The patent application was first filed with the United States Patent Office (USPTO) on February 16, 2006 as application number 60/774,923. Exactly a year later the same application was filed via the Patent Cooperation Treaty (PCT). The PCT application is numbered PCT/US2007/004506 with a corresponding publication number of WO/2007/100584.
The applicants are cited as the Government of the United States of America, as represented by the Secretary, Department of Health and Human Services -National Institutes of Health,, Office of Technology Transfer, 6011 Executive Blvd., Suite 325, Rockvillle, Maryland 20852-3804 (US) and the Government of the United States of America, as represented by the Secretary, Department of Health and Human Services - Centers for Disease Control and Prevention, 4770 Biford Hwy (K79), Atlanta, Georgia 30333 (US).
In the description of the application the applicant notes ‘The significant public health impact of Influenza A and B virus infections is compounded by the threat of emerging virus strains. Concerns exist that avian influenza virus (H5N1), endemic in poultry in Southeast Asia, may trigger a pandemic in humans should the virus evolve to spread from human-to-human’.
It goes on to state that the ‘invention provides a vaccine strategy for controlling influenza epidemics, including avian flu, should it cross over to humans, the 1918 strain of flu, and seasonal flu strains. In addition, the invention is designed to lead to a combination vaccine to provide a broadly protective vaccine'.
Whilst acknowledging the existence and availability of other patents for the treatment of bird flu, citing those owned by Sanofi Pasteur, Inc. and Chiron Corporation as examples, the applicant nevertheless proffered that there was still a concern that the production by these companies would not be sufficient to meet demands were there to be a worldwide pandemic. The applicants relied on a 2004 World Health Organization (WHO) which highlighted the need for a ‘new broad-spectrum influenza vaccine’ to treat with multiple influenza strains.
What is controversial about this particular patent application is that the new vaccine incorporates one to four genes from a H5N1 strain which was isolated from an Indonesian victim of bird flu in 2005. It goes further by also incorporates genes from flu strains in Thailand, Hong Kong and South Korea. It is worth noting that the strain that contains the genes was transferred to the WHO Global Influenza Surveillance Network (GISN) by Indonesia for characterization for public health purposes.
This is a troubling development as one of the applicants, the Centers for Disease Control (CDC) is a WHO Collaborating Centre for influenza and virus studies. The mandate of Collaborating Centres is to receive influenza viruses from donor country for public health characterization purposes. 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 GISN’s effectiveness rests on the prompt sharing of and access to viruses from all donors. However, one wonders how many donor countries will wish to continue to share influenza viruses for research and vaccine development if it is that Governments who operate Collaborating Centres are minded to make proprietary claims over the materials which they have received as a result of the GISN system. Obviously this patent application built on the back of the GISN system of virus sharing will call into question the entire system and may very well undermine its effectiveness.
As for the application itself there are far reaching implications for developing countries especially when one considers that this particular patent application for a bird flu vaccine designates over 100 countries states, including most Latin American, African, and Asian countries.
What can be done? What of the rights of the Indonesian Government which supplied the strain from which the gene has been extracted? Does the human victim from whom the gene was extracted have a proprietary right to his gene?
It seems that it is these occurrences which strengthen the call for a reform of patent laws. It would seem patently unfair (pardon the pun) for the US Government to be able to assert ownership of a gene that was provided in good faith for public health purposes and to gain a potential financial windfall by acquiring a patent for commercial exploitation.
The developments in this one will be worth following.