[Ip-health] Mashelkar Commission Report

[Carlos M Correa]

I will be grateful if you circulate the following text:

I refer to some articles published in India regarding the Technical Expert
Group (TEG) Report on Patent Law Issues (also known as the 'Mashelkar
Committee Report').  The TEG cited extensively a 2000 paper that I wrote for
the South Centre, entitled Integrating Public Health Concerns into Patent
Legislation in Developing countries, to support its conclusion that it would
not be compatible with the Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS) to limit the grant of patents for
pharmaceutical substances to new chemical entities.  The quotation that the
TEG refers to was in the context of whether it would be TRIPS-compliant for
some countries to continue to exclude all pharmaceutical inventions
altogether or a set of them, such as essential medicines.  I concluded that
it would not be compatible for countries that did not recognize product
patent protection for pharmaceuticals, such as India, to continue to exclude
them once the TRIPS agreement was fully implemented in these countries.
This, of course, is a very different question than the TEG was apparently
asked to answer.  To my understanding, the relevant question before the TEG
was: "Whether it would be TRIPS compatible to limit the grant of patent for
pharmaceutical substance to new chemical entity or to new medical entity
involving one or more inventive steps."  This is a completely different
question from whether it would be TRIPS compliant to exclude pharmaceutical
products from patentability altogether.   In my opinion, the approach taken
by the TEG - to treat the issue as a binary, yes or no situation - overlooks
an array of interesting, complicated and critically important issues
relevant especially to the Indian situation.  A significant portion of my
scholarship since (and including) the 2000 South Centre paper that the TEG
quotes, has been dedicated to the many options available to developing
countries under the TRIPS agreement to limit the grant of a large number of
'secondary' patents that pharmaceutical companies routinely apply for and
use to unduly delay the entry of affordably priced generic medicines (see,
in particular, Guidelines for the examination of pharmaceutical patents:
developing a public health perspective, Working Paper, WHO, ICTSD and
UNCTAD, 2006, available at
http://www.iprsonline.org/resources/docs/Correa_Patentability%20Guidelines.pdf).
The TEG had, in my view, the opportunity to explore the various means
available to India (and other developing countries) to limit the grant of
patents that only cover minor, often trivial developments or uses of
existing pharmaceutical products, and to provide the government concrete
guidance to avoid the proliferation of patents that may restrict legitimate
competition and erode the role of India as a world supplier of active
ingredients and medicines.



Carlos M. Correa

University of Buenos Aires