New Delhi: Switzerland-based multinational Novartis and US-based Eli Lilly and Company have vehemently opposed any move to issue compulsory licences that would allow generic versions of their critical breast cancer drugs to be made available. The companies have told the Kerala High Court that sales of their drugs are high despite their prices, seen as prohibitive in India.
The pharmaceutical giants were responding to a writ petition in the Kerala High Court opposing compulsory licensing for their HER2-negative breast cancer drugs under the Indian Patent Act, 1970 — a move that could allow generic drug makers to introduce competition and lower the cost of the drugs. ThePrint has seen the affidavits, filed in court last month.
Novartis’s drug Ribociclib is marketed under the brand name Kryxana in India and costs nearly Rs 70,000 a month. Eli Lilly and Company makes a drug called Abemaciclib, which costs Rs 95,000 a month.
HER2-negative breast cancer is a type of cancer in which the cancerous cells do not contain high levels of the protein HER2. It’s seen in nearly 45 percent of all breast cancers categorised as “invasive”.
The pharmaceutical giants’ responses came on the back of notices that were issued to them in March. The petition was initially filed by a now-deceased breast cancer patient who sought judicial intervention to bring down the cost of Ribociclib.
After being diagnosed with Luminal A breast cancer — a very aggressive form of HER2-negative breast cancer — in July 2021, the petitioner, Saroja Radhakrishnan, had asked the court to direct the government to issue a compulsory licence for producing a generic version of the drug.
The petitioner had died a few months after filing the petition but the high court eventually took it up suo motu and also began inquiring into other patented drugs to treat HER2 negative breast cancers — such as Eli Lilly and Company’s Abemaciclib and American multinational Pfizer’s Palbociclib.
Palbociclib went off-patent in January this year, lifting restrictions and giving several drug makers the opportunity to launch their own generic version of the drug. These are now available for as little as Rs 4,000 a month.
All three drugs belong to a class of medicines called CDK 4/6 inhibitors — a class of medicines used to treat certain types of HER2-negative breast cancer.
Responding to a query by ThePrint, Novartis said that it remains committed to improving patient outcomes by providing quality innovative medicines such as Ribociclib.
“At this point, we are unable to provide any further comment since the matter is sub judice,” its spokesperson told ThePrint by email.
Likewise, a spokesperson for Eli Lilly and Company also told ThePrint that it couldn’t comment on the issue because it was a subject of ongoing litigation.
The development comes three months after Mumbai-based pharma major Glenmark announced it was slashing the price of Trumab, its version of Trastuzumab, a drug used in the treatment of HER2-positive breast cancer. The decision meant that Trumab’s cost was slashed to Rs 15,749 per 440 mg vial from Rs 54,000 — making it the most affordable brand of the drug in India.
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‘Need to enforce patents and encourage innovation’
In its affidavit in the high court, Novartis argued that Ribociclib was priced at Rs 23,625 for 21 tablets — among the “lowest in the world”.
Insisting that there’s no undersupply of the drug in India, the Swiss pharma company argued that in the healthcare segment, the public interest element “is not a one-way street”.
“While there is public interest in enabling access to generic versions of existing pharmaceutical products at lower prices, there is also a public interest element involved in enforcing patents and encouraging innovation leading to the creation of future pharmaceutical products,” it said. “Thus, there is the need to balance both these interests.”
Eli Lilly and Company’s arguments were also on similar lines. It said that “incentivising and protecting the invention of the patentee is of paramount importance to encourage innovation as it ultimately addresses the interest of the public”.
In India, a compulsory licence has been issued only once — in 2012 for Bayer’s Sorafenib Tosylate to treat late-stage lung cancer. This brought down the cost of the drug steeply, from Rs 4,13,000 a month to Rs 8,800.
‘Growing sale of drugs in India’
During a hearing in the breast cancer drugs case in December 2022, the Union health ministry had told the Kerala High Court that while there is an unmet medical need related to breast cancer drugs in India, it does not qualify as a “national or extreme emergency”.
But figures from Indian Council of Medical Research’s National Cancer Registry Programme show that nearly 2,00,000 breast cancer cases are detected in India every year, meaning that one in 22 women get it. Its high mortality — with one out of the two afflicted women dying — also means that it’s one of the leading causes of cancer deaths among women in India.
Breast cancer is divided into three subtypes, depending on whether the tumour is driven through the estrogen receptor (ER+), the HER2 negative receptor or neither (triple negative).
Ribociclib and Pablociclib are prescribed for late stage or metastatic HER2 negative breast cancer, while Abemaciclib can be for both early and late stages.
In its affidavit, Noravtis said that its sales figure for Ribociclib stood at Rs 12.7 crore with a volume of 8,000 units in 2018 — the year the drug was first launched in India.
Sales have only gone up since, according to the affidavit: Rs 37.18 crore with a volume of 24,859 units in 2019, Rs 48.15 crore in 2020 with a volume of 33,191 units, Rs 59.90 crore with a volume of 39,968 units in 2021 and Rs 83.67 crore with a volume of 53,061 units in 2022.
“Based on the sales, it is estimated that approximately 267 nos. of patients in 2018, 829 nos. of patients in 2019, 1,106 nos, of patients in 2020, 1,332 nos. of patient in 2021 and 1,769 nos. of patients in 2022 were benefiting from Ribociclib in India,” it said, adding that the petitioner’s argument that the demand for Ribociclib is not being fulfilled owing to public non-commercial use “is completely flawed”.
Eli Lilly and Company also made similar arguments. In its affidavit, the company said that in 2020-21, it had imported Rs 4.3 crore worth of Abemaciclib — a drug first approved for use in 2019. This figure rose to nearly five times within the first year, according to the affidavit — in 2021-22, the company imported Rs 21.3 crore worth of the drug.
The company also added that there was no shortage of the crucial medicine in the country.
Chaitali Rao, a legal researcher at Third World Network — an international non-profit that works on issues relating to development, developing countries and North-South affairs, — pointed out that Novartis said in its affidavit that it serves 24 percent of the patients who use CDK 4/ 6 inhibitors for breast cancers.
“So, by its own admission, Novartis means that 24 percent of patients are not benefitting from generic Palbociclib,” she said. “Also, Eli Lilly has admitted that it’s the only drug for early stage HER2 negative breast cancer. So, the disease can be prevented from advancing if a higher number of patients get it at a cheaper price.”
The lack of a generic alternative for Ribociclib and Abemaciclib would lead to “great disparity”, she said. “This is because they cannot do anything to get a lower-priced generic (drug) as oncology is a prescription-based market.”
(Edited by Uttara Ramaswamy)
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