TWN Info Service on Intellectual Property Issues (Aug08/05)
19 August 2008
Third World Network

WHO-linked centre lays patent claim related to bird flu virus
Published in SUNS #6539 dated 15 August 2008

Bogota, 14 Aug (Edward Hammond*) -- In a development that is likely to raise more pressing questions about reform of the WHO Global Influenza Surveillance Network (GISN), an international patent application has surfaced in which the US Centres for Disease Control (CDC) and US National Institutes of Health claim ownership of Indonesian influenza genes.

A recent patent search has revealed that the CDC, which is a WHO collaborating centre, is applying for a patent for a new vaccine against influenza, particularly for bird flu (H5N1). The vaccine incorporates genes from a H5N1 strain isolated from an Indonesian human victim of bird flu in 2005.

The strain that contains the genes was transferred to the WHO GISN by Indonesia for characterization for public health purposes, but may wind up as the property of the US government.

Under US law, the US government agencies would offer licenses to the technology to pharmaceutical companies. The patent application indicates that the US government intends to pursue the claim in most countries of the world, including Indonesia itself, as well as neighboring countries.

The application was first lodged in the United States on 16 February 2006, and then filed with the World Intellectual Property Organization (WIPO) on 16 February 2007. It was first published as application WO2007/100584 on 7 September 2007 on a WIPO internet database, but is only now coming into public light.

The patent application claims a new vaccine against influenza, particularly for Bird Flu (H5N1). The vaccines incorporate one to four genes from a H5N1 strain isolated from an Indonesian human victim in 2005 (denominated A/Indonesia/5/05).

The patent application also claims similar vaccines that incorporate genes of flu strains from Thailand (A/Thailand/1(KAN-1)/04) and A/Ck/Thailand/1/04), Hong Kong (A/Hong Kong/156/97) and South Korea (A/Ck/Korea/ES/03).

The vaccine is of a new type called a DNA vaccine. These stimulate the immune system like others vaccines, except instead of using a traditional approach, such as injecting a dead virus, they consist of lengths of genetically engineered DNA called plasmids. This type of vaccine is under development in a number of biotech labs.

Influenza has eight genes in total, so the US government's DNA vaccines will incorporate up to 50% of the flu strain's genome. In order for the H5N1 genes to work in the DNA vaccine, they are "codon optimized", meaning that small genetic changes are made to the natural H5N1 genes. These changes are mostly designed to enhance the key natural genetic properties of the flu strain.

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 US patent claims are especially relevant to the ongoing discussions of the WHO Pandemic Influenza Preparedness Inter-Governmental Meeting (WHO PIP IGM). The WHO PIP IGM was formed by the World Health Assembly in 2007, in response to developing country concerns about the WHO GISN, particularly the appropriation of GISN materials for making commercial vaccines that are costly and un-affordable to developing countries, and a lack of benefit sharing related to influenza viruses. The next negotiating session of the PIP IGM is scheduled to begin in Geneva on 9 November.

The question of WHO Collaborating Centres asserting patents related to WHO system viruses has been raised repeatedly in the PIP IGM's deliberations. In addition to the US CDC, there is evidence that another US-based WHO Collaborating Centre, St. Jude Children's Research Hospital in Memphis, Tennessee, has improperly capitalized on its WHO status in order to make proprietary claims.

According to sources, in a closed session at the WHO Interdisciplinary Working Group on Pandemic Influenza Preparedness, convened in Singapore from 31 July through 4 August 2007, the Director of the WHO Collaborating Centre at the US CDC stated to governments that the Centre had no interest in patents related to GISN materials. The Working Group meeting took place more than a year after the US CDC filed for patent related to the Indonesian, Thai, Hong Kong, and Korean H5N1 genes.

In addition to ownership of this patent application, the US CDC website lists several proprietary H5N1-related technologies for sale, raising further questions about CDC's handling of WHO GISN influenza materials.

In the DNA vaccine patent application, the vaccine bearing the Indonesian H5N1 genes is the exemplary embodiment, and the application's front page focuses on a large graphic with "A/Indonesia/5/05" in the title.

Another issue that may raise concerns is that, according to the application, the US government intends to assert ownership of the patent in most of the world, including Indonesia itself, as well as most other developing countries. This includes other developing countries affected by H5N1, such as China, Vietnam, Malaysia, Egypt, and Nigeria.

In total, the application designates over 100 states, including most Latin American, African, and Asian countries. In practice, patent applicants do not always follow through on all such national designations.

As was recently discussed at the WIPO Symposium on Public Policy Patent Landscaping in the Life Sciences (Geneva, 7-8 April), however, information on the national phase of most patent applications is publicly unavailable, and WIPO's own PatentScope database only reflects national phase applications in a few dozen countries.

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.

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