Info Service on Health Issues (Jun14/01)
MERS Virus Claimed in Dutch University's International Patent Application
Austin, Texas, USA, 6 June (Edward Hammond*) - An international patent application claiming the MERS virus and its use in diagnostics and vaccines has been published.The application is by Erasmus University in the Netherlands. Erasmus has been embroiled in a controversy over how it obtained the virus, which was sent to the Netherlands without permission from the government of Saudi Arabia, the country of origin of Erasmus’ samples.
Erasmus filed its first MERS patent application in September 2012, a few weeks after receiving the Saudi virus samples. It delayed sending the virus to other laboratories while it prepared that application, eventually providing it only under a controversial material transfer agreement reserving intellectual property rights for the University. This provoked concern and, in May of last year, under pressure, Erasmus said it would “change” its patent application - without specifying exactly how. While many understood that Erasmus would make its claims narrower, this did not turn out to be the case.
The exact content of the patent application was secret until its recent publication.
Critics charge that the patent claims may impede efforts to control MERS by discouraging research and development, and may lead to Erasmus profiteering from the public health threat.MERS has spread beyond the Arabian Peninsula, and is viewed with increasing concern by the World Health Organization.
The first MERS cases were observed in Saudi Arabia in 2012.An Egyptian doctor working in a Jeddah hospital isolated the virus from a human sample, but was unable to identify it. He sent samples to Erasmus University to see if they could.But neither the doctor nor Erasmus obtained permission from Saudi authorities, who have sovereignty over the virus sample under the UN Convention on Biological Diversity. The Dutch scientists identified the virus as a new one and then prepared a patent claim over it.
Erasmus is at the forefront of research on new viral diseases, but has repeatedly turned itself into a lightning rod on health and science policy issues, both because of its aggressive intellectual property claims and because of dangerous experiments favored by its researchers.
In the mid-2000s, Erasmus tried to patent the SARS virus, an effort stopped in part by WHO intervention. More recently, Erasmus has defiantly defended highly controversial “gain of function” studies to deliberately create dangerous new strains of pandemic influenza, a research agenda that has been vehemently criticized by influential scientists as posing too great a risk to the public.
Erasmus’ corporate spinoffs, including Vironovative (www.vironovative.com), control University-developed intellectual property over viruses, such as human metapneumovirus (hMPV). For hMPV, Erasmus’ corporate entity forces other companies to sign licensing agreements and pay royalties in order to market hMPV diagnostic tests.
The MERS international patent application, WO2014045254, was published on 27 March but went publicly unnoticed until recently. The application’s claims are strikingly aggressive.It claims the virus as a whole, and its genetic material, particularly the unique variations that differentiate MERS from related viruses and appear to enable it to infect humans. Erasmus’ patent claims then go on to lengthily claim any MERS diagnostics, as well as use of the virus in a vaccine.
The public controversy surrounding MERS, Erasmus and its claims is complex.Widely published Northern journalists and commentators who cover emerging viruses have printed comments critical of the Saudi government’s response to MERS, which some developed country health officials regard as insufficient.
On the other hand, these same commentators are not well versed in the Biodiversity Convention and not focused on the complicated interplay between public health and patents, which plays out more prominently in other areas, such as cancer and HIV drugs.
After briefly giving the subject attention in early 2013, media have not reported on intellectual property (IP) and access and benefit sharing (ABS) questions, and public discussion of MERS has attached insufficient importance to ABS issues and, indeed, to the legitimacy and propriety of lodging intellectual property claims on the virus and its parts in the first place.
In some respects, the current debate over MERS is reminiscent of the situation that faced Indonesia in the mid-2000s, when it was criticized over its response to H5N1 pandemic influenza.While media and commentators vociferously complained about the government’s response, in developed countries patents were being taken on Indonesian influenza viruses (and those from other countries). These patented treatments were scarce in wealthy countries and, generally, unavailable in developing countries at all.
Indonesia took action on ABS and patent issues on H5N1, temporarily halting its virus sharing. The initiative eventually led to the WHO Pandemic Influenza Preparedness Framework, an international agreement providing for access to influenza viruses and more equitable sharing of treatments developed from them.
In the case of MERS, some countries on the Arabian Peninsula have the economic means to purchase diagnostics and treatments on the open market if they become available, although they may have to pay royalties to Erasmus. The same cannot be said, however, of all countries in the region and adjoining areas of Africa and Asia. Given the potential for MERS to spread, in reality no country can consider itself safe.
Erasmus has sent mixed signals about its intent. After May 2013, when it said it would reduce the scope of its claims, Erasmus filed a second and a third patent application in the United States. These latter two applications don’t claim the virus as a whole, and are more specifically directed to rights over unique genetic features of MERS.
The US Patent and Trademark Office have published none of Erasmus’ three US patent applications, but they were released as part of the file for the international patent application.
It thus remains unclear what the final form of the patent claims will be in the United States.
Erasmus’ international patent application further muddies the waters. It was filed in September 2013 – about four months after Erasmus suggested it would reduce the scope of its claims.But instead, the international filing claims everything, and is every bit as aggressive as Erasmus’ first patent application lodged in the United States – the one it said it would pare down.
Erasmus may be pursuing a strategy of ambiguity, perhaps hoping to keep companies and competing research teams uncertain about the MERS intellectual property landscape, reserving the initiative for itself.
But should disease agents be patentable at all? Erasmus’ claims, even in their narrowest form, are not to a specific diagnostic or vaccine. Rather, they aim to control the key genetic variation of MERS likely to be targeted by any diagnostic or possible treatments.
In this case, the questions are sharpened by the fact that Erasmus acquired MERS virus without complying with the Convention on Biological Diversity (CBD), and without permission of the Saudi government, which might have required Erasmus not to exert proprietary claims over the virus, as a condition of providing the virus to the Dutch lab.
Saudi Arabia may wish to raise the issue directly with the Dutch government and in appropriate international forums to inform that Erasmus University did not access the MERS virus in accordance with the requirements of the CBD (to which both countries are a contracting party), and that Erasmus is attempting to assert intellectual property over material that is misappropriated.
Parties to the CBD, who will meet in the Republic of Korea in October, may wish to consider this issue. The CBD Parties, in the negotiation of the Nagoya Protocol concluded in 2010, has affirmed the Convention’s applicability to pathogens. Erasmus’ obtaining of MERS without following the CBD requirements and subsequent patent claims stand in opposition to the Convention.The MERS case is also informative for governments implementing the Nagoya Protocol, who are establishing legal checkpoints to ensure that access and benefit sharing requirements are followed. In particular, this case yet again underscores the need to include patent offices as a checkpoint.
From a public health perspective, all countries have reason to pay attention. In the MERS case, Erasmus’ claims may discourage research and development of diagnostics and treatments, or make them more expensive, or both. This may slow or limit the ability for any government to respond to a MERS outbreak, particularly less wealthy countries.
In the broader public health view, Erasmus’ attempt to patent the MERS virus is the latest in a series of problematic cases of research institutions trying to patent newly discovered disease agents as a means to control and profit from the use of these agents by others. That is, to profit not only from diagnostics and treatments that patent claimants themselves develop, but also from those developed by others, through patents that claim key parts of disease agents and must be licensed in order to commercialize a product.
Governments may wish to consider if patent claims over human pathogens, including their sequences, should be permitted at all.+
(* Edward Hammond is Director of Prickly Research)