Patent linkage system and impact on access to medicines - Update on Bayer Corporation and another v Union of India and other

[Guest guest]

Bayer Corporation and another v Union of India and other

The Delhi High Court is presently hearing a petition, which could have a crucial

impact on access to generic medicines.

In November 2008, Bayer Corporation filed a Writ Petition before the Delhi High

Court against the Union of India, the Drug Controller General of India (DCGI)

and Cipla 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 the marketing approval to generic versions of

the drug, while its patent is in force. Sorefenib tosylate, the drug in

question, is a drug used to treat advanced renal cancer and liver cancer.

The system that Bayer wants the courts to implement is otherwise known as the

patent linkage system in which the drug regulatory authority, the DCGI in this

case, would refuse to grant marketing approval to a generic manufacturer to

manufacture and sell a drug if the drug is patented in the country.

The patent linkage system is against public health policy as it

will unnecessarily delay the entry of cheap generic medicines into the

market and thereby adversely affect access to generic medicines.

On 7.11.2008, the Delhi High Court granted an injunction and stopped the DCGI

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

order is passed in this matter.

In January 2009, Cancer Patients Aid Association (CPAA) filed an

intervention application to be impleaded as Respondents as the question involved

was of crucial public health concern.

The case was listed for hearing before Justice Ravindra Bhatt on 19.1.2009.

During the hearing, CPAA argued that Bayer was seeking to introduce the patent

linkage system in India despite a clear rejection of this policy by Parliament.

It argued that Bayer was attempting to link two different regulatory and legal

systems, viz. the patent system and the drug regulatory system-which have been

enacted with different objectives.

Justice Bhatt observed that this is a policy issue. He allowed the

intervention application and permitted CPAA to file its counter affidavit.

Justice Bhatt also modified the stay order and clarified that the stay would

apply only on to Sorefenib tosylate, the drug in this case, with respect to

Cipla, and would not extend to any other person.

The matter has been posted for final hearing on 18 and 19 February 2009.

Parties are to file written submissions before the date of hearing.

In Solidarity,

Lawyers Collective HIV/AIDS Unit

Delhi

E-MAIL: <aidslaw1@...>