Major Drug Companies approach Industry Ministry and Patent Controller

[Guest guest]

Dear Forum members,

If you are interested in the issue of how HIV drugs are manufactured

and sold in India, you may find the following news item interesting.

Please note that Indian AIDS NGOs and policy makers are yet to

articulate their concerns, regarding- how patent laws would affect

access to treatment for people living with HIV/AIDS in India to the

Industry ministry and the Patent Controller of India. [Moderator]

_________________________________________

Drug majors approach industry ministry and Patent Controller for

information on EMR submissions

December 18, 2000. K G Narendranath, New Delhi

Concerned over the potential misuse of the EMR (exclusive marketing

right) provision in the Indian Patent Rules by transnational pharma

giants, leading Indian drug companies are seeking a more transparent

regime for EMR grant. The Indian Pharmaceutical Alliance, the group

of nine leading domestic pharma companies, has urged the Indian

Patent Control Office and the WTO wing in the ministry of industry &

commerce that they be given access to the details of EMR submissions

by MNCs.

The move is in the wake of reports and hearsays that many MNCs are

filing submissions that violate the conditions of Indian government

for EMR grant.

Among the EMR filings, which the IPA find objectionable, is

Kline Beecham's claim on Rosiglitazone. Further, Glaxo Wellcome,

which is on a merger path with SKB, is learnt to have filed another

objectionable EMR application with IPCO. Though the Patent Controller

is yet to grant the EMR for Rosiglitazone to SKB, the IPA has already

raised a hue and cry on its non-compliance with the conditions.

As per the EMR provision incorporated in Indian Patent Rules, a

product for which original patent was granted prior to 1995, is not

fit for an EMR in the country. Further, EMR can be granted only for

new molecules, not derivatives.

An IPA functionary told Pharmabiz.com that government appeared to be

reluctant to furnish details of the EMR submissions, although there

has not been any such confidentiality in the country about patent

applications. The information being sought includes the product name

and the name of the company, which seeks the EMR.

Out of the 35-40 new molecules being introduced in the world every

year, only 8-10 is launched in India in the same year. As EMR is

provided in India only for the intervening period before the

introduction of a full-fledged product patent system on

pharmaceutical products-- from 2003 to 2005-- the number of new drugs

that are eligible for an EMR must be 15 to 20. However, the MNCs are

violating the conditions set by the Indian government for grant of

EMR and seeking it for other products too, sources alleged.

Between the filing of patent and the commercialization of the drug,

there is usually a time lag of 10 years and in rare instances, this

is reduced to eight years.

In the case of Rosiglitazone, the original patent was granted in

1998, and subsequently SKB secured two more patents on the invention

by introducing its derivatives.

The IPA therefore is planning to contest the EMR application on

Rosiglitazone on two grounds-the original patent grant was in 1998

and the EMR is sought for a derivative.

Meanwhile, ambiguity persists in the industry circles over the

definition of EMR and its extent and scope. Patent law experts are

divided on this. The contestation is that EMR is the right only to

produce and export or produce and market and no right are granted

under it to take up promotional activities of the product.

For Indian companies however, EMR gives little opportunity. They are

hardly eligible for EMR operational from 2003 to 2005 because of that

they must have secured the original patent during 1995-'96 in a

country, which was giving product patent then. And such claims are

almost non-existent.

Source: The pharmabiz.com: Copyright © iPharma India Ltd.