The first ever compulsory license granted for the cancer drug
Nexavar to the Indian Pharma company Natco, which has offered to sell the
monthly dose of the medicine at Rs. 8,800 vis a vis Rs. 2,80,000 being charged
by the Bayer AG of Germany due to its monopoly
is a welcome move of the Indian Patent Office. The bold ruling of P H Kurian,
the Patent Controller of India is the
first ever step of the Indian Patent Office, ever since the change of law from,
process patent to product patent on the drug molecules, invented after January
1, 1995. Indian Patent office has paved the way for the future course, for the
patent administrators in India and world over, especially in the developing
countries.
The multinational companies dubbing the decision ‘as disappointing
and another blow to innovation’, should feel ashamed for profiteering more than
3300 percent out of human sufferings. The Indian generic company Natco would
also invest in the R & D, to develop the process to synthesise that drug at
its end, and earn profit even at a price just 3% of what is being charged by
the monopoly manufacturer, the Bayer AG of Germany and that too after paying a
royalty of 6 % to the Bayer AG, as ruled by the patent controller. There are a
number of other drugs, which also fall in the category of monopoly drugs, even
as per the definition of the Food and Drugs Administration (FDA) of the US.
Most of which are patented and exhorbitantly priced. All these need to be contested
for compulsory licensing.
Some such examples, out of scores of such monopoly priced drugs,
need a mention here. A single 50 ml injection of Roche’s anti-cancer drug
Herceptin is sold at Rs. 1,35,200,
Merck’s Erbitux costs Rs. 87,920, Bristol-Myers-Squibb’s Ixempra sells at Rs.
66,460, Pfizer’s Macugen is being sold at Rs. 45,350, and Sanofi-Aventis’
Fasturtec at a price of Rs. 45,000. Most
of these are used against Cancer, Chronic pain management, Diabetes,
Cardio-Vascular disorders and other Chronic ailments.
There is a point to feel jubilant for the masses, yet,
caution is also needed, and public-health-groups should be vigilant to join as
intervener, if the Bayer moves to the Supreme Court. Otherwise, if the Bayer
would move to the Supreme Court and get an injunction, the issue would hang in
air for an indefinite period. One should not forget that when Novartis, which
was charging approximate Rs. 11,00,000 for its anti-cancer drug ‘Glivec’,
obtained a stay from the Chennei High Court for more than a year, against the
economically affordable Indian version of its basic compound, the Imentinib and
24,000 blood cancer patients had to suffer for months during the period of stay, obtained on false pre-text of the
molecule being of a date later than January 1, 1995. While the molecule was older
one and the court vacated the stay after
the hearing was over.
In this case also, a section of commentators are advising the
Natco to go for a compromise with Bayer and not to insist to sell Nexavar at
such a low price. But, since the Natco would already be paying 6 % royalty on
its sales, as ruled by the patent office, to the Bayer for its invention, even at this low price. This 6 percent is a fair reward for Bayer’s
invention. So, people should raise strong voice to strong then the hands of the
patent office and the Indian Pharma company Natco, with the purpose, that other
Indian companies also come forward to
apply for compulsory licenses to make the costly monopoly medicines available
at affordable prices.
This single decision in the history of new post-WTO patents
regime has already sent shivers down the spine of the foreign Pharma MNCS.
Therefore the ‘ Roche Holding AG’ a
swiss pharma MNC has within days of this decision, bowed down and has announced
to sell cheaper versions of its two costly anti-cancer drugs the Herceptin and
Mabthra.
The single injection of Herceptin is available at Rs.
1,35,000 and Mabthra at Rs. 76000. But the proposed prices for a cheaper
version of the two, would not be as low
as is being offered by the Natco by virtue of its compulsory license . Hence,
other Indian pharma companies should come forward to make the costly monopoly
priced medicines available at affordable prices, including these two. Moreover,
Roche has though announced to sell these two medicines at a lower price, by a
different name in India, but that would be too take i.e by the end 2012 or 2013.
Moreover, such a move
by the other Indian pharma companies would save costly foreign exchange for the
country, help to improve country’s balance of trade, enhance R & D in the
pharma sector and facilitate growth of the Indian pharmaceuticals sector. This
would also pave the way for the Indian generic sector to improve its outreach
world-wide, if the Indian players succeed in getting compulsory licenses in
other countries as well, as has happened when the sun pharma of India had got a
compulsory license from the US for the anti-cancer drug Lipodox, the monopoly
drug of Johnson & Johnson.
So, the social organisations, government and all political
parties should explicitly support the Natco and Indian patent office in order
to pave the way for many more such compulsory license applications. It is also necessary,
to ensure that the Bayer AG do not drag the issue to the Supreme Court to kill
time and compel the Natco to agree to compromise with the monopoly firm Bayer.
Moreover, pressure of public opinion is also necessary so that issue is not
dragged to the Dispute Settlement Body of the WTO, some time later.
The US protest over this issue of compulsory license to the
Natco for this life saving drug issued by the Indian Patent Office on the
ground of public health problem, is altogether unwarranted. The allegation of
the visiting US Commerce secretary that it would discourage new investments
& dilute the international patents regime is not sustainable on any count. The
Natco has been asked to pay a royalty of
6% to the Bayer AG is the fair reward for the Bayer AG, the inventor.
Profiteering to the extent of 3300% in the name of promoting research cannot be
justified, that too in case of medicine for deadly diseases like Kidney &
liver cancer. The Minister of Commerce
& Industries of India, the Mr. Anand Sharma has rightly defended the
issuance of the compulsory license, by the Indian patent office and the Government of India should stay firm on
this issue and continue to do so in other such cases too. The patent office has
strictly complied with agreement on TRIPS of the WTO. Patent should be used
only as a means for fair rewards for the R & D, instead being allowed to be
used as a tool for monopoly profiteering.
