The Kerala High Court on Wednesday sought expert opinions from four institutions on whether a cheaper off-patent breast cancer drug can be used as a substitute for a costlier patented alternative, even as it examined whether patients can be denied access to life-saving treatment because of the high cost of patented medicines.
Event Context
Justice Harisankar V Menon impleaded the National Cancer Institute at Jhajjar, the Regional Cancer Centre in Thiruvananthapuram, the Drugs Controller General of India (DCGI) and the Chittaranjan National Cancer Institute in Kolkata in a suo motu petition. The court asked them to examine whether Palbociclib, manufactured by Pfizer and no longer under patent protection, can be used as an alternative to Ribociclib, a more expensive patented breast cancer drug manufactured by Novartis.
The issue of the high cost of patented medicines first came before the high court in 2022 through a petition filed by a breast cancer patient. The petitioner, however, died while the matter was pending.
During detailed arguments on Wednesday, amicus curiae advocate Maitreyi Hegde submitted that Ribociclib is prohibitively expensive and beyond the reach of many patients in India.
Palbocyclib under generic brands cost between ₹2000- ₹8000 for a bottle of 21 capsules. Ribocyclib costs between ₹17000- ₹25000 for a box of 21 capsules.
The matter has been posted for further hearing on August 21. The institutions have been directed to submit their expert reports before the next date of hearing.
Team Analysis
She urged the Union government to consider invoking provisions of the Patents Act, including Section 92, which provides for compulsory licensing, and Section 100, which allows the government to use a patented invention for public purposes without the patent holder’s consent.
The submissions were opposed by counsel appearing for the drug manufacturers. They argued that the government, through an order issued in October 2022, had already recognised Palbociclib as a substitute and pointed out that the drug is no longer under patent protection.
The court then observed: “In view of the afore, the question is as to whether the second medicine – Palbociclib – is a medicine which can be used for treating the situation noticed in this writ petition. If that be the case, I am of the opinion that there is no requirement for making reference to the provisions of sections 92, 100 prima facie.”
