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Indian High Court Rejects Bayer Complaint For Patent Linkage

By Intellectual Property Watch

Indian generics manufacturer Cipla can get marketing approval for its generic cancer treatment Soranib, the Delhi High Court ruled Tuesday, and the Indian drug regulatory authority does not have to check its patent status first. The court this week rejected a complaint by drug multinational Bayer against the Union of India, the Drug Controller General of India and generic drug producer Cipla. Bayer sought a court order requiring DCGI to consider the patent status of kidney cancer drug, sorafenib tosylate (sold under the brand name Nexavar), before granting marketing approval for a generic version of the drug. At issue was whether it is legitimate to link a potential violation of IP rights to processes regulating a drug?s entry onto the market that are generally based on drug quality, efficacy and safety.

Full post as published by Intellectual Property Watch on August 21, 2009 (boomark / email).