AMTC Letter to Patent Office on Exclusive Marketing Rights

[Guest guest]

Dear Moderator,

Please find below a letter send by Affordable Medicine and Treatment Campaign

(AMTC) to the ControllerGeneral of Patents regarding the opposition procedure

for EMR Application prnding before Indian Patent Office. In the same letter

AMTC expressed its intention to oppose Bayer's EMR application on Gatifloxacin.

Kindly post this.

For AMTC

Gopakumar

E-mail: <aidslaw@...>

March 3, 2004

Dr.S.N.Maity

Controller General of Patents, Trademarks & Designs

Todi Estates, III Floor, Lower Parel (West)

Sun Mill Compound, Lower Parel (West)

MUMBAI 400 013.

Dear Mr. Maity

Ref: EMR for Bayer's drug - Gatifloxacin (Tequin)

Affordable Medicine and Treatment Campaign (AMTC) is a national campaign aimed

at creating 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. It consists of civil society organisations, NGOs, patients groups,

healthcare providers and concerned individuals. The campaign was initiated in

2001 with the following mission statement:

The right to life and health is a fundamental right guaranteed to every person

living in India and is non-negotiable. This campaign aims 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. This

campaign shall be democratic and participatory. It will seek the mobilization of

communities and civil society to make state, national and international

agencies and industry accountable for securing health for all.

We have learnt that the patent office is currently processing ten

Exclusive Marketing Rights (EMR) applications, mainly from drug

companies, overseas multinationals and domestic (Indian).

As you know, products for which EMR have been claimed include common

antibiotics,life saving drugs etc. We are extremely concerned about EMRs being

issued for various products because such monopoly rights have serious

implications on the affordability of those drugs, and thus the right to

health and treatment. The international experience has been that EMR

holders, especially MNCs, take advantage of monopoly rights to fix high

prices, which are detrimental to the interest of the patient, the large

part of whom in India not be able to afford such drugs. The case of

Glivec, where the EMR holder sells the product at a very high price (Rs.

1, 20000 per month) excluding vast majority of CML patients from taking

advantage of the new drug illustrates this point.

The AMTC, as an interested party, would like to be heard before such

applications are granted or rejected. We feel the need for an

opportunity to raise valid and tenable objections on validity of any

particular EMR before you or in any other appropriate forum. We

understand from press reports that grant of EMR can be opposed,

documents which decides the EMR therewith can be inspected and copies

can be obtained after paying the prescribed fees. However, the Indian

Patents Act is silent on the procedure for the opposition of EMR

applications, and the Rules under the Act are vague. As such, we request

you to provide us information as to the procedure for opposition, the

fees required for the same and the grounds for eligibility for

intervention in such matters.

We would also like to bring your attention to the particular EMR

application that is pending before you, in respect of a drug called

Gatifloxacin ( to file EMR for anti-malarial drug - Business

Standard, 27-11-2003). As you know, Gatifloxacin is not a new molecule

and is a pre-1995 invention. Please find enclosed a copy of a the front

page of the U S patent( 4,980,470) obtained from the US patent office

website, which clearly states that that the patent for this product was

originally filed on 21st January 1986.

Hence we feel that the compound per se is not eligible for the grant of

an EMR. We think that an EMR on Gatifloxacin, will have disastrous and

detrimental consequences on the Indian patient population. Such an

action will block the entry of generic manufacturers and affect the

availability of drugs at reasonable prices. We request you to give us an

opportunity to express our views on this matter in future proceedings in

this matter.

Finally, this is a request for an appointment with you to discuss some

of these issues on behalf of the AMTC.

We look forward to hearing from you at the earliest.

Warm regards,

For AMTC

Vivek Divan

Project Co-Ordinator, Lawyers Collective HIV/AIDS Unit, Mumbai

Encl:

1. News paper cutting of Business Standard

2. Abstract on US patent Gatifloxacin

3. Copy of Orange Book

C.C.to: The Controller of Patents, Trademarks & Designs

The Patent Office, Nizam Palace

2nd M.S.O. Building, 7th Floor

234/4, A.J.C Bose Road,

Kolkata 700 020

Phone: 2281 3419-20-21-22