New Delhi: A consignment of drugs sent by Dr Reddy’s Laboratories Ltd (DRL) from India to Brazil has been seized in transit by Dutch customs on charges of patent infringement.
India’s commerce department has reacted strongly against such seizures in the European Union (EU), this being the second such seizure in the Netherlands in three months.
DRL’s consignment, worth $500,000 (Rs2.4 crore), was of bulk drug losartan used to lower blood pressure. The patent for losartan in the Netherlands is held by US-based DuPont under the Cozaar brand.
Commerce secretary G.K. Pillai said the department has taken up the matter with the European Commission (EC) and has written to them. “This is an act of piracy by the European Union. The consignment was going to Latin America and was seized in Europe... This is a dangerous thing happening, which is totally uncalled for. It is part of the strategy by these countries to target generic drugs from India.”
Mint had reported on 12 December that an increasing number of shipments of Indian small and medium-sized bulk drug makers were being seized at European ports on charges of patent infringement. This is the first time a shipment of a large Indian company has been seized.
To be sure, some Indian patent lawyers argue that the EU is following local laws and India cannot question their implementation.
“If the consignment does infringe a patent, then you cannot question the EU for seizing it under their patent laws,” said Shamnad Bashir, a professor in intellectual property law at the National University of Juridical Sciences, Kolkata.
Rajeshwari Hariharan, a partner at law firm K&S Partners, agreed. “There are cases where a product is in transit and is seized at a transit point. If this DRL product was in transit via the Netherlands, and was seized there due to patent infringement, it is a valid argument for the EU,” she said. “In fact, India takes the same stance.”
Others, however, view this as a public health issue. “The EC regulations that have led to the seizure of Indian generic drugs in transit to Brazil have created barriers to the export of affordable, quality, low-cost generic drugs from India to other developing countries. This is part of the IP (intellectual property) enforcement agenda,” said lawyer Leena Menghaney, who is also India project manager for the Campaign for Access to Essential Medicines, an initiative of Medecins Sans Frontieres, a non-profit organization.
“The fallout will be on patients’ lives in the developing world who will not be able to access affordable life-saving drugs from India,” she said.
Industry lobby group Indian Pharmaceutical Alliance (IPA) has also urged serious action on the matter.
“We are concerned that all our exports of generic medicines to South America and Africa passing through Europe will come to standstill unless the government were to challenge the EU Council Regulation of 22 July 2003 and seek its amendment,” D.G. Shah, secretary general, IPA, has written in a letter to the commerce department.
A medium-sized Indian company, whose consignment worth $100,000 was also seized at a European port while going to Latin America, said it now sends the drug through a different route. It also said it was not big enough to fight an expensive legal battle in the EU.
The commerce department seems to be gearing up to tackle that, too. “We are willing to assist the company through the Pharmaceutical Export Promotion Council (Pharmexcil),” secretary Pillai said.
However, Pharmexcil executive director P.V. Appaji admitted that India should not expect drastic changes in EU regulations since “we cannot dictate our terms on them”. At the same time, Pharmexcil is encouraging smaller drugs makers to get advise the issue. “We will provide the company with our adviser, who will highlight all potential legal issues with regard to patent before they ship a consignment through a particular route. This adviser will be available to these companies at throwaway prices,” Appaji said.
Emails to the European Commission, World Health Organization and World Trade Organization remained unanswered. A DRL spokesperson said the company was unavailable for answer owing to a holiday.
Asit Ranjan Mishra in New Delhi contributed to this story.