New York: India's Dr Reddy's Laboratories and other generic drug manufacturers
suffered a setback when a US court ruled against them in a patent infringement case
over wide-spectrum antibiotic Cipro, upholding the patent held by Bayer AG.
The court accepted the Bayer AG's argument that distribution of generic version of
Ciprofloxacin (Cipro) in the US would infringe the patent held by it.
The court decision last week, experts say, means that Dr Reddy's, to which the Food
and Drug Administration had granted approval in July for launching generic version
of 100, 250, 500 and 750 mg version of Cipro, would not be able to market the drug
in the United States.
The generic manufactures had filed Abbreviated New Drug Applications (ANDAs) with
the Food and Drug Administration (FDA) seeking approval to market the generic
version of Cipro. But Bayer sued them arguing that their applications infringed its
patent and the suit stayed the ANDAs before
FDA.
Several drug manufacturers, led by Reddy Cheminor, US subsidiary of Dr Reddy's Labs,
Sachein Pharmaceutical and Mylan Labs, challenged the validity of the patent to
Bayer. But after highly technical arguments, the court on August 9 decided in favour
of the Bayer.
Reddy's Labs, like several other drug makers, are seeking to market in the US
generic versions of drugs whose patents have expired. The cost of generic drugs is
low - less than one-third of those with brand names. And generic drug manufactures
want to take advantage of it to promote their products.
Recently, in a letter to editor in a leading daily, a reader said he had gone to
India where he bought one year's supply of prescription drugs for himself and his
wife.
The cost was so low in India compared with similar drugs in the United States that
he could finance his entire trip from the money he saved.
PTI