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2 Feb 2010

High Court of Delhi

[PDF] Bayer Corporation & Another vs. Union of India & Others

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In the writ petition the appellants Bayer Corporation and Bayer Polychem (India) Ltd...sought directions inter alia to restrain the Drug Controller General of India (DCGI), respondent No. 2 herein, from granting a drug licence to Cipla Ltd...to manufacture, sell and distribute its drug “sorafenib tosylate”, prescribed for the treatment of advanced renal cell carcinoma...It would be stretching the language of Section 17B (b) DCA to an impermissible limit to hold that all generic versions of patented drugs, for which marketing approval is sought from the DCGI in terms of the DCA, should be considered to be "spurious‟ drugs...by accepting Bayer‟s contention that every generic drug would be a spurious drug, this court would be subjecting manufacturers of generic versions of patented drugs to prosecution under the DCA although the Patents Act does not provide for such a consequence. This is yet another reason why the attempt at bringing in patent linkage on the basis of the existing provisions of the Patents Act and the DCA cannot be countenanced...The appeal is accordingly dismissed.