A recent ruling from the Kerala High Court could change how India deals with cancer drugs that are patented and priced way out of reach for most patients.
What happened?
A former bank employee, diagnosed with a type of advanced breast cancer, had been taking a drug called Ribociclib costing around ₹58,140 for just 21 days of treatment.
Unable to afford it long-term, she approached the Kerala High Court asking for the price to be lowered.
Sadly, she passed away in 2022, but the court didn’t drop the case. It continued hearing the matter as a public health issue, and even expanded it to include another similar drug, Abemaciclib.
On September 28, 2026 the court delivered its verdict: the central government can use Section 100 of the Patents Act to allow a patented medicine to be manufactured and supplied to needy patients, even without the patent holder’s permission as long as it’s done on a non-commercial basis.
What is Section 100, in simple words?
Think of it as an emergency power. Normally, a patent holder (like a pharma company) has exclusive rights to sell their drug. But Section 100 says the government can use a patented invention for “government purposes” and the court ruled that protecting public health counts as a government purpose.
So if a life-saving drug is priced too high, the government could step in and get it made for patients who need it.
How is this different from “Compulsory Licensing”?
India already has another tool called compulsory licensing where a generic company applies to manufacture a patented drug without the original company’s consent.
This has been used only once in India, in 2012, when Natco Pharma got permission to make Bayer’s cancer drug sorafenib.
The difference? Compulsory licensing needs a generic company to step forward first and often ends up in long legal battles.
Section 100, on the other hand, doesn’t depend on any company volunteering the government itself can initiate it. That makes it a potentially faster, more direct tool.
Does this mean the medicine gets cheaper right away?
No, and this is important. The court didn’t order an immediate price cut. It said the government must first collect data: how many patients need the drug, how many can’t afford it, and whether current price-control measures are even working. Only after that can the government decide whether to act.
There’s no deadline set for this data collection, and no specific ministry has been assigned the job yet. This means real change could take a long time possibly even longer than the remaining life of the drug’s patent itself.
Why does this matter so much?
Because the numbers are staggering. These medicines Ribociclib and Abemaciclib belong to a class called CDK4/6 inhibitors, used for a specific type of hormone-driven breast cancer.
A third similar drug, Palbociclib, is already off-patent and available as a generic but these two are still patent-protected, which is exactly why they remain so expensive.
And despite the high prices, the companies haven’t exactly struggled Abemaciclib alone made $19.6 billion in sales over six years, and Ribociclib made $12.7 billion, figures that experts say go well beyond what it typically costs to research and develop a new drug.
Meanwhile, patients are simply priced out. A study from Tata Memorial Hospital found that barely 1.6% of patients who actually needed immunotherapy could access it. Cost being the biggest reason.
What else can the government do?
Section 100 isn’t the only tool available. The government also has the National Pharmaceutical Pricing Authority (NPPA), which already caps trade margins on 42 cancer medicines at 30%.
Experts suggest more cancer drugs could be brought under similar price controls, especially where there’s a huge gap between what it costs to make a drug and what patients end up paying.
The bottom line
This ruling doesn’t instantly make cancer drugs affordable. But it opens a real legal door, one that didn’t clearly exist before for the government to intervene when patented medicines become too expensive for the patients who need them most.
Whether that door actually gets used depends entirely on how fast the government moves from here. For now, it’s a meaningful step, but the real test is still ahead.
Desclaimer
This article is for general information only and reflects publicly reported legal developments. Generic Hope is an independent healthcare advocacy platform and does not provide legal advice.