E-drug: Import of generic drugs (cont)
---------------------------------------------
Just a few words to complete Wilbert Bannenberg's answer to the
questions below.
What is the situation of other countries where Glaxo has not filed a
patent. Could they import the Cipla generic equivalent?
Yes, countries where Glaxo has not filed any patent to protect
Combivir can perfectly import Cipla or any other generic equivalent.
> If Glaxo filed the patent only this year [2000], does it mean that Ghana
can not import generics for the next 20 years - even if the patent
expires in other countries?
No, Glaxo cannot anymore file patent applications regarding the Combivir
today because this drug is now known everywhere, and therefore cannot
meet the basic condition of absolute novelty required for a patent to
be granted for any invention. Depending on the nature of the first
patent application filed, the original manufacturer of a new drug has
either a maximum of 12 months (system of the Paris Convention) or 20
or 30 months (system of the Patent cooperation Treaty -PCT) to file
similar patent applications in other countries. Once these delays are
expired, it is not any longer possible to file patent application for
the invention claimed.
As far as I know, the first patent application for combivir was 31 October
1996, and as Glaxo then filed a international application using the PCT
system, it benefited of a 30 months period (that was until 31 April
1999) to file a similar application in the countries of its choice.
If a country is already exporting a generic equivalent of a drug to another
country. What is the effect of both countries implementing TRIPS now. For
example India exports ciprofoxacin to Egypt [Egypt has its own generic
equivalent of the drug already on its market]. Would the situation continue
after both countries become TRIPS compliant? Also could India export the
drug to another country now based on this precedence?
If a country is already exporting a generic equivalent of a drug to another
country, such a situation shouldn't change with the implementation of
the TRIPS Agreement. Indeed, the TRIPS Agreement only requires WTO
countries to make patents available for patent applications filed as
from 1st January 1995 (the first patent application of ciprofloxacin
is much older). Countries that are allowed transitional periods to
implement the TRIPS standards should then have provided for a mailbox
system since 1995 to receive those patent applications even if they
could not be immediately examined, and stock them until the
application of TRIPS in that country.
In the example below, the implementation of TRIPS will not prevent
India from continuing to export ciprofloxacin to Egypt or any other
country where Bayer has not been granted a patent for ciprofloxacin.
And the situation will continue for all countries such as Egypt
where generics are available on the market today. The implementation
of TRIPS should only have effect with regards to new pharmaceutical
inventions for which patent applications have been filed since 1st
January 1995 or a year before (system of the Paris convention).
Some countries however have accepted, under the pressure of the
multinational pharmaceutical industry, to grant patents for drugs
that had been first claimed earlier than 1995, but this is a kind of
'TRIPS-plus'
measure that is going beyond the requirements of TRIPS.
Pascale Boulet
Legal adviser
MSF Campaign for Access to Essential Medicines
PascaleBoulet@aol.com
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