THE Delhi High Court has dismissed an appeal by Bayer Corporation, an MNC drug

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firm, seeking to stop the Drug Controller of India (DCGI) from granting marketing approval to Cipla to launch a generic version of a patented cancer drug.

That means a generic drug licensed to a company under the Drugs and Cosmetics Act will be allowed to be marketed in India, even if a patent for the drug is held by another firm. Generic drugs are generally cheaper than patented ones.

Bayer Corporation had made its plea on the ground of `patent linkage' that ties regulatory approval of generic medicines with their patent status.

A division bench of the high court upheld an earlier single bench judgement that any linkage would have to be introduced as a policy decision by the government. "It is not for the court to determine if the government should bring in a system of patent linkage," the bench of chief justice A P Shah and justice S Muralidhar said.

The court further said there was "considerable literature on the topic with many a developing country resisting it in the interests of public health care that is both affordable and accessible. The court cannot and ought not to dictate that policy shift."

Bayer Corporation India spokesman Aloke Pradhan said, "Bayer is disappointed and disagrees with the court's decision and will consider its legal options in this regard. Bayer HealthCare intends to defend the patent vigorously."

Cipla's joint managing director of Cipla Amar Lulla said the decision was "fair and reasonable because what is being demanded is not even within the purview of established Trade Related Intellectual Property Rights (TRIPS) provisions," adding, "I hope Bayer sees reason and does not prolong the legal battle."

Bayer had filed the writ petition in 2008 against the government, the DCGI, and Cipla, seeking an order that the drug regulator should consider the patent status of its drug, `Sorefenib tosylate', before granting a marketing approval to any generic versions of the drug. The drug is used to treat renal cancer.

Cipla had put in an application before DCGI for marketing approval of the generic version of Sorefenib called `nexavar'.

According to directorgeneral of Indian Pharmecutical Alliance D G Shaw "Bayer wanted to set a legal precedent which would require the DCGI to link regulatory approval of generic medicines with their patent status regardless of whether the patent granted is valid or not."