Oct 17, 2007 (CIDRAP News) – The World Health Organization (WHO) yesterday released a report on patenting issues related to influenza viruses, following up on a resolution adopted by the World Health Assembly in May to address the concerns of Indonesia and other developing countries about access to pandemic flu vaccines and treatments.
The report was prepared by the Geneva-based World Intellectual Property Organization (WIPO) and will be presented at a WHO intergovernmental meeting on virus sharing and access to vaccines, which will take place in Geneva from Nov 20 through 23. Like the WHO, WIPO is a United Nations agency.
Indonesia stopped sending H5N1 samples to the WHO last December as a protest, saying the country couldn't afford the vaccines that drug companies would develop from the virus samples they submitted. Since then Indonesia has shared only a few samples.
Indonesia's action raised the possibility that it and other countries affected by H5N1 flu might claim legal ownership of H5N1 isolates. Researchers need H5N1 samples to track the virus's evolution and drug susceptibility and to develop vaccines.
The 41-page WHO report emphasizes that its purpose is to provide technical background information on patent issues related to influenza viruses, not to address questions such as benefit sharing, virus surveillance, or vaccine production.
The pace of patent activity surrounding H5N1 and other avian flu viruses has picked up dramatically, the report says. The first patent applications was made in 1983, but 35% of all patent requests referring to avian flu viruses or H5N1 were made in the first 9 months of this year. "There is considerable diversity in this activity, with publications from over 100 different actors representing a mix of private firms, individual inventors, public sector institutions, and government agencies," the report notes.
In reviewing general patent law principles, the authors state that naturally occurring substances that are not altered by human interventions are not considered patentable. "Hence, a wild flu strain as such would be inherently unpatentable—put simply, it cannot be seen as an 'invention', the fit subject matter of a patent," the report says.
Also, there is no international patent, the authors say. A Patent Cooperation Treaty exists to administer international patent applications, but to enforce patent rights, a party must actively seek patents though a country's national system or a regional group such as the European Patent Office.
The authors, while not making definitive legal assessments, highlight several observations. Among them:
- Early, open publication of the gene sequence of a newly isolated flu virus strain would preclude patent protection, but would facilitate broad-based research and development.
- Sequencing a gene using regular laboratory techniques is not likely to be considered inventive or nonobvious enough to warrant a patent.
- Unless there is a clearly disclosed and defined new and useful function, most countries deny patent protection for gene sequences.
- Initial searches did not find any patents for wild viruses, though there were several for newly engineered genetic materials such as synthetic virus-like particles (VLPs), methods of producing them, and vaccines produced from them.
- Patent rights are not absolute. For example, many national patent laws allow researchers to use patented inventions for certain purposes related to research but not to commercial application.
The authors write that future editions of their report will include clearer depictions of patenting scenarios along the vaccine development pipeline, such as inventions that incorporate genetic material from flu viruses and new vaccine production technologies.
In the years ahead, the patent system will face several complex challenges, the report says. For example, the system will have a role in clarifying technology partnerships, will induce investments in vaccine production by affording exclusivity in certain instances, and will provide greater transparency in vaccine research and development.
In line with the resolution adopted by the World Health Assembly in May, a WHO working group of 24 countries has been working on several projects, such as drafting standardized terms and conditions for sharing of viruses and devising oversight mechanisms. According to previous news reports, finalized documents will be submitted at the WHO's intergovernmental meeting in November.
WHO working paper on patent issues related to influenza viruses
Jun 19 CIDRAP News story "Virus ownership claims could disrupt flu vaccine system"
May 23 CIDRAP News story "WHO adopts resolution on flu virus sharing"
Aug 1 CIDRAP News story "WHO working group grapping with virus-sharing issues"