[Ip-health] DownToEarth.org- A bad example from the US

[Terri - Louise Beswick]

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A bad example from the US



A public sector technology transfer bill focuses exclusively on
patenting



India has played a crucial role in making essential medicines available
and affordable for patients in the developing world through generic
drugs. This has been possible by linking India's patent policies and
laws to public interest. Similarly, policies that align public funded
R&D in India with public health have the potential to provide incentives
to the development of medical technologies (vaccines, diagnostics and
medicines) crucial for treating neglected diseases like malaria,
tuberculosis, paediatric aids and kala-azar.



Recently Indian policymakers have drafted a bill seeking to provide
incentives to research and transfer of technology by public funded
institutions.



The provisions of the Protection and Utilisation of Public Funded
Intellectual Property Bill, 2008 (pupfip Bill) are similar to the usa's
Bayh-Dole Act. Once this bill is passed, scientists, research
institutions and universities will have the mandate to create
intellectual property on know-how resulting from government grants. The
intellectual property, including patents, can then be exclusively
licensed to industry.



The US model of technology transfer adopted in the Indian bill assumes
the public will fund research and the results will be patented and
commercialized through exclusive licensing to industry. This approach
has failed in the development of technologies for diseases that
predominantly affect poor patients in developing countries like India.
Despite the US Bayh-Dole legislation and similar legislations in Brazil,
China and South Africa, virtually no research into tuberculosis drugs
has been carried out since the 1960s. The sputum test used widely in
India and other developing countries to detect patients with active
pulmonary tuberculosis was developed in the 1880s and is hampered by
very low sensitivity. So only about 45 per cent of infections are
detected by sputum microscopy. Recipients of government funding in the
US have pursued patents with industry that are not aligned to public
interest. They have used licensing provisions that hinder research and
prevent access to the medicines that are results of government-funded
research.



 People living with hiv/aids will testify about their struggles to
access a number of medicines patented and exclusively licensed to
pharmaceutical companies. Patients in a number of developing countries
cannot afford antiretrovirals such as didanosine, ritonavir and
tenofovir developed with government funds. Cancer patients have had a
similar experience with the drug imatinib, developed with critical
inputs from scientists and resources from public funded institutions and
then exclusively licensed to Novartis.



The bill does state that "the ultimate objective, is to ensure access to
such innovation by all stakeholders for public good." But it does not
have enough provisions to ensure this objective is met. Missing are
safeguards for ensuring fair pricing and access to products of research,
including technologies developed using public resources. There is also
nothing on the right of the government to override the patent and
license agreement in public interest. Patentees and licencees also do
not have to pay royalty-free licenses to researchers and scientific
institutions-this is crucial to avoid stifling of follow-up research.



The bill's biggest drawback is that it considers patenting as the only
incentive to promote "creativity and innovation". Patents should be just
one of the ways for doing so (with safeguards to avoid abuses). For
example, in csir's Open Source Tuberculosis Drug Discovery programme,
all the research results are available online. If the bill is passed in
its current form, researchers involved in this project will be violating
the law by publishing the results online without first filing for
patents.



It is essential the law approved by Parliament should not damage both
science and health. So this bill should be subjected to a wider public
debate.



Leena Menghaney works in India for the Campaign for Access to Essential
Medicines (Access Campaign)



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