E-drug: Glaxo's claims of patent protection on antiretrovirals in Ghana
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Dear all,
There has been some confusion recently about the patent status of
GlaxoWellcome (now GlaxoSmithKline) products in Ghana.
The below is a technical explanation of some information I gathered during a
visit to the headquarters of the African Regional Industrial Property
Organization (ARIPO), the regional body that Glaxo has claimed issued
patents for Glaxo products in Ghana.
In a letter to Amar Lulla, Managing Director of Cipla, Ltd. (available at
www.cptech.org/ip/health/africa/, along with several other documents
pertaining to this case), the Head of Patents in Glaxo's Intellectual
Property Rights Division, G.G. Brereton, wrote that "Glaxo Group Limited has
exclusive rights under the following patents that cover lamivudine and
zidovudine formulations in Ghana: AP11, AP136, AP182, AP300." This
statement is untrue. Glaxo sought to protection for these patents in Ghana,
but it was not successful, for a simple reason: Until the introduction of
the Patent Law of December 30, 1992 (which entered into force on June 18,
1993), Ghana did not allow the patenting of pharmaceutical products.
Patents numbers AP11, AP136, and AP182 were all granted before this date
(December 22, 1987, October 29, 1991, and June 30, 1992, respectively),
meaning that under ARIPO regulations, they cannot be in force in Ghana.
Patent AP300 is a different case: it was applied for before Ghana allowing
the patenting of pharmaceutical products (on June 2, 1992), but was only
granted on January 20, 1994, after Ghana's new patent law entered into
force. The legal validity of such a patent is debatable, although the Head
of Examinations at ARIPO, Christopher Kiige, clearly stated his position
when he told the Wall Street Journal on December 1, 2000, "If [Glaxo
officials] went to court they would lose". Moreover, as Cipla stated in a
September 22, 2000 letter to Glaxo, "The fourth patent (AP300) was
granted after the above date [when Ghana introduced patent
protection], but it relates only to crystalline lamivudine." The
Cipla product that Glaxo
alleged infringed its patent was coformulated AZT/3TC, which is a different
formulation (and made by a different process) than crystalline lamivudine.
Thus it is difficult to understand how Glaxo can claim in good faith that
the importation of Cipla's coformulated AZT/3TC into Ghana represents an
infringement of any patents held by Glaxo.
Best,
Toby Kasper
M�decins Sans Fronti�res - South Africa
Toby Kasper <tobyk@mweb.co.za>
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