The Affordable Medicines and Treatment Campaign (AMTC) has raised serious concerns on certain provisions in the Patent amendment ordinance and demanded to withdraw the TRIPS PLUS incorporated in the ordinance.

AMTC noted the ordinance extends the scope of patentability beyond the TRIPS requirements by amending Section 3(d) of the Patents Act to provide patents to new use of known medicines. There is no obligation under TRIPS to provide a patent to either new use or new dosage of known medicines, and the ordinance has limited the right of pre-grant opposition, which is vital to block trivial patents. However, there is no obligation under TRIPS to change the pre-grant opposition procedure. The objector is no longer treated as a party, and will not have the right to participate in all the proceedings in the grant of the patent, except for maximum allowing a written representation, AMTC says.

Currently, there are approximately 6000 applications for patents pending in the mailbox, and in the absence of an effective pre-grant opposition mechanism, these 6000 applications would escape public scrutiny, said AMTC.

Commenting on the compulsory licensing provision, it said the provision favours only the interests of multinational companies and the cumbersome procedures needs to be simplified. It lacks any time line for the final disposal of the application. Issuing compulsory licences for various products is quite common in the developed countries, but seldom done in developing countries like India. Therefore for the effective working of the compulsory license mechanism, procedures have to be simplified.

Further, the ordinance mandates compulsory licensing by an importing country with no or insufficient manufacturing capacity in the pharmaceutical sector. In this case, the Indian drug companies would not be able to export to Least Developing Countries (LDCs) in the absence of a compulsory license granted by the LDC. This provision only helps multinational pharmaceutical companies who want to block generics from entering countries that desperately need cheap drugs.

AMTC noted that neither the contents of the Patent (Amendment) bill nor the text of the ordinance were made public until the ordinance was promulgated on 26 December 2004, despite the fact that public at large, as an affected party, have a right to be consulted and heard. AMTC demanded that a transparent public debate be initiated on the provisions of the ordinance and proposed bill, before it is made as a law.

The Third Patents Amendment Bill and now the ordinance will trade away its rights to protect the public health of people who need access to low-cost, quality generic medicines. The ordinance in its present form seriously compromises people's ability to access affordable medicines.

AMTC felt that despite the detrimental effect that the TRIPS agreement is going to have on its citizens' right to health, India has, to a large extent, already implemented its obligations under TRIPS by amendments to the Patents Act 1970 introduced in 1995 and 2002. These amendments effectively provide protection for both product and process patents, extend the period of protection from 7 to 20 years, set up the mail box facility for product patent applications and provide for the granting of Exclusive Marketing Rights (EMR) in the interim period between 1.1.95 - 1.1.2005. Compulsory licences have also been incorporated with all the required safeguards. Thus the only amendment required to be made by the government to comply with TRIPS are minimal amendments which are required to process product patent applications, AMTC added.

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.