Generic drugs not ipso facto spurious: High Court

Upholding the decision of a Single Judge, the Delhi High disposing off an intra-court appeal recently declared that generic drugs by themselves cannot be declared as 'spurious' for the reason that they violate the patent of another medicine. The matter was argued by former Union Law Minister and Senior Advocate Mr. Shanti Bhushan representing Bayer Corporation seeking directions to the Drug Controller General of India for declaring that Cipla's drug 'Soranib' (which was a generic version of Bayer's 'sorafenibtosylate') was spurious in terms of recently amended Drugs and Cosmetics Act, 1940.

The High Court dismissed the challenge, inter alia holding as under;

35. ... Cipla rightly states that it will use its own brand name and label and therefore there is no question of manufacturing a drug under a name which belongs to another drug. Further, the terms 'imitation' and 'substitute' occurring in Section 17 B (b) DCA should be read in conjunction with the other words “in a manner likely to deceive”. This envisages a situation where a generic manufacturer is passing off its drug as that of the patent holder by way of deception. Cipla states that it is not trying to pass off its drug as that of the appellant. 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.

36. There is another aspect of the matter that requires to be adverted to. The manufacture or marketing of spurious drugs under the DCA attracts penal consequences whereas the Patents Act itself does not envisage penal consequences in the event of an infringement of a patent. Therefore, 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. 

Have a look at the decision.