[Ip-health] India: Bayer appeals against compulsory licence order

Jamie Love james.love at keionline.org
Sat May 5 14:12:16 PDT 2012


Posted: Sat, May 5 2012. 1:00 AM IST

Bayer appeals against compulsory licence order

C.H. Unnikrishnan

German drug maker Bayer HealthCare AG has appealed against the
compulsory licence granted to Natco Pharma Ltd to manufacture and
market cancer drug Nexavar by India’s Controller General of Patents.
Bayer filed its appeal at the country’s Intellectual Property
Appellate Board on Friday.
The country’s patent office had, in a landmark decision in March,
granted a licence to Hyderabad-based Natco to make and sell a copy of
Bayer’s liver and kidney cancer medicine on the ground that the drug
patented by Bayer was not fully accessible to local patients because
of its cost and other reasons.

"We strongly disagree with the conclusions of the Patent Controller of
India and have appealed his order with the Intellectual Property
Appellate Board," said a Bayer India spokesperson.

The compulsory licensing decision, the first in the country, met with
mixed reactions. It was welcomed by some developing countries and
healthcare groups as a step towards making the costly cancer therapies
accessible to poor patents. Drug companies condemned the move as one
that would kill the incentive for drug research and didn’t respect
intellectual property rights.

It also triggered a large price cut by other drug makers, including
local company Cipla Ltd, for their cancer drugs.

"We will rigorously continue to defend our intellectual property
rights, which are a prerequisite for bringing innovative medicines to
patients," said a Bayer spokesperson.

According to Bayer, the challenges faced by the Indian healthcare
system have little or nothing to do with patents on pharmaceutical
products as all products on India’s essential drug list are not

"Rather, the order of the Patent Controller of India damages the
international patent system and endangers pharmaceutical research," it
said in an email response to queries on Friday.

Bayer’s Nexavar, which was granted a patent in India in 2008, was
priced at `2.8 lakh for a month’s treatment. Natco, in its application
for a compulsory licence, claimed it would be able to supply a copy of
the drug at `8,880 for a month’s therapy.

The patent office of India, after a series of hearings, concluded that
the foreign company failed to convincingly argue that it could make
the drug accessible to Indian patients at an affordable price. Also,
the company continued importing the product ever since it had been
granted a patent, which is another ground for allowing a compulsory

"The limited period of marketing exclusivity (patent protection) made
possible by patents ensures that the costs associated with the
research and development of innovative medicines can be recovered, and
to facilitate access for patients to innovative treatments, Bayer has
had a patient access programme in place since the launch of Nexavar in
India in 2008," Bayer said in its release.

According to the World Health Organization, India has an estimated
29,000 liver and kidney cancer patients.

P.H. Kurian, the then controller general of patents, who issued the
compulsory licence order, on Friday said that "it’s Bayer’s
prerogative to appeal against the order, and it can put its arguments
before the appellate authority".

M. Adinarayana, company secretary, Natco, on Friday said, "We haven’t
received any notice in this regard so far, and if the appeal comes up,
we will be able to file a reply and will present our case in the

Namrata Nandakumar contributed to this story.

James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.  Sometimes I am
using my MaxRoam number: +447937390810

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