A recent landmark ruling by the Delhi High Court has thrown the spotlight back on the intricate and often protracted world of pharmaceutical patent litigation in India. The court allowed domestic major Dr Reddy's Laboratories to manufacture the blockbuster weight-loss drug semaglutide, patented by global giant Novo Nordisk, for export to certain markets. This decision, while specific, underscores a broader question: is India's judicial system equipped to handle such highly technical disputes efficiently?
The Semaglutide Case: A Microcosm of Patent Complexity
In May 2025, Novo Nordisk filed a patent infringement suit against Dr Reddy's and a contract manufacturer, alleging unauthorized production of semaglutide, which is under patent protection in India until March 2026. The Danish innovator sought an injunction to halt this activity.
Dr Reddy's defense hinged on challenging the validity of Novo's patent (IN'697). The company argued it lacked novelty and inventive step, as the compound was already disclosed in an earlier, now-expired genus patent (IN'964). This, they claimed, was a classic case of "evergreening" or "double patenting," a strategy used by innovators to extend market monopoly.
On December 2, 2025, Justice Manmeet Pritam Singh Arora of the Delhi High Court delivered a nuanced verdict. The court rejected Novo's plea to restrain manufacturing for export to countries where it holds no patent. It found Dr Reddy's had raised a credible challenge to the patent's validity. However, the court explicitly barred domestic sales until the patent expires, noting Dr Reddy's began production without first challenging the patent.
Why Drug Patent Cases Are Uniquely Challenging
These disputes are not merely legal but deeply scientific. The semaglutide case, for instance, revolves around the substitution of a single amino acid in the compound's chain—swapping Alanine for α-aminoisobutyric acid—which enhances stability. Dr Reddy's contended this science was known since the 1990s.
Such granular, molecule-level arguments are common. In a similar victory in October, Natco Pharma successfully challenged Roche's patent on the SMA drug Risdiplam by arguing it covered only a specific compound, not broad structural protection. Resolving these cases demands expertise not just in law, but in biology, chemistry, and commerce. Litigants and courts often rely on subject matter experts to navigate this technical maze.
The Judicial Framework: From IPAB to Specialized High Court Divisions
The institutional mechanism for handling these cases has seen significant change. In 2021, the government dissolved the Intellectual Property Appellate Board (IPAB), which was plagued by delays and resource constraints. All pending cases were transferred to various High Courts.
In response, the Delhi High Court established a dedicated Intellectual Property Division (IPD) in 2022, streamlining procedures for IP disputes. High Courts in Madras, Calcutta, and Karnataka have since followed suit, creating specialized benches. This has improved the landscape from two decades ago, with the Delhi High Court now being a primary hub for IP litigation.
Despite these advances, timelines remain a critical concern. Patent disputes can stretch for years, often outlasting the commercially crucial period of patent exclusivity itself. This delay is a significant setback for both innovators seeking to enforce rights and generic companies aiming to launch products promptly after patent expiry.
The recent rulings and the enduring complexities fuel the ongoing debate: does India need specialized courts, with judges trained specifically in IP and sciences, to expedite and deepen the adjudication of these high-stakes pharmaceutical patent wars? The evolution from the IPAB to High Court IP divisions is a step, but the question of further specialization remains pivotal for India's ambition to be both an innovation hub and the pharmacy of the world.
