The Kerala High Court on Monday suggested that the Central government could invoke its powers under Section 100 of the Patents Act, 1970 (Act), to improve access to heavily priced patented breast cancer medicines [In Re Exorbitant Pricing of Life Saving Patented Medicines]

Justice Harisankar V Menon, however, left the final decision on this matter to the Central government, terming it a policy decision.

"It is for the Central Government to consider whether Section 100 of the (Patents) Act requires to be invoked since ultimately the same is a policy decision," the Court said.

Section 100 allows the central government to authorise the use of patented invention for government purposes, even without the patent holder's consent. The Court observed that Section 100 could be invoked by the government to increase access to expensive medicines for needy patients, on a non-commercial basis.

"Section 100 is required to be invoked in circumstances where the Government is required to intervene, such as an instance where the medicine manufactured on the basis of a patent is being sold at an exorbitant price," the Court noted.

However, it refrained from directing the government to invoke Section 100 in the present case concerning breast cancer drugs.

Instead, it said that the government should collate the required data to examine whether a particular medicine is affordable or not and intervene only if necessary.

"It is for the Central Government to consider whether Section 100 requires to be invoked after collecting the necessary statistics ... This is especially so, since this Court is of the opinion that the required data to decide whether the particular medicines in question are affordable or not, has not been brought on record," the Court held.

The case before the Kerala High Court involved the issue of whether the Central government needs to invoke its powers under the Patent Act, 1970, to improve access to expensive patented medicines, particularly drugs used for treating breast cancer.

The proceedings revolved around Ribociclib, a patented breast cancer drug manufactured by Novartis, and Palbociclib, another breast cancer drug whose patent had expired and which is available at a significantly lower price.

The Court sought expert opinions from cancer institutions and the Drugs Controller General of India (DCGI) to find out whether Palbociclib could be used as an alternative drug to Ribociclib.

Based on the expert opinions, the Court concluded that the two could not be interchangeable, however, it did not direct the government to exercise this power in respect of the drug Ribociclib, noting that sufficient data to determine whether the medicines in questions were affordable had not been placed before it.

The Court, instead asked the government to collect the necessary data to determine whether a particular medicine is affordable and to invoke Section 100, if an intervention is found necessary not just in this particular case but also for other life-saving treatment.

The proceedings trace its 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 Maitreyi Sachidananda Hegde, who had earlier represented the petitioner, was appointed as amicus curiae (friend of court).

She argued before the Court that patent should not stand in the way of public health and stated that Palbociclib could not be treated as a substitute for patented drugs Ribociclib and Abemaciclib because of differences in their use and toxicity profiles.

The amicus thus urged before the Court that the Central Government should consider using powers available under the Patents Act to improve access to such medicines.

Novartis and Eli Lilly, which manufacture Ribociclib and Abemaciclib respectively, opposed such intervention by the government, stressing the importance of patent protection. They argued that the Patent Act already balances the rights of patent holders with public health considerations.

The Central Government, on the other hand, argued that the affordability of medicines had to be considered from the perspective of both the patients as well as the manufacturers and maintained that in the present circumstances, there was no need to invoke Sections 92 and 100 of the Patents Act.

Senior Counsel G Shrikumar instructed by advocates P Arun Kumar and Praveen Ananad appeared for Eli Lilly.

Senior counsel Joseph Kodianthara, instructed by advocates John Vithayathil and Hemant Singh, represented Novartis.

Additional Solicitor General of India (ASGI) P Sreekumar and Deputy Solicitor General of India (DSGI) OM Shalina, appeared for the central government.

Senior counsel TA Shaji appeared for Regional Cancer Centre (RCC).

Advocate KM Gopakumar represented the husband of the original petitioner and the subsequently impleaded breast cancer patient.

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