Concerns Regarding Patent Amendment Ordinance

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Concerns Regarding Patent Amendment Ordinance promulgated on 26 December

2004, by the UPA Government

On 26 December 2004 the government promulgated an Ordinance amending the

Patent Act 1970. The Affordable Medicines and Treatment Campaign (AMTC)

would like to raise certain serious issues regarding the process as well as

content of the Ordinance. The provisions of the Patent Amendment Ordinance

promulgated by the UPA government on 26 December 2004, contradict the

National Common Minimum Program and seriously affect the constitutional

right to health and life. As per the Common Minimum Programme, the UPA

government promised, “to take all steps to ensure availability of life

savings drugs at reasonable prices”.

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 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.

However “TRIPS-PLUS” standards are being introduced through the Patent

Amendment Ordinance that takes India way beyond the commitments agreed to

under the multilateral agreement of TRIPS governed by the WTO. The Third

Patent Amendment Bill was to be tabled in the parliament by the UPA

government during the winter session (December 2004). However, due to

concerns being raised by members of the government and civil society the UPA

government failed to introduce the proposed Bill. The government has now

amended the Patent Act by converting the draft bill into an Ordinance and

avoided all informed public debate on the issue (Copy of the Ordinance is

available at http://lawmin.nic.in/Legis.htm). The ordinance route of

amending law allows no public debate on an issue of vital public interest

and falls short of the transparency requirement of a democratic government.

Public Interest Groups working on health are gravely concerned that India

through 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.

Objections Against the Ordinance - Why is the Ordinance TRIPS PLUS?

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. (Pg 2 of the

Ordinance)

The Ordinance has limited the right of pre-grant opposition. 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. At the most a

written representation is allowed. There is no obligation under TRIPS to

change the pre-grant opposition procedure. Currently there are approximately

6000 applications for patents pending in the mailbox. In the absence of an

effective pre-grant opposition mechanism, these 6000 applications would

escape public scrutiny. Pre-grant opposition is absolutely essential for

blocking trivial patents (Pg 9 of the Ordinance).

The compulsory licence regime within the present Patents Act contains

cumbersome procedures without any time line for the final disposal of the

application. Issuing compulsory licences for various products is quite

common in the developed countries, but it has seldom been done in developing

countries like India. Therefore for the effective working of the compulsory

license mechanism, procedures provided for compulsory licensing need to be

simplified.

The Ordinance requires 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 licence granted

by the LDC. This provision only helps Multi-National Pharmaceutical

Companies who want to block generics from entering countries that

desperately need cheap drugs (Pg 16 of the Ordinance).

The people at large, as an affected party, have a right to be consulted and

heard. 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. The AMTC protests the manner in which the government is

circumventing democratic participation in passing of this law and demands

that a transparent public debate be initiated on the provisions of the

Ordinance and proposed Bill. AMTC also demands that “TRIPS-PLUS” provisions

be removed from the proposed Bill/Ordinance as vital concerns of the Indian

people i.e. their health interests should supersede the profit motives of

MNCs.

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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.

For more information contact the Affordable Medicines and Treatment Campaign

e-MAIL:<amtc_india@...>