INDIAN PHARMA
SMILES AS KENYA 'TRIPS' PFIZER PATENT
In what would likely be a windfall gain for India 's generic
drug companies, the Kenyan government is learnt to have initiated
a process to issue a compulsory licence to procure antibiotic
azithromycin, a new generation drug on which Pfizer holds
the patent rights. This licence, to be issued under paragraph
6 provision of the Doha Declaration on Trips and public health,
will have a substantially bigger size compared to the first
such licence, which domestic major Cipla has recently obtained
from the Malaysian government.
Indian drug companies which manufacture
and market generic versions of azithromycin include Wockhardt,
Alembic and FDC. One or more of these companies are likely
to be the beneficiaries of the Kenyan licence which is expected
to be an omnibus one, covering supplies of the drug to the
entire Sub-Saharan African countries, according to sources
tracking the Kenyan move.
Sources said the licence to be issued
by Kenya will aim to get from the CL holder azithromycin formulations
in quantities that are enough to treat over 2m likely cases
of pneumonia in sub-Saharan Africa .
Patent on Azithromycin is held by Pfizer.
The MNC, which markets the drug in world markets that recognise
product patents under the brand name Zithromax is, however,
yet to launch the drug in India for want of patent protection.
A macrolide antibiotic with varied uses, including for treatment
of opportunistic infections caused by HIV/AIDS, the market
for azithromycin is close to $1bn at present, and it is expected
to grow considerably in next few years.
The compulsory licence which Cipla has
obtained from the Malaysian government is for supply of four
specified anti-retroviral drug formulations. The licence is
being regarded as a test case regarding the enforceability
of para 6 provision. The provision is meant to enable a generic
drug manufacturer to manufacture and export a patented drug
to a country with insufficient/no manufacturing capacity in
the pharmaceutical sector. The facility can be used subject
to specified conditions and safeguards formulated under the
August '03 Geneva drug deal, which was alleged to be tilted
in favour of the patent holders.
Under the licence, Cipla is empowered
to export and sell the medicines under fixed ceiling prices
to the government of Malaysia for exclusive supply to government
hospitals for two years. According to the compulsory licence
issued by the Malaysian government, compensations to the patent-holders
require to be paid within two months of the date of import.
The compensation amount is yet not known. Cipla is understood
to be making its first shipment of the drugs under the Malaysian
licence shortly. Among the APIs, the patents of Didanosine
is held by Bristol-Myers Squibb, while GlaxoSmithKline owns
the patent of Lamivudine and Zidovudine.
