[Ip-health] Former UN Special Rapporteur Mr. Anand Grover's note on the Indian Prime Minister's announcement on change in the IP regime.

rameshwari rao rameshwarirao at gmail.com
Fri Jan 30 02:29:41 PST 2015

*High Alert:* Indian Prime Minister announces change in the IP regime!

Under the recent pressures from the United States the Indian government
headed by Prime Minister Mr.   Narendra Modi has announced possible changes
in India’s IP regime, which might adversely affect access to medicines.
>From inside sources it appears that PM Modi is very keen to assure the US
President Barack Obama and US multinational companies (MNCs) that India
will agree to the changes proposed by them. Inside sources also reveal that
two issues likely to be worked upon are Data Exclusivity[1]
and Patent Linkage[2]

India is the largest provider of generic high quality medicines at
affordable rates to patients in India as well as other developing
countries. This was possible because in the 1970s, faced with patents owned
by rich MNCs and medicines’ prices which were amongst the highest in the
world, India introduced significant changes in its patent law. In
particular, it did away with product patents and only preserved process
patents. This, along with the industrial policy, gave a huge boost to the
Indian generic industry. From being a minor partner to the Western
pharmaceutical companies, the Indian generic industry became a dominant
force in the market and the pharmacy of the poor across the globe.

India signed on to the TRIPS Agreement because it allowed flexibilities
which it could use fully. In particular, it has used patentability
criteria, opposition procedures (i.e. pre and post grant oppositions,
revocations and counterclaims) and compulsory licenses. All these
flexibilities are now under attack by the US government at the behest of
their industry. Not only do they want to dismantle India’s existing IP
regime but also introduce TRIPS-plus and other measures.

Prime Minister Modi has come to power on the promise of development, which
he seeks to achieve by providing sops to corporate giants in India as well
as the US and EU, all of whom have one aim – pursuit of profits. With the
US pressure to change the IP laws after the PM’s recent visit to the US,
the PM has set up an IP Think Tank to come up with a national IP policy as
well as a high-level bilateral IP Working Group to see what could be agreed
to in terms of the demands of industry.

During President Obama’s visit to India the PM has announced that IP would
be protected with strong indications that measures related to data
exclusivity and patent linkage are in the offing. An Oxfam study in Jordan
reveals that after Data Exclusivity was introduced, owing to the absence of
generic substitutes, certain medicines costed over a *1000 per cent more*
in Jordan than in its neighbouring country Egypt.

Both Patent Linkage and Data Exclusivity delay the entry of generic
medicines thus allowing monopolistic pricing to thrive even if this means
that patients across the world are denied access to affordable medicines.
If Prime Minister Modi succeeds in bringing about these two measures he
would only be emboldened to dismantle the very core of the Indian IP
regime, which is what the US IP industry wants.

We are sending this email to all of you to apprise you of the worrying
developments regarding the changes proposed to India’s IP regime. Kindly
circulate this message widely to your network of contacts inviting them to
call upon Prime Minister Modi to resist dismantling India’s pro-public
health laws at the behest of the US!


Mr. Anand Grover

Senior Advocate
Former UN Special Rapporteur on the Right to Health

Delhi, India.


Exclusivity:* to obtain marketing approval, the original drug manufacturer
must undertake various phases of clinical trials, data of which is to be
submitted to the Drug Controller. When the generic version of a drug is to
be registered, the manufacturer has only to prove that the product is a
‘bio-equivalent’ of the original product. The Drug Controller would rely on
the trial data of the originator company to evaluate the safety and
efficacy of the drug. This expedites the entry of generics into the market.
Data Exclusivity prevents such reliance over the originator’s trial data,
which is necessarily done to delay market entry for generic drugs.

Linkage:* it refers to a practice where the status of a drug patent and its
marketing approval are linked. No marketing approvals are granted if the
patent subsists in the register, thus delaying generic drug entry into the

In a case between Bayer (a pharmaceutical  MNC) and Cipla (an Indian
generic company), the Delhi High Court had noted the Indian patent system
was distinct from the drug regulatory system with no linkage between them
and so, Bayer can't prevent the drug controller  from granting marketing
approval to generic versions of patented drugs. This was also upheld by the
Supreme Court of India in February2010.


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as it is, Infinite". -William Blake.  *

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