[A2k] SUNS: US agency claims another patent over bird flu virus materials

[Sangeeta]

IP: US agency claims another patent over bird flu virus materials
SUNS #6564 Thursday 9 October 2008

Bogota, 8 Oct (Edward Hammond*) -- A top government health institute in the
United States has applied for another patent relating to the avian flu
virus, a move that raises further questions about the US government's
commitment to fair and equitable sharing of benefits of influenza research.

In an international patent application (WO2008112017, published 18 September
2008), the US National Institutes of Health (NIH) has laid patent claims
related to strains of the H5N1 viruses obtained from human victims of avian
flu in Indonesia, Thailand and China.

More than a hundred countries, including Indonesia and China, have been
designated in the patent application as countries in which the applicant
intends to pursue the application.

The claims in this application are in addition to another patent application
by the NIH on H5N1 virus parts that came to light in August. In that
application, the NIH together with the US Centres for Disease Control,
another government agency, claimed a patent for a new vaccine against
influenza, especially bird flu. The vaccine incorporates genes from a H5N1
strain from an Indonesian victim of bird flu (see SUNS #6539 dated 15 August
2008).

Another patent application (WO2008110937) was also filed on 18 September by
A US-European company HuMabs LLC , which laid patent claims to all human
(and some animal) antibodies against the critical HA gene of the H5N1 "bird
flu" virus. It also claimed DNA (and amino acids) taken from at least 3
Vietnamese survivors of H5N1. (See SUNS #6559 dated 2 October 2008).

These applications heighten concerns raised by developing countries that the
present international system for sharing of influenza viruses (the Global
Influenza Surveillance Network, under the World Health Organisation) is
unfair, and that the benefits of influenza research should be shared fairly
and equitably.

The first page of the new NIH patent application features a diagram of an
influenza strain. However, the patent application's claims are not primarily
directed to vaccine strains. Rather, they concern genetic components and
protein products of specific H5N1 viruses, as well as the antibodies
associated with them.

The NIH's patent application confirms fears expressed by developing
countries that the GISN is allowing widespread proprietary claims to be
lodged on viruses given to WHO for public health purposes.

In particular, the patent application will raise more questions about the US
Department of Health and Human Services, which hosts a WHO Influenza
Collaborating Centre, yet continues to make proprietary claims over WHO
materials.

Specifically, the patent application claims the so-called "wild type" (i.e.
unaltered) hemagglutinin (HA) protein produced by three H5N1 strains:
A/Indonesia/5/05, A/Thailand/1-Kan-1/04, and A/Anhui/1/05 (China).

In addition, it claims any DNA or RNA that encodes the three Asian HA
proteins. This would include the naturally occurring HA gene of each strain.
It also claims any DNA or RNA that is 98.5% or more identical to that, which
potentially encompasses the HA genes of other H5N1 strains.

The NIH further specifically claims the HA gene of A/Thailand/1-Kan-1/04
with one to three site mutations (i.e. minor genetic code changes).

The marked acceleration in such patent claims since late 2006 is adding
impetus and urgency to the discussions of a group of member states of the
World Health Organisation, which is considering ways to reform the WHO's
GISN to make it more equitable and ensure fairer benefits to developing
countries.

The patent application WO2008112017 concerns H5N1 vaccines. The NIH patent
application was first lodged on 10 October 2006, but because of patent
processing and publication rules, it was only made public last week.

The NIH's approach focuses on viral proteins, which are immunogenic (i.e.
which cause an immune reaction in an infected animal).

In a vaccine, the viral proteins can directly protect an individual, or the
proteins can be used in manufacturing antibodies, which also have the
potential of preventing or treating H5N1 infection.

The patent application also claims all antibodies specific to the proteins
it claims. This could be interpreted to extend to an assertion of ownership
of antisera produced in the bodies of survivors of those strains in Asia, as
well as by persons inoculated with vaccines expressing the relevant HA
genes, or containing their proteins.

A question that this new publication of the application raises is how many
more US government patent applications have been filed on H5N1 but have not
yet been divulged.

Secret patent applications may raise concern among diplomats from other
governments, who have been trying to negotiate reforms to the WHO GISN with
the United States; but without the benefit of knowledge of the patent
claims.

This may prompt another attempt, following a similar discussion at a WHO
meeting in 2007 in Singapore, to oblige governments that host WHO Influenza
Collaborating Centres to divulge the patent claims they have made to viruses
obtained through the WHO GISN, so that the WHO PIP IGM negotiations can be
conducted with a common understanding of the extent of proprietary claims
over WHO GISN materials.

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.

A WHO Intergovernmental Meeting on Pandemic Influenza Preparedness (PIP IGM)
is scheduled to reconvene in Geneva in November to continue negotiations on
the reform of the GISN.

Recent patent applications by NIH and others  indicates that there is high
interest in collecting immune cells from other survivors of H5N1 infection.

This is particularly the case for those who survive (and, potentially, are
killed by) infection by the family of H5N1 strains classified as Clade 2
types, which have appeared in Asia, Africa, and the Middle East.

It is possible that additional patent applications have been filed that
claim specific human H5N1 Clade 2 antibodies but have not yet been
published.

There is legitimate scientific purpose in collection of blood samples from
H5N1 survivors post-infection, however, governments, health care
institutions, and individuals should be aware that there are also active
commercial interests that are seeking these samples in order extract
proprietary products from them.

Vigilance should be exercised over collection and transfer of these samples
and close attention paid to the terms of any consent, material transfer, or
other agreements associated with them.

This vigilance should extend to the final disposition of clinical blood
samples, collected at hospitals and clinics in order to provide health care,
as these samples can also be used for purposes beyond patient care.

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