[Ip-health] TWN Info: Sovereignty and patents at the fore in debate over MERS virus

Sangeeta Shashikant ssangeeta at myjaring.net
Fri May 31 08:48:43 PDT 2013


Title : TWN IP Info: Sovereignty and patents at the fore in debate over MERS
virus
 Date : 31 May 2013

 Contents: 

TWN Info Service on Intellectual Property Issues (May13/15)
31 May 2013
Third World Network
www.twn.my

Health: Sovereignty and patents at the fore in debate over MERS virus
Published in SUNS #7595 dated 31 May 2013

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unpublished claims is causing consternation in research circles, as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.130512/22
227 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.








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