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TRIPPed

TRIPPed

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Published by Lina Krishnan
As Government of India debates the Patents (Amendments) Ordinance, a look at how the patents regime could change our healthcare [edited cover story for Down To Earth]
As Government of India debates the Patents (Amendments) Ordinance, a look at how the patents regime could change our healthcare [edited cover story for Down To Earth]

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Published by: Lina Krishnan on Jun 09, 2009
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09/14/2010

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13/04/09 5:10 PMdown to earth, onlinePage 1 of 3http://www.downtoearth.org.in/fullprint.asp
VOL 13 ,NO 21 Monday, March 21, 2005
Headline
:
TRIPPEDIntro:
On December 26, 2004, the Union government of India issued the Patents (Amendments) Ordinance, which willchange 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 protectedso 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 theamendment 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 lifesaving drugs could be on the list? How will the Indian pharmaceutical industry cope, as a major quantum of drugsthey manufacture goes out of their hands? Will patients now have to pay twice, thrice or ten times of what they paynow 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 wayhealthcare 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. Hisdoctors prescibed him an anti-cancer drug, Glivec. He could afford it, they said; the cost of treatment would come tobetween Rs 9,000 to Rs 12,000 per month. But then things changed. Out of the blue, in November 2003, Ranasuddenly 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 bythe government. The company had also filed, and won, an injunction against all other Indian companies manufacturinga ‘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 couldcomply 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 thatdo not allow companies to sell what is known in the pharma parlance as ‘copycat drugs’. The 1999 amendmentprovided for exclusive marketing rights, which gave the inventor company 5 years of protection. Now, with theproposed 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 1970patent protection act, protected only the
 process
involved in developing drugs and not the end
 product 
itself. SeveralIndian companies had innovated, by producing the same drug through a different process. These drugs, called
 
13/04/09 5:10 PMdown to earth, onlinePage 2 of 3http://www.downtoearth.org.in/fullprint.asp
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 toinvest 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 naturallaws;
an invention the primary or intended use or commercial exploitation of which could be contrary topublic order or morality or which causes serious prejudice to human, animal or plant life or health orto the environment;
the mere discovery of any new property or mere new use for a known substance or of the mere useof a known process, machine, or apparatus unless such known process results in a new product oremploys 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 andanimals;
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 andpharmaceuticals for product patents. (In other words, the provision for process patents for thesesectors 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 scrutinyby others, before the patent was granted. Under the proposed amendment, the patent office would berequired only to release the initial publication; the name, the address of the applicant, what is soughtfor, and a small abstract; to the public domain. (Which means a change in basic procedure: now thedetailed patent application does not have to be made public and therefore, people who have objectionswill never know, until the patent has been granted. This will reduce the transparency. In the situationwe are in, with a weak and inexperienced patent office, combined with unclear provisions, this couldlead 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 orwrongful mentioning in complete specification, source and geographical origin of biological materialused in the invention and anticipation of invention by the knowledge, oral or otherwise available withinany local or indigenous community in India or elsewhere, and the Controller shall consider and disposeof such representation in such manner and within such period as may be prescribed. (The change

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