Poorer countries where bird flu is spreading may patent individual strains of the virus as a way to help them negotiate lower prices for vaccines and treatments.
The plan is being advanced by a new program, announced today, that urges participating countries to place genetic information about their individual bird flu strains into central databases in return for rights that will allow the countries to control who uses the data.
While nations such as Indonesia have been increasingly willing to share such information, government leaders have expressed concern they may not be able to afford the products that result. The new program would help countries charge for information involving their individual strains, or negotiate low prices for drugs and tests developed from the data.
"This is an independent effort to bring scientists together to collaborate, share data and put in place some protections that will also be good for the countries of origin of the flu strains," said Nancy Cox, head of the CDC's influenza branch, in a telephone interview yesterday.
International researchers have expressed concern with getting access to data from the countries in which the virus has been found. For instance, China recently revealed that it had a bird flu death in late 2003, two years before officially revealing any infections to the WHO.
Timely information
Companies need timely information about mutations in H5N1 flu strains to design defenses against a deadly pandemic that may occur if the virus gains the ability to spread among people. In a letter to the journal Nature released today, about 70 scientists — including Cox, representatives of United Nations health agencies, and six Nobel Prize winners — supported the new program, called the Global Initiative on Sharing Avian Influenza Data.
Under their own patent laws, countries can take ownership of rights to biological organisms isolated from their residents and poultry and decide which companies or researchers use them. International legal groups such as the Geneva-based World Intellectual Property Organization, an agency of the United Nations, help protect those rights.
In the past, countries have not protected rights to virus strains used to create vaccines for seasonal flu, Cox said.
"There's been a tradition developed over the years where the flu viruses isolated anywhere in the world were considered to be part of the global domain," she said. "If we had concerns about intellectual property, we wouldn't be able to update the annual vaccine in a timely manner."
Deadlier potential
The much deadlier potential of H5N1 may change that thinking as developing nations become more concerned about getting pandemic vaccine than seasonal vaccine, Cox said.
The H5N1 virus has killed millions of birds and infected at least 241 people, 141 of whom have died. Scientists are concerned that millions more people may die if H5N1 mutates into a form that spreads easily from human to human.
The new program will collaborate with Cambia, a Canberra, Australia-based non-profit research organization, and Science Commons, based in Cambridge, Massachusetts, to write agreements and patents that will allow the flu strains to be shared, said Peter Bogner, the program's director.
"Intellectual property is the most important part of this," he said yesterday in a telephone interview. Bogner said his background is in licensing media, and that he became involved in a health-care project for the first time because of the threat of a pandemic.
Public databases
Countries that join the data-sharing program will post their genetic sequence data in public databases, such as those at GenBank, run by the U.S. National Institutes of Health, and the European Molecular Biology Laboratory, Bogner said. Companies that want to use the viruses will be able to obtain them from laboratories that do bird flu testing, such as those affiliated with the World Health Organization.
The idea of licensing biological products or organisms, as in H5N1's case, isn't new. For instance, GlaxoSmithKline Plc's Rotarix vaccine for diarrheal disease was developed from a virus Cincinnati Children's Hospital licensed to Glaxo's partner Avant Immunotherapeutics Inc. in exchange for royalties.
Increasingly, companies have paid poorer countries or their indigenous populations for biological materials isolated from plants used in traditional medicines or other sources.
New Approach
The new program's approach appears to offer benefits for all parties that might be involved, said Michael Gollin, founder of Public Interest Intellectual Property Advisors in Washington, which also gives assistance to developing countries on intellectual property rights.
"If the countries that have the viruses can get preferential treatment on access to vaccines and drugs, then there's incentive to participate," said Gollin, who said he has helped Kenyan tribes negotiate rights to a molecule used in a fabric softener, among other projects. "The leverage seems to be there."
Access to flu virus data has risen recently. Indonesia, the country hardest-hit by bird flu with 46 deaths, offered in the last two weeks to share information on viruses isolated in the country. On Aug. 22, the CDC made public data on 650 influenza genes and pledged to publish data about hundreds of viruses annually in the years to come.
Combimatrix, a Mukilteo, Washington-based maker of tests for influenza said today it has used the Indonesian information to develop a new version of its influenza testing system than detects a wider a variety of strains.
'Challenging'
Amit Kumar, the company's president and chief executive officer, said he was concerned that the need to obtain licenses might interfere with the quick exchange of data in some cases.
"It's going to be very challenging when a country in Southeast Asia says we've got some information about a diseases that has killed people and we're not going to give that out unless a company gives us a licensing fee or royalties," Kumar said yesterday in a telephone interview.
"It's not an ideal situation but it's going in the right direction to enable companies and academic researchers to utilize information," he said.
Developing countries are most interested in making sure they have the same protection from a worldwide pandemic that will be enjoyed by richer nations, said Bogner.
The new program's "initiative is really looking to protect against exploitation," he said. "I never thought there would be cash transactions involved."
China
International researchers have expressed concern about access to data from countries such as China, which recently revealed that it had a bird flu death in late 2003, two years before officially revealing any infections to the WHO.
Drugmakers Sanofi-Aventis SA, GlaxoSmithKline Plc, and Novartis AG that make vaccines against less lethal annual flu strains are also developing shots against strains of the H5N1 Avian influenza.
"Preparing for a potential avian influenza pandemic requires the efforts of all involved including industry, government, and even the citizenry of the afflicted nations," said Alison Marquiss, a spokeswoman for Novartis' vaccines unit, in a telephone interview. "To act quickly, it's important that the right structures are put in place for people to have access to information they need."