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| HC rejects Bayer's patent plea on cancer drug |
| BS Reporter / New Delhi Feb 10, 2010, 00:30 IST |
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A bench of the High Court here today dismissed an appeal by Bayer, the German pharmaceutical company, on an earlier decision to allow marketing of generic versions of its patented drug.
The earlier decision came last year by a single judge of the same HC, Ravindra Bhat. He had rejected Bayer’s plea to prevent the Drugs Controller General of India (DCGI) from giving marketing approval to generic versions of its patent-protected cancer drug, sorefenib tosylate.
Bayer sought a patent linkage system, where the drug controller refuses to grant or delays marketing approval to a generic manufacturer to make or sell a drug which is patented.
The two-judge bench of Chief Justice A P Shah and S Muralidhar said it found no ground “to reverse the well reasoned judgment” of Justice Bhat.
On introducing patent linkage in India, the court said it couldn’t read into the statute a provision that plainly does not exist.
“The scheme of both the Patents Act and the Drugs and Cosmetics Act are distinct and separate and … the attempt by … Bayer to establish a linkage cannot be countenanced. Whether patent linkage should be introduced is an issue that requires a policy decision to be taken by the government. It is not for the court to determine if the government should bring in a system of patent linkage.”
Y K Sapru, chairperson of the Cancer Patients Aid Association, who had intervened in the case, said he was “glad that the court has rejected Bayer’s attempt to introduce a policy change, which would have adverse consequences for access to medicines”.
Bayer had argued that patent linkage was in-built in Indian law, and that granting marketing approval to generic versions of patented drugs would infringe the patent holder’s rights.
The company also wanted the generic versions of patented drugs to be classified as “spurious drugs” under the Drugs and Cosmetics Act, 1940.
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