Details emerge about seized generic shipment in Paris

The shipment of generic medicines that was detained in Paris last month contained 1.74 million tablets of the antiplatelet drug clopidogrel, manufactured by Indian company Macleods Pharma, and was en route to Venezuela.

Clopidogrel is sold by Sanofi-Aventis in Europe as Plavix and Iscover and is the company's third top-selling product, recording sales of €2.05bn in the first nine months of this year. It is indicated for the reduction of atherothrombotic events in cardiovascular patients.

The seizure of shipments suspected of patient infringement by customs under EC Regulation 1383 is an ongoing source of controversy, with the Indian pharmaceutical sector claiming it is a measure designed to interrupt the legitimate trade in generic goods and is having a deleterious effect on access to medicines in the developing world.

The issue has become mixed up with a debate on the conflation of patent and trademark rights, and it has been asserted that, in some cases, brand owners have asked for shipments to be seized on the grounds that they are counterfeit.

Reports emerging from Indian newswires have indicated that the seizure was instigated by the brand owner for violation of patent rights, but this was strongly denied by Sanofi-Aventis, which told SecuringPharma.com that it has already asked for the release of the shipment.

EC Regulation 1383 allows customs to act either independently in seizing suspect goods, or following an application by the brand owner.

A spokesman for the company said that Sanofi-Aventis only became aware of the seizure after it had been alerted by French customs (SNDJ), and there was no request made by the company.

"Sanofi was made aware on October 19 that a shipment of 1.74 million doses of clopidogrel had been detained in Paris," he said. The company "informed customs on October 23 that no action would be taken."

A clopidogrel shipment was also seized by Dutch customs authorities last October and released seven months later. Under the EU Regulation 1383 shipments are supposed to be released within 20 days, unless the patent holder proceeds with a legal challenge for intellectual property infringement.

The spokesman said the company made no application for seizure in this case either, and had also asked for release of the shipment soon after it was intercepted. "It was a customs decision to detain the goods further," he said.

Meanwhile, generic clopidogrel using a different salt of the active ingredient (clopidogrel hydrogen sulphate instead of the originator's clopidogrel bisulphate) has already been launched in several EU markets, including Germany, the UK, Denmark, Netherlands, France and some eastern European markets and are expected to be available widely across the EU by the end of the year.

India has taken its concerns about EU seizures in front of the World Trade Organization (WTO) council.


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