[Ip-health] DNA- Indo-Jap FTA: Data exclusivity threat to generics

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Indo-Jap FTA: Data exclusivity threat to generics

Priyanka Golikeri / DNA

Tuesday, September 29, 2009 2:49 IST

Mumbai: Amid fresh talks on the India-Japan free trade agreement (FTA),
concerns are being expressed about certain measures that could hamper
generic drugs and access to medicines.

 According to intellectual property (IP) experts keeping close tabs on
the FTA, Japan is pressing amongst other thing, for 'data exclusivity',
which could increase costs and delay the process of bringing low-cost
generic drugs to the market if it is granted.

Usually, for registering generics, the drug controller general of India
(DCGI) refers to the clinical trials data of the innovator company. If
data exclusivity is granted, the domestic drugmaker would have to
conduct all the clinical trials required to bring the generic to the
market, as the DCGI would not be allowed to rely on innovator data for
registering generics.

An IP professional based in New Delhi, working in the area of access to
medicines, told DNA Money, "Data exclusivity is beyond the ambit of the
TRIPS agreement of the world trade organisation (WTO), which India is
party to. Article 39.3 of TRIPS requires countries to protect innovator
data against disclosure and unfair commercial use, but nowhere does it
state that countries should provide exclusive rights to the innovator
for a given period."

The professional added that DCGI relying on innovator data to register
generics is TRIPS compliant as the regulator is not a commercial
organisation. Moreover, Japan is also calling for stringent enforcement
of other IP measures, including criminal procedures for patent
infringement.

An IP expert from Third World Network, an NGO involved in issues
relating to development, said, "Currently in India, patent infringement
is a civil liability. Japan is arguing for making it a criminal
liability, whereby the state will be obliged to take action. This would
mean a massive discouragement for generic companies."

Another crucial clause that Japan is negotiating for is to grant patents
to naturally occurring micro-organisms. This already exist in nature and
are therefore, not inventions but can only be considered as discoveries.


According to the New Delhi based IP expert, while TRIPS requires
patenting of micro-organisms, member states have the flexibility of
limiting it to modified micro-organisms.
"It is important to limit the patentability criteria when it comes to
micro-organisms, as it leads to companies being granted patents for
products and technologies that make use of the genetic materials,
plants, etc that have long been identified, and used."

Japan's is the second-largest pharmaceutical market in the world behind
the US, valued at over $60 billion.
India's drug exports to Japan were around Rs 305.16 crore in the period
between April 2008 and February 2009, as per data by the Pharmaceutical
Exports Promotion Council (Pharmexcil), under the ministry of commerce
and industry.

Like the FTA with Japan, India is also negotiating FTAs with the
European Union and the European Free Trade Association (EFTA), which has
countries such as Switzerland, Iceland, Lichtenstein as members, all of
which are pressing for data exclusivity.

http://www.dnaindia.com/money/report_indo-jap-fta-data-exclusivity-threa
t-to-generics_1293636

http://www.dnaindia.com/money/report_indo-jap-fta-data-exclusivity-threa
t-to-generics_1293636

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