Managing Intellectual Property

Indian court provokes storm over drugs patent linkage (full version)

19 January 2009

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 was argued today, German pharmaceutical company Bayer has 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 in court. Argument in that case began today.

In the other case, on December 18, the Delhi High Court granted an interim injunction to US drugs company Bristol-Myers Squibb that prevents Indian generic company Hetero Drugs from making,...



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