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As Outbreak Continues, Confusion Reigns Over Virus Patents
28 May 2013 4:45 pm
Are Dutch scientists hampering the fight against a lethal new coronavirus by patenting the virus and making it needlessly difficult for other scientists to study it? Accusations to that effect were flying last week at the World Health Assembly (WHA), the annual meeting of the world's health ministers in Geneva, Switzerland. Margaret Chan, the director-general of the World Health Organization (WHO), used strong words in an apparent attack on virologist Ron Fouchier and his colleagues at Erasmus MC in Rotterdam, the Netherlands.
But there is nothing unusual about the arrangement under which Fouchier has shared samples of the virus, several scientists and an intellectual property expert tell ScienceInsider. And so far, nobody has offered concrete examples of how the legal arrangements have slowed down research. The criticism is "completely unjustified," says Christian Drosten, a virologist at the University of Bonn in Germany who has developed diagnostic tests for the virus. "Nothing was blocked."
Fouchier's group identified the virus, now called Middle East respiratory syndrome coronavirus (MERS-CoV), in June last year after receiving a sample from Ali Zaki, an Egyptian doctor working at the Dr. Soliman Fakeeh Hospital in Jeddah, Saudi Arabia. MERS has since sickened 49 people—five more cases were reported today by the Saudi government—and killed 24, sparking fears that it might start spreading globally, like its distant cousin SARS did in 2003.
Last week's debate started with a 20 May CBC story that quoted Frank Plummer, the head of Canada's National Microbiology Laboratory (NML) in Winnipeg, as saying that the Rotterdam group had made it hard for others to use the virus. "[T]here was a lot of negotiation and a lot of lawyers involved both with us and the Americans and others around the world," Plummer said, "which slowed things down quite a bit."
On 23 May, Saudi Deputy Health Minister Ziad Memish chimed in at WHA, complaining that intellectual property considerations were slowing down the development of diagnostic tests. "We are still struggling with diagnostics and the reason is that the virus was patented by scientists and is not allowed to be used for investigations by other scientists," Memish was quoted as saying by French press agency AFP. According to the report, he went on to charge that contracts had been signed with vaccine and drug companies, which he said need to give their approval every time another lab wants to use the virus.
Chan seemed to endorse Memish's comments afterward. "Why would your scientists send specimens out to other laboratories on a bilateral manner and allow other people to take intellectual property right on new disease?" she asked, according to AFP, which said she added, to thundering applause: "No IP (intellectual property) should stand in the way of you, the countries of the world, to protect your people."
Erasmus MC denied the allegations in a press statement issued on Friday. "Rumours that the Viroscience department of Erasmus MC would hamper research into the MERS coronavirus are clearly wrong and not based on facts," the statement read. Virologist Ab Osterhaus, who heads the department, says that he doesn't understand the controversy. "We have given this virus to virtually any lab that has asked for it," Osterhaus says.
The debate has been confusing in part because commenters have mixed up two different things: patents on the one hand, and so-called material transfer agreements, or MTAs, on the other.
Erasmus MC has applied for a patent on "use of the sequence and host receptor data" because without patents, companies would never invest in making diagnostics, vaccines, or antiviral medication for MERS, Osterhaus says. But the application is still pending, and it may take months before patent authorities rule on it and the patent becomes public. Erasmus MC has not yet gauged commercial interest, Osterhaus says -- let alone given companies control over who can get their hands on the virus, as Saudi Arabia's Memish claimed.
At issue now is the MTA, a document that most biomedical laboratories routinely use when they exchange cells, samples, or pathogens. It governs, among other things, what the receiving labs can do with the virus. The MTA for the MERS virus, which was obtained by ScienceInsider, stipulates that the virus material still belongs to the original provider (in this case Erasmus MC) and that the recipient cannot give it to other labs. It also asks for written consent from Erasmus for using the virus for commercial purposes.
While Erasmus's MTA is not claiming ownership of the virus in countries where it exists or has been isolated, it is protecting its legal ownership of the virus samples that it shares with other institutions, says David Fidler, a legal scholar at the Indiana University, Bloomington, who has studied the international sharing of pathogens. "The press release and the MTA preserve Erasmus's rights to seek IP rights for vaccines and medicines related to research done on the virus sample from Saudi Arabia," he says. But Erasmus's MTA is "a fairly standard agreement," Fidler says. "There is nothing here that suggests to me that this needed a massive amount of negotiation … nothing where I thought that's unusual or highly restrictive."
Other scientists agree. Matthew Frieman, a coronavirus researcher at the University of Maryland School of Medicine in Baltimore, says that he ordered the virus as soon as he heard about it. It took a couple of weeks to get the paperwork done, he says, "but there was nothing unique about that process." Drosten, who has developed a diagnostic test using the virus from Erasmus MC, says that "anyone can use [the virus] for free." "What really shocks me is that the WHO seems to be buying into" the complaints, he says.
WHO spokesperson Gregory Härtl declined to answer questions about Chan's comments. A spokesperson for Plummer said that he was unavailable for an interview to clarify his complaints; instead, the spokesperson sent a written statement confirming that there had been "some delays and restrictions placed on the [lab] in obtaining this virus."
Memish, in an interview with ScienceInsider yesterday, says that he had not seen the MTA himself. "I spoke to many scientists that said they were not willing to take the virus because the MTA was too restrictive," Memish says, but he did not give specific examples. "I made my comments on this assumption," he says. But Memish says that the issue has not impeded research in Saudi Arabia itself, where most cases of the virus have been found.
Even if the MTA does not impede sharing of the virus, questions about intellectual property rights may well surface in the future. Memish says that his main gripe is with the fact that Zaki sent a virus sample taken from a patient in Saudi Arabia to Rotterdam in the first place and that Erasmus MC has been able to file for patents as a result. "Samples … were shipped outside of the country without the knowledge or permission of the Ministry of Health and I cannot believe that any country on this planet would allow this to happen," Memish says.
Zaki says that he gave a sample from the same patient to the Saudi Ministry of Health first. "They tested for swine flu and did not continue," he told ScienceInsider yesterday. Only then did he reach out to Fouchier. "We have the right to confirm results anywhere in the world," he says. Memish says that's simply not true; his ministry was never informed of a new disease at the Jeddah hospital, he says, and first learned of it 3 months after the patient died, when Zaki sent information about it to ProMED, an e-mail list for disease outbreaks. "To [Zaki], a Science or Nature paper seems to be more important than human lives," Memish says. Zaki, who is now working in Egypt, says that he has not only been forced to resign but that "they closed the lab [in Jeddah] and asked for all the material to be destroyed."
Whoever is right, all parties agree that the virus was originally isolated in Saudi Arabia. Thus, the real question behind the discussions is whether Saudi Arabia should benefit in some way from whatever comes out of research on the virus, Fidler says.
The global health community has debated similar issues before. In 2007, Indonesia triggered a crisis when it stopped sharing samples from people infected with the influenza strain H5N1, over concerns they would be used to develop pandemic vaccines that the country would not be able to afford. That issue was eventually resolved in 2011 through a sharing system called the Pandemic Influenza Preparedness Framework, which rewards countries for sharing their viruses.
The agreement applies to only flu viruses and not coronaviruses such as MERS. Still, by now, "virus sharing and benefit sharing are linked in global health," Fidler says. "Despite emphasizing that it is acting for global health, Erasmus does not mention the benefit sharing issue in the press release." But Osterhaus, who has written Chan a letter to clarify his position, says that Zaki's is the first name on the patent. "We intended to share from the very beginning, and we did not understand initially that there were problems between Zaki and the Saudi government," he says.
The dispute may not be resolved any time soon, Fidler says. "It touches on enough hot spots that have not gone away that this may linger on, even when we have all the facts on the table and nobody is to blame in particular," he says. "That is unfortunate because it looks like this is a dangerous virus and we should be able to do this better."