E-DRUG: Glaxo Attempts to Block Access To Generic AIDS Drugs in Ghana
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[some time ago we reported in E-drug that Glaxo accused Cipla of infringing
on its patent rights of Combivir in Ghana.
The Wall Street Journal has an article today (World AIDS day!) that
those patents may not be valid in Ghana. Morale: Ministries of
Health should check carefully whether new drugs are actually patent protected
in their countries. Assuming that they are might be a costly mistake. Generic
copies are much more affordable! Copied as fair use. Thanks to Health-Gap for
posting this. WB]
The Wall Street Journal, December 1, 2000
Glaxo Attempts to Block Access To Generic AIDS Drugs in Ghana
By MARK SCHOOFS, Staff Reporter of THE WALL STREET JOURNAL
In the midst of the wrenching international debate over how to get
expensive HIV drugs into Africa, pharmaceutical giant Glaxo Wellcome PLC
has set off a new controversy by trying to block access to less-costly
generic versions of its top-selling AIDS medicine.
In letters to a drug distributor in Ghana and an Indian generic-drug
maker, Glaxo said sales of generic versions of its drug, Combivir, in
Ghana would be illegal because they would be violating company patents.
As a result, the Indian company, Cipla Ltd. of Bombay, has stopped
selling its low-cost version in Ghana, a small country in west Africa.
However, officials at the multilateral African agency that issued the
Glaxo patents in question said they are either invalid in Ghana or don't
apply.
Glaxo's actions are "wrong," said Christopher Kiige, head patent
examiner of the African Regional Industrial Property Organization. He
says: "If [Glaxo officials] went to court they would lose." A Glaxo
spokesman in London says the drug maker believes its drug is
patent-protected in Ghana but declined
to provide an explanation or legal documentation.
This clash may seem like a tiny dust-up in a far-off minor market. But
the conflict is the latest skirmish in one of the most contentious
issues emerging in sub-Saharan Africa, where 25 million people are
infected with HIV, but only a tiny proportion have access to
life-prolonging HIV drug cocktails.
<SNIP>
Indeed, the product in question is becoming increasingly valuable to
Glaxo. Combivir is a combination of two principal AIDS drugs, AZT and
3TC. Total world-wide sales of AZT, 3TC, and Combivir are expected to
top $1.1 billion this year, up from about $775 million in 1997,
according to IMS Health, a drug marketing-research firm in Westport,
Conn.
But as the AIDS pandemic is killing many millions of people in the prime
of their lives and producing millions of orphans, public-health
officials and grass-roots activists are increasingly advocating that
African nations begin buying generic drugs, even if it means that
intellectual-property rights are
violated.
In South Africa, the Treatment Action Campaign, an AIDS advocacy group,
recently imported a generic version of Pfizer Inc.'s expensive
antifungal drug, Diflucan, which treats two opportunistic illnesses
common in AIDS patients. And this week, the South African government
granted a legal exemption to the group, allowing it to continue
importing the drug.
The battle in Ghana is being watched closely elsewhere partly because it
involves Cipla, one of the world's major producers of generic AIDS
medicines. Cipla's stature, and its ability to market its drugs
throughout Africa, may be why Glaxo has moved so aggressively in Ghana,
according to industry analysts. Glaxo says it is simply protecting
patents in a routine fashion.
Several months ago, Healthcare Ltd., a pharmaceutical distributor in
Accra, Ghana, purchased a small consignment of Duovir, Cipla's version
of Glaxo's Combivir. Soon afterward, Glaxo sent letters to Cipla and
Healthcare charging that "importation of Duovir into Ghana by Cipla or
its affiliates represents an infringement of our company's exclusive
patent rights." As a result, Cipla stopped selling Duovir in Ghana,
according to Amar Lulla, CEO of Cipla. Healthcare, the Ghana
distributor, said boxes of Duovir remain unopened in its offices and
that no patients have received any of the drug.
In its letters, Glaxo said four patents issued by the African Regional
Industrial Property Organization in Harare, Zimbabwe, provide the
company exclusive marketing rights to its drug in Ghana. But three of
those patents "are not valid in Ghana," says ARIPO's Mr. Kiige. The
fourth patent covers a specific formulation of the drug, but Cipla said
that patent doesn't pertain to its product.
Mr. Kiige said the three patents are invalid because at the time they
were issued Ghana didn't grant patent protection to pharmaceuticals.
Indeed, Ghana had filed legal documents, obtained by The Wall Street
Journal, that clearly state the country had rejected the three patents.
Ghana's registrar of patents declined to comment. While the dispute is
continuing, neither Cipla nor any other generic drug maker is expected
to provide generic AIDS drugs to Ghana.
"Glaxo has called out the dogs," says Toby Kasper, an activist in
Capetown, South Africa, with Doctors Without Borders, which has been
fighting for lower-priced drugs throughout the continent. Mr. Kasper
says Glaxo's action "goes a long way to explaining why there is so much
skepticism in the developing world towards the negotiations" between the
five drug makers and African nations.
Write to Mark Schoofs at mark.schoofs@wsj.com
Copyright � 2000 Dow Jones & Company, Inc. All Rights Reserved.
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