Kerala High Court| Consider compulsory licensing of breast cancer drug Ribociclib; HC directs Central Government

Kerala High Court

Kerala High Court: While adjudicating a petition filed by a breast cancer patient seeking to afford life-saving medicines which otherwise cost more than twice her monthly income, V. G. Arun, J. directed Central Government to consider compulsory licensing of the breast cancer drug “Ribociclib”.

The petitioner, a retired Bank employee receiving a monthly pension of Rs. 28000, was diagnosed with HER2- Negative Metastatic Breast Cancer.

The petitioner submitted that she is undergoing ‘targeted therapy’ treatment and the monthly cost of the medicines for treatment works out to Rs. 63,480 of which the costliest medicine is Ribociclib, which alone costs Rs. 58,140 per month.

Ribociclib is not manufactured in India and according to the petitioner, if the medicine is manufactured in India, the cost will come down substantially and will be affordable to persons like the petitioner. Although, Ribociclib presently enjoys a patent monopoly, and its manufacturers are hence prevented from producing the medicine without the consent of the patent holder.

Referring to Section 92 of the Patents Act, 1970 which provides for a compulsory licence, and Section 100 which empowers the Government to requisition life-saving medicines in cases of extreme necessity, the petitioner had approached various authorities with a representation to make the life-saving drug available at affordable price.

Though the petitioner had received an acknowledgement from the Union Ministry of Women and Child Development, her representation is still pending before the Department for Promotion of Industry and Internal Trade, New Delhi (Respondent-3). Therefore, as an interim measure, the petitioner had approached the Court seeking directions to the Industry and Internal Trade Department to consider her representation and take a reasoned decision without further delay.

The Court noted that as per the available statistics, an alarming number of women succumb to breast cancer by reason of their inability to afford expensive treatment and medication. Referring to the Constitutional mandate, the Court stated that the right to life guaranteed under the Constitution, coupled with the State’s duty to improve public health, calls for emergent and effective action in the matter.

Considering the seriousness of the matter, the Court directed Department for Promotion of Industry and Internal Trade (‘R-3′) to consider the petitioner’s representation and pass a reasoned order within four weeks after consultation with the other authorities.

The matter is posted on 18-07-2022 for further hearing.

[X v. Union of India, 2022 SCC OnLine Ker 3361, decided on 14-06-2022]


Advocates who appeared in this case :

Maitreyi Sachidananda Hegde, Advocate, for the Petitioner.


*Kamini Sharma, Editorial Assistant has reported this brief.

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