The Kerala High Court has directed several expert bodies to provide their insights on whether the breast cancer medication Palbociclib, an off-patent drug, could serve as a viable alternative to the patented Ribociclib. This directive came during a hearing on Wednesday in the case titled xxx v Union of India & ors. The outcome could influence whether the Indian government should employ the Patents Act, 1970, to enhance access to expensive medications.
Justice Harisankar V Menon included the National Cancer Institute in Jhajjar, Chittaranjan National Cancer Institute in Kolkata, the Regional Cancer Centre in Thiruvananthapuram, and the Drugs Controller General of India in the proceedings, requiring them to evaluate the interchangeability of Palbociclib with Ribociclib for breast cancer treatment. The Court highlighted that if Palbociclib is indeed suitable for the case at hand, there might not be a need to invoke compulsory licensing under Sections 92 or 100 of the Patents Act.
Section 92 allows the central government to issue compulsory licenses in situations like national emergencies or public, non-commercial use without the patent holder’s consent. Section 100 permits the government to authorize the use of a patented invention for public purposes.
The Court stated, “The question is as to whether 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 Sections 92 or 100, prima facie.”
Amicus curiae Maitreyi Sachidananda Hegde argued that public health should not be compromised due to patent restrictions. She emphasized that the Act aims to make patented inventions available at reasonable prices and urged the government to leverage its powers to ensure drug accessibility.
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Conversely, Senior Counsel S Sreekumar, representing Eli Lilly, and Senior Counsel Hemant Singh, representing Novartis, contended that the government’s earlier position negated the necessity to invoke Sections 92 or 100. They highlighted that Palbociclib, initially patented by Pfizer, is now off-patent and accessible in India at a much lower cost through multiple manufacturers.
Recognizing these submissions, the Court focused on the interchangeability of the drugs and requested expert opinions. The case is scheduled for further hearing on August 21, when expert assessments and counter affidavits from the respondents are expected.
This legal matter originated from a petition filed in June 2022 by a cancer patient seeking affordable access to Ribociclib, a costly drug manufactured by Novartis, priced at approximately ₹78,468.75 per month. Due to patent protections, Ribociclib remains unaffordable for many, as other manufacturers are barred from producing the drug without patent holder consent. Sadly, the petitioner passed away in September 2022.
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Subsequently, the Court decided to continue the case suo motu, under the title ‘In Re Exorbitant Pricing of Life Saving Patented Medicines.’ Advocate Hegde, who previously represented the petitioner, was appointed as amicus curiae. Recently, a letter from Jyotsana Singh and KM Gopakumar, co-conveners of the Working Group on Access to Medicines and Treatment, was addressed to Chief Justice Soumen Sen, urging expedited adjudication of the matter. Consequently, the case was heard today.
