Direction for the compulsory license of the lifesaving breast cancer drug “Ribociclib”

Direction for the compulsory license of the lifesaving breast cancer drug “Ribociclib”

The Department for Promotion of Industry and Internal Trade (DPIIT) has been directed by the Kerala High Court (Court) to consider the compulsory license of the lifesaving breast cancer drug “Ribociclib”.


While hearing a petition filed by a retired Bank employee (Petitioner), who got diagnosed with HER2- Negative Metastatic Breast Cancer, the Court emphasized the issue of the unaffordability of expensive treatment and medication due to which an alarming number of women are succumbing to Breast Cancer.


It was the case of the Petitioner that the Ribociclib is patented in India, therefore the manufacturers are prevented from producing the medicine without the consent of the patent holder. It was further contended by the Petitioner that since the drug is not manufactured in India, the cost of the drug is exorbitant and the monthly cost of the drug for treatments comes to INR 58,140/-. The Petitioner averred that if the drug is manufactured in India, the cost will come down substantially and will be affordable to the patients.


The Petitioner also pointed out section 92 and section 100 of the Patents Act, 1970. Section 92 empowers the Central government to issue compulsory licenses subject to three conditions; a) there must be a national emergency; b) the requirement must be extremely urgent; c) it must be for public non-commercial use. As per section 100, the government, or any person authorized by it, is empowered to use the patented invention for purposes of government.


The Ministry of Women and Child Development, being Respondent in the present petition, confirmed that the representations concerning the above-said issue made by the Petitioner before various authorities are pending before DPIIT for adequate consideration. The Court, in view thereof, has passed an interim direction directing DPIIT to take up the pending representations and pass a reasoned order after consultation with the other authorities within four weeks.


The matter is now listed for 18 July 2022 before the Court for further directions.


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