When the Delhi High Court cleared the way for Zydus Lifesciences to launch a biosimilar version of Nivolumab, one of the world’s most expensive and widely used cancer immunotherapy drugs, it reopened an old,
unresolved question — how far should the law go in protecting pharmaceutical innovation when millions of patients are priced out of life-saving treatment?
“We are therefore unable to satisfy ourselves that, on this material, the learned single judge was justified in entirely injuncting the appellant from releasing its product in the market,” the court observed. The court noted Nivolumab is a life-saving cancer drug and that the patent is nearing expiry. It held that the balance of convenience lay in permitting the biosimilar’s sale for the remaining patent term, while safeguarding the patentee’s interests.
By allowing Zydus to enter the market months before the original patent expires, the court signalled that public interest could not be placed on hold while corporate litigation plays out. For patients, doctors and policymakers, the decision marks a moment that could reshape how cancer care is accessed, funded and regulated in India.
Is This A Breakthrough Immunotherapy?
At the centre of the case is Nivolumab, a breakthrough immunotherapy drug sold globally as Opdivo. It has transformed outcomes for several cancers, including lung cancer, melanoma and kidney cancer, by enabling the immune system to attack tumours more effectively.
In India, however, the promise of immunotherapy has largely remained confined to those who can afford it. A single course of treatment can cost several lakh rupees per month, often running into tens of lakhs over the course of therapy. For many families, that price tag is catastrophic.
The Delhi High Court’s decision to permit Zydus Lifesciences to manufacture and sell a biosimilar version of Nivolumab before patent expiry effectively brings that reality into sharp legal focus. The court acknowledged that delaying access until every legal challenge is resolved would impose an unacceptable cost on patients who cannot afford to wait.
Understanding India’s Cancer Divide
Few cities reflect India’s healthcare inequality as starkly as Delhi. The capital hosts some of the country’s most advanced oncology centres, attracting patients from Uttar Pradesh, Bihar, Rajasthan, Haryana and beyond. It is also a city where public hospitals struggle with capacity while private cancer care remains prohibitively expensive for most.
In practice, this has created a two-tier cancer system. Patients with insurance or personal wealth may access immunotherapy early. Others rely on older, more toxic treatments or abandon care altogether. Oncologists in Delhi routinely face the ethical dilemma of knowing that a superior drug exists but is financially out of reach for the patient sitting in front of them.
The Zydus ruling holds the potential to narrow this gap. If a biosimilar enters the market at a significantly lower price, it could shift treatment decisions not just in elite private hospitals but also in government facilities and charitable cancer centres across the city.
Public Interest Versus Patent Protection
Legally, the case pits Zydus against Bristol-Myers Squibb, the multinational company that developed Nivolumab. But in substance, the dispute goes far beyond two corporate entities.
The dispute arose from a patent infringement suit filed by ER Squibb and Sons LLC and other Bristol Myers Squibb group entities, holders of Indian Patent No. IN 340060, which covers the monoclonal antibody Nivolumab, marketed globally as Opdivo, and in India as Opdyta. Bristol Myers Squibb alleged that Zydus Lifesciences’ proposed product ZRC-3276 infringed its patent and sought a quia timet injunction to restrain its manufacture and sale even before commercial launch.
In July 2024, the SEC’s CDSCO recommended that Zydus’ Nivolumab be granted permission to manufacture and market the drug.
A division bench of Justices C Hari Shankar and Justice Om Prakash Shukla on Monday held that “where the product in question is a life-saving drug, the Court has to err in favour of public interest… Withholding such therapy from the public can cause untold and irreparable prejudice to lakhs of lives, and it is, therefore, only where the Court is in possession of irrefutable material to indicate that a patented product is being released in the market without permission of the patentee… that an injunction can issue.”
India’s Patent Law A Tussle Between Innovation And Public Health
This tension was famously tested in the Supreme Court’s 2013 decision in Novartis v. Union of India, which denied patent protection to a modified cancer drug on the grounds that it did not meet India’s strict standards for innovation.
The Supreme Court’s landmark ruling denied Novartis a patent for a modified, beta-crystalline form of its anti-cancer drug Glivec (imatinib mesylate), upholding Section 3(d) of India’s Patent Act, which prevents patents on new forms of known substances unless they show significantly enhanced therapeutic efficacy, protecting public health and access to affordable generics. The SC found Novartis’s modification lacked the required breakthrough therapeutic benefit over the original imatinib, rejecting claims of enhanced bioavailability as insufficient.
The Delhi High Court’s approach follows a similar logic. While it did not strike down the patent outright, it made clear that public interest considerations carry significant weight when access to essential medicines is at stake. The court’s reasoning suggests that patent rights, though important, are not absolute, particularly when delay could cost lives.
Why The Timing Of The Ruling Matters
One of the most closely watched aspects of the decision is its timing. Allowing a biosimilar to enter the market before patent expiry is unusual and controversial. Pharmaceutical companies argue that such moves undermine the incentives needed to invest billions in research and development.
The court, however, took a different view. It recognised that the remaining patent term was short and that continued exclusivity would prolong high prices without serving a proportionate innovation benefit. In effect, the court asked whether enforcing exclusivity for a few more months justified keeping a critical drug beyond the reach of most patients.
For patient advocates, this reasoning marks a significant shift. It suggests that courts may increasingly scrutinise not just the legality of patents, but their real-world impact on healthcare access.
What This Means For Cancer Treatment Costs
While final pricing details will only emerge once Zydus launches its biosimilar, industry estimates suggest a substantial reduction compared to the originator drug. Even a 30 to 40% price cut could translate into savings of several lakh rupees over a typical course of treatment.
In Delhi’s public hospitals, where budgets are stretched and immunotherapy use is tightly rationed, such reductions could expand eligibility criteria. More patients might be offered advanced treatment earlier, rather than as a last resort.
For private hospitals, lower prices could also alter insurance coverage dynamics. Insurers that currently limit or exclude immunotherapy might revisit those policies if costs fall, potentially widening access for middle-class patients.
What Is Pharma Industry’s Innovation Anxiety?
The pharmaceutical industry’s concerns are not without substance. Developing a biologic drug like Nivolumab requires enormous investment, long clinical trials and high failure rates. Companies argue that weakening patent enforcement risks discouraging future breakthroughs.
This anxiety is particularly acute in cancer research, where innovation often comes with high upfront costs and uncertain returns. Multi-national firms worry that if India becomes too permissive, it could set precedents that ripple across other emerging markets.
The Delhi HC ruling, however, does not abolish patents or endorse blanket early entry. Instead, it underscores that courts may intervene selectively, especially when drugs address serious diseases and affect large patient populations. The challenge now is whether a stable, predictable framework can emerge that reassures innovators while safeguarding access.
A Legal Signal Beyond One Drug
Legal experts see the Zydus decision as a signal rather than a revolution. It does not automatically open the floodgates for biosimilars to bypass patents. But it does suggest that courts are willing to engage more deeply with public health evidence when adjudicating such disputes.
Future cases involving expensive cancer therapies, rare disease drugs or gene-based treatments may increasingly reference this ruling. The question will be whether courts consistently apply similar standards or treat each case as a unique balance of facts.
For Delhi’s legal ecosystem, where public interest litigation and healthcare policy often intersect, this sets the stage for more active judicial involvement in access-to-medicine debates.
What It Could Mean For Government Health Spending
If biosimilar prices drop significantly, the impact on public health budgets could be substantial. Delhi’s government hospitals, which currently rely on a mix of state funding and central schemes, may be able to treat more patients within the same budget envelope.
This could also influence national programmes such as Ayushman Bharat, where cost-effectiveness determines which therapies are included. Cheaper immunotherapy options might make their way into publicly funded treatment protocols, altering cancer care pathways across the country.
In a system where out-of-pocket spending remains high, even incremental changes in drug pricing can have outsized effects on household financial stability.
How It Will Impact Patients
Ultimately, the significance of the Delhi High Court’s ruling lies not in legal doctrine but in lived experience. For patients facing a cancer diagnosis, time is not an abstract concept. Delayed access can mean disease progression, diminished survival odds and irreversible financial distress.
By foregrounding public interest, the court acknowledged a reality that oncologists and families have long articulated: access delayed is often access denied. The ruling brings the law closer to the clinic, where decisions are measured not in legal timelines but in months of life.
As biosimilars move from the courtroom to the pharmacy shelf, the real verdict will be delivered not by judges, but by patients who can finally afford a chance at treatment.
/images/ppid_a911dc6a-image-176829522849361073.webp)
