Zydus, Natco launch versions of drug facing court battle

Ranbaxy, which first launched a generic version of Hepatitis-B drug Baraclude, was taken to court.

Domestic drug makers Zydus Cadilla and Natco Pharma have launched generic versions of US drug major Bristol Myers Squibb (BMS)’s Baraclude, a chronic Hepatitis-B treatment drug that has a patent protection in India.

The product launch is significant as Ranbaxy, the country’s largest drug firm, that first launched the formulation’s generic version, was taken to court by BMS on complaints of patent infringement. The high court here is yet to decide the case. The next hearing is tomorrow.

Though all three companies declined to comment on the development, industry players said BMS was waiting for the HC verdict to initiate legal proceedings against the other two.

The entry of other players, with a much lower price tag than that of BMS, is expected to trigger a price war even before the HC ruling comes in. Drug trade channels are anticipating another price cut as they expect Cipla, the fourth company readying the generic version, to outsmart all others with a price at least 50 per cent less than the lowest today.

“The business-as-usual response from the generic companies even when the product has a patent protection is what worries research-based drug firms. The recent plea (to the Prime Minister’s Office) of the Organisation of Pharmaceutical Producers of India (the industry association that represent multinational drug firms) to strictly enforce India’s own patent laws come in this context,” said an executive with an international pharma company.
 

PRICE WAR
Brand	Company	Price per tablet in '/ (0.5 mg)	Price in ' (1 mg)
Baraclude	BMS	212	312
Entaco	Ranbaxy	82	169
Entehep	Zydus Cadilla	75	147
X-vir	Natco	82	147
Source: Drug trade

The representatives of generic drug companies, however, said the domestic players were ignoring the patent status of ‘Baraclude’ as it did not merit patent protection under Indian laws.

“The company (BMS) had applied for a patent for Baraclude in 2002. The patent office rejected the application in 2007, as it was found to be a pre-1995 molecule, which cannot be patented in India. BMS applied for a review of this order and in 2008, the office granted the patent without a speaking order,” generic industry representatives said.

All generic companies will have to withdraw their products and pay penalties if the court decides in favour of BMS.