Novartis, Eli Lilly get court notices in case related to breast cancer drugs

(Image via pallaviaiyar.substack.com/)

The Kerala High Court has issued notices to two multinational drugmakers in a case related to the availability of generic versions of crucial breast cancer drugs.

The notices to Swiss pharma maker Novartis and US-based Eli Lilly & Company were issued in a case filed by a now-deceased breast cancer patient, who sought judicial intervention to ask the government to help lower the cost of an anti-breast cancer drug.

After being diagnosed with HER2 negative, or Luminal A breast cancer, in July 2021, the petitioner, a retired bank employee, asked the court to direct the government to issue a compulsory licence for producing a generic version of Ribociclib, a drug developed and marketed by Novartis.

The petitioner passed away a few months after filing the case but considering the importance of the matter, the high court registered a suo motu writ petition.

A Novartis spokesperson, responding to a query by Moneycontrol, said the company has faith in the Indian Judicial system and is committed to protecting the patent rights of Ribociclib.

“At this point in time, we are unable to provide any comment since the writ petition is sub judice,” the spokesperson said. “Novartis remains committed to improving patient outcomes by providing quality innovative medicines such as Ribociclib.”

Eli Lilly, which makes another anti-breast cancer drug, had not replied to Moneycontrol’s query at the time of publishing this story.

Compulsory licence

Under Section 100 of the Patent Act, the government can issue a compulsory licence on a patented drug, but this provision has been utilised only once. In 2012, when a generic drugmaker was allowed to produce Bayer’s Sorafenib Tosylate, a drug for late-stage lung cancer. The move brought the cost of the drug down to Rs 8,800 from $5,000 or Rs 4,10,000.

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Currently, three drugs are available in India for the treatment of late-stage HER2-negative or Luminal A cancer, which is considered one of the most aggressive forms of breast cancer. These are Ribociclib by Novartis, Abemaciclib by Eli Lilly, and Palbociclib by Pfizer.

The patent on Palbociclib expired in January and at least one drugmaker in India has launched its generic version, while others are expected to follow, lowering the price by 90-95 percent per month.

The other two drugs, costing Rs 58,000-95,000 per month, are still under patent and remain prohibitively expensive.

Those advocating a patent waiver on these drugs cite the sales data of these companies to say that there is huge unmet demand for these medicines. Even though there are thousands of breast cancer patients who require this medicine, the high prices of the drugs prevent access, they said. Many of those who buy the drugs do so under extreme financial stress.

The cost of cancer treatment has been a hotly debated topic, with several parliamentarians demanding government intervention to cut the prices of life-saving medicines.

The 139th Report of the Rajya Sabha’s Departmental Standing Committee on Health titled, “Cancer Care Plan and Management: Prevention, Diagnosis, Research and Affordability of Cancer Treatment,” said that about 40 percent of cancer hospitalisation cases were financed mainly through borrowings, sale of assets, and contributions from friends and relatives.

Considering such a glaring gap in the affordability of quality cancer care, the committee said there may be a strong need to make cancer care inexpensive through interventions by both the government and private sector companies.