Supreme Court of India dismissed Bayer's plea for patent linkage

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SUPREME COURT OF INDIA DISMISSES BAYER’S PLEA FOR PATENT LINKAGE

1 December 2010, New Delhi.

The Supreme Court of India today dismissed the appeal filed by Bayer

Corporation and Bayer Polychem (India) Ltd. (collectively referred to asBayer)

challenging the judgment of the Delhi High Court dismissing Bayer’s attempt to

introduce the system of patent linkage in India.

The case involved an issue of larger public interest because, in effect, the

patent linkage system sought by Bayer would have delayed the entry of generic

versions of medicines in the market and therefore adversely affected access to

medicines.

As you may recall, a Division Bench of the Delhi High Court had in February 2010

dismissed Bayer’s pleas that the patent linkage system exists in India and that

the Drug Controller General of India (DCGI) should be restrained from granting

marketing approval to generic versions of its patented drug,sorafenib tosylate,

while its patent subsists.

This decision of the Delhi High Court allowed Indian generic drug manufacturer,

Cipla Ltd. (hereinafter referred to as Cipla), to move forward with the generic

version of sorafenib tosylate.

The Delhi High Court had held that the patent system was distinct

from the drug regulatory system with no linkage between them and that the Indian

law did not prevent the drug regulatory authority from granting marketing

approval to generic versions of patented drugs.

A Division Bench comprising Justice A. Alam and Justice RM Lodha today

refused to entertain the special leave petition filed by Bayer against the Delhi

High Court’s decision.

The judges took into account the fact that the Drug Controller General of India

had already granted marketing approval to Cipla and that Bayer’s suit for

infringement was pending before the Delhi High Court. During the proceedings,

the judges observed that it could not be said that the DCGI did not have the

authority to grant marketing approvals to generic versions of patented drugs.

They also observed that the ultimate relief sought by Bayer

was to prevent Cipla from marketing its generic version of Bayer’s patented

drug. They pointed out that this issue of injunction ought to be decided in the

suit for infringement under the Patents Act.

Dismissing the petition, the Supreme Court expressed hope that the Delhi High

Court would decide Bayer’s infringement suit in six months.

Effectively, today’s decision means that the ruling of the Delhi High Court that

there is no patent linkage system in India has not been set aside and is still

valid.

Note: Patent linkage is a system in which the drug regulatory authority of a

country refuses to grant or delays a marketing approval to a generic drug

manufacturer to manufacture and sell a patented drug.

Patent linkage is known to be against public health interests as it delays the

entry of cheap generic medicines into the market and keeps medicines out of

reach of those who need them.

In solidarity,

Lawyers Collective HIV/AIDS Unit, India