The Indian pharmaceutical landscape is witnessing a surge in high-stakes legal confrontations. Domestic generic drug manufacturers are increasingly locking horns with global innovator companies in patent courts, reigniting a crucial debate. This clash centers on balancing the protection of innovation with the imperative of making essential medicines accessible and affordable for millions.
The Core of the Conflict: Patents vs. Generics
When a global drug company invents a new medication or a novel method of producing it, it typically secures a patent. This intellectual property (IP) right grants the innovator an exclusive monopoly to market the drug for a period, usually 20 years. During this time, the drug is often priced high, allowing the company to recoup its massive research and development investments.
Indian pharmaceutical firms, which are the world's leading producers of generic medicines, operate on a different model. Generics are bioequivalent copies of branded drugs. To launch a generic version, companies must either wait for the original patent to expire or legally challenge the validity of that patent in court. These disputes can stretch for years and seldom reach a full trial.
Indian courts have adopted a nuanced stance. They rigorously examine drug patents to prevent "evergreening"—a practice where innovators make minor, incremental changes to a drug (like a new formulation or salt) to extend their patent monopoly beyond the legitimate term. This principle was famously established in the landmark 2013 Supreme Court ruling against Novartis AG for its cancer drug Glivec. The court rejected the patent application, stating it did not demonstrate enhanced therapeutic efficacy.
Why Indian Companies Enter the Legal Fray
The motivations for Indian drugmakers to challenge patents are multifaceted. First, it offers a significant competitive edge. If a company successfully reverse-engineers a drug and wins a patent challenge, it can enter the market years before the patent's natural expiry. This allows it to capture market share by offering the drug at a substantially lower price, undercutting the innovator.
Secondly, these battles are often framed around public interest and accessibility. A prime example is the case involving Natco Pharma and Roche over Risdiplam, a treatment for spinal muscular atrophy (SMA). Natco argued against patent evergreening, and the Delhi High Court permitted the launch of a generic version, citing the public's need for an affordable life-saving drug. Natco subsequently priced its version at ₹15,900 per bottle, a dramatic reduction from Roche's price of over ₹6 lakh.
While earlier disputes focused on critical areas like cancer, cardiac, and rare-disease drugs, the battleground is expanding. In 2025, three Indian majors—Natco, Dr Reddy’s, and Sun Pharma—initiated patent challenges against Danish giant Novo Nordisk for its blockbuster weight-loss and type 2 diabetes drug, semaglutide (sold as Ozempic). This marks a strategic shift towards lucrative lifestyle medication markets.
High Risks and Even Higher Rewards
Pursuing patent litigation is not for the faint-hearted. The costs, especially in markets like the United States, are enormous. A case can drag on until the patent expires, negating any first-mover advantage. Domestically, a failed challenge can result in the generic company having to pay damages to the innovator.
However, the potential payoff is colossal. A victory can unlock exclusive, early access to multi-billion dollar markets. Indian firms have successfully employed this strategy abroad. In 2022, companies including Dr Reddy’s, Natco, and Cipla began selling the blood cancer drug Revlimid in the US in limited quantities after settlements with the innovator. This early entry significantly boosted their revenues ahead of the patent's full expiry.
In the ongoing semaglutide case, both Dr Reddy’s and Sun Pharma have received permission from the Delhi High Court to manufacture and export the drug to countries where Novo Nordisk lacks patent protection. This grants them a valuable early-mover advantage in the global weight-loss drug market, with the key patent set to expire in March 2026.
The Evolving Landscape and Consumer Impact
The ultimate beneficiary of a successful patent challenge is often the end consumer. Lower-priced generic versions dramatically increase accessibility to essential treatments. The Risdiplam case is a textbook example of how legal action can bring down drug costs by over 95%.
The trend of patent challenges is intensifying. With stronger balance sheets, Indian companies are now more willing to take on complex, high-risk litigation. Furthermore, price erosion in key markets like the US is pushing them to seek higher-margin opportunities, including challenging hard-to-break patents and investing in in-house innovation.
The legal process itself is becoming more streamlined. Following the dissolution of the under-resourced Intellectual Property Appellate Board (IPAB) in 2021, several high courts—including those in Delhi, Madras, Calcutta, and Karnataka—have established dedicated Intellectual Property Divisions (IPDs). These specialized benches are expected to handle patent cases more efficiently, reducing delays.
As Indian pharmaceutical giants grow in confidence and capability, the patent wars against global innovators are poised to continue. These battles will remain a critical mechanism for shaping a pharmaceutical ecosystem that strives to reconcile rewarding genuine innovation with the fundamental goal of affordable healthcare for all.
