[A2k] TWN INFO: Massive patent claims on antibodies and genes of bird flu survivors

[Sangeeta]

Massive patent claims on antibodies and genes of bird flu survivors
SUNS #6559 Thursday 2 October 2008

Bogota, 1 Oct (Edward Hammond) -- A US-European collaboration has laid
patent claims to all human (and some animal) antibodies against the critical
HA gene of the H5N1 "bird flu" virus, an international patent application
released last week reveals.

The company has also specifically claimed DNA (and amino acids) taken from
at least 3 Vietnamese survivors of H5N1. The DNA, which encodes antibodies
useful for fighting bird flu infection, is contained in human cell lines
established from the victims' blood.

The patent application (WO2008110937) was published on 18 September 2008. It
is the latest in a string of aggressive H5N1 claims by companies and
government laboratories in the United States and Europe.

If granted, the patent application could have profound effects in limiting
research on antibody treatments against the potentially pandemic H5N1 type
of influenza. It could also earn its owners huge profits from the blood of 3
(or 4) Vietnamese persons who were nearly killed by the virus.

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.

A WHO Intergovernmental Meeting on Pandemic Influenza Preparedness (PIP IGM)
will reconvene in Geneva in November to continue negotiations on the reform
of the WHO's Global Influenza Surveillance Network (GISN) which has been
criticized for allowing the viruses and other samples it collects for public
health to be used for purposes of private profit.

The patent application was submitted by HuMabs LLC, a relatively unknown
company in California. HuMabs is owned, however, by Synergenics, a private
venture capital-type firm financed and led by William Rutter. A prominent
figure in biotechnology, Rutter is known for co-founding the company Chiron
and as a former Director of Switzerland-based life science giant Novartis.

The scientific lead of HuMabs, and the sole inventor indicated on the patent
application, is immunologist Antonio Lanzavecchia, an Italian researcher who
leads the Institute for Research in Biomedicine (IRB) located in Bellinzona,
Switzerland.

The blood samples were collected in late 2004 and early 2005 at the
Hospital for Tropical Diseases (HTD) in Ho Chi Minh City, Vietnam. Some
details have been published about the H5N1 victims whose blood was used.

Two were men, 22 and 23 years old when infected. They were  hospitalized 7
and 3.5 weeks, respectively. A third victim was a 26-year-old woman whose
hospitalization was relatively short, at ten days. It is from her blood that
the most promising antibody, called  FLD21.140, was isolated. There is no
published information about the 4th blood donor.

The collections were part of a research program sponsored by the UK's
Wellcome Trust and conducted by Oxford University scientists, who maintain a
Wellcome-sponsored research centre at the Hospital. The Oxford scientists
say they obtained informed consent from the Vietnamese H5N1 victims, who
were treated at the Hospital.

The blood samples were sent to US and Swiss researchers collaborating with
the Oxford team at the US National Institutes of Health (NIH) and the IRB in
Switzerland.

In research with mice, antibodies extracted from the blood samples proved
highly effective against Vietnamese-type (Clade 1) H5N1 viruses and
partially effective against other (Clade 2) H5N1 types. The antibodies
target the HA (hemagglutinin) gene of the influenza virus, preventing or
inhibiting infection.

In parallel, the Wellcome Trust public relations department facilitated
media access to the Oxford team in Vietnam, and a feature article about the
research appeared in the Times (London) in October 2006.

The Times author highlighted a charming 11-year-old girl who beat the odds
and survived H5N1 and noted, with no apparent irony, that "H5N1 patients are
often the rural poor, with no phone and little contact with doctors", and
that several of the H5N1 victims interviewed were suffering ongoing
financial crises as a result of their hospitalization. Nothing was stated in
the article about patents and profits.

In May 2007, the HTD/Oxford/NIH/IRB team jointly published the mouse
experiments, which were portrayed as a significant step forward in H5N1
research. The Wellcome Trust simultaneously put out a press release on 29
May 2007. A footnote to the press release stated "Worldwide rights to the
antibody technology have been licensed to HuMabs, LLC, a US-based business
with offices in Bellinzona."

Sixteen months later, in September 2008, the HuMabs/Lanzavecchia patent
application was published by the World Intellectual Property Organization
(WIPO). The application claims not only DNA from the 4 Vietnamese victims
that encodes 11 specific antibodies, it goes much further.

It specifically claims that HuMabs has invented the DNA and amino acids of
ANY human monoclonal antibody against ANY H5N1 strain including all
monoclonal antibodies that target the HA gene. The patent application claims
many variants of these antibodies, including any that has the same
"complementarity determining regions" ("CDRs"). CDRs are short amino acids
that help target the virus and fight infection.

With respect to Clade 2 H5N1 viruses, the patent application claims any
antibody that can neutralize them -- animal or human, mono or polyclonal.

The patent application raises ethical questions for several reasons. It
claims the DNA of H5N1 victims as property, potentially enabling profit from
the sale of parts and products of the human body.

This concern is amplified by particulars of this case, specifically, the
disparities between the reportedly poor Vietnamese H5N1 victims, and the
privileged European scientist and wealthy US venture  capitalist who are
making the property claims. Details of the consent forms signed by the
Vietnamese victims and what, if any, additional agreements exist have not
been made public.

In addition, antibody treatments are generally expensive and difficult to
reliably produce, formulate, and distribute, raising questions about who
will have access to the treatment (if it works), particularly in the event
of a pandemic.

Many developing countries, and particularly poor citizens thereof, already
are unable to access H5N1 treatments due to high costs. Even if HuMabs
attempts to make its high-tech treatment available, it may not be possible
to produce this in the quantity and at the price necessary for it to be
useful to most of  the world's population.

Finally, there is the startling breadth of the patent claims -- to any H5N1
human monoclonal antibody. It amounts to a general patent claim on part of
the human body -- any person's body.

Any person infected with H5N1 or who receives H5N1 vaccines will produce
H5N1 antibodies. Thus, HuMab's patent claims DNA and natural products of all
humans who have the misfortune of being exposed to H5N1 or the benefit of
being vaccinated. +

[See also http://immunocompetent.com]