Kerala HC directs Health Ministry, DoP to reply on unaffordability of patented cancer drug Ribociclib

The case concerned a petitioner diagnosed with HER2- Negative Metastatic Breast Cancer who was undergoing 'targeted therapy' treatment. The monthly cost of the medicines for treatment worked out to Rs. 63,480/. However, the petitioner was receiving a monthly pension of Rs. 28000/ only, and, eventually succumbed to her illness.

The most pricey medicine in the treatment Ribociclib, alone costed Rs 58,140/- per month. Ribociclib is presently not manufactured in India and enjoys patent monopoly and their manufactures are hence prevented from producing the medicine without the consent of the patent holder.

The petitioner had submitted that "if the medicine is manufactured in India, the cost will come down substantially and will be affordable to persons like the petitioner". She had referred to Section 92 of the Patents Act, 1970 which provides for compulsory license and Section 100 which empowers the Government to requisition life saving medicines in cases of extreme necessity.

Pointing out these aspects and requiring immediate action, the petitioner had submitted representation before various authorities, and consequently received an acknowledgment from the Secretary of Ministry of Women and Child Development informing that her representation was placed before the the Department for Promotion of Industry and Internal Trade (DPIIT).

As an interim measure the petitioner had sought a direction to the DPIIT to consider her representation and take reasoned decision thereon without further delay.

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In light of the death of the petitioner who had espoused this cause having not been able to afford the Ribociclib drug for treatment of her breast cancer, on September 16, 2022, the Court had taken suo motu cognizance of the issue of unaffordability of patented life-saving medicines.

Advocate Maitreyi Sachidananda Hegde was appointed the amicus curiae, and the petitioner's name was substituted as "In Re Exorbitant Pricing of Life Saving Patented Medicines" on directions given by the court.

The amicus curiae, submitted that the authority to take decision under Section 92 or Section 100 of the Patent Act ought to be of the Joint Secretary level as the Assistant Patent Officer could not decide whether the issue falls within the government realm or not.

The Amicus also argued that the legal question which has been raised could be decided by the Court.

It was further submitted by the Amicus that the counter Affidavit that had been submitted by DPIIT and Patent Department suffered from certain drawbacks for not addressing whether reasonable discretion had indeed been exercised in the instant case or not.

Meanwhile, the counsel appearing on behalf of the Department for Promotion of Industry and Internal Trade (DPIIT) and the Controller General of Patents, Patent Department, Standing Counsel T.C. Krishna submitted that the situation to invoke Sections 92 and 100 for compulsory license of the patented drug as sought for in the plea, was not prevalent as of present.

The counsel further sought how far the court could interfere in this case, since the plea had sought that the drug be made available at a reasonable price. He questioned whether the Court could suggest what a 'reasonable price' would be to the government.

In response to a question, advocate Rahul Bajaj, who represents an intervenor, clarified to the Court that cancer was not part of the list of the notifiable diseases list issued by the Central Government.

Arguing further, the Counsel for the respondents submitted that the government has to take the decision in this regard, before the Patent Department could go ahead with compulsory licensing or any other such measure.

Advocate Bajaj pointed out that the right to health in Indian and International spectrum includes within its ambit the right to life-saving medicines, as well. Hence, the counsel submitted that the issue could not merely be looked into from a policy lens alone, but that it is a rights-based issue in itself.

Noting that the matter had to be taken up at the higher level, Justice V.G. Arun warned that if the counter is not filed within the given time, the court would be constrained to proceed with the case based on the "uncontroverted averments in the writ".

The case has been posted for the next hearing on November 2, 2022, reports Live Law.