Report From India: A new patent battleground has formed over India's drug shipments through the European Union. - Pharmaceutical Technology

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Report From India: A new patent battleground has formed over India's drug shipments through the European Union.
Patent infringement claims and a lack of clear global trade distribution routes may be unraveling the country's generic-drug export industry.


Pharmaceutical Technology
Volume 33, Issue 7

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).


ADAM JONES/GETTY IMAGES
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).

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


Table I: Indian drug exports seized in Europe.
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).

"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.


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