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VOL 13 ,NO 21 Monday, March 21, 2005

Headline : TRIPPED

Intro:On December 26, 2004, the Union government of India issued the Patents (Amendments) Ordinance, which will
change the way the country does business on protecting the intellectual property rights of pharma companies,
amongst others. Now, the ordinance is before the parliament, which has to do one of three things: amend it, pass it or
reject it.

So, will the ordinance become law? At risk is the armtwisting deadline set up by the World Trade Organization
( WTO) , egged on by US corporate interests. They want the intellectual property of the large companies to be protected
so that they can invest more in research and development and find more cures for new and life-threatening diseases.

At risk also is the issue of the health of millions of Indians, who many believe may be at the losing end if the
amendment allows for monopolies in the critical business of medicine to thrive.

But what are product patents and how do they differ from the process patents that were followed earlier? Which life
saving drugs could be on the list? How will the Indian pharmaceutical industry cope, as a major quantum of drugs
they manufacture goes out of their hands? Will patients now have to pay twice, thrice or ten times of what they pay
now for a drug? What about the poor who cannot pay? Will access to drugs be affected once generic equivalents of
patented drugs stop being made locally?

Are there any ways India could protect its citizens through the bewildering maze of patentspeak? The very way
healthcare operates in this country is about to change. We need some answers, quickly.

CLIFFORD POLYCARP investigates the imlpications of entering a new patent regime.

PATENT RITES
Patents get a makeover

Santosh Rana has a type of blood cancer — chronic myeloid leukaemia — that was detected in early 2003. His
doctors prescibed him an anti-cancer drug, Glivec. He could afford it, they said; the cost of treatment would come to
between Rs 9,000 to Rs 12,000 per month. But then things changed. Out of the blue, in November 2003, Rana
suddenly found he could not afford his cancer treatment anymore. The same drug now cost him Rs 1,20,000 per
month.

His doctors explained that what had changed was that Novartis India had been granted exclusive marketing rights by
the government. The company had also filed, and won, an injunction against all other Indian companies manufacturing
a ‘copycat’ version of the drug. The very sort of drug that Rana was buying each month.

This was 2003. In 2005, the situation will change even further, as the government gets ready to pass the Patents
(Amendment) Ordinance 2004. The Indian Patents Act 1970, was amended in 1999 and 2002, so that India could
comply with the provisions set out by the Trade Related Aspects of Intellectual Property Rights ( TRIPS ) agreement of
the WTO .

This agreement is meant to protect the rights of the inventors — from drugs to seeds — and builds in provisions that
do not allow companies to sell what is known in the pharma parlance as ‘copycat drugs’. The 1999 amendment
provided for exclusive marketing rights, which gave the inventor company 5 years of protection. Now, with the
proposed third amendment, this provision will be further tightened.

The ordinance of the government of India provides for product patents, instead of process patents. India’s 1970
patent protection act, protected only the process involved in developing drugs and not the end product itself. Several
Indian companies had innovated, by producing the same drug through a different process. These drugs, called

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generic versions, came at much lower costs. But while end users benefitted, the inventor companies cried foul,
arguing that the costs of their invention were not paid. This loss, they said, would mean that they would not be able to
invest further in drug research, and that would end up endangering even more lives.

---------- BOX:Definitive changes ----------

The Indian Patent Act 1970 (after amendments in 1999 and 2002) and the Ordinance

DEFINITION OF INVENTION
• “A new product or process involving an inventive step and capable of industrial application

• Inventive step means a feature that makes the invention not obvious to a person skilled in the art

• Capable of industrial application, in relation to an invention, means that the invention is capable of
being made or used in an industry

DEFINITION OF WHAT CANNOT BE PATENTED

• an invention which is frivolous or which claims anything obviously contrary to well established natural
laws;

• an invention the primary or intended use or commercial exploitation of which could be contrary to
public order or morality or which causes serious prejudice to human, animal or plant life or health or
to the environment;

• the mere discovery of any new property or mere new use for a known substance or of the mere use
of a known process, machine, or apparatus unless such known process results in a new product or
employs at least one new reactant;

• plants and animals in whole or any part thereof other than micro-organisms but including seeds,
varieties, species and essentially biological processes for production and propagation of plants and
animals;

• an invention, which in effect, is traditional knowledge or which is an aggregation or duplication of

known properties of traditionally known component or components.”

SECTION 5: deleted. The amendment removes the exemption allowed to food, chemicals and
pharmaceuticals for product patents. (In other words, the provision for process patents for these
sectors has been removed)

SECTION 22 TO 24: deleted. These sections provided for the detailed publication of the patent application,
prior to the grant of the patent. This information would be available in the public domain, for scrutiny
by others, before the patent was granted. Under the proposed amendment, the patent office would be
required only to release the initial publication; the name, the address of the applicant, what is sought
for, and a small abstract; to the public domain. (Which means a change in basic procedure: now the
detailed patent application does not have to be made public and therefore, people who have objections
will never know, until the patent has been granted. This will reduce the transparency. In the situation
we are in, with a weak and inexperienced patent office, combined with unclear provisions, this could
lead to a situation of enormous misuse).

SECTION 25 AND 26, WHICH CONCERNS OPPOSITION TO THE PATENT, IS SUBSTITUTED. SOME GROUNDS FOR
OPPOSITION INCLUDE:

(a) Patentability including novelty, inventive step and industrial applicability, or (b) non-disclosure or
wrongful mentioning in complete specification, source and geographical origin of biological material
used in the invention and anticipation of invention by the knowledge, oral or otherwise available within
any local or indigenous community in India or elsewhere, and the Controller shall consider and dispose
of such representation in such manner and within such period as may be prescribed. (The change

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replaces the opposition procedure prior to the grant of this patent with a feeble provision).

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