[india-drug] Generics industry and patenting system

[Sunitha Srinivas <s.srinivas@ru.ac.za>]

(Source:
http://www.expresspharmapulse.com/story.php?&idno=378
Thanks 
As the requirement of the anti retro viral drugs is becoming crucial,
these issues regarding Generic drugs are of prime importance. Idrug
participants are urged to ensure an useful discussion regarding this.
Thanks?SS)


Generics industry needs to wake up to fight against frivolous patenting
system
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EPP News Bureau - New Delhi || Added 16:53:05 hrs on January 7th, 2004


"Data Exclusivity is not a TRIPs provision. If the patent is strong,
data exclusivity is not significant at all. Article 39 of TRIPs
agreement which talks about data protection against unfair commercial
use is being misinterpreted by the US to delay generic entry," stated
James Love, director, Consumer Project on Technology, the
Washington-based organisation focussing on IPR & healthcare.

He was talking at the international conference on IPRs & Public Health
organised here by the Indian Pharmaceutical Alliance (IPA) and FICCI.
Giving his comments during the session, Sharad Gupta, joint secretary,
Department of Chemicals & Petrochemicals said, the term Data
Exclusivity is a wrong usage. It is data protection against unfair
commercial use and it cannot mean market exclusivity. Along with IPR,
data protection can be invoked under CL provisions, he said. The
conference asserted the fact that
the country need not have to go beyond the obligations of TRIPs
agreement in any form, be it patent laws or free trade agreements.
With the R&D productivity falling consistently over the past years,
pharma biggies are increasingly looking at ways and means to ensure
ever-lasting patent rights for their existing products.

With substantiating evidence, Dr Yehuda Liveneh, director, patent
department, Teva Pharmaceuticals, Israel, said that to have evergreen
patents companies take different approaches including patenting
processes, polymorphs, hydrates, metabolites, ultrapure forms, and the
like. He also pointed out that if the originator company sues the
generic manufacturer, FDA cannot approve ANDAs before 30 months if the
case is not resolved. This creates unwarranted delays in the generic
entry. In the case of Nabumetone where BMS obtained a frivolous patent,
it took as much as four years before Teva could settle the case and
introduce generic version in the US.

Maria Fabiana Jorge, president, MFJ International, LLC, a global
consulting firm specializing in international business and foreign
trade, cautioned that the free trade agreements so far are in the
direction of achieving committments from developing countries that go
beyond TRIPs obligations. S N Menon, special secretary, Trade Policy
Division, Ministry of Commerce, said that during the trade negotiations
with the US the country has experienced the same wave.

Talking at the session Dr Juan Rovira, Senior Health Economist, World
Bank, said that the existing patent regime need to be changed. By
linking R&D incentive to market exclusivity the goals of public health
priorities cannot be achieved, he added.

The existing legal system encourages creation of IPR not innovation, Dr
Rovira stated. According to D G Shah, secretary general, IPA,
research-based companies must look for new discovery to drive growth or
be part of the generic sector and drive growth through volume. He was
of the view that this would not only revive research but also integrate
the two sectors and promote access to medicines.

J V R Prasada Rao, secretary, Health, delivering the key note address
stated that generics are imperative to ensure quality drugs at
affordable rates and India is set to become global leader in generics
in near future. The country needs a legislation in favour of generics,
he asserted.

All stake holders including the industry, the regulatory agencies and
the trade have to work towards enhancing the confidence among consumers
with regard to use of generics, he said. Habil Khorakiwala, president,
Indian Pharmaceutical Alliance stated that the patent regime will give
a boost to original drug discovery research and up the momentum in
reverse brain-drain to India. He said that India is an ideal location
for pharma majors to outsource R&D, toxicity and clinical trials.


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