E-DRUG: Import of generic drugs (2)
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What is the situation of:
1. other countries where Glaxo has not filed a patent. Could they import
the Cipla generic equivalent?
There are no "international" patents. All patents are national, and have
to be filed in each individual country. Some regions have institutes
recommending patents (e.g. West Africa, ARIPO in Southern Africa) but
national patent laws will decide whether these are validated.
TRIPS is not an international law, it is an agreement between countries
to set a minimum level of intellectual property protection in their national
legislation.
If:
1. a developing country does not (yet) have a Patent law, or
2. a drug company does not file a patent in that particular country within
one year of the first international filing, or
3. if the patent is not granted (received too late, or not a new
"invention"), or
4. the drug company does not pay its annual registration fees
then that particular patent is not protected in that country, so in
principle all generic companies are free to market their product there
without infringing on patents (provided they get their product registered
of course)
I don't know the Ghana Patent laws, but for example, Swaziland does
not have a Patent Law (yet). So generic ciprofloxacin or antiretrovirals
such as AZT and 3TC can be legally marketed in Swaziland without
infringing patent rights.
Morale: Health Ministries should confirm with their Patent offices
whether new essential drugs are protected in their country. If not, then
they should actively search for more affordable generic equivalents.
2. 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?
Patents have to be filed in each country within one year of the first
international filing. They are then valid for 20 years (or more, depending
on national patent laws).
If a drug company files a patent "late", it is no longer a new "invention".
Theoretically the patent should then be refused, but this depends on
national patent laws.
Some countries' patent laws allow "2nd use patents". This is a new
patent based on a new invention for an existing product (eg AZT
received a 2nd use patent when it was invented to work against HIV).
But if the "2nd use patent" was granted on false information (the
"invention" was not new) then it could be challenged in the courts, and
declared invalid.
Morale: Health Ministries should monitor their Patent Offices, otherwise
they risk not having access to more affordable generics!
2. 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 exports the drug to
another country now based on this precedence?
The national patent law situation before and after TRIPS will decide on
this. If a country does not yet have patent protection (no patent law, or
only process protection for pharmaceuticals), such a country could
legally import generics for products that were patented before 1996
(when TRIPS became valid). This is the case for ciprofloxacin, AZT, 3TC
etc in many developing countries.
Once TRIPS becomes operational in a country by adopting TRIPS
compliant patent laws (least developed countries in 2006, "normal"
developing countries in 2000), the products files internationally after 1
January 1996 will become protected. This is the case of new anti-
retrovirals, such as efavirenz.
I don't know the specific Egyptian patent laws. If ciprofloxacin was
legally on the market in Egypt, it will probably remain legal to market it
even after TRIPS, as ciprofloxacin patent was filed before 1996 (it
expires in Europe in 2001, so was filed 1981). TRIPS implementation
will not change that.
For India it is the same: if it was legal under Indian patent law to
produce a generic ciprofloxacin (probably because the generic company
managed to patent a different synthesis route in India?), then it will
remain legal to do so after TRIPS kicks in, as the ciprofloxacin patent
was older than 1996.
Please note that TRIPS is a MINIMUM agreement. Countries are free to
institute higher levels of patent protection if they want so. Some
developed countries have been promoting "TRIPS-PLUS" in developing
countries, eg Kenya. But why should developing countries do so? They
have no obligation under TRIPS to go beyond the required minimum
protection, and will only pay much more for the patented drugs!
All developing countries should introduce the three "health safeguards"
that are permitted under TRIPS in their national patent laws:
1. Parallel import
2. Compulsory licensing
3. Bolar or "early working" provision
Morale: Health Ministries should get a good patent lawyer to make their
case with their Ministry of Trade or Commerce, and get those permitted
safeguards into law before TRIPS kicks in.
kind regards
Wilbert Bannenberg
Wilbert Bannenberg, E-DRUG moderator
Box 456, Irene 0062, South Africa
Tel work +27-12-3120374/5 Fax +27-12-3236745 Cellphone +27-82-5756249
Email bannew@hltrsa.pwv.gov.za (work)
Email WilbertBannenberg@compuserve.com (private)
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