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TWN Info Service
on Intellectual Property Issues (Oct08/03) 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.
Massive
patent claims on antibodies and genes of bird flu survivors
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 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. 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 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 The blood samples
were collected in late 2004 and early 2005 at the Hospital for Tropical
Diseases (HTD) in 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 The blood samples
were sent to US and Swiss researchers collaborating with the 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. 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 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]
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