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AFRO-NETS> In Nigeria, a drug 'patent' fight like no other


 
In Nigeria, a drug 'patent' fight like no other
-----------------------------------------------
 
A drug 'patent' fight is playing out in Nigeria presently. It has 
broad implications for the pharmaceutical industry as a whole and the 
practice of Intellectual Property Law in the country. 
 
Here is the publicly available story so far.
 
Greenlife Pharmaceuticals Company Limited is a Nigerian corporation 
that applied for and obtained approval for the sale of 'Alaxin' in 
Nigeria from the National Agency for Food Drugs Administration and 
Control (NAFDAC). 
 
Greenlife imports 'Alaxin' into Nigeria from GVS Laboratories in In-
dia and Chile, South America. 'Alaxin' is said to be a brand of a new 
generation anti-malarial drug containing Dihydroartemisinin. Dihy-
droartemisinin is a derivate of Artemisinin. Greenlife contends that 
Dihydroartemisinin is a generic substance. 
 
Artemisinin has been known to the Chinese for 2,000 years as an 
herbal medicine, qinghaosu. It is obtained by extraction from the 
wormwood (Artemisia annua, a relative of the herb used to make ab-
sinthe). Artemisinin has been found to be highly effective at killing 
malaria parasites. It is now the drug of choice in cases where the 
malaria parasite is resistant to the first line anti-malarial drugs; 
chloroquine and sulfadoxine-pyrimethamine. 
 
Two days after Greenlife launched 'Alaxin' into the Nigerian market; 
its warehouse was raided by a special squad consisting of court bail-
iffs and heavily armed policemen. The squad was said to have acted on 
the order of a Federal High Court presided by Justice C.P.N. Senlong. 
The raiding team broke into Greenlife's premises to seize all of 
Greenlife's 'Alaxin' the alleged patent infringing drug; sales re-
cords, packaging, get up, marketing and distribution resources per-
taining thereto.
 
Unknown to Greenlife officials, Churchbells Pharmaceuticals Company 
Limited, another Nigerian pharmaceutical company, had two days ear-
lier to the raid at Greenlife's premises, filed ex-parte motion pray-
ing the Federal High Court in Lagos to order the raid on the ground 
that Greenlife continued to infringe its patent rights to Dihydroar-
temisinin despite the order of court to refrain.
 
In Suit No. FHC/L/718/2203 between Beijing Cotec New Technology 
Corp./Churchbells Pharmaceuticals Ltd., (Plaintiffs) Vs. GVS Labs and 
five others - including Greenlife (Defendants), a Federal High Court 
presided by Justice C.P.N. Senlong had ruled that the plaintiff was 
the owner of the registered patent No.13566. The Honorable Justice 
ordered Greenlife and other defendants to refrain from infringing on 
the patent of Dihydroartemisinin, by producing, causing any other 
person to produce, importing, distributing by way of trade or offer-
ing for sale or storing any anti-malaria drug which has the active 
ingredient, without consent of the plaintiff, pending determination 
of the Motion of Notice for Interlocutory Injunction filed on Jul 23, 
2003.
 
The Court also permitted the plaintiffs/applicants, their solicitors, 
Court Bailiffs and the Police to break open any premises where prod-
ucts of the subject matter of dispute are being kept for the purpose 
of obtaining relevant evidence of patent infringement.
 
Apparently, at the time Greenlife applied to register 'Alaxin' with 
NAFDAC for sale in Nigeria as provided by law, Churchbell objected to 
the registration claiming that it had sole patent rights to Dihy-
droartemisinin and that all products containing the substance, no 
matter how named should not be registered for sale in Nigeria by 
NAFDAC. Churchbell itself had earlier applied for and obtained NAF-
DAC's approval to sell 'Cotexin' in Nigeria. 'Cotexin' is a Chinese 
made brand of the anti-malaria drug, Artemisinin. Churchbell's objec-
tion was allegedly over-ruled by NAFDAC on the grounds that Chur-
chbell could not claim to hold a valid patent in a generic substance 
in Nigeria.
 
Now, Churchbell is back in court. This time, the defendants are 
NAFDAC and Greenlife. Churchbells is claiming that as the sole fran-
chise owner of Cotexin in Nigeria, another third generation anti-
malaria drug made in China and marketed in the country, it is auto-
matically the sole franchise owner of all third generation anti-
malaria drugs in the country with the active ingredient Dihydroar-
temisinin, since, according to Churchbell, it has a registered ?pat-
ent? over dihydroartemisinin. Churchbells is challenging NAFDAC's 
registration and licensing of 'Alaxin' for sale in Nigeria. 
 
These fundamental questions beg to be addressed among others: A) Is 
Dihydroartemisinin a generic or proprietary substance? B) If generic, 
is it patentable anywhere, inclusive of Nigeria? C) If not pat-
entable, how did Churchbell receive a 'Patent' in Nigeria for a non-
patentable generic substance? D) If Dihydroartemisinin is not pat-
entable, is Churchbell's 'patent' valid and should it subsist? E) Can 
a regulatory authority be sued for registering a product that alleg-
edly infringes a competitor's patent rights? F) Does Greenlife have 
in any remedy in law against Churchbell?
 
Comments are welcome.
 
Sources: 
1. Company sues NAFDAC for breaking its monopoly. August 7, 2003 
http://www.datelinehealth-africa.net/betav1.0/news/detailnews.asp?news_id=6931
 
2. Dihydroartemisinin: court restrains Greenlife, others. August 5, 
2003 
http://www.datelinehealth-africa.net/betav1.0/news/detailnews.asp?news_id=6906
 
3. Greenlife cries out against seizure of 'Alaxin'. August 2, 2003 
http://www.datelinehealth-africa.net/betav1.0/news/detailnews.asp?news_id=6854
 
 
--
A. Odutola 
Centre for Health Policy & Strategic Studies, (CHPSS)
Lagos, Nigeria
mailto:chpss_abo@yahoo.com

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