On Jan. 12, 2009, a ship loaded with the bulk drug losartan, used to lower blood pressure, from Dr. Reddy's Laboratories (Hyderabad,
Andhra Pradesh, India) dropped anchor at an European port. Although the shipment's final destination was Brazil, European
officials seized the ship's cargo and ended up sending it back to the manufacturer in India. Authorities charged that the
drug on board infringed the patent of the original drug, Cozaar (losartan potassium). Losartan is not patented in India or
Brazil. Cozaar is protected in The Netherlands until September 2009 under a patent held by DuPont; Merck and Co. (Whitehouse
Station, NJ) holds the product's marketing rights (1).
Another drug shipment of clopidogrel bilsulfate from an Indian manufacturer, Ind-Swift Laboratories (Chandigarh), bound for
Venezuela made a pit stop at a Dutch port on Oct. 15, 2008. The local customs agency seized the consignment on charges of
counterfeiting and patent infringement. A trade promotion agency in India objected to the claims, arguing that the drugs were
perfectly legal in the market they were meant for—Latin America in this case. Ind-Swift appointed a lawyer in Amsterdam to
secure the release of the goods, worth $50,000. At the end of May 2009, diplomacy and legal channels helped to release the
shipment back to the manufacturer, although the European Commission is still reviewing the case in The Netherlands (1).
ADAM JONES/GETTY IMAGES
Dutch authorities seized yet another shipment from India on Nov. 12, 2008. This time, the detained product was generic abacavir
sulfate used in lamivudine tablets, an antiretroviral HIV/AIDS treatment. Bound for Nigeria, the abacavir tablets were found
to violate patent rules and declared counterfeit. The cargo was not returned to its Indian manufacturer, Aurobindo Pharma
(Hyderabad), and was in fact, burned (1).
The response from India
These are only a few examples (see Table I), and the abacavir seizure was the veritable last straw for the Indian government.
Feeling hounded at European ports and dismayed at the long list of seizures of Indian drug exports, India's leaders complained
to the World Trade Organization (WTO).
Table I: Indian drug exports seized in Europe.
"We have raised the issue with the expectation that the European Commission will urgently review the relevant regulations
... and bring them in conformity with the letter and spirit of the TRIPS [trade-related intellectual property rights] agreement
and the rules-based WTO system," said Indian government officials in a statement to the WTO council. The statement added that
it was not a case of temporary detention, "as some consignments have been held for over months, with procedures initiated
for their destruction as well."
India's $12-billion domestic pharmaceutical industry gets 40% of its revenue from generic-drug exports around the world. Although
drug seizures happen from time to time, the sudden increase in seizures in Europe touched on sensitive nerves—those of rich
and poor countries and of those fighting for the right to access affordable medicine. The repeated seizures also enraged advocacy
groups and nonprofit organizations such as Oxfam International and Knowledge Ecology International, which sent letters voicing
their concern to the World Health Organization (WHO) and WTO (2, 3).
What was particularly embarrassing about these events was that the abacavir cargo was paid for by international donor goverments,
an aid facet amply supported by European Union nations such as France and the United Kingdom. The particular consignment of
antiretroviral drug was to be distributed in Nigeria by the Clinton Foundation, established by former US President Bill Clinton.
Moreover, GlaxoSmithKline (London), which holds the patent for abacavir and markets it under "Ziagen," did not object to Aurobindo
Pharma manufacturing the drug for Nigeria's population. The Indian company obtained a waiver under TRIPS.