[Ip-health] Times of India: Big Pharma lobbies hard to curb generics

Shailly shailly.17 at gmail.com
Wed Aug 15 22:25:21 PDT 2012

Big Pharma lobbies hard to curb generics

Rupali Mukherjee, TNN | Aug 16, 2012, 05.20AM IST


MUMBAI: India's tag of 'pharmacy of the developing world' is at a serious
threat. Not only has the US devised new treaties to challenge generic drugs
being shipped from India, the EU has also upped the ante. Worse, Big Pharma
is increasingly adopting tactics to protect its intellectual property,
challenging domestic industry in courts, all of which may adversely impact
access to legitimate generic medicines in developing countries.

At stake is a huge portion of the $10-billion drugs exported from the
country to save lives of millions, particularly in developing countries.

At the centre of it lies the new round of plurilateral treaties initiated by
the US over the last few months, which include Anti-Counterfeiting Trade
Agreement (ACTA) seeking to create an additional framework for IPR
protection (going beyond the TRIPS Agreement), and the Trans-Pacific
Partnership Agreement (TPPA) which aims at extra judicial enforcement, even
as its companies are urging the government to take a "hard line" against
countries like India and Brazil to stem the issue of compulsory licences.

The European pharma industry, on its part, has again stressed that the
threat of 'counterfeit medicines' is substantive and growing.

One of the biggest barriers for the generic industry was put in place in
1995, according to industry experts, when India signed the WTO TRIPs
agreement. Implemented in 2005, it is now restricting generic companies to
manufacture affordable copycat versions for domestic use, and for exports.
So newer medicines were invented post-1995 - crucial for HIV, Hepatitis C
and cancer treatment - and are patented, creating roadblocks to their
manufacture, sale and availability in India.

Long-drawn-out expensive legal patent disputes, infringement suits and huge
damages claimed by multinational companies have made generic companies wary,
with very few challenging the Big Pharma even when the patents itself are
weak. Natco and Cipla are, however, exceptions to the rule.

"This has had a chilling impact; companies' freedom to operate has gone down
significantly as they can only manufacture new drugs invented before 1995,"
says Leena Menghaney, lawyer with Medecins Sans Frontieres, a global medical
aid organization.

This is impacting access on the ground. For example, a new HIV medicine
raltegravir patented in India costs over $2000 per patient per year. "The
generic industry is at a risk like never before, and mainly because of a new
round of plurilateral treaties like ACTA and TPPA in the US, and
intellectual enforcement measures undertaken by Europe," says D G Shah,
secretary general of Indian Pharmaceutical Alliance.

The Indo-EU free trade agreement being negotiated at present, particularly
the proposed IP (intellectual property) enforcement measures, may create
roadblocks to the supply of generic drugs shipped from the country, similar
to seizures by agencies in 2009 at European airports. The proposed IP
enforcement provisions may have harmful impact on generics production as it
may lead to legitimate drug shipments getting blocked when shipped from the
country if an MNC claims infringement of their IP.

These "excessive intellectual property enforcement provisions" in ACTA and
the EU-India FTA are aimed at stamping out competition through intimidation,
industry experts say.

The IP enforcement provisions in ACTA and the EU-India FTA negotiations also
dictate the way disputes around patents and trademark infringements will be
managed by Indian courts, adds Menghaney. "The Indian judiciary will have
its hands tied and will no longer be able to balance intellectual property
rights with people's right to health. The stringent provisions also target
third parties - including treatment providers - by exposing them to the risk
of punitive action in trademark and patent infringement allegations. The EU
wants India to agree to IP enforcement measures that could block medicines
at Indian ports on their way to patients in other developing countries, and
could even draw treatment providers into court proceedings".

Over the last couple of months, the US government has expressed its "dismay
and disappointment" at the compulsory licence given to Natco to launch
generic cancer drug, Nexavar, in the domestic market at 97% of the price
charged by MNC Bayer. In fact, in her testimony before the US Congress, US
Patent and Trademark Office deputy director Teresa Stanek Rea reportedly
states that her agency was trying to stop these compulsory licences, and
stem the tide of IP infringement in countries like India, Thailand and

Industry body OPPI, which represents MNCs' views, feels the grant of
compulsory licence should be taken after exhausting all other access
improvement measures. Its director general Tapan Ray says: "While none can
deny that all citizens of India should have access to innovative and
life-saving medicines, as will be required for their medical treatment, it
appears rather impractical to envisage that routine grant of CL by the
Indian Patent Office, as has been done recently to Natco, will be able to
resolve the critical issue of access to patented medicines, on a long term

Another showdown against the generic industry - being keenly watched the
world over and approaching this month - is the Novartis case in the Supreme
Court, where it is defending its patent on blockbuster cancer drug Glivec.

In 2006, Novartis had sued the Indian government for not granting a patent
for Glivec, and also challenged the validity of Section 3(d) of the Indian
Patent Act, which deems any incremental or frivolous innovation


Shailly Gupta

Policy Advocacy Officer

Medecins Sans Frontieres

Access Campaign

C 236 Defence Colony

New Delhi, India

Tel: +91 11 46573730-31

M: 9899976108

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