A division bench of the Delhi High Court has ordered Natco Pharma to maintain status quo on the launch of its generic version of Risdiplam, an oral treatment for spinal muscular atrophy (SMA), until the next hearing on April 2. The ruling temporarily reverses an earlier decision that had allowed the Indian generic manufacturer to proceed with its plans.
The court's decision comes in response to an appeal filed by Swiss multinational F. Hoffmann-La Roche AG against a single judge order that had previously refused to grant an injunction against Natco Pharma.
Patent Dispute Background
Roche holds a registered "species patent" for Risdiplam, the active pharmaceutical ingredient in its commercial product marketed globally under the brand name Evrysdi. The patent is valid until May 2035, and Roche had sought an interim injunction to prevent Natco from manufacturing the compound in India.
In the original ruling on March 24, Justice Mini Pushkarna had rejected Roche's petition, stating that Natco Pharma "has prima facie raised a credible challenge to the validity of the suit patent." The single judge had also considered submissions from SMA patients that Roche's approved drug was not available at an affordable price, concluding that "public interest would outweigh the need for grant of injunction."
Significant Price Differential
The pricing disparity between the branded and generic versions represents a central issue in the case. According to sources, Roche imports and sells Evrysdi at a maximum retail price of approximately Rs 6 lakh per bottle containing 750 microgram/mL of Risdiplam in India. Natco claims it can manufacture the drug locally and make it available at a price that is 80-90% lower than Roche's offering.
Roche has defended its pricing strategy, stating that since launching Evrysdi in India in 2021, the company has been "actively collaborating with local authorities to implement tailored pricing" and supports patients through assistance programs to make the medication more affordable.
"We are also supporting patients through our patient assistance program which makes Evrysdi more affordable. Our commitment to patients in India began well before it was commercially available," a Roche Pharma India spokesperson said.
Patient Advocacy in the Legal Battle
Two SMA patients, Seba PA and Purva Mittal, had intervened in the case to highlight the urgent need for the court to consider their right to life, as well as the significant negative impact an injunction could have on access to Risdiplam, given the substantial price difference between the patented drug and its anticipated low-cost generic alternative.
SMA is a rare genetic disease 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. Risdiplam is indicated for patients two months of age or older.
Roche's Compassionate Use Program
Roche has emphasized its commitment to patient access, noting that in 2020, before Evrysdi was commercially available in India, the company initiated a Compassionate Use Program (CUP) for SMA patients. According to Roche, 52 patients across India are receiving the medication free of cost through this program, and over 270 SMA patients in India have benefited from Evrysdi since its launch.
Court-Mandated Financial Transparency
While the original ruling had allowed Natco to proceed with its launch plans, it included several conditions to protect Roche's interests. The court had directed Natco to file its list of assets, along with market values, within four weeks. Additionally, the generic manufacturer was ordered to maintain complete accounts of the manufacture, sale, and supply of its products, and file quarterly statements of accounts supported by affidavits, as well as annual statements of sales authenticated by its auditor.
The division bench led by Justice Hari Shankar will hear the case on April 2, at which point a decision will be made regarding whether Natco can proceed with manufacturing and selling its generic version of Risdiplam in India.
This case highlights the ongoing tension between intellectual property protection for pharmaceutical innovations and the public health imperative to ensure affordable access to life-saving medications, particularly for rare diseases where treatment options are limited.
