[Ip-health] Supreme Court of India dismissed Bayer's plea for patent linkage

prathibha siva prathibha.siva at gmail.com
Wed Dec 1 01:21:42 PST 2010


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 as
Bayer) 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

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