Delhi HC denies stay against Natco Pharma, potentially paving way for affordable generic drug

SMA

The Delhi High Court has denied an injunction request from Swiss pharma major La Hoffman Roche on March 25, in an alleged patent infringement case against Natco Pharma, potentially opening the door for access to a generic of the patented drug Risdiplam at a fraction of the marketed cost.

An injunction is an order issued by a court, to a party, requiring them to either perform or abstain from a specific act.

Roche had moved the court seeking interim injunction for restraining the infringement of the Suit Patent No. IN 334397, arguing that it has a term of 20 years from May 2015 till May 2035. It said there has been no pre-grant or post-grant opposition, or any revocation proceedings filed against the suit patent in India.

Roche counsel argued that the plaintiffs have voluntarily provided a heavy price reduction and

discounts to the Government of India for the cause of patients of SMA - a genetic condition - in India.

Seba PA and Purva Mittal, two young women battling SMA, had intervened in the case to highlight the urgent need for the court to consider their right to life in the matter, as well as the significant negative impact an injunction could have on access to the drug Risdiplam, given the price disparity between patented drug and its anticipated, low-cost generic.

SMA is a genetic condition that causes muscle weakness and atrophy, due to damage to nerve cells in the spinal cord, leading to difficulty with basic functions like walking, breathing, and swallowing.

Roche, through its Patient Support Program (PSP) is offering Evrysdi (Risdiplam), for Rs 72 lakh annually for the first two years and Rs 56 lakhs annually for the third year. Patients and their families are demanding immediate action to ensure that scientific advancements and life-saving medications for rare diseases become accessible to all.

Since early 2021, courts have been addressing petitions related to SMA, advocating for local production and generic competition to address the high cost of treatments driven by patent monopolies.

One of the patients and the petitioner, Seba said, "I believe that the court's decision will provide relief to SMA patients in our country. I welcome this decision and urge Natco Pharma to supply the generic drug without delay, at a price accessible to patients."

“While effective therapies such as Risdiplam have been proven to save lives and improve quality of life, their prohibitive costs have kept them out of reach for many patients. We hope this judgement will pave the way for affordable access for SMA patients," Purva Mittal, who has been living with SMA, said.

While the Indian government has increased funding for rare disease patients under the National Policy for Rare Diseases, providing up to Rs 50 lakh per patient, this amount remains insufficient due to Roche’s exorbitant monopoly pricing, creating significant barriers to continued therapy, as the government is unwilling to raise the funding limit.

For Seba’s treatment, the Center of Excellence (CoE) for rare disease treatment procured 24 bottles of

Risdiplam at Rs 2,03,840 per bottle. With an annual requirement of 30 bottles, the total yearly cost

of her treatment reaches Rs. 61,15,200—far exceeding the Rs 50 lakh limit. As a result, her drug supply ended on 15 February 2025, causing a dangerous interruption in treatment and leaving her in fear of hospitalization.

Seba’s lawyer, Anand Grover, welcomed the Delhi High Court’s ruling, emphasizing that it will

prevent many unnecessary SMA-related deaths. He added that in pharmaceutical patent enforcement cases, public health considerations must take precedence. Rajeswari Hariharan, who appeared for Purva Mittal, hailed the judgement and said that the reasoning of the court will go a long way in facilitating affordable access to medicines for rare diseases.

Evidence shows that generic competition can lower drug prices significantly. Risdiplam, being a small molecule drug, is less complex to manufacture, making affordable generic production and supply immediately feasible.