What’s the matter?
Natco Pharma has gone to the Delhi High Court to challenge the Indian Patent Office’s decision to grant Novartis a second patent for its breast cancer drug ribociclib, sold as Kisqali.
Novartis already holds a patent on this drug in India an existing patent (IN 283133) valid until May 2027. But on July 10, 2026, Novartis secured a second patent on the same drug, which would push its market exclusivity all the way to 2029.
The Delhi High Court briefly heard the matter on August 5, with the next hearing set for September 16, 2026.
Why did Natco challenge it?
Natco’s argument is simple: this is double protection for the same medicine, and Indian law doesn’t allow that.
Natco alleges that by securing a second patent on the same drug, Novartis is effectively delaying the entry of generic versions into the Indian market extending exclusivity two extra years beyond what the original patent already allowed.
This is what’s often called “evergreening” when a company patents small variations of an existing drug just to block competitors longer, without offering patients anything genuinely new.
Why is Novartis trying to extend the patent, and until when is it valid?
The motivation is straightforward: money. Every extra year of exclusivity keeps the Indian market to itself, with no generic competition to bring prices down.
Novartis’s existing, original patent on ribociclib in India is valid until May 2027. It’s the newly granted second patent the one Natco is challenging that would stretch this exclusivity to 2029 if allowed to stand.
The global and Indian breast cancer picture
This case isn’t just a legal footnote it sits against a genuinely alarming health backdrop.
Globally: Breast cancer caused an estimated 694,000 deaths worldwide in 2024 and was the most common cancer in women in 164 out of 186 countries. There were around 2.3 million new cases in women in 2022, and researchers project the burden will keep rising sharply in the coming decades.
In India: The numbers are genuinely sobering. India ranks third globally in breast cancer incidence with 192,020 cases in 2022, but actually leads the world in mortality, with 98,337 deaths that year. That gap high deaths despite lower case numbers than some countries points to late diagnosis and poor access to treatment.
This is precisely the kind of disease burden where a widely accessible, affordably priced targeted therapy could save enormous numbers of lives.
How would an affordable price actually help Indian patients and could it bring foreign patients here too?
For Indian patients:
A generic version of ribociclib, priced in line with India’s typical generic drug economics, could bring monthly costs down from lakhs of rupees to a small fraction of thatvpotentially making it viable for far more middle class families to self-pay when scheme coverage doesn’t fully apply, and easing the burden on government scheme budgets stretched across millions of patients.
For foreign patients:
India is already a major hub for cancer medical tourism. Patients from the US, UK, Africa, the Middle East, and Southeast Asia already travel to India for cancer treatment, saving 70–90% compared to Western costs and India offers a dedicated Medical Visa category specifically for patients and their attendants, designed to cut through red tape quickly.
A large part of that affordability advantage comes directly from generics:
India is a world leader in generic drug manufacturing, which alone makes cancer treatment 80–90% cheaper. If an affordable, India-made ribociclib generic becomes available here sooner, it would only strengthen this pull potentially bringing patients from lower- and middle-income countries specifically for affordable, high-quality breast cancer treatment they simply cannot access at home or in the West at $19,000-a-month pricing.
My take
This case is about more than a legal technicality. It’s about whether a patient in Nagpur or Patna gets to access a modern cancer therapy in 2027, or has to wait until 2029 or never gets it at all. India’s patent law was written specifically to prevent “evergreening,” precisely because patient lives shouldn’t be collateral in a company’s exclusivity strategy.
Government schemes are doing important work, but they can’t fully substitute for what real price competition from generics delivers at scale.
Natco’s challenge deserves to succeed, and Indian patients and potentially patients well beyond India’s borders deserve to see it through.