Kerala High Court Seeks Expert Opinion On Substitutability Of Patented Breast Cancer Drugs With Cheaper Alternative

The Kerala High Court on Wednesday (July 15) sought expert opinion on whether Palbociclib, a cheaper drug that is no longer under patent and is also locally manufactured, can be used as a substitute to patented Ribociclib and Abemaciclib, for treating breast cancer.

Justice Harisankar V. Menon suo motu impleaded the National Cancer Institute (Jhajjar), Chittaranjan National Cancer Institute (Kolkata), the Regional Cancer Centre (Thiruvananthapuram) and the Drugs Controller General of India and issued notice to them.

The Court has also directed them to file their respective reports regarding the substitutability of Ribociclib with Palbociclib. The direction was issued in a suo motu petition raising the issue of exorbitant pricing of life-saving patented breast-cancer drugs.

The Court today heard detailed arguments by Amicus Curiae Advocate Maitreyi Hegde and also, the senior counsel Joseph Kodianthra, S. Sreekumar and Hemant Singh appearing for the drug manufacturing companies.

Advocate Maitreyi pointed out that Ribociclib, being manufactured by Novartis is a costly medicine, which used to cost around Rs. 58,000 in 2022 and that it costs about Rs. 75,000 now. The life-saving medicine, however, is exorbitantly priced and unaffordable by most patients in India as it is not manufactured here, she submitted.

She sought an intervention by the Central government invoking the provisions of the Patent Act, particularly Sections 83 and 92. According to her, the Central government can invoke Section 92, which provides for compulsory license. Section 83 deals with general principles applicable to working of patented inventions.

She also suggested an alternative, to invoke Section 100, which authorises the government to requisition life-saving medicines in cases of extreme necessity "for the purposes of the government". She pointed out that Section 100 has never been invoked by the government.

This was opposed by the patent-holding drug manufacturing companies. They pointed out that the government has already found no reason to invoke the afore provisions in an order passed in October, 2022. They further informed the Court that the afore order recognises a substitute, Palbociclib – originally manufactured by Pfizer - is out of patent and is being manufactured in India and available at a cheaper, affordable price.

Hearing the submissions, the Court observed:

"In view of the afore, the question is as to whether the second medicine – 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 the provisions of Sections 92, 100 prima facie."

However, the submission of the amicus was that the government recognised Palbociclib as a substitute without carrying out extensive study in the matter. She further submitted that the drugs are not interchangeable, in so far as their clinical and toxic profiles are different.

It was also stated that when generic drugs come into the market, the price of patented drugs will come down, which is not the case herein as the prices of Ribociclib increased even after the expiry of patent granted to Palbociclib.

Refuting the submission, Sr. Adv. Hemant Singh pointed out that Ribociclib as well as Palbociclib are only two different molecules used for treating the same kind of breast cancer and therefore, interchangeable.

"In view of the afore submissions, I am of the opinion that the views of the National Cancer Institute, Chittaranjan National Cancer Institute (Calcutta), the Regional Cancer Centre, Thiruvananthapuram as well as the Drug Control of India is required," the Court opined.

The case is posted for consideration next on August 21 (Friday). The afore suo motu impleaded parties are to submit their reports by then.

The petition was initiated originally in 2022 by a breast-cancer patient, who succumbed to the disease while the plea was pending.

Thereafter, the Court decided to take up the issue suo motu under the name “In Re Exorbitant Pricing of Life Saving Patented Medicines.” Advocate Maitreyi Sachidananda Hegde, the counsel who was appearing for the late petitionerm was appointed as the amicus curiae in the case. 

Recently, a letter written by the co-convenors of the Working Group on Access to Medicines and Treatment addressed to the Chief Justice of the Court had sought administrative intervention to expedite the final hearing of the case, pointing out the larger interests involved in the issue.

While hearing the petition today, Justice Harisankar orally asked if a Division Bench should be hearing the case since there are public interest elements pursuant to the order to hear it as a suo motu plea:

"Just one query, ultimately, pursuant to this order, is it not something like a public interest matter? If it is public interest, it should be considered by the DB. I have no problem in hearing the matter...This is a petition filed by an individual. The individual is no more. That was reported to the Court. The Court, even after taking note of the death of the individual, directed this matter to be kept on board as a special matter considering the special nature and renaming the cause title also."

Adv. Maitreyi however submitted that various suo motu matters are heard by Single Benches as well and the present case was posted before several benches already and pleadings are already completed. She also pointed out that whatever the decision passed by the Court, it is likely to be appealed against.

Agreeing, Justice Harisankar orally said: "Ultimately, they will go before the Division Bench and say that this was public interest matter...Somebody will be taking it up...Personally, what you submitted, I feel that that should be accepted. Ultimately, because of the pricing alone this particular individual person passed away. At that time, it was around Rs. 60,000 a month. Within 3 months' time she passed away."

Case Title: In Re Exorbitant Pricing of Life Saving Patented Medicines

Amicus curiae: Maitreyi Sachidananda Hegde

Counsel for the respondents: S. Sreekumar (Sr.), Joseph Kodianthra (Sr.), Hemant Singh (Sr.)