NEW DELHI : The Delhi High Court has turned down a plea for an interim injunction filed by Swiss pharmaceutical company F. Hoffmann-La Roche AG against Indian drugmaker Natco Pharma Ltd., accused of producing Risdiplam, a treatment for Spinal Muscular Atrophy (SMA), without authorization.
In a landmark decision influencing the availability of critical medicines, Justice Mini Pushkarna underscored that public health must outweigh corporate monopolies, particularly when a drug is beyond the reach of most Indian patients.
“When a life-saving drug is the sole treatment for a rare disease, affordability must be prioritized. Courts, when considering injunctions, must factor in public interest. While financial compensation can remedy patent disputes, the public cannot be compensated for denied treatment,” observed Justice Pushkarna.
Case Background
SMA is a severe genetic disorder that progressively weakens muscles, leading to physical deterioration and a high infant mortality rate. The condition affects 1 in 10,000 newborns worldwide and 1 in 7,744 births in India. Roche introduced Evrysdi (Risdiplam) in July 2021, offering new hope to patients. However, the exorbitant annual cost of ₹2.2 million to ₹7.2 million has made it unaffordable for many Indian families.
Roche’s Claims vs. Natco’s Stand
Roche alleged that Natco Pharma was preparing to commercially produce Risdiplam in violation of its Indian patent, valid until 2035. Natco, however, contested the claim, arguing that Risdiplam was already covered under Roche’s previous international patents, and accused Roche of engaging in “evergreening”—a tactic to extend patent exclusivity by filing a modified version of an existing drug.
Court’s Observations & Verdict
The Court found merit in Natco’s defense, identifying key legal concerns such as prior disclosure (Section 64(1)(e)), lack of innovation (Section 64(1)(f)), and misrepresentation (Section 64(1)(j)). It pointed out that Risdiplam was already encompassed under Roche’s previous patents in the US, Canada, and Australia.
Referring to Justice Prathiba M. Singh’s authoritative book on Patent Law, Justice Pushkarna emphasized that in cases involving essential medicines, public health takes precedence over pharmaceutical profits. The ruling also cited earlier Delhi High Court judgments that had denied injunctions on costly cancer drugs to protect patient access.
Striking a Balance: Innovation vs. Public Welfare
Acknowledging the critical nature of SMA and the absence of alternative treatments, the Court ruled that permitting Natco Pharma to manufacture Risdiplam at a reduced price would immensely benefit patients who cannot afford Roche’s imported version.
The Court concluded that rejecting the injunction would ensure broader access to treatment while still allowing Roche to seek monetary damages if its legal challenge prevails. The ruling reinforces the judiciary’s increasing commitment to balancing patent rights with urgent public health needs.