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NGO opposes EMR for Bayer's Gatifloxacin

P.T. Jyothi Datta

Mumbai , April 5

CAMPAIGNERS for affordable medicines have now trained their guns on Bayer's antibiotic drug gatifloxacin, sold under the Tequin brand name. Bayer has sought an exclusive marketing right (EMR) for gatifloxacin and the application lies at the Indian Patent office, pending a decision.

However, Affordable Medicines and Treatment Campaign (AMTC), a platform of non-governmental organisations, has contested Bayer's application on the grounds that "gatifloxacin is not a new molecule and is a pre-1995 invention." Gatifloxacin is used to treat bacterial infections of the lungs, sinuses, skin and urinary tract.

In its letter to the Controller General of Patents, AMTC points out that the "US patent office Web site states that the patent for this product was originally filed on January 21, 1986. Hence, we (AMTC) feel that the compound per se is not eligible for the grant of an EMR." Granting an EMR, which would give the company exclusive rights for five years, would affect the availability of the drug at "reasonable prices," AMTC added.

Despite efforts to reach the company, no official response was available from Bayer on the issue.

Meanwhile, lawyers specialising in Intellectual Property Rights (IPR)-related issues told Business Line that more hair-splitting was in the offing on the validity of patent and EMR applications.

"Pharma companies are eligible to apply for product patents and EMRs only for a new drug or a post-1995 discovery. However, drug firms try to keep a monopoly on their products by tweaking the patent, changing its delivery system or dosage form and claiming an additional period of exclusivity on existing drugs. When a product is new, companies are given a 20-year period to get their return on investments made in research. But after that, competition should be allowed, as it brings prices down and is good for the consumer," they point out.

AMTC said that globally Bayer's Tequin has two dosage strengths, 200 and 400 mg — both are priced at about $252 (Rs 11,030) for 30 tablets and $736 (Rs 32,214) for 90 tablets. This works out to about Rs 367 per tablet.

A clutch of Indian companies including Emcure, Aristo Pharma, Wockhardt Ltd, Nicholas Piramal, Ranbaxy and Cipla make the same drug. Prices for the 200-mg tablets range from Rs 18.5 for five tablets to Rs 50, that is, about Rs 3 to Rs 10 per tablet, point out industry representatives.

Prices for the 400-gm dosage varies from Rs 28 for five tablets up to Rs 350. This works out to Rs 5 to Rs 70 per tablet.

"Given that an average antibiotic course is taken over five days or a week, the cost to a patient increases," said AMTC representatives.

Further, AMTC officials point out that the Indian Patent Act is silent on the procedure for the opposition of EMR applications. "There should be a procedure of pre-grant opposition, where even civil society can go through the data published and express their objections, if any," they point out.

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