Kerala High Court seeks expert opinion on whether patented breast cancer drug has viable substitute

The Kerala High Court on Wednesday directed four expert bodies to submit their views on whether the breast cancer drug Palbocilib, whose patent has expired, could be used as a substitute for the patented drug Ribocilib [xxx v Union of India & ors].

The issue raised by the Court will have a bearing on whether the Central government needs to invoke its power under the Patents Act, 1970, to improve access to costly medicines.

Justice Harisankar V Menon made the National Cancer Institute at Jhajjar, the Chittaranjan National Cancer Institute at Kolkata, the Regional Cancer Centre (RCC) at Thiruvananthapuram and the Drugs Controller General of India (DCGI), parties to the case and directed them to submit their opinion on whether Palbociclib can safely and effectively be interchanged with Ribociclib for treating breast cancer.

The Court observed that if Palbociclib could indeed be used to treat the condition involved in the present case, then prima facie, there may be no reason to invoke compulsory licensing provisions under Sections 92 or 100 of the Patents Act.

Section 92 empowers the central government to use compulsory licenses in circumstances, such as national emergency, extreme emergency or public, non-commercial use, enabling others to manufacture a patented product without the patent holder's permission, while Section 100 allows the central government to authorise the use of patented invention for government purposes, even without the patent holder's consent.

"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," the Court added.

Amicus curiae (friend of court) Maitreyi Sachidananda Hegde argued before the Court that patent should not stand in the way of public health.

She stated that the Act itself envisaged patented inventions to be made available to the public at reasonably affordable prices and urged the central government to exercise its powers to improve accessibility of the drug.

However, Senior Counsel G Sreekumar appearing for Eli Lilly and Senior Counsel Hemant Singh for Novartis opposed the submission by relying on the Central government's earlier stand that there was no necessity to invoke Sections 92 or 100.

They stated that the drug Palbociclib, which was another drug in the same class, that was earlier patented by Pfizer, is now off patent and available in India through multiple manufacturers at a significantly lower price.

Taking note of the submissions the Court observed that the central issue was whether the drugs could be interchangeable and sought for the opinion of the expert bodies.

The matter has been posted to August 21 for the expert opinions along with counter affidavits from the respondents.

The proceedings trace their origin to a petition filed in June 2022 by a cancer patient in need of life-saving drugs that were flagged for being exorbitantly expensive.

The petitioner had sought directions for affordable access to Ribociclib, a patent drug manufactured by Novartis, which currently costs about ₹78,468.75 per month.

The petitioner had contended that the drug remained expensive and inaccessible for many patients due to the patent protection which prevented other manufacturers from producing or selling the medicine at a lesser price without the consent of the patent holders.

In September 2022, the petitioner succumbed to her illness.

On September 16, 2022, the Court decided to continue considering the matter as a suo motu case under the title 'In Re Exorbitant Pricing of Life Saving Patented Medicines.'

Advocate Hegde, who had represented the petitioner, was appointed as amicus curiae.

Recently, a letter was addressed to the Kerala High Court Chief Justice Soumen Sen, tracing the case history and the continued delay in adjudication of the matter.

The letter was submitted by Jyotsana Singh and KM Gopakumar, co-conveners of the Working Group on Access to Medicines and Treatment, requesting the Chief Justice to take administrative steps to ensure an early and uninterrupted final hearing of the matter.

The matter then came up for hearing today.

[Live Coverage]