The Kerala High Court on Wednesday sought expert opinions from four institutions on whether a cheaper off-patent breast cancer drug could be used as an alternative to a more expensive patented alternative, even as it examined whether patients could be denied access to life-saving treatment due to the high cost of patented drugs.
Justice Harisankar V Menon approached the National Cancer Institute in Jhajjar, the Regional Cancer Center 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, which is made by Pfizer and is no longer under patent protection, could be used as an alternative to Ribociclib, a more expensive patented breast cancer drug made by Novartis.
The issue of the high cost of patented drugs was first brought before the Supreme Court in 2022 by a petition filed by a breast cancer patient. However, the petitioner died while the case was pending.
During detailed arguments on Wednesday, amicus curiae counsel Maitreyi Hegde asserted that Ribociclib is too expensive and out of reach for many patients in India.
Palbocyclib under generic brands costs between $2000- $8000 for a bottle containing 21 capsules. Ribocyclib costs between $17000- $25,000 for a box containing 21 capsules.
She urged the Union Government to consider giving effect to the 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 consent of the patent holder.
Lawyers representing drug manufacturers have opposed these requests. They argued that the government, through an order issued in October 2022, had already recognized bociclib as an alternative, and noted that the drug was no longer under patent protection.
The court then observed: “In light of the above, the question is whether the second medicine – Palbociclib – is a medicine that can be used to treat the condition mentioned in this petition. If so, I am of the view that there is no requirement to refer to the provisions of Sections 92, 100 prima facie.”
The matter was sent for further hearing on August 21. The institutions were directed to submit their expert reports before the next hearing date.
