The Affordable Medicine and Treatment Campaign (AMTC), an NGO initiative for accessibility and affordability of medicines and treatment for all in the country, are planning to oppose Bayer India Pharmaceuticals Ltd's EMR application being filed for gatifloxacin (Tequin) with the Indian patent office, it is learnt.
According to Vivek Divan, project coordinator of the Mumbai based Lawyers Collective HIV/AIDS Unit, gatifloxacin is not a new molecule and is a pre-1995 invention. As per the U S patent (4,980,470) information available from the US patent office, the patent for this product was originally filed on January 21, 1986. Hence, the compound was not eligible for the grant of an EMR, said Vivek Diwan in a letter to the patent and trademark authorities in Mumbai and Calcutta.
As per a communication published in the AIDS-INDIA e-FORUM network, he said an EMR on gatifloxacin would have disastrous and detrimental consequences on the Indian patient population. Such an action would block the entry of generic manufacturers and affect the availability of drugs at reasonable prices. The international experience has been that EMR holders, especially MNCs, take advantage of monopoly rights to fix high prices. In the case of Glivec, the EMR holder was selling the drug at unaffordable prices.
Expressing concern over granting of EMRs, he said since such claims include common antibiotics, life saving drugs etc., monopoly rights have serious implications on the affordability of those drugs, and thus the right to health and treatment, said the letter.
AMTC also observed that the Indian Patents Act was silent on the procedure for the opposition of EMR applications, and the rules under the Act were vague, though the grant of EMR could be opposed. The letter from AMTC also sought for an appointment with the authorities to explain their stand on the issue.
It is to be noted Nicholas Piramal had filed application for EMR for its anti-malarial drugs Aablaquine (bulaquine) and Movoquin. Other companies that have applied for EMRs include Wockhardt for antibiotic Benzoquinolizines, Ranbaxy for a process of antibiotic Cipro, Schering Plough for biotech cancer drug Interferon alpha and Bayer for antibiotic Gatefloxacin. Some EMR applications rejected by the authorities include Roche's HIV/AIDS drug Saquinavir, GlaxoSmithKline's anti-diabetic drug Rosiglitazone and new drug delivery system of Ranbaxy.
AMTC consists of civil society organizations, NGOs, patients groups, healthcare providers and concerned individuals and the campaign was initiated in 2001 with aim to demand and create an environment that will ensure sustained accessibility and affordability of medicines and treatment for every individual in India, including access to affordable Anti-Retroviral Therapy for persons living with HIV/AIDS, informed the communication.