Bayer's petition against the Indian government - High Court hearing today

Bayer's petition against the Indian government - High Court hearing today

In August 2009, the Delhi High Court in India had rejected the petition filed by German multinational pharmaceutical company, Bayer Corporation, seeking to stop the Drug Controller of India (DCGI) from granting marketing approval to a generic version of a patented cancer drug. The Court made clear that "Bayer's argument of inferring drug agencies' role in patent policing or enforcement is unacceptable". The decision is available here

Bayer has now filed an appeal against the decision before the division bench of the Delhi High Court. The appeal is going to be heard on 18 November 2009.

The case was first filed in 2008 by Bayer before the Delhi High Court on the grounds that the DCGI has entertained the application for granting marketing approval to a generic version of the anti-cancer drug sorafenib tosylate - for which Bayer has obtained a patent (IN215758) in India.

By filing this case against the Indian government, Bayer wanted to set a legal precedent which would require the Drug Controller of India to link regulatory approval of generic medicines with their patent status regardless of whether the patent granted is valid or not, says treatment rights activist Leena Menghaney.

She adds further that linking a drug's registration to its patent status (also known as 'patent linkage') seeks to create a new role for national drug regulatory authorities as 'enforcers' of drug patents. Normally, it is up to patent holders to ensure their patents are enforced. Patent linkage requires drug regulators to block the registration (also known as 'marketing approval') of generic versions of a drug that is under patent unless the patent holder gives consent - even if the generic has been proved to be of quality, safe and effective. Without registration a drug cannot be marketed and sold therefore, if the patent holder does not gives consent, the effect of this linkage would be to delay or even block generic competition and access to affordable drugs until the patent expires.

MSF is concerned about this court case which is yet another attempt by multinational pharmaceutical companies to use litigation to prevent competition and undermine the use of provisions in Indian law to safeguard public health.

Patent linkage will undermine the 'Bolar/Early Working' exception that allows a generic producer to manufacture the patented drug and obtain marketing authorisation in advance, so that a generic can be put on the market as soon as the patent expires.

It will have had an especially harmful effect in relation to compulsory licenses. Compulsory licenses can be issued to generic producers if patented essential drugs are not available or affordable in India, or if countries that lack production capacity order essential drugs from India. Even if India were to issue a compulsory license to overcome a patent barrier for a life-saving medicine, this provision could block or considerably delay the marketing approval of the drug rendering the compulsory license useless.

Use of such public health safeguards will become increasingly important, as the effect of the introduction of stricter patent rules for medicines required under the TRIPS Agreement is felt in India.

In a similar attempt to force the Philippines to adopt patent linkage, U.S. multinational pharmaceutical company, Pfizer Ltd. In March 2006 sued the government-owned company Philippine International Trading Corporation (PITC), the Bureau of Food and Drugs (BFAD) and two BFAD officials in their personal capacity.? PITC had begun the process of registering the affordable versions of amlodipine besylate with the BFAD by submitting imported samples from India so it could obtain marketing approval (registration) and then promptly enter the market when Pfizer's Philippines patent on amlodipine besylate expired in June 2007.? The drug used to treat high blood pressure was considerably cheaper in India.

For more information contact: Leena Menghaney
Phones: +91 11 46573731, +91 11 46573730

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