Delhi High Court Rejects Bayer's Plea for Patent Linkage

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Delhi High Court Rejects Bayer’s Plea for Patent Linkage

The Delhi

High Court today rejected an attempt by Bayer Corporation, a multinational

pharmaceutical company, to sanction the patent linkage system in India through a

court direction. While holding that unpatented (generic) drugs are not spurious

drugs, Justice Ravindra Bhat held that this petition was an attempt to tweak

public policy. While dismissing the petition, the Court also held that this is

a vexatious and luxury litigation which should discouraged and imposed cost of

approximately Rupees 6 lakhs to be paid by Bayer Corporation to

Respondents—Union of India and the Cipla Ltd.

Patent

linkage is a system in which the Drug Controller refuses to grant or delay a

marketing approval to a generic drug manufacturer to manufacture and sell a

drug if the drug is already patented. Patent linkage is known to be against

public health interests as it will delay the entry of cheap, generic medicines

into the market and keep medicines out of reach of those who need them.

Bayer Corporation had filed a

Writ Petition before the Delhi High Court against Union of India, the Drug

Controller General of India

and Cipla Ltd. seeking an order that the DCGI should consider the patent status

of its drug, Sorefenib Tosylate, before granting a marketing approval to any

generic pharmaceutical company and refuse marketing approval to any generic

company. Sorefenib Tosylate is used to treat kidney cancer and is sold by Bayer

at Rs. 2, 85,000 (Rupees two lakh eighty five thousand) for 120 tablets

for a month dosage.

On 7.11.2008,

the Delhi High Court had granted an interim injunction to Bayer stopping the

DCGI from granting marketing approval to the generic company (Cipla) until a

final order is passed in this matter.

CPAA had filed an intervention

application to be added as a party, which was allowed by the Delhi High Court.

It was pointed out by CPAA that due to the stay in this case, the DCGI is not

accepting the applications for marketing approval from any generic companies on

any drug. The Court had then clarified that the stay would operate only

with respect to the drug in question in the matter, i.e. Sorefenib Tosylate

CPAA had urged that the

introduction of patent linkages in India would have adverse public

health consequences. India

does not recognise a patent linkage system. The patent system and the drug

regulatory system are two separate and independent mechanisms, which are

regulated by two separate laws. It had argued that despite the fact that the

Legislature has kept the patent and regulatory systems separate, Bayer is

attempting to link the two independent and separate systems and introduce a

policy change through the Court. It was also pointed out that the litigation was an

attempt to introduce a TRIPS-plus requirement in India.

If introduced, the patent linkage

system would have seriously impacted the early entry of generic drugs into the

market. Such early entry of generic drugs is possible either through

mechanisms such as compulsory licensing within the Patents Act itself, or where

there is a bona fide belief that a patent has been wrongly granted. This is

especially important as India

is now witnessing an increase in the number of patents being granted to drugs

by the Indian patent office.

The judgement will be made available on our website, www.lawyerscollective.org, as soon

as we obtain a copy.

In Solidarity,

Lawyers Collective HIV/AIDS Unit