciences (Geneva, 7-8 April), however, information
on the national phase of most patent applications is publicly unavailable,
and WIPO's own PatentScope database only reflects national phase
applications in a few dozen countries.

A major component of the GISN, which is the WHO's present influenza virus
sharing system, are the four WHO Collaborating Centres (the CDC based in the
US, and other centres in the UK, Australia and Japan) which are tasked with
conducting various assessments on flu viruses given by influenza affected
countries, for public health purposes.

However, in the recent past, confidence in the system has been undermined as
it has been revealed that some of the viruses collected through the GISN are
developed into proprietary and expensive products that developing countries
cannot afford.

The GISN system is also seen as lacking transparency and benefiting the WHO
designated laboratories as well as researchers, vaccine and diagnostic
manufacturers largely based in developed countries but failing to provide
equitable benefits from the use of the virus, in particular to developing
countries hit by avian flu.

Since May 2007, efforts have been underway in the WHO to reform the GISN
system and for this purpose several meetings have been held.

Developing countries including the Africa Group, Thailand and Indonesia have
proposed that there should be no intellectual property claims by companies
or research institutions over products derived from shared biological
materials.

(* Edward Hammond is an independent researcher and an expert on patents and
biological resources. He contributed this article to SUNS.) +