By Jyotsna Singh & KM Gopakumar

On October 9, the Delhi High Court delivered a landmark judgment that could redefine access to life-saving medicines in India. In rejecting Swiss pharmaceutical giant Roche’s appeal against Natco Pharma, the court upheld the right of people living with spinal muscular atrophy (SMA) to affordable treatment. Roche had sought an interim injunction against Natco, claiming the generic version of Risdiplam infringes Roche’s patent.

The company argued that allowing a local producer to sell it would result in irreparable damage during the pendency of its patent infringement suit. The Supreme Court upheld the high court’s order, denying Roche’s appeal to block Natco’s generic version.

Earlier in March, a single-judge bench of the Delhi High Court had rejected Roche’s plea for interim injunction, finding that the validity of the patent is questionable. Roche immediately appealed against that court order—and lost again. The division bench largely agreed with the single-judge bench. It appreciated the credible challenge on the validity of Roche’s patent and found merit in the argument that the patent failed to qualify as an invention, while rejecting the appeal.

As India’s laws don’t allow patents on mere tweaks to existing knowledge, the patent itself was an attempt to extend a monopoly. If allowed, Roche’s patent would expire in May 2035. The rejection of Roche’s claim has meant a new lease of life for SMA patients, who are mostly children. The rare genetic disease leads to degeneration of motor neurons, causing progressive muscle weakness. Children lose the ability to walk, sit, or move on their own.

They find it difficult to even breathe due to weak respiratory muscles. The slightest cold can be a cause for alarm, and families lacking resources are forced to watch children die. Many patients die young, while those who reach adulthood are often severely disabled, and dependent on others to even drink water as they cannot hold a glass.

Risdiplam, though not a cure, halts the progression of the disease. If taken early, it allows patients to live relatively normal lives. But in the most vulgar display of greed, Roche made it almost impossible to access. On October 9, the Delhi High Court delivered a landmark judgment that could redefine access to life-saving medicines in India. In rejecting Swiss pharmaceutical giant Roche’s appeal against Natco Pharma, the court upheld the right of people living with spinal muscular atrophy (SMA) to affordable treatment.

Roche had sought an interim injunction against Natco, claiming the generic version of Risdiplam infringes Roche’s patent. The company argued that allowing a local producer to sell it would result in irreparable damage during the pendency of its patent infringement suit. The Supreme Court upheld the high court’s order, denying Roche’s appeal to block Natco’s generic version.

Earlier in March, a single-judge bench of the Delhi High Court had rejected Roche’s plea for interim injunction, finding that the validity of the patent is questionable.

Roche immediately appealed against that court order—and lost again. The division bench largely agreed with the single-judge bench. It appreciated the credible challenge on the validity of Roche’s patent and found merit in the argument that the patent failed to qualify as an invention, while rejecting the appeal. As India’s laws don’t allow patents on mere tweaks to existing knowledge, the patent itself was an attempt to extend a monopoly. If allowed, Roche’s patent would expire in May 2035.

The rejection of Roche’s claim has meant a new lease of life for SMA patients, who are mostly children. The rare genetic disease leads to degeneration of motor neurons, causing progressive muscle weakness. Children lose the ability to walk, sit, or move on their own. They find it difficult to even breathe due to weak respiratory muscles. The slightest cold can be a cause for alarm, and families lacking resources are forced to watch children die.

Many patients die young, while those who reach adulthood are often severely disabled, and dependent on others to even drink water as they cannot hold a glass. Risdiplam, though not a cure, halts the progression of the disease. If taken early, it allows patients to live relatively normal lives.

But in the most vulgar display of greed, Roche made it almost impossible to access. It priced the medicine at 6.2 lakh per bottle of 30 tablets. At this rate, it costs nearly72 lakh per year per patient. Melissa Barber, a health economist at Yale University, has estimated the cost of production. Her analysis shows that one year of Risdiplam costs 3,024 per patient per year, which includes a 20% markup. That’s 0.04% of Roche’s price (or 2,380 times3,024).

This is not a case of recovering research costs or maintaining quality; it is pure profiteering. The pricing makes the drug inaccessible even to upper-middle-class families, let alone the vast majority of Indian patients.
Natco announced that it will sell the medicine for 15,900 per bottle—a 97% reduction in price. The impact is clear when measured against the Indian government’s National Policy for Rare Diseases, which provides50 lakh per patient annually. Under Roche’s monopoly pricing, that fund barely covered eight bottles—less than one year’s supply. On the other hand, at Natco’s price, it can now cover 315 bottles for the same amount.

Depending on the age and weight, patients need one to three bottles per month. At reduced price, Rs 50 lakh can cover nine-24 years of supply per patient. Without the patent barrier, other companies can also enter the market and competition may further bring down the price. However, since rare diseases cannot achieve economy of scale, a centralised procurement system can reduce the cost drastically and facilitate supply. The government should ensure such procurement and provide Risdiplam to all patients who need it free of cost.

We can also expect more detection of cases with reduced medicine prices. Doctors are reluctant to diagnose patients who can’t afford treatment. This will now change as more SMA patients will be able to access treatment due to more diagnosis.
This episode shows that mistakes in granting patents can have far-reaching consequences, leading to unnecessary litigation and denial of treatment. The high court judgments show that Roche was granted the patent wrongfully. Roche’s monopoly has cost a lot of lives.

Therefore, the Indian Patent Office should take utmost care while granting patents. The Risdiplam case shines a light on a deeper systemic problem: the growing imbalance between intellectual property protection and public health needs. The patent system was originally designed as a social contract—companies would get temporary exclusivity in exchange for genuine innovation that benefits the public. In return, they were expected to make their inventions available at fair prices. That bargain has been broken. Today, pharmaceutical giants routinely use patent laws as weapons to stifle competition and prolong monopolies. The result is a distorted market where the right to health becomes secondary to profit margins, as seen in this case.

Ultimately, this judgment is not just about one medicine or one company. It is about what kind of society we want—one that values monopoly profits, or one that ensures no one dies because they cannot afford the price of survival.

This is not a case of recovering research costs or maintaining quality; it is pure profiteering. The pricing makes the drug inaccessible even to upper-middle-class families, let alone the vast majority of Indian patients. Natco announced that it will sell the medicine for 15,900 per bottle—a 97% reduction in price. The impact is clear when measured against the Indian government’s National Policy for Rare Diseases, which provides Rs 50 lakh per patient annually. Under Roche’s monopoly pricing, that fund barely covered eight bottles—less than one year’s supply. On the other hand, at Natco’s price, it can now cover 315 bottles for the same amount.

Depending on the age and weight, patients need one to three bottles per month. At reduced price, Rs 50 lakh can cover nine-24 years of supply per patient. Without the patent barrier, other companies can also enter the market and competition may further bring down the price. However, since rare diseases cannot achieve economy of scale, a centralised procurement system can reduce the cost drastically and facilitate supply. The government should ensure such procurement and provide Risdiplam to all patients who need it free of cost.

We can also expect more detection of cases with reduced medicine prices. Doctors are reluctant to diagnose patients who can’t afford treatment. This will now change as more SMA patients will be able to access treatment due to more diagnosis.
This episode shows that mistakes in granting patents can have far-reaching consequences, leading to unnecessary litigation and denial of treatment. The high court judgments show that Roche was granted the patent wrongfully. Roche’s monopoly has cost a lot of lives.

Therefore, the Indian Patent Office should take utmost care while granting patents. The Risdiplam case shines a light on a deeper systemic problem: the growing imbalance between intellectual property protection and public health needs. The patent system was originally designed as a social contract—companies would get temporary exclusivity in exchange for genuine innovation that benefits the public.

In return, they were expected to make their inventions available at fair prices. That bargain has been broken. Today, pharmaceutical giants routinely use patent laws as weapons to stifle competition and prolong monopolies. The result is a distorted market where the right to health becomes secondary to profit margins, as seen in this case. Ultimately, this judgment is not just about one medicine or one company. It is about what kind of society we want—one that values monopoly profits, or one that ensures no one dies because they cannot afford the price of survival.

Jyotsna Singh & KM Gopakumar are respectively health journalist and legal researcher on IP and trade issues; both are co-conveners, Working Group on Access to Medicines and Treatment

Disclaimer: Views expressed are personal and do not reflect the official position or policy of FinancialExpress.com. Reproducing this content without permission is prohibited.