London/New Delhi, Aug. 23: GlaxoSmithKline (GSK), the world’s second largest drugmaker, has slammed lawsuits against Ranbaxy and Novartis, accusing them of using a stolen bacteria to make copies of a GSK antibiotic called Augmentin.
GSK has also asked the US government to bar number three European drug-maker Novartis from importing generic versions of Augmentin into the US after they went on sale this summer.
“We have reason to believe they use the stolen strain of bacteria that is a trade secret owned by GSK,” a GSK spokesman said.
In its lawsuit, GSK says the generic version of Augmentin sold by Geneva Pharmaceuticals, a unit of Novartis, uses a type of bacteria the company developed in the 1980s to produce a main ingredient for Augmentin. The bacteria was allegedly stolen by a former GSK employee.
GSK is also taking legal action in a Philadelphia County court against Ranbaxy Laboratories and Teva Pharmaceuticals of Israel. The two companies have yet to launch their generic versions of Augmentin but GSK said it had evidence they also used the stolen bacteria.
In Delhi, Ranbaxy officials rubbished the claims. “Ranbaxy has not indulged in any stealing or any unlawful or unethical conduct in regard to Augmentin-GSK. Ranbaxy is confident of its position in the context of the law suit filed by GSK in this regard,” said a company spokesperson.
The spokesperson said Ranbaxy has applied to the US Food and Drug Administration, for its approval to launch the generic version of Augmentin and is awaiting approval.
The lawsuits are part of GSK’s fierce legal battle to fend off challenges to Augmentin, the company’s second-biggest selling product, which lost US patent protection in May.
The launch of a cheap generic form of Augmentin is expected to slice into profits and GSK shares have fallen over 20 per cent this year, partly on concerns about such competition.
While legal battles over patents are commonplace in the drug industry, claims of stolen trade secrets are more unusual and more difficult to prove. GSK compared its trade secret for one of the main ingredients of Augmentin to the secret formula for Coca-Cola.
GSK said that while patents have a finite life, trade secrets go on forever. The GSK lawsuit does not accuse Novartis or any other maker of an Augmentin copy of being involved in the theft.
In a statement, Novartis said: “We are confident that the lawsuit will show Novartis acted in a legally and ethically correct manner.”