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Info Service on Intellectual Property Issues(Aug09/03) The seizure has caused outrage among the governments exporting and importing the drugs and health groups. They are concerned that sick people are being deprived of low-cost medicine, and that some European governments are blocking legitimate trade between developing countries in order to unfairly promote the commercial interests of their big drug companies. Regards
GLOBAL
TRENDS WITH MARTIN KHOR A
global controversy has arisen over the seizure of low-cost generic medicine
in European ports in transit from A
NEW threat to the health of people in developing countries is being
caused by European Customs authorities seizing legitimate low-cost generic
medicine being shipped from The
medicine was being shipped mainly from Often,
the Customs’ actions were instigated by complaints from big European
companies alleging that the medicine may be counterfeit and violate
their However, it turned out that the medicine was not counterfeit product nor in violation of patent laws, but was legitimately produced by Indian companies and being imported by Brazil, Peru, Colombia, Mexico, Nigeria and otherdeveloping countries at prices much lower than the branded drugs. The seizure has caused outrage among the governments exporting and importing the drugs and health groups. They are concerned that sick people are being deprived of low-cost medicine, and that some European governments are blocking legitimate trade between developing countries in order to unfairly promote the commercial interests of their big drug companies. According
to the Wall Street Journal of Aug 6, there have been more than 20 cases
since late last year when Customs officials in the The European countries are said to be especially misusing the European Commission’s Regulation 1383/2003, which allows the seizure of medical shipments if they are suspected of containing counterfeits or infringing other intellectual property laws. Last week, Indian Commerce Minister Anand Sharma said his government had protested to the European Union that its action was ‘absolutely wrong’. The
Federation of Indian Chambers of Commerce and Industry said the country’s
pharmaceutical companies had been ‘severely hit’. The Indian companies
are incurring extra costs by making use of transit hubs outside of A group of 16 non-governmental organisations have also protested against the Dutch and German actions. The Wall Street Journal report details some of the seizure which are at the centre of the uproar: --In
October 2008, Dutch Customs at The
drug was produced by the Indian firm Ind-Swift, and the seizure was
made on behalf of the European company Sanofi, which consented to the
release of the drugs only in May this year. Ind-Swift has re-routed
all its shipments through --In
November 2008, Dutch officials seized two shipments en route to The
rivastigmine medicine, seized on behalf of Novartis company, was detained
for five months before being allowed to proceed to --In
December 2008, Dutch Customs seized blood pressure drug Losartan which
was en route to -
In February 2009, the AIDS medicine abacavir which was bound for --
In May 2009, the generic drug amoxicililin (used in treating many bacterial
infections) was seized in Frankfurt airport en route from It was released after GSK, the company holding the patent, informed the Customs that there was no trademark infringement. At
a WTO meeting on June 8, The European Commission responded that it is fully committed to ensuring access to medicine, but it must continue to allow its Customs authorities to act against counterfeit products. It claimed its Customs regulation was in line with WTO rules Wall Street Journal AUGUST 6, 2009 By
JOHN W. MILLER in On more than 20 occasions since late last year, border inspectors in the Netherlands and Germany have held up Indian medicines used to treat AIDS, Alzheimer's disease, heart conditions and other ailments, saying they violated patent laws in the EU, although the drugs weren't intended for sale there, according to EU and Dutch customs officials and to lawyers for Indian pharmaceutical companies. At the request of companies including Sanofi-Aventis SA, Novartis AG and Eli Lilly & Co., the drugs were then detained for periods that extended for as long as eight months, according to letters sent by the companies to customs officials and reviewed by The Wall Street Journal. Indian generics makers say they have had to divert shipments at higher cost to transit hubs outside the EU, and to hire lawyers to defend their right to have the drugs shipped safely to their destination. Dutch customs officials are still holding on to the Indian generics drug giant Cipla Ltd.'s shipment of a schizophrenia medicine seized in November, according to Cipla and Lilly. "We
see this as an attack on the Indian generics industry," says Rajeev
Kher, joint secretary of commerce in This
handout picture released by the Spanish police on June 09, 2009 shows
fake Viagra pills seized after the arrest of four people suspected of
importing tens of thousands of the fake versions of the impotence drug
in Alicante. Spanish police said they have seized more than 9,000 fake
Viagra pills produced in EU officials say their national customs agencies have the right to enforce intellectual property laws in their countries, and they deny any violations of other WTO rules. The EU is "complying with its WTO obligations," says spokesman Michael Jennings. Some
trade experts say The
world's biggest pharmaceutical companies often hold patents on their
medicines in the Weaker
patent laws in developing countries allowed An EU regulation adopted in 2003 tasks national customs offices with policing intellectual-property laws on goods entering or transiting through their posts. The goal, EU officials say, was to take a bite out of the world's $500 billion annual trade in counterfeit goods, which are illegal copies of products masquerading as the real thing, usually of low quality. The law wasn't applied aggressively to pharmaceuticals until last year. The EU launched a crackdown aimed specifically at "counterfeit" medication, EU officials say. However, generic drugs, which are regulated replicas of brand-name drugs, are getting caught in the same dragnet. EU
and On
Oct. 8, Dutch customs agents at One
ingredient identified the drug as under patent to Sanofi-Aventis of
In
two letters, a lawyer for Sanofi told the recipient in The second letter, reviewed by The Wall Street Journal, was titled "counterfeit clopidogrel" and threatened "further action" if the goods weren't destroyed and the claim wasn't settled out of court. In April, the claim was settled. Sanofi consented to the drugs' release in May, six months after the shipment was seized, according to Ind-Swift and Sanofi. A spokesman for Sanofi said the company doesn't comment on cases involving other pharmaceutical companies. Ind-Swift
has since changed the route of all of its shipments, sending them instead
through The European Federation of Pharmaceutical Industries and Associations said in a statement that EU countries have the right "to stop products that they suspect may be counterfeit from entering the supply chain." In November, Dutch officials seized two shipments from Mumbai-based Cipla, one of capsules of the Alzheimer's disease medicine rivastigmine and another of tablets of the antipsychotic medicine olanzapine, according to Cipla and Dutch customs officials. Novartis, manufacturer of rivastigmine, asked Cipla to sign a letter admitting that it had infringed on the European company's patents and promising that Cipla wouldn't do so again, Cipla and Novartis said. Cipla refused, saying the company believes a shipment in transit can never infringe on an EU patent, said Patsy Jeffery, who handles legal affairs at Cipla. The
shipment, bound for The
Peru-bound shipment of olanzapine, the schizophrenia treatment that
is one of the biggest-selling medicines in the world, is still being
held in the A spokesman for Lilly, Jamaison Schuler, says the company is discussing with Cipla how to "amicably settle this dispute." In general, he says, the company believes customs should check generics in transit to make sure they're not counterfeit and they don't violate patent laws. Dutch officials say they were merely doing their jobs. "We subscribe to the rights of developing countries to have access to this medication," says Ruud Stevens, a spokesman for the Dutch economics ministry. "But we have to enforce EU patent law." After
Write
to John W. Miller at john.miller@wsj.com and Geeta Anand and at geeta.anand@wsj.com
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