Managing Intellectual Property

Controversy over drugs patent linkage in India

01 February 2009

Managing Intellectual Property

Two disputes before the Delhi High Court have raised the issue of patent linkage between the India Patent Office and the Office of the Drug Controller General of India

Peter Ollier, Hong Kong

Two patent disputes before the Delhi High Court have raised the issue of patent linkage between the India Patent Office and the Office of the Drug Controller General of India (DCGI)

The disputes threaten to require the Drug Controller to consider whether generic drugs infringe patents before it issues marketing approval.

In one case, which had its first hearing on January 19, German pharmaceutical company Bayer sued Indian generic Cipla for patent infringement over the drug sorafenib. Sorafenib, which is marketed under the brand name Nexavar, is used in treating kidney and liver cancer. Crucially, Bayer also named the government of India in the suit saying that the DCGI should not grant marketing approval for a patented medicine.

The Delhi High Court made an order in November asking the DCGI not to grant approval for Cipla's version of the drug before the case had been heard...



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