According to Munjal, the authorities have seized it saying it is counterfeit, as Ind-Swift does not have marketing rights in the EU. The company sells the drug in India as Pentagon-D.
“Patent legislations have been around in Europe for some time but there seems to be a sudden interest in enforcing it, but it is unreasonable to enforce it on goods in transit,” said Munjal.
“We are already pursuing possibilities of sending consignments through routes where it doesn’t touch European ports while in transit. Another alternative we are looking at is having a storage facility in a non-European country, from where we can serve our markets,” he said. Significantly, pantoprazole is an unbranded bulk drug, which means the consignment can’t be an instance of trademark counterfeiting.
The EU patent for the molecule is held by a privately held Swiss company Nycomed SCA which acquired the original patentee Altana Pharma AG in 2006, and Wyeth in the US.
Bigger Indian generic drug makers that Mint contacted, including Sun Pharmaceutical Industries Ltd, said that while they are yet to face similar issues, they think “it (the definition of counterfeit medicine) is a very important issue and needs to be debated as it can have serious impact on Indian pharma exporting companies.”
Problematic definition
Patent lawyers said the definition of a counterfeit drug is problematic.
“The IMPACT definition is certainly problematic in that it uses the term ‘when there is a false representation in relation to its identity, history or source’. If the word ‘false’ is defined quite loosely, it could potentially even catch legitimately approved generics, whose brands are similar to the innovator,” said Shamnad Basheer, a professor in intellectual property law at the National University of Juridical Sciences, Kolkata.
India’s reservations about the IMPACT definition were raised at a meeting of the taskforce held at Bonn in Germany in the last week of November. This resulted in the word history being dropped from the draft of the definition, as it could lead to multiple interpretations and could be misused, as reported in Mint on 3 December.
A final decision on this will be taken in May next year at a world health assembly meeting, though that draft was finalized last week at Tunisia.
“As to whether or not foreign authorities can capture Indian goods in transit on account of IP violations depends solely on the respective national laws of the foreign country concerned. Some countries permit such seizures—others do not. This has nothing to do with the IMPACT definition or the WHO,” Basheer, however, said.
To be sure, Greg Perry, director general of the European Generic Medicines Association had told UK-based trade journal Pharma Times just ahead of the Tunisia meeting: “The problem in the definition does not lie with IMPACT, which is doing an excellent job in dealing with the real problem of fake products being pushed by criminals.”