Healthy Skepticism Library item: 15086

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Publication type: news

Mukherjee R.
Fate of generics hinges on Bayer case
The Times of India 2009 Jan 19
http://timesofindia.indiatimes.com/Fate_of_generics_hinges_on_Bayer_case/rssarticleshow/3998349.cms

Full text:

The fate of generic pharma industry and particularly accessibility of medicines will be decided when multinational Bayer’s case

against the government comes up for hearing in the Delhi High Court on Monday.

Bayer has taken the Union government and its drug controller to court, indirectly seeking patent linkages linking regulatory approval of generic medicines with their patent status. In other words, patent linkages mean that no marketing approval is given for generic versions of medicines, which have been granted a patent in India.

This is one of rare instances an MNC suing the Indian government to introduce higher intellectual property standards, than what is required under Trips agreement (trade-related aspects of intellectual property rights), experts say.

Since the government has been made a respondent in Bayer’s petition, generic industry has asked ministry of health to defend before the court about the decision of not implementing a Trips-plus provision like patent linkages in India.

The Indian Pharmaceutical Alliance has asked the health ministry to ensure that registration of generic drugs does not get affected with their patent status.

The grounds of Bayer’s petition are that the drug controller entertained Cipla’s application for grant of marketing rights to generic version of its anti-cancer drug, ‘Nexavar’, for which it has obtained a patent in India. If marketing approval were granted, its patent rights would be affected, it says.

The case has a huge impact on accessibility of medicine and generic production in general as it may encourage patent holders to approach courts to prevent or delay marketing approval of affordable versions of patented drugs.

Bayer had earlier requested the drug controller to reject Cipla’s application, as well as grant a hearing to the company before taking any decision on the matter. But this was not done, it adds.

The court in its interim order in November directed the drug controller from taking any decision on Cipla’s application.

By seeking rejection of Cipla’s application, the MNC wants to link marketing approval to the drug’s patent status, which has potential to cause serious harm, experts say.

This is because patent linkages create barriers to the use of compulsory licenses, which are issued to generic producers if patented drugs are not available or affordable, or if countries that lack production capacity order drugs from countries like India.

Linking patent status and registration of medicines means that the drug regulatory authority is required to withhold marketing approval to a generic version of a patented drug regardless of whether the patent granted is valid or not, they added.

Moreover, public health experts point out that marketing approval for a drug is not an infringement of a patent, and the generic company can be challenged once it launches the drug, not at the stage of applying for registration.

During last year multinational pharmaceutical companies lobbied with the drug controller to reject marketing approval to generic companies on patented drugs. Any approval of generic versions of patented drugs would according to them be in violation of their patent rights and would lead to increased litigation.

Proposals to link registration of drugs with their patent status are not new and have been promoted by MNCs and their associations. Several developing countries have faced pressure to introduce patent linkages. In 2001, a group of companies took the South African government to court to prevent it from importing cheaper AIDS medicines, and more recently, Pfizer sued the Philippine government.