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Learn to patent products the US way - Financial Express

Anju Ghangurde ()
March 23, 1998

Title: Learn to patent products the US way
Author: Anju Ghangurde
Publication: Financial Express
Date: March 23, 1998

Tough the signing of the WTO agreement makes it obligatory for
India to usher in the product patent regime by 2005 for
pharmaceuticals and agrochemicals, the new government should
ensure that domestic industry is well-supported to get its act
together on the R&D ,front in the interim. Besides, India could
take more than a leaf out of the US' books to actually assert her
"national interests robustly". Industry experts say that the
"trick lies in playing by the rules and beating them at it".

The country's rich scientific base, strong links between industry
and academia, enhanced efforts to maintain confidentiality of
joint research efforts and high research-based incentives could
go a long way in ' nurturing domestic challenge on the product
patents front. India's successes in the case of the first
indigenously developed anti-leprosy vaccine and a hepatitis-B
vaccine at half the innovator's cost are examples of the rich
scientific talent available. Such a strategy may also be
accompanied by a gradual reduction in the number of drugs under
price control (but followed up with strict price monitoring)
which will also indirectly help spruce up domestic R&D effort.

The country must withstand any pressure to usher in product
patents before time, as the fact remains that India, like all
other developing countries, can use the transition period up to
January 1, 2005, to amend national laws to include product
patents for pharmaceuticals and agrochemicals. However, in terms
of Article 70.8 and 70.9 of TRIPS, developing nations must
provide for a mall box to receive applications for product
patents and grant exclusive marketing rights on these, subject to
certain conditions. So while India must support domestic
industry. it cannot dishonour these international commitments.

On legitimate protection for domestic industry, the way out is
shown by the US, the principle votary of free trade. In a recent
speech made at an Indian Drug Manufacturers' Association (IDMA)
function. former RBI governor S Venkitaramanan, points out how
the superpower merely pays only lip service to the concept of
free trade.

The US has its own legislation which legally allows it to deviate
>from its much touted concept of free trade. "Wherever, the WTO is
in conflict with US interests, the USA can refer to Section 301.
Section 301 enables the US government to punish countries for
alleged deviation from free trade, even though the deviation may
be in keeping with the principles of the WTO. Besides, the US
congress has also called on its trade representatives to give a
specific report on various matters arising out of the
implementation of the WTO agreement, every six months. The
Congress has even reserved to itself the powers to review and
take decisions about continuing in WTO," Venkitaramanan said.

Research Foundation for Science, Technology and Ecology's
director Vandana Shiva in a recent article said that a
significant distortion in the US Patent Law is the interpretation
of the term "prior art", which currently permits patents to be
filed on discoveries in the ITS, despite the fact that identical
ones may be already existing and in use in other parts of the
world. Unless Section 102 of the US Patent Law is changed. new
examples of biopiracy will continue. she says.

While several such examples could be cited, a provision in the
Canadian laws (though now being contested by the European Union)
is a worthy example of government initiative to spur generic R&D

The Canadian government is reportedly defending certain sections
of Canada's patent law which allows manufacturers to stockpile
for upto six months, so that generic drugs are ready to hit the
market as soon as the patent expires. Put simply, the deletion of
this provision would delay a generic company from beginning the
regulatory approval process until after the date of patent expiry
of a product, thus effectively extending the actual period of
patent protection for another 3 to 5 years. The Canadian Drug
Manufacturers Association (CDMA) says that these provisions allow
its members to conduct important research prior to patent
expiration in Canada and if this is stopped it would result in
billions of additional costs, besides enhancing the effective
period of protection. The EU on the other hand alleges that the
research and stockpiling provisions are not compatible with
Canada's obligations under the WTO.

Here, it would also be worth mentioning how several companies use
new drug delivery systems to get an extension of a patent life.
Cipla chairman YK Hamied in a recent speech points out several
such cases. For 20 years, cyclosporin was marketed as a normal
product and then close to the expiry of the patent, a
microemulsion form of cyclosporin was introduced. The originator
withdrew the older product from the market, thereby extending
their monopoly for another 20 years, he says. Clearly, if the
domestic drug industry is crying itself hoarse on the patents
issue, it has strong reasons for doing so.

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