0.0 Context

0.0.1 The Delhi High Court delivered a verdict that may allow early entry of a cheaper biosimilar version of Nivolumab.
0.0.2 The ruling is significant because the drug is widely used in cancer treatment but remains unaffordable for most Indian patients.
0.0.3 The case highlights the tension between patent protection and public interest in access to life-saving medicines.

0.1 What Is the Drug

0.1.1 Nivolumab is a monoclonal antibody used in cancer treatment.
0.1.2 It works by enhancing the body’s immune response against cancer cells.
0.1.3 It belongs to the class of immunotherapy drugs, distinct from chemotherapy.

0.2 Therapeutic Importance

0.2.1 Proven effective against a range of cancers, especially lung cancer.
0.2.2 Improves survival outcomes and quality of life for patients.
0.2.3 Used after surgery, in advanced-stage cancer, or along with chemo-radiotherapy.

0.3 Patent Holder and Market Control

0.3.1 The drug is patented in India by Bristol Myers Squibb (BMS).
0.3.2 The Indian patent was granted in 2020 and expires in May 2026.
0.3.3 The drug is sold as Opdivo globally and Opdyta in India.

0.4 Affordability Challenge

0.4.1 Monthly treatment cost ranges between ₹2.5–3 lakh, depending on dosage.
0.4.2 Immunotherapy drugs are not covered under PMJAY, limiting public access.
0.4.3 Most patients rely on out-of-pocket expenditure, making treatment inaccessible.

0.5 Dosage and Administration

0.5.1 Administered through intravenous infusion.
0.5.2 Standard adult dosage is 240 mg every two weeks or 480 mg every four weeks.

0.6 Entry of Biosimilars

0.6.1 Zydus Lifesciences developed a biosimilar version of Nivolumab.
0.6.2 Biosimilars are highly similar biological drugs but significantly cheaper.
0.6.3 Zydus claimed its version would be around 70% cheaper than the original.

0.7 Legal Dispute

0.7.1 BMS challenged Zydus, alleging patent infringement.
0.7.2 A single-judge bench initially barred Zydus from launching the drug.
0.7.3 Zydus appealed, citing public interest and imminent patent expiry.

0.8 Delhi High Court Verdict

0.8.1 A division bench overturned the injunction against Zydus.
0.8.2 The court prioritised public health considerations over short remaining patent life.
0.8.3 The judgment noted that the patent was due to expire in about four months.

0.9 Impact on Drug Pricing

0.9.1 Biosimilar entry can reduce treatment cost to one-third or one-fourth.
0.9.2 Zydus estimated annual treatment cost at ₹3.86–6.46 lakh.
0.9.3 This can substantially expand access to cancer immunotherapy.

0.10 Broader Implications

0.10.1 Reinforces judicial role in balancing IPR and right to health.
0.10.2 Encourages domestic pharmaceutical innovation in biosimilars.
0.10.3 Sets a precedent for prioritising patient affordability in life-saving drugs.