Info Service on Health Issues (May13/10)
Sovereignty and patents at the fore in debate over MERS virus
Austin, Texas, 30 May (Edward Hammond) - This year's World Health Assembly (WHA), which ended on 28 May, found the World Health Organisation (WHO) again involved in a debate related to intellectual property rights over a dangerous new pathogen.
This time, the discussion concerns the Middle East Respiratory Syndrome (MERS) virus, the subject of serious public health concerns as well as a patent application by the Netherlands' Erasmus University.
The potential for future allegations of infringement of Erasmus' as yet unpublished claims is causing consternation in research circles, as scientists scramble to understand this new virus, which has a very high lethality rate in reported cases.
The virus was sent to Erasmus without authorisation of the Saudi government, which has sovereign rights, and which has criticised Erasmus' intellectual property stance.
Aspects of the debate are reminiscent of the one that began in 2007 on access and benefit-sharing for H5N1 influenza virus. Those talks started with sharp divisions, but by 2011, resulted in adoption of the Pandemic Influenza Preparedness (PIP) Framework, an agreement creating global access and benefit-sharing procedures for potentially pandemic influenza viruses.
The debate about MERS samples began last year when a Saudi doctor sent a sample of an unidentified respiratory pathogen to Erasmus. Erasmus determined that it was a new coronavirus (SARS is another coronavirus), but delayed several months before making it available to others.
In December of last year, the Saudi Deputy Health Minister criticised the situation, noting that the virus had been sent to Erasmus without his government's permission.
When Erasmus eventually began sharing the virus, it did so under a material transfer agreement (MTA) with very strong provisions to protect its own intellectual property, prompting objections from some scientists and suspicions that the Dutch university had submitted patent applications.
These suspicions were confirmed on 28 May by Science magazine, to which Erasmus admitted an as yet unpublished claim over use of the virus.
Objections to the Erasmus MTA from research institutions were inexactly articulated, however, and discussions conflated several issues, including access to the virus, possible restrictions on experiments, and concerns over intellectual property. Indeed, even when the virus became available to researchers from other sources, criticism was still levelled at the Erasmus MTA.
Underlying the discontent are institutions and scientists who don't like the intellectual property-related provisions of the MTA, although not necessarily for selfless reasons.
The IP-related provisions of the MTA are strong enough that other research institutions have misgivings about working with the virus for fear of allegations of patent infringement but also because Erasmus' MTA might have exactly the legal effect it is intended to: preventing others from successfully advancing their own patent claims.
One prominent US researcher, who reluctantly signed the MTA, summed up how he felt US universities viewed the intellectual property dimensions: "MTAs are a problem across the Atlantic - especially in context of ligation of disputes. Most universities aren't positioned financially to fight things out in a European court."
Nevertheless, confusion about the MTA's alleged restrictions on research experiments versus its restrictions on making patent claims (or other commercial activities) has characterised the debate and related press coverage. In reality, Erasmus appears to have imposed few if any restrictions on the types of experiments that non-commercial institutions can conduct but, at the same time, it has attempted to monopolise MERS-related intellectual property.
The only version of the MTA thus far made public was obtained by Third World Network, which has been investigating this case for potential biopiracy. (The agreement is available at: www.twn.my/title2/intellectual_property/info.service/2013/ipr.info.130512/22227 717951a47369b9515.pdf)
The content of the Dutch patent application remains unknown, due to normal procedures at patent offices, where publication of applications is delayed for six months or more from the time of their submission.
Erasmus University, however, has been embroiled in patent controversies in the past, and is known for an aggressive stance on intellectual property.
In 2003, it was one of several institutions that filed for a patent on SARS, triggering debates that also drew in WHO. In that case, competing claims and criticism ultimately left no institution with broad intellectual property control over the virus.
In the case of another pathogen, human metapneumovirus (hMPV), Erasmus has obtained patent rights that effectively control access to diagnostics and vaccines. Erasmus sells hMPV diagnostics licenses to industry, earning royalties from test sales.
It sold rights to vaccines to MedImmune (now AstraZeneca) for a $10 million down payment and future profit sharing. Erasmus has also pursued its rights to hMPV in developing countries, obtaining a patent in India.
The combination of Erasmus' IP-focused MTA, track record of patent claims on other viruses, and commercial licensing of hMPV diagnostics and vaccines, make understandable concern that it may seek to tightly control commercial diagnostics and vaccines for MERS, which could potentially limit their availability and increase their price.
Meanwhile, the Saudi government, which continues to face new MERS cases, has questioned the legitimacy of the transfer of the virus to Erasmus in the first place and, at the WHA last week, criticised Erasmus' position, which it said was impeding availability of diagnostics.
The WHO Director-General, while regretting that the unauthorised export had been allowed to happen, expressed support for Saudi Arabia's concern, saying that intellectual property cannot be allowed to stand in the way of public health action on MERS.
Saudi sovereignty over the virus that was sent to the Netherlands and claimed by Erasmus is clear as a matter of law.
The Convention on Biological Diversity (1992), to which Saudi Arabia and the Netherlands are parties (as are practically all other UN members except the US), establishes obligations for access and benefit-sharing for biodiversity, including prior informed consent of the providing country and mutually agreed terms for utilisation of the material. These obligations are further detailed by the Convention's Nagoya Protocol, which is presently gathering ratifications for entry into force.
The situation of Erasmus having obtained the virus and placed intellectual property claim over it without the consent of the Saudi government and without an agreement for benefit-sharing appears to be at odds with the requirements of the Convention.
The return to the WHA of patent and sovereignty issues over emerging viruses as the MERS epidemic worryingly unfolds suggests that controversies caused by intellectual property claims over newly identified pathogens will continue to occur unless broader solutions are found to allow viruses to be distributed to researchers while protecting sovereign rights.
Such a solution would need to reflect the rights and obligations of governments under the Convention on Biological Diversity and its Nagoya Protocol. This could include a prohibition on patent claims and pre-existing understandings for access to viruses and benefit-sharing. In some respects, WHO has previously grappled with similar issues, particularly the debates over H5N1 and other potentially pandemic influenza viruses, where the PIP Framework, which reflects Biodiversity Convention principles, was developed.
In the case of influenza, however, WHO has a network of affiliated collaborating centres and national laboratories. A similar structure does not exist for coronaviruses and many other pathogens. Thus, the similarities between the situations are limited.
While Erasmus has admitted to having filed a patent application related to the virus, and has prohibited commercial use of its virus isolate in its MTA, the specific patent claims it has made have yet to be published.
Uncertainty about their scope and fear of patent infringement allegations appear to be a cause for concern among research institutions. At the same time, the legitimacy of Erasmus' claim to the virus in the first place is suspect, given that Saudi Arabia has said that government permission was not obtained for it to be sent to the Dutch lab and mutually agreed terms for its use in diagnostics and vaccines plainly do not exist.
The unsettled situation will surely require greater discussion before resolution, while the repeated return of problems related to patents and benefit-sharing for emerging viruses suggests a need for controls on intellectual property and updated international procedures, consistent with biodiversity agreements, on access and benefit-sharing for pathogens.